Breaking Down Pharma in the Current Environment – FDA Watch
Shelly and Wayne chat with Dr. Michelle McMurry-Heath, Founder and CEO of BioTechquity Clinical, and Alan Minsk, Partner, Chair of the Food & Drug practice, and Co-Chair of the Life Sciences industry team at Arnall Golden Gregory LLP. You’ll hear their thoughts on the potential effects that FDA staffing cuts may have on drug and biologics approvals; how the current environment may affect investments in drug and biotech development; what companies can do to amid agency staffing shortages; how FDA can aim to include all demographics of patients in trials; and much more.
Headlines
Pharma: Trump administration makes exception for pharmaceuticals amid rollout of tariffs
Devices: Industry continues to face the consequences of cutbacks at CDRH
Food: Food company completes FDA pre-market consultation for human food made with cultured pork fat cells
Cosmetics: PCPC executive issues statement on impact of Trump administration’s reciprocal tariffs on cosmetics and personal care products industry
Resource Links
Pharma: Dr. Janet Woodcock, spoke out about FDA staffing cuts at a recent session of the Biopharma Congress
About Our Guests
Dr. Michelle McMurry-Heath
Dr. Michelle McMurry-Heath is a physician, scientist, regulator, policymaker, independent director, and global medical innovation strategist. She is the Founder and CEO of BioTechquity Clinical, a novel clinical research organization designed to help drug and device innovators enroll and conduct diverse clinical trials. Before founding BioTechquity, she was the CEO of the Biotechnology Innovation Organization (BIO) where she launched the industry-wide BIOEquality Agenda. She is a former regulatory and clinical leader at both the US Food & Drug Administration (FDA) and Johnson&Johnson where she led a global team responsible for trials and regulatory approvals in 150 countries. She has experience on Capitol Hill and was the Founding Director of the Aspen Institute health program. Dr. McMurry-Heath has committed her career to the belief that medical innovation can improve lives and unlock opportunity for all people if inclusively conducted and equitably distributed.
Alan Minsk
Alan Minsk is a partner, chair of the Food & Drug practice, and co-chair of the Life Sciences industry team at Arnall Golden Gregory LLP. Alan also serves as general counsel of The Sharing Alliance Inc. Alan focuses his practice on advising pharmaceutical, biologic, medical device, cosmetic, and food companies.
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FDA Watch Podcast 