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

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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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