Winning Grants 3031275152, 9783031275159

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AAPS Introductions in the Pharmaceutical Sciences

Sean Ekins

Winning Grants

AAPS Introductions in the Pharmaceutical Sciences Volume 17 Founding Editor Robin Zavod, Chicago College of Pharmacy Midwestern University Downers Grove, IL, USA Series Editor Claudio Salomon, National University of Rosario Rosario, Argentina

The AAPS Introductions in the Pharmaceutical Sciences book series is designed to support pharmaceutical scientists at the point of knowledge transition. Springer and the American Association of Pharmaceutical Scientists (AAPS) have partnered again to produce a second series that juxtaposes the AAPS Advances in the Pharmaceutical Sciences series. Whether shifting between positions, business models, research project objectives, or at a crossroad in professional development, scientists need to retool to meet the needs of the new scientific challenges ahead of them. These educational pivot points require the learner to develop new vocabulary in order to effectively communicate across disciplines, appreciate historical evolution within the knowledge area with the aim of appreciating the current limitations and potential for growth, learn new skills and evaluation metrics so that project planning and subsequent evolution are evidence-based, as well as to simply “dust the rust off” content learned in previous educational or employment settings, or utilized during former scientific explorations. The Introductions book series will meet these needs and serve as a quick and easy-to-digest resource for contemporary science.

Sean Ekins

Winning Grants

Sean Ekins Collaborations Pharmaceuticals Inc. Raleigh, NC, USA

ISSN 2522-834X     ISSN 2522-8358 (electronic) AAPS Introductions in the Pharmaceutical Sciences ISBN 978-3-031-27515-9    ISBN 978-3-031-27516-6 (eBook) https://doi.org/10.1007/978-3-031-27516-6 © American Association of Pharmaceutical Scientists 2023 Jointly published with American Association of Pharmaceutical Scientists This work is subject to copyright. All rights are solely and exclusively licensed by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publishers, the authors, and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publishers nor the authors or the editors give a warranty, expressed or implied, with respect to the material contained herein or for any errors or omissions that may have been made. The publishers remain neutral with regard to jurisdictional claims in published maps and institutional affiliations. This Springer imprint is published by the registered company Springer Nature Switzerland AG The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland

But it is pretty to see what money will do. (Samuel Pepys)

For Maggie, Penelope and Enzo

Preface

Like 99.99% of you reading this book, I will be the first to admit that I am not a ‘professional grant writer’ and I would hesitate to call myself a writer either. Having won grants for other people’s companies as a scientist/employee and for companies that I have co-founded or founded myself, I have seen first-hand the impact that such grants can bring in hiring people, developing technologies (whether software, molecules or in making other discoveries), building companies and enabling the creation of intellectual property. To echo Samuel Pepys’s quote on the previous page, it is pretty to see what money will do. I have also served on many study sections tasked with reviewing various types of grants, from NIH grants through to foundation grants. This process maintains the confidentiality of the material under review but is also insightful for the reviewers to experience and see at close quarters the expectations of your peers and what it takes to score them well. Without sharing any confidential information, I can now share my insights from the many grants I have submitted and from the perspective of completing the components of the complete write-review-win cycle. For many readers, winning grants will also be important for your career, team, company, state and country. I would also say that it is your patriotic duty (but that may be going a bit far) as our nation competes with every other country around the globe to develop the next breakthrough products, whether they are devices, drugs, software or beyond. So, you will need to know how to write and submit grants repeatedly because you will likely have this weight on your shoulders at least metaphorically for the rest of your working career. I also have a unique perspective as I have also experienced grant failure or rejection, however you want to describe it; at times it seems never ending. Sometimes you will miss funding by a literal point on the score and more often by a mile as you have complete disasters. Sometimes you can predict the response, otherwise you will be taken by complete surprise (preferably in a good way). Admittedly failure is an important part of grant writing and winning grants, as you will learn from this, so you need to prepare, grit your teeth, read the reviews and try again. If you are very lucky, you may only have a 100% record for the first grant and after that it is downhill from there. Based on my own experience, having persistence will pay off, xi

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Preface

and if you do it long enough, you will consistently win more grants. You will likely also experience both grant ‘famine’ and grant ‘feast’ periods. Just like there are swings in employment and the stock market, there will also be shifts in grant funding, changes in funding priorities that may directly or indirectly impact you and your probability of success. It is almost inevitable that as an academic or a small business owner, you will need to write grants at some point in your career. Writing them though is not enough, what you also need to know is how to win grants. While there has been much that has been written about writing grants, the mysterious special ability called ‘grantsmanship’ or perhaps more correctly ‘grantspersonship’, it occurred to me that there is a need to come at this differently and spill the beans. As I said I am not a great writer (as you will see), but I have mostly learnt from my writing mistakes (so please send me feedback), so that I can try to craft a story in each grant proposal that I write. The difficulty in winning a major grant, in particular a National Institutes of Health (NIH) grant like an R01, in the USA is often described, it is increasingly competitive and seemingly gets tougher every year. But there are other types of grants that are worth trying for which may have an increased probability of funding. Your proposal must also stand out, it must connect with the reviewers in a positive way and make an impression. This is certainly true for all types of grants, always give the reviewer what they want or are looking for to maximise your score. But also, you may need to connect to the program officer, the committee that ultimately makes funding decisions and you must take care of a myriad of other details outside of the main event which is describing the ‘science’. In some cases, you may also need to literally negotiate to get your grant over the line and funded. Thinking of it as a battle may not be too far away as a comparator as there is elements of strategy that come in. This means you absolutely cannot solely rely on just outwriting the competition. It is more than that as you have to out-think, out-strategise and outschmoose them as well. If you have been continually funded for decades, you likely will not need this book and I congratulate you on your terrific success, but if you want to keep being funded, there is no guarantee that the skills and research that got you there will keep you in your position. What was a hot technology 4-5 years ago when you won the grant is not the new thing anymore, you will need to do something different, but what? You therefore need to not only think about continually writing great grants, you need to put it into practice and win them. Having written and won grants from the NIH and DOD over the past 18 years (and longer by the time you read this), I can speak with some degree of authority and yet I feel I am still in ‘grant learning mode’. Without being over-confident, I can say that I have absolutely no idea when I submit a grant whether it will be funded. Like you I am still hoping for a bit of luck. But I can be prepared, do my best and make sure that I comply with all the requirements. Each grant and study section will be different even with agencies like the NIH. Whether a big or small grant, it does not seem to make a difference as the reviewers will critique your efforts, they may not like it, they may reject your ideas or they may love it. Perhaps their responses are somewhere in this sliding scale. You only have some small degree of control on the grant until the proposal leaves your hands or more correctly you click ‘submit’

Preface

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as it is electronic. You will also need to think of ways to differentiate your grant from the hundreds of others being submitted, but you cannot change who you are, your history, so how you describe yourself and your team participating in the proposal will also have an impact. Similarly, where you work, your facilities and collaborators or lack of will also influence the reviewers. You could therefore spend hundreds of hours on writing your grant proposal or just a day and the outcome might still be the same. Believe me as I have virtually done this experiment as you will see. This small book is a summary of my own adventures and personal experiences of grant writing and overall preparation and will hopefully provide some advice that will help you learn how to do a better job of winning grants yourself. At the very least by getting all of this out in the open, I can feel some degree of being able to help a few others in this quest for the seemingly grant winning perfection. But first I should answer the question you are going to ask. Why am I writing this? This book initially came about after what can only be described as a dry grant spell (a famine) during 2020-2021. It was one of those moments where you think perhaps you have completely lost your touch; in this case I must thank the COVID-19 pandemic and the vagaries of the US government deciding to massively fund research on this virus to what seemed like almost near exclusion of everything else. It was at this low point when my wife Dr. Maggie Hupcey who is the COO of our company suggested this idea. ‘You could always write a book on writing grants’. Then as luck would have it, a notice of award came in soon after just in the nick of time to ‘keep the company lights on’ and I realized we should start this idea afresh and at the same time try to help others to realize their potential through winning grants. I could either spend my time and work on writing a few more grants or I could write this book. I then drafted an outline in the space of a week and what followed has been the most incredible grant “feast” with several more grants awarded. Naturally this put a halt to writing while we dealt with bringing in multiple grants back-to-back alongside hiring staff in the most difficult hiring environment for years! The 9 months since writing the first draft have also enabled me to decrease my grant writing for the first time since starting the company. That also made me realize that this book was only going to happen if I could get a publisher interested and that would provide the incentive. So here we are, finally, you get to hear about my over >27 years of experience in pharmaceutical industry and for most of them I have been writing grants. Over the last few years, I have been immensely fortunate to work with several other terrific scientists in my small grant-funded company that have also helped write and win some of the grants (and hopefully learnt something from this process) while ultimately performing the work we proposed with collaborators. I would like to thank my colleagues Dr. Ana Puhl, Dr. Thomas Lane, Dr. Fabio Urbina, Dr. Patricia Vignaux, and former colleague Ms. Kimberley Zorn for all their help writing and winning these grants over the past 7 years. To those collaborators on grants, Dr. Vadim Makarov, Dr. Stephen Wright, Dr. Nathan Cherrington, Dr. Jonathan Cooper, Dr. Miriam Braunstein, Dr. Anthony Hickey, Dr. Seth Kullman, collaborators at Battelle, Dr. Jair de Siqueira Neto, Dr. Joel Freundlich, Dr. Craig McElroy and the many collaborators that have not been funded (yet), a very big

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Preface

thank you too. Also, I would like to thank the many scientists and others that have provided letters of support that may also have helped in winning grants. Many other scientists and friends have assisted us get to this point and provided encouragement along the way, including Ms. Andrea Barry (who was our willing I-Corps business consultant), Dr. Antony Williams, Dr. Joshua Pierce, Dr. Robert Reynolds, Dr. Nancy Connell, Dr. Ethan Perlstein, Dr. Aaron McMurtray, Dr. Christopher Southan, Mrs. Sharon King and Mr. James Wikel. Finally, a big thank you to Maggie, our family and our parents for their support and allowing me the opportunity and space to write grants at the most inconvenient times. Without the considerable funding from NIH, DOD, DTRA, NC Dept of Commerce and the many program officers, I would not have written this; I cannot thank them enough for supporting my companies work and in some ways this book indirectly. Fuquay Varina, Raleigh, NC, USA  Sean Ekins December 2021 and November 2022

Contents

1

Why You Need This Book������������������������������������������������������������������������    1

2

What You Need to Do Before You Write a Grant����������������������������������    5

3

The Idea����������������������������������������������������������������������������������������������������   15

4

Go Solo or Collaborate?��������������������������������������������������������������������������   19

5

What the Entrepreneur Needs to Know������������������������������������������������   23

6

The Grant Package����������������������������������������������������������������������������������   27 Cover Letter ��������������������������������������������������������������������������������������������    28 Narrative��������������������������������������������������������������������������������������������������    29 Summary��������������������������������������������������������������������������������������������������    29 Aims��������������������������������������������������������������������������������������������������������    29 Research Strategy������������������������������������������������������������������������������������    30 References/Bibliography��������������������������������������������������������������������������    38 Budget Justification����������������������������������������������������������������������������������    38 Facilities and Resources��������������������������������������������������������������������������    41 Equipment������������������������������������������������������������������������������������������������    52 Optional Documents��������������������������������������������������������������������������������    52 Authentication of Key Biological and Chemical Resources����������������    52 Resource-Sharing Plan������������������������������������������������������������������������    53 SBIR/STTR Commercialisation����������������������������������������������������������    54 Commercialisation Plan ����������������������������������������������������������������������    54 Vertebrate Plan ������������������������������������������������������������������������������������    68 Select Agent Research��������������������������������������������������������������������������    73 Inclusion of Human Subjects and Clinical Trial Plan��������������������������    73 Introduction������������������������������������������������������������������������������������������    74 Progress Report������������������������������������������������������������������������������������    75 Multiple PD/PI Leadership Plan����������������������������������������������������������    75 Consortium/Contractual Arrangements ����������������������������������������������    77

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Contents

7

The Main Event – Writing It������������������������������������������������������������������   79

8

Edit, Polish, Shine and Repeat����������������������������������������������������������������   85

9

Are You Ready to Submit It?������������������������������������������������������������������   87

10 Post-submission Steps to Win the Grant������������������������������������������������   89 11 An SBIR Case Study��������������������������������������������������������������������������������   93 Afterthoughts������������������������������������������������������������������������������������������������������  99 Resources����������������������������������������������������������������������������������������������������������  103 Index������������������������������������������������������������������������������������������������������������������   105

About the Author

Sean  Ekins is founder and CEO of Collaborations Pharmaceuticals, Inc. (CPI) which is focused on using machine learning approaches for rare and neglected disease drug discovery. Sean graduated from the University of Aberdeen, receiving his M.Sc. and Ph.D. in Clinical Pharmacology and D.Sc. in Science. He was a postdoctoral fellow at Eli Lilly, before working as a senior scientist at Pfizer and then returning to Eli Lilly. He went on to join several startup companies at increasingly senior levels. Since 2005 he has been awarded numerous grants as PI for a wide array of start-up companies totaling over $12.2M as well as performing as a consultant on others. Since 2016 he has additionally won over 20 grants from NIH and DOD (STTR/SBIR grants, R21, UH2 and R01) totaling over $16.7M for CPI. He has a passion for advancing new technologies for drug discovery and is a prolific collaborator. He has authored or co-authored over 355 peer-reviewed papers and book chapters and edited 5 books on different aspects of drug discovery research and topics for Wiley. Coverage of his recent research has also appeared in The Economist, Financial Times, The Washington Post, Wired, Scientific American as well as several podcasts. When he is not writing, he enjoys cycling and crate digging at record stores around the world. Sean can be contacted at [email protected]

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Abbreviations

BrIDGs CDA CDMO CEO COO CRO DOD EIN EMA FAIR FDA IACUC IND IP JIT MTA NIH NOA NSF PDB PDF PI RFA RFP ROI SBIR STTR VC VCOC

Bridging Interventional Development Gaps Confidential disclosure agreement Contract Development and Marketing Organization Chief executive officer Chief operating officer Contract research organisation Department of Defense Employer identification number European Medicines Agency Findability, accessibility, interoperability and reusability Food and Drug Administration The Institutional Animal Care and Use Committee Investigational New Drug Intellectual property Just in time Materials transfer agreement National Institutes of Health Notice of award National Science Foundation Protein Data Bank Portable data format Principal investigator Request for application Request for proposal Return on investment Small Business Innovation Research Small Business Technology Transfer Venture capital Venture Capital Operating Company

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Chapter 1

Why You Need This Book

Abstract  This chapter forms an introduction to non-dilutive small business grants and the authors experience of winning grants for well over 18 years. It provides a high-level overview of what it takes to write and win them as well as scale this process to enable you to write many grants in parallel. Keywords  NIH · SBIR · STTR

Hopefully the title grabbed your attention. You may be going to submit your first grant or do a grant resubmission, or you might be already well funded and curious about what this book has to offer. Either way, you cannot fail to recognise the challenges you face when trying to win a grant. On the one hand, you must do the science, manage a lab perhaps, let alone write the grant. You may have administrators who help with all the paperwork (lucky you), but the majority of this is on your shoulders. If you are an academic, your tenure likely depends on it, your future is riding on this grant, and your students’ future also depends on you. But no pressure! If you are an academic, aspirations of being the department chair, of fame and fortune and so on will not matter unless you win grants. These may be from any source, but it is likely that most are going after funding from the National Institutes of Health (NIH), National Science Foundation (NSF) and Department of Defense (DOD), followed by big research and philanthropic foundations. In contrast to an academic, you may have a dream of starting your own small company doing scientific research, and one way to fund it is to go after small business innovation research (SBIR) or small business technology transfer (STTR) grants – basically, a non-dilutive alternative to angel or venture capital (VC) funding. It may not be a fast way to gain investment, but as they say, slow and steady wins the race. If you can write a grant proposal that demonstrates your business idea, concept or product, this is a fantastic place to start. The pot of grant money is there, and now you just need to get some of it. You should give it a try because it represents ‘free money’ with few, if any, strings attached other than annual reporting, financial compliance etc. © The Author(s), under exclusive license to Springer Nature Switzerland AG 2023 S. Ekins, Winning Grants, AAPS Introductions in the Pharmaceutical Sciences 17, https://doi.org/10.1007/978-3-031-27516-6_1

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1  Why You Need This Book

I have never been an academic, apart from holding several adjunct positions at a few universities and briefly  being in  an entrepreneur in residence position at the University of North Carolina (UNC)-Chapel Hill. I have always worked in the pharmaceutical industry and for biotech companies. After doing a 2-year postdoc in the industry and then working for a couple of big pharmaceutical companies (Pfizer and Eli Lilly), I joined a small start-up biotech in 2001 and learnt the pros and cons of working in a small VC-funded company. Then in 2004, I was hired by another small start-up software company (Company #1) without any VC funding. My role was to help them apply and develop their software product while also writing a Phase II SBIR grant. Up until that point, I had never written a grant application, although I had written about 40 scientific papers over the preceding decade. It was a huge challenge as I not only had to write the whole grant based on data from Phase I on a technology I had no experience with, but I also had to draft a commercialisation plan, a document that was essentially the business plan for the company. This was the epitome of a baptism by fire. The first submission of this grant was unsuccessful, but I heeded the reviewer’s feedback and then resubmitted. We were successful this second time and won the grant within a year of the first attempt, and this funding went on to build the foundation for the company. Little did I know that this would set the scene for the next 18 years up until the present. I ultimately left the company after a couple of years, but it went on for several more years until the founders sold it to Thomson Reuters in a successful exit. My next foray in 2006 was using my newfound grant-writing prowess to help an academic start up a biotech (Company #2). This led to three more small business grants in a little over a year. In 2008, I then started working remotely at a small software company (Company #3), helping build their scientific credibility, being the lead scientist on a Bill and Melinda Gates Foundation funded grant and ultimately writing and winning two Phase I and two Phase II STTR and SBIR grants, as well as participating in a European FP7 grant for them over the next 8 years. I went on to become the chief strategy officer (CSO) of this company. While still at this company, in 2012, I also  helped co-found a rare disease start-up (Company #4) as chief executive officer (CEO) with the parent of a child with a rare disease. For this company as a sideline I wrote several grants with scientists in academia working on the rare disease (composed of four distinct diseases) we were focused on. Surprisingly, this rare disease grant writing was much harder than I imagined. I was collaborating with excellent scientists to write these grants for the company to fund their work. As a team, we still had to build the credibility for the reviewers, and it took over 3 years to do this until we finally had a grant funded, which then enabled us to win others (an example of success breeding success). In total, I was able to win five grants for this company with the help of experts in these rare diseases over a few years, bringing in approximately $7.5  M to the company to fund the science as well as develop treatments for this rare disease. In parallel, I was also assisting with several other rare disease foundations and providing my expertise in grant and article writing, which helped broaden my rare disease network. While at Company #3, I had also been incubating an idea to build on all the scientific collaborations ongoing in different neglected and rare diseases to ultimately create a small-molecule intellectual property (IP), which was outside of Company #3’s goals. It was made clear to me that if I could get grants for other

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people’s companies then why not do it for my own company that I had complete control of. It took several years to get this off the ground, but I started to incubate the idea, until one day, I put the paperwork in and formed Company #5 (Collaborations Pharmaceuticals, Inc). Then I was able to start all over again and put some grants together and submitted them. It is important to note here that some of these grants were related to software development and several combined software with experimental validation or even solely experimental work, even though at that time I did not have a lab. Ultimately, in 2016, I left Company #3 to focus my efforts on Company #4 and start-up Company #5. Within a few months, my first grant for this new company came in and then another. This enabled us to hire our first employees and rent a small office so I could move out of my home office. If you are still following, I was now CEO of two small companies (in different states) collaborating with scientists all over the country working on STTRs and SBIRs and still working from home. This continued for several years until 2019 when I had to make a choice. I quit Company #4 and focused my efforts on the growing team of ten of us at Company #5. In some ways, this decision was out of my hands as there are important requirements such that for some grants (SBIRs) you must provide most of your effort to the company with that grant. This ultimately led to having to make this difficult choice. While at Company #3, I had also given some thought to submitting more than one different grant in a cycle and to the concept of creating an approach that I termed ‘grantstorming’, which was basically creating a pipeline to facilitate the scaling of what I was doing on both the scientific and grant-writing side. Company #3 opted to hire more grant writers but did not focus on scientific expertise. We also did not go after other types of NIH grants at that point. I learnt from this, and at Company #5, we subsequently applied for many different types of grants and won them  – not only SBIR and STTR but also R21, R01, UG2/UG3, DOD, Defense Threat Reduction Agency (DTRA) grants and grant supplements. Our first grant was an STTR, which also provided an opportunity for us to submit an application for a matching grant from our state (One NC matching grant). This application took about 4 hours of work to fill out forms, and it yielded approximately $32,000 over the next year or so – quite possibly the best return on investment (ROI) on any writing I had done until that point! We also tried applying for NSF grants along with other senior co-investigators, but with no success to date. Importantly, though, we started to submit multiple grants in a small business grant cycle. For STTRs and SBIRs, there are three submissions per year – currently 5 January, 5 April and 5 September, dates that change depending on whether the day falls on a weekend or holiday in any given year. So imagine if you could submit five grants per cycle; that is 15 per year or ten grants per cycle, to give you 30 a year and so on. It seems crazy to do, but I was spurred into action because I realised the bigger companies going after these types of grants employed teams of grant writers, and while we could not fund a team, we could scale what we did without outside help. The turnaround cycle is so quick that you can submit and re-submit the grant in a year and learn from the reviews. If you were able to have this many ideas, you will quickly learn from the study sections what they are looking for and hone your ideas and writing. Yes, this is a considerable amount of work for a small company without professional writers, but writing two or five grants is not that much more work than writing one grant.

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1  Why You Need This Book

Another way to think about these small business grants is that a Phase I grant currently is one page of aims, six pages of strategy, one half page of summary and three sentences of narrative. Whereas a Phase II grant application has a limit of 12 pages for strategy and 12 pages for commercialisation plan as well as everything else. Therefore a Phase II grant approaches five times the amount of work of a Phase I. So it is a lot easier to write less than eight pages on a topic than 25 – which goes without saying, which would you select? Due to my expertise with small business grants, I am going to focus on these for the remainder of the book. Much of what I describe, with a few exceptions, can be directly transferred to other grant types. Prepare yourself. Like anything you do that is new, the first time you write a grant will be daunting and have an initial very steep learning curve. It may be stressful as you learn a new process, and you must identify pieces of information that you may have never heard of before. But there will also be items that you need to create which can be used in future for other proposals, so there will almost be an initial investment of your time that has to be made for the first grant application which will benefit you in future. This hopefully may provide some consolation. It will take far longer than you had thought to submit the grant, but once you have done it, you are better placed the next time. Over years of writing and winning grants, you will also learn about different requirements for each kind of grant or the needs of funding bodies, and this will help lessen the stress. Also, you will start to think of how you can improve the grant preparation process and do more, perhaps even leading you to submit two grants instead of one. Your strategy will have to change over time as you learn what works and what does not, and you will also adjust to changes that may occur in the process over time. So why am I writing this? After eighteen years of writing grants at a rate of initially one to two a year then perhaps a handful and now anywhere from 10–30+ grants submitted a year gives one a unique perspective, albeit in a very focused area, of what wins grants. I have now won and have been a principal investigator (PI) on well over 30 grants in this time, bringing in close to $30 M for the five different companies I have worked at taking this approach. It is also worth noting that with some success also comes failure, and that is to be expected. While we have put together what we thought were excellent proposals with terrific collaborators including solid preliminary work, they have ultimately not been scored or if they were scored, it was not good enough to be funded. Then there have been grants we have submitted with no preliminary work and with less experienced teams who have no prior funding themselves, that have scored some of my best scores. This makes you wonder, can you predict a winning grant? I know you can benefit from my grant-winning experience. At Company #5, we can have a narrowly defined influence on the world with the science we do or the software products and molecules we create, but if we can inspire you to write grants that get funded, that will also be impactful. While working on COVID-19 drug discovery, a science journalist suggested that our efforts would be a footnote in history. I now offer that either we can be a footnote in history or this book can help you create it as you win grants based on the approach it describes. Before you start writing a grant, though, there are a few things you need to do, as you will see in the next chapter.

Chapter 2

What You Need to Do Before You Write a Grant

Abstract  Preparing for writing a small business grant requires you to bring together a number of items that can be gathered beforehand. These include a biosketch and writing about your facilities and equipment. The chapter includes the author’s bio­ sketch as an example. Keywords  Biosketch · Phase I · Phase II · RFP

The first steps in the grant proposal process are not related to writing about the science or may not even involve writing at all. There are many different types of grants offered by the National Institutes of Health (NIH), for example (https://grants.nih. gov), and these are listed as they are released on their website. You will need to decide which grant is the most appropriate for your needs. There are short grants (6 months to a year) all the way to multi-year grants (2–5 years). There are grants that are trying to capture new ideas (R21) or technologies and literally you do not need any data for, then there are grants intended for an investigator with an established laboratory and considerable data to build on (R01). There are grants that are very specific, literally asking for proposals in a very narrow area that seem almost tailored to a few laboratories. Grants most suitable for academics may also be accessible to companies, whereas grants tailored to small businesses may be out of reach for academics (unless they have a company or can participate in a collaboration between a small business and an academic). If you are a small company, you should be particularly encouraged to pursue small business grants – these are represented by small business innovation research (SBIR) and small business technology transfer (STTR) grants that are funded through government set-aside money (currently this is well over $1B), and this may vary year to year. Besides the three omnibus cycles mentioned in Chap. 1, there may also be specific requests for proposals (RFPs) that are outside of these deadlines. There are also STTR and SBIR contracts that become available in specific research areas outside of these cycles and versions that are set up asking for the delivery of a specific item or new technology. © The Author(s), under exclusive license to Springer Nature Switzerland AG 2023 S. Ekins, Winning Grants, AAPS Introductions in the Pharmaceutical Sciences 17, https://doi.org/10.1007/978-3-031-27516-6_2

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SBIR and STTR grants have their own set of rules, such as how much work must be done by the company and how much time the principal investigator (PI) must assign to the company. It is best to see the most up-to-date rules ­(https://www.sbir.gov and https://seed.nih.gov). These seem so that an academic cannot double-dip with these grants and other grant types while ensuring the PI is also engaged with a company. As these grant types are attempting to build companies in the USA and create jobs for Americans, these rarely allow foreign involvement (except under special circumstances). There would have to be a very strong justification to allow it. As STTR grants require an academic component, the percentage involvement in different phases is also specified. That is another important take home for these grants as they have a Phase I, Phase II and Phase IIB, as well as direct to Phase II, fast track (combined Phase I and Phase II) etc. Phase I is normally a 6-month to 12-month grant, and Phase II is normally 2 years (although you may justify a third year). Each grant type has a budget limit, which will be described in the request for application (RFA), but if you are working on a topic that may fit within the list of exceptions for a particular institute, the ceiling may increase. Again, this is an insight that many ignore opting for the default budget maximum for each grant type and certainly calls for a careful reading. My first experience with these grants was initially preparing a Phase II grant. Over time, I have been able to submit and win Phase I, Phase II and Phase IIB grants. The latter is considered more of a ‘commercialisation’ type grant, to submit if you have completed Phases I and II. It enables you to add something else to your product or to make it more marketable. I have attempted a straight to Phase II proposal; this requires you to write the full 12-page strategy for the proposal and the 12-page commercialisation and implies you have already generated substantial preliminary work to justify funding. A fast-track proposal offers you the possibility of being able to submit Phase I and II grants together, and if successful, you would avoid having to submit them separately and save some time. I have personally never taken this approach and have not had to review such a proposal, perhaps because such a submission is a considerable effort for either a first-time submitter or someone who is more experienced. For these reasons, I would not recommend such a grant to an entrepreneur just starting off on their journey of submitting grants as it would be almost impossible unless you had a mountain of preliminary data! If you are an academic and keen to start your own company, pursuing an STTR would be an ideal approach. Here is one possible scenario I can imagine. By writing a proposal, you can perhaps identify a PhD or postdoc from your group who could serve as the PI and help start the company. They would gain the independence to help write the proposal and run the company. Alternatively, you might want to identify a consultant or someone else with the requisite scientific experience in the topic to give it credibility. The STTR approach would enable your group to obtain some useful funding for the project while also starting a business that would create intellectual property (IP) and enrich the university. This would be a best-case scenario. Of course, each university might have strict rules to ensure there are no conflicts of interest and that students are not exploited. So best get some advice before embarking on this. As an entrepreneur outside of academia, I have often engaged with academics who I have collaborated with, looked for molecules and technologies

2  What You Need to Do Before You Write a Grant

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that might be of interest to my company and then written the STTR. If you get to a Phase II submission, you would then need to clarify and negotiate the IP situation with the academic institute. Reviewers would certainly be looking for this to be documented in a proposal. You will also need to read carefully the RFA/RFP that is provided by the grant agency. This is normally a very long web page that you can print out. This also has all the small print and exact requirements of what the funding agency is looking for and when they need it. If you can give yourself at least a month or two before the deadline, you then have ample time to organise everything and do what is needed. If you need to ask questions, they will usually provide a few names of officials at the NIH who you can contact. This is your opportunity to contact the programme manager for the grant. Many times, for a particular RFP, they will also have webinars and provide opportunities to ask questions. This may not increase your chances of getting the grant, but at least it will give you the opportunity to show your interest. I attended one such recent webinar, and the programme officer did a live search of grants and technologies to demonstrate some of the ideas they were looking for and surprisingly listed some of our own grants, which further confirmed to me why we should pursue submitting a grant to their RFP! If you want to ask more detailed questions outside of the webinar, you may want to also schedule this well in advance of the grant deadline. If you are writing a grant for the first time and are not a part of a university, then you need to fulfil the registration requirements needed to submit grants. This is described at the beginning of the RFP. Each organisation will have different requirements, so it is worth double-checking in each case. For example, current SBIR and STTR grants from the NIH require you to register in the System for Award Management (SAM), SBA Company Registry, eRA Commons and Grants.gov before you submit a proposal. These may take some time, and each step will be sequential and take several days to weeks, so this is another reason to not do this last minute. Once these steps are complete, you will be able to submit a proposal. The RFP will also lay out exactly what the requirements are for each part of the grant or refer you to other web pages for things like the start dates, specific regulations for the grant type etc. So before writing, prepare yourself for some significant reading of these dos and don’ts. You will also need to gather additional materials. For example, you will have to prepare a biosketch (Fig. 2.1) for each of the key personnel on the grant. I would assume that each scientist could do their own, but do not take it for granted that they will already have one. For NIH grants, usually biosketches are a maximum of five pages (unless instructions differ) and have a format and rules all their own. You may also want to prepare a document for any other funding or support you or these key persons have as well. Biosketches need to have some link to the grant in question, and so it is worth having a degree of customisation on the initial page, where you provide a brief biographical summary of your expertise. This could be in the form of adding your references that relate to that project or any grant-specific expertise. There are several grant types that may require much smaller biosketches and the references in a specific format or limited to a small number, so it is worth checking this as well.

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Impressing on the reviewers that you have the facilities and equipment for the proposed project is also key. It is worth spending some time detailing this down to the smallest feature. For example, if you have computers or servers and need them for your project, it may be important to provide exact specifications because if you do not, you can imagine the reviewers will ask for them. Always think ‘what have I

Fig. 2.1  An example of a 5-page NIH biosketch

2  What You Need to Do Before You Write a Grant

Fig. 2.1 (continued)

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Fig. 2.1 (continued)

2  What You Need to Do Before You Write a Grant

2  What You Need to Do Before You Write a Grant

Fig. 2.1 (continued)

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Fig. 2.1 (continued)

2  What You Need to Do Before You Write a Grant

2  What You Need to Do Before You Write a Grant

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not included that the reviewers will likely ask for?’ Eventually, you will get to a point where you close down every potential gap you can imagine. You can think of the actual text you write for the grant as the tip of the iceberg; there is much more underneath that will also be needed to determine the outcome of the grant. You will be evaluated on what you prepare in your biosketch, facilities and letters of support almost as much as what you write in the strategy and aims. This brings us to another important element of a proposal which is to demonstrate why it will have impact or commercial potential as detailed in the letters of support. It is worth thinking about these letters at the outset. Who do you know that would vouch for you or you have worked with that would be relevant to the proposal? Perhaps you already have some customers or clients you could ask. If you are fortunate and can ask these people well ahead of the deadline, they may even write them for you. Otherwise, I would recommend that you provide a rough draft that they can each edit. This will be greatly appreciated because like you, they are probably also incredibly busy, so anything you can do to decrease the friction of the request will help you and them. Also, by tailoring the letter yourself, you can say nice things! It will be important that each letter is personalised, refers to the proposal in question, is signed and is on an official letterhead. As a reviewer, it should be impossible to know if a support letter is written by the individual or the PI unless two or more are essentially the same. Pictures can save significant descriptions. If you have a lab or office, why not take photos and add them to your facilities so the reviewer can see your space and that you have the equipment needed? If you have an office floor plan, include that too. Your grant may require equipment or materials that you can include. It will be helpful for your budget justification to obtain quotes. The companies would likely also appreciate it if you gave them some time to do this rather than make last-minute requests. Similarly, there may be work that you cannot do with your own facilities or equipment, but perhaps a contract research organisation (CRO) or another lab will perform fee-for-service work for you. Obtaining a quote for such big-ticket items will be essential, because you can guarantee if you do not include such a quote, then the reviewers will almost certainly request one. Your job in winning the grant is to show that you have covered all these bases. Writing the proposal itself is an important part, and that’s down to your science and storytelling ability, but anticipating the needs and likely questions of reviewers is also critically important and should not be overlooked. By now, you may feel like you are ready to write, but there is one small thing you need – the idea. The next chapter will make the point that the idea may be impacted by other factors as well.

Chapter 3

The Idea

Abstract  Every grant requires a central idea and you need to come up with it. This chapter provides some examples from the author’s own experience. Timing may also be important as well as an awareness of what ideas may be received well. Keywords  I-Corps · Idea · SBIR · STTR · Timing

Every grant has an idea at its core, preferably something that will be considered as novel, although it does not necessarily have to be your own idea. Ideally it needs to be something that will lead to a product (if it is a small business grant) that will capture the reviewer’s imagination and interest such that they will then be enthusiastic and score your proposal highly. While there are plenty of books on creativity and brainstorming to help you have ideas, I would rather not tread the same ground here, so go buy and read one. What I will do, though, is provide a bit of insight from my own perspective of how some ideas came about that then eventually led to grants, which you can probably extrapolate to your own case. The first grant I won at my current Company #5 was a small business technology transfer (STTR) with an academic collaborator. It went back perhaps 3–4 years earlier to a project we were doing to see if a computational approach could help us find molecules with a particular bioactivity. You could call that the ‘idea’. Could we enrich in vitro testing so we then would be able to test fewer compounds and find interesting molecules worthy of further exploration? We ultimately built a computational model and used it to score compounds while then selecting seven compounds to test, out of which five had promising activity. Fast-forward a few years, I was thinking about starting the company, and this project was one I thought we could expand as we had by then a publication and some preliminary data. One of the compounds was very interesting because it did not have in  vivo activity, and so we planned to explore it further and make some analogues in the hope of improving the activity in mouse. We had plenty of preliminary data for the STTR and a starting core molecule structure (a hit), as well as ideas of what to make next, so we had enough material to fill six pages for a grant. Ultimately, the grant was funded, and © The Author(s), under exclusive license to Springer Nature Switzerland AG 2023 S. Ekins, Winning Grants, AAPS Introductions in the Pharmaceutical Sciences 17, https://doi.org/10.1007/978-3-031-27516-6_3

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we made new molecules in our year-long project, but unfortunately, we could not get to anything that was active in the mouse model. While it was not exactly a novel product idea (fusing machine learning models to design compounds for an infectious disease target), the molecules created were new and perhaps might be useful elsewhere. Another early grant, a Phase I small business innovation research (SBIR), was developed around providing machine learning software for drug discovery and delivering the computational models in a format others could use themselves. Again, it was far from a novel concept, although the approach to doing it was. We could build on our years of generating such models built with expensive commercial software (which did not enable model sharing) as we aimed to build our own software for internal and customer use as a demonstration, with lots of examples of collaborations. This then led us to develop suites of models that became a starting point for additional separate grants and were further developed as products. We ultimately created brands around each collection of models and developed the software. In the process, we also used the software to find new molecules for projects, creating intellectual property (IP) and trademarking the software. The one overarching ‘big idea’ was to create a company that could do software development to build tools for machine learning and benefit from this to help enable drug discovery collaborations. We would create software that could be licensed or used internally on fee-for-service projects with clients or for our own projects. As we were developing our software grants, performing some consulting work for clients was very helpful in testing the software and getting feedback from customers. This is what our company has become. The few initial small business grants shaped the course and vision for the company. It is hard to know from the outset if an idea for a grant is going to be fundable. From my own experience, there have been plenty of grants that I have written around what we thought were solidly novel ideas or concepts, but they were either not scored or scored poorly. It is clearly about more than the idea alone. The team involved, the facilities, the business plan involved as well as what competition exists all likely contribute to the overall score the reviewers provide. Sometimes it depends on the grant type, your luck and timing. Yes, timing! Some grant cycles tend to be tougher than others, perhaps because of an increase in submissions, while other very focused RFPs may only have a small number of submissions, and yours might be one of the few, or the only one submitted. At times, a grant submission feels more akin to a lottery. If you do not submit a grant proposal, you will then lose out on the opportunity. It is a tough choice, but it is also yours alone to make. Do you have a good idea, and do you feel lucky? Sometimes your ideas can be too far ahead of what is the current state of the art, and that may hinder your progress. It is possible they are a little ahead of their time. For example, after consulting with other collaborators, I have written grants on open source, machine learning and blockchain in drug discovery years before they became commonplace. This hurt us as the reviewers could not understand why these technologies would be helpful; they were not yet mainstream. Hence, it is probably better to do a proposal for a technology that is of its time, now. While you may get critiqued for the novelty, if the idea is sound and you have demonstrated past success and all the other factors are good, then you will do well.

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For example, working on a novel class of molecule for a well-known disease target may be justified if there is drug resistance and the current drugs available will lose their utility. Again, it may depend on the funding opportunity. For example, if there is a call for collaboration in a particular disease area between the USA and a second country, you can bet I am going to find a collaborator to help in that country. One of our early grants was just such a grant that needed to be on a US-Russia collaboration. It just so happened I had been working with Company #3 as part of an international collaboration, and one of the team was from Russia. Once we reached the end of the project we were on at the time, we were both looking for the next funding opportunity for our work, and this was the most promising opportunity we had seen. We then found a second collaborator in the United States to work with us on a three-lab R01 proposal that was funded. It does not hurt to be an opportunist when it comes to grants. You may not be an expert in a particular area, but if you see a great grant opportunity with funding, then why not set yourself the challenge to write something and force yourself to come up with a proposal that addresses the funding agency needs? You may even learn something new in the process that could send you in a promising direction. If it helps, you can tell yourself that if you do not, then someone else will and you will miss a golden opportunity. A few examples from my own experiences may inspire you. Several years ago, a grant supplement was available to encourage scientists to work on Alzheimer’s disease. Grant supplements can be thought of as a bonus grant often only available if you already have grant funding, as an NIH institute may want to encourage research on a particular area or attract a certain kind of scientist to a topic of research. My company had never done any projects related to this major disease specifically, but we were able to write a short proposal applying our recently received machine learning SBIR work to several targets for the disease. We had a very small amount of preliminary data on a target involved in Alzheimer’s disease and did little research to see what data were publicly available. We were awarded the supplement grant after a relatively minimal effort. The upside of this work was that it opened doors and led us to finding one of our molecules with activity against an Alzheimer’s disease target. It also gave us additional data to include in an SBIR Phase IIB submission and final report, demonstrating the further application of our technology. Another supplement obtained by our company was a diversity supplement, literally a grant for our laboratory to hire an under-represented minority. We had an intern who had worked for us over the summer months, and we had a grant awarded that we thought they could contribute too, so we wrote a brief proposal and a career development plan, and we were awarded this supplement. There seems to be no limit on these kinds of supplements, so it requires that you find the right person and check to see if they are still awarding them. Ultimately, it comes down to communication with your programme manager. What is often overlooked are the opportunities that come along once you get awarded a small business grant – not only matching grants from your state (perhaps) but also commercialisation consulting and supplements to participate in I-Corps. The latter was probably the most useful from a business perspective while also the most exhausting initiative to help us with commercialisation. At the end of a

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multi-­month project, we had interviewed nearly 200 people, attended multiple conferences and really understood our market, product and what to do next. This was incredibly useful to provide us with solid data and content for a Phase II commercialisation plan and other immensely valuable insights. If you can participate in any of the ‘commercialisation’ initiatives or I-Corps programmes, I highly recommend them if your time allows. The important takeaway here is you need to be committed. If you do not put the effort in, then do not bother to do it because someone else could benefit from the opportunity in your place. Sometimes timing is everything when it comes to writing grants. Several years ago, I had been networking and had written an R21 with an academic, which did not get funded. However, we quickly found another opportunity, but this time, it was a Defense Threat Reduction Agency (DTRA) request for application (RFA) focused on nerve agents. This was new to me as a research area, but we were able to put a collaboration together with a large research institute and a university, proposing to look at molecules that had been used in recent poisoning incidents. While our proposal was in review, the Novichok incident occurred in Salisbury, UK, which gave our proposal a very high degree of relevance and timeliness such that the grant was ultimately awarded. No amount of future prediction would have led to this; it was down to current events that we had no control over. For years, I had been submitting grants on developing machine learning models for antivirals to enable drug discovery based on our work on Ebola and Zika viruses. These would have been great opportunities to position us well for the next outbreak, but the proposals were sadly never funded. Subsequently, when COVID-19 happened, we had grant text and materials ready. However, with many laboratories closed, other scientists were also likely spending their time writing grants on COVID-19 as we found that attempts to fund such work, whether alone or with collaborators, was impossible. These latter examples show that timing can either work against you or for you when it comes to submitting grants. Therefore, having the right idea in the right place at the right time is critical to your grant-winning success. Once you have the idea for the grant, you need to assess if you can do it alone or whether you will require collaborators. The next chapter will share the pros and cons of each direction.

Chapter 4

Go Solo or Collaborate?

Abstract  You may be well positioned to pursue and write a grant solo, while in other cases you may benefit from the experience of a collaborator. Knowing when to go in either direction is important as is selection of a collaborator, and some considerations are presented along with the pros and cons. Keywords  Collaborator · Intellectual property · STTR · SBIR

When you are starting out on your grant-winning odyssey, there are definite advantages to having a collaborator. It helps to have at least different perspectives when writing a proposal as well as a division of labor for the actual project. If the collaborator already has a track record in winning grants, that may help considerably too. Especially if you are a new investigator, learning the ropes from a seasoned professional can accelerate your development and deliver a proposal that may be greater than the sum of the parts. Ultimately with academic grants, the funding bodies are looking for scientists who are independent, which seems strange when in other efforts we are looking for scientists to collaborate and be a part of a team. I have always wondered why there is so much focus on the individual when really in 99.99% of cases, none of the science gets done without a team. From the writing side, it becomes more of a rite of passage, writing your first solo grant and hopefully getting it funded on your own. This may not be the best choice if it is your first grant. If you are running a company as mentioned earlier, you have the choice of pursuing small business technology transfer (STTR) and small business innovation research (SBIR) grants, but do not solely limit yourself to these because you are also able to go after many other types of grants from the National Institutes of Health (NIH) and others as well. While it may be helpful from the outset to focus on STTRs and SBIRs, opening your eyes to what else is out there from the funding perspective may increase your odds of success. I am sure most companies only focus on SBIR and STTR grants, but you may have less competition if you look elsewhere as well. There may also be specific calls for proposal submissions that might align with your capabilities. © The Author(s), under exclusive license to Springer Nature Switzerland AG 2023 S. Ekins, Winning Grants, AAPS Introductions in the Pharmaceutical Sciences 17, https://doi.org/10.1007/978-3-031-27516-6_4

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As a small company, it may help to do STTRs first as you set up your team. The advantage is that you do not need a laboratory as you can leverage the academic collaborator, who presumably has this and access to equipment. You can also benefit from the facilities page from the university and their letter of intent, which will provide more credibility for the proposal. Of course, you and your company need to bring something to the table as you must explain what you will do, so it is important to spell out your role or your team’s capabilities as well and how they complement the collaborator. From my experience submitting early STTRs, we initially offered the computational capabilities that balanced our academic collaborators’ biology or chemistry expertise. Choose your collaborators wisely because you could be working with them for many years, at least 6 months to a year if you get a Phase I grant and 2 to 3 years for a Phase II STTR grant. It is important to make sure you both (or all, if there is more than one collaborator) have similar goals and are aligned with the project and importantly putting the required effort in. There have been examples I have been aware of where an academic lab will treat you as a funding source providing minimal assistance in writing the grant. Clearly that is not ideal. Generally, co-writing grants with academic labs has been a valuable experience, although oddly not as successful as one would expect in my case. This could simply be down to the choice of project, as in many cases, the investigators have all had good academic track records of funding and been productive. Perhaps the grants were reviewed by academic peers who felt challenged, or possibly the projects were perceived as too academic and not product driven. Collaborations are not quite at the level of a marriage! Be aware that not all collaborators may have your level of initiative or enthusiasm for a project. If you are the main principal investigator (PI) on a multi-year project, you may have to make the difficult decision at some point to find another collaborator if they are not delivering on the milestones or there are other issues that threaten to derail a project. This can certainly be stressful but can make the difference between the success or failure of a project in total. This would be a good point to talk with the programme officer and obtain their advice. If you must make a decision to replace a collaborator at any point in a project that is ongoing, get it in writing and inform their institute. Having gone through such an experience myself, it is not pleasant. First is the realisation that the collaborator was not delivering and then that you alone can fix this. Of course, the knock-on effects are predictable. You have no option but to fire the collaborator and hire someone else who can do the same tasks and is equally well qualified. From my own experience, I have found that collaborations have a finite lifetime. There may be short-lived ones where a divergence of opinion may separate you quickly in the space of a few months to years. Then there is mid-range collaboration, which starts to go downhill after 5–10 years. Life happens; one of you will lose focus on what you are doing, and this may create a rift. Perhaps the collaboration has run its course, and neither of you knows how else to call it off. Then of course there may be long-term collaborations going longer than 10 years, where you may participate on and off with projects that run their course. It is therefore very

4  Go Solo or Collaborate?

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important from the outset to understand what each party wants from the collaboration and then enjoy the ride. Overall, I would say I have had many more successful collaborations than failures, and hence that is why I called my company Collaborations Pharmaceuticals, Inc.! Collaborations are central to my company. This certainly helps when we reach out to academics with potential ideas or molecules that may be of interest. For my own personal fulfilment, collaborating with younger scientists who are starting out can be an important way to provide some of the experience to help them on their journey while at the same time learning something new yourself. Also, working with older, more established scientists is valuable because they are at a different part of their career, and they have generally seen it all. Doing a grant solo can also be seen as one way to keep all the money on offer or retain intellectual property (IP), but this may not be the case; you may still do it solo but have external consultants, a contract research organisation (CRO) or contract development and manufacturing organisations (CDMOs) that do some of the work; they are just not on the grant as a key person or PI. Doing a grant solo does put all the emphasis on you alone or your company, in which case you can involve your colleagues in its preparation. Again, this provides you with a training opportunity for the team and the potential to get fresh perspectives on your idea or proposal. Ideally, your own team members will also help you write it and may have a more intimate understanding of the technical details of the work they have undertaken or that you are proposing. Going solo on a grant can also provide you with a validation that perhaps you now have the credibility to not need a collaborator or a larger organisation behind you. This may not only be good for the psyche of the team in a small company but also encourage you to do more of the same. This kind of positive reinforcement may need to be balanced with the company’s long-term goals because your independence may also mean that you do not have someone else to fall back on if you hit a hurdle. As a small company working on such grants, you also must be thinking about how it gets you to the final product that can be monetised or sold. If you are working on a collaborative grant, you can bet that the academic institute will be thinking about the IP and how they can get a return on the project, which you will have to share in. You may also have several meetings with their business development staff or lawyers concerning the life of a grant. It is important that you stand up for your input and clearly track your contribution to an invention that may be made during the time of the award (or afterwards). It is also important to say if you do not think there is anything to protect if it does not work out. In doing so, you can save everyone’s time and money in pursuing fruitless patents. Most grants will not cover your legal fees for patent preparation or filing anyway, so if you are doing a grant solo, you will be footing the bill for this if needed, while if you are part of a collaboration with academia, they may cover a part of this. It is important that you have delineated who does what in this regard at the outset, and this may be captured in your contract with them, whether that represents a material transfer or confidentiality or other types of document that you will sign. If you are running a company funded by yourself, creating IP alone or with others may be of less concern, whereas if you intend to obtain angel or venture capital

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4  Go Solo or Collaborate?

(VC) funding, they may be more interested in IP that you solely control. So again, it will be important to plan for where you are going as a company and then pursue the type of grant that is right for you and your collaborator at that specific stage of your company or research group. ‘Life happens’ is a very broad way of saying there is only so much you can control. You can have a great idea and write and submit a proposal, but you only have limited control over whether you have done enough to obtain funding. When you collaborate, something may change the course or plans of the collaborator that you cannot foresee. This could literally be anything, like them changing jobs and laboratories and having to rebuild everything. Or they may be sick, requiring prolonged periods away from work. They may also not be able to obtain tenure and decide to quit. Any of these outcomes could slow, halt or result in a major setback of your project or grant writing. I have experienced many of these types of events. You have literally no control, and the best you can do is try to extend the clock. You can reach out to the grant programme officer and try to obtain a no-cost extension if you have the grant. You may even need two such extensions depending on how long such a situation lasts. COVID-19 is a prime example that impacted many laboratories as universities were shut down or reduced staffing density, resulting in many projects getting delayed for 6  months or a year or more. These types of situations could come at any stage and at any time. A hurricane may flood the lab of a collaborator or cause another lab doing your critical experiments to shut down mid-study, thereby resulting in the study having to be repeated or cancelled. A collaborator could drop out at the point of grant submission, and you may then only have days or hours to decide what to do next. The collaborator may call time after a Phase I STTR and be unwilling to continue to a Phase II. This may be because they see no outcome that is positive for them, or they just do not want to put the effort into the proposal or instead would rather do their own R01 or another solo grant. This would basically cut you out. You may think these scenarios cannot happen; they can, and you need to be ready for the outcomes and how they will affect you. This may be unthinkable, but what if you become ill and are unable to be the PI on your grant, do you have a deputy or backup plan in place? If you do not, you need to think about it before it happens. As a small business, it is also important to have key person insurance that would enable the company to hire a replacement for you if you are incapacitated or worse. Thus, allow the company and those you employ to continue for a while longer until a solution can be found. You want to write and win a grant, but these are certainly critical issues we all face at some point, and they may impact not only the grant but your company as well, so it is best to consider them now rather than later. Once you have decided if you are going to collaborate or go solo on a grant, as an entrepreneur you need to plan for success. What happens when you get the grant? The next chapter points out a few things you should be aware of so can you realise what you are embarking on before you dive in and start becoming a grant winner.

Chapter 5

What the Entrepreneur Needs to Know

Abstract  Before you write and win the grant that could determine the success of your company, there are several things the budding entrepreneur needs to know that will set them up for success. These include office or lab space, hiring staff, the need for bookkeeping, legal assistance and generally learning what it takes to run a company. Keywords  Book-keeping · Office space · Laboratory · Hiring staff · Running a small company · Legal advice Whatever it is that made you want to start your own company, means that you have thought about your goals to some extent and hence winning grants is being considered part of that plan. Otherwise, you would not be reading this! While there are plenty of places to find advice and guides for writing grants, there are few guides on how to start winning grants and doing it repeatedly. Imagine if you are looking to win grant after grant for your group or company; you do not realise it, but you will need help doing this. My first grants for my company were written in my home office (in fact, nearly every grant that I have written for former companies were also written in my home office  too). At one home, it was literally in our basement without windows. My advice would be to write where you are most comfortable or wherever works or is feasible. If you write well in a coffee shop, that is great, but putting that on the facilities document of the grant is not a good idea. This is fine if you are just writing, but if you win grants and need to hire staff, they may not always be able to work from home, in a coffee shop or in a library. This may be that first ‘turning point’ for a small company post-grant success, as you need to face up to the reality of being a small business now and rent an office or join a co-working facility. Depending on your location, you may have different options, locally, close  to where you live  – on a business campus or even in an incubator. If you just need a place for a few computers, this is one thing, but if you need a laboratory with specialised facilities like chemistry hoods, then that will lead to significant equipment needs and so on. One of the challenges in some locations in the USA is a severe shortage of affordable incubators with laboratories for small companies that are equipped for science © The Author(s), under exclusive license to Springer Nature Switzerland AG 2023 S. Ekins, Winning Grants, AAPS Introductions in the Pharmaceutical Sciences 17, https://doi.org/10.1007/978-3-031-27516-6_5

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work. From personal experience, the first grant won pushed me to rent an office and then hire staff. But after several grants in the space of a year, it became apparent that we needed to have a space where we could have a refrigerator to store molecules that we were shipping to contract research organisations (CROs). After scouting out laboratories at several local universities, I found a small (800 sq. ft) lab in a university incubator space. Then we needed to purchase a balance for weighing materials and a freezer. We eventually expanded into a second laboratory and fitted it out with cell culture equipment and turned that into a biosafety level 2 lab. Then we expanded into a third lab space as our team grew and we needed more office space. Your first needs may be office space, followed by people, then equipment, and all of these can be covered in your grants. This is just the beginning. You may be able to administer one grant perfectly fine, drawing down finances and tracking everything yourself, but quickly it can get out of hand, and you will identify the need for a part-time bookkeeper and someone to keep track of ordering, organising wages and benefits and more. If you are a scientist founder, all of this can become overwhelming very quickly, especially if you are a first-time company founder and trying to manage the science or do the work that you proposed in the grants at the same time. Many of these different non-science aspects can be outsourced to other companies that specialise in helping small companies. If you start to win grants above a certain threshold amount, this may trigger annual audits in order to be compliant with National Institutes of Health (NIH) or other funding agency regulations. You must be aware of this and everything else from the outset of winning a grant. It is fair to question if you want to keep doing everything yourself at this point. Your first employees will define the company; they can clearly make or break your success, so it is important you find good reliable people you can work well with. If it looks like they are not going to work out, then the best thing to do is to first tell them they are not meeting expectations, and if this does not improve the situation, then it is time to find someone else. In the beginning, there may well be just a few of you in a small office or laboratory, so you can quickly see who is not working out. Ideally, you may want to find staff that can do more than one thing, so you have options as you expand. Having employees who can also multitask is important. You could think of hiring students or fresh PhD or MS graduates at the start, and as the company grows. Eventually  you may need to add more mature individuals with years of experience, who will then bring additional capabilities and credibility to your grants and help attract investors. Grants will get you so far, but as the salaries increase, you will also reach the threshold for some of the grant-funding institutes. You will also need to think about how to supplement these. Obviously, starting and running a small company is a 24/7 operation; that goes without saying if you are truly invested in its success. From my experience, it is on your shoulders as a founder/owner/chief executive officer (CEO) or whatever you want to call yourself. The buck stops with me. You can rent a space, but who cleans it? Who supplies the beverages, snacks, printer refills, paper? What if you run out of something essential or the computer fails or the internet does not work and so on? All these are what seem to be ‘small things’ that could halt your company’s progress for hours, days or longer and affecting productivity. If your internet router gives up,

5  What the Entrepreneur Needs to Know

25

then you need to go to the store and spend time setting it up. This is not in any way glamorous, but you may not be in this situation if you had not won the grant, so be thankful. You have created a job for yourself and perhaps many others. You are helping build the small business ecosystem. If you are in academia, all the above are generally taken care of after you win a grant. You must just keep winning grants, and your future is almost predestined. But as an entrepreneur, winning is only the start. What is missing in all of this is visibility. As a founder-owned company, you are your own marketing machine. You win a grant, but who will know about it? You can post it on social media – assuming you have a company website, you could post it there too. You could spend the money and do a press release (look for the best deal as some companies enable you to do multiple in a year at a reduced price1). Perhaps you collaborated with an academic lab and they will put out a press release, so that is taken care of. You could let other organisations in your city or state know that you have been successful. All of this may seem self-serving, but it can open doors in your area; it can make bigger companies aware of what you do. Having a presence and communicating your successes are part of running a company and, generally, networking. Each grant you win is an investment in more ways than one. Over time, they can all add up. Each time you share news of these successes with your growing army of followers, you are also building a brand which is another part of small business grants, getting visibility for your product that comes from the grant. Sure enough, you could hire someone to do this for you, and maybe once you become successful and much larger, you will indeed do this, but at the start, it is all on you. So it is also important to remember – do not forget to put out the trash as well. Can you think of anything else you need? For example, when drafting a patent, you could save some money by doing this yourself before handing it over to a good patent lawyer. Confidentiality disclosure agreements (CDAs), material transfer agreements (MTAs) and other such forms – sure you could find examples online that you could edit, but why not get your own custom versions from a lawyer? You may not need a company lawyer in-house, but you can leverage them when needed. It is the same for accountants – you will need one for filing taxes and to help when it comes to the eventual audit. Some grants will require you to have financial controls in place as well, and you will need to write them too. The Department of Defense (DOD) has regulations for information technology (IT), and that is on you too, unless of course you invest in a consultant who can do this work for you. You can see the pattern that is developing here. You win a grant, and the floodgates open in the amount of work it takes to keep the ship afloat, let alone aimed in the direction in which you want it to go. You will feel at times like you are doing literally everything; the grant was the tip of the iceberg because it will create work that you would not have foreseen. Now imagine scaling this as you win grant after grant, and you can see why you need to hire good people to help you make progress. Of course, you will also need to remember that the reason you pursued grant funding is because it is non-dilutive, it is free, and buys you time before you eventually will lose some or most control upon angel or venture capital (VC) investment. The longer you can stretch non-dilutive funding, the more value you can retain for yourself. It is as simple as that. If you can do something that needs to be done and it

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is important for the project or company, clean the coffee maker, vacuum the floor, just go ahead and do it yourself. You are also hopefully setting a positive example to your employees; if they see you, the CEO/founder, doing it, they will realise that you are not above doing the humblest of tasks. Never lose sight of that; you are the principal investigator (PI) on the grant, and you will own the company and literally everything you will need. I often joke when giving tours of our lab – the ultraviolet-­ visible (UV-Vis) spectrophotometer is the BMW I did not get the chance to buy. I am telling you all these realities before you write the grant because once you are successful, all this will be yours. Do you still want to do it? If so, then proceed further. If not, then now would be a good time to think about why you started the company and how you plan to go forward. The next chapter will bring you to the various elements of the grant and will provide examples from my winning grants that may help you structure your own or, at the very least, give you an idea of what you have gotten into.

Chapter 6

The Grant Package

Abstract  This chapter describes all the main parts of the grant package with examples from the author’s own grants. The sections include the cover letter, narrative, aims, research strategy, references, budget justification, facilities and resources, equipment, authentication, resource sharing plan, SBIR/STTR commercialisation history, commercialisation plan, vertebrate plan, select agent research, human subjects, introduction, progress report, multiple PI plan and consortium agreements. Keywords  Cover letter · Narrative · Aims · Research strategy · References · Budget justification · Facilities and resources · Equipment · Authentication · Resource sharing plan · SBIR/STTR commercialisation history · Commercialisation plan · Vertebrate plan · Select agent research · Human subjects · Introduction · Progress report · Multiple PI plan · Consortium agreements

By now, you are thinking we are nearly halfway through the book and have not learnt anything about what should be written. Well, that is simply because most of a grant (e.g. a National Institutes of Health (NIH) grant) is not the written text on what you plan on doing; it is instead the biosketches, facilities, equipment, letters of support and more. Each type of grant is slightly different, depending on the institute. For example, a typical NIH grant will have the following documents in addition to the biosketches (described earlier), and you can consider this a checklist of sorts: cover letter, narrative, summary, aims, research strategy, references/bibliography, budget justification, facilities and resources, equipment, authentication of key biological and chemical resources, as well as data and software sharing plan. Optional forms also include small business innovation research (SBIR)/small business technology transfer (STTR) commercialisation, commercialisation plan (for Phase II SBIR and STTRs only), vertebrate plan, human plan, progress report and introduction (for re-submissions only). You could initially simply create these as separate files, or you can concatenate them into one big document while preparing them, whichever fits your style. Either way, ultimately, each file will need to be saved as a Portable Document Format © The Author(s), under exclusive license to Springer Nature Switzerland AG 2023 S. Ekins, Winning Grants, AAPS Introductions in the Pharmaceutical Sciences 17, https://doi.org/10.1007/978-3-031-27516-6_6

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(PDF) for upload into the eventual grant, paying strict attention to border/margin, spacing and font sizes. Of course, technology and requirements change, so what may be needed at the time of writing this may not be the same as when you are submitting the grants, so it would be good to check the request for proposal (RFP). Let me now add a little more detail about how I would go about writing these documents.

Cover Letter The cover letter (Fig. 6.1) is a document that is not seen by the reviewers, just the programme management and grant officials. This is usually a one-page letter (with a header and personal signature). It is a good idea to specify the grant title and the grant type you are submitting for. I also include an extensive list of people or companies that I do not want to review the grant. This is culled from a list of people who might be seen as competition or who could benefit from knowing about my work. You should also ensure this cover letter has a letterhead for a professional appearance.

Fig. 6.1  An example of a cover letter

Aims

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Fig. 6.2  An example of a narrative

Narrative The narrative (Fig. 6.2) is a three- to four-sentence accessible summary of the grant, distilling the essence of what the product is (if it is an SBIR/STTR) or what the grant is about and aims to achieve at the end. I would normally do this last once I have completed everything else.

Summary For the summary (Fig. 6.3), I always aim to write about a half page of text, describing in an accessible way the justification for the proposal (with some brief background), which is the focus of the grant. Importantly, this will be made public if the grant is funded, and it will appear in the NIH RePORTER database; therefore, do not write anything that can be considered confidential in the summary!

Aims The Aims (Fig. 6.4) is probably one of the most important documents in the proposal. Normally, you have a full page to expand upon the summary, so definitely add more detail and focus on what will be achieved. I usually use a quarter of the space for a brief background justification of the grant proposal and then more details on the usual two to three aims. I then break each aim into sections, such as an objective, rationale, approach and milestones. Structuring in this way forces you to think about what you are doing and how the aims fit together. Ideally, it is best not to have dependent aims (otherwise, the reviewers will pick up on that), although sometimes this is unavoidable, and if so, justify why this is the case. If you have space at the end of the aims, in one or two sentences you can summarise what will be ultimately achieved at the culmination of the grant. If it is a Phase I (SBIR or STTR) proposal, you could end with a summary of what you would propose for Phase II. Spending more time tightening up the Aims and making it accessible and clear to the reader is advisable. It also needs to reflect the Strategy document exactly because if your

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Fig. 6.3  An example of a summary

aims differ in both, the reviewers will spot it, and that might impact your grant score. If the reviewers are in a rush, it is likely they will focus attention on the Aims.

Research Strategy Simply stated, the Research Strategy (Fig. 6.5) is the main document in which you must explain what you want the money for. If you have considerable unpublished and confidential data on this, then it is well worth adding a statement at the outset or highlighting such data. The request for application (RFA) will usually give you a clear idea of what they require in each section of the proposal, and the research strategy is important, so please check beforehand and ensure you follow to the letter what is requested. I normally break the six pages (for a Phase I proposal) to 12 pages (for a Phase II proposal) up into sections as follows: firstly, a ‘significance’ section to provide a background to the grant, and depending on the space available, I would dedicate at least 20% to this. In the next section, I would briefly describe myself and my team and why I am uniquely qualified to do the work or develop the technology/product. It is also a good idea to describe the potential impact of the technology or product when you are finished. This is a good lead into a brief section on the

Research Strategy

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Fig. 6.4  An example of aims

‘commercialisation pathway’. In a Phase II STTR or SBIR, this can be expanded into a separate 12-page document (see later). Many grant types are looking for innovation, so you may want to clearly list any innovative aspects of the proposal. If you are also able to include some preliminary work of your own or from others, you should summarise it. This can include some degree of detail on experimental

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Fig. 6.5  An example of a research strategy. Redactions are for confidentiality purposes

Research Strategy

Fig. 6.5 (continued)

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Fig. 6.5 (continued)

6  The Grant Package

Research Strategy

Fig. 6.5 (continued)

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Fig. 6.5 (continued)

6  The Grant Package

Research Strategy

Fig. 6.5 (continued)

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6  The Grant Package

methods. If this is a Phase II proposal, you should include a summary of the Phase I results as a mini report and ideally show that you achieved the aims you proposed. If you did not, then you should provide an explanation to justify any alternative steps that were undertaken. By this point, you can focus on why all these data justify getting more funding. The next section on strategy and methodology should proceed aim by aim and ideally expand on the text from the separate one-pager aims and go into deeper detail on what you plan on doing if funded. This section represents the bulk of the grant (so try to aim for 60%). Include clearly measurable milestones and alternatives if things do not go to plan. Adding some detail to a grant timeline or a grant chart is helpful for reviewers to see how each aim or part of an aim fits together. You do not need fancy software to produce such graphics, an Excel or PowerPoint image should suffice. Just ensure that it is clear and readable. The final section of the strategy should be the expected outcome or result. This is a further place where you can address alternatives if the project does not go as planned, and you can also describe ideas for the future if you are ultimately successful. I should also point out that any figures or tables should all be legible, so you should ensure they are high resolution. As the requirements for grants change periodically, it can feel like you must address everything. However, resist the temptation to squeeze it all in. Some sections of the grant, like authentication, can be uploaded as separate sections, so you can briefly refer to this in the strategy and point to the fact that there is more detail in a separate document.

References/Bibliography There is usually not a great deal of information on formatting the references/bibliography (Fig. 6.6), but unless specified, it probably helps to use the ‘NIH format’ in reference manager software, like Endnote, or pick a well-known journal type. Again, it is important to not neglect this section. Some grants may not allow references or have strict limits on the number of references.

Budget Justification Depending on the grant type, one can think of budget justification (Fig. 6.7) as a high-level budget listing the personnel and materials. I usually write a short paragraph on each key person named in the budget and why they are relevant, describing their role and expertise. If you plan on a travel budget, explain what it is for, whether that is attending a conference, training or meeting a collaborator or consultant. It will help break down the number of flights and hotels with an approximate cost estimate. The materials and supplies needed can be addressed at a high level as you do not need to list small consumables. If you request a budget for a piece of

Budget Justification

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Fig. 6.6  An example of a reference document that has been abbreviated and uses the ‘NIH format’ in Endnote

equipment, plan on providing much more detail and a separate quote to justify it. Some grants may not allow this. You can list any consultants or sub-awards as well. If you are a small company, it helps to outline your facilities and administration (F&A) and fringe rates. Do not list items like laboratory or office rental fees or

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Fig. 6.7  An example of budget justification – redactions to obscure personnel

anything that should be covered by the F&A. If you are applying for an STTR and SBIR, you can also request a fee, which is currently up to 7%, so please remember to detail how much you are requesting. The fee can be used for things that are outside the grant, such as legal fees. You do not have to list how you plan on spending these fees. The important thing to remember is to make your budget reasonable to get the work done. If you ask for equipment or funds that are excessive, the reviewers or administrators may pick up on that, and they can propose budget cuts, which you really want to avoid if possible.

Facilities and Resources

41

Facilities and Resources Like an animal puffing itself up to make it look bigger to a predator, you need to make your small company look credible, and the Facilities and Resources (Fig. 6.8) section is a potentially infinite-sized document with which to do this. If there is information you cannot fit into the Research Strategy section due to page restrictions, then consider adding it to this section. In all my years of grant writing, I have not seen any comments that have made me change the format. Firstly, you would like to describe your office or laboratory environment, and if you have a floor plan, include it so the reviewers can see what they are getting for the money asked for. Go into some detail about your space and facilities. If you are a chemistry laboratory, then detail the equipment the lab offers, the chemical hoods,

Fig. 6.8  An example facilities – redactions to obscure personnel

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Fig. 6.8 (continued)

6  The Grant Package

Facilities and Resources

Fig. 6.8 (continued)

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Fig. 6.8 (continued)

6  The Grant Package

Facilities and Resources

Fig. 6.8 (continued)

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Fig. 6.8 (continued)

6  The Grant Package

Facilities and Resources

Fig. 6.8 (continued)

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Fig. 6.8 (continued)

6  The Grant Package

Facilities and Resources

Fig. 6.8 (continued)

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Fig. 6.8 (continued)

6  The Grant Package

Facilities and Resources

Fig. 6.8 (continued)

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the gases etc. If your space is in an incubator, then describe what other services are provided as part of your rental fee. Please do include photographs to show off what you have, even if modestly equipped, but remember it helps if your space is preferably organised (think tidy) and professional looking. If the only major equipment you have is computers, then list them all in some detail (brand, chips, memory, graphics cards etc.). Similarly, servers, printers owned by you or software that you license are all important to include to emphasise that you have the tools needed to do the work. If there is software or equipment that you have developed, it is worth also highlighting that in some detail, as well as an asset, especially if it was developed with an earlier grant. It may be important that this is outside of the present grant if you are trying to win a grant for software development. You can also summarise your company and describe your employees (perhaps add an organisational chart), as well as consultants and a scientific advisory board. If you have collaborators involved in the proposal, it is also worth adding their facilities section to yours, making clear to separate their laboratory information from your own. Reviewers will certainly look for this in a proposal where there are collaborations and multiple principal investigators (PIs). It is also worth listing any additional facilities you can access or leverage, such as through adjunct appointments or memberships. In our Facilities document, I also describe in some detail the software developed to show that we have developed a tangible product.

Equipment If you have a laboratory inventory of major equipment (Fig.  6.9), it is probably worth providing this listing for completeness. If you have no laboratory, then exclude it. If you have collaborators involved in the proposal, also add their equipment section, again making clear to separate what is theirs from your own.

Optional Documents Authentication of Key Biological and Chemical Resources Although the Authentication of Key Biological and Chemical Resources (Fig. 6.10) section could be seen as optional in most grants, you will need something like this document. There is considerable concern about data reproducibility and quality in biomedical science. Underlying this involves ensuring the quality of the materials used, whether they are chemicals, reagents, cells or other critical materials used in a grant. You will need to justify how you will ensure that what you use is what you say it is. If you are developing software, then you may also need to address how you will ensure software quality and interoperability; perhaps also mention how it would

Optional Documents

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Fig. 6.9  An example of an equipment document

Fig. 6.10  An example of authentication of key biological and chemical resources

comply with any desired requirements needed for the grant (e.g. findability, accessibility, interoperability and reusability (FAIR)).2

Resource-Sharing Plan I always think of the resource-sharing plan (Fig. 6.11) as a data and software-­sharing plan because these are the aspects my company will normally develop in any proposal. It could also relate to molecules or equipment if that is your forte. But this section’s content is dependent on the grant type as there may be specialised

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Fig. 6.11  An example of a data and software-sharing plan

data-sharing requirements; e.g. if the grant is focused on developing software for the community, then you need to specify that at the culmination the software will be made (freely) available and how you plan on doing it via repositories like GitHub or specific databases like the Protein Data Bank (PDB) for protein structures. Similarly, if you are creating data during a proposal, then you need to deposit them somewhere publicly, if that is your goal, or you could publish them and share them with the community. You could do some, any or all of the above, the key thing is to justify it. If you are creating a commercial product and your software or data are integral, it would be reasonable and prudent to not make either available, except if licensed etc. It may also be worth stating that you may share the data after you have patented them if you are creating intellectual property that could ultimately be valuable.

SBIR/STTR Commercialisation The SBIR/STTR Commercialisation (Fig.  6.12) document needs to only list any Phase II SBIR or STTR grants obtained by the company. Include the institute, the grant number, the dates, your role and a (very brief) summary of the grant. You can also include how the grants have led to revenue or consulting fees as desired. This document may not be needed for all grants.

Commercialisation Plan Prepare yourself; if the grant is a Phase II SBIR or STTR, you will need to submit a detailed commercialisation plan (Fig. 6.13). I would look at this as having an equivalent impact as the strategy because this is demonstrating that you have a plan for the final product. Think of it as a 12-page business plan, a space for you to ‘sell’ your idea and the company prospects, your product and ultimately how you see it making money. Again, if there is information that you do not have space for in the research plan, then it might fit in this section. I always start this document with a statement of my product need – literally, why it is needed and what gap it fills in the marketplace. It is important not to reiterate

Optional Documents

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Fig. 6.12  An example of SBIR/STTR commercialisation history

everything in the Research Plan or Aims, but make sure you cover at a high level the key points you need to get across to the reviewer to show the value of what you are proposing in the grant. It does not hurt to also summarise very briefly what was achieved in Phase I (or up until that point if it is a direct to Phase II proposal). Again, if you have won any grants up until this point (including the Phase I grant), you can list them in a small Commercialisation History section by providing as much detail as you can. Include a fundraising plan for the company if you have one and how you plan to raise any money, whether from angels, venture capital (VC) companies or other sources of dilutive or non-dilutive funding. This could include a listing of companies you have pitched to over the past year. You may want to describe any business proposals or contracts that you have pending or any negotiations in play at that time that you feel comfortable and are permitted to mention. Obviously, if it is highly confidential, you can obfuscate it as well. If you have major customers and they allow you to mention them, it would benefit your proposal to do so. It is important to illustrate what your company’s plans are, what it wants to be in 5 years and what products it has, for example; these are all good areas to address in some detail. You can dream a little here, but make it sensible and grounded. Imagine the future of the company, but at the same time it must be plausible. The grant proposal you are pursuing may be just one aspect of the company, and there may be other capabilities or expertise you could highlight and describe in the summary of the company. Who the key employees in the company are and what their background is are certainly some things worth adding to the grant. You can really go into some detail listing what they have developed, discovered or published or anything that is relevant to the grant. If you have a company pipeline of assets (e.g. molecules, software or other products), you can also describe them and add a table or graphic as well. In the commercialisation plan, it is also important to communicate that you have done your homework and market research for the product area you are developing. Fixating on your product for 12 pages is not going to be enough if there is a competing product that you have neglected to mention, and the reviewers will know about it. Do your homework before writing this section, and of course, that will take

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Fig. 6.13  An example of a commercialisation plan (see case study in Chap. 11) – redactions to obscure personnel

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some additional time. You should therefore list your competitors and their products, as well as how your product stacks up against them. This could be done in concise paragraphs of text, or you can tabulate the products and show the pros and cons. If you are creating something as a product, you will also need to describe how you will protect any intellectual property you create, whether by keeping it secret, patenting or trademarking and so on. If you have patents or trademarks for your products already, then list them all as they will help instil further credibility for your company. Similarly, if you have Food and Drug Administration (FDA) or European Medicines Agency (EMA) orphan drug designations, investigational new drug applications (INDs) or other approvals, you should also add them for the same reason if they are relevant to the proposal. Developing a product is one thing, but how do you plan to make it and market it to the customer? These may not be things you can include in the costs of the grant (similarly, legal fees are non-allowable), so you need to explain how you will do things, such as those that are outside the grant but key to commercialisation. Again, anything you can add here to demonstrate you have thought about it and come up with a solution should help the reviewers see that you are thinking about these things ahead of time, being proactive rather than reactive. What is the market size and value of the product? Can you put a number to the disease or the product type, and if so, what is it? Perhaps someone else has already estimated the market size, and you can cite it. Beware of those consulting companies that provide extortionate reports on such topics, but at the same time, you can learn from the information they make available because it might help you. How will you generate revenue? This could be licensing, consulting all the way through to the sale of your company. These can also be expanded upon with estimates of how much each would deliver. All these steps may lead to a return on investment (ROI) for the grant. If the grant investment is $1 M but you see the product leading to a valuation of $10 M for your company and an eventual sale, you can achieve a 10x ROI. Twelve pages of deep commercialisation discussion may also benefit from an executive summary at the outset or at the end so that it refreshes the reviewer on where you are going or have gone in the document. This will also reiterate key points for them to remember. Reviewers may not pay as close attention to this section, but any way you can make it easier for them to digest or remember it will also greatly benefit you. Consider providing concise statements that may draw the attention of the reviewers such that they may reuse them in their reviews. In this way, you can essentially put words into their mouth.

Vertebrate Plan If you include any vertebrate animals in your proposal, you will need to provide a detailed vertebrate plan (Fig. 6.14), which will provide details on their use, including a summary of the proposed study and a justification for their use. The type and number of animals will need to be described. The justification for doing animal

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studies needs to be clearly stated. How you will address pain and distress for the animals and finally how you will euthanise the animals at the end or at any time during the study will also need to be detailed. If there are ethical approvals pending, then these need to be stated as well. Depending on the animal type, the number of studies and their type, this section will vary in length. For example, are you working with fish embryos, mice, through to non-human primates, each will have different needs. It is essential to include this document even if you are not doing the work yourself, e.g. if it is outsourced to a collaborator or a contract research organisation (CRO). In this case, they may be able to help you draft it or provide the language and details you will need. If this document is incomplete, it may create a red flag during the review process, so it is well worth being comprehensive. Having the CRO or an expert go through this document or, better still, having them write it would be the ideal situation if this is an area you have less or no experience with.

Select Agent Research If your proposal includes a biological agent with the potential to pose a severe threat to public health and safety, then you will need to provide a Select Agent Research document with information on what the agent is and how you or your collaborator/s will ensure compliance with regulations to guarantee there is no accidental exposure. A laboratory needs to describe the registration status of the institute and where the agent will be used. Clearly, you will also need to describe the security and other steps in place to ensure the agent cannot be obtained by those without authorisation. This is a specialised document, and if you have collaborators that are working with the select agent, you should obtain their help for this section and have them write it so it is convincing.

Inclusion of Human Subjects and Clinical Trial Plan If your proposal includes a clinical trial or uses humans in any way, then you will need to prepare this document. There is likely to be a whole section of the submission dedicated to this if appropriate. For example, if you are using human research subjects to gather data in any way, then you will need to document it to comply with regulations. There will be very specific requirements if it is a clinical trial, such as inclusion and exclusion criteria. If this is not your specialty, then a consultant or collaborator that can help would be ideal to accurately prepare this.

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Introduction If you are re-submitting a grant, you normally have a single page to rebut and address the reviewers’ comments, and this is called the Introduction (Fig.  6.15). Although you may disagree with the reviewers strongly, it is probably best not to

Fig. 6.15  An example of an introduction (see case study in Chap. 11)

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fight them and to outright dismiss their comments but to just highlight the major issues you have addressed and not focus on why you think you are right. Bite your tongue; do what they say is probably the wisest move. It can help your cause if you thank the reviewers and tell them you have done as they requested and move on. If you have new results or publications since the first submission, then highlight them, especially if they help address reviewer comments. Do not expect the reviewers to notice any changes you have made (unless you mark them up) as you may have a totally new set of reviewers for the re-submission. You only have a page to fill, so make every word count. If you have lots of comments to address, think carefully which ones are critical and worth describing as others may be less impactful. Sometimes writing less can be more impactful. You will notice in Fig. 6.15 how there is a line space between the short paragraphs. This can draw attention to what has been addressed. In contrast, a full page of single-spaced text may be a suboptimal way of communicating what has changed.

Progress Report If you are re-submitting a grant, you will need a progress report (Fig. 6.16) in which you may include a summary of any publications, presentations, posters or other materials that you have generated in the interim. This will illustrate what you have done and the overall productivity, which may impact the proposal. If you are writing a Phase II grant, this information may also be included in the commercialisation plan as part of your marketing, as an example. It may be advantageous to repeat it to emphasise productivity.

Multiple PD/PI Leadership Plan If there are multiple PIs on the grant, it is important to describe the role of each and how there is a complementarity of each person’s skill sets in the multiple professional development (PD)/PI leadership plan (Fig. 6.17). It will be key to describe how often each will communicate and how they will do it (whether this is in person, by Zoom or by phone). Also, the decision-making process for the PIs could be described and the responsibilities for each defined. In case there are conflicts or major disagreements between PIs during the project, you will also need to have a plan to resolve them with some neutral decision-making individual or body. Similarly, it is worth describing who does what with the budget and reporting process.

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Fig. 6.16  An example of a progress report

Fig. 6.17  An example of a multiple PI leadership plan – redactions to obscure personnel

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Consortium/Contractual Arrangements If you have a collaboration with an academic institute, this document may be an agreement that you have both signed, or it could be a brief letter of intent confirming that if the work is funded, the institute will do the work proposed. Similarly, if you have any outside group, like a CRO or a contract development and manufacturing organisation (CDMO) that is performing a substantial portion of the work in the grant, you could also add a letter from them or a quotation. Similarly, if you have licensed some intellectual property as part of your proposal, this might also be a place to add a letter from the licensee. Some reviewers may identify it if it is missing, and this could derail your proposal, so it is best to include it. Now that you have a better idea of all the grant components, it is time to get to writing, and there are some tips that may help as you approach the main event.

Chapter 7

The Main Event – Writing It

Abstract  Writing the grant can be overwhelming so this chapter eases the reader into the author’s strategies for making this easier whether doing this solo or as part of a collaboration. The first draft is just the beginning. Keywords  Strategy · Writing · Organisation · SBIR · STTR

If it is your first time writing a grant, then by now you may be just a little overwhelmed by all the different aspects that you need to prepare. Even if the grant is small, you will likely need to literally tick off many of the boxes and complete most of the documents in the preceding chapter. In addition, the grant package will have other sections that you need to complete separately. Depending on the grant submission  method used for the proposal, a current small business innovation research (SBIR) grant application requires multiple portable document format (PDF) files into which you attach the individual documents (as PDF files) described in the preceding chapter. While the mechanism for putting such grants together changes regularly, the essential information needed will not. An SBIR also has several parts that require filling in several forms in order to provide information, which include: the SF424 form which lists the submission type, principal investigator (PI) and other information related to the PI and company, SBIR/STTR information relating to type of grant, and the company, the key person section which needs contact details for each person, other project information where you can expand on if other countries are involved etc. All the sections in the preceding Chap. 6 require you to write. While the ‘main event’ of the grant, the strategy, may only be 6–12 pages of text depending on the type of grant, the other sections will ultimately add up to several times this. A budget justification may be at least one to two pages, and facilities could be one to ten or more pages. Even if many of the other documents only represent a single page, this is still an additional page that you must write. Of course, at this point, you could hire a grant writer, but they will predominantly focus on the aims and strategy. You still need to write coherently to ensure your message in your biosketch gets across to the reviewers. The onus then is on you to do all this and polish up this capability. © The Author(s), under exclusive license to Springer Nature Switzerland AG 2023 S. Ekins, Winning Grants, AAPS Introductions in the Pharmaceutical Sciences 17, https://doi.org/10.1007/978-3-031-27516-6_7

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If you are confused as to where the best place is to start writing the grant from scratch, you can always start small. Craft a summary document of what you want to do, then expand to an outline of the aims and then onto the strategy. The very short narrative could be left until last when you already have a solid strategy and you have read it enough times to know it in your sleep. A succinct explanation of the grant is probably the least important thing you might think about, but for a reviewer, it is a sound bite that they can quickly repeat when they write their grant review. It helps to have already written something previously that will be the subject of the grant, and that can help when it comes to writing six pages of a single-spaced strategy. Perhaps you have one or more manuscripts, a report or a white paper that you can use to provide a foundation for writing. These may provide you with the bulk of the text or science, which you can extract and use to build up the skeleton of the strategy. If you are starting a grant from scratch, you need to consider that it will take you far longer, and it is important to take this into consideration to give yourself plenty of time to put the proposal together. If you have never done a grant and you need to learn everything as you are doing it, then it may take you several weeks to prepare, whereas once you have written a grant on a topic, perhaps you could do another on a similar or closely related topic in just a few days. Honestly, once you have done it once, the second is easier. Putting a multiple-PI grant together may require discussions until you both (and all) have agreed on the plan. But still, someone must take responsibility and write a first draft. If you are the main contact PI, then it is your responsibility, and there is no getting away from that. You will need to ensure that everyone involved knows the deadline and delivers their part on time as the last thing you need is a collaborator who becomes a bottleneck and holds you up or delays progress. A busy PI submitting too many grants at the same time might not be able to afford much time for your current grant, so you may want to rethink if they are the right person to work with altogether. Frankly, it goes without saying that everyone is busy with their own career, family and life in general, and they might not be good collaborators once the grant is funded as you would be fighting for their time with their other competing interests. If you can do a rough draft of the strategy with all the main components as a dry run, you will also see how the distribution in terms of page space allocation appears. If half of your strategy is taken up with an introduction to the topic, then you need to substantially trim it. If you have less than a page on what you plan to do with the funding, you may want to increase that dramatically. The strategy, after all, is not a platform for you to review the topic. Which brings us to the heart of the matter. You may be the expert on the topic of the proposal or you may have invented or discovered the subject, but you still must ‘sell’ the idea and why it is important to fund it, whether that is because it is an exciting new area of science or an important new class of drugs for disease ‘X’ or even a piece of technology that will revolutionise drug discovery, for example. You not only need to distil into a few pages your knowledge, excitement and passion for the science and where you want to take it, but you are also selling your idea, to the extent that you need to get the reviewer to see it and the commercial potential the same way you do.

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If there are gaps in the science or what you are describing, it is probably best that you mention them; otherwise, you are providing the reviewers with ammunition to use against you, and they will find the gaps to be sure. The reviewers may not put all their attention into reading every page of the proposal, but they will find holes in a proposal if you leave them wide open. Try writing defensively, by imagining what the reviewer may see as a weakness, either agree, yes, it is a weakness or find and propose a solution and that is what you would do with the funding. If a colleague asks me to review their grant, I would be looking for the weaknesses. As an aside, if you get a colleague to read your final draft grant (even if it is just the strategy), that is always helpful so you can obtain another fresh perspective on it. After spending day after day reading the same text, you will miss small errors in it. Take a break from it for days, a week or longer and go and do something else, then come back to it with fresh eyes. Alternatively, instead of reading the text on the screen, periodically print out your work, sit down and read through it with a pen or pencil in hand. I can guarantee that doing this will immediately make you rewrite sentences, replace words, even rearrange whole paragraphs and see obvious errors that you would have missed otherwise. Your reading pace will be dramatically different when you do this versus doing it on the screen, and you may also hear your inner voice speaking the words in a different manner. These are admittedly really very simple strategies and very low tech, but you need to leverage everything you have in your toolbox. Of course, using a spell checker and grammar-checking software is also important and could help with the quality of your overall proposal. If your finished work is full of typos, it is not going to reflect well on you at all, and the reviewers may also infer that your science will be of poor quality as well. If you are writing the grant completely on your own and you have reached this point, you deserve some encouragement. You may not be a professional writer, and I do not think that you need to be. Just use all the skills and tools available to you. If you have a writing style that is different from that of your collaborators on the grant, it will be important for you to ensure the strategy reads seamlessly (look for the use of different tenses); otherwise, it may not facilitate easy reading for the reviewers. A choppy-reading strategy document that jumps around stylistically will do you no favours. You are taking on this responsibility for the team, so the final edits must rest with you as well. It is always a good idea to write as concisely as possible and get to the point (this book included, that is why it is short). The reviewers will have limited time, so by reaching the point quickly, they can see the goal of the proposal, and then everybody wins. There are plenty of books on good writing style, such as Strunk and White,3 which are well worth the investment. There are also dedicated books on grant writing in other areas. You can benefit from consulting too; go do a bit of searching at your local library or bookshop, which will provide another opportunity to take a break from writing. The way you organise and lay out the strategy is also important. If you can make it clean and uncluttered such that it is easy to read with font sizes that do not require a magnifying glass, then again that will aid your cause. Try to provide white space in between sections, and make sure any figures or tables are spread out and close to where they are cited. If I am honest, I probably spend far too much time working on

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the figures and adjusting their size and moving them around. Again, a figure included should be something that provides valuable information and communicates well to the reader what it is about and stands alone. Figures without legends do not help anyone, and I would discourage them altogether. If the data are shoddy and the resulting graph looks suspicious, you should perhaps reconsider its inclusion. If you have amazing preliminary data, please make sure you stress this in the text and that the figure legend clearly describes what it reflects. Taking care of and devoting time to your Strategy section to make it look as professional as possible will pay off. Again, as you obtain experience with grant submissions, you can rapidly progress through your strategy writing and what is needed to be convincing and win the grant. But the first few proposals are going to seem like a ‘trial and error’. Perhaps especially once you get to ‘bigger ticket’ grants or when you progress to a Phase II proposal, writing can also feel like you are writing 5x Phase I proposals as the workload is much more substantial even though the strategy is only double the number of pages. Breaking a big grant into smaller sections (see Afterthoughts), like taking chunks and getting a team member or collaborator to write it, can take a bit of the pressure off, and any other writing approach you can apply that gets what you need when you need it is certainly worth trying. For example, setting yourself micro-deadlines, like setting a goal of writing the introduction by lunchtime or writing 500 words in a day, might work for you. Something that is measurable and that you can use to spur yourself on may help make it seem less like climbing a mountain in a day. The grant strategy is almost certainly the main event, and you will spend most of your time on it. It should perfectly encapsulate, from the first page to the last, what the grant is about and what your plan of action is. Whether you can achieve it is in the eyes of the reviewers, but if you can write a near-perfect proposal and convince them you can do it, then you are obviously closer to winning. Any of the other parts of the grant could also hinder your score, but the strategy is the keystone of the proposal. Other types of grant-funding agencies will have a different array of forms to fill out, but the common documents, such as the Aims and Strategy, are going to almost certainly be the focus of any reviewer. Your proposal must speak to me as a reviewer and tell me why it is important, what data if any you must generate to support it and what you plan to do to develop it further. Ultimately, what is the endpoint or product of the proposal? How will it have an impact? How will it make money? What will it do for the company or society in general? Writing a grant is almost definitely a roller coaster adventure the first time you do it. There are so many unknowns, and the learning curve is steep. But the next few times, it will be easier unless it is a grant from a different funding body, for example from the National Science Foundation (NSF) or Department of Defense (DOD), in which case you may have a new set of rules to learn for the grant, new requirements, new font size, new budget, other limitations for the biosketch and more. The journey of grant writing can be quite repetitive; there may be some detours along the way and frustrations, but ultimately, winning grants is the destination or finish line you must aim to reach. Investing time in writing the strategy is well worth it in the same way that writing a manuscript may bring you visibility for your science, or you can think of creating

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content that can be used in a future grant as preliminary work. Once you have a strategy or whole grant written, you can reuse small parts of it for your future grants, but ensure your grants are unique. Quite often, even bits of my failed grants may pave the way for the future writing of winning grants or even help inspire writing papers. Take an idea or concept that does not work in one context, but try it in another. Having a biosketch done and ready may also help you if someone else invites you to be a contributor to their grant at short notice. A few minutes spent updating it will be a small investment compared to the likely several hours putting it together from scratch. Over time, you will see your grant writing as an immense canvas that you have created and can zoom into at any time to extract pieces that you need for the next project. Clearly, you do not want to be writing the same thing repeatedly, but once you have written that first grant proposal, the next one will be certainly less onerous and, may I say, enjoyable. Consider the first draft of the whole grant as just the beginning, but you can try to improve it before you are ready to submit it, and I would highly recommend ensuring you leave time for that. The next short but important chapter offers some advice and strategies to do this repeatedly.

Chapter 8

Edit, Polish, Shine and Repeat

Abstract  It is likely that what you write in the first draft of the grant will need editing and further refinement. This chapter makes the point that it should go through several iterations until you eventually draw the line and stop. Keywords  Editing the grant · Checklist

Time will always be your number one enemy when preparing the grant proposal. The deadline for submission looms large on the horizon, and it will feel like you still have most of the grant to do as pressure builds up. You can always keep on writing, but eventually page limits and time will surely prevent you from going further. Reaching the maximum number of pages will also cause you to rethink how to squeeze in what you have missed. Perhaps you forgot some data you should add. If you are indecisive, then writing a grant will be exasperating. There is an infinitely large array of options on how to write, reword, organise or present the proposal. For example, do I highlight, italicise or underline that text? Do I want to put that section in a box to draw more attention to it? My answer is – do all these things in moderation. You can do much more too, but it comes down to you what works for you. Are you happy with the finished product, and does it hold together or look disjointed? The above is not really writing the grant, but it is important for editing it. You can write a grant, but can you also edit? This is yet another important skill you need to add to your list. Why would I include a chapter on editing a grant in a book on winning grants? Editing is vitally important; it can save you from making mistakes, and it enables you to shorten the proposal so you can have more space to insert something else that may really make the proposal shine and stand out from the pack. One cannot underestimate also doing this repeatedly. Editing it once is sufficient but may not be enough. Ideally, you will be editing as you go, as ideas pop into your head, or following meetings with your collaborators. Writing the proposal is certainly progress, and once you have a draft, you will want to read it carefully and edit it, iterating through a few cycles until you literally have no more time left. I would call this the edit, polish, shine and repeat cycle. If © The Author(s), under exclusive license to Springer Nature Switzerland AG 2023 S. Ekins, Winning Grants, AAPS Introductions in the Pharmaceutical Sciences 17, https://doi.org/10.1007/978-3-031-27516-6_8

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you plan on at least doing this four times at the minimum, you should have a proposal in good shape. Obviously, some sections may require much more attention than others (Abstract and Strategy would be my suggestion to focus on). Yes, that is right. Please read the whole proposal at least four times all the way through, and ideally have others read it too if you can. Each time you will find something you missed, such as small typos and punctuation or grammar issues but perhaps something bigger too. Of course, this is only my recommendation. I would also probably do it many more times if this were a very high-value proposal, and of course it depends on how much time you want to invest in the proposal. Small edits can make a huge difference. Perhaps the units of measurement were incorrect, maybe a reference was missing or maybe your figure and table numbers do not synchronise with the text. If you cannot read the figure or text on the screen, then you need to increase the size. If you need to make some space to add something else, you can move text or cut sections that repeat or seem unnecessary. Tightening up the proposal through several cycles of editing is slow, but it will pay off. Having others read through at the draft stage is an obvious safety net for you to identify items you may have missed. By now, you are possibly getting to the point literally hours before the deadline, and you are still tweaking the strategy. Yes – that’s me nearly every time. It is not ideal. However far in advance I start a grant, it virtually always goes down to the wire. I think it is from that desire to constantly improve it. Does it impact whether I win the grant or not? Probably not. Perhaps a better way to do this is to come to an agreement with yourself or the team that you will submit a few hours or even a day before the deadline. This way, it will prevent last-minute edits and give you time to double-check for any errors. Knowing when to stop editing, a process that literally could go on infinitely, may not be something you give any thought to at the beginning, but when you get to this point, you will realize you need to allocate time to do it, and it can throw open more time requirements. It may force you to check something you have written; perhaps the automated bibliography references were not imported correctly, and the reference list is incorrect (yes this has happened to me). Finding an error like this could ultimately open a whole can of worms, in that you need to add the references separately one at a time, that then slows you down. You may become so close to your proposal that you literally dream about what you are writing; it becomes an obsession. The first grant you write, as I have stated, is monumental, so once you complete it, you are no sooner on to the next one. I can see why it would inhabit your dreams or nightmares. Often, the subject is the error or typo I missed. Did I put the correct figure in the proposal? Or did I arrange it correctly or describe the important result correctly? All these things and more may haunt you. Having a checklist of what you need for the grant proposal may be another useful aid. One line could be editing the proposal, and when that is completed, you move on to the next stage. Perhaps this would be compiling the final versions, creating portable document formats (PDFs) for submission or doing something else important in readiness for submission. Depending on your level of organisation or attention to detail, you could agonise over this process. How to know exactly when you are ready to submit the proposal is a go/no-go decision that only you can make, so let us learn more about that in the next chapter.

Chapter 9

Are You Ready to Submit It?

Abstract  When you are finally happy, you need to then submit it, and depending on the grant submission system used this may involve several validation steps. It is possible there are things that hold you up at this point and it is important to check steps here to avoid catastrophe. Keywords  Grant submission · Errors · Validation

Now that you have all the necessary pieces for the grant submission and they have been edited and checked repeatedly, you may be ready to submit, or at least you might think so. Each grant funding source will have different websites for you to upload your files to, so it pays to follow the advice or request for proposal (RFP) closely and prepare for this moment because it may also take much longer than you imagine. Some funding bodies or grant types may have multiple systems, and if you are in academia, your university may even take care of the submission for you. For example, the National Institutes of Health (NIH) uses grants.gov (one of the grant submission systems you need to be registered to use ahead of time), which allows you to download a grant package consisting of multiple forms in portable document format (PDF), which you then fill out and then upload back into the system. For a simple grant with a few key people on the grant, it may still take you over an hour to fill out, add text documents as PDFs and upload. Each grant package then generates a unique identifier, which should help prevent uploading the sections from another grant you might be working on. This does not, however, prevent you from uploading the wrong pieces you have been working on into each package piece. From experience, catastrophic failure is possible with a submission. I have erroneously uploaded a section from one grant into a second that I was working on and did not look closely enough at the submission. Subsequently, the grant was triaged, and the reviewers picked up on my error. This was embarrassing as well as a complete waste of the time that was invested in writing the proposal. The take-home message is that it pays to check and double- or triple-check everything. You may have everything done and ready, but you should pause before you submit. The grants.gov © The Author(s), under exclusive license to Springer Nature Switzerland AG 2023 S. Ekins, Winning Grants, AAPS Introductions in the Pharmaceutical Sciences 17, https://doi.org/10.1007/978-3-031-27516-6_9

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system has several approaches to validate a grant before submission so you can avoid having to retrieve a grant once submitted to fix any errors. Other systems, such as Application Submission System & Interface for Submission Tracking (ASSIST), which is another grant submission mechanism that the NIH uses, also have their own idiosyncrasies that are included as checks to prevent errors, at least that is what you hope they are. If you encounter useability issues at grants.gov and NIH Commons, they have very helpful support staff you can call or email. Some errors that you may find in the software may be real bugs. One recent example I discovered in ASSIST was that it would not allow me to use the country RUSSIA in any drop-down menu as it kept giving me an error upon grant validation. The only fix I could use was to select another country. Obviously, if I need to choose between reporting the bug and submitting the grant, my goal is the latter, so if the help desk cannot fix the software problem, then you need to use your common sense and work around it. It may also be worth following up and reporting any issues you have to the programme officer after grant submission in case there are any later repercussions. You now have all the grant pieces validated successfully without errors, but there are warnings; these, however, may not prevent you from submitting the proposal, but it is still worth seeing if you can address them for your own peace of mind. Both grants.gov and ASSIST provide a mechanism to create a final PDF of the complete grant. It is also valuable to download and spend some time checking through this. You might find something you missed otherwise. It could be something that you picked up in the strategy – perhaps the PDF conversion did not work correctly, in which case you need to go back to the original word-processing file, re-export to PDF (perhaps toggling the PDF quality type, e.g. internet quality vs printing), upload it to the section of the grant and, in turn, upload this form to grants.gov. Then you will be well served by repeating the validation, saving the complete PDF and checking again for errors. Yes, it is incredibly repetitive and time-consuming, and if you are running close to the deadline, you might not have this luxury. This is another good reason to not leave it until the last minute to perform all these steps. At this point, if you are satisfied and have checked and caught any remaining errors, then you should hit the ‘submission’ button. The relief should rush over you, but wait, you are not done; you now need to download the submission validation so you have a record of the date and time the grant was submitted. If you still have time before the grant deadline, you have some more time to look over the grant package. At this point, I would resist doing anything else to the grant unless it is critical. If you see a typo, I would recommend letting it pass at this point. However, if you are missing a letter of support or something else of a similarly high value, you will need to pull back the proposal and re-upload and go through all the preceding validation steps all over again, if time permits. You might think that after submission you are done, but no! the next chapter will share some of the important post-submission steps that could help you win the grant.

Chapter 10

Post-submission Steps to Win the Grant

Abstract  The grant submission is not the end and could actually be considered as the beginning. Post review there are several steps you can take to provide additional information to the NIH before the actual acceptance of a grant. Knowing what to do from Just In Time through to when the NIH program officer requests more forms for you to fill out is important. Keywords  Just in time · SBIR · STTR · Notice of award · Program officer

Submitting the grant package is not the end as this only gets your grant submitted for review. Between this point and the review (which will be at least several months and perhaps longer), there may be additional information you can provide to the study section, such as a paper that you just have accepted in the interim. You can prepare a brief document listing your grant information and the manuscript details and send this along to the programme officer. They do require a specific format, and they will normally notify you by email once a proposal is assigned to a study section for review. Once your grant is reviewed, you will then find out in your Commons account (for National Institutes of Health (NIH) grants) whether it was triaged or has a score. This is always a nerve-wracking, nail-biting and stressful moment. There is a ‘dare I look to see if it was scored’ moment. If you receive a reasonable score (which depending on the institute pay-line will vary), you may be asked to provide ‘just in time (JIT)’ information. Currently, any grant scoring less than 30 for a small business innovation research (SBIR) or small business technology transfer (STTR) grant is automatically asked for this information. Initially, this may be limited to any changes in your Current Other Support, your listing of grants awarded or pending as well as other material support, which may impact your time available to work on a grant. If there is an overlap, then you will need to propose how you would adjust the key person’s time. If you need any certification for the proposed work, such as an institutional review board approval for human subject work or Institutional Animal Care and Use Committee (IACUC) approval, then this information needs updating. © The Author(s), under exclusive license to Springer Nature Switzerland AG 2023 S. Ekins, Winning Grants, AAPS Introductions in the Pharmaceutical Sciences 17, https://doi.org/10.1007/978-3-031-27516-6_10

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At this point, you may also have to fill out an SBIR/STTR funding agreement, which provides more information on your company. If your grant has a very good score or is borderline, it may go to the committee meeting, where the programme managers and officials decide on what to fund. If your grant is borderline, it may be useful to the programme officer if you respond to the reviewers’ comments or at the least respond to the resume and summary discussion section. This can be as simple as providing the programme officer with a half page to a full page of text rebutting the comments or agreeing with them. This could be a critical step and well worth volunteering to the programme officer. You may also receive a request to provide more information to the programme officer; this could be information on any vertebrate section authorisation, other funding or budgeting questions. You might have exceeded the budget, and they want to know how you will address that, for example. Your timely attention to these tasks is important. If there are any questions that you think you need clarification on, it will be best to email and/or set up a call with the programme officer. This is what they are there for. Of course, if you reach this stage, you are very close to funding, so you need to make sure you take it over the line and try not to fumble. It is key to be calm and ensure that you address all the requests that come your way, whether they are from the NIH, National Science Foundation (NSF), Department of Defense (DOD) etc. It might be challenging, but it may adversely impact your future funding and opportunity to win the grant if you do otherwise. As you get closer to potential funding (there is no guarantee of course), if you are applying for an STTR/SBIR, the NIH will request a whole array of information, including some of the aforementioned items, such as response to the summary statement, updated other support, SBIR funding agreement, SBIR-STTR venture capital operating company (VCOC) certification, financial questionnaire, date of last or next audit, Employer Identification Number (EIN), most recent W9, negotiated facilities and administrative (F&A) rate agreement, copy of a signed lease or use agreement, copy of small business administration registration (if applicable), proof of active registration in System for Award Management, confirmation of principal investigator (PI) employment as well as any certification (if applicable). Preparing all these forms can easily take most of a day or more the first time, so be prepared, but this is also a potentially promising sign. Some or all of these forms will need to be uploaded to Commons for submission. Again, if you have any questions at this point, you can and should reach out to the grant administrator who sent you the email. Depending on the grant type submitted and the funding body, similar steps may need to be fulfilled as you progress along the pathway to eventual award. At this point, you have literally done about as much as is possible or even necessary to win a grant. But it is still possible that you can still fail at this point as the institute may run out of funds and your grant may not get selected, or there may be other reasons which you may never find out about that will come into play. If there is one thing you can do along the way, it is to communicate politely with your programme officer and grant administration staff. They will generally be honest with you if they do

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not think you will be funded. They, of course, are impartial, but you can certainly help yourself by providing everything they need from you. In some cases, they may be working to very tight funding deadlines that they need to have things completed by. If you are lucky, days or possibly weeks later, you will find an email from the NIH in your inbox simply headed ‘NoA’ with your grant number and name. It will provide you with an attachment, which is the actual notice of the award and information on the start date, grant management official, programme official, grant specialist and any other specific requirements, such as how you cite the grant. If you reach this point, Congratulations! You have now won a grant. Perhaps it is your very first one. Enjoy the dopamine high; celebrate (briefly) because now the real work begins. You have the funding and will need to do the work you proposed. Potentially years of work enabled you to reach this point, and it is worth savouring at least for the first few times. Let your team and collaborators know; thank profusely anyone who got you to this point. I can guarantee that everyone will appreciate your reaching out and may help amplify your success. I would normally contact anyone who provided a letter of support because in some cases, these can have an impact if you are trying to demonstrate that your peers also believe in your idea. If you are a small company, this is one of those moments to put out a press release and post your grant news on your website and LinkedIn. If it is a very big grant or for an important research area, perhaps you will want to get the local press involved. You never know it could be a slow news day and they need content, so it is always worth trying. At the very least, they may put it on their website, which will likely see far more traffic than your company website. It may also be worth sending a brief email to your grant programme officer thanking them for their support as well! During the period of your grant, it is possible that your programme officer may reach out to you if they must present to their management. They may ask you for information on your grant or even slides at any time to present to their management. You should be as responsive as possible and provide what they need. A programme officer may also personally reach out to you at any point and recommend that you submit to an upcoming request for proposal (RFP). From my experience, I would propose that you comply if you have the bandwidth. Being sought out is a good sign; it means they are interested in your work and that they really want your input. Similarly, if you are contacted to serve on a study section, if you are available, it is also in your best interest because, if for no other reason, participating will provide a clearer understanding of how the system works. If you can do this for a few different funding bodies, you will also obtain insights that permit a much broader perspective. Your reviewing capabilities may not be limited to your own country. If you become an acknowledged expert in a particular scientific domain, then you will find that requests to review grants will arrive from all around the globe. The next challenge will then be to decide which ones you would want to participate in. Similarly, the programme officer may suggest that you submit an abstract to a conference. If you can fit it into your schedule, then it can be used to highlight your grant and keep them happy.

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It may seem unusual, yet all these post-grant submission steps in some ways are connected. You become a part of the grant ecosystem. Perhaps karma is not the right word, but helping the programme officers do their job will not go unrecognised. It also helps to build these relationships with them because you are all moving in the same field; you may one day be a colleague, or they could work for you. You will likely meet repeatedly at conferences; they can help you connect with other scientists, and so it becomes another important step in building your network. And you thought you were just trying to win a grant, but getting there may also open other doors. It is difficult to predict what may happen, but having an open mind and saying ‘yes’ more often than ‘no’ to some of the requests that come your way once you win a grant may also catalyse your future grant success. Winning the first grant is an important starting point; the challenge is then being able to sustain it and build on this repeatedly over many years and win more. If your plan is to build your academic lab, you have no choice but to do just this. In a small company, you have more options for funding. Getting grants is a validation of what you are doing, and the strings attached to the funding are generally very limited, if any. Your goal now is to make it happen; show that you can deliver on what you set out to do, and hopefully success will follow. How you get to write and ultimately win a grant can begin with the most innocuous of events; perhaps you meet someone, they share an idea and that kick-starts a project. The next chapter describes an SBIR case study from my own recent experience. This illustrates a complete cycle from idea to grant.

Chapter 11

An SBIR Case Study

Abstract  This chapter shares a case study from the author from beginning to successful grant awards. This example shows the need for persistence and how the process can be lengthy. Keywords  SBIR · I-Corps · Phase I · Phase II · Press release

Several years before I founded CPI, I attended a lunch meeting organised by the North Carolina Biotechnology Center, which brought together several rare disease advocates. I got to talk with one of them and learnt that they had helped fund an academic, Dr. Sandra Hofmann, to develop an enzyme replacement therapy for Batten disease (CLN1). This stuck with me such that when I started the company, one of the first steps I did was to reach out to see if I could connect to this scientist and then try to obtain a grant to fund the further development of their project. In 2016, I used some elements of the information provided in their earlier publications to draft a proposal for the NCATS BrIDGs programme with the simple aims to generate (1) source of clinical grade enzyme; (2) distribution studies in a larger animal; and (3) IND enabling immunotoxicology and formal toxicology studies in two species, including rodents and non-human primates. After doing this, I then drafted the orphan drug designation for submission to the Food and Drug Administration (FDA). This was awarded 6 months later. The BrIDGs proposal was ultimately rejected; I re-submitted, and again, it was rejected. In mid-2017, we were connected to Dr. Jonathan Cooper and subsequently put together small business innovation research (SBIR) focused on Aim 1. Production and characterisation of rhPPT1 and Aim 2. Intracerebroventricular and intrathecal administration of rhPPT1, which was submitted for the September cycle. By December, this was scored (35), which was promising, and by the following July 2018, we were submitting all the required forms to the NIH. Ultimately, the grant was awarded ($229,560), and we were off and running. After this was funded, we then applied for a diversity supplement to employ a scientist (who at the time was doing an internship with us) to work on further aspects of the project. This was ultimately awarded as well ($127,300). In © The Author(s), under exclusive license to Springer Nature Switzerland AG 2023 S. Ekins, Winning Grants, AAPS Introductions in the Pharmaceutical Sciences 17, https://doi.org/10.1007/978-3-031-27516-6_11

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February 2019, we applied for and were accepted into the NIH I-Corps programme ($54,663). As you can see, very quickly we were able to obtain additional funding, and it was like the SBIR opened additional doors. We participated in the NIH I-Corps programme (Spring 2019 cohort) to perform customer discovery and plan the commercialisation pathway. This programme was a nearly 2-month programme in which we were tasked with interviewing 15 people a week to reach over 100, along with presentations and deliverables. We put together a team that was closely involved with the CLN1 Batten disease project at the scientific and business levels. Each team member dedicated well over 20h/week to the programme for 2 months. Ultimately, we conducted 164 interviews, including with patients, physicians, neurologists, contract development and manufacturing organisations (CDMOs), the FDA, regulatory consultants, rare disease foundations, hospitals, specialty pharmacies and insurance companies, and we attended six conferences, enabling us to talk to stakeholders and learn about our product development and pathway moving forward to eventually lead to the customer. This inspired us to try to apply for a direct phase II SBIR grant in September 2019, which was triaged. We re-submitted again in January 2020, and this was again triaged. We then waited until we had some data from our Phase I proposal and submitted in January 2021, and even this was triaged! We waited and re-submitted, adding in all the responses to reviewers (and the budget ballooned to $6.9M) in September 2021 so that by December, we had a score of 25! This was clearly in the fundable range, but I was contacted by the programme manager and was told that they could only award $3M (which was nearly double the allowable budget). We had to go back to the budget and find a way to do as much as we could. I was also told there was no guarantee it would be awarded by the committee and that I should re-submit the proposal. Clearly, due to NIH rules, I could not re-submit again, so I would have to try a direct to Phase II but request up to $3M over 2 years. This was submitted in January 2022, and in April, it was scored with a 24. So now, we had two grants for basically the same work pending and spent several months getting all the ‘paperwork’ in shape. Because there were animal studies proposed, we had to provide additional documentation (institutional assurance) from the company doing this work; we also had to justify them doing the work in Canada as our only option for the type of study required. By early June 2022, we had received the notice of award for the Phase II SBIR ($3M) and put out a press release (Fig. 11.1)! The direct to Phase II proposal was discarded. If you were able to follow this, you will have also noted that we had to basically submit a total of five Phase II or direct to Phase II proposals before we won one, and the one that was awarded was our fourth try. This would not have been possible without the assistance of our academic collaborators Dr. Jonathan Cooper and Dr. Mark Sands, as well as letters of support from many rare disease families and foundations. Now the work for the next stage of the project has begun and is currently underway.

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Fig. 11.1  Our press release announcing the award of our Phase II SBIR for our Batten disease project

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Fig. 11.1 (continued)

11  An SBIR Case Study

11  An SBIR Case Study

Fig. 11.1 (continued)

97

Afterthoughts

Abstract  This chapter makes the case that once you have the first grant you should try to win more and go after different types of grants. This chapter shares some of the author’s experiences with much larger grants as well. Keywords  Omnibus; STTR; SBIR; Winning grants

You have done it; you have won your first grant. Now, are you ready to do it again and again? You will find that it really was not that difficult. How much time and effort do you want to spend on writing grants in your life? Remember, you now have a grant, and you have time allocated to working on it. Firstly, you will want to sign up to notifications to find out about future grants to pursue. Spend some time regularly checking the National Institutes of Health (NIH), National Science Foundation (NSF) and Department of Defense (DOD) websites to see what calls are coming through. Better still, have someone in your team do this for you. Reach out to the programme officers, and they will also notify you of the grants they are managing. This is simply good planning for the future. You have much of what you need for that next grant already written. You have the biosketch, facilities and more. Importantly, you know how to fill out the forms, what is needed to submit and the timing for each step. You have become a grant expert even though you may not think so! Over time, you can explore the different types of grants and cross them off your list. If you get to become so fluent in writing them, perhaps you do not really need to budget so many weeks to do a grant – how about just a week? Maybe you could challenge yourself to do a grant in a day. A day – define that however you want as 24 h or an actual 8 h workday. You might ask, why would I want to do this? Perhaps you have submitted the grant you planned to write, and you have some time left over before the deadline. Could you submit a second grant on a different project? It is a useful exercise to challenge your writing abilities. Almost like fast-forwarding a © American Association of Pharmaceutical Scientists 2023 S. Ekins, Winning Grants, AAPS Introductions in the Pharmaceutical Sciences 17, https://doi.org/10.1007/978-3-031-27516-6

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movie, you can see all the stages in preparing the package, but now, just speed it up. Perhaps you can literally copy the grant package forms so you do not have to spend time filling out every form again. You will, however, need to make some changes to the grant title and perhaps the key people and budget. This will save you some time. The main things you will need to write are the narrative, summary, aims and strategy, and if this is a Phase Ismall business innovation research (SBIR) grant, that will mean approximately 6.5 pages of text. I have not included a small business technology transfer (STTR) grant as that will include an academic collaborator, and it would be virtually impossible to obtain their documentation and budget in a day as it would usually have to go through several levels of management at the university or research institute. It is important if you are going after the same request for proposal (RFP) to make sure both grants are distinct. Ideally, if you are submitting to an OmnibusSBIR, you could ensure the projects are so distinct that they go to different study sections, in theory, but there is no guarantee. Perhaps one grant is on heart disease and another is on antiviral research, or one is on a computational technology and the other is on a molecule for a rare disease. Ideally, the topics could be so far apart that there would be no conceivable overlap in study sections. You do yourself no favours if you are competing with yourself in the same study section. Although saying that, having multiple grants in the same study section might work in your favour if they are truly different; then the reviewers can see the scope and breadth of your expertise. Also, it is probably best not to get too carried away after your first grant. Remember, slow and steady wins the race. You can train yourself to keep coming up with ideas so that you submit a new grant at every SBIR/STTR cycle. That would be three grants a year. You could do this for years. From my own experience, it is achievable, and you can get to this stage if you have the time. You could also spread your collaboration wings and actively find new people to work with and set a goal of submitting grants with them in each cycle. Maybe you have complimentary expertise that they may want, perhaps a technology or a molecule that may have a useful activity for them to study. This achieves a few objectives. It builds your network; it may enable the creation of new data and then potential intellectual property (IP) and publications. It may also put you on the map as others will see your capabilities and want to work with you. This is exactly what you need if you are building your business – knowing people who can connect you to others. There is no quick win here, but the slow and likely steady approach of building such relationships will help expand your grant-writing and -winning capabilities. If you can possibly collaborate with an academic group, it is likely they may also want to pursue much bigger grants. These could include centre grants that fund multiple principal investigators (PIs), possibly core facilities and an administrative core for many years (usually five). Naturally, these are also very big, normally many tens of millions of dollars in total. If you can participate in a small way, even as a consultant on such a grant, I would recommend it, again because it will expose you to a new experience where you must collaborate with a bigger team than perhaps you would ordinarily. While you may be working on a very small part of the proposal, having the benefit of a larger institute and team with likely far more

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experienced scientists involved will also provide potential learning opportunities. You will see that the proposal that is ultimately submitted will exceed many hundreds of pages and that such teams have dedicated groups to facilitate these types of submissions. They will also work to very tight deadlines, so it is important you can deliver your contribution on time. If the team you are involved with is fortunate to win such a grant, it may benefit you by providing some income, but also several years of work and new opportunities to do science and attend regular meetings. Because of the size of these grants, there will likely be heavy involvement from the funding institute (e.g. NIH) such that you may be able to interact with them for site visits or reverse site visits –another fantastic opportunity for them to put a name to your face and increase your exposure as well as get on their radar. There may be a point in time after years of writing and winning grants and being a part of teams, small or large, when you have built up your collaborator network where you essentially have all the components of a centre grant team. Then all you must do is wait until there is an RFP that fits you and your idea perfectly. Such an opportunity is literally a once (or twice) in a career opportunity, at which point, there is no decision to make because to miss the opportunity would be like not looking for Halley’s comet in the sky when it arrives, and you would have many decades to wait for the next opportunity. If you decide to pursue a centre-type grant as the PI, here is some advice. Do it once because afterwards, you will likely never want to repeat it. From my experience of being a consultant, a collaborator and a PI on such grants, it represents a massive amount of time. Writing these types of grants again is just one component as you have all the logistics and ‘paperwork’ to do. A typical centre-type grant may consist of multiple sections, an overall component that integrates all the sections and tells the full story and an administrative core that performs the project management and makes sure the work and reporting are done on time. You may have multiple core groups that act as ‘service groups’ for the PIs, and then you have multiple PIs who must write what are usually R01-type scientific proposals. You might have a proposal that includes four cores and six projects. This represents well over 100 pages of (single-spaced) text to write, and perhaps you have over 20 key people on the project for which you need to gather biosketches and facilities and so on. Your ultimate grant package may easily be 800 to over 1000 pages! So effectively, you may be writing an equivalent of 10–12 grants in one go. Hopefully your collaborators will help in the writing endeavour, but coordination will also be your responsibility. These types of centre grants may take several months of team effort if you have this much time available. Doing one in 3 weeks is not optimal, but that is my experience never to be repeated. The odds of winning such a grant may also be incredibly small such that you will need to read the instructions carefully to ensure you comply with exactly what is requested. As with other grants, obtaining letters of support from bigger organisations or companies that have expertise in the grant or your proposal will benefit you. If you are a very small company, providing conclusive evidence that you will be able to do the work and be around for the next 5 years of the grant will assist you greatly. You may want to use technologies to facilitate your collaborative writing and ensure you check and re-­ check your writing. When it comes down to submission, the responsibility is all

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yours, and it can be derailed at any moment by PI dropouts, the non-delivery of text or just the stress that is created for your team. Getting across the finish line with at least a day to spare in case you have technical issues to fix will also be highly recommended. I can honestly say that it is far less work to help another group with their centre grant than doing one yourself. The exhaustion and sense of relief that follows the submission of such a grant has made it abundantly clear to me where the sweet spot is, and that is Phase I and Phase II SBIRs/STTRs! If you are competitive, then writing grants can be considered the Olympics, except there are no silver and bronze, only gold medals. What you are up against are potentially tens to hundreds of other scientists or entrepreneurs just like you. They may have more funding, bigger labs, more equipment, hundreds of publications in top journals, even more experience and so on. Your task is to stand out from the pack. You have reached the first rung on the ladder; you may have won a few more grants and have been on other winning grants with collaborators. You may have a pretty good strike rate for submissions and wins. Yet you still will not be able to predict if you are going to win even after years of doing it. You may also reach the point in your career where you no longer need to win grants. Perhaps you hired someone to take over the responsibility, perhaps your funding needs are bigger or maybe you had a successful exit and sold your company. These may be potential outcomes that are facilitated by winning grants. It all returns to the idea, writing it down, telling a story, engaging reviewers and ensuring they are as enthusiastic as you are. Winning grants is bigger than needing to be just the best scientific communicator; you also need to be the entrepreneur, the project manager, the operations specialist, the marketing guru, the human resource expert and the salesperson. If your team has all these skill sets, fantastic; otherwise, good luck as you navigate learning them all quickly by yourself. I am passionate about winning grants because it has opened many doors for me; it has helped companies support hiring key staff and funded academic labs to do experiments that have led to publications and patents. Ultimately, science has moved ahead on projects of interest to the companies I have worked with or my own company. Building companies through grants is just one such example. Doing so repeatedly can be a career. Doing it successfully for a long time is a valuable transferable skill. But enough about why I think it is important to win grants; put the book down and go and apply what you have now learnt in the preceding chapters to win your next grant. Good luck!

Resources

1. Anon, EIN presswire. https://www.einnews.com/#. 2. Anon, THE FAIR DATA PRINCIPLES. https://www.force11.org/group/fairgroup/fairprinciples. 3. Strunk Jr., W.; White, E. B., The Elements of Style. 4th Edition ed.; Pearson: 1999. https://grants.nih.gov https://www.sbir.gov https://seed.nih.gov

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Index

A Aims, 4, 13, 27, 29–30, 38, 55, 82, 93 Authentication, 27, 38, 52–53

H Hiring staff, ix, 24, 102 Human subjects, 89

B Biosketche, 7, 13, 27, 82, 83, 99, 101 Book-keeping, 24 Budget justification, 13, 27, 79

I I-Corps, 17, 18, 94 Idea, 1–3, 5, 7, 13, 15, 16, 18, 21–23, 26, 28, 30, 38, 54, 77, 80, 81, 83, 85, 91, 92, 100–102 Intellectual property (IP), 2, 6, 7, 16, 21, 22, 54, 68, 77, 100 Introduction, 27, 74–75, 80, 82

C Checklist, 27, 86 Collaborator, 4, 15–22, 38, 52, 73, 80–82, 85, 91, 94, 100–102 Commercialisation plan, 2, 4, 18, 27, 54–68, 75 Consortium agreements, 77 Cover letter, 27, 28 E Editing the grant, 85 Equipment, 8, 13, 20, 23, 24, 27, 39–41, 52, 53, 102 Errors, 81, 82, 86–88 F Facilities and resources, 27 G Grant submission, 16, 22, 82, 87, 88

J Just in time (JIT), 89 L Laboratory, 5, 17, 18, 20, 22–24, 39, 41, 52, 73 Legal advice, 23 M Multiple PI plan, 52, 75, 76 N Narrative, 4, 27, 29, 100 National Institutes of Health (NIH), 1, 3, 5, 7, 8, 17, 19, 24, 27, 29, 38, 39, 87–91, 93, 94, 99, 101 Notice of award, 94

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106 O Office space, 24 Omnibus, 5, 100 Organisation, 7, 21, 25, 86, 101 P Phase I, 2, 4, 6, 16, 20, 22, 29, 30, 38, 55, 82, 94, 100, 102 Phase II, 2, 4, 6, 7, 18, 20, 22, 27, 29–31, 38, 54, 55, 75, 82, 94, 95, 102 Press release, 25, 91, 94, 95 Program officer, viii, x Progress report, 27 R References, 7, 27, 38, 86 Request for proposal (RFP), 7, 28, 87, 91, 100, 101 Research strategy, 27, 30–38, 41 Resource-sharing plan, 53–54 Running a small company, 24 S SBIR/STTR commercialisation history, 54, 55 Select agent research, 73

Index Small business innovation research (SBIR), 1–3, 5–7, 16, 17, 19, 27, 29, 31, 40, 54, 55, 79, 89, 90, 92–95, 100 Small business technology transfer (STTR), 1–3, 5–7, 15, 19, 20, 22, 27, 29, 31, 40, 54, 55, 79, 89, 90, 100 Strategy, 2, 4, 6, 13, 29, 38, 81–83, 86 T Timing, 16, 18, 99 V Validation, 3, 21, 88, 92 Vertebrate plan, 27 W Winning grants, 4, 19, 23, 25, 26, 82, 83, 85, 101, 102 Writing, 2–7, 13, 18–20, 22, 23, 28, 41, 55, 75, 77, 79–83, 85–87, 99–102