RealPharma: Conversations with Pharma Pathfinders

👩‍🔬👨‍⚕️ 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

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

🎙️ 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!

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.

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

Episode Title:Paging Dr. ChaptGPT with Bryce Sady AI Adoption in Healthcare: Navigating the Present and Shaping the Future with Bryce Sady Episode Description:On today's insightful episode of RealPharma, hosts Dr. Na-Ri Oh and Ian Wendt sit down with Bryce Sady, Vice President of Product Development at PSL Group's Medical Education and Communications Division, a veteran innovator at the intersection of healthcare data, education, and AI. Together, they dive into the fascinating landscape of artificial intelligence in healthcare and pharmaceuticals. From practical applications, barriers, and regulatory hurdles, to how clinicians and pharma professionals are integrating AI into their workflows, Bryce sheds light on current adoption rates and trends across the healthcare ecosystem. Key Highlights: How healthcare professionals' AI adoption rates compare to the general public (hint: it might surprise you!) The real-world, practical AI use-cases currently shaping clinician workflows. Challenges and opportunities around integrating AI into heavily regulated environments. Insights on clinician education and how platforms like PSL Group’s "Doogle" are changing the landscape. Predictions for near-term trends in AI, including the pivotal roles of ambient scribes and patient communication tools. Ethical considerations and liability discussions as AI becomes essential in clinical decision-making. Bryce also shares his personal inspirations drawn from Tracy Kidder's powerful book, Mountains Beyond Mountains, reflecting on the importance of patient-centered perseverance in healthcare innovation. Who should listen?Healthcare professionals, medical educators, pharma marketers, digital health innovators, and anyone curious about the rapidly evolving role of AI in healthcare. Contact Bryce Sady on LinkedIn: https://www.linkedin.com/in/brycesady Companies and Resources mentioned: DougallGPT: https://dougallgpt.com/ Instar Research: https://www.instarresearch.com/ PeerDirect: https://peerdirect.com/ Tracey Kidder, Mountains Beyond Mountains. (2003) https://a.co/d/9mDpHgR How the U.S. Public and AI Experts View Artificial Intelligence. Apr 3, 2025. https://www.pewresearch.org/internet/2025/04/03/artificial-intelligence-in-daily-life-views-and-experiences/ The state of AI: How organizations are rewiring to capture value. Mar 12, 2025. https://www.mckinsey.com/capabilities/quantumblack/our-insights/the-state-of-ai Physician sentiments around the use of AI in heathcare: motivations, opportunities, risks, and use cases. February 2025. https://www.ama-assn.org/system/files/physician-ai-sentiment-report.pdf The Healthcare AI Adoption Index. Apr 18, 2025. https://www.bain.com/insights/the-healthcare-ai-adoption-index

🎙 Episode Title: The Future of Biotech Guest: Andrew Craig, Founder of Plain English Finance | Author of Our Future is Biotech 📌 Episode Summary In this bold and wide-ranging conversation, Ian Wendt and Na-Ri Oh sit down with Andrew Craig—British investor, entrepreneur, and author—to explore how biotechnology is poised to shape the next century in the same way physics and computing shaped the last. Craig draws on his decades of experience as a London and New York investment banker and as a former partner at WG Partners, where he advised more than 60 biotech companies and worked on marquee deals like the $7.6B sale of Nordia Bank and IPOs for brands like EasyJet and Burberry. But his latest passion lies at the intersection of finance and innovation: making the case that our future is biotech—without a question mark. 🔍 Topics Covered Why biology will define the 21st century: Andrew outlines the structural and technological reasons biotech is primed for exponential impact. CRISPR, AI, and the "exponential stack": How data storage, ML, and sequencing speed make today's breakthroughs possible. Fixing Europe's biotech lag: The cultural, capital, and regulatory headwinds slowing biotech innovation in the UK and EU. Rebuilding trust in pharma: Why good actors in drug development don’t get headlines—and how that hurts innovation. From Oxford Biomedica to DNA-based storage: Vivid examples of tech cost reductions and where we're headed next. The case for optimism: How to resist the press's negative bias and invest in human progress—literally. 📚 Resources & Links 📘 Andrew’s latest book: Our Future is Biotech on Amazon 📕 His first bestseller: How to Own the World on Amazon 🌐 Plain English Finance: www.plainenglishfinance.com 🔗 Connect with Andrew on LinkedIn: linkedin.com/in/andrewcraigpef 🧠 Memorable Quotes “The last century was about physics and tech. The next one will be about biology—and by extension, biotech.” “If success begets success, then a crop of billion-dollar biotech companies in Europe can kickstart a self-sustaining cycle of innovation and investment.” “People forget that the smartphone they hold was a $100 million science project in the 1990s. Biotech is heading the same direction.” “We need to fight the narrative that pharma is inherently bad. There are good actors, and we must do a better job telling those stories.” 📈 Key Takeaway Biotech isn't just a sector—it's a structural solution to some of humanity’s greatest problems. From disease treatment to environmental restoration, the converging forces of AI, genetics, and biological engineering make this the most consequential time in science since the industrial revolution.

🎙️ RealPharma Podcast Episode Title: Cracking the Code on Patient Engagement: Conversational AI with Dan Fox 🗓️ Release Date: May 5, 2025🎧 Hosts: Dr. Na-Ri Oh & Ian Wendt🎤 Guest: Dan Fox, Managing Director of Healthcare at Drips Episode Summary: In this eye-opening episode, we welcome Dan Fox, a trailblazer in AI-powered patient communication, to explore how proactive outreach and conversational AI are reshaping healthcare engagement. As the Managing Director of Healthcare at Drips, Dan shares how his team is using SMS-based AI to boost patient adherence, improve outcomes, and build trust—even in the face of complex compliance and tech fluency challenges. From personalized text reminders that get 60–80% response rates to thoughtful strategies for integrating AI without sacrificing patient experience, Dan takes us deep into what’s working (and what’s not) in healthcare communication today. Plus, he shares what excites him most about the future—including AI therapists, ambient scribes, and closing the tech adoption gap in health systems. 🔑 Key Topics Covered: Why “attention” is the biggest communication challenge in healthcare How AI-driven SMS is outperforming traditional channels like email and mail Real-world outcomes: 4.1% improvement in national medication adherence rates Navigating regulatory complexity with Drips' proprietary “rules engine” Why many healthcare orgs use “compliance” as a crutch against innovation Texting seniors? Yes—it works (and they even say “thank you, sweetie” ❤️) The future of AI in healthcare: from virtual triage to AI therapists 🧠 Notable Quotes: “We’re not using generative AI in our consumer outreach—because every single word needs to be approved. But we use AI to scale natural conversations.” – Dan Fox “Trust is everything. We use personalization and omnichannel context to build it—one message at a time.” – Dan Fox “We don’t want PHI. We just want to start the right conversation.” – Dan Fox 📘 Resources Mentioned: Drips.com – Learn more about their AI-powered engagement solutions CMS Star Ratings: Why medication adherence matters Companies like RxAnte mentioned for rules-based healthcare targeting 📩 Connect with Dan Fox: Website: drips.com LinkedIn: https://www.linkedin.com/in/dsweeneyfox/ Role: Healthcare Strategy Lead 🎧 How to Listen: Available wherever you get your podcasts—Spotify, Apple Podcasts, Amazon Music, and more.