RealPharma: Conversations with Pharma Pathfinders

Epizody

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  Good Intentions, Bad Outcomes: Rethinking Healthcare Policy with Deborah Williams 10.07.2026 58min

  When Healthcare Policy Incentives Backfire: 340B, Hospital Pricing, MFN, and Drug Affordability with Deborah Williams Healthcare policies are often evaluated by what they are intended to accomplish. But what happens when the incentives created by those policies produce very different results? In this episode of RealPharma, Ian Wendt and Dr. Na-Ri Oh speak with longtime health policy expert Deborah Williams about the unintended consequences embedded in the U.S. healthcare system—from hospital reimbursement and industry consolidation to the 340B Drug Pricing Program, biosimilars, most-favored-nation pricing, and pharmaceutical innovation. Deborah argues that healthcare policy must be judged not by its stated purpose, but by the behaviors, financial incentives, and measurable outcomes it creates. The discussion examines why transparency alone may not lower healthcare costs, how hospital systems use their political and economic influence, and why policies designed to improve affordability can sometimes contribute to higher prices. The conversation also explores the practical and constitutional uncertainties surrounding most-favored-nation drug pricing, the Trump administration’s GARD, GLOBE, and GENEROUS models, and the potential downstream effects of pricing reform on research, development, manufacturing, and patient access. Topics Discussed Why healthcare policy should be evaluated by results rather than intentions The history and limitations of diagnosis-related groups, or DRGs Why MACRA has failed to create an effective physician payment system Whether healthcare price transparency can meaningfully reduce costs The effects of hospital consolidation and certificate-of-need laws Why hospital systems have become so politically difficult to challenge Indiana’s effort to cap hospital prices relative to Medicare rates The widening divide between large health systems and rural hospitals How nonprofit hospitals deploy capital and justify tax-exempt status The role of hospital employment in local political influence Why 340B purchasing incentives can favor higher-priced branded products How 340B spreads may undermine biosimilar adoption Whether 340B savings are reaching vulnerable patients Alternatives to funding safety-net and uncompensated-care services through drug discounts Why policymakers may need to separate hospital support from pharmaceutical pricing The rationale behind most-favored-nation drug pricing Whether European countries are likely to pay more for pharmaceuticals How Medicaid best-price rules affect commercial contracting The relationship between direct-to-consumer pricing and 340B exposure GARD, GLOBE, and GENEROUS drug-pricing models The legal and constitutional questions surrounding mandatory drug rebates Pharmaceutical manufacturing reshoring and national economic policy How interest rates and global reimbursement policies affect drug development The need to measure the quality—not merely the quantity—of pharmaceutical innovation Why every healthcare payment system has both intended and unintended consequences Key Takeaways Policy intentions do not guarantee beneficial outcomes Even carefully designed reimbursement systems can produce distortions once stakeholders respond to the incentives. Deborah emphasizes that policymakers must continuously measure what happens after implementation rather than assuming a program is working because its goals are admirable. Transparency is necessary, but not sufficient Publishing hospital prices may help patients and purchasers compare costs, but transparency has limited value when every available option is still unaffordable. Meaningful reform may also require addressing hospital concentration, market power, and state certificate-of-need restrictions. Hospitals possess considerable economic and political power Large health systems are often among the biggest employers in a congressional district or state. That employment base, combined with campaign contributions
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  The New Biopharma Talent Market: AI, M&A, and a K-Shaped Recovery 20.04.2026 53min

  Episode SummaryIn this episode of Real Pharma, hosts Na-Ri Oh and Ian Wendt sit down with Kristiaan Rawlings, Executive Director at EPM Scientific, to unpack what is really happening in the biopharma talent market right now. From the surprising resurgence of market access hiring to the growing influence of AI in recruiting and candidate preparation, this conversation explores the forces reshaping commercial talent strategy in 2026. The group also digs into salary inflation, title compression, M&A-driven hiring shifts, hybrid work expectations, and why communication skills and executive presence may matter more than ever. What We Cover Why market access has re-emerged as one of the hottest hiring areas in biopharma How companies are responding to policy shifts, competition, and launch pressure What the current K-shaped hiring market means for candidates in high-demand vs. lower-demand functions Why specialists in forecasting, analytics, and insights may need to broaden their skill sets How AI is affecting interviews, candidate prep, and recruiting workflows The continued importance of presentation skills, executive presence, and storytelling How M&A activity is influencing hiring, retention packages, and future job movement What’s happening with salary growth, especially at the director, senior director, and VP levels Why hybrid work is still the norm and fully remote roles remain limited What candidates should know before making a move in 2026 Key TakeawaysBiopharma hiring is not following a single trend. Some functions are seeing intense demand and rising compensation, while others are consolidating under broader roles. Kristiaan explains that market access, select commercial operations roles, and experience in competitive therapeutic areas are commanding a premium right now. At the same time, he notes that professionals who can combine technical skill with strong communication and leadership presence are consistently outperforming others in the interview process. The episode also highlights a more nuanced view of AI: it is not simply replacing jobs, but it is changing how work gets done. Used well, AI can improve recruiting efficiency, candidate prep, and search precision. Used poorly, it can make candidates sound generic, underprepared, or overly scripted.
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  What Farmers Know About Cancer with Chris Gregg 30.03.2026 58min

  🧠 Episode Summary What if we’ve been thinking about cancer all wrong? In this deeply personal and paradigm-shifting episode of RealPharma, hosts Dr. Na-Ri Oh and Ian Wendt sit down with Dr. Christopher Gregg—neuroscientist, entrepreneur, and stage 4 cancer patient—to explore a bold new vision for cancer care. Dr. Gregg shares how his own diagnosis sparked a radical rethink of oncology: moving away from the “war on cancer” mindset toward managing it as a chronic, controllable condition. Drawing inspiration from agriculture, AI, and evolutionary biology, he introduces the concept of “algorithms as drugs”—dynamic, data-driven treatment strategies designed to outmaneuver resistance. This conversation blends cutting-edge science with raw human experience, offering a hopeful and pragmatic roadmap for the future of precision medicine. 🔑 Key Topics Covered Why curing cancer may not always be the best goal—and what to aim for instead The concept of adaptive therapy and managing cancer like a chronic disease What elephants, farmers, and pests can teach us about treatment resistance The limitations of today’s drug development and clinical trial systems “Algorithms as drugs” and the future of programmable medicine How AI, smartphones, and behavioral data can unlock scalable precision care The role of value-based care models in accelerating innovation Dr. Gregg’s personal journey living 7+ years with stage 4 cancer Building Storyline Health, Primordial AI, and Uncharted Health The importance of patient agency—and the risks of unguided experimentation     🚀 Why This Episode Matters Cancer care is at an inflection point. While billions are spent developing new drugs, Dr. Gregg argues that the real breakthrough may come from how we use the drugs we already have. By combining AI, real-time patient data, and systems thinking, this approach could dramatically extend lives, reduce costs, and make care more human-centered. 🔗 Learn More Explore Dr. Gregg’s free masterclass: Uncharted Health Follow developments from Storyline Health and Primordial AI Stay tuned for upcoming clinical applications of algorithm-driven care 🎧 About the Guest Dr. Christopher Gregg is a Professor of Neurobiology and Human Genetics at the University of Utah, a leading researcher in genomics and brain science, and a biotech entrepreneur. His work spans neuroscience, AI, and precision medicine—and is deeply informed by his personal experience living with metastatic cancer.
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  The Opioid Reckoning (Part 2): Paul Farrell Jr. 10.03.2026 52min

  The Opioid Reckoning (Part 2): Litigation, Accountability, and the Fight for Justice with Paul T. Farrell Jr. In Part 2 of our deep dive into the opioid crisis, hosts Dr. Na-Ri Oh and Ian Wendt continue their conversation with Paul T. Farrell Jr., the West Virginia attorney who helped lead the historic national opioid litigation. This episode moves beyond the legal strategy discussed in Part 1 and explores the human toll, the documentary that captured the battle, the controversial trial outcome, and the surprising legal reversal years later. It’s a story of perseverance, public health accountability, and the long arc of justice. 🎬 From Courtroom to Documentary Paul shares the unexpected origin story behind the PBS documentary The Bitter Pill, directed by Clay Tweel. What began as a filmmaker casually attending a hearing soon turned into a seven-year chronicle of the opioid litigation, capturing the rise of a local lawsuit in Huntington, West Virginia into a nationwide legal movement. The documentary highlights not only the legal fight but also the devastating real-world impact of the opioid epidemic on families, healthcare workers, and communities. ⚖️ The Trial That Shook the Case A major focus of the episode is the Cabell County trial, the first major test of the legal strategy that ultimately helped drive national settlements. Paul explains how: The case became the bellwether trial for thousands of similar lawsuits. A national settlement framework complicated the ability to settle locally. The federal judge ultimately ruled against the plaintiffs on legal grounds—even as similar arguments succeeded in other jurisdictions. For Paul and his team, the ruling felt like a devastating setback after years of work. 💰 The $50 Billion National Settlement Despite the loss in the bellwether trial, the broader litigation resulted in nearly $50 billion in settlements with pharmaceutical manufacturers, distributors, and pharmacies. Paul explains the goals behind the settlement: Transparency around how opioid pills were distributed across the U.S. Accountability for the systemic failures that fueled the epidemic Funding for opioid abatement programs, rather than compensation for individual claims In West Virginia, settlement funds were allocated through a unique structure that created the West Virginia First Foundation, a statewide public-private trust designed to ensure funds are used specifically to combat addiction and support recovery programs. 🔄 A Stunning Legal Reversal The documentary originally ends on a bleak note after the Cabell County loss. But the story didn’t end there. In October 2025, the Fourth Circuit Court of Appeals reversed the trial court’s decision, reopening the case and giving Cabell County another opportunity to argue its claims. For Paul, the decision brought a sense of vindication after years of uncertainty and reignited the fight for accountability. 🧠 Has the System Changed? The episode closes with a broader discussion about whether the opioid crisis could happen again. Paul reflects on changes across the healthcare ecosystem: Greater scrutiny and transparency in medical research and publishing Stronger safeguards for pharmacists and prescription monitoring Increased attention to controlled substance distribution practices But he also warns that the incentives in healthcare and pharmaceuticals remain powerful—and vigilance will be essential. 💡 Final Reflections When asked what sustains him through years of litigation, setbacks, and public scrutiny, Paul points to faith, community, and the people who show up along the journey at the right moments. It’s a fitting close to a story that began with one lawsuit in a small Appalachian city—and grew into one of the largest public health litigations in U.S. history. 🎧 In This Episode The origin and filming of The Bitter Pill documentary Inside the Cabell County bellwether trial Why the national opioid settlement unfolded t
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  The Opioid Reckoning (Part 1): Paul Farrell Jr. 02.03.2026 1h 3min

  The Opioid Reckoning (Part 1): Paul Farrell Jr. on Litigation, Accountability, and the System That Failed West Virginia has had the highest drug overdose death rate in the United States for over a decade. In a state with fewer than 2 million people, 780 million prescription opioids were distributed in just six years. For Paul Farrell Jr., a Huntington, West Virginia native and mass tort attorney, those numbers weren’t abstract statistics. They were neighbors. Friends. Family members. In Part 1 of this two-part episode, hosts Na-Ri Oh and Ian Wendt sit down with Paul to unpack how the largest civil litigation in American history — the opioid multidistrict litigation (MDL 2804) — came together, and how it reshaped the conversation around corporate accountability in the pharmaceutical supply chain. This is not just a legal story. It’s a story about systems failure — across manufacturers, distributors, regulators, policymakers, and healthcare stakeholders — and what happens when transparency finally forces a reckoning. In This Episode Growing up in Huntington, WV as the opioid crisis escalated The investigative journalism that exposed 780 million pills — and the moment Paul decided to act What “public nuisance” law is — and why it became the legal breakthrough strategy The role of distributors as the “choke point” in the opioid supply chain How 3,000+ cases consolidated into the largest MDL in U.S. history Why abatement — not just financial damages — became central to the settlement strategy Internal company communications that revealed troubling attitudes toward affected communities The intersection of regulation, enforcement, and corporate responsibility How transparency and subpoena power changed the trajectory of the crisis Why This Conversation Matters For those working in pharma, healthcare, commercialization, policy, compliance, or distribution, this episode challenges us to examine difficult questions: Where does responsibility truly lie in a complex healthcare ecosystem? What happens when financial incentives distort oversight? And how do we prevent the next Pandora’s box from opening? This episode sets the foundation for a deeper conversation about accountability, culture, regulation, and reform. Coming Next Week: Part 2 There was simply too much to cover in one episode. In Part 2, we’ll explore: The evolution of the litigation and key tipping points The role of state attorneys general and settlement frameworks The ongoing PBM litigation The documentary The Bitter Pill And what lasting change should look like for the industry Make sure to subscribe so you don’t miss it.
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  Ending The Diagnostic Odyssey with Josh Resnikoff 17.02.2026 58min

  Ending the Diagnostic Odyssey: Rare Disease, Employers & Reimagining Health Plans Hosts: Na-Ri Oh & Ian WendtGuest: Joshua Resnikoff, Founder & CEO, Sunstone Health Episode Overview What if the biggest innovation in rare disease wasn’t a new drug—but a new way to navigate the system? In this episode, Na-Ri and Ian sit down with Joshua Resnikoff, biomedical engineer turned founder of Sunstone Health, to explore how employers can fundamentally rethink healthcare spending—while dramatically improving outcomes for families facing rare diseases. Josh’s journey into healthcare reform wasn’t academic—it was personal. After years navigating the healthcare system to diagnose his son’s rare periodic fever syndrome, Josh experienced firsthand the emotional, financial, and systemic toll of what’s known as the diagnostic odyssey. That experience sparked a mission: compress a seven-year diagnostic journey into just 12 weeks. This conversation dives into rare disease, employer-sponsored health plans, insurance mechanics, and why aligning incentives might be the key to transforming care. 🔬 From Scientist to System Builder Josh’s background as a biomedical engineer at Harvard’s Wyss Institute The rare disease journey that reshaped his career Why getting a diagnosis—even without treatment—changes everything The emotional and economic cost of delayed diagnosis 🧬 The 7-Year Diagnostic Odyssey On average, it takes: 7 years from first symptom to effective treatment for rare disease patients Countless ER visits, specialist referrals, medication trials, and escalating costs Significant emotional strain—rare disease families face dramatically higher stress and divorce rates Sunstone’s model reduces that timeline to approximately 12 weeks using: Whole genome sequencing AI-powered clinical interpretation Expert clinician review (human-in-the-loop model) Direct coordination with local care teams The result?Earlier intervention. Reduced healthcare utilization. Better outcomes. 💼 Why Employers Are the Key Josh explains why self-funded employers—not traditional commercial insurers—are uniquely positioned to drive change. Key insights: ~2/3 of Americans receive insurance through employers Many large employers are self-funded, meaning they pay claims directly Employers think in long-term employee retention (not 12-month insurance cycles) Better healthcare = healthier employees = higher retention & productivity Sunstone’s innovative model: No per-employee-per-month subscription fees Employers only pay when a family receives actionable results High ROI through reduced ER visits, unnecessary treatments, and delayed care 🛡 Insurance 101 (Made Understandable) The episode breaks down: Fully insured vs. self-funded plans Third-party administrators (TPAs) Stop-loss / reinsurance How high-cost cases (like $2M gene therapies) are financially managed The takeaway:When diagnoses happen earlier, total system costs often decrease—even when advanced therapies are involved. 🤝 Mission-Driven Innovation A powerful theme throughout the conversation: Many leaders in the rare disease ecosystem—including Josh—entered the field because of their own children. That lived experience shapes: Sunstone’s patient-first data ownership model Continuous reanalysis of patient data Clinical trial matching Ethical alignment with families As Josh says: “Even if this whole thing went belly up, we will have helped hundreds of families—and I’d feel good about that for the rest of my life.” 🚀 Recent Milestones Successfully raised Series A funding 800+ community investors via WeFunder Integration with Broad Clinical Labs Expanded epilepsy and autism-focused programs Rapidly growing employer pipeline 🔗 Learn More 🌐 Sunstone Health: https://sunstonehealth.com 💼 Connect with Josh on LinkedIn
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  Beyond Survival: Why Empathy Is the Missing Prescription in Pharma with Matthew Zachary 26.01.2026 59min

    🎙️ Beyond Survival: Why Empathy Is the Missing Prescription in Pharma Episode Summary: In this no-holds-barred conversation, Na-Ri Oh and Ian Wendt sit down with Matthew Zachary—brain cancer survivor, founder of Stupid Cancer, host of Out of Patients, and a relentless disruptor in patient advocacy. At 21, Matthew was diagnosed with brain cancer and faced a life-altering decision: take chemotherapy and lose his identity as a musician, or reject treatment and risk everything. That decision became the first of many moments where he saw the cracks in the healthcare system—specifically, the glaring absence of empathy. Now, nearly three decades later, Matthew shares how his experience transformed into a mission to fix what’s broken: in pharma, in media, in patient engagement—and in how we talk about what matters most. This isn’t your typical Pharma Podcast. It’s a masterclass in calling out BS, rethinking metrics that matter, and re-centering real human lives in healthcare strategy. What You’ll Hear in This Episode: 🎹 The life-defining decision Matthew made at 21—and why he turned down chemo 💊 How a lack of empathy almost cost him everything 🧠 The problem with patient engagement that’s all talk and no trust 🎤 The rise of Stupid Cancer and the “Howard Stern of Healthcare” era 📺 Why DTC ads may be a $28 billion distraction 🧵 The missing link between pharma marketers and patient communities 🔥 How compliance is killing creativity—and what to do about it 🗳️ Why Matthew is building a voter movement out of patient voices Memorable Quote: “If there is no empathy, there is no conversation.” – Matthew Zachary Mentioned in the Episode: Stupid Cancer Out of Patients Podcast Matthew’s upcoming book: We the Patients: How to Understand, Navigate, and Survive America’s Healthcare Nightmare WeThePatients.org Guest: Matthew Zachary (@MatthewZachary)   Let me know if you'd like a shorter version for Spotify/Apple Podcast platforms or suggested social media captions to promote the episode.
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  Breaking the Silence: Why Pharma Needs to Speak Up with Brian Reid 12.01.2026 52min

    🎙️ Real Pharma – Episode Title: Breaking the Silence: Why Pharma Needs to Speak UpHosts: Na-Ri Oh & Ian WendtGuest: Brian Reid, Founder & Principal at Reid Strategic 🔍 Episode Summary: In this episode of Real Pharma, Na-Ri and Ian sit down with Brian Reid—a healthcare communicator, strategist, and former journalist who's worked across government, pharma, and media—to explore a provocative question: Why is the pharmaceutical industry so quiet when it comes to telling its own story? Together, they unpack the communication failures shaping drug pricing, PBMs, the Inflation Reduction Act (IRA), biosimilars, and the broader healthcare system. Brian argues that the problem isn’t a lack of data or platforms—it’s a lack of courage, clarity, and commitment to narrative. From the importance of speaking up in a noisy media environment to the myth of reputational risk, this conversation is a must-listen for anyone in life sciences, policy, or healthcare storytelling. 🧠 What You’ll Learn: Why pharma’s “default to silence” is damaging public trust—and what the industry can do instead The communications trap around complex topics like PBMs, pricing, and benefit design How public perception problems could have been avoided with smarter storytelling (hello, Hep C) Why simplicity is power—and how “pharm-to-table” and Mark Cuban are reframing the narrative The case for overcommunication in the face of misinformation and AI-driven “slop” Why the Medicare Prescription Payment Plan was a missed communication opportunity—and how to fix it 🔊 Quotable Moments: “We're in a 30-year experiment of what happens when pharma steps back from the policy debate—and the results are in.” – Brian Reid “I just want pharma to beat Bigfoot in public trust. That’s my goal.” – Brian Reid “When in doubt, just shout. Say something. Do something.” – Na-Ri Oh “It’s not always about having the perfect message—it’s about showing up and making the case.” – Ian Wendt 🧭 Resources Mentioned: Cost Curve – Brian Reid’s daily newsletter on healthcare policy: ReidStrategic.com KFF’s piece on complexity as a barrier to affordability Examples from Mark Cuban’s Cost Plus Drugs and Eli Lilly CEO Dave Ricks’ public podcast appearances 👥 Connect with Brian Reid: 💼 Website: ReidStrategic.com 📬 Newsletter: Cost Curve 💬 LinkedIn: Brian Reid  
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  Formulation as Strategy: Why CDMOs Matter More Than Ever 15.12.2025 45min

  Episode Title: Formulation as Strategy: Why CDMOs Matter More Than EverGuest: Elizabeth Hickman, President & CEO, Austin Pharmaceutics Episode Overview In this episode of RealPharma, hosts Nari Oh and Ian Wendt sit down with Elizabeth Hickman, President and CEO of Austin Pharmaceutics, to unpack one of the most critical—and often misunderstood—elements of drug development: formulation and the evolving role of CDMOs. As drug molecules become more complex and solubility challenges grow, CDMOs are no longer just manufacturing vendors. They are strategic partners helping biotech and pharma companies bridge the gap between discovery and commercialization. Elizabeth shares her journey from commercial pharma leadership to running a science-driven CDMO, and explains why formulation decisions made early can determine whether a promising molecule ever reaches patients. 🔍 Key Topics Covered The expanding role of CDMOsWhy CDMOs are shifting from executional partners to strategic extensions of pharma and biotech teams. Why formulation is make-or-breakHow solubility and bioavailability challenges derail up to 80% of modern drug candidates—and why these issues must be addressed early. From “undruggable” to developableHow AI-driven discovery and structure-based drug design are unlocking new targets while creating new development hurdles. Inside Austin Pharmaceuticals’ approachA look at Austin’s proprietary Kinetisol® technology and how amorphous solid dispersion can improve bioavailability, scalability, manufacturability, and sustainability. Small biotech vs. big pharma dynamicsWhat early-stage companies should look for in a CDMO partner—and the most common mistakes teams make when selecting one. Patient impact starts with formulationHow pill burden, dosing frequency, and manufacturability directly affect adherence, cost, and competitiveness. The future of CDMOsReshoring, cost pressures, AI adoption, and the growing need for talent with both scientific depth and entrepreneurial mindset. 💡 Memorable Takeaways “Formulation is where promising molecules either become viable drugs—or stall out.” Solving in-vivo performance alone isn’t enough; scalability and manufacturability must be designed in from day one. The best CDMO relationships are built on transparency, urgency, and shared long-term vision. Advanced formulation isn’t just a technical advantage—it’s a competitive and economic one. 👤 About the Guest Elizabeth Hickman is President and CEO of Austin Pharmaceutics, a U.S.-based early-phase CDMO specializing in formulation development for challenging small-molecule drugs. With a background spanning commercial strategy, drug launches, and executive leadership, Elizabeth brings a sponsor-centric mindset to CDMO partnerships—helping clients accelerate innovation while reducing risk.
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  Untangling the IRA with Emma Cousin 08.12.2025 46min

  🎧 Hosts: Na-Ri Oh & Ian Wendt🎓 Special Guests: Emma Cousin (PhD Candidate, Choice Institute – UW), Amos Fung (RealPharma Intern & Student Pharmacist) 🔍 Episode Summary: In this thought-provoking episode, hosts Na-Ri Oh and Ian Wendt sit down with Emma Cousin, a PhD candidate at the Choice Institute, University of Washington, to unpack the real-world implications of the Inflation Reduction Act (IRA)—particularly the Medicare Drug Price Negotiation Program. Joining them is Amos Fung, a RealPharma intern who brings a front-line pharmacy perspective to the policy conversation. Together, they discuss: 📜 A primer on the IRA’s healthcare provisions—what it is, how it came to be, and why it matters now. 💊 How CMS selects drugs for Medicare negotiation and whether this process constitutes true “negotiation.” 👩‍⚕️ The ripple effects on pharmacists, pharmacies, and patient care. 💸 The looming concerns around cashflow, operational readiness, and access as the 2026 implementation date approaches. 🧠 How researchers like Emma are modeling long-term effects—and what metrics we’ll need to track to assess the IRA’s success. 🔄 Unintended consequences and who might be left behind—especially independent pharmacies and vulnerable communities. 📈 A candid discussion on myths around drug pricing and why “good intentions” in policy still need strong evidence and thoughtful execution. 🎯 Key Takeaways: The IRA marks the first time Medicare can directly negotiate drug prices—albeit in a tightly structured format that raises questions about the fairness of “negotiation.” Pharmacies face operational and financial strain, particularly smaller or independent ones, due to rebate lags and implementation complexities. Patients will benefit from caps on out-of-pocket costs, but awareness and education are lacking—many don’t realize what the law offers. Stakeholders like pharmacists, researchers, and policy influencers need better communication and clearer technical standards from CMS. Evidence-based policy should be the north star for drug pricing reforms, but real-world implementation remains messy and evolving. 🧠 Resources & Mentions: Brian Reid & Adam Fein – Top newsletters to follow for updates on drug pricing policy. CMS Guidance Documents – Frequently updated, but often inaccessible to non-policy experts. National Pharmaceutical Council, Milliman, Portal (Harvard) – Organizations doing forward-looking modeling and policy impact research.
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  Reinventing Cell Therapy with Acoustics 24.11.2025 51min

  Reinventing Cell Therapy with Acoustics, Microfluidics & High-Throughput Engineering In this episode, hosts Na-Ri Oh and Ian Wendt sit down with Dr. Andrew Gray — immune cell engineer, biotech founder, venture capitalist, and CEO of CellEcho — to explore how a new acoustic-powered gene-delivery platform may redefine the boundaries of cell therapy. The conversation spans the current state of the cell therapy landscape, the persistent barriers to scalability, and why CellEcho’s ASOP platform (Acoustically Stabilized Oscillatory Pockets) could unlock a new era of faster, cheaper, and more effective cell engineering. 🔬 Episode Highlights 1. The State of Cell Therapy: Breakthroughs & Bottlenecks Despite scientific success, many pharma companies are exiting cell therapy due to cost, complexity, and manufacturing burdens. Conversely, major players like BMS continue doubling down, acquiring companies such as Orbital Therapeutics. Autologous therapies remain logistically overwhelming and expensive—often ~$400k per dose. 2. Why Cell Therapy Is So Hard to Scale “Vein-to-vein” timelines are still measured in weeks, not days. Manufacturing is bespoke: each patient’s cells must be extracted, engineered, expanded, frozen, shipped, and reinfused. Viral vectors and current non-viral delivery methods introduce cost, complexity, and biological limits. 3. The Next Frontier: In Vivo, Allogeneic & Beyond Allogeneic CAR-Ts remain challenging due to immune rejection and complex engineering. In vivo CAR-T offers promise but is limited by the small genetic “payload capacity” of lipid nanoparticles. Solid tumors remain particularly difficult: only ~9% response rates in some indications. 4. Introducing CellEcho & the ASOP Platform CellEcho’s technology emerged from UC Irvine’s microfluidics program. By applying precision acoustic energy, the platform can: Hold cells in place using thousands of stable micro-eddies Open controlled, programmable “portals” in cell membranes Sequentially deliver multiple genetic payloads with high efficiency Achieve 1 billion cells/hour processing rates Reduce dose production costs by ~100× Enable high-throughput engineering, not just manufacturing This unlocks the ability to test dozens to hundreds of engineered CAR-T variants in days—rather than the years needed today. One academic lab spent 6 years evaluating 11 CAR-T variants.CellEcho tested 8 variants in under 48 hours — and aims for 100+ per week. 5. From Better Manufacturing to Better Medicines While CellEcho originally targeted faster manufacturing, Andrew shares that the bigger opportunity is designing entirely better therapies, not simply making today’s ones faster. This includes: Engineering CAR-Ts with multiple CAR constructs Arming cells with resistance to tumor suppression signals Precise control over expression levels (avoiding under- or over-expression) Unlocking new indications: autoimmunity, neurodegeneration, regenerative medicine 6. Personal Motivation & Mission Andrew shares how his mother's struggle with myasthenia gravis sparked his lifelong journey in immunology. His 20-year career investigating immune evasion, Tregs, and tumor microenvironments culminated in his conviction that next-generation cell engineering is essential. 7. What’s Next for CellEcho Currently initiating pre-seed fundraising Supported by multiple federal grants (including NSF SBIR) Expanding early partnerships with Stanford, Mass General Brigham, and industry collaborators Building a fully automated, AI-augmented cell therapy design platform Dual strategy: Cell-therapy-development-as-a-service Proprietary therapeutic pipeline in select indications 💡 Key Takeaways Cell therapy works — but not broadly or efficiently enough. Engineering complexity, not biology alone, is the rate-limiting step. Acoustic microfluidics enables a scalable, programmable, non-viral way to engineer livin
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  Food as Medicine: Promise, Pitfalls, and the Politics of the Plate 10.11.2025 53min

  👩‍🔬👨‍⚕️ Hosts: Na-Ri Oh & Ian Wendt 🎧 Guest: Dr. Ron Shigeta – Biotech visionary, co-founder of IndieBio, and food innovation expert. 🧬 Episode Summary: In this deeply insightful and refreshingly candid episode, Ian and Nari welcome back biotech veteran Dr. Ron Shigeta to explore the evolving landscape where food, health, and biotech collide. From the collapse of the lab-grown meat hype cycle to the challenges of democratizing access to functional food, Ron brings hard truths, historical context, and cautious optimism to the table. As the U.S. federal government embraces its Make America Healthy Again (MAHA) agenda—reforming food policy to prioritize public health—the conversation asks:👉 Can we finally treat food as medicine, and make it scalable, credible, and affordable?👉 What went wrong with cultured meat—and what comes next?👉 Why does Ron really hate the term “food tech”? If you’ve ever wondered whether the future of wellness lies in your fridge, your pharmacy, or your feed, this one’s for you. 🔑 Key Topics Covered: MAHA & Food Policy Shifts:What the government’s new approach to food says about public health—and why it matters. Cultured Meat's Cautionary Tale:Why the dream of lab-grown meat stumbled—and how the next wave of companies might succeed. Ultra-Processed vs. Ultra-Useful:A frank conversation on consumer trust, marketing blunders, and what “processed” really means. Food as Preventative Medicine:From diabetes to GLP-1s to micronutrients—why we’re ignoring the obvious. Pharma’s Cost Spiral & Innovation Trap:$2M gene therapies, $500K cancer cures, and why food might be the only scalable solution left. The Neuroscience of Eating:Food isn’t just fuel—it’s identity, emotion, and the deepest form of human behavior. Why “Food Tech” is Bad Branding:Ron’s passionate take on why the tech world misunderstands how people eat. 🧠 Memorable Quotes: “Technology for the public will always win—because once people use it, they can’t let it go.” – Ron Shigeta “We’ve invented healthcare Americans can’t afford.” – Ron Shigeta “Nobody buys food because it’s high-tech. Nobody. That’s not how trust is built.” – Ron Shigeta 📚 Mentioned in This Episode: MAHA (Make America Healthy Again) policy initiative GLP-1s and the rise of preventative obesity drugs Blue zones and the elusive science of longevity Golden rice and biotech’s public trust problem OneSkin and peptide-based functional cosmetics Ron’s upcoming book on food, neuroscience, and the future of health  
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  From Job Search to Power Move: How Top Talent’s Playing 2025 27.10.2025 48min

    🎙 Episode Title: From Job Search to Power Move: How Top Talent’s Playing 2025🧠 Guests: Kristiaan Rawlings, Executive Director at EPM Scientific🎧 Hosts: Na-Ri Oh & Ian Wendt Episode SummaryLayoffs. AI. Resume black holes. The biopharma hiring market feels noisy—and not in a good way. But beneath the doomscrolling, there’s a more nuanced story unfolding. In this episode, Kristiaan Rawlings returns to RealPharma to deliver a data-backed pulse check on the state of hiring across the industry. Drawing from hundreds of hours of direct conversations with execs, talent leaders, and hiring managers, Kristiaan unpacks: 📈 Which therapy areas and functions are hiring (and which are not) 🧠 How AI is actually being used in recruitment—and where it falls short 👀 Why 70% of senior roles are now confidential 🤝 The traits that are getting candidates hired in 2025 💸 Sign-on bonuses: who’s getting them, how to ask, and what to watch out for Whether you're job hunting, hiring, or just trying to read the market right—this conversation brings the clarity. Resources & Links🔗 Connect with Kristiaan Rawlings on LinkedIn🌐 Explore non-confidential roles at EPM Scientific
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  Where Policy Meets the Pharmacy Counter 13.10.2025 55min

    Where Policy Meets the Pharmacy Counter Featuring Congressman Jake Auchincloss Episode SummaryIn this episode of RealPharma, hosts Na-Ri Oh and Ian Wendt sit down with Congressman Jake Auchincloss (MA-04) to dissect the tangled web of policy, profit, and politics driving America’s drug pricing system. From pharmacy benefit managers (PBMs) to the politics of tariffs, this discussion explores the push for transparency, fair competition, and sustainable reform in healthcare. Auchincloss, a Marine veteran and member of the House Energy and Commerce Committee, brings a rare combination of policy depth and industry fluency. Together, they unpack how entrenched middlemen have distorted the system—and what bipartisan solutions could finally restore balance between innovation and access. What You’ll Learn: Why PBM reform has momentum but keeps stalling in Congress How the Pharmacists Fight Back Act could level the playing field for independent pharmacies The purpose of the Patients Before Monopolies Act and how it targets vertical integration Auchincloss’s vision for a “biotech social contract” that links innovation, IP protection, and insurance design The real story behind drug import tariffs and the risks of chaotic trade policy How U.S. innovation compares to China’s rapidly advancing biotech ecosystem The importance of aligning drug pricing reform with patient access and national competitiveness Memorable Moments: “PBMs deserve to be bulldozed for their behavior over the last two decades.”“There’s no moral hazard in getting sick—no one fakes chemotherapy to get free drugs.”“The most expensive thing in the world is what hasn’t been invented yet.” Why It Matters:As drug costs rise and innovation races ahead, the U.S. faces a defining choice: will healthcare policy reward breakthroughs or bureaucracy? Congressman Auchincloss argues that reform is not just about prices—it’s about preserving America’s leadership in biomedical innovation while ensuring patients can actually access the medicines that save lives. Guest:Congressman Jake AuchinclossU.S. Representative for Massachusetts’ 4th DistrictMember, House Committee on Energy and Commerce Hosts:Na-Ri Oh & Ian Wendt
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  Conversations, Not Campaigns: The Art of Authentic Engagement in Healthcare 06.10.2025 52min

    Episode Title: “Conversations, Not Campaigns: The Art of Authentic Engagement in Healthcare” 🗣️ Episode Summary In this episode, hosts Dr. Na-Ri Oh and Ian Wendt sit down with Colin Hung — healthcare technologist, marketing strategist, and co-founder of the long-running #HCLDR (Healthcare Leadership) Twitter community. Colin shares his journey from biomedical engineering to becoming one of the most respected community builders in digital health. Together, they explore what authentic engagement really looks like in the healthcare and pharma industries — from how companies can move beyond broadcasting to truly listening, to how AI can support rather than replace human connection in patient advocacy. 🧭 Key Themes & Takeaways From Engineer to Connector: How Colin’s early career in biomedical engineering shaped his systems-thinking approach to digital health. Building #HCLDR: The story behind one of the most influential online healthcare communities — what made it work, and how it evolved over 13 years. Conversation > Communication: Why genuine listening and empathy are more powerful than any marketing message in healthcare engagement. Pharma’s Challenge: How manufacturers can engage meaningfully online despite regulatory constraints — and why showing up as people first matters most. AI in Healthcare: The promise and pitfalls of AI in patient engagement — and how to use it responsibly to empower, not replace, the human touch. The Future of Digital Communities: What comes next for online healthcare engagement now that #HCLDR has passed the torch to new community creators. 👥 Guest Bio: Colin Hung Colin Hung is a healthcare technologist, community strategist, and co-founder of the #HCLDR community. With more than 25 years in health IT, Colin has been a driving force in bringing together patients, clinicians, and innovators to discuss the future of care. He’s also a writer, speaker, and advocate for inclusive, patient-centered technology. 🔗 Connect with Colin: LinkedIn: https://www.linkedin.com/in/colinhung/ Twitter (X): https://twitter.com/Colin_Hung 🏷️ Organizations, Movements & Mentions #HCLDR (Healthcare Leadership) — A global online healthcare leadership community founded in 2012 that brought together patients, providers, and industry leaders for weekly discussions on improving healthcare.🔗 https://hcldr.wordpress.com🔗 https://twitter.com/search?q=%23HCLDR       🎧 Listen & Subscribe Find The RealPharma Podcast on: Spotify Apple Podcasts Google Podcasts
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  Building the Highway for AI in Pharma: A Conversation with Ilya Burkov 22.09.2025 47min

    🎙️ Episode Title: Building the Highway for AI in Pharma: A Conversation with Ilya Burkov 📍 Episode Summary In this episode of RealPharma, hosts Na-Ri Oh and Ian Wendt sit down with Dr. Ilya Burkov, Head of AI Cloud at Nebius, to explore the critical infrastructure enabling the AI revolution in drug development. While the headlines often focus on the promise of AI, Ilya brings us backstage—where the real acceleration happens. From GPU scalability and regulatory compliance to synthetic data and digital twins, this conversation unpacks how the roads, bridges, and power lines of cloud infrastructure are shaping the future of biopharma R&D. Whether you're a biotech founder, pharma executive, or AI enthusiast, this episode offers a 360° view into the unseen tech powering the next generation of therapies. 🧠 What You’ll Learn Why AI needs more than just models—it needs muscle. The role of GPUs-as-a-service in reducing drug discovery timelines How infrastructure and compliance go hand in hand in regulated industries Why digital twins and synthetic control arms could be the future of clinical trials Challenges biotech startups face—and how AI-first models could level the playing field The ethical promise of fully virtual drug pipelines     🧭 Key Quote “Think of AI in pharma as the car. What we’re building is the highway—bridges, power, road signs—so researchers can just drive.”— Dr. Ilya Burkov   🧰 Resources & Mentions Ilya Burkov on LinkedIn Nebius AI Cloud FDA Digital Health Initiatives 👥 About the Guest Dr. Ilya Burkov is Head of AI Cloud at Nebius, where he leads teams building cloud platforms purpose-built for AI workloads in life sciences. With a background in large-scale computing and a deep understanding of compliance in regulated industries, Ilya bridges the gap between bleeding-edge technology and real-world healthcare impact. 🎧 Listen & Subscribe Find RealPharma on your favorite podcast platform:Apple Podcasts | Spotify | Amazon Music  👉 Don’t forget to rate and review the show—it helps others discover the future of pharma!  
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  Inside the CMC Black Box: A Deep Dive with Reza Oliyai 08.09.2025 47min

    🎙️ Episode Title: Inside the CMC Black Box: A Deep Dive with Reza Oliyai 🧾 Show Notes: What exactly is CMC — and why is it behind more FDA rejections than any other category? In this episode of RealPharma, hosts Na-Ri Oh and Ian Wendt sit down with Dr. Reza Oliyai, former SVP of Pharmaceutical & Biologics Operations at Gilead Sciences, and now Founder & CEO of Oliyai Consulting, to demystify the world of Chemistry, Manufacturing, and Controls (CMC). With over three decades of experience and a role in advancing 200+ drug candidates and 27 product launches, Reza offers a front-row seat to what goes wrong — and right — in the drug development journey. 🔍 In this episode, we explore: What CMC really means — and why the "controls" part is most overlooked Why 74% of FDA complete response letters involve CMC issues The pitfalls of the “Phase 1 mentality” in late-stage development AI in CMC: helpful tool or overhyped distraction? How to evaluate CDMO partners (and why big pharma’s pick might be your wrong fit) The evolving geopolitical landscape and its impact on global manufacturing What startups, investors, and boards need to understand about CMC before it’s too late Career advice: what it takes to lead in this increasingly complex field 🧠 Key Quote: “CMC is a black box to most executives. That’s a problem. Because it’s also the number one reason drugs get delayed.” — Dr. Reza Oliyai Whether you're in manufacturing, regulatory, executive leadership, or just trying to understand what actually gets a drug to market — this episode is a must-listen. 🔗 Resources & Mentions: Oliyai Consulting Reza Oliyai on LinkedIn FDA’s recent publication of Complete Response Letters 👤 About Our Guest: Dr. Reza Oliyai is a globally recognized leader in pharmaceutical operations, with deep expertise across small molecules, biologics, ADCs, peptides, siRNA, and more. After 28 years at Gilead Sciences, he now advises over 100 organizations worldwide through his firm, Oliyai Consulting.  
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  Can We Say That? Dara Katcher Levy on the AdPromo Regulatory Landscape 25.08.2025 58min

  In this episode of RealPharma, Ian Wendt and Na-Ri Oh sit down with Dara Katcher Levy, a regulatory attorney at Hyman, Phelps & McNamara, P.C.—widely regarded as one of the nation’s top firms in food and drug law. Dara brings decades of expertise in promotional review, labeling negotiations, and post-market compliance, helping life sciences companies navigate the complex world of FDA regulations. Together, they unpack the most pressing regulatory questions facing biopharma in 2025: DTC Advertising Under Fire: Why the U.S. remains one of only two countries allowing direct-to-consumer (DTC) prescription drug ads, and the political push to restrict them. AI in Pharma Marketing: How AI is being adopted to streamline promotional reviews, where it adds efficiency, and where compliance risks still demand human oversight. FDA Enforcement Trends: Why the Office of Prescription Drug Promotion (OPDP) has shifted its focus from celebrity DTC ads (think Serena Williams and Brittany Mahomes) to healthcare professional materials, and what that means for manufacturers. Telehealth & Influencers: The murky legal ground when platforms like Hims & Hers Health, Inc. or paid content creators promote prescription drugs. Should they be held to the same standards as manufacturers? First Amendment vs. FDA: A deep dive into recent enforcement controversies—like the warning letter to Sprout Pharmaceuticals over its CEO’s personal Instagram post—and whether FDA is overreaching in regulating speech. Dara also shares how she advises clients to balance responsible communication with compliance, and why she believes patients benefit from more information, not less, so long as it’s presented transparently and fairly. Resources & References Hyman, Phelps & McNamara, P.C. – Dara’s firm, specializing in FDA law. FDA OPDP Enforcement Letters Database – Track recent untitled and warning letters. Food, Drug, and Cosmetic Act (FDCA) – The foundation of FDA authority. FDORA (Food and Drug Omnibus Reform Act of 2022) – Recent legislation impacting drug development and promotion. Addyi (flibanserin) – Sprout Pharmaceuticals – Case study mentioned in FDA’s 2024 enforcement actions.  
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  From Rock Star to Rare Disease Revolutionary: Casey McPherson’s Fight for His Daughter’s Life 11.08.2025 55min

  Episode Title: From Rock Star to Rare Disease Revolutionary: Casey McPherson’s Fight for His Daughter’s Life In this deeply personal and inspiring conversation, hosts Na-Ri Oh and Ian Wendt sit down with Casey McPherson, founder and CEO of AlphaRose Therapeutics—and acclaimed recording artist—to explore how one father’s determination to save his daughter’s life is shaking up the rare disease drug development model. Casey shares his journey from fronting rock bands to founding a biotech company, sparked by his daughter Rose’s diagnosis with an ultra-rare genetic disorder. He discusses why the current rare disease model is broken, how Alpha Rose is reimagining the path from diagnosis to treatment, and the emotional and ethical complexities of innovating in this space. What You’ll Learn in This Episode: How Casey’s music career prepared him to run a biotech startup. Why rare disease families face a “diagnostic odyssey” and what needs to change. The gap between available technology and systemic barriers to treatment. How AlphaRose Therapeutics is creating scalable models for ultra-rare diseases. The promise—and challenges—of engaging with regulators like the FDA in new ways. Why the Leonard Cohen classic Hallelujah has become a personal anthem for Casey. Links & Resources: AlphaRose Therapeutics StartEngine – Invest in Alpha Rose (crowdfunding equity round open until August) Leonard Cohen – Hallelujah (Jeff Buckley cover) People Magazine feature on Casey McPherson Follow Casey on Instagram
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  Behind the PBM Curtain: Antonio Ciaccia Exposes the Game 28.07.2025 59min

    Episode Title: Behind the PBM Curtain: Antonio Ciaccia Exposes the Game Show Notes:In this compelling episode of Real Pharma, hosts Na-Ri Oh and Ian Wendt welcome back Antonio Ciaccia, CEO of 46brooklyn Research and President of 3 Axis Advisors, for a hard-hitting discussion on the power and pitfalls of pharmacy benefit managers (PBMs). PBMs remain one of the most opaque and influential forces in healthcare—shaping drug prices, patient access, and payer negotiations—often under the guise of cost savings. Antonio, widely recognized as one of the most outspoken voices for transparency in the pharmaceutical supply chain, takes us deep inside the systemic problems that have led to distorted pricing models, misaligned incentives, and challenges for manufacturers, payers, and patients alike. Key Topics Covered: The Gross-to-Net Bubble: How rebates, discounts, and government distortions drive higher list prices and undermine value-based formulary design. PBM Consolidation & Vertical Integration: The impact of PBMs owning wholesalers, specialty pharmacies, and even repackaging themselves as drug companies. The 340B Program & Market Distortions: Why hospitals and covered entities are often incentivized to favor higher-priced drugs over clinically superior, cost-effective alternatives. Policy and Reform: What’s being done at the state and federal levels, including the FTC investigations, Medicaid reforms, and disruptive models like Mark Cuban’s Cost Plus Drugs. Burn It Down or Fix It? Antonio’s candid take on whether incremental improvements can save the current system or if structural overhaul is the only way forward. What Manufacturers Should Know: Strategies for navigating PBM-driven formularies, access barriers, and rebate-driven contracting. Antonio also shares actionable insights for payers, manufacturers, and policymakers on how to realign incentives and reduce inefficiencies that inflate costs without adding value. Why Listen:If you work in pharma, healthcare policy, or benefit design—or simply want to understand why your medications cost what they do—this conversation is a must-listen. Antonio’s expertise cuts through industry jargon and exposes the real forces driving the drug pricing crisis. Resources & Links: 46brooklyn Research – Data-driven analysis on drug pricing. 3 Axis Advisors – Market intelligence and consulting on drug pricing and PBMs. Related Episodes: 340B or Bust: Is This Program Failing the Sick