Making Medicine

Incubate Coalition

There's a scientific breakthrough in your medicine cabinet. But how did it get there? At a time when medicines are helping us all live longer and healthier lives, this podcast will explore where these taken-for-granted miracles come from, how many of them almost never happened, where the life science ecosystem is taking us next, and most importantly, what it means for patients. From chance meetings that led to new ideas, to risky investments that never pay off, hear from the people behind today's and tomorrow's treatments, vaccines, technologies, devices, and yes, cures. In this golden age of health discovery and innovation fueled by record breaking investment in the life sciences, we'll bring guests who really understand what it means to be Making Medicine.

  1. 5d ago

    How Research Universities Power America’s Innovation Engine | How America Makes Medicine Ep. 2

    🇺🇸 Every breakthrough medicine starts somewhere. Discover how research universities, NIH funding, and American innovation change lives. Every new medicine’s journey begins long before it reaches a patient. In Episode 2 of our How America Makes Medicine series, John Stanford sits down with Kate Hudson of the Association of American Universities (AAU) to explain why research universities are one of America's greatest strategic advantages. From federally funded NIH research to technology transfer, startups, biotechnology companies, and ultimately life-saving medicines, this conversation reveals the innovation pipeline that has powered American pharmaceutical leadership for generations. The discussion explores why curiosity-driven research matters, how the Bayh-Dole Act transformed commercialization and why America faces increasing competition from China in scientific research and biotechnology. Whether you're interested in biotech, healthcare policy, drug discovery, academic research, or the future of American competitiveness, this episode explains why basic research remains one of the country's most important long-term investments. Topics include: 🔹 NIH and NSF research funding 🔹 Research universities and scientific discovery 🔹 Technology transfer and commercialization 🔹 Drug discovery and pharmaceutical innovation 🔹 Bayh-Dole Act 🔹 mRNA vaccines 🔹 Basic research versus applied research 🔹 America's biotechnology ecosystem 🔹 Competition with China 🔹 The future of scientific innovation This episode is part of How America Makes Medicine, a seven-part series celebrating 250 years of American pharmaceutical innovation. If you're passionate about biotechnology, pharmaceutical innovation, healthcare policy, scientific discovery, or the history of medicine, subscribe to the Making Medicine Podcast and follow How America Makes Medicine as we continue telling the story behind the medicines that have shaped our world. Watch the full episode and let us know your thoughts below ⬇️ Why should taxpayers invest in basic scientific research? Is America doing enough to maintain leadership in biotechnology? What breakthrough medicine do you think will define the next 25 years? Drop your thoughts in the comments below 👇 👍 Subscribe to the Making Medicine Podcast so you don't miss the next chapter of How America Makes Medicine, our seven-part documentary series celebrating 250 years of American pharmaceutical innovation. If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: X: https://x.com/MakingMedPod Instagram: https://www.instagram.com/makingmedicinepod/ TikTok: https://www.tiktok.com/@makingmedicinepodcast?lang=en LinkedIn: https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true Timestamps: 00:00 Why Research Universities Matter to American Pharmaceutical Innovation 01:28 Meet Kate Hudson of the Association of American Universities 04:20 The History of America's Research Universities 08:32 Why Universities Drive Scientific Discovery 10:42 NIH Funding, NSF Grants & Basic Research Explained 14:09 Why the Free Market Alone Won't Create Medical Breakthroughs 16:05 mRNA Vaccines Took Decades of Research 18:55 The True Return on Investment in Scientific Research 21:18 Why Scientific Talent Matters More Than Ever 24:10 OMB Proposal, NIH Grants & Research Stability 29:20 Why Uncertainty Slows Drug Discovery 33:12 Technology Transfer & How Universities Create Biotech Startups 35:40 Crossing the Valley of Death in Drug Development 38:10 Bayh-Dole, China & America's Innovation Advantage 41:58 Episode Wrap Up & Next Episode Preview  DISCLAIMER: We're reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.  #HowAmericaMakesMedicine #biotech #drugdiscovery #ResearchUniversities #innovation #healthcarepolicy #science #pharmaceuticalinnovation #technologytransfer

  2. Jul 23

    250 Years of American Pharmaceutical Innovation | How America Makes Medicine Ep. 1

    🇺🇸 How America Makes Medicine begins with the remarkable story of 250 years of American pharmaceutical innovation. Welcome to How America Makes Medicine, a new seven-part series from the Making Medicine Podcast celebrating 250 years of American pharmaceutical innovation.  As the United States celebrates its *250th anniversary, this inaugural episode of the series traces the extraordinary journey from the medicine chest of 1776 to today's breakthrough therapies. Throughout How America Makes Medicine, we'll explore the discoveries, scientists, entrepreneurs, manufacturers, regulators, and patients who transformed medicine from simple remedies into one of humanity's greatest achievements. Part I of How America Makes Medicine follows some of the most significant milestones in pharmaceutical history, from the commercialization of insulin and the biotechnology revolution to monoclonal antibodies, HIV therapies, precision medicine, the Human Genome Project, gene therapy, and mRNA vaccines. Along the way, we examine why manufacturing, scientific collaboration, and decades of research are just as important as the discoveries themselves in bringing new medicines to patients.  This episode covers 🔹 How insulin changed diabetes from a fatal diagnosis into a manageable disease 🔹 The biotechnology revolution and recombinant DNA 🔹 The birth of modern biotech 🔹 Monoclonal antibodies and targeted medicine 🔹 HIV therapies and one of medicine's greatest public health successes 🔹 The Human Genome Project and precision medicine 🔹 Gene therapy and cell therapy 🔹 The decades of research behind mRNA vaccines 🔹 Why manufacturing, regulation, and scientific collaboration remain essential to the next generation of medical breakthroughs Throughout How America Makes Medicine, we explore not only breakthrough discoveries but also the people, companies, manufacturers, researchers, regulators, and patients who made those discoveries possible. This seven-part documentary series celebrates 250 years of American pharmaceutical innovation and highlights how curiosity, entrepreneurship, manufacturing excellence, and scientific persistence continue to improve lives around the world. If you're passionate about biotechnology, pharmaceutical innovation, healthcare policy, scientific discovery, or the history of medicine, subscribe to the Making Medicine Podcast and follow How America Makes Medicine as we continue telling the story behind the medicines that have shaped our world. Catch the full episode and Join the Conversation ⬇️ Which medical breakthrough do you think has had the greatest impact on humanity? What innovation do you believe will define the next generation of medicine? Which chapter of pharmaceutical history would you like us to explore in a future episode? Drop your thoughts in the comments below 👇  👍 Subscribe to the Making Medicine Podcast so you don't miss the next chapter of How America Makes Medicine, our seven-part documentary series celebrating 250 years of American pharmaceutical innovation. If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: X: https://x.com/MakingMedPod Instagram: https://www.instagram.com/makingmedicinepod/ TikTok: https://www.tiktok.com/@makingmedicinepodcast?lang=en LinkedIn: https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true Timestamps: 0:00 250 Years of American Pharmaceutical Innovation | Introduction  0:52 Benjamin Rush & Colonial Medicine | America's First Medical Innovator  2:32 American Apothecaries to Modern Drug Manufacturing  4:05 The U.S. Patent System & Pharmaceutical Innovation  5:06 FDA History | Frances Kelsey, Drug Safety & Public Trust  6:23 Eli Lilly, Insulin & the Birth of Modern Pharmaceutical Manufacturing 8:53 The Biotechnology Revolution | Recombinant DNA & Genentech 11:32 Monoclonal Antibodies, HIV Therapies & Modern Biopharmaceuticals 13:15 The Human Genome Project, Precision Medicine & Gene Therapy 14:45 mRNA Vaccines | Why Medical Breakthroughs Take Decades 16:08 The Five Pillars of American Pharmaceutical Innovation 17:35 Clinical Trials, Patients & The Next 250 Years of Medicine 19:40 How America Makes Medicine | Episode 2 Preview & Subscribe DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.   #HowAmericaMakesMedicine #pharmaceuticalinnovation #biotechnology #healthcareinnovation #humangenomeproject

  3. Jul 16

    FDA Leadership, China & The Future of American Biotech

    🇺🇸 FDA leadership, China's growing role in clinical trials, NIH research, and biotechnology innovation are shaping the future of American medicine. This week on the Making Medicine Podcast, John Stanford breaks down the latest developments in the search for the next FDA Commissioner, including the three reported finalists: Dr. Heidi Overton, White House health policy adviser; Dr. Jeffrey Vacirca, oncologist and CEO of New York Cancer & Blood Specialists; and Dr. Stephen Ferrara, Deputy Assistant Secretary of Defense for Health Affairs and former CIA Chief Medical Officer. John explores what the next FDA leader could mean for regulatory modernization, drug development, and the future of American biotechnology. This episode covers: 🔹 The latest FDA Commissioner search and what the three finalists could mean for the agency 🔹 Congressional hearings on FDA modernization and biomedical innovation 🔹 China's rapid expansion in global clinical trials and growing biotech competitiveness 🔹 Patent eligibility reform, intellectual property protections, and the future of biotech investment 🔹 NIH research funding, research security, and protecting American scientific leadership 🔹 FDA Approvals Corner featuring new therapies from Rigel Pharmaceuticals, BeOne Medicines, AstraZeneca, Gilead Sciences, AbbVie, Haisco Pharmaceutical Group, Shionogi, Wockhardt, Bayer, GSK, and Viridian Therapeutics From FDA leadership and congressional hearings to intellectual property, research security, and global competition with China, this episode examines the policy decisions shaping the future of biomedical innovation. John also highlights why protecting NIH-funded research, modernizing the FDA, and strengthening America's innovation ecosystem remain essential to delivering the next generation of medicines and improving patient access. The episode concludes with another edition of FDA Approvals Corner, celebrating newly approved therapies across oncology, infectious disease, cardiovascular medicine, rare diseases, anesthesia, and diagnostic imaging, highlighting the continued progress being made for patients around the world. Watch the full episode and Join the Conversation ⬇️ Who should lead the FDA? How should America compete with China's growing biotech industry? What role should NIH-funded research play in future drug development? Drop your thoughts in the comments below 👇 👍 Like and subscribe for more conversations on biotechnology, healthcare policy, FDA news, clinical trials, pharmaceutical innovation, and life sciences. If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: X: https://x.com/MakingMedPod Instagram: https://www.instagram.com/makingmedicinepod/ TikTok: https://www.tiktok.com/@makingmedicinepodcast?lang=en LinkedIn: https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true Timestamps: 00:00 Why American Biotech Matters 01:35 FDA Leadership Search 03:14 FDA & China Hearings 05:13 Clinical Trial Competition 06:25 Patent Reform Explained 07:52 NIH Research Security 08:58 Why NIH Funding Matters 09:19 FDA Approvals Corner 11:32 July FDA Outlook DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor. #fda #biotech #healthcarepolicy #clinicaltrials #NIH

  4. Jul 9

    Japan's Biotech Transformation: Drug Pricing, Clinical Trials & Global Investment

    Japan's biotech industry is at a crossroads. Drug pricing reform, clinical trials, venture capital investment, and life sciences policy are all in flux as the country tries to figure out its path forward.  This week on the Making Medicine Podcast, guest host John Guy, Incubate's Policy Director, is joined by John Gutierrez of Ascenta Capital and Josh Lipscomb, Incubate’s International Programs Manager, to recap their recent biotechnology delegation to Japan. After meeting with government officials, investors, startup founders, and policymakers across Tokyo, they discuss the challenges Japan faces in strengthening its biotech ecosystem and the open question of whether pharmaceuticals can become a bigger driver of economic growth. This episode covers  🔹 Japan's biotech growth strategy — and its limitations  🔹 Drug pricing reform and the slow pace of pharmaceutical innovation 🔹 Drug lag and ongoing barriers to patient access 🔹 International clinical trials and the difficulty of attracting startup investment 🔹 Venture capital gaps in Japan's life sciences ecosystem 🔹 Takeaways from the BIO International Convention One of the takeaways is that Japan has moved past simply acknowledging its biotech challenges and has started attempting policy reforms. The discussion explores whether changes to drug pricing, international clinical trial access, startup support, and venture capital could meaningfully accelerate innovation, or whether structural hurdles will continue to slow patient access to new medicines. The conversation also touches on Japan's presence at the BIO International Convention, where government leaders, investors, and entrepreneurs made the case for the country as a destination for biotech investment — even as it continues to compete with more established markets. As global competition for innovation intensifies, it remains to be seen how much ground Japan can gain in the future of drug development. Watch the full episode and Join the Conversation ⬇️ Can Japan become one of the world's leading biotech ecosystems? Is drug pricing reform the key to attracting more biotech investment? What lessons can other countries learn from Japan's approach to life sciences innovation? Drop your thoughts in the comments below 👇   👍 Like and subscribe for more conversations on biotechnology, healthcare policy, drug pricing, venture capital, clinical trials, pharmaceutical innovation, and global life sciences. If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: X: https://x.com/MakingMedPod Instagram: https://www.instagram.com/makingmedicinepod/ TikTok: https://www.tiktok.com/@makingmedicinepodcast?lang=en LinkedIn: https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true Tmestamps 00:00 Japan Drug Lag Explained  01:45 Japan's Biotech Growth Strategy 06:10 Drug Pricing Reform 08:24 Why Japan Misses New Medicines 11:42 Japan's Innovation Advantage 13:35 Building Japan's Startup Ecosystem 14:42 BIO International Convention 16:28 Japan's Global Investment Strategy 19:00 What's Next for Japan Biotech 22:44 Outro DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor. #biotech #Japan #DrugDevelopment #ClinicalTrials #HealthcarePolicy #Making Medicine

  5. Jul 2

    Maria Thacker Goethe on Biotech Growth, Clinical Trials & US Competitiveness

    Georgia's life sciences industry is growing fast. Biotech manufacturing, clinical trials, workforce development, and healthcare policy are reshaping America's innovation economy. This week on the Making Medicine Podcast, John Stanford sits down with Maria Thacker Goethe, President and CEO of Georgia Life Sciences, to discuss why Georgia has become one of the fastest-growing biotechnology hubs in the United States and what it will take to keep America globally competitive. Fresh off the BIO International Convention, Maria shares how policy conversations have evolved from niche discussions to a central focus for biotech leaders. From clinical trial modernization and manufacturing investments to workforce shortages, drug pricing, and China's expanding biotechnology capabilities, she explains why policy decisions now directly influence innovation, investment, and patient access. This episode covers: 🔹 Georgia's rise as a national life sciences and biomanufacturing hub 🔹 Why workforce development has become biotech's biggest challenge 🔹How universities, industry, and government are building the next generation of talent 🔹China's growing influence in biotechnology and global drug development 🔹Drug pricing, innovation, and protecting investment in breakthrough medicines 🔹 Operation Trial Blazer and the future of faster clinical trials 🔹Why collaboration remains America's greatest competitive advantage One of the biggest takeaways is that biotechnology is no longer just about scientific discovery. It's about building an ecosystem where policy, workforce, capital, manufacturing, and research all work together. Maria explains why states like Georgia are proving that biotech leadership isn't limited to Boston or San Diego, and why strategic investments in people and infrastructure will determine America's future competitiveness. Whether discussing clinical trial reform, rare disease innovation, or the balance between national security and global scientific collaboration, this conversation highlights how today's policy decisions will shape tomorrow's medical breakthroughs. Watch the full episode and Join the Conversation ⬇️ Can Georgia become one of America's top biotech hubs? What is the biggest challenge facing US biotech today: workforce, capital, or policy? Should America focus more on innovation than restrictions to stay globally competitive? Drop your thoughts in the comments below 👇  👍 Like and subscribe for more conversations on biotechnology, healthcare policy, FDA modernization, clinical trials, workforce development, drug pricing, life sciences investment, and healthcare innovation. If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: X: https://x.com/MakingMedPod Instagram: https://www.instagram.com/makingmedicinepod/ TikTok: https://www.tiktok.com/@makingmedicinepodcast?lang=en LinkedIn: https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true Timestamps 00:00 Operation Trial Blazer & US Clinical Trials 05:01 BIO 2026 and US Biotech Competitiveness 08:46 Georgia's Life Sciences Growth  12:07 Building the Next Biotech Hub 18:15 Drug Pricing and Biotech Innovation  21:29 Operation Trial Blazer Reforms 22:11 China and US Biotech Competition  26:18 Biotech Workforce Development 30:06 Why Biotech Needs Skilled Trades 33:21 Georgia Life Sciences Summit 35:42 Closing Thoughts DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor. #biotech #lifesciences #healthcarepolicy #clinicaltrials #drugdevelopment

  6. Jun 25

    Why FDA Instability is Driving Biotech Capital Abroad — What Investors Are Saying

    FDA instability is reshaping biotech investment decisions in real time. Investors are recalibrating risk, pulling back, and even shifting capital abroad. In case you missed it: We are bringing one of our most critical recent conversations to unpack how regulatory uncertainty is shifting the future of medicine. FDA instability is reshaping biotech investment decisions in real time. Across the board, investors are recalibrating risk, pulling back on funding, and even shifting capital abroad. In this episode of the Making Medicine Podcast, John Stanford is joined by Rachel Sher of Manatt Health to unpack new, original research conducted with investors across the biotech ecosystem. The goal was simple: move beyond speculation and understand whether recent leadership changes, staffing cuts, and policy uncertainty at the FDA are actually dictating investor behavior. The signal is clear. Across venture capital, public equity, private equity, and industry investors, the vast majority agree that recent changes at the FDA have fundamentally altered how they allocate capital and view the attractiveness of U.S.-based drug development. This Episode Covers Four Major Themes: 🔹 Regulatory Instability: Growing investor concern over shifting FDA standards. 🔹 Shifting Portfolios: A reduced appetite for funding complex product categories like gene therapy and vaccines. 🔹 Global Competition: Increasing attention and capital flowing toward China and other international markets. 🔹 The Innovation Pipeline: Broader fears that instability across agencies like the NIH and FDA will weaken long-term medical breakthroughs. At the center of it all is one core issue: regulatory predictability. When investors lose confidence in policy clarity and institutional knowledge, the consequences extend far beyond individual companies—they dictate where innovation happens next. Even with these concerns, investors still want to back innovation in the United States. The question is whether policymakers and regulators can restore the stability and trust that made the U.S. the global leader in biotech in the first place. Watch for a grounded conversation on what investors are really saying, what it means for the biotech ecosystem, and why FDA predictability matters more than ever.  Check out the full report https://www.incubatecoalition.org/post/one-pager-complete-report-regulatory-instability-at-fda-is-reshaping-biotech-investment Join the Conversation ⬇️ Do you think FDA instability is already changing the future of biotech investment? Are investors right to look abroad when U.S. regulatory signals become less predictable? What matters more right now: speed, stability, or scientific consistency? Drop your thoughts in the comments below 👇 If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: X: https://x.com/MakingMedPod Instagram: https://www.instagram.com/makingmedicinepod/ TikTok: https://www.tiktok.com/@makingmedicinepodcast?lang=en LinkedIn: https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true 👍 Like and subscribe for more biotech and healthcare policy coverage. Time Stamps 00:00 Intro & Disclaimer 00:16 Investors Say FDA Changes Are Impacting Decisions 03:22 How We Surveyed Investors (Research Design) 07:27 Theme 1: FDA Instability & Investor Uncertainty 10:22 Investors Repricing Risk in Biotech 12:05 “Chaos Is the Only Thing” – Investor Quote 13:00 Theme 2: Pullback from Gene Therapy, Vaccines, Oncology 14:28 Theme 3: Capital Shifting Abroad (China & Competition) 17:02 Theme 4: NIH Cuts & Long-Term Innovation Risk 25:24 Key Takeaway: Regulatory Predictability Drives Investment DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor. #Biotech #FDA #BiotechInvesting #HealthcarePolicy #DrugDevelopment #makingmedicine

  7. Jun 18

    China’s Biotech Rise: What Tim Scott Saw Inside Shanghai

    China's biotech innovation is accelerating. Clinical trials, NIH funding, and global competition are reshaping healthcare. Biocom’s President & CEO Tim Scott explains why America should focus on "playing to win" rather than "playing not to lose." China’s biotech industry is moving faster than many policymakers realize. From investigator-initiated clinical trials and massive patient registries to government-backed investment strategies, China is rapidly becoming a major force in global drug development. This week on the Making Medicine Podcast, John Stanford sits down with Tim, fresh off a biotech delegation trip to Shanghai. He shares firsthand observations from China's rapidly growing life sciences ecosystem, what surprised him most, and what American biotech leaders should learn from the experience. This Episode Covers 🔹 Why major pharmaceutical companies are increasingly sourcing innovation from China 🔹 How China’s investigator-initiated trial system accelerates drug development 🔹 The role of patient registries and trial-ready cohorts 🔹 Why China is becoming a global biotech powerhouse 🔹 The debate over biosecurity, protectionism, and global scientific collaboration 🔹 NIH funding, workforce development, and America’s innovation advantage 🔹 How the United States can remain the world leader in biotechnology One of the most thought-provoking moments comes when Tim compares the biotech race to the New York Knicks' championship run, arguing that America must focus on "playing to win" through investment, innovation, NIH funding, and scientific leadership rather than simply "playing not to lose" by slowing competitors down. The analogy becomes a powerful framework for understanding the choices facing US policymakers as China continues to expand its role in global drug development. The conversation ultimately challenges listeners to think beyond today's headlines and consider how the United States can maintain its leadership in biotechnology while continuing to deliver breakthrough medicines for patients around the world. The question is no longer whether China matters in biotech. The question is how America responds. Will the US continue playing to win through investment and innovation, or will it focus primarily on slowing competitors down? Watch the full episode and Join the Conversation ⬇️ Do you believe China is now a permanent biotech superpower? Can the United States maintain its leadership in biomedical innovation? Should scientific collaboration continue despite growing geopolitical tensions? Let us know your thoughts in the comments below 👇 If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: X: https://x.com/MakingMedPod Instagram: https://www.instagram.com/makingmedicinepod/ TikTok: https://www.tiktok.com/@makingmedicinepodcast?lang=en LinkedIn: https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true 👍 Like and subscribe for more biotech and healthcare policy coverage. Timestamps 00:00 China Biotech Competition 01:00 California Life Sciences Leadership 07:45 Pharma Licensing Deals in China 13:10 China Clinical Trials Explained 20:00 Drug Pricing and Biotech Innovation 23:18 Shanghai Biotech Ecosystem 25:28 China's Biotechnology Growth Strategy 35:28 Biosecurity and US-China Biotech Policy 40:20 Playing to Win in Biotech 42:10 Knicks Analogy and Innovation Leadership 43:20 NIH Funding and American Innovation 47:35 AI, China and the Future of Biotechnology 49:58 Outro  DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor. #Biotech #China #DrugDevelopment #ClinicalTrials #HealthcarePolicy

  8. Jun 11

    Patient Advocacy, FDA Partnerships & Building the Infrastructure of Drug Discovery

    Rare diseases. Patient advocacy. Drug development. FDA partnerships. Clinical trials. Patient organizations have evolved into powerful engines of drug development, building registries, funding research, shaping clinical trial design, and partnering with regulators to accelerate new treatments. This week on the Making Medicine Podcast, John Stanford sits down with Lisa Bonebrake, Executive Director of the Alport Syndrome Foundation, and Janis Naeve, world-class VC and Co-Founder & Partner of Bright Frontier, to discuss the evolving, high-impact role of patient organizations in modern drug development. Patient advocacy groups are building the critical data and clinical infrastructure required to advance medical research. Lisa shares how the Alport Syndrome Foundation is directly de-risking clinical trials, building global patient registries, and driving the ASCENT Initiative, a historic public-private partnership with the FDA to establish surrogate endpoints for kidney disease. The discussion also explores the venture capital perspective with Janis Naeve, highlighting why investors view patient-led data infrastructure as a "highway" for innovation, how pharmaceutical companies can successfully integrate patient feedback into trial design, and why establishing clear regulatory pathways is vital to accelerating rare disease treatments. This Episode Covers 🔹 Why patient advocacy groups are the new infrastructure of drug discovery 🔹 The real impact of Alport syndrome and the importance of early genetic testing 🔹 The ASCENT Initiative and establishing surrogate endpoints with the FDA 🔹 The impact of Alport syndrome and the importance of early genetic testing 🔹 Why pharmaceutical companies must include patient voices in clinical trial design  🔹 The venture capital perspective on funding rare disease innovation 🔹 Regulatory clarity and de-risking biotech investment 🔹 How public-private partnerships accelerate the timeline for lifesaving treatments Patient advocates are no longer passive charities, they are the essential infrastructure of modern drug discovery. This conversation serves as a blueprint for the future of healthcare policy, exploring how rare disease organizations are partnering with the FDA, saving pharma millions by rescuing flawed clinical trials, and driving venture capital investment to accelerate lifesaving treatments. Join the Conversation ⬇️ Should patient organizations have a larger role in shaping FDA regulatory pathways? What's the biggest obstacle preventing more rare disease drug development? How can policymakers better support patient-led research infrastructure? Let us know your thoughts in the comments below 👇 If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: X: https://x.com/MakingMedPod Instagram: https://www.instagram.com/makingmedicinepod/ TikTok: https://www.tiktok.com/@makingmedicinepodcast?lang=en LinkedIn: https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true 👍 Like and subscribe for more biotech and healthcare policy coverage. Timestamps 0:00 - The Real ROI of Patient Advocacy 0:26 - Welcome to the Making Medicine Podcast 1:52 - Breaking News in Alport Syndrome Research 4:03 - What is Alport Syndrome? 5:58 - Redefining the Role of Patient Organizations 9:09 - A VC Investor’s Perspective on Rare Disease 11:38 - The ASCENT Initiative & FDA Public-Private Partnership 18:03 - Understanding Surrogate Endpoints in Clinical Trials 25:19 - How to Build a Fearless Patient Advocacy Group 30:26 - Why Pharma Needs to Listen Directly to Patients 35:31 - Educating the Biotech Industry on Patient Integration 39:35 - Key Takeaways for Policymakers and Investors DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor. #rarediseases #drugdevelopment #clinicaltrials #fda #biotech #patientadvocacy #makingmedicine #podcast

See All (88)

Trailer

Ratings & Reviews

5
out of 5
16 Ratings

About

There's a scientific breakthrough in your medicine cabinet. But how did it get there? At a time when medicines are helping us all live longer and healthier lives, this podcast will explore where these taken-for-granted miracles come from, how many of them almost never happened, where the life science ecosystem is taking us next, and most importantly, what it means for patients. From chance meetings that led to new ideas, to risky investments that never pay off, hear from the people behind today's and tomorrow's treatments, vaccines, technologies, devices, and yes, cures. In this golden age of health discovery and innovation fueled by record breaking investment in the life sciences, we'll bring guests who really understand what it means to be Making Medicine.

Information

  • Creator
    Incubate Coalition
  • Years Active
    2021 - 2026
  • Episodes
    88
  • Rating
    Clean
  • Copyright
    © Copyright Making Medicine Duality
  • Show Website
    Making Medicine

You Might Also Like