Medical Affairs plays a critical role in life-cycle management. In this excerpt of “Defining the Course & Navigating the Finish Line,” Dr. Crowley-Nowick discusses how to achieve better outcomes for patients using a synchronized approach, from development to commercialization.

Medical Affairs in the Stern

Steering also means adequately synchronizing the effort. The timing for strategy and execution of a Medical Affairs plan is similar to a cox’s plan for a regatta. If it is not perfectly synchronized, the coordination of a program can suffer, and it becomes impossible to fluidly and consistently navigate the course. By maintaining a consistent role throughout the lifecycle of a drug, Medical Affairs can aptly steer a team to better outcomes.

The role of Medical Affairs is also at the stern throughout the lifecycle of a drug. As a coxswain is not a rower in the race, they still maintain an equally important and arguably, more critical position. Behind every action, they direct the effort and help the team harness and achieve its potential.

1

Development Strategy
Portfolio Management

Provide insights and intelligence from the clinician and patient

Offer knowledge about disease state, clinical practice, reimbursement, current and future competitive landscape

Enhance development decisions

2

After Proof
of Concept

Provide insights and intelligence from the clinician and patient

Create the narrative and rapidly publish clinical trial results

Build a multi-channel communication program

Engage with clinical trial sites to generate interest and support patient enrollment

Identify evidence gaps and develop a continuing research strategy

Educate Providers, Patients and Payors around the clinical need (the “why”)

3

Launch
Readiness

Provide insights and intelligence from the clinician and patient

Define medical strategy and integrated tactics with timebound deliverables

Refine the scientific narrative and confirm the value proposition

Ensure data are available to all decision makers

Initiate Early Access Programs or Named Patient Programs

4

Post
Launch

Provide insights and intelligence from the clinician and patient

Engage and respond to queries about the data

Participate in scientific exchange to identify remaining data gaps and landscape evolution

Execute Phase 4 collaborative and ISS research programs

Communicate expanding data sets and refine narrative

Transition to life-cycle management and potential supplemental indications

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