The Coming Impact of REMS on Pharmaceutical Marketers

New powers were legislated to the FDA with the REMS provision (Risk & Evaluation Mitigation Strategies). Much more than just another regulatory entity, the FDA & REMS become literally & figuratively, a partner on the product management team. All new approved drugs will be subject to varying degrees of requirements from a minimal post marketing/Phase IV study over timelines to provisions dealing with how and to whom the drug is provided and delivered. Pharmaceutical Marketers will now have to be more specific in projecting patient populations; indeed, these market segments will be smaller and more targeted than previous blockbuster markets.

The role of the sales rep will change dramatically from a "pill pusher" (as one former major pharma CEO characterized the industry) to an advocate advising the doctor on safety and proper usage. A key issue will be how to incentives and compensate a rep who does not aim to have the doctor use more of the drug but to use it more effectively and most likely, lower sales.

Areas Covered in the seminar:

• Category Captain Management: holds that in a marketplace where physical products are becoming increasingly "me-too" How can the firm become indispensable and a source of competitive advantage to its customers.
• What can be learned from IBM; GE, especially GE Healthcare; Kraft Foods; OM Scott.
• What is the difference between strategy & tactics?
• What is a Sustainable Competitive Advantage?.
• Implications & Relation to Category Captain Management of the July 2004 criminal trial decision, "The TAP 8".
• A Brief word on the PhRMA Code and NO-NO’s under the Code.
• A brief word about the diminishing returns on too many reps chasing too few doctors.

Who Will Benefit:

• Pharmaceutical and Medical Device firms
• Marketers
• Product/Brand managers
• Strategy planners
• Sales trainers/educators
• Ad Agencies

Instructor Profile:

William Trombetta, is Professor of Pharmaceutical Marketing, ST Joseph’s University. In addition to his PhD in Marketing from Ohio State University, he is also an attorney licensed in New Jersey and New York, specializing in healthcare antitrust law. Bill has authored over 60 articles in refereed academic journals and conferences. He is a nationally recognized speaker on healthcare topics and serves on numerous advisory boards, including Pharmaceutical Executive. In 2000, he started the Online Executive Pharmaceutical Marketing MBA and has over 7 years distance education teaching experience. He has taught at Bocconi University’s Masters in Health Management Program in Milan and Chinese Pharmaceutical University in Nanjing.

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