NIH and VC Funding; Growth Engines for the Life Science Industry; Exploring Similarities, Differences, and Overall Objectives. A panel discussion at the 14th Annual Non-Dilutive Funding Summit featuring: Ram May-Ron, Managing Partner, FreeMind Group | B. Christopher Kim, Managing Partner, Novatio Ventures | Dr. Matthew Portnoy, Director, Division of Special Programs – Office of Extramural Research, NIH

 

Adam Ruben

doi:10.1126/science.caredit.a1600164

‘Twas the night before grant deadline, 7:15.
Many creatures were stirring, thanks to caffeine.
The comments accepted, the references done,
In hopes someone might fund my first R01.

I wrote like a showman. My prose was terrific.
My font was New Roman. My aims were specific.
I showed prior data and new innovation—
I even nailed my budget justification.

The footnotes were hung like superscript pendants,
Each at the end of a well-crafted sentence.
I sighed with relief; it had all turned out fine,
And I dreamed of the day when I’d hear the pay line.

I’d labored for months while my spouse gazed with pity:
This would have to influence my tenure committee.
The time and the effort I’d spent really showed.
Now the grant was complete; it was time to upload.

When what should my wondering eyes chance to scan
But the tiniest typo in my research plan?
Then more and more errors came as I read through!
And I knew it would never survive peer review.

So quickly I rose from my chair made of vinyl
And opened the files I’d all labeled “FINAL.”
“Sweet merciful Darwin!” I cried to the heavens.
“There’s no Figure 6! There are two Figure 7s!”

My spacing was shrunk and my margins too wide!
My titles and headings were right-justified!
Even the sections I’d thought in grand shape
Had been converted from portrait to landscape!

What fate had befallen my grant so idyllic?
The tables were merged—and is that Cyrillic?
So many errors! Oh, how could this be?
All I did was convert from Mac to …

Uh-oh.

Now swiftly I read one line to the next,
Putting symbols back in and repairing the text,
Fixing all of the words over which I had sweated,
The objects and worksheets that now were embedded.

“But it’s science!” I screamed, my heart pitter-patting.
“Why must I spend all my time on formatting?
Why would anyone panic? Why would they care if
My spacing was close, or my font had a serif?”

When all of a sudden, there came such a din
That I ran to the door—and then he walked in.
“Cease your worry!” said he, in his bold way of talking.
“All good scientists get a grant in their stocking.

You’ve done all the research that one could deem prudent.
(Well, not you—your postdocs and graduate student.)
Your grant is the greatest thing since streptomycin!”
And I knew right away he was Neil deGrasse Tyson.

He was dressed in a blazer; his elbows were patched.
And, like most astronomers, none of it matched.
His mustache, so bushy! His loafers, how dirty!
His visage, so kind, and his necktie, how nerdy!

“Oh please, Dr. Tyson!” I then interrupted.
“The grant is due soon, and my file’s corrupted!
If my department chair sees that I’ve flunked,
I might be demoted to teaching adjunct!”

With a wink and a nod and a friendly high-five,
He placed in my hand a USB drive.
The files it held were my own grant, but better!
He even provided a new cover letter!

As I marveled and gawked at my mended submission,
With every page break in its proper position,
He climbed in his sleigh. (Why a sleigh? Don’t ask me.)
He took up the reins, and he shouted with glee:

“Now funding! Now finance! Now tech transfer offers!
On private foundations! On government coffers!
Now sit back and watch as your budget increases
For keeping your postdocs on H1-B visas!”

“Oh, thank you!” I yelled, “for each PDF’d page!
My lab techs will cheer at their new living wage!
On supplies and equipment we’ll run up a tab.
My undergrads won’t have to sleep in the lab!”

I dreamed of results from the money we’d spend,
Professional meetings we now could attend,
The safety routines we’d bring up to compliance,
The last-author papers I’d publish in Science.

For grant applications are vaguely abusive;
Funding is fleeting and tenure elusive.
In science, we struggle for basic support.
I guess we’re less vital than, say, a sport.

He pointed his sleigh toward a twinkling star,
Then flew off to help with an SBIR.
And I heard him exclaim, in a voice to enchant,
“Merry deadline to all! Now go start your next grant.”

 

Read online

Amber Dance

Nature 540, 471–473 doi:10.1038/nj7633-471a

Published online 14 December 2016

This article was originally published in the journal Nature

Nervous about your grant application’s chance of success? Get help to make every word count.

Read article online

Jiri Lukas’ research centre was at a crossroads four years ago. Bankrolled by the Novo Nordisk Foundation, the organization was facing a mid-term evaluation, and its funding was at risk. Lukas, executive director of the Center for Protein Research at the University of Copenhagen, wanted to apply for a grant extension, but was worried that his efforts would be wasted. It was rare at the time for foundations that award grants for biomedical research to further their support beyond one-time, limited-term funding.

A colleague told Lukas that the science in his application was strong, but that the application itself didn’t make the best case for the societal impact and unique nature of the centre. The colleague advised Lukas to consult with scientific-communication specialists at Elevate Scientific in Malmö, Sweden. “The rest was kind of a fairy tale,” Lukas says. With help from Elevate, the centre won the extension.

When it comes to seeking either government or private funding, grant writers and editors are a useful resource for scientists in both academia and industry. Scientists call on them for a variety of reasons. Some simply don’t have time to do it themselves. Others know that they aren’t good writers, or lack a sufficient command of English. Some are struggling to get funding. Grant writers can help with finding the right organizations to fund a project, as well as with writing the application. They can hone and focus the message, ensure consistency between sections drafted by different authors and assure adherence to strict page limits. Grant writers and editors help with everything that isn’t the science, yet can still significantly affect a proposal’s chance of success.

Many researchers still go it alone in preparing grant applications, but the funding landscape has changed, and scientists are now less hesitant to ask for help, says Sheila Cherry, president of Fresh Eyes Editing in Dayton, Ohio. Many funders expect applicants to seek assistance. The written guidelines from the US National Institutes of Health (NIH), for example, make that clear: “If writing is not your forte, seek help!”

There should be no shame in asking for guidance, says Anders Tunlid, a microbial ecologist at Lund University in Sweden who has reviewed grants for the European Research Council. “We need to accept that this is the way we all do it,” he says. “I don’t think that everyone has written their proposals themselves.” Colleagues may be willing to review an application’s scientific content — but they are typically too busy to spare the hours needed for fine-tuning.

“Everyone needs a little bit of help, if only to find typos,” points out David O’Keefe, senior grant writer at the Salk Institute in La Jolla, California.

The Salk offers the service for free to its researchers, but external help comes at a price: basic editing services can run from US$500 to thousands of dollars, depending on the application. “It’s an investment, for sure,” says Stefano Goffredo, a marine ecologist at the University of Bologna in Italy. But after spending months on a proposal, he thinks it’s worth opening his wallet to get a professional polish.

Without that polish, it’s all too easy for reviewers to quickly discount an application, says Laura Hales, principal of the Isis Group, a scientific consulting and communications service in Cambridge, Massachusetts. She has served as a reviewer herself and can attest to the fact that first impressions count for everything. “You have,” she says, “one chance.”

Independent data are essentially non-existent on how professional grant-writing services affect success rates. Companies’ claims for success range from more than three times the average rate for NIH grants to six times the average rate for the European Union’s Horizon 2020 grants. But the companies themselves concede that they can offer no guarantees. “Just because I know the formula doesn’t mean I’m going to get every one,” says Hales.

Find your match

Institutions might pay for support for a junior scientist’s first few grants, says Susan Marriott, president of BioScience Writers in Houston, Texas, but the support can be useful for mid- to later-stage-career researchers, too. Working with Elevate Scientific was a “humbling” experience, says Lukas, even as a senior scientist. The editors identified unclear sections, improved graphics and strengthened the logic in the proposal to communicate the message more effectively.

Senior researchers in a collaboration may also use a grant editor as a project manager to ensure that all the pieces come together in a neat package by the submission deadline. It was just such a multi-investigator project that led Bruce Johnson to call in Fresh Eyes Editing. Every author tends to use their own formatting for elements such as headings and references, he notes, and editors can give the document a consistent style. “It makes it look so much more professional,” says Johnson, chief clinical research officer at the Dana Farber Cancer Institute in Boston, Massachusetts.

Editors also catch inconsistencies and redundancies in the content. For example, a large document on lung cancer does not need to repeat in every author’s section that it’s the leading cause of cancer deaths in the United States. And one scientist might cite a statistic that 15% of people with lung cancer have a certain mutation, whereas another might write 25%. That inconsistency could cause reviewers to think that the collaborators aren’t talking to one another, Johnson says, which would not inspire a sense of confidence that the team could carry out the project together.

Grant helpers vary in the assistance they provide, and at different stages of the proposal process. Some get involved at the very start, strategizing about where to apply for funding. “It’s not only about how you write an application,” says Ram May-Ron, managing partner with the FreeMind Group in Boston. “The search starts with identifying which funding opportunity is the best one for a particular part of a research project.

Scientists may have heard of big funding initiatives, such as Horizon 2020, but there might be other opportunities they should consider, says Eran Har-Paz, vice-president for sales at Sunrise Projects in Rosh Ha’Ayin, Israel. “We try to build a strategy, a few alternatives to submit to,” he says. “Don’t put all your eggs in one basket.”

At this level, grant helpers may reach out to programme officers, says May-Ron. For example, they might ask whether an agency has funded similar research recently, and whether they’re at all interested in doing so again. “If you go to the right place, you’re already in a better position,” he points out.

This full-scale service comes at a price, of course. Har-Paz estimates that the simplest proposal might cost a few thousand euros, with the cost escalating to 20,000 (US$21,414) or more for elaborate applications. That includes not only the strategizing, but also writing the majority of the application.

Some scientists already hand off much of the writing to others. Cath Ennis, a project manager and grant writer in Vancouver, Canada, might contribute an abstract, literature review, impact statement or budget, depending on the scientists’ needs — but never the research plan itself. “Our role is to take all the jobs that we can from the principal investigator, so they can focus more on the research,” she says.

Other grant professionals stick to editing — but that’s more than just dotting i’s and crossing t’s. Grant editors consider content, clarity, logic and flow.

Grant professionals can be found in a variety of places: some work for a company and others as freelancers whereas some institutions have in-house specialists (see ‘How to become a grant writer’). “Start talking early,” advises Marriott, who is also a virologist at Baylor College of Medicine in Houston. “Even if you don’t have a grant ready yet, even if you don’t know what you’re going to write.” It’s beneficial to get on an editor’s calendar as early as possible, because by the time the deadline rolls around, they could have many scientists clamouring for their attention. Later on, editors may be still able to help, but in a more limited fashion, she says.

Scientists tend to look for someone with a PhD and the right technical expertise. But the match doesn’t have to be exact. “I’ve edited grants about nuclear physics,” says Ennis, whose background is in cancer biology. “I can still catch a typo when someone’s put ‘proton’ instead of ‘photon’.”

Equally important, Ennis says, is to look for editors who specialize in the kind of grant one’s after — say, NIH, Horizon 2020 or foundation grants. Every programme has its own requirements, and the professional should know those inside out.

With candidates in mind, the next step is to get to know them. Ask a potential editor or writer about their process, and the services they do and don’t provide, advises Cherry. “It’s a lot more than just, ‘What’s your fee and how soon can you get this done?’” she says.

Timing and costs are, nonetheless, key questions. It’s best to get an estimate in advance to avoid a surprise charge later. One should also ask for a confidentiality clause in the contract.

Then, be prepared for plenty of back-and-forth. “Remember that it’s a collaborative process,” says Cherry. “Don’t be afraid to bring up concerns and make sure you’re really collaborating.”

 

 

A tough and ever-changing question.

Perhaps a quick personal historical overview might help shed light on the statement above. When I started out in this field in many years ago, there was a “three strike” policy. That basically meant that you could submit an original proposal, and then two revisions. If you didn’t get the award you had to change direction. In some cases, this caused some of our clients to regard the original as a type of “feeler” to send out before getting down to things in the following proposals. Others, correctly, took every proposal seriously. But however you looked at it, you were out after three tries.

After a few years, the NIH, presumably trying to reduce reviewer workload, if I recall correctly, changed this to a two-strike policy. That means that you had the original and a single try at a resubmission before you were “out of there” with the research idea. This caused general unhappiness in the field, because having just one chance to resubmit was kind of harsh. Researchers really didn’t like having to change projects, after getting an almost-funded 17 percentile for example. I also personally believe this didn’t make much sense when the paylines are so competitive. I mean, the difference between awarded and not-awarded is sometimes negligible in terms of score, and in the very-subjective range of reviewers’ decisions.

The surprising next move was that the NIH did an almost complete 180 degree turn in terms of concept. After a few years of having the rough two-strike policy, they went with the complete opposite, and this is what we currently have now. Yes, you can now still only resubmit (revise) your proposal once for each original, but can then go ahead and continue the cycle as many times as you like: Original – resubmission – original – resubmission and on and on. No formal limits. We may note here that the second “original” is also referred to as a “virtual A2” by the NIH itself (A2 refers to a second resubmission).

Joel Knopf
Manager of Consulting Services

 

In our next resubmission posts we will discuss:

After months of hard work developing your SBIR proposal, there’s nothing quite as disappointing as having a few preventable errors keep your application from getting reviewed.

Recently, the NIH’s Center for Scientific Review (CSR) published their “Top 10 Submission Show Stoppers for NIH Small Business Applicants – SBIRs.” At FreeMind, we took a look at the top CSR preventable errors and suggested how to best tackle these ahead of time.

  1. Not Having Multiple Registrations in Place: The SBIR/STTR application process requires five. Your application needs to pass through the government-wide portal (Grants.gov). To do this, your company needs an active System for Award Management (SAM) account, which expires after 12 months. To get this account, your company needs a DUNS number, a Taxpayer Identification Number (TIN), and a CAGE code. Getting these numbers and having an active account can take up to 8 weeks. Complete these registrations early so you and your collaborators can be ready on submission day. You and your institution also need separate NIH eRA Commons registrations.

FreeMind: The CSR is entirely correct that proper registration is vital to submission, you can’t technically submit without this. However, they have overlooked another required registration to the SBA. A downloadable PDF is actually required from that site in your application package.

  1. Failing to Appreciate the Fact that Submission Is a Multi-Step Process: Your application must pass through Grants.gov and then through the NIH eRA system. These systems have separate checks/validations. If your application is stopped at Grants.gov, be sure to alert both help desks immediately. After eRA acceptance, NIH staff performs additional, manual compliance checks.

FreeMind: This is correct, and exactly why you should aim at submitting ahead of time. The helpdesks can indeed be very helpful, and make sure to keep your ticket number for later reference. One item of note here is that the new submission system for the NIH “ASSIST” does the compliance error checks before submission, which does save a little time. *This isn’t relevant if submitting via PDF package.

  1. Submitting Your Application at the Last Minute: Electronic submission errors can take hours to fix. Give yourself peace of mind and submit early—days, not hours or minutes! Only error-free applications submitted on time can be sent forward to reviewers.

FreeMind: Not much to say here except to enthusiastically agree. You’ll be doing yourself a favor by planning and managing your time correctly, targeting a 24-48 hour pre-deadline submission.

  1. Attempting to Fix a Warning after the Deadline: Warnings are not show stoppers. Your application will be accepted with a warning. But if you seek to fix a warning after the submission deadline by rejecting your application and submitting a corrected one, your application will be late and will not go forward.

FreeMind: This is a technical point, and a fine one to be made. There are very few [acceptable] reasons to submit after the deadline. And, if you already had your application in the system, there’s no acceptable reason to submit a correction after the deadline. Errors must be fixed (if not using ASSIST), but warnings will not stop the submission.

  1. Not Using the Right Application Form: Different types of grants (with different activity codes) have different forms, and the forms can change. Make sure you are using the right one. Go to the NIH Guide to Grants and Contracts and pull up the Funding Opportunity Announcement (FOA) associated with the specific grant you want. You will be directed to the right form. Our forms are regularly updated, so don’t assume last year’s form will work!

FreeMind: The recent move to Forms-D exemplifies this point exactly. Always keep your eye open and finger on the pulse in regards to what are the correct forms.

  1. Not Giving the SBIR/STTR Instructions Enough Attention: They hold the keys to a successful submission and contain step-by-step guidance and specific submission and review considerations for your proposal.

FreeMind: The devil is in the details. Beyond just getting your grant in there for review technically, there’s a lot that you need to consider, plan and fret on in order to out that excellent proposal that has a chance of winning. Review considerations are a good place to start, but there are lot of informal improvement items not mentioned there.

  1. Producing an Incomplete Application: Including appropriate details in your research proposal is important, so make sure your final grant package has everything you need. Be sure to provide enough information in the Research Strategy section for reviewers to understand what problem you aim to solve, what experimental methods you will employ, how you plan to analyze the results, and what your milestones for success are. Also, make sure to include your budget! Applications lacking sufficient detail cannot be sent to reviewers.

FreeMind: In brief, you MUST get the reviewers enthusiastic about your work. They can’t do that if they don’t know what you’re doing, why, and how.

  1. Overstuffing Your Application: NIH will not let you exceed the page limit by putting important research strategy information in sections of the application that are not page-limited, such as the Vertebrate Animals or Human Subjects sections.

FreeMind: You might be tempted to put in that missing explanation on using a certain animal model tacked on with a little preliminary results you have on the model in the vertebrate Animals section. After all, 12 pages for Research Strategy is indeed very limited. Don’t do it. It’s quite possible that the reviewers will disqualify you for this.

  1. Submitting a New Application but Referring to Previous Review Outcomes or Criticism: Since NIH now accepts previously reviewed applications as “new,” be careful not to refer to the score of the earlier application or discuss how reviewer comments were addressed.

FreeMind: Indeed a “new” proposal is exactly that – new. It’s definitely tempting to address critiques, but leave that for resubmissions.

  1. Using a Small Font: NIH can withdraw your application before review if you ignore standards for font and text size. Even if we don’t withdraw such an application, reviewers will likely struggle to read your application and see its merits.

FreeMind: Always stick with the guidelines for font, margins, page limits, etc. No fooling around here. We’ve seen applications dismissed for using the wrong font type.

To summarize and conclude, there are many pitfalls and challenges in submitting a successful SBIR or STTR grant to the NIH. Some of these are indeed technical – and the CSR has mentioned some of these above. It should be noted however, that a technically fit SBIR proposal is a far cry from a winning proposal. It is defining your aims correctly, planning your endpoint milestones prudently, and many additional, non-technical but highly relevant attributes that make up a winning proposal. We will be discussing some of these in later blog entries.

 

Joel Knopf
Manager of Consulting Services

This video was written, produced, and narrated by our own VP, Ayal Ronen. Ayal worked closely with Wander productions to make this excellent introductory video come to light.

The purpose of this funding opportunity announcement (FOA) is to encourage applications to the newly authorized Direct-to-Phase II SBIR grant mechanism.  Applications are invited from eligible United States small business concerns (SBCs) that have demonstrated the scientific and technical merit and feasibility of the prototype stage of developing a biomedical technology that has commercial potential, R&D that is characteristic of Phase-I (R43) SBIR projects.  The Direct-to-Phase II grant mechanism is intended to facilitate SBIR-type R&D, to expand R&D opportunities for applicant small business concerns (SBCs), and to enhance the pace of technology development and commercialization.

read more: https://grants.nih.gov/grants/guide/pa-files/PAR-14-088.html

 

Meet FreeMind at the Partnership in Clinical trials event in Las Vegas on March 30th to discuss sources of funding able to fund your clinical trial!

For more than 22 years, Partnerships has been a cornerstone for thousands of clinical executives to partner, learn, and innovate. This coming year, we’re taking PCT to a whole new level. Watch and let Partnerships be your main destination for productivity, meetings, and ideation in 2014.

In 2013 NIH alone awarded some $10B to clinical studies and roughly $3.5B to clinical trials, from Phase I through Phase III.