Archive for: October, 2015

NIH "High Risk" Programs-Part 3-New Innovator Award Program

Oct 26 2015 Published by under Uncategorized

I have previously discussed the history of the NIH Director's Pioneer Award program. The daughter program of the Pioneer program is the NIH Director's New Innovator Award program. This program was created in 2007 when Congress was working on an appropriations package in February for the fiscal year that started the previous October. I was involved in the conception of this program and I recall quite clearly how I was sitting in a meeting when someone from the NIH Director Elias Zerhouni's office came in and asked if I could spare a few minutes to speak with Dr. Zerhouni and the NIH Budget Director. Needless to say, I said that I could. In the course of the budget negotiations, Congressional members and staff had heard Dr. Zerhouni's strong concern about the plight of young investigators and had been pleased with the initial progress with the Pioneer program. They wanted to know if NIH could establish a "junior Pioneer" program if they provided some additional funding. I was asked what I thought of the idea and if we could set up such a program. Again, needless to say, I indicated that I thought we could do that. The bill was passed with $40M for this new program in the budget for the NIH Common Fund.

This was mid-February and this program has to be set up from scratch and operationalized to get these funds out the door by the end of the fiscal year (September 30, 2007). After the meeting, I walked back to NIGMS and found Judith Greenberg and others involved with the Pioneer program (which was now being administered through NIGMS) and told them that I had so much faith in them that I had committed us to build this new program on this very short timeline. I am not sure they were entirely thrilled with me but, as always, they rose to the occasion and got right to work on the many tasks that needed to be tackled.

The first key question was how to target the program to young investigators since basing eligibility on age was clearly not legal. We came up with the idea of using time since an individual had received their "terminal degree" (typically PhD or MD). But, what was the appropriate time period? After some discussion and a little analysis, we settled on 10 years (with some exceptions for clinical training or time off for family responsibilities). This decision became the basis for the subsequent NIH definition of an "early stage investigator (ESI)".

The second key question was how large the awards should be. The NIH Budget Director John Bartrum had very cleverly required that this awards be made with a new mechanism, the DP2. This mechanism is quite unusual in that it allows NIH to commit funds for multiple years from the same fiscal year. This was done to avoid adding to the commitment base with these awards. Normally, when an institute funds a multi-year award in one fiscal year, this commits the institute to funding out years of the award in subsequent fiscal years. Since NIH does not know the appropriation level for the next fiscal years, this can be a real challenge. Making lots of commitments and then receiving a poor appropriation the next year can limit the number of new and competing grants substantially, leading to low success rates and other issues. With the new DP2 mechanism, NIH could fund each entire award out of one fiscal year without taking on any new commitments. The decision was made that the awards be $1.5 M direct costs over 5 years (but paid to the institution in the first year). Thus, with $40M and an estimated average grant size of $1.5M direct plus ~$1.M indirect) = $2.5M, we expected to be able to make about 14-16 awards.

The next challenge was writing the Request for Applications and getting the word out about this program so that eligible individual would have some time to get their applications conceived and submitted. It is a testament to Judith Greenberg and her coworkers that the RFA was published on March 9, 2007, approximately 3 weeks after the bill was passed. Trust me, the NIH bureaucracy does not normally work that fast. We worked with our communication staff to publicize the funding opportunity through every reasonable channel we could think of since our fear was that eligible folks would not find out about the program in time to submit applications. Applications were due on May 22 with this short period dictated by the need to get the applications processed, reviewed, and funding decisions made by September 30. Our publicity approach was successful when we realized that we had 2153 applications in by the deadline. This, of course, created a new challenge with funds for 14 awards and 2153 application leading to a projected success rate of a whopping 0.6%.

We had taken the lessons that we had learned through the Pioneer program and made sure that all stages of the process emphasized that innovative research could be expected from scientists of all genders and from diverse backgrounds. The review process (again, set up on a short timescale) involved a 2 phase electronic review. No interviews were included (in distinction to the Pioneer award). We spent considerable time orienting each group of reviewers so that they understood the vision for the program in all aspects. When the reviews were completed, we has an outstanding set of highly ranked applications. I set to work soliciting funds from institutes to increase the number of awards. This was challenging since these awards cost about $2.5M a pop but the lack of out-commitments was a selling point. By September 30, we were able to make a total of 30 awards to some outstanding scientists including 12 women and 18 men in a range of fields. I had the privilege of personally calling these individuals to tell them that they would likely be receiving these awards (and getting some additional information to make sure that they were still eligible).

Based on the successful launch, funds were provided for the New Innovator program in subsequent years. After the program had been running for three years, we initiated an outside process evaluation, parallel to the one for the Pioneer program. This report contains considerable information about the program, including comparisons of the applicant, finalist, and awardee pools.

New Innovator Gender

There were no statistically significant differences between the compositions of the applicant and awardees pools with regard to either gender or race/ethnicity.

The New Innovator program continues to the present with 497 applicants and 41 awards in fiscal year 2015. The goal of enabling young scientists to get off to a running start in hugely important and others feel the same way. Bruce Alberts, when he was Editor of Science magazine (and a reviewer for the New Innovator program) called for increasing the number of awards to 500 per year. One of the most touching (but also distressing) experiences that I had with this program was receiving several emails from unsuccessful applicants telling me how much fun it had been to write an application about what they actually want to achieve as opposed to what they thought they could get funded to do. This seems to me to be a significant indictment of the current state of affairs. In addition, of course, it is essential that support is available to sustain these careers once they are launched.

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Gender Balance in NIH High Risk Research Programs-2015

Oct 23 2015 Published by under Uncategorized

When the NIH High Risk Research Program awardees for 2015 were announced concerns were raised about the balance of women and men among the awardees. This portfolio includes four programs:  NIH Director's Pioneer Award, NIH Director's New Innovator Award, NIH Director's Early Independence Award, and NIH Transformative R01 program.  These gender distribution among the awardees is shown below:

Pioneer: 10 men, 3 women (23% women)

New Innovator:  28 men, 13 women (32% women)

Early Independence:  13 men, 3 women (19% women)

Transformative R01:  10 men, 3 women (23% women)


Overall, women hold approximately 27% of research project grants at NIH so that the percentages in the High Risk programs do tend to be low. However, as I noted in my previous post, it is difficult to interpret these percentages without knowledge of the pool of individuals who applied to these programs.

Information about the applicant pool is not publicly available directly. However, I filed a FOIA request on October 8th and was pleased to receive the response yesterday (October 22nd, 2 weeks, record time for me...Thank you NIH staff and NIH FOIA office).

Below is the information that I received regarding the applicant pool gender composition:

Pioneer:  154 men, 49 women, 5 unknown/withheld (24% women among known)

New Innovator:  349 men, 138 women, 10 unknown/withheld (28% women among known)

Early Independence:  36 men, 26 women, 18 unknown/withheld (42% women among known)

Transformative R01:  248 men, 64 women, 17 unknown/withheld (21% women among known)


Note that gender information is not available for 18/80 = 22.5% of the applicants for the Early Independence Award. This may reflect that many of these applicants are new to NIH and have not provided this information. If we assume that all of the applicants with unknown gender are men, then the percentage of women is 33%. If we assume that all of these applicants are women, the percentage of women is 55%.


For the Pioneer program, the percentage of women awardees matches the percentage of women applicants. Based on the numbers, the p-value is 1.00, that is, there is no evidence that these distributions are different.

For the New Innovator program, the percentage of women awardees is slightly higher than the percentage of women in the applicant pool (32% versus 28%). The p-value is 0.72, indicating that the gender distribution of awardees is reasonably likely given the gender distribution of applicants.

For the Early Independence program, the percentage of women awardees is lower than the percentage in the applicant pool (19% versus 33-55%). Using the numbers for those with known gender, this mismatch has a p-value of 0.15. This is concerning as I will return to shortly.


For the Transformative R01 program, the percentage of women awardees is slightly higher than the percentage in the applicant pool (23% versus 21%). The p-value is 0.74.

Thus, for three of the programs, there is either no evidence of bias going from the applicant pool to the awardee pool. However, the percentages of women in the applicant pools are relatively low (21 to 28%). Particularly for the New Innovator program, the fact that only 28% of the applicants are women may reflect the pool of eligible faculty (although examining this will require additional data) or may reflect the likelihood that eligible women apply at the same frequency as do eligible men.


The most concerning data are for the Early Independence program. There is reasonably strong evidence for bias against women in moving from the applicant pool to the awardee pool (although knowledge of the magnitude of this effect is limited by the missing data for the applicant pool). There are at least two levels where this bias may be manifest. First, of course, is the review and selection process. But, one should keep in mind that this program requires considerable evidence of institutional support. Each institution is limited to two applicants and the application requires details about institutional support. Regardless of the sources, the NIH should examine this aspect of this program in short order to understand and try to correct any shortcomings of the process. This program has the potential to be particularly valuable for women since it is intended to shorten the time to independence, potentially better aligning the career path with biological clocks for those interested in having a family.

The data that I obtained allow one additional bit of analysis. The success rates for the program are as follows:

Pioneer:  13/208 = 6.3%

New Innovator:  41/497 = 8.2%

Early Independence:  16/80 = 20%

Transformative R01:  13/329 = 4.0%

While these success rates are low but the application processes, at least for the Pioneer and New Innovator awards, are relatively streamlined and, in my opinion, many additional scientists should consider applying to these programs. For the Early Independence program, the success rate is relatively high, but this reflects the limitation of two applicants per institution. This limitation presents another point of potential bias toward particular types of applicant.

The program are important in their own right and are flagships for NIH. It is essential that they be examine carefully to ensure as much as possible that they are serving their stated goals and are capturing the full range of outstanding scientific talent in the community.

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NIH "High Risk" Programs-Gender Issues-Part 1-Pioneer Program

Oct 12 2015 Published by under Uncategorized

With the recent announcement of the "high-risk" research awards from the NIH, a discussion on Twitter began around the relatively low number of women awardees for these awards. I will return to this issue later but first I want to provide some background. For this post, I will focus on the first in this suite of what is now four programs.

The NIH Director's Pioneer Award (DP1) was initiated as part of the original NIH Roadmap for Medical Research. The award was intended to be an experiment driven by a frequent concern raised to Elias Zerhouni, then the NIH Director, that there were a number of highly innovative researchers in fields relevant to the NIH mission who were not applying to NIH because the relatively opacity and complexity of the NIH application process.

There were a large number of nominees (the program initially involved nominations rather than applications) and most of the nominations were submitted shortly before the deadline catching the NIH slightly off guard (more of this later). The Pioneer application involves a 5 page essay (rather than the more standard R01-type application of 25 pages at the time) and 22 of the most highly rated applicants are interviewed in person in Bethesda. This program was initiated just as I was starting my position as Director of NIGMS and I was not involved in the program in the first year.

When the first Pioneer awards were announced in September of 2004, I was surprised and disappointed by the outcome. There were nine recipients, several of whom were relatively well established within the NIH community including, for example, Steve McKnight (who was already well recognized within NIH as an innovative and productive scientist although he has gone on to make some controversial statements about the scientific community) and Homme Hellinga (who was recognized as a rising star at the time although much of his research has turned out to be, at best, irreproducible). I was hoping to go back to my office to google the awardees because I had not heard of them or did not know much about them. In addition, all nine of the awardees were male and this, appropriately, raised concerns within the scientific community both outside and inside NIH.

After the next meeting of the Institute and Center directors, I was sharing my views with Raynard Kington, then Deputy Director of NIH. He listened carefully and told me that Dr. Zerhouni needed to hear such concerns and I dutifully went back to my office and composed a long email. A couple of days later, I walked into a meeting at which both Drs. Kington and Zerhouni were present. They called me over and asked if I/NIGMS would like to take over running the Pioneer program. I was delighted if a bit daunted by this opportunity and asked some of my key colleagues including former acting-NIGMS Director Judith Greenberg if she would be willing to help with this effort.

We had a bit of time to review the processes that were used the first year and made a number of small changes including removing a "leadership potential" criterion that was used the first year since it seemed to peripheral to the goals of the program and had the potential to introduce biases of various sorts, allowing self-nominations and later applications, recruiting a more diverse pool of reviewers (more on this later), reaching out more aggressively through many outlets about the Pioneer program, reminding applicants and reviewers at all stages that "pioneering" researchers are quite diverse in all dimensions including gender, race and ethnicity, field, and career stage.

We again received a large number of applications and the process worked fairly smoothly. The end result was 13 awardees in a wide range of fields and career stages including 7 men and 6 women. As one would expect given access to $500K per year for 5 years as well as a competitive selection process, these investigators have done quite well, some exceptionally so.

The process continued for several more years with relatively similar results. After a total of five years were complete (so that we would have a reasonable data set), we initiated a process evaluation. This was completed and released in 2010. This is quite a thorough report and I encourage interested readers to have a look in its entirety.

With regard to gender distributions of Pioneer applicants, interviewees, and awardees, the key findings were:

The percentage of female applicants ranged from 22% to 27% with a mean of 25%. This number increased the year after we took over the program, a reassuring results after the results of the first year.

The percentage of female interviewees was 27% and the percentage of female awardees was 29%. The differences between these percentages and the applicant pool were not significantly significant.

The percentage of female awardees at 29% was higher than the percentage of female R01 awardees over the same period (23%).

One striking and distress result from the first year was the percentage of women among the reviewers. These results are shown below:

Pioneer Evaluators

While it is important to keep in mind that gender makeup of a review groups often does not eliminate or even reduce unconscious gender bias (example), the results from the first year of the Pioneer program were quite worrisome. The NIH staff running the program did not anticipate the number of nominees (1331) and had to scramble to recruit enough reviewers on short notice. With that constraint, the result was 59 men and 4 women including only 1 woman on the interview committee.

As an aside, the first years of the Pioneer program were run before existed. A special system had to be built and this allowed collection of data about exactly when applications were submitted. The results for the first year that NIGMS ran the program are shown below:

Pioneer timing

This shows the number of nominations/applications as a function of the data from the opening of the submission site (3/1) to the closing date (4/1). This reveals that many applicants submitted within the last few days before the due date. In addition, the eventual awardees (shown with red bars) tended to submit late in the day including a few minutes before the deadline. I would never have some much faith in a website.

I will discuss some of the other programs in subsequent posts. For now, I welcome thoughts about this analysis of the Pioneer program including gender balance issues. I have submitted a FOIA request for information about the applicant pools for these programs for the current year so that I hope to have data to do some analysis beyond looking at the awardees.

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Lasker to Nobel: Clinical versus Basic-Part 2

Oct 12 2015 Published by under Uncategorized

In a recent post, I analyzed more than 50 years of Lasker Award winners with regard to the likelihood that a winner went on to receive a Nobel Prize. Six percent of the Lasker Clinical Science awardees had gone on to receive Nobel Prizes compared with 48% of the Laster Basic Science awardees.

Driven in part by a comment on this post, I looked at the degrees received by these Nobel laureates in the course of their training. Of the six Clinical Science awardees, 2 had MDs, 1 had an undergraduate medical degree (MB ChB), 2 had PhDs, and 1 had an engineering degree. As far as I can tell, none of the six were active in clinical practice.

Of the 58 Basic Science awardees, 22 had MDs (or MD-PhDs). Some of these MDs completed internships and residencies, but very few of them appear to have been active in clinical practice passed their training.

For Nobel prizes that went to multiple researchers, there do not appear to be few or no examples of awards to clinical sciences and basic scientists working together on a project.

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Lasker to Nobel: Clinical versus Basic

Oct 07 2015 Published by under Uncategorized

In response to my recent post regarding Nobel Prizes, a commenter suggested that comparing the number of winners of the Lasker Award for Clinical Medical Research who had gone on to receive a Nobel Prize with the number of winners of the Lasker Award for Basic Medical Research who had done so would be one way to quantity any bias toward basic science in the Nobel Prizes. This seemed like a reasonable suggestion so I tallied the numbers for these categories.

Since 1960, 100 individuals have won or shared the Lasker Award in Clinical Medical Research. Of these 6 have gone on to receive Nobel Prizes (including Youyou Tu this year). 121 individual have won or shared the Lasker Award in Basic Medical Research over the same period. Of these 58 have gone on to win a Nobel! Needless to say, this is statistically significant with p < .00000000001.

This clearly reflects a bias favoring basic research although there are some additional factors affecting these numbers such as that approximately a third of the Lasker Basic Medical Research awardees have gone on to win Nobels in Chemistry rather than Physiology or Medicine. There may be more tomorrow morning.

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Nobel Prize Week

Oct 02 2015 Published by under Uncategorized

The Nobel Prizes will be announced next week starting with the Physiology or Medicine Prize on Monday morning. Nobel week took on substantial significance to me during my time as Director of NIGMS. NIGMS had hired a talented science writer in the Communications Office who pointed out that Nobel week was actually quite stressful for science writers. They wake up early in the morning, find out who won the prize, and then have to have a story ready for their editor in short order that might actually be on the front page without knowing the science or having sources available to talk in the early morning. At her suggestion, we started reaching out to reporters prior to the announcements based on the fact that many Nobel Prize winners had been supported by NIH (and, in particular, NIGMS, more on that later) in the past. Every year that I was Director, either the Physiology or Medicine Prize or the Chemistry Prize was awarded to one or more NIGMS grantees.

The outreach strategy was quite successful. I woke up, looked at the Nobel announcement, and then started fielding emails and phone calls from reporters. One of my favorite moments was in 2006 when I was asked by a New York Times reporter why the US tended to do so well with Nobel Prizes. I remember thinking that if I blew this one, I would probably not have a job by the end of the day. I commented that it reflected taxpayer support for science through agencies such as NIH and NSF. This was paraphrased in the article:

Dr. Jeremy M. Berg, director of the National Institute of General Medical Sciences at theNational Institutes of Health, said the honor showed the importance of taxpayer-supported basic research that is not aimed at a certain goal. His institute has provided financial support for Dr. Kornberg’s work since 1979, even when it was unclear if the research would be successful, he said.

Now for some data. Over its history, NIH has supported a total of 145 Nobel laureates. Since its founding in 1962, NIGMS has supported 81 Nobel laureates. This represents 56% of the Nobel Prize winners with approximately 8% of the overall budget. NCI appears to have supported the second most with 29 laureates. Bear in mind that many Nobel laureates have been supported by more that one institute.

While I was President of ASBMB, I wrote a column on the role of serendipity in important discoveries. I examined all of the Nobel Prize winners in Physiology or Medicine, or Chemistry for a 25 year period and subjectively scored the discoveries as serendipity (such as the discovery of RNA interference), driven by problem selection (such as the determination of the structure of RNA polymerase), or a hybrid of these two factors. Overall, I concluded that, of 117 laureates, 14 made serendipitous discoveries, 72 won based on choosing a clearly fundamental problem, and 31 were hybrids.

I have my predictions made for the prizes for this year. I am usually wrong, but have gotten a couple right over the years. One of my long-running favorites, Carl Djerassi, died in February having never been awarded a Nobel despite leading the invention of the birth-control pill and many other fundamental contributions to chemistry. We'll find out what happens next week.

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