Vicki Seyfert-Margolis, the Senior Advisor for Science Innovation and Policy for the FDA Commissioner’s Office, explains what regulatory science is and what's behind the agency's new strategic plan to advance regulatory science.
- Listen to the Podcast
- Read the Transcript
- Consumer Update: FDA Modernizing Regulatory Science
- Press release: FDA: Regulatory science plan positions agency to foster innovation through better science
- Blog post: Fostering Innovation Through Better Science
More About Dr. Seyfert-Margolis
Vicki L. Seyfert-Margolis, Ph.D., is the Senior Advisor for Science Innovation and Policy for the FDA Commissioner’s Office. Dr. Seyfert-Margolis focuses on initiatives in regulatory science and innovation, personalized medicine and scientific computing and informatics. Previously, she served as Chief Scientific Officer at Immune Tolerance Network (ITN), a non-profit consortium of researchers seeking new treatments for diseases of the immune system. At ITN, she oversaw the development of more than 20 centralized laboratory facilities, and the design and execution of biomarker discovery studies for over 25 Phase II clinical trials. As part of the biomarker efforts, she established construction of a primer library of 1,000 genes that may be involved in establishing and maintaining immunologic tolerance and co-discovered genes that may mark kidney transplant tolerance. Dr. Seyfert-Margolis was also an Adjunct Associate Professor within the Department of Medicine at the University of California, San Francisco. Prior to academia, she served as Director of the Office of Innovative Scientific Research Technologies at the National Institute of Allergy and Infectious Diseases at NIH, where she worked to integrate emerging technologies into existing immunology and infectious disease programs. Dr. Seyfert-Margolis completed her Ph.D. in immunology at the University of Pennsylvania’s School of Medicine. Dr. Seyfert-Margolis has co-authored numerous publications and has lectured internationally on various topics.
Jeff: Hello. I’m Jeff Ventura of the U.S. Food and Drug Administration. On February 24, 2010 the agency launched its Advancing Regulatory Science Initiative. Later that year the FDA released a framework document Advancing Regulatory Science for Public Health, which outlined FDA’s intention to unleash regulatory science’s potential to improve public health.
Now the agency is set to release the strategic plan for regulatory science calling for a sweeping modernization of the science used in developing and evaluating products critical to the nation’s health, economy and security.
Joining me today to help us understand just what this plan is about is Vicki Seyfert-Margolis, the Senior Advisor for Science Innovation and Policy for the FDA’s Commissioners’ Office. Vicki, welcome.
Vicki: Thank you, Jeff.
Jeff: What is regulatory science? Why don’t you take us through that?
Vicki: Well first of all, the definition is really it’s a science that’s an applied science, really focused on developing new tools, standards and approaches to asses safety, efficacy and quality of the products that we at the FDA are responsible for regulating and reviewing. And I think it’s important to note that this is an area we identified as a gap that exists between basic research and discovery, which is ongoing and very vibrant, and actual delivery of products to the market and to the patients who need them. So this is an area that we think is critical for making that link between discovery and actual product in the clinic.
Jeff: Very interesting. As I mentioned in the introduction, the agency issued a white paper last year on regulatory science. How is this plan that we are releasing today, how is this different from what we released a year ago?
Vicki: The plan we released a year ago is very, really quite a broad overview of the areas that we thought in broad terms were going to be important for advancing regulatory science. And in fact, they included some of the things that we talk about in this report today but in this report we go into much greater detail with specifics about what kinds of areas in particular scientifically we think need further attention and investigation.
Jeff: And so in terms of that specificity, give us a little more detail in terms of the plan and what it includes.
Vicki: Well the plan really is addressed to, I think, cover some of those gaps that we’ve identified between basic R&D and product. So it includes things like modernizing toxicology, innovations and clinical trials, we know that this is critically important to come up with better and more efficient clinical trial design strategies; manufacturing, when we have complex new products or products such as nanotechnology we need to look at our manufacturing approaches differently; an emphasis on computing and harnessing information sciences to improve health outcome; and then of course we need a focus on food safety and how to protect public health with respect to the foods arena.
One more interesting thing in the report that we did focus on was behavioral science and how we can do a better job of communicating to the different audiences that we think need to be better educated about what we’re doing at the agency and about the products that we regulate.
Jeff: So tell us a little bit about what changes at the FDA in terms of this plan, what - do processes change? Walk us through that a little bit.
Vicki: I don’t think it’s really a change in terms of our - certainly not in terms of our review processes except to the extent that this knowledge and this base of science we think it will really help facilitate a better understanding during the review process and of course make for a more effective review process.
I think what will change is an awareness not only within the agency in terms of really beefing up the scientific knowledge base within the agency with - in particular with respect to some of the areas that we laid out, but also how we’re going to be engaging the external world including other government agencies, academia and industry partners to try to accomplish some of the tasks that have been laid out in this plan.
Clearly this is something that we can’t do alone as an agency; but it’s something that we think is important and necessary to really get better, more effective and safer products to the market.
Jeff: Interesting. Okay. And how does someone listening to this podcast at home benefit from the FDA improving regulatory science? What’s the connection between the plan and say, you know, a consumer at home who doesn’t really even understand what regulatory science is until this podcast?
Vicki: Well I think in one area in particular they’ll be able to understand and appreciate it more immediately and that’s the communications and behavioral science which is really to help consumers and professionals make better and more informed decisions about the products that they’re using, medical products and others that they’re using, and about how we are making decisions and how the decisions may impact them.
On the other fronts, I mean things like personalized medicine, things like manufacturing and health information technologies are going to seem a little bit more remote from the consumer but I do think if we do this right, the consumer will benefit from having things that they can’t see, better, safer food supply in terms of we’ll see less outbreaks if we’re doing our job more effectively.
Jeff: Certainly very important.
Vicki: And on the medical products side I think this is where we’ll see a real impact. We’re really hoping to beef up that pipeline so that there will be more and more innovative products that come on the market to help people with chronic and life-threatening diseases and I think that’s where the consumer really needs to - I should say where the consumer would really appreciate or feel the investments that are made in this area.
Jeff: Sure, sure. And let’s talk just a minute about industry. What is the takeaway for industry in terms of this plan? What should they be thinking?
Vicki: Well, you know, certainly we’ve been engaging industry, in particular the pharmaceutical and biotechnology sectors, for quite some time now because there have been some issues with productivity. As I’ve pointed out, there’s been a lot of investment in basic research and development in fact at record-breaking levels both in the government sector and in the private sector over the last several years and that’s been steadily rising. But what we’re not seeing is the same rise in output that is in innovative new medical products coming out of the pipeline.
And I think everybody recognizes we’re at a crossroads here where the science has put us in a fundamentally different place. Products are more complex and products that work better and are more targeted, you know, are difficult to develop. And so this area of regulatory science is really aimed at helping bring innovation to industry and identifying some of those key areas along the product development pipeline that I think we all agree needs attention. So I think industry will be very positive about this report and it will be well received by the people working in industry.
Jeff: And I think that really gets to, you know, our last question which you have somewhat answered in that response, but tell us a little bit about why is this so important? In other words, can the agency afford not to do this? Is it really primarily as you said - I mean is it really about innovation at this point?
Vicki: I think it’s not just something that the agency can’t afford to do. I mean clearly what we’re doing is putting out a call to action if you will. I think it’s something that the scientific community, the medical product development sector of industry and I think the people involved in monitoring the safety of both medical products and food I think it’s something we all can’t afford to not do.
So for the agency, I mean clearly these are things that we need to do to help ensure better, safer products. We’re going to continue going about our business and doing it in a very high-quality fashion but I think this is really about how do we get to that next level, how do we get to those next generation medical products that incorporate things like investments in the human genome project and investments in new technologies as I mentioned like nanotechnology or in more complex biological type, biologic products.
I think all of these kinds of investments are going to be necessary for us to take the science that we’ve invested it to the level of bringing it to the product in the market. So this really is something the agency - I would say, yes, the agency definitely needs to do this and will do it to the extent it can but I think it’s something that the entire scientific and medical product enterprise needs to be investing in.
Jeff: Vicki Seyfert-Margolis is the Senior Advisor for Science Innovation and Policy for the FDA’s Commissioner’s Office. Vicki, thanks for joining us today.
Vicki: Thank you, Jeff.