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

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

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, 

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.

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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.

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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.

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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.

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#AdamBaumgart #RBQM #ClinicalTrials #RiskBasedQualityManagement #ClinicalData #PharmaLeadership #PharmaPrescribed #LifeSciences #ClinicalResearch #AstraZeneca #Covance #ACDM #MensHealth #AdamWalker

Helen Palk on 30 Years of NHS Nursing, COVID Vaccines & Human Side of Healthcare | Pharma Prescribed

Helen Palk — general practice lead nurse with nearly 30 years in the NHS — joins Adam Walker for one of the warmest and most grounded conversations on the Pharma Prescribed Podcast.

Inspired by her grandmother, an army nurse who cared for injured troops during the Second World War, Helen's path began behind a pharmacy counter and took her through urology, theatre recovery, midwifery and finally to general practice in the southeast of England — where she has been ever since.

This is a conversation about what nursing actually looks like from the inside: the intimacy, the consent, the emergencies that change your mind about a career, the COVID vaccine hubs that ran on sheer goodwill, and why a smile is still the most powerful clinical tool in the room.

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Steven Thompson on AI, Clinical Trial Activation & Why 85% of Trials Are Delayed | Pharma Prescribed

Steven Thompson — founder of Next Trial AI — joins Adam Walker to explain why 85% of clinical trials are delayed before a single patient is enrolled, and what he's building to fix it.

Steven spent two decades in high-stakes regulatory environments: first with American Airlines on FAA compliance, then with Embraer in Brazil, then building data engineering pipelines for oncology and vaccines at Biogen and Takeda. When his father died of cancer — after going through an informed consent process based on static eligibility data that couldn't predict whether he'd even tolerate the trial — it became personal.

Now, from his base in Brazil, Steven is building the infrastructure that makes clinical trials predictable. Trial ready in 30 days. Zero rejection packets. AI that is provably right — not probably right.

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#StevenThompson #NextTrialAI #ClinicalTrials #AIinPharma #TrialActivation #ClinicalResearch #PharmaPrescribed #AdamWalker #ArtificialIntelligence #DrugDevelopment #RBQM #FDA #MHRA #BrazilHealthcare #LifeSciences

Amelia Wrighton on suicide loss, grief & the charity that helped Adam's family | Pharma Prescribed

⚠️ This episode discusses suicide loss and grief. Please take care. If you need support: Samaritans → 116 123 (UK, free, 24/7)

Amelia Wrighton — co-founder and CEO of Suicide&Co — joins Adam Walker for the most personal conversation on the Pharma Prescribed Podcast.

Amelia lost her mother to suicide at 19. She navigated that grief alone, without signposting, without counseling, suppressing everything until alopecia and a mental health crisis forced her hand. A decade later she met her co-founder Emma — who had lost her father — and the parallels in two completely different lives were the catalyst for Suicide&Co.

For Adam, this episode is deeply personal. He lost his sister Naomi to suicide in September 2024. Suicide&Co supported his family from day one. This is his first public conversation about it.

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Scott Schliebner on DCTs, Patient-Centric Trials & 30 Years of Pharma Innovation | Pharma Prescribed

Scott Schliebner — founder of Ascent Biostrategies and veteran of nearly 30 years across biotech, CROs and nonprofit life sciences — joins Adam Walker for a candid, longitudinal view of how drug development actually evolves. And how often it refuses to.

From being one of the first to transition a clinical team from paper CRFs to electronic data capture, to building DCT infrastructure at PRA Health Sciences before COVID made it suddenly essential, Scott has watched innovation after innovation hit the wall of a deeply conservative industry. His verdict? Patching on technology doesn't work. What does is putting patients in the room before the protocol is written.

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Helene Quie on MedTech Regulation, Danish Innovation & Getting Devices to Patients | Pharma Prescribed

Helene Quie — cell biologist turned MedTech CEO — joins Adam Walker for a wide-ranging conversation about what it really takes to get a medical device from concept to market.

Helene founded qmmed Consulting in 2006 after senior roles at Cook Medical, where she entered an industry she describes as "cowboy land" — a Wild West of medical device regulation that has since evolved into one of the most complex risk-based frameworks in global healthcare. From hospital beds to artificial hearts, from software apps to cardiac stents, she has spent 30 years helping manufacturers navigate the 2,000 documented steps between a good idea and a patient benefit.

Adam lived and worked in Copenhagen from 2015 to 2017 — this episode is also a warm conversation about Denmark's extraordinary MedTech ecosystem, its flat culture of sharing, and what the rest of the world could learn from it.

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#HeleneQuie #MedTech #MedicalDevices #qmmedConsulting #EuropeMDR #MedTechRegulation #ClinicalTrials #PharmaPrescribed #AdamWalker #Denmark #NovoNordisk #CookMedical #HealthcareInnovation #AIinMedTech #LifeSciences