The Medical Plan is a periodic, usually annual, consolidated document detailing the Medical Affairs activities to be undertaken and/or funded for a licensed product. Medical Affairs (MA) demonstrates leadership and value through this strategic planning process that aligns all Medical Affairs competencies needed to support the product and organization. The MA team navigates the complex therapeutic environment for the product, acknowledging challenges, taking advantage of opportunities, and filling scientific gaps. The Medical Science Liaison (MSL) is well-suited to provide real-world clinical insights to the comprehensive and supportive tactical plan that can provide the most impact to the stakeholders in a therapeutic space while taking the MA team closer to achieving annual goals.
The five steps to writing a medical plan are:
- Analyze the external environment/competitive landscape
- Look at the available internal environment (study data, safety, place in therapy, indication)
- Perform a SWOC (Strengths, Weaknesses, Opportunities, and Challenges)
- Develop key medical objectives
- Add tactics after strategy, considering available budget and realistic timelines
A critical success factor for developing a solid medical plan is to include all functions in Medical Affairs and align with cross-functional partners. It is important to work with clinical development, HEOR/Market Access, publication planning while addressing/incorporating the global standpoint. Commercial and Medical can discuss/align regarding product strategies (SWOC, data gaps, strategic imperatives, etc.). However, once the strategy has been aligned and agreed upon, the translation of the strategy into the Medical Affairs tactical and operational plans needs to be developed separately.
Many teams view the Medical Plan as a static document when in reality it needs to be addressed periodically for feasibility and relevance with the ever-changing healthcare dynamic. If the plan is not reviewed and a detailed execution plan is not in place, the timelines and programs are often delayed or eliminated.
The MSL can show immense value in the Medical Plan process. Bringing real-world clinical insights can shape situational analysis, medical strategy, and resultant tactics. The role of the MSL in providing this information is vital to the success of the Medical Plan, and every MSL should be actively contributing to the plan.
When the MSL has the opportunity to contribute to the Medical Plan, the focus should be on both short and long-term strategies and tactics, keeping in mind where the indication/product is within the lifecycle. The MSL is specially equipped to bring learnings from field communication during the pandemic. This includes incorporating digital programs that broaden the reach such as social monitoring (Key Opinion Leader, KOL/Digital Opinion Leader, DOL)), virtual scientific education programs, and hybrid KOL engagement planning to name a few. The winners will be those who succeed in positioning the science, especially those who can combine and analyze data sets to ultimately improve patient outcomes. This involves the incorporation of real-world evidence, utilization of digital health and electronic medical records, and innovative ways of mining data.
The recent position paper in the Journal of Therapeutic Innovation & Regulatory Science in July 2021, “Promoting Best Practices for Medical Science Liaisons Position Statement from the APPA, IFAPP, MAPS, and MSLS,” intended to provide recommendations that will help lay the foundation for best practices for MSLs and their activities. One of the three key activities for the MSL is gathering insights. “MSLs are well-positioned to gather insights from the field that can be used to inform internal clinical development, marketing, and market access in developing their strategies. These insights may be based on expert opinion, observations of barriers in the patient journey or questions that emerge in scientific exchange.”
In today’s hybrid peri-pandemic era, MSLs have that unique ability to collect timely, relevant, and actionable insights from experienced KOLs. This is one area that the MSL can clearly demonstrate value for the Medical Plan while contributing to the science and therapeutics that will ultimately help patients.
Susan Malecha, PharmD, MBA
Susan Malecha is a results-driven versatile medical professional with a proven track record for achievement in the pharmaceutical/biotechnology industry. An accomplished author, she has lectured extensively and is called upon to present the latest developments in the areas of medical affairs for the pharmaceutical industry. Dr. Malecha is an active member of Healthcare Businesswomen’s Association (HBA), as the current President of the San Diego Chapter. She is also Vice-President, Board of Directors, Health Care Communicators of Southern California, and Board Director for California Special Projects Fund for American Association University of Women. Earning her BS in Pharmacy from Butler University, she completed her Doctor of Pharmacy at University of Illinois at Chicago and earned her Masters of Business Administration from Keller Graduate School of Management. Dr. Malecha is a certified Etiquette Consultant and currently the Senior Director, Medical Affairs at Puma Biotechnology.