Bilal Bham on Life Sciences Strategy, Human Perspective & Building Amodaia | Pharma Prescribed

Andy York on AI, Data Science & Why 80% Accuracy Isn’t Good Enough | Pharma Prescribed Podcast

Adam Walker sits down with Andy York — statistician, clinical data science leader, and former VP of Clinical Data Science at Novo Nordisk — for a masterclass in where pharma's data revolution has been, where it's heading, and why the AI hype needs a reality check. With over 30 years spanning Roche, Covance, and Novo Nordisk, Andy now advises Verisian, a company building next-generation AI and traceability tools for clinical reporting. He brings rare historical depth and hard-won perspective to one of the industry's most pressing questions: can we actually trust AI with patient safety? In this episode: Why 80% AI accuracy equates to a process out of control — and what the Six Sigma reality check means for drug development The journey from paper CRFs and carbon copies to EDC, CDISC standards, and AI-assisted programming SAS vs R vs Python — what the shift to open source really means for regulatory submissions How guardrails, not raw AI, are the key to hitting 95%+ accuracy in clinical reporting The future of statistical programming: from code developers to validators Why pharma's AI revolution will realistically take a decade — and what to do in the meantime Career advice for the next generation entering clinical data science Whether you're a statistical programmer, data scientist, biometrician, or simply curious about AI's real role in drug development, this conversation will challenge your assumptions and sharpen your thinking. 🎙️ Pharma Prescribed is hosted by Adam Walker, biometrics consultant and independent voice in clinical research and healthcare leadership. 🔗 Listen on all platforms: pharmaprescribed.com 📧 Connect with Adam: https://www.linkedin.com/in/adam-walker-2327951/ ⏱️ CHAPTERS 00:00 Introduction 01:00 Meet Andy York — Career & Mission 02:00 Why Pharma? The Noble Cause Behind the Data 04:30 Lessons From 30 Years — Advice for Newcomers 05:30 From Paper CRFs to EDC: How Data Collection Evolved 07:00 Standards, CDISC, SAS & the Programming Revolution 08:30 AI in Pharma — The Reality Check 10:00 The 80% Problem & Six Sigma Thinking 11:00 Guardrails: How to Make AI Reliable in Clinical Reporting 13:00 Human in the Loop — The FDA's Stance on AI Submissions 15:00 Parallel Streams & Freeing Up Resource Through Automation 17:00 Expanding Drug Indications With AI Efficiency 18:00 Conference Trends — The Move From SAS to R 20:00 Open Source vs Validated Systems — Regulatory Perspectives 23:00 SAS, R, Python — The Right Language for the Right Job 24:30 Future Roles: From Programmer to Data Scientist 27:00 The Next Generation — Gamers, AI Natives & Skills for Tomorrow 29:00 Science Fiction Becoming Science Fact 30:30 Verisian's Roadmap — What's Coming Next 32:30 Andy's Closing Advice for Programmers at Every Stage 🏷️ TAGS clinical data science, statistical programming, AI in pharma, drug development, clinical trials, SAS vs R, open source pharma, CDISC standards, regulatory submission, FDA AI, Novo Nordisk, Verisian, biometrics, data science careers, pharma podcast, clinical research, Adam Walker, Pharma Prescribed, Andy York, EDC, SDTM, ADaM, PharmaVerse, R consortium, double programming, AI accuracy, patient safety, pharmaceutical industry, clinical data management, real world evidence, pharma careers

Dermot Whelan on Burnout, Anxiety & the Science of Mindfulness | Pharma Prescribed Podcast

Dermot Whelan — broadcaster, comedian, bestselling author and certified meditation teacher — joins Adam Walker for one of the most personal and practical conversations on the Pharma Prescribed Podcast. This episode holds a special place — meeting Dermot in Prague in early 2025,  in the middle of my own grief, was one of the moments that led to this podcast existing. Dermot left his radio show at Today FM at the height of its ratings to dedicate himself full-time to making mindfulness accessible. In this conversation, he shares the panic attack in 2007 that changed everything, why stress has terrible marketing, and the simple tools — including Navy SEAL box breathing — that can shift your nervous system in just 16 seconds. Adam opens up about his own breakdown following his father's stroke, and how meeting Dermot at a conference in Prague in early 2025 became a turning point. Raw, warm, and full of practical frameworks you can use today. 🎧 LISTEN ON YOUR PREFERRED APP Spotify → https://open.spotify.com/episode/2wcigm9yKnpbvD86nGPRRV Apple Podcasts → https://podcasts.apple.com/us/podcast/pharma-prescribed-with-dermot-whelan-broadcaster/id1829715970?i=1000771679527 Amazon Music → https://music.amazon.com/podcasts/1a43eb87-b83e-441d-9a87-321263e3f821/adam-walker%E2%80%99s-pharma-prescribed-podcast Podbean → https://pharmaprescribed.podbean.com/ 📖 WHAT WE COVER - Why Dermot walked away from radio at the peak of his career - The 2007 panic attack that woke him up — and what he learned from it - Why stress has terrible marketing (and the study that proves it) - The 'busyness badge of honour' and how modern society got addicted to overwhelm - The DRAMA framework: a science-backed filter for choosing hobbies that actually reset you - Box breathing: the 16-second Navy SEAL technique for immediate calm - Why your heart is a better compass than your brain - What Everest Base Camp taught Dermot about values and simplicity - The moment Adam asked Dermot for a hug — and why vulnerability changes everything ⏱️ CHAPTERS 0:00 Meet Dermot Whelan 3:40 Audience Softening and Curiosity 7:20 Early Anxiety Signs 11:00 Adam Shares His Breakdown 14:40 Reframing Stress as Helpful 18:20 Modern Busyness and Noise 22:00 Everest Base Camp Reset 25:40 Advice to a Younger Self 29:20 Skateboards and the DRAMA Framework 33:00 Protect Your Reset Rituals 36:40 Heart as Compass 40:20 16-Second Box Breathing 44:00 Gratitude and Farewell 👤 ABOUT DERMOT WHELAN Dermot Whelan is one of Ireland's most recognised broadcasters and the author of the bestselling books Mind Full and Busy and Wrecked. A certified Masters of Wisdom and Meditation teacher, he hosts The Mind Full Podcast and has helped thousands reframe stress and reclaim their wellbeing. 🌐 https://www.dermotwhelan.com 📸 Instagram: https://www.instagram.com/dermotwhelanofficial/ 🎙️ ABOUT PHARMA PRESCRIBED Pharma Prescribed is the podcast for people who want the conversations the life sciences industry rarely makes time for — hosted by biometrics consultant Adam Walker. New episodes every week covering clinical research, digital health, mental wellbeing and leadership. 🌐 https://pharmaprescribed.com 💼 LinkedIn: https://www.linkedin.com/in/adam-walker-2327951/ #DermotWhelan #Mindfulness #BusyAndWrecked #MentalHealth #Meditation #Burnout #BoxBreathing #PharmaPrescribed #Wellbeing #StressManagement

Sharmila Hume on Brain Injuries, Suicide Prevention & the Body's Hidden Signals | Pharma Prescribed

⚠️ This episode discusses suicide, traumatic brain injury, and grief. Please take care if these topics are difficult for you. Sharmila Hume — known as the "Biomedic Detective" — joins Adam Walker for one of the most profound and wide-ranging conversations on the Pharma Prescribed Podcast. Originally trained as a telecoms engineer, Sharmila rebuilt her life after her own battle with ME and fibromyalgia, then spent months in Mexico rehabilitating her brother Arnie after a near-fatal head-on collision with a drunk driver. When Arnie later died by suicide, Sharmila connected the dots between his unaddressed traumatic brain injury and his death — and turned that grief into a mission. Today she runs the Headstrong campaign and her Bioperformance System, using German bioresonance technology to treat the body as a communication network — identifying and clearing the disruptions that conventional medicine misses. This is a conversation about what we overlook, and what it costs us. Adam also opens up about the death of his sister Naomi by suicide, and the striking connections between viral meningitis, brain function, and the mental health crisis that followed. Recorded during Mental Health Awareness Week. 🎧 LISTEN ON YOUR PREFERRED APP Spotify → https://open.spotify.com/search/Sharmila%20Hume%20pharma%20prescribed/episodes Apple Podcasts → https://podcasts.apple.com/gb/search?term=Sharmila%20Hume+pharma+prescribed Amazon Music → https://music.amazon.com/podcasts/1a43eb87-b83e-441d-9a87-321263e3f821/adam-walker%E2%80%99s-pharma-prescribed-podcast Podbean → https://pharmaprescribed.podbean.com/ 📖 WHAT WE COVER - Sharmila's diagnosis with ME and fibromyalgia at age 15 — and how it sparked everything - The 2009 phone call that changed her family's life: Arnie's near-fatal crash in Mexico - Two months of improvised rehabilitation in a foreign country — with a surgeon's blessing - The Will Smith film Concussion that unlocked the connection between TBI and suicide - What bioresonance technology actually does — explained clearly, no jargon - Why viruses, heavy metals and modern technology disrupt the brain's regulatory systems - The link between post-viral infection, long COVID, mood changes and suicide risk - Why "it's all in your head" is the most dangerous thing a doctor can say - How grief and trauma are stored physically in the body — and how to release them - "Receipts for love are grief and anxiety" — the Scott Galloway quote that stopped Adam cold - Why mental health cannot be resolved without first addressing physical health - The DRAMA of Sharmila's golden rule: never stop learning ⏱️ CHAPTERS 0:00 Introduction & Trigger Warning 2:15 Meet Sharmila Hume 8:40 Brain Science Meets Innovative Care 21:30 Rethinking Recovery 35:00 What's Next — Headstrong & the Future 👤 ABOUT SHARMILA HUME Sharmila Hume is a healthcare practitioner, biomedic detective and creator of the Bioperformance System. Trained in telecoms engineering, she transitioned into healthcare after her own recovery from ME and fibromyalgia and her experience rehabilitating her brother following a catastrophic road accident. She leads the Headstrong campaign to raise awareness of the long-term impact of brain injuries on male mental health and suicide prevention. 🌐 https://www.holistichub.uk 📸 Instagram: https://www.instagram.com/bioperformance_uk/ 💼 LinkedIn: Search "Sharmila Hume" 🎙️ ABOUT PHARMA PRESCRIBED Pharma Prescribed is the podcast for people who want the conversations the life sciences industry rarely makes time for — hosted by biometrics consultant Adam Walker. New episodes every week covering clinical research, digital health, mental wellbeing and leadership. 🌐 https://pharmaprescribed.com 💼 https://www.linkedin.com/in/adam-walker-2327951/ #SharmilHume #BrainInjury #SuicidePrevention #MentalHealth #TBI #Bioresonance #Headstrong #LongCovid #MEfibromyalgia #PharmaPrescribed #MentalHealthAwarenessWeek #AdamWalker

Bilal Bham on Life Sciences Strategy, Human Perspective & Building Amodaia | Pharma Prescribed

Bilal Bham — founder and CEO of Amodaia — joins Adam Walker to explore what it really takes to guide a biotech, pharma or medtech company through its most critical decision points. Bilal brings nearly two decades of life sciences experience across regulatory affairs, medical affairs, market access, marketing communications and fundraising. But what sets him apart is the lens through which he approaches all of it: lived experience. His own journey with Graves' disease and thyroid eye disease, alongside family mental health challenges and his experience as an autistic leader, has shaped a consultancy built around the belief that science and human perspective are inseparable. This is a conversation about the gap between clinical data and commercial reality — and what it takes to close it. 🎧 LISTEN ON YOUR PREFERRED APP Spotify → https://open.spotify.com/episode/6gPpTo25uSfdcVQCtcBw2X Apple Podcasts → https://podcasts.apple.com/us/podcast/pharma-prescribed-with-bilal-bham-ceo-of-amodaia/id1829715970?i=1000769475494 Amazon Music → https://music.amazon.com/podcasts/1a43eb87-b83e-441d-9a87-321263e3f821/adam-walker%E2%80%99s-pharma-prescribed-podcast Podbean → https://pharmaprescribed.podbean.com/ 📖 WHAT WE COVER - What Amodaia does and why integrated consultancy beats siloed departments - Navigating regulatory, medical affairs and market access as a unified strategy - Why patient-first thinking must drive commercial strategy — not follow it - Bridging the gap between clinical data and the human story payers and providers need to hear - Fundraising realities for emerging biotechs at critical decision points - How lived experience with chronic illness and neurodiversity shapes Bilal's leadership - Why the most important question in drug development is still: does this improve a patient's life? ⏱️ CHAPTERS 0:00 Introduction & podcast mission 1:00 Meet Bilal Bham — founder of Amodaia 2:00 The mission: helping biotechs survive & reach patients 3:30 From medical writing to cross-functional consultancy 5:00 "Telling them their baby's ugly" — diagnosing client friction 7:00 The consultation process: NDAs, diagnostics & trust building 9:00 Trust, loyalty, respect — Amodaia's six core values 11:00 Shared experience: redundancy as the spark for independence 12:30 Losing his father, returning home & going freelance 15:00 Growth strategy & the AI reset reshaping life sciences 17:30 Building proprietary AI vs off-the-shelf tools 20:00 Breaking pharma silos — why pillars beat silos 22:00 The AI stack: Claude, ChatGPT, Scite, Perplexity & beyond 24:30 Scaling lean — seven-figure revenue without a big headcount 26:30 It takes a village: mentors inside and outside the industry 30:00 Self-education through audiobooks — dead time to active time 32:30 Empathy as a leadership principle — "it costs nothing to be nice" 33:00 Living with autism, ADHD & the power of neurodiversity 37:30 Masking, diagnosis & finding a methodology that works 40:00 Routine as regulation — bookending the day 42:00 Quick-fire round 44:00 Closing reflections 👤 ABOUT BILAL BHAM Bilal Bham is the founder and CEO of Amodaia, a senior-led life science consultancy supporting biotech, pharma and medtech teams across regulatory affairs, medical affairs, market access, marketing communications and fundraising. With nearly two decades in life sciences, he brings both strategic rigour and a human perspective shaped by his own experience with Graves' disease, thyroid eye disease and life as an autistic leader. 💼 LinkedIn: Search "Bilal Bham Amodaia" 🎙️ ABOUT PHARMA PRESCRIBED Pharma Prescribed is the podcast for people who want the conversations the life sciences industry rarely makes time for — hosted by biometrics consultant Adam Walker. New episodes every week covering clinical research, digital health, mental wellbeing and leadership. 🌐 https://pharmaprescribed.com 💼 https://www.linkedin.com/in/adam-walker-2327951/ #BilalBham #Amodaia #LifeSciences #Biotech #PharmaStrategy #MarketAccess #RegulatoryAffairs #PatientFirst #PharmaPrescribed #AdamWalker #HealthcareLeadership #Neurodiversity

Adam Baumgart on RBQM, AI in Clinical Trials & 38 Years of Hard-Won Pharma Wisdom | Pharma Prescribed

Adam Baumgart — biometrics and risk consultant with 38 years across AstraZeneca, Covance and beyond — joins Adam Walker for a masterclass in risk-based quality management, the future of clinical trials, and what it actually takes to build a career worth having. Adam fell into clinical research in 1988 when data was collected on non-carbon required paper. He's watched the industry move from paper forms to web-based entry, integrated databases, and now AI-driven analytics. Along the way he discovered a passion for RBQM — and spent four years leading the risk-based monitoring initiative at Covance that transformed how clinical trials are overseen. This episode is part technical deep-dive, part career masterclass, and part honest conversation about mentorship, loss, men's mental health and the Monday morning accountability group that changed both Adam's life and the host's. 🎧 LISTEN ON YOUR PREFERRED APP Spotify → https://open.spotify.com/episode/6XT6cpwCmk4eo3KookDaMA Apple Podcasts → https://podcasts.apple.com/us/podcast/pharma-prescribed-with-adam-baumgart-from-paper-to/id1829715970?i=1000767784416 Amazon Music → https://music.amazon.com/podcasts/1a43eb87-b83e-441d-9a87-321263e3f821/adam-walker%E2%80%99s-pharma-prescribed-podcast Podbean → https://pharmaprescribed.podbean.com/ 📖 WHAT WE COVER - RBQM explained simply: the four pillars of quality by design, risk management, quality control and quality assurance - Why 38 years of broad experience is what made RBQM click — and how to accelerate that understanding - From paper forms in 1988 to AI copilots in 2025: the technology evolution in clinical data - Critical to quality factors: the one place every company should start before anything else - How to reduce 60 active risks down to 20 manageable ones — and why that changes everything - The skills young people need now: critical thinking, data science, UX awareness and relationship building - Why programming experience — even two years of it — makes you a fundamentally better clinical trial professional - Mentors that shaped him: from Glaxo Med Africa to an inspiring father-in-law who was a post-war refugee - 10 years teaching clinical data management for ACDM — and why giving back matters - Ryan Parke's Monday morning men's accountability group: what it is and why it works - Visualization, discipline and learning to follow your passion without guilt - Operation Cyclops: cataloguing a comic collection started in 1976 ⏱️ CHAPTERS 0:00 Introduction & podcast mission 1:00 Meet Adam Baumgart — biometrics & risk consultant 2:00 Mission: transforming RBQM across the industry 3:30 RBQM explained in plain English — the four pillars 7:00 How a career spanning 38 years led to this passion 9:00 From agrochemical field trials to clinical data management 11:00 Lean Six Sigma, the 2014–2017 guidance changes & the RBQM spark 13:00 Mentors: Glaxo Med, Covance & an extraordinary father-in-law 16:00 Giving back through ACDM — 10 years of teaching 19:00 From paper to pixels: the technology evolution since 1988 22:00 Why trials are exponentially more complex than they used to be 23:00 Key skills for the next generation: critical thinking & data science 25:00 UX design, relationship building & not being intimidated by brilliant people 27:00 The value of two years programming — and why it still pays off 30:00 Building RBQM from scratch: where to start 31:00 Critical to quality factors — filtering out the noise 33:00 Ryan Parke's Monday morning men's group & the power of accountability 37:00 Visualization, discipline & being forgiving of yourself 39:00 Quick-fire round 43:00 Closing reflections & how to connect 👤 ABOUT ADAM BAUMGART Adam Baumgart is a biometrics and risk consultant with 38 years of experience across clinical research organisations and pharma, including leadership roles at AstraZeneca and Covance. He is an advisor at ZS Associates and Alcedo Consulting, a volunteer expert on RBQM for the Association for Clinical Data Management (ACDM), and a passionate advocate for risk-based approaches to clinical trial quality. 💼 LinkedIn: Search "Adam Baumgart" 🎙️ ABOUT PHARMA PRESCRIBED Pharma Prescribed is the podcast for people who want the conversations the life sciences industry rarely makes time for — hosted by biometrics consultant Adam Walker. New episodes every week covering clinical research, digital health, mental wellbeing and leadership. 🌐 https://pharmaprescribed.com 💼 https://www.linkedin.com/in/adam-walker-2327951/ #AdamBaumgart #RBQM #ClinicalTrials #RiskBasedQualityManagement #ClinicalData #PharmaLeadership #PharmaPrescribed #LifeSciences #ClinicalResearch #AstraZeneca #Covance #ACDM #MensHealth #AdamWalker