Module 6_ Medical Affairs and Key Opinion Leaders (KOLs)

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Northeastern University *

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5219

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Medicine

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Oct 30, 2023

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Medical Affairs: BioProcess International “The Role of Medical Affairs in Moving from R&D to Commercialization” ● https://bioprocessintl.com/analytical/qa-qc/the-role-of-medical-affairs-in-moving-from-ran dd-to-commercialization-341871/ ● Biotechnology companies should understand the language of pharmaceutical companies and know how the industry operates ○ Make early decisions regarding their investigational products that could lead to future success ● Medical affairs: bridge between development and commercialization Background: ● Primarily work on postapproval activities and has both the scientific and clinical expertise to support commercial products ● Examples of medical affairs functions include: ○ Managing key thought-leader relationships ○ Publishing data from corporate-sponsored trials ○ Presenting educational information about a product or therapeutic landscape ○ Answering questions from healthcare providers regarding product safety or efficacy that isn’t addressed in a product’s label ○ Supporting research initiatives outside labeled indications for marketed products Core Competencies: ● Medical communications/publications: directs and plans for all drug-related publications, such as abstracts, posters, and manuscripts ○ Developing a strategic plan that integrates and aligns the timing of clinical trial data locks with the release of key data points at scientific meetings ■ Outlines the timing of abstract submissions and defines when key manuscripts can and should be published in the years leading up to or following a launch ■ Publication of interim data for either early stage or pivotal trials ○ Developing clear and consistent language to describe clinical results ● Medical science liaisons (MSLs): support a range of educational and/or research goals ○ Scientific and clinical expertise that allows them to cultivate relationships with both external and internal patients ○ “Medical” face of the company ○ Strong ties with both community and academic physicians

● Medical information: address typical concerns about commercial drug products, including safety, efficacy, dosing, and administration ○ Primary recipients of questions from patients, healthcare providers, and other interested parties ○ Must be equipped with fair and balanced, prewritten letters that accurately describe the information a company has available about each newly approved agent Case Study: ● An oncology-focused biopharmaceutical company was facing challenges ○ Its drug in development was for a disease state rarely seen, especially in the community setting ○ Unique mechanism of action and complex dosing ○ Relatively small and unknown company ● Hired the consulting firm Zipher Medical Affairs 12 months before launch to provide strategic and medical affairs services ○ Developed a launch strategy, tactics, and related training programs ○ MSL slide decks and complete speaker notes ○ A four-person on-demand MSL team was provided 6 months before launch ■ Fully integrated into the medical affairs team ■ Educate healthcare professionals upon drug approval ● Information about company to increase awareness ● Disease-state education ● Safety and efficacy profile of the drug ○ Advantage of dedicated experts focusing on the development of a solid medical launch strategy and related tools ○ Highly successful launch Medical Science Liaison Society ● https://themsls.org/ PMLiVE “Medical Affairs - the time for change is now” ● https://www.pmlive.com/pharma_intelligence/medical_affairs_-_the_time_for_change_is _now_1018766 ● Pharma companies are under pressure to prove the direct and indirect value of their medicines, devices and services to a wider, more diverse group of stakeholders ● Defining and delivering value ● Stakeholder agreement ● Regulatory pressure ● All-rounders required ● Medical education - leading by example

● Driving value Key Opinion Leaders (KOLs): PharmExec.com “Eight Tips on Improving KOL Engagement” ● https://www.pharmexec.com/view/everest-medicines-pfizer-receive-fda-clearance-for-ulc erative-colitis-treatment ● Obtain honest feedback ● Strategically target KOL - understand their needs ● Differentiate KOL roles ● Address globalization ● Hit the target ○ Must meet very specific needs ● The need for a normative database ○ Identify real issues from the occasional MSL-specific problem ○ Science liaisons can be compared not only to a normative database but to specific competitors ● Streamline the process ○ Targeted questionnaire ● Key performance indicator (KPI) and identifying value PharmExec.com “What Key Opinion Leaders Really Want from Pharma” ● https://www.pharmexec.com/view/what-key-opinion-leaders-really-want-pharma ● KOLs prefer to engage with MSLs, compared to sales or marketing ○ MSLs typically have strong clinical and educational backgrounds within the medical field Compliance with Physicians and KOLs: Investopedia “What Are Sunshine Laws? Definition, Purpose, Examples” ● https://www.investopedia.com/terms/s/sunshinelaws.asp ● Sunshine laws: regulations requiring transparency and disclosure in government or business ● Make meetings, records, votes, deliberations, and other official actions available for public observation, participation, and/or inspection

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