RealPharma: Conversations with Pharma Pathfinders

RealPharma
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For biopharma pros seeking insightful discussions and a deeper understanding of the pharma world, join Dr. Na-Ri Oh and Ian Wendt as they talk with industry leaders and luminaries to delve into biotechnology, pharmaceuticals, and healthcare. RealPharma podcast aims to challenge your viewpoints, deepen your understanding of the pharma world beyond the headlines, and explore emerging trends in medical innovation.

  1. 3일 전

    Food as Medicine: Promise, Pitfalls, and the Politics of the Plate

    👩‍🔬👨‍⚕️ 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

    54분
  2. From Job Search to Power Move: How Top Talent’s Playing 2025

    10월 27일

    From Job Search to Power Move: How Top Talent’s Playing 2025

    🎙 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 Summary Layoffs. 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

    48분
  3. Where Policy Meets the Pharmacy Counter

    10월 13일

    Where Policy Meets the Pharmacy Counter

    Where Policy Meets the Pharmacy Counter Featuring Congressman Jake Auchincloss Episode Summary In 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 Auchincloss U.S. Representative for Massachusetts’ 4th District Member, House Committee on Energy and Commerce Hosts: Na-Ri Oh & Ian Wendt

    55분
  4. Conversations, Not Campaigns: The Art of Authentic Engagement in Healthcare

    10월 6일

    Conversations, Not Campaigns: The Art of Authentic Engagement in Healthcare

    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

    53분
  5. Building the Highway for AI in Pharma: A Conversation with Ilya Burkov

    9월 22일

    Building the Highway for AI in Pharma: A Conversation with Ilya Burkov

    🎙️ 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!

    48분
  6. Inside the CMC Black Box: A Deep Dive with Reza Oliyai

    9월 8일

    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.

    47분
  7. Can We Say That? Dara Katcher Levy on the AdPromo Regulatory Landscape

    8월 25일

    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.

    59분
  8. From Rock Star to Rare Disease Revolutionary: Casey McPherson’s Fight for His Daughter’s Life

    8월 11일

    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

    55분
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For biopharma pros seeking insightful discussions and a deeper understanding of the pharma world, join Dr. Na-Ri Oh and Ian Wendt as they talk with industry leaders and luminaries to delve into biotechnology, pharmaceuticals, and healthcare. RealPharma podcast aims to challenge your viewpoints, deepen your understanding of the pharma world beyond the headlines, and explore emerging trends in medical innovation.

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