FDA commissioner delivers a life science innovation pep talk
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Raleigh, N.C. — The opportunities for the life science industry to offer prevention, diagnosis, treatment, and cures for diseases are stronger today than ever before, according to U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg, M.D., who opened the CED Life Science Conference in Raleigh.
She urged industry stakeholders to delve deep into science, connect to others, and collectively build for the future. “How we work together now is the engine for the future.”
Recapping a brief history of the U. S. Food and Drug Administration (FDA) and its evolving role in evaluating drugs and focusing on safety, Hamburg shared her excitement about the potential of today’s innovations to help patients.
“It’s difficult to differentiate science from what could be considered science fiction,” she noted while describing new treatments including targeted delivery, radio frequency medical and bionic devices, mitochondrial modifications, and regenerative and stem cell medicine.
“With developments in engineering, the life science industry is increasingly in a position to harness advances to create exciting, tailored treatments for individuals and groups. That’s why the FDA recently created a guide for mobile health-related apps – to ensure the best science is available to support products that make a real difference for patients.
“Innovation isn’t important simply because it creates something new – it’s only important if what it creates makes a meaningful and positive difference in people’s lives.” She said the FDA is in the midst of a critical transformation as overseer of the safety and efficacy of drugs and medical devices.
Two organizations, the Center for Devices and Radiological Health (CDRH) – a branch of the FDA, and the Medical Device Innovation Consortium (MDIC) – a patient-centered public-private partnership, are important players to further positive advances in science and technology by encouraging collaborations and partnerships.
“The FDA works closely with many stakeholders. We all play a role as we strive to create ways to promote public health and develop expedited processes,” Hamburg said.
“Some criticize the FDA for moving too quickly,” she noted, referring to the accelerated FDA approvals: Fast Track, Priority Review, and Breakthrough Therapy designation. “We’re balancing the eagerness to address patients with the most urgent needs with the risks and benefits.
“The U.S. is the global focal point of life sciences,” according to Hamburg, who recently visited India to further strengthen cooperation between the FDA and its Indian regulatory counterparts. “We have the most dynamic biotech, biomedical and pharmaceutical industries doing state-of-the-art work. Success is unprecedented with these kinds of partnerships. Great minds can take action in new ways, together.”
Hamburg commended North Carolina for its outstanding research institutions, innovation, and commitment to understanding and meeting the unmet needs of patients’ healthcare needs. “We’re looking to the best thinkers to solve global problems locally, by collaborating.
“No one can whistle a symphony. We’re making beautiful music that can save lives. We know it can be done, and there’s so much that still needs to be done. I’m eager to work with you and urge you all to continue collaborating.”
[The two-day conference ended Thursday.]
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