MEDICAL AFFAIRS
CREATING VALUE-BASED STRATEGIES
The strategic value of Medical Affairs is based on “knowledge expansion” and “problem solving”. When we achieve these values through innovation and collaboration, value is created.
Medical Affairs activities not connected to either knowledge expansion or problem solving are simply activities with no purpose or value.
Adapted from Neil Gray, inVentiv Health
INTERFACING SCIENCE AND BUSINESS
Good Medicine is Good Business
“We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they have never failed to appear. The better we have remembered it, the larger they have been.”
— George Wilhelm Merck; Address to the Medical College of Virginia, Richmond, VA (December 1, 1950)
The primary focus of R&D is establishing the efficacy, safety of product, identifying patient populations, dosing, and generating data for FDA filings and approval.
The primary focus of Commercial is to launch and commercialize approve products, gain market access, increase market share, and increasing profits for the organization.
The role of a successful Medical Affairs function is to effectively support as well as transition between R&D and Commercial to effectively maximize and communicate the value of products to physicians, providers and payers. Medical Affairs must also focus on the internal stakeholders as well as external stakeholders.
DELIVERING WITH QUALITY, INTEGRITY AND COMPLIANCE
Within the pharmaceutical industry, we do not develop widgets, or gimmicks. We develop medicines for the treatment of diseases that impact patients, their families and caregivers. Every medicine will not benefit every patient. In all of our endeavors we seek to properly identify and those patients who will achieve the highest benefit with the least risk, communicate accurate information to treating physicians, and demonstrate the value of our products in the context of healthcare. This must be done with quality, integrity and compliance with an eye on stakeholder needs and product lifecycle.
Successful and Compliant Collaborations Between Medical/Commercial Adds Value
• Appropriate marketing ensures
• Patients have access to products they need
• Products are used correctly for maximum patient benefit
• Inform HCPs about product benefits and risks to advance appropriate patient use
Ensures HCPs have the latest and most accurate information regarding their products
• Ethical relationships with HCPs are critical to achieving goals
• Industry Guidance: AMA, PhRMA
• Increase scrutiny at Federal and State Levels
FOCUS ON PATIENTS, PHYSICIANS AND PAYERS
My personal mission for Medical Affairs is to improve patient quality of health through informed treatment decisions. Medical Affairs creates value for products by providing timely, accurate, relevant, quality information to patients, physicians and payor through a variety of means including:
• Phase 3b/4 clinical development programs that go beyond drug approval to address the needs and issues of our patients and their physicians
• HEOR data generation
• Publications/publication planning that delivers a continuous flow of information about our products to ensure that informed treatment decisions can be made
• Medical Education initiatives that provide a forum of up-to-date information on diseases and treatment paradigms
• Building relationships with Key Thought Leaders to help shape development programs, remain on the cutting edge of medicine, enhance education and future initiative
• Developing useful and informative product dossiers to facilitate formulary decisions
