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Speaker: Marina Brodsky, PhD, Independent Consultant, formerly Vice President, Medical Affairs, Pfizer, Inc.
Medical Affairs (MA) research is integral to the two overarching goals of MA as they engage the healthcare community: 1. to transform data/information into knowledge about the product and its appropriate use(s), for external communication, and 2. to collect and transform raw facts, data points and input from external customers into insights and knowledge about the unmet medical need, for internal use.
MA research is capable of adding value throughout the life cycle of a medicine. Pre-launch, it is conducted to enhance the understanding of disease mechanism(s) and patient subgroups with potentially different responses to treatment, to advance the development of diagnostic or assessment tools, support meaningful differentiation, explore additional indications and help understand the likely impact of guidelines and/or prevailing treatment practices. Post-launch, it is implemented to confirm efficacy and/or safety of the medicine in the clinical setting, guide proper use in subpopulations, develop new indications and address specific safety concerns/complete regulatory commitments.
Valuable evidence can be generated through various types of MA Research, including retrospective and prospective analyses of real world data (reviewed in detail in a recent MAPS webinar entitled “Patient Centric Real World Data & Evidence Generation”); meta-analyses and sub-analyses of published clinical trials and internal safety and efficacy databases; and prospective interventional or observations trials in patient subpopulations/controlled trials in new indications. A thoughtful MA research strategic plan focused on the needs of customers and stakeholders (rather than on individual deliverables) will help prioritize objectives and select the most appropriate types of research to achieve them.
In most cases, effective and value-added execution of MA Research requires seamless collaborations with internal cross-functional colleagues (R&D, Clinical Sciences, HEOR, Regulatory, etc.), and/or external healthcare community. Other success factors include deep understanding of data sources and their limitations, alignment on goals across functions, and pragmatic approach, i.e., proactive evaluation of risks and costs.
After completing this Webinar, participants will be able to: