Remarks by Dr. Hahn to the Global Coalition for Regulatory Science Research September 30, 2020

Speech | Virtual

• Speech by: Stephen M. Hahn, M.D. ; Commissioner of Food and Drugs - Food and Drug Administration ( December 2019 - January 2021 )

I’m delighted to be with you today for this important meeting of the Global Coalition for Regulatory Science Research.  I only wish that we could be together in person.

I want to thank Bill Slikker and his co-chair of the Scientific Program Committee, Marta Hugas, for their hard work in putting this event together. 

The importance of the issues you are addressing here is magnified in the context of the current public health emergency we are dealing with. 

COVID-19 has created unprecedented challenges affecting all sectors of our global community. These challenges have brought into focus the importance of collaboration among all public health stakeholders, from academia and industry to government agencies both domestic and international.

It has been gratifying to see how our governments have been able to build on existing working relations, through both formal working groups as well as informal technical consultations, to discuss some of the most urgent issues related to the pandemic.

We have seen again and again the power of working together, comparing perspectives, and sharing findings and strategies on inspections, lab test methods and scientific assessments.

 Understanding how we each approach balancing risks and benefits in such a significant public health crisis has built trust and respect among our experts and confidence in our decision-making.

But while we are faced with the reality of the COVID-19 pandemic right now, it also underscores the reality and many other demands of the global environment we live in. 

The need to collaborate on issues of health and safety in the context of our regulatory work is a principle that applies whether it involves containing and controlling disease or ensuring the safety of food and medical products

This Global Summit on Regulatory Science provides an important venue for regulatory scientists from around the world to share approaches and experiences and to collaborate and agree upon common research approaches and goals.  It’s been a pleasure to watch this group grow in size and impact for nearly a decade now.

And over the years regulatory scientists have been able to employ an ever-increasing number of emerging technologies to inform and enrich their work. Indeed, that’s the appropriate theme for this year’s gathering, “Emerging Technologies and their Application to Regulatory Science.” 

Now, as you know, the FDA is a science-based agency, and we are committed to the principle that each of our decisions must be based on good data and sound science. 

We look to data to meet our wide-ranging oversight responsibilities,  including the development of treatments for rare diseases,  toxicological and other studies and postmarket surveillance;  responses to food safety threats; research on the dangers of tobacco products,   and risk assessment and inspection, compliance, enforcement and prevention activities.

Increasingly sophisticated computing and large data sets  allow us to more effectively and efficiently apply scientific advances to the development of new treatments, cures, and approaches to some of the most challenging diseases and stubborn health problems our society faces – including the response to COVID-19.

And we’ve learned how to gather more and better data and be more creative in the way that we gather, aggregate, analyze, classify, process, manage, index, and apply that data. 

Harnessing the power of big data is a key element of our efforts, having an impact on everything from the development of safety standards, to the ability to make more accurate assessments, or tracking food related outbreaks. 

Using sophisticated computing to examine large, good quality data sets we can:
• identify the source of tiny bacteria in food;
• track biohazards;
• develop individualized medical treatment based on a person’s genetic profile;
• enable program reviewers to correlate data collected by field inspectors; and
• support FDA’s scientists and regulatory reviewers in their ability to handle product submissions with huge amounts of research and clinical data.

One way to employ the potential power of large amounts of information is through the use of artificial intelligence and machine learning.

FDA has established an artificial Intelligence Working Group comprising scientists with AI expertise from across our centers and offices to share best practices and harness the power of this technology in our regulatory activities. 

We are looking to develop a nimble and efficient approach, that incorporates artificial intelligence and machine learning, to enable the evaluation and monitoring of a device throughout its total product life cycle.

We are also employing artificial intelligence and machine learning to gather postmarket data on how certain regulated products are being used or misused as in the case of opioids.

Big data analytics – in the form of whole genome sequencing – is already being employed to develop enhanced early warning mechanisms on reported foodborne illnesses and pathogens isolated from food samples.

This is information that can be exchanged with and between other countries to identify illness clusters when they are smaller. The FDA participates in the global database known as GenomeTrackr, which is a shared repository of such genome sequence data.

We are also working with international partners in the Latin American region, as well as with the European Food Safety Authority, to explore and expand the utility of whole genome sequencing and the reach of the GenomeTrackr network. 
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Our response to the COVID-19 pandemic has also relied on the use of big data.

We recognize the potential for real-world data from electronic health records, insurance claims, patient registries and lab results to inform our science-based response to this unprecedented public health emergency.

Evaluation of real world data has the potential to provide a wealth of rapid, actionable information to better understand COVID-19 disease symptoms, support evaluation of therapeutics, diagnostics, and vaccines, and understand available medical product supplies to help mitigate potential shortages.

That’s why FDA is working to advance collaborations with public and private partners to collect and analyze a variety of real-world data sources.

One example is the COVID-19 Evidence Accelerator, organized by the Reagan-Udall Foundation for the FDA in collaboration with Friends of Cancer Research. It’s developing evidence on the natural history of cancer patients with COVID-19 that can help to answer such questions as the efficacy and safety of immunotherapy to treat patients with lung cancer or melanoma.

Of course, meaningful data aggregation relies on the development of common data elements. During this pandemic, FDA has been working with stakeholders to harmonize standards of big data so that the same lab test is described the same way every time.

I’ve touched on just a few of the many emerging technologies that FDA and other regulatory bodies are employing for regulatory purposes to help assess the safety and effectiveness of products.

International collaborations in regulatory science and policy are important, especially in these areas of rapidly evolving technological advancements. When we partner with our regulatory counterparts we gain unique perspectives that advance scientific knowledge and ultimately benefit consumers, patients and other stakeholders.

I am pleased that this distinguished group of global scientists and regulators is focusing its efforts on this topic. 

I look forward to a productive meeting, and to seeing the results of your efforts.

Thank you.