Making Medicine

🇺🇸 Artificial intelligence is reshaping biotech, drug discovery and medicine. But how much of the AI revolution is real, how much is hype, and what could it mean for the future of American medicine?

In Part 6 of our How America Makes Medicine series, host John Stanford sits down with physician-scientist and venture capitalist Patrick Malone to explore how AI and machine learning could transform drug development, biotech investing and the way new medicines reach patients.

Could AI agents and computational drug discovery allow a handful of people, or even one founder, to build a billion-dollar biotech company? Can better access to clinical trial and regulatory data accelerate innovation? And if AI makes drug discovery faster and cheaper, can it overcome the industry's biggest bottleneck: clinical trials?

John and Patrick also examine the future of U.S. biotechnology, FDA modernization, venture capital, China's growing biotech capabilities and what America must do to remain a global leader in life sciences.

Plus, John breaks down the latest biotech headlines and traces the evolution of AI in medicine, from early computer models and the Human Genome Project to AlphaFold and today's AI-driven drug discovery platforms.

What happens next could reshape how America makes medicine. It’s an important conversation about the future of biotech you can’t afford to miss.

We explore
🔹 What's real, and overhyped, about AI drug discovery
🔹 The rise of smaller, AI-powered biotech companies
🔹 Why clinical trials remain a critical bottleneck
🔹 The widening "Valley of Death" for biotech innovation
🔹 Clinical and regulatory data's role in the AI revolution
🔹 FDA modernization and Operation Trial Blazer
🔹 Venture capital and the future of drug development
🔹 U.S. biotechnology leadership and competition with China
🔹 What the next generation of American biotech could look like  

This episode is part of How America Makes Medicine, a seven-part series exploring the people, science, institutions, and business decisions behind 250 years of American pharmaceutical innovation.

From research universities and biotechnology startups to pharmaceutical manufacturers, investors, regulators and patients, the series examines how America's medicine ecosystem was built and what it will take to keep innovating.

Join the Conversation ⬇️
How much do you think AI will change the way new medicines are discovered and developed over the next decade?
Could a one-person or small-team biotech really become a billion-dollar company, or is the industry too complex for that model?
What should America prioritize most to remain a global leader in biotechnology: AI and data, faster drug development, more investment, or stronger domestic capabilities?
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 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:
https://x.com/MakingMedPod
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Timestamps
00:00  Could One Person Build a Billion-Dollar Biotech?
00:17  How America Will Make Medicine
01:36  This Week in Biotech: Headlines
03:34  The History of AI in Drug Discovery
10:08  Meet Patrick Malone: From Medicine to Venture Capital
15:07  AI Drug Discovery: What's Real and What's Hype?
17:32  The Billion-Dollar Biotech of the Future
21:51  What's Changing in Biotech Venture Capital?
23:49  Is Biotech's Valley of Death Getting Wider?
25:36  Does America Have the Data AI Needs?
29:28  Why Biotech Needs a Stronger Voice in Washington
32:30  Faster Drug Development and Operation Trial Blazer
35:04  U.S. Biotech, China and the Future of Competition
45:58  Closing

DISCLAIMER: We're reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

#ArtificialIntelligence #Biotechnology #DrugDiscovery #FutureOfMedicine #MakingMedicine

🇺🇸 Venture capital helped build America's biotech industry, but what happens when that capital stops flowing?

In Episode 5 of the How America Makes Medicine series, John Stanford sits down with Michael Rome, Managing Director and Head of Therapeutics Investing at Foresite Capital, to explore the role of biotech venture capital in building America's drug development ecosystem.

The episode examines the history of venture capital and biotech investing, tracing how America's unique approach to financing high-risk science helped transform academic discoveries into companies and, ultimately, new medicines. From early investment models to the rise of venture-backed biotechnology companies, the history reveals how investors began taking risks on scientific ideas that traditional pharmaceutical companies were often unwilling or unable to pursue.

John and Michael then explore how biotech investors evaluate companies, scientific opportunities, and emerging drug-development technologies today. Their conversation covers early-stage biotech investing, specialist versus generalist investors, biotech IPOs, mergers and acquisitions, capital formation, and the role investors play in determining which scientific ideas move from the laboratory into clinical development.

The discussion also examines how drug pricing policy, FDA policy, government regulation, and uncertainty in Washington can influence investment decisions and the availability of capital for emerging biotech companies. John and Michael discuss the importance of maintaining a strong U.S. innovation ecosystem as biotechnology becomes increasingly global, including competition for scientific talent, investment, and drug development between the United States and China.

What happens to American drug development if investors become less willing to take scientific risks?

We explore
🔹 The history of venture capital and American biotech innovation
🔹 Michael Rome and the role of therapeutics investing
🔹 How venture capital helps fund scientific discovery
🔹 Biotech startups and early-stage drug development
🔹 How investors evaluate biotech companies and scientific opportunities
🔹 Specialist versus generalist biotech investors
🔹 Biotech IPOs, mergers and acquisitions
🔹 Capital formation and the future of biotech investment
🔹 Drug pricing policy and its impact on biotech investment
🔹 FDA policy, government regulation and investment uncertainty
🔹 America's biotechnology ecosystem and global competitiveness
🔹 Competition for scientific talent, investment and innovation
🔹 The role of venture capital in bringing new medicines to patients

This episode is part of How America Makes Medicine, a seven-part series exploring the people, science, institutions, and business decisions behind 250 years of American pharmaceutical innovation.

From research universities and biotechnology startups to pharmaceutical manufacturers, investors, regulators and patients, the series examines how America's medicine ecosystem was built and what it will take to keep innovating.

Join the Conversation⬇️
What do you think is the biggest challenge facing biotech investors today?
How important is venture capital to developing the next generation of medicines?
Can the United States maintain its leadership in biotech as global competition increases?
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 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: https://x.com/MakingMedPod
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Timestamps
00:00 Introduction: Venture Capital and the Drug Development Pipeline
01:36 Headlines: mRNA Cancer Vaccine and the FDA
05:15 History: How Venture Capital Became Part of Medicine
07:29 Genentech and the Birth of Venture-Backed Biotech
09:30 Michael Rome's Path from Scientist to Biotech Investor 
12:40 Why Los Angeles Is Emerging as a Biotech Hub 
13:32 Inside Foresight Capital's Biotech Investment Strategy
16:00 A Day in the Life of a Biotech VC
19:15 Don't Chase the Headlines: How Investors Evaluate Biotech Data
21:30 Specialist vs. Generalist Capital in Biotech
24:51 What Happens to Medicine Without Venture Capital?
27:15 Washington's Growing Influence on Biotech Investment
30:44 The IRA and the "Pill Penalty"
33:00 China, Biotech Licensing, and Bringing Innovation to the U.S.
36:53 How Biotech Capital Gets Recycled in America
39:16 Inside a $2 Billion Biotech Exit
43:46 Closing: The Day in the Life of a VC

DISCLAIMER: We're reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
 
#HowAmericaMakesMedicine #biotech #venturecapital #drugdevelopment #pharmaceuticalinnovation

🇺🇸 Why does so much pharmaceutical innovation come from small biotech companies? And how do different parts of America's medicine ecosystem work together to turn scientific discoveries into medicines for patients?

In this episode of How America Makes Medicine, John Stanford sits down with Dr. Jeremy Levin, a longtime pharmaceutical and biotechnology leader, to explore the interconnected ecosystem behind American drug innovation and the complementary roles of small biotech companies and larger pharmaceutical manufacturers.

Levin's career includes leadership roles at Novartis, Bristol-Myers Squibb, Teva Pharmaceuticals, and Ovid Therapeutics. He also discusses the "String of Pearls" strategy, a targeted approach to acquisitions and partnerships designed to strengthen pharmaceutical pipelines and advance promising innovations.

The conversation examines why small biotech companies are an important source of innovation, while larger pharmaceutical manufacturers contribute scientific expertise, capital, manufacturing capabilities, regulatory experience and global infrastructure. Together, these different strengths help move discoveries from research and development toward patients.

The episode also explores drug pricing policy, Most Favored Nation pricing, the Inflation Reduction Act, venture capital, pharmaceutical regulation and biotech investment, including how policy uncertainty can affect the development of future medicines.

Levin also discusses China's growing biotechnology capabilities and America's global innovation advantage, arguing that the United States must continue strengthening its research infrastructure, technical expertise and investment environment to remain a leader in biotechnology and drug development.

We explore:
🔹 Small biotech and pharmaceutical innovation
🔹 Small biotech and larger pharmaceutical manufacturers
🔹 Jeremy Levin and the "String of Pearls" strategy
🔹 Bristol-Myers Squibb and biotech acquisitions
🔹 Drug discovery and development
🔹 Venture capital and biotech investment
🔹 Drug pricing and pharmaceutical policy
🔹 Most Favored Nation pricing and the Inflation Reduction Act
🔹 NIH, FDA and America's research ecosystem
🔹China's growing role in biotechnology
🔹 America's global biotechnology advantage
🔹 Innovation, investment and patient access

How America Makes Medicine is a seven-part series exploring the people, science, institutions and business decisions behind 250 years of American pharmaceutical innovation.

From research universities and biotechnology startups to pharmaceutical manufacturers, investors, regulators and patients, the series examines how America's medicine ecosystem was built and what it will take to keep innovating.

Technical note: Near the end of the episode, Dr. Levin loses his internet connection and continues the conversation by phone. His video is temporarily replaced with a still image while the conversation continues.

Watch the full episode and let us know your thoughts below ⬇️
What role should small biotech companies play in America's future drug-development strategy?
Can the United States maintain its biotechnology advantage as global competition increases?
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:
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Timestamps
00:00 Jeremy Levin and America's Biotech Innovation Engine
00:38 Jeremy Levin's Career in Pharmaceutical Innovation
03:04 The "String of Pearls" Strategy
05:37 The Birth of America's Biotechnology Industry
07:19 Why Patients Drive Drug Development
11:56 How Biotech Acquisitions Strengthen Drug Pipelines
16:20 Small Biotech and Larger Pharmaceutical Manufacturers
20:20 Why Small Biotech Drives Drug Innovation
21:43 Drug Pricing, Policy and Biotech Investment
28:10 How Policy Uncertainty Affects Drug Development
38:35 Biotech in the Balance: America's Innovation Advantage
40:57 NIH, FDA and America's Research Ecosystem
42:20 China and the Global Biotechnology Race
46:58 Protectionism and the Future of Innovation
49:09 How America Can Compete Through Innovation
50:44 The Football Analogy: Who Will Win?

DISCLAIMER: We're reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.  

#HowAmericaMakesMedicine #MakingMedicine #biotech #drugdevelopment #pharmaceuticalinnovation #lifesciences #medicalinnovation #biotechnology

🇺🇸 Every breakthrough medicine begins with a scientific discovery. But turning that discovery into a *treatment* that reaches patients*requires navigating one of the most challenging journeys in medicine.

Before a new therapy can change lives, promising science must attract funding, become a startup company, navigate years of development, survive the *"Valley of Death,"* scale manufacturing, and ultimately secure the support of larger pharmaceutical companies capable of bringing lifesaving treatments to patients around the world.

In Episode 3 of How America Makes Medicine, John Stanford sits down with Sheila Mikhail, serial biotech entrepreneur and co-founder of AskBio, Bamboo Therapeutics, Chatham Therapeutics, and M34, to explore what it really takes to build a biotech company from groundbreaking science. Drawing from decades of experience in gene therapy, Sheila shares how perseverance, early-stage investment, scientific innovation, and smart partnerships help move promising discoveries from university laboratories to patients.

We explore:
🔹 The real journey from scientific discovery to approved medicine
🔹 Why the "Valley of Death" threatens breakthrough innovations
🔹 How SBIR funding helps launch biotech startups
🔹 Why early-stage companies eventually partner with Big Pharma
🔹 The future of gene therapy and Alzheimer's research
🔹 Manufacturing innovation and lowering the cost of advanced medicines
🔹 America's biotechnology ecosystem and global competition
🔹 How AI could transform drug development

One of the conversation's strongest themes is that great science alone is never enough. Every successful medicine requires scientists, entrepreneurs, investors, regulators, and pharmaceutical companies working together to move discoveries from the laboratory to patients.

This episode is part of How America Makes Medicine, a special editorial series from the Making Medicine Podcast exploring the people, policies, discoveries, and innovations shaping the future of American medicine.

Watch the full episode and let us know your thoughts below ⬇️
Why do you think so many promising medical discoveries never become medicines?
Should America invest more in early-stage biotechnology?
What breakthrough technology will define the next generation of medicine?
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:
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Timestamps
00:00 Patients Don't Care Where Medicine Comes From
00:35 Why Every Medical Breakthrough Needs an Entrepreneur
01:54 The Bayh-Dole Act and the Birth of Modern Biotech
04:40 How AskBio Was Founded
07:05 Betting on Gene Therapy Before Anyone Else
11:10 Building Biotech Companies Without Venture Capital
16:30 Why SBIR Funding Saves Medical Innovation
19:10 Is China Winning the Biotech Race?
24:20 Lower Drug Costs Through Better Innovation
26:10 AI, Gene Therapy & the Future of Drug Development
34:00 Making Gene Therapies Affordable Worldwide
39:10 When Should a Startup Partner With Big Pharma?
43:40 Lessons From Selling AskBio to Bayer
50:15 AI, Innovation & The Next Generation of Medicine

DISCLAIMER: We're reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

#HowAmericaMakesMedicine #biotech #genetherapy #drugdiscovery #medicalinnovation #healthcarepolicy #sbir #biotechnology #pharmaceuticalinnovation #innovation

🇺🇸 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
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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

🇺🇸 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
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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

🇺🇸 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.

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.

We explore:
🔹 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

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
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TikTok: https://www.tiktok.com/@makingmedicinepodcast?lang=en
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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

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.

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.

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

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:
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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

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.

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.

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


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

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.

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

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.

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 👇

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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