"Having worked in pharmacovigilance and marketing I believe you can have the biggest impact on patient lives in Medical Affairs. It is the function that has the most critical role in supporting HCPs to ensure that they have the right information to make informed clinical decisions on the treatment of their patients. For me, it should be the heart / the core of any pharmaceutical company."
Ghiesla Nel, BPharm, BCMAS
IPSEN Biopharmaceuticals
Pharmaceutical and biotechnology companies (ie., 'Pharma') began building medical affairs organizations during the late 1990's. The primary purpose of medical affairs is twofold:
Educate and communicate scientific information to healthcare providers in an objective unbiased manner
Generate new data for the medical community or for the purpose of enhancing a product's on-label indication (typically in a post-marketing setting via investigator-initiated studies (IIS) or phase IIIb/IV studies).
Pharmaceutical and biotechnology companies (ie., 'Pharma') began building medical affairs organizations during the late 1990's. The primary purpose of medical affairs is twofold:
Although variations exist among companies, most medical affairs organizations contain the following departments:
Medical Strategy
Medical Operations/Excellence
Field Medical Affairs (Medical Science Liaison Teams)
Scientific/Medical Communications
Health Economics Outcomes Research (HEOR)
Pharmacovigilance (Drug Safety)
Medical/Drug Information (ie., Call Center)
The First MSLs
Pharmaceutical Research and Manufacturers of America (PhRMA) becomes the first organization seeking to bring together the pharmaceutical industry behind common issues.
The First MSLs
Upjohn Pharmaceutical establishes the first Medical Science Liaison (MSL) teams.
PhRMA Code Established
Pharmaceutical Research and Manufacturers of America (PhRMA) establishes its industry standard Code, defining the appropriate interactions with Healthcare Providers (HCPs)
The Medical Affairs Firewall
By 2005, most major pharmaceutical companies have established an internal firewall between the Medical Affairs operations marketing / commercial operations.
Enter HEOR
Health Economics Outcomes Research (HEOR) becomes an increasingly active function of Medical Affairs
Board Certified Medical Affairs Specialists Program (BCMAS)
After forming in 2014, the Accreditation Council for Medical Affairs (ACMA) becomes the first accredited organization to board certify medical affairs / MSL professionals with the BCMAS
KOLs and Patient Advocacy
The concept of tradition Key Opinion Leaders (KOLs) expands to include patient advocacy, regulatory, and payors.
Predictive Analysis
Predictive Analytics begins to play an increasingly important role in driving the strategies of medical affairs professionals.
Artificial Intelligence
Artificial Intelligence becomes increasingly crucial in shaping the strategies of medical affairs professionals
As the name implies, the medical strategy teams set the strategic direction for the department determining the issues, gaps and opportunities that exist. Medical strategy includes medical directors, who may collaborate with marketing and clinical development teams to ensure proper alignment.