As the swine flu pandemic shows signs of leveling off, FDA Chief Scientist Jesse Goodman is ready to turn attention back to his original mission: improving the agency's scientific capacity and integrity.

Goodman had only been acting chief scientist for about a month when he was tapped to coordinate FDA's response to the H1N1 epidemic - including securing vaccinations, antivirals, rapid diagnostics and protective equipment for the public health emergency (¹ Also see "FDA Chief Scientist Goodman Spearheads Agency Response To Swine Flu" - Pink Sheet, 4 May, 2009.).

"It's certainly been challenging," said Goodman, formerly the director of FDA's biologics center. "It's certainly been a very intense effort involving hundreds or thousands of individuals across the government."

FDA was hardly derailed by the initial outbreaks, he maintains, but the Office of Chief Scientist now has more time to focus on defining its own mission and priorities for 2010 and beyond.

Top among them will be fine-tuning the office's recent reorganization, which shifted combination products, pediatric devices and other areas to a new cross-cutting Office of Special Medical Programs, and brought new offices - including the Office of Scientific Integrity and the Office of Science and Innovation - under the chief scientist's purview (² [A#00710340001]).

In a December interview, Goodman provided updates on the reorganization, H1N1, transforming product development and other ongoing initiatives.

"The Pink Sheet": The flu response was clearly a huge effort on FDA and other agencies' parts. What has the impact been on the Office of Chief Scientist?

Jesse Goodman: I think that FDA, based on its resources and its tremendous breadth of responsibilities, is always to some degree dealing with whatever emerges as an unexpected high priority or emergency at that moment.

However, it does tax our capacity.

The Office of the Chief Scientist is a fledgling office. So in one sense, the capacity to do tons more and to help lead the pandemic response does impact us. But in another sense, we're [still] working to define and build what the office does.

"The Pink Sheet": Have other projects or priorities been put on the back burner so FDA could focus on H1N1?

Goodman: Personally and for many of my staff, and frankly for staff in other centers, everybody has said, 'well, the public health and safety of our country and dealing with this public health emergency is the first priority.'

Mostly people have just worked harder and longer, but certainly other things that we'd love to spend more time working on, some things get put on the back burner.

In this case, setting up an incident command approach really helped. We had a team across the agency that constantly communicated and coordinated; it was very intense for those people, but it made the overall process efficient.

"The Pink Sheet": Do you have a sense of when you'll be able to redirect attention back to the day-to-day work?

Goodman: We have been. We are, and we're making a lot of progress in those areas, too.

In the initial weeks, our incident team met twice daily. Now we have coordination meetings across the FDA once weekly. We've been very conscious of staying on the ball, but shifting our resources and attention as appropriate to other matters.

Engaging Colleagues Outside FDA

"The Pink Sheet": Such as?

Goodman: We've been very engaged in the last few months, also, on moving forward the general science agenda, beginning to engage with people on the outside, our colleagues at NIH, etc., on what we philosophically hope will be a major initiative to strengthen the scientific capacity of the FDA.

This public health response fits right in with that. This has been about, 'how do we bring the best science to bear, how do we collaborate, how do we get to outcomes that improve people's health?'

"The Pink Sheet": This summer, the Office of Chief Scientist underwent some major changes. Why reorganize?

Goodman: I think if I step back on this, it will help to frame both the big vision and why.

There's a broad consensus both within our leadership at FDA and on the outside, as exemplified to some degree by the Science Board's assessment about two years ago, that there is a real need for FDA to strengthen its scientific capacity, strengthen its engagement with the rest of the scientific community outside FDA (³ Also see "FDA Should Look Through IIRIS To Improve Science, Panel Says; Funding Is Worry" - Pink Sheet, 10 December, 2007.).

There really had not been tremendous and deliberate focused attention on those needs. In fact, there was an erosion of FDA's capacity in general.

This office was relatively recent and essentially was taking on a large number of disparate functions that weren't necessarily focused on that key issue of rebuilding the science capacity at FDA and advancing the applied regulatory science that is needed to address the gap between basic biology, proofs of concept and products that can help people.

This office had gotten huge. We had many, many components that were not under a strategic umbrella. So we said: if we want to focus on strengthening science, strengthening our scientific approach to public health, how should we focus on core functions?

We also saw there were some functions that weren't being explicitly met.

"The Pink Sheet": How has the restructuring played out? Has everything more or less fallen into place, or are you still solidifying everyone's role?

Goodman: It's a work in progress, but what we've done is said is that things that are ongoing and programmatic and not so much focused on science and innovation per se, those we would put into other parts of the commissioner's office, and we would focus on this core portfolio.

We are still in the process of working out the details of that.

We're trying to create this office that serves as an advocate and an enabler for innovation, collaboration, partnering, and for explicitly supporting the scientific capacity of FDA.

There's just this incredible opportunity to transform product development, medicine and public health. We're in a position where we can help catalyze change.

But if we don't invest and do that, I think some of these gaps we see between discovery and products that really help people [will remain].

Transforming Product Development

"The Pink Sheet": How is the concept of FDA's scientific mission changing?

Goodman: Product development is going to be completely transformed. Suddenly we have access to all this other knowledge and information - biochemical pathways, genomic and proteomic information - that is going to totally transform how we think about safety and effectiveness.

We have to think about how we capture and learn from that data during the development of a product.

People talk about some of this as personalized medicine. I think of it as better, more scientific medicine that's going to identify a lot of opportunities for new therapies and target the therapies to individuals.

We [also] see the development and the expertise of our people that are here as very important, so we really want to strengthen professional development, scientific exchanges.

I think that helps them make better decisions, science-based decisions.

"The Pink Sheet": You mentioned some gaps and some areas where you wanted to add more capacity. What are the roles of the new offices in your domain, and do they address some of those gaps?

Goodman: Absolutely. This is all about how do we get there. The Office of Scientific Integrity - the vision of that office is to be an advocate for and developer of policies around the integrity of our scientific processes.

As you know, there are external issues that can come up where somebody might disagree with a regulatory decision. There are currently ways that people can work with our ombudsman or go through a formal appeals process on those issues. This brings some of that existing capacity together.

In addition, during the last couple years, there's been an effort to improve, when there are scientific differences within FDA, how those are appropriately handled. And even more importantly, how do we create a culture where discussions and issues and concerns are brought up and clearly addressed?

Those processes are predominantly in the centers, but we also recognize that the policies around them have to be strong to be sure decisions are made on the best science and everybody's being heard.

"The Pink Sheet": So the office will set FDA's overarching policies on scientific integrity?

Goodman: [The office] is to help advocate and provide policies that support integrity internally. Potentially, there are instances where substantive disagreements may require input that cut across centers or rise above the center level.

This office will deal with the routine things that have occurred, but in a more unified way and guided by policies that are intended to support scientific integrity.

"The Pink Sheet": What is the mission and scope of the Office on Science and Innovation?

Goodman: That office is really to serve as the focus for this broad effort to promote innovation, to support collaboration across the centers and support expertise in emerging science.

For example, we have a cross-agency working group on nanotechnology. We're working to resolve and provide pathways for these issues around co-development of diagnostics and other products. These are things that cut across multiple centers, involve new technologies.

Ultimately our vision is that this office also provide more support for strategic, mission-targeted research.

Developing Better Evaluative Tools

"The Pink Sheet": So you want to foster more product research?

Goodman: Not just NIH research, but research around things like tools for [product] development, evaluative tools, standards.

We would love to have much stronger partnerships with our colleagues at NIH and elsewhere. There's an incredible opportunity there in terms of moving things from the NIH world of ideas to the world of products that are safe and effective.

This office would bring all this under a strategic envelope where the leadership of FDA would be defining what are the main scientific priority areas and what are the opportunities where FDA can really make a difference.

"The Pink Sheet": How does FDA's broader scientific vision play out at the center level? Are there things happening on the center level and things happening on a broader level, or is it more coordinated?

Goodman: I think the answer is both. We really want to create both. The day-to-day work of product review, the people with expertise in specific areas, those are in the centers. What we want to do is help enable that and support a culture in the agency where things that can enhance science that are center-specific originate from the centers, ideas that benefit everybody can originate from the centers or the commissioner's office, and we help support those.

"The Pink Sheet": The Center for Devices and Radiological Health's new task force on integrating new science into decision-making seems like one example of a center taking initiative on scientific issues... ( ⁴ Also see "FDA Eyes The Future: 2010 Workshop To Address Integration Of "New Science"" - Medtech Insight, 21 December, 2009. ).

Goodman: With CDRH, they are very enthusiastic about us building an architecture and infrastructure that supports exactly the kind of efforts they're doing. And conversely, I'm really enthusiastic to see the energy that is coming from there that embraces this same idea.

What you're seeing is enthusiasm across the agency to engage in this.

- Jessica Bylander ( ⁵ j.bylander@elsevier.com )

State Of The Science At FDA: Catching Up With Jesse Goodman

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