A former CDC head on key R&D areas, public trust and if we learned anything from COVID-19

When Dr. Julie Gerberding took the helm of the Foundation for the National Institutes of Health, the many roads of her life’s work intersected at just the right place.

An infectious disease doctor, Gerberding spent her career rising through the ranks of academia and government, eventually becoming a powerhouse in U.S. healthcare. In 2002, Gerberding was named director of the CDC (the first woman to hold that post) and in 2010 went on to Merck & Co. where she held several executive positions including as president of vaccines.

“Right now I’m exactly where I should be in bringing the academic perspective and my time at CDC seeing health challenges in the U.S. and around the world together with my understanding of how industry works and how science is translated at scale,” Gerberding said.

In her current gig as CEO of FNIH, which she started last year, Gerberding has a front-row seat to many quickly moving trends in biopharma. A nonprofit focused on public-private collaborations that advance biomedical breakthroughs, FNIH has raised $1.55 billion to date in support of 122 active research partnerships, educational initiatives and more. Its programs include a cross-sector effort to validate biomarkers, HIV research, and the “longest continually monitored Alzheimer’s disease study.” 

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“My view is that health security is just as important as other pillars of a nation’s security.”

Dr. Julie Gerberding

CEO, president, FNIH

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Most recently, FNIH selected eight rare diseases for its gene therapy clinical trial program run through a consortium of NIH Institutes, life sciences companies and patient organizations. 

As Gerberding looks ahead, the lessons she learned from working her way up from being a medicine resident to a tenured associate professor at University of California San Francisco to her time in the public health spotlight and in vaccine development at a pharma giant are never far from her mind.

“It’s been challenging to build trust across the three sectors [of academia, government and industry],” she said. “But by building these relationships and taking advantage of scientific advances, we’re only limited by our imagination and willingness to invest.”

So when PharmaVoice recently caught up with Gerberding, we tackled it all: her reflections on being at the CDC through 40 public health emergencies, how the agency can rebound from its pandemic troubles, the most bustling areas of pharma research and what 2024 could have in store. 

This interview has been edited for brevity and style.

PHARMAVOICE: In your current role at FNIH, you’ve got a front-row seat to a lot of exciting innovation. What are some of the most bustling areas of interest? 

DR. JULIE GERBERDING: [In cancer] there has been a dramatic transformation with immunotherapies and beyond. That scientific capability, discovery science and translational science is game changing for many cancers, but not all. So there’s still a need for more investment in that space. 

Another important lens to me is gender equity. I was thrilled when [the White House recently launched] an initiative in women’s health research addressing diseases specific to women as well as those that are more common or present differently in women.

In 2024, we are launching a major program in ALS. We need scientific breakthroughs to validate biomarkers that predict disease progression. It’s a broad search for targets and pathways, but we would like to understand with precision what is causing ALS and why it’s different in different patients. This will also be an area [where] combination therapies may be important. 

Another area that we’re excited about is preeclampsia. Maternal mortality in the U.S. is unacceptably high, but this is also a huge global problem. We have learned how to prevent bleeding complications and infections even in resource-limited areas, and now we are tackling preeclampsia, a third major cause of preventable maternal mortality.

The biggest area of challenge is mental health. There has been very little discovery science that has resulted in new targets or categories of treatment. Accurate diagnosis is a major challenge. Diagnosing ‘depression’ is like diagnosing ‘chest pain’ — it can have many underlying etiologies but treatment is non-specific and mostly proceeds by trial and error. The new postpartum depression treatments are breakthroughs that target a very specific etiology and give promise to the hope that other precision therapies may emerge.

How is the environment for partnerships around these issues?

The big, wonderful thing about the current environment is that science is on our side. We’re exploding with tools and tech to solve unmet medical needs that have plagued many for a long time. The downside is that the society we’re working in is not so sure we’re on the right path, and we’re contending with major issues with trust and confidence in the validity and utility of what we’re working on. We also need sustained investments in implementation research to create a framework for health that is available to everyone.

You mentioned the lack of public trust. What was your experience with combatting reputational issues while at the CDC?

I was fortunate when I was CDC director that we were not plagued with significant reputational issues. When I left, it was the most trusted agency in government according to national polling data. Part of that [was] probably our response to the first SARS epidemic. Even though it had a high mortality rate and a tremendous economic impact, society did not completely shut down. But it was still a frightening outbreak and a wake-up call because people weren’t prepared. And CDC was in the hot seat for that one. But I was fortunate because the government delegated the responsibility to managing the public health decision apparatus to the CDC and we were allowed to lead press conferences from our Atlanta headquarters, not the White House.

Fast forward to now and — not because of any particular party but because of the nature of our government — everything is pulled to the White House and that lends to the politicization of [public health emergencies]. Once you lose trust like the CDC did during the early days of COVID-19 — partly because of missteps and because they weren’t leading the communication — it’s impossible to recover in the midst of a crisis. It’s going to take time and a lot of transparency to rebuild that trust, not just from the CDC director and her teams, but also from the entire public ecosystems in states and local communities.

Have these reputational issues impacted your work at FNIH?

My perception from the heads of research in life sciences companies and academic health centers [is that] we are all collectively worried about trust in science and scientists. It’s a shared concern.

What can pharma do to help restore trust in science? 

It’s a complicated question because the nature of the private sector is that it’s private. A lot of the knowledge and resources that sit inside a company are not easily shared because of the priorities and commercial interests. [But] one of the more remarkable things we’ve participated in with pre-competitive partnerships [is] how willing scientists are to collaborate and share information. That lets all boats float higher in the rising tide.

We’ve learned that we can share data without providing anti-competitive or IP information with tools and databases that maintain confidentiality.   

There are always opportunities for improvement. The industry could always improve transparency and champion more equitable and affordable access, and inclusive and innovative clinical trial models. 

You’ve spoken out about the need to strengthen pandemic preparedness and for Congress to reauthorize the Pandemic and All Hazards Preparedness Act (PAHPA). Have you sensed willingness among lawmakers to accomplish that? 

I’ve learned through many years — going back to the beginning of the HIV pandemic — that when people are in crisis, all hands are on deck. And as soon as it’s diminished, we move into complacency. All you have to do is look at the CDC budget over time and you can see that pattern. This is not a way to build a resilient nation of biopreparedness. From a policy perspective, we need to demand that leaders make sustained investments in pandemic preparedness. So I put the burden of that on the leadership of our government. Governments have to take a primary role and my view is that health security is just as important as other pillars of a nation’s security.

It feels like momentum for pandemic preparedness is slowing down, despite COVID’s major toll. Do you think this time will be different? 

No. I applaud certain efforts that are under way, and I think the PAHPA is the right thing to do. The question is: Will Congress fund what’s necessary to realize that strategy? It’s critical to fund it … [but] I’m not confident in that sustained effort to advance our biosecurity. 

If we didn’t learn that lesson from COVID, I don’t know what it will take.