EPISODE · Aug 24, 2025 · 49 MIN
#144 | How Clinicians Build the Evidence That Gets a Medical Device Adopted
What really gets a medicine from the lab bench into clinical practice — and why does one of the most important functions in that journey stay almost invisible?When most people think about pharma, they think about the finished product — the pill, the injection, the treatment in a clinician’s hand. But between discovery and patient access sits a long, complex path shaped by evidence, regulation, stakeholder trust, and real-world decision-making. In this episode, Abdulhamid Al-Khatib pulls back the curtain on medical affairs and shows why it plays such a critical role in turning science into access, data into decisions, and innovation into real patient impact. By listening, you’ll:Understand what medical affairs actually does across the full product lifecycle — from early evidence generation to launch and long-term clinical useLearn how real-world evidence, stakeholder insights, and patient voice influence uptake, payer access, and strategic decision-makingDiscover how trust, scientific credibility, and cross-functional influence shape whether a medicine succeeds in the real worldPress play now to understand the overlooked function that helps move medicines from promising science to meaningful patient access.Link: https://medicalaffairs.org/International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Code of PracticeDescription: This code sets out a global framework for ethical interactions with healthcare professionals, medical institutions, and patient organizations.Link: https://www.ifpma.org/resource-centre/ifpma-code-of-practice/FDA Guidelines on Scientific ExchangeDescription: The U.S. Food and Drug Administration (FDA) provides specific guidance on how pharmaceutical companies can engage in truthful, non-promotional scientific exchange with healthcare professionals, particularly concerning unapproved uses of approved products. These are often referenced in industry training and SOPs.Link (example of related guidance): https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugsInternational Society for Pharmacoeconomics and Outcomes Research (ISPOR)Description: A leading professional society for health economics and outcomes research. They have published numerous "Good Practices" reports that guide the design and reporting of real-world evidence (RWE) studies.Link (to their RWE resources): https://www.ispor.org/strategic-initiatives/real-world-evidenceICH E6(R2) Good Clinical PracticeDescription: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. The ICH E6(R2) guideline for Good Clinical Practice (GCP) is the global standard for designing, conducting, recording, and reporting clinical trials involving human participants.Link: https://www.ema.europa.eu/en/ich-e6-good-clinical-practice-scientific-guidelineGood Publication Practice (GPP) for Company-Sponsored Biomedical Research: 2022 UpdateDescription: This guideline provides best practices for the ethical and transparent planning, development, and dissemination of company-sponsored research.Citation: DeTora, L. M., et al. (2022). Good Publication Practice (GPP) guidelines for company-sponsored biomedical research: 2022 update. Annals of Internal Medicine, 175(11), 1601-1610.Link: https://www.ismpp.org/gpp-2022General Data Protection Regulation (GDPR)Description: A European Union regulation on data protection and privacy for all individuals within the EULink: https://gdpr.eu/what-is-gdpr/
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What this episode covers
What does “great” Medical Affairs look like in 2025? We talk evidence, access, patient voice, and how to work with Commercial without crossing the promotional line. Abdul Hameed Al-Khateeb, Country Medical Director, shares practical lessons on measurement, real-world evidence, and where AI actually helps. 📺 Watch on Youtube: https://youtu.be/KEMIBr4-tXI 📝 Join the mailing list to get the show notes for every episode here: https://thesalesaccelerationformula.com/podcast-show-notes (https://thesalesaccelerationformula.com/podcast-show-notes) Definitions of things mentioned in the episode Medical Affairs Professional Society (MAPS) Description: A global non-profit organization that provides frameworks, guidance, and educational resources for medical affairs professionals. Their work on measuring the impact of medical affairs is particularly influential. Link: https://medicalaffairs.org/ (https://medicalaffairs.org/) International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of Practice Description: This code sets out a global framework for ethical interactions with healthcare professionals, medical institutions, and patient organizations. Link: https://www.ifpma.org/resource-centre/ifpma-code-of-practice/ (https://www.ifpma.org/resource-centre/ifpma-code-of-practice/) FDA Guidelines on Scientific Exchange Description: The U.S. Food and Drug Administration (FDA) provides specific guidance on how pharmaceutical companies can engage in truthful, non-promotional scientific exchange with healthcare professionals, particularly concerning unapproved uses of approved products. These are often referenced in industry training and SOPs. Link (example of related guidance): https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs (https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs) International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Description: A leading professional society for health economics and outcomes research. They have published numerous "Good Practices" reports that guide the design and reporting of real-world evidence (RWE) studies. Link (to their RWE resources): https://www.ispor.org/strategic-initiatives/real-world-evidence (https://www.ispor.org/strategic-initiatives/real-world-evidence) ICH E6(R2) Good Clinical Practice Description: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. The ICH E6(R2) guideline for Good Clinical Practice (GCP) is the global standard for designing, conducting, recording, and reporting clinical trials involving human participants. Link: https://www.ema.europa.eu/en/ich-e6-good-clinical-practice-scientific-guideline (https://www.ema.europa.eu/en/ich-e6-good-clinical-practice-scientific-guideline) Good Publication Practice (GPP) for Company-Sponsored Biomedical Research: 2022 Update Description: This guideline provides best practices for the ethical and transparent planning, development, and dissemination of company-sponsored research. Citation: DeTora, L. M., et al. (2022). Good Publication Practice (GPP) guidelines for company-sponsored biomedical research: 2022 update. Annals of Internal Medicine, 175(11), 1601-1610. Link: https://www.ismpp.org/gpp-2022 (https://www.ismpp.org/gpp-2022) General Data Protection Regulation (GDPR) Description: A European Union regulation on data protection and privacy for all individuals within the EU Link: https://gdpr.eu/what-is-gdpr/ (https://gdpr.eu/what-is-gdpr/)
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#144 | How Clinicians Build the Evidence That Gets a Medical Device Adopted
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