MAPS 2030 VISION FOR MEDICAL AFFAIRS
Medical Affairs will be a strategic leader at the center of clinical development and commercialization efforts, addressing unmet patient, payer, policymaker, and provider needs that advance clinical practice and improve patient outcomes.
The following authors contributed to this publication:
- Sanjay Gandhi, VP, Global Head Medical Affairs and Medical Strategy, Phillips
- Daniel McBryan, SVP, Medical & Value Partnership, Sage Therapeutics
- Lucie Williams, Vice President Global Head of Medical Excellence, Ipsen
The views expressed in this paper are those of the authors and do not represent their organizations.
Introduction
New treatments aim to improve patient outcomes. New treatments also drive a company’s ability to invest in the development of future therapies that continue to improve patient outcomes. But what happens when a new treatment is no longer “new”?
Historically, at the end of a product’s period of exclusivity when generics are allowed to enter the market alongside a company’s product, innovator biopharmaceutical companies would pivot to producing an authorized generic while focusing on approval of novel assets in the company’s pipeline.
More recently there has been a paradigm shift in how companies plan for and deliver on the “long tail” of a drug’s impact even after Loss of Exclusivity (LoE) – a process known as lifecycle management (LCM). In this new paradigm, Medical Affairs is an essential partner in ensuring that approved treatments benefit new and expanded patient populations beyond the initial indicated population.
This article leverages the input of 21 biopharmaceutical and MedTech leaders from the MAPS Strategic Leadership Council to describe how to have effective lifecycle management.
This article leverages the input of 21 biopharmaceutical and MedTech leaders from the MAPS Strategic Leadership Council to describe how to have effective lifecycle management.