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#144 | How Clinicians Build the Evidence That Gets a Medical Device Adopted
Description
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 use
- Learn how real-world evidence, stakeholder insights, and patient voice influence uptake, payer access, and strategic decision-making
- Discover how trust, scientific credibility, and cross-functional influence shape whether a medicine succeeds in the real world
Press 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 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/
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
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
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
Good Publication Practice (GPP) for Company-Sponsored Biomedical Research: 2022 Update
Description: This guideline provides best practices for the ethical and transparent