FDA Commissioner Margaret Hamburg delivered this year’s keynote speech in front of a packed room of pharma and bioscience personnel at the 46th annual meeting of the Drug Information Association, which opened Monday morning. Hamburg started her speech by explaining how her earliest goal as FDA chief was to build the field of regulatory science—an area hasn’t received the focus or the dollars it needs to advance.
“How do we make sure that we fully translate research into real-world products and programs that really matter?” Hamburg asked. “We all recognize that a gap has formed between bioresearch and the development of those products. With the disclosure of knowledge and capabilities emerging from many domains in research from around the globe comes the fundamental question: How do we make sure that we fully translate the potential and promise of that research into a real world product and program that really matters?”
Hamburg noted that a gap has formed between biomedical research and the development of new medical products, and urged industry to work with government to help close that gap.
She also said that industry is lacking the science and tools to assess and evaluate safety and efficacy. In other words, the US needs to beef up its regulatory science. “Billions of dollars have been invested in biomedical research, but this research will not translate into real life therapies for those that need them until we make an appropriate investment in regulator science,” Hamburg said. “We can no longer rely on techniques and approaches of the 20th century for the preventions, treatments and cures of the 21st century.”
According to the commissioner, new advancements in regulatory science can make the difference in speeding evaluation of new products, tracking safety, recognizing potential problems early on, and helping hone in on drugs that work or that have specific side effects to a targeted sub-population of patients.
Hamburg listed some opportunities for regulatory sciences.
- Promising research is underway using stem cells for brain function loss in the case of Parkinson’s disease and treating other medical conditions.
- NIH, industry, and foundation are working together to create an artificial pancreas for juvenile diabetes, which would continuously monitor patients’ blood sugar and automatically inject the proper amount of insulin.
- Basic research is identifying potential tumor markers to indicate whether a patient’s cancer will respond to a specific therapy.
However, she pointed out that none of these treatments will come to fruition unless regulatory science is improved to help turn raw research into actual products.
She talked about FDA’s new initiative to work with TB researchers and companies to help create combination products, thereby fast-tracking much-needed treatments to patients in underdeveloped countries. “In might not be a sexy as discovery, but regulatory science is a dynamic and essential part of our scientific enterprise,” Hamburg said. “We want FDA to serve as a gateway, not a barrier, to the products that people need and count on every day.”
Hamburg said that the number of foreign products product US patients use has increased significantly. “The numbers are mind-boggling,” she said.
“This year, about 80 percent of the active pharmaceutical in drugs we consume come from outside of our borders,” Hamburg noted. while acknowledging the recent mess with the tainted heparin and the growing number of counterfeit drugs. She said that oversight has to keep up with the growing global economy. This includes adding more sophisticated security strategies and establishing foreign offices.
“FDA will never have the resources to inspect every foreign manufacturer or every shipment of product from overseas,” Hamburg said. “The truth is that we need new approaches.”
She suggested building a global channel that everyone shares, and building stronger relationships with sister regulatory bodies and overseas pharma companies.
“Today, we are involved in a large amount of international activities including efforts to harmonize scientific standards, share technical expertise, and provide training in applicable regulatory disciplines and import requirements,” Hamburg said. “Public health protection is a global endeavor…that is a win-win situation for all involved”