The Measurers Size Up Stem Cells

By Jeanne Loring

Last week I visited NIST, the National Institute for Standards and Technologies in Gaithersburg, Maryland as a member of a review panel. NIST is the science branch of the US Department of Commerce, which is the business part of the government, and is not officially associated with other acronyms, the NIH, NSF, DOD, DOE, or the FDA.

I discovered something exciting that is a secret to most biologists.NIST clock

It wasn’t the atomic clock, which is the official time standard, or the U.S. National Prototype Kilogram.

As the nations “standards bearers”, NIST calibrates things, from high-energy electron beams to laboratory thermometers, and is the place to buy from its catalog of 1,194 standard reference materials (SRMs), from standards to measure blood cholesterol and Portland Cement to a Calibration Standard for High Resolution X Ray Diffraction.

The NIST labs reminded me of one of my favorite places, a hardware store, where I’m fascinated with all of the small objects in the bins and wonder what they are used for. NIST’s bins are no secret to chemists, physicists, and engineers, but there hasn’t been much for biologists.Kilogram standard

But biologists have a bin or two at NIST, and may soon even have some containing things specifically for the stem cell community!

Some of the projects I learned about are a protein delivery system that has clinical applications, development of advanced microscopic imaging technology, forensic-type standards for cell line identification, and quality control standards for cell culture three-dimensional matrices.

NIST has clout. When the FDA or other government agency needs help with solid scientific information, they turn to NIST. Last fall, the FDA used DNA standards provided by NIST for the first approval of a DNA sequencing instrument for clinical diagnostic tests- Illumina’s MiSeq instrument.

The great news for us is that NIST has decided to help stem cell researchers by developing standards that we can all use as benchmarks for our research and clinical applications. But they won’t make a big deal of it; NIST does their work quietly, choosing projects not on the basis of headline-grabbing potential, but on the potential to improve the quality of our science. Stem cell science needs NIST.

What do you think needs to be standardized in our field?

Literally unbelievable secret GOP plan for NIH Sequestration

The GOP, guided by nationally-respected CEOs, has devised a 20-point plan (below) to turn NIH into a for-profit enterprise in reaction to Sequestration.

  1. $1,000 service fee per grant application.
  2. Destination fee: Applicant’s proposal is guaranteed to be assigned to requested study section. $5,000.
  3. Extra “baggage” fee to those whose previous grants were triaged to make those outcomes unviewable by reviewers of their new proposal: $1,000 per outcome
  4. Optional 30-min. video proposal rather than written grant proposal: $10,000.
  5. For-proifit NIH swag e-store on Commons website*. E.g. NIH sweatshirt $99.95. NIH mug, $27.95.
  6. First-class upgrade for “coach” grant proposals, lowers percentile score up to 3%, $10,000 per 1%.
  7. Third time’s the charm option: allows A2 revision. $25,000
  8. Blue state institutions get 10% less overhead.
  9. Late fee (late grant still accepted): $5,000 per day late, up to 5 days.
  10. Expediting fee: $5,000 to get review results within 1 month; otherwise now takes 6 months
  11. Bonus pubs charge: $1,700 for each additional pub listed on biosketch above 15.
  12. $10,000 bump fee: allows applicant to remove 1 study section member from reviewing their grant.
  13. New NIH VISA Card, 1% cash back, $1,000 annual fee, can be used for the new grant charges described here or at Subway.
  14. Typo forgiveness, $5,000. Screens grants for typos and common grammatical errors prior to study section.
  15. Even-odd grant review. Grants from zipcodes that are even numbers are reviewed one year and those with odd zipcodes are reviewed the next.
  16. Color figure fee: $1,000 per color figure in grant
  17. Page charge, $1,000 per page beyond 8 pages.
  18. Phone-a-friend at NIH program. $5,000 for 30 rollover minutes chat time & $10,000 for unlimited texts with PO.
  19. NIH Grant Tips Apps for iPhone and Android, free-ish, in game charges apply.
  20. Avoid open-access fee. To keep proposal confidential and keep it from going on the Internet, $10,000.

*note, we take PayPal or new NIH Visa card.

Perfect storm dodged: what are three key challenges for stem cell field going into 2013?

I recently attend a conference in Florida called The World Stem Cell Summit. It was very enjoyable and unique in that it brings together and is open to all constituents of the stem cell world. I gave a couple talks and did an “expert” luncheon at this meeting, but what I enjoyed most was talking with people at the reception the first night and the awards dinner the last night.

In my first talk as part of a panel on the stem cell advocacy post-election agenda, I argued the field faces three key problems.

What are these three problems?

You can see my talk (at least the slides, not me) and hear my talk if you go here.  I also said some other fun stuff about my blog, outreach to non-English speaking countries, and so forth.

However, I’ll also summarize them here.

First, we have a serious science funding problem. The NIH budget has been stagnant (in real dollars, but declining against biomedical inflation) or actually going down for quite a few years now. What this translates to is that the funding rates at most NIH institutes are abysmal. For example, to be essentially guaranteed of funding at NCI you need to be in the top 7%. Since most scientists I think would agree that about the top 25% of grants are meritorious, what this means is the majority of good science is going unfunded including that on stem cells of course. Every year we get closer to CIRM potentially ending its funding or shifting gears to become a private foundation with far less funds most likely, the NIH budget situation becomes more perilous as well. More broadly we have a generation of young scientists that are discouraged and an increasing number do not believe their future will be a bright one in science. That makes the future of science just that much less promising.

Second, we have what I call the Big Chill for hESC research. While the Sherley v. Sebelius case so far has gone our way so far at least (fingers crossed that the Supreme Court takes a pass), the net effect has been that hESC is in a freezer. The number of hESC papers is down. The number of scientists who want to work on hESC is down. Scientists view it as too risky. We still need hESC research folks so we need to advocate for it and make clear that iPSC have not somehow made hESC unnecessary. hESC are many years ahead of iPSC in terms of clinical translation.

Third, we have the push for stem cell deregulation. This poses a serious and growing threat to the legitimate stem cell field. If you think that rogue stem cell clinics just operate outside the U.S. you are wrong. If you think that rogue stem cells clinics in the U.S. do not affect or threaten you as an academic or industry scientist, you are wrong. Unlicensed stem cell clinics are sprouting up across the U.S. like mushrooms and with a static FDA budget, more and more patients are receiving unlicensed and untested treatments. More and more patients will be injured, possibly file suit, and overall lower the view of the American people of the stem cell field. We need legitimate stem cell scientists to publicly advocate for the FDA regulating more than minimally manipulated stem cells as drugs and against unlicensed clinics.

 

Part II of former NIGMS Director Jeremy Berg interview: what surprised him most about NIH, what he would change, and looking to the funding future

Yesterday I had part I of my interview with NIGMS former Director, Dr. Jeremy Berg.

Today we have part II of the interview, which I found very interesting and helpful in providing a glimpse into NIH. I appreciate Dr. Berg doing the interview and his frankness.

Given the budgetary issues facing NIH in terms of funding from the federal budget, where do you see funding levels in the coming year? In the next 5 years? 

Answer: The next year is particularly hard to predict.  If sequestration (across the board cuts to all discretionary programs) goes into effect, the funding situation will be horrible.  It is projected that sequestration would result in an 8.2% cut to the NIH budget.  Given that approximately 80% of the NIH budget is already committed to ongoing grants and fixed costs, this would represent a 8.2% of the overall NIH budget taken out of 20% of the budget available for new and competing grants.  This corresponds to a 41% cut in funds for new and competing grants.  NIH would very likely cut committed grant budgets to some extent to reduce the damage, but the result would certainly unprecedentedly low success rates for grants.  If sequestration foes not take effect, this is still going to be a tough year.  The appropriations bill passed by the Senate Appropriations subcommittee has a 0.3% increase for NIH whereas the House Appropriations subcommittee has no increase.  Furthermore, each of these bills has some additional problematic features in terms of how the funds are distributed and other policy riders.  Usually, one would expect the finally appropriation (likely through a continuing resolution) to be between these figures.  This is well below inflation and the number of applications is up.  This would lead to lower success rates than the last year (which showed record lows) or the current year.  In the longer term, a lot depends on the overall economic situation.  If the economic situation improves substantially, then leaders in Congress and the scientific community may be successful in advocating for increases in the NIH budget, ideally increases greater than biomedical inflation.  At the same time, it is likely that the number of applications will decline somewhat over the five-year period if NIH appropriations do not increase as investigators dependent on extramural funding for their position are laid off or seek other positions.  It is crucial that the scientific community work hard and effectively to communicate the impact of continued sub-inflationary increases in the NIH budget will have on scientific medical program and American scientific leadership and competitiveness.

If you could wave a magic wand and make one change about the NIH funding system overall to make it, in your opinion, work better overall, what would it be? 

Answer: One change that would be on the list would be to develop a system for providing feedback to reviewers.  Some reviewers are outstanding, writing critiques that lay out the important issues in a manner that guides Council members and program staff in making funding recommendations and helps applicants and program staff formulate strategies when considering submission of amended applications.  Furthermore, some reviewers read and understand the programmatic goals associated with different funding opportunities, using different considerations, for example, when reviewing R21s compared with R01s.  However, other reviewers do not do nearly as good a job in these areas.  However, reviewers do not get constructive feedback to help them improve their reviewing skills.  NIH has discussed developing such a system over the years but, for a variety of reasons, has never elected to tackle this.  Properly implemented, such a reviewer evaluation/feedback system could lead to an improvement in the system, perhaps a substantial one.

What would you say was the most surprising thing you learned from your experience as a Director? 

Answer: I learned a tremendous amount during my time as NIGMS Director on many fronts.  Many of these surprises were positive.  For example, the competence and commitment of the staff members at NIH and, particularly, at NIGMS exceeded my expectations.  These people, in all roles…program officers, scientific review officers, grants management staff, administrative staff and so on, are highly committed to the NIH mission and helping scientists succeed.  On the negative side, I was sometimes surprised that relatively individuals at NIH realized how much power they had with the large amounts of data that NIH has at its disposal to analyze the outcomes of NIH programs and the potential impact of potential policies.  Over my time at NIH, I worked with others inclined toward such data analysis to try to provide a stronger factual and scientific basis for NIH policies.  I have been delighted to see such efforts continuing to grow to other institutes and the Office of the Director as revealed, for example, by the Rock Talk blog.