The 2nd Boston Medical Affairs Seminar in Boston, Ma
December 12, 2017
The 2nd Boston Medical Affairs Seminar was held under the direction of Shahin Gharakhanian MD and Barry Lubarsky PhD (Sr Medical Director, Alkermes), in Boston, 12.2017. Seminar Abstract is as follows:
- During the past decade, Medical Affairs has become a critical function within all pharmaceutical and biotechnology companies. A high-performance Medical Affairs team will not only support but drive the safe, effective and appropriate use of medications throughout a product lifecycle. The first Medical Affairs Seminar focused on “Launching a High Value Medical Affairs Team”. The theme of this 2nd Seminar is “Value Creation on the product highway”. The Seminar is organized at a period, during which, clinical decision making is becoming complex, new medical care models are emerging, global medical affairs’ alignments are a necessity, and clinical development has become a continuum from registration to generation of Real World Evidence. The prevailing model for highly effective Medical affairs Teams are to deliver, cross-functionally, in four critical areas on the product highway:
- In early development within – the Product Team – notably connecting to patients and realities of medical practice.
- During the regulatory submission process as part of the regulatory review and submission task force, sometimes focusing on specific topics.
- For launch via Medical Education, Medical Information Services, Publications, MSL: Medical Sciences Liaisons all defined and coordinated within the Global Medical Plan.
- Post-launch, as part of teams working on access, knowledge management, health economics and outcomes research, and LCM: Life Cycle Management.