A Unique Challenge in Biotech/pharma
Positive patient outcomes are the holy grail of any biotech/pharma product. If everyone’s vision is aligned, then why, according to Bain and Company, do 50% of all drug launches fail to meet company expectations? And how can this be true if organizations have access to more data and scientific insights than ever?
Biotech/pharma organizations face a unique imperative — understanding and communicating complex science across a vast array of stakeholders influencing purchasing decisions (Plantevin, 2017).
This unique challenge presents an urgent opportunity for organizations to become medical and scientific leaders within their treatment area, but only if they can bring together the competencies required to do so.
Medical Affairs is the Solution
According to Grace E. Macalino, PhD, MPH, Founder and CEO of Marimac Insight, “Medical Affairs is a powerful voice for the patient and an expert on the organization’s unique marketplace. Top Medical Affairs teams can deliver value and impact, driving successful product launches and overall company strategy.”
Answering the Call: A Competency Framework for Medical Affairs
Medical Affairs must seize the opportunity for a strategic leadership role in biotech/pharma value creation. McKinsey (2019) describes four key priorities for delivering maximum value to patients and the organization:
- Innovate evidence generation
- Accelerate access to treatments
- Transform and personalize medical engagement
- Step up internal medical leadership
Given these priorities and Medical Affairs’ critical role in managing risk, we propose the following competencies will be necessary for a Medical Affairs team to perform at its ideal operating state:
Strategy and Leadership. At each stage of the product life cycle, Medical Affairs provides critical strategic input regarding the patient population and care marketplace. Related responsibilities include developing a medical strategic plan and providing input to the brand plan, prioritizing initiatives, and setting the agenda for future growth.
- Science and Data. At its heart, Medical Affairs provides scientific oversight and rigor to everything the organization does. This daunting task includes responding to medical information requests, developing the evidence-generation strategy, leading studies (e.g., clinical trials, real-world data (RWD) analyses, etc.), and managing scientific priorities. The COVID pandemic highlights another layer–identifying how science and data outcomes can be impacted by external factors.
- Risk Management. Protecting patients and the organization from risk is an important role for Medical Affairs. Responsibilities include performing risk assessments, advising regulatory affairs, reviewing marketing and promotional materials, documenting evidence gaps and opportunities, and practicing pharmacovigilance.
- Collaboration. Medical Affairs must liaise with senior management, R&D, and Commercial to ensure all functions are aligned behind a patient-focused vision. Ideally, Medical Affairs teams coordinate cross-cutting initiatives and lead targeted interventions to improve medical-commercial collaboration across the organization.
- Strategic Medical Communications. Medical Affairs must ensure the core messages related to their product are reaching the right audiences in the right way, while remaining clear, consistent, and most importantly, evidence-based. Related responsibilities include building a scientific communications platform, implementing Key Opinion Leader (KOL) strategies, and serving as the “voice of the patient.”
In addition, the rapidly evolving healthcare and biotech/pharma environment requires an expanding expertise and focus on developments in research, changing technology, and the exploding availability of data; these roles are interwoven throughout the competencies.
Bottom Line for Medical Affairs
Given the unique challenges facing biotech/pharma, Medical Affairs stands ready to help their organizations by taking a leadership role in their treatment area. With the right balance of competencies and experience, Medical Affairs can help solve some of the toughest challenges facing healthcare today.
[Note: this is the first blog in a series about the importance of Medical Affairs. Stay tuned for more Insights. To sign up for our weekly newsletter, click here.]
Bedenkov, A., Moreno, C., Bate, R., Ipatov, A., Surmont, F., & Beekman, M. (2019, October 11). Silent (R)evolution in Medical Affairs Through the Power of Partnerships and Collaborations. Retrieved May 27, 2020, from http://www.pharmexec.com/silent-revolution-medical-affairs-through-power-partnerships-and-collaborations
McKinsey & Company. (2019, April). A Vision for Medical Affairs in 2025. Retrieved May 22, 2020, from https://www.mckinsey.com/~/media/McKinsey/Industries/Pharmaceuticals%20and%20Medical%20Products/Our%20Insights/A%20vision%20for%20medical%20affairs%20in%202025/A-Vision-for-Medical-Affairs-in-2025.ashx
Medical Affairs Professional Society. (2020, May 28). Communicating the Value of Medical Affairs. Retrieved May 28, 2020, from https://medicalaffairs.org/wp-content/uploads/2020/05/MAPS-White-Paper_Comm-Value-of-Medical-Affairs_May2020.pdf
Plantevin, L., Schlegel, C., & Gordian, M. (2017). Reinventing the Role of Medical Affairs. Retrieved May 22, 2020, from https://www.bain.com/contentassets/f4702d29aeba409cbc425ab418d130f8/bain_brief_reinventing_the_role_of_medical_affairs.pdf