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GEN’s editor in chief, John Sterling, interviews life science academic and biotech industry leaders on important research, technology, and trends. These podcasts will keep you informed with all the important details you need.

INTERACTING WITH THE FDA-ISSUES AND STRATEGIES

5/8/2008

- Interview with Bruce Mackler, Ph.D., J.D., senior advisor on FDA matters and due diligence concerns to financial groups and investment companies

KEYWORDS:
FDA
,
Regulatory

In essence, all the activities surrounding biotech R&D are directed toward one goal: getting a drug product on the market. To accomplish this, biotech and pharma firms need to obtain final product approval from the U.S. Food & Drug Administration which has, within its mandate, the ultimate responsibility for ensuring the availability of safe and effective biotherapeutics and other drugs on behalf of the American public. How that federal agency carries out its mandate is often a point of contention, depending on whom you talk to. In general, consumer groups tend to call for more FDA oversight of new drug development while industry officials often complain that the agency is too rigid.

During this week's GEN podcast, Dr. Bruce Mackler, a scientist and lawyer, draws upon his 28 years of FDA legal and regulatory experience to provide valuable insights o the FDA. Specifically, Dr. Mackler looks at the the current performance of the FDA and talks about the main criticisms that he hears from biotech and pharma officials about their dealings with the agency. He discusses how the FDA tends to react to criticism and how responsive the agency is to suggestions for improvement. Dr. Mackler also gives his opinion on why Dr. Janet Woodcock recently returned as permanent director of FDA's Center for Drug Evaluation and Research (CDER) and what series of challenges she can expect to face. In addition, Dr. Mackler offers several key tips for biotech officials who want to work with the FDA in the best manner possible for both sides.

Bruce F. Mackler is a senior advisor in FDA matters and FDA due diligence issues to financial/investment groups and companies. He is effective in developing and implementing FDA strategies for product approval of biologics, drugs and medical devices in the US and the global market place. Bruce couples his scientific knowledge (M.S., Ph.D. Immunology) with practical, hands-on regulatory experience of 27 years of FDA legal work on traditional and biotechnology derived products. He continues to provide FDA advice to US and European financial (venture capital and royal fund investment groups and stock analyst) groups, directly to biomedical product companies and is available to assist you. His grasp of the technical and FDA issues is augmented by his understanding of the commercial realities facing biomedical companies and products in the marketplace including the intended use claims, reimbursement and cost of goods. His business acumen is on his work experience including that in a family business in the packaging field, operationally in organizing and managing multidiscipline research laboratories and as management of several biomedical commercial entities. He has a proven record of accomplishments in moving technology from the laboratory into animal and human testing and FDA marketing submissions.

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