The Rx Marketer's Reference Guide, 2nd Edition presents the sequential flow of required product development, launch, and post-launch information. It allows brand managers, the Product Development Team, the Life Cycle Management Team, and other participants to understand their roles and responsibilities and how they fit in the overall commercial aspects of drug development, launch and marketing.
How pharmaceutical products are developed, approved, reimbursed and marketed will be undergoing fundamental changes at least through 2020. The use of genomics, databases, advanced technologies, and biomarkers will speed candidate identification, decrease the size of potential patient populations, enable outcomes-based reimbursement, and, for select products, decrease clinical trial/development timelines.
Biomarker targeting and use of other advanced drug development tools will reduce the risk of clinical failure and will result in the combination of Phase I and II and/or Phase II and III clinical trials – shortening the development timeline. The shift in reimbursement towards only reimbursing those products that show a clinical benefit versus existing products means that
not all products will get reimbursed and that products may not be launched in certain markets. Any products that are not therapeutically unique will require earlier commercial assessments versus truly unique drugs. The gradual shift, that has begun, from selling a drug to selling an outcome means that the type of information captured throughout development will have to be tailored to how the product will be positioned and how it will be reimbursed, promoted and sold.
No guide can address all the specific needs required for the successful development of a brand unless it is specifically tailored to that product. The Rx Marketer's Reference Guide, 2nd Edition is a reference tool for Rx marketers and the respective Rx company functions and teams to begin the development of the respective brand plans.
The content is organized to assist the user in defining:
1) the flow of product development activities throughout the product development, launch and post-launch periods,
2) support, through content listings, the development of marketing research that flows from one study to the next, and
3) through checklists, what should be contained in brand planning, marketing and life cycle management plans.
It also provides insights relative to who should be considered for inclusion in the respective product development committees.
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Edmund L. Valentine has over 27 years of global healthcare industry experience. He is the author of Multi-Trillion Dollar U.S. Healthcare To 2020 Gold Rush, Industrializing Healthcare, and has been the editor of multiple editions of MMC International's Trends Shaping U.S. Pharmaceutical Industry Strategies reports as well as therapeutic area reviews. Valentine is Chairman and C.E.O. of MMC International, a strategy, general management, business development, marketing and technology assessment advisory firm primarily focusing on the global healthcare industry. He is a recognized authority on the trends shaping the U.S. healthcare system.