RealPharma: Conversations with Pharma Pathfinders

• Inside the CMC Black Box: A Deep Dive with Reza Oliyai

    🎙️ 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.  

  --------  

  47:23

  --------

  47:23
• Can We Say That? Dara Katcher Levy on the AdPromo Regulatory Landscape

  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.  

  --------  

  58:40

  --------

  58:40
• From Rock Star to Rare Disease Revolutionary: Casey McPherson’s Fight for His Daughter’s Life

  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

  --------  

  55:24

  --------

  55:24
• Behind the PBM Curtain: Antonio Ciaccia Exposes the Game

    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  

  --------  

  59:39

  --------

  59:39
• 340B or Bust: Is This Program Failing the Sick

    🎙️ 340B or Bust: Is This Program Failing the Sick? This week on Real Pharma, hosts Dr. Na-Ri Oh and Ian Wendt dive into the tangled world of 340B with returning guest William “Bill” Sarraille—one of the most respected voices in healthcare law, an active patient advocate, and a rare disease patient himself. The 340B Drug Pricing Program was intended to help vulnerable patients by requiring drug manufacturers to provide discounted medications to covered entities. But as Bill puts it, has the program strayed too far from its patient-first mission? With explosive growth, patchwork state laws, opaque data, and billions on the line, is it still doing what it was designed to do—or are the sick paying the ultimate price? 🔍 In this episode, we explore: ✅ How 340B ballooned from a modest program to a behemoth that may soon outpace Medicare Part D ✅ Why transparency remains elusive—and who’s resisting it ✅ The uncomfortable reality: charity care rates at major hospitals vs. billions in 340B profits ✅ The looming risks to rare disease innovation and patient access ✅ Bill’s insider perspective on why patients often aren’t seeing the savings ✅ What changes might be coming from state houses, courts, and possibly Washington Bill also shares candid insights from his own journey as a rare disease patient—and why that makes him both more hopeful and more skeptical than ever. 💡 Links & Resources Mentioned Bill Sarraille on LinkedIn: https://www.linkedin.com/in/william-sarraille-634a8827/ ADAP Advocacy Association: https://www.adapadvocacy.org/ 340B Report (for policy resources & updates): https://340breport.com/  

  --------  

  54:38

  --------

  54:38

More Health & Wellness podcasts

Trending Health & Wellness podcasts

About RealPharma: Conversations with Pharma Pathfinders