Optimizing Medical Affairs
Medical Affairs organizations emerged over the past half century in response to federal regulations mandating the separation of Medical and Commercial activities within drug companies. Many companies also chose to focus R&D resources on developing new products and moved post-launch activities, such as finding new indications for existing drugs, into the Medical Affairs function.
Continued pressure from regulatory agencies and public sentiment have pushed more and more activities into Medical Affairs organizations. Today, these organizations commonly support the following medical activities:
Relationship management and communication of product information with healthcare providers, payors, and other medically-focused customers (e.g., regulators, institutional leaders) in collaboration with field medical teams, including medical-science liaisons.
Post-launch clinical trials, including the planning and execution of phase IIIb/IV company-sponsored interventional and observational studies and support of investigator-initiated studies.
Medical information services, including the medical staff sitting in centralized call centers to distribute medical information in response to drug-information inquiries.
Medical communications, including the writing and support for peer-reviewed publications and other medical and scientific communications.
Medical education, including the planning and grant support for medical education to healthcare providers and the training of internal teams (e.g., salesforce).
Medical strategy, including development and leadership of the medical-brand strategy for each product by Medical Directors and the collaboration with Development, Commercial, and others to shape the product’s cross-functional life cycle strategy and planning.
Health Economics and Outcomes Research (HEOR) activities, including research and communications related to product value (e.g., product value dossiers, patient-related outcomes, health technology assessments)
The greater focus within pharma on risk management, the emergence of new types of data and the increasing sophistication of patients and other stakeholders present more challenges and opportunities to which Medical Affairs personnel must adapt. Success in the future will require strong relationships with a broader range of stakeholders such as patient advocacy groups and payors.