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Making Medicine

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Episodes

FDA Approvals Corner, Immigration Warnings & Germany's MFN Complication | Making Medicine Headlines

07 May 2026

Contributed by Lukas

Gene therapy breakthroughs. The first oral GLP-1 pill. A troubling signal for scientific talent. And a German pricing move that could quietly reshape ...

Senator Todd Young on China, FDA Reform, and Why Biotech Is National Security

30 Apr 2026

Contributed by Lukas

Biotech is no longer just about medicine. It is now a frontline issue in national security, global competition, and economic independence.In this epis...

FDA Instability Is Changing Biotech Investment—What Investors Are Saying

23 Apr 2026

Contributed by Lukas

FDA instability is reshaping biotech investment decisions in real time. Investors are recalibrating risk, pulling back, and even shifting capital abro...

FDA Signals Are Breaking Biotech | Collapse, Breakthrough, and What Congress Does Next

16 Apr 2026

Contributed by Lukas

FDA signals are starting to break down, and biotech is feeling it. One company is collapsing while another is breaking through.As lawmakers return to ...

Tariffs, MFN & FDA Delays: Why Biotech Is at Risk

09 Apr 2026

Contributed by Lukas

Tariffs, MFN pricing, and FDA delays are colliding, and small biotech is paying the price. One company already collapsed. More could follow.In this ep...

The China Biotech Threat Is Already Here | John Gutierrez on Capitol Hill, Drug Pricing & FDA

02 Apr 2026

Contributed by Lukas

Last week, seven leading life sciences investors went to Washington. They met with the National Security Commission on Emerging Biotechnology, walked ...

Biotech, National Security, and Global Competition | Dr. Rozo (NSCEB) | JPM Re-Air

26 Mar 2026

Contributed by Lukas

In this special re-air of the Making Medicine Podcast, we revisit a timely conversation with Dr. Michelle Rozo of the National Security Commission on ...

Solving Japan's Drug Lag: Why PM Takaichi Must Agree to a Fair U.S. Pricing Deal

19 Mar 2026

Contributed by Lukas

With Japanese Prime Minister Sanae Takaichi meeting President Trump this week, we are re-airing our special episode from Tokyo. We explore why the U.S...

Regulatory Risk: How FDA Instability Is Threatening America's Biotech Investment Edge

12 Mar 2026

Contributed by Lukas

The FDA is managing today's rapid scientific advancements with funding and staffing close to 2016 levels. We break down the PDUFA VIII negotiations ne...

China Just Passed the U.S. in Drug Clinical Trials

05 Mar 2026

Contributed by Lukas

China has now overtaken the United States in new drug clinical trials. At the same time regulatory uncertainty and funding lapses are raising new ques...

Why 95% of Rare Diseases Still Have No Treatment

26 Feb 2026

Contributed by Lukas

About 90–95% of rare diseases still lack an FDA-approved treatment, underscoring the urgency for continued innovation on behalf of the estimated 30 ...

Protecting Progress in Rare Disease Innovation

26 Feb 2026

Contributed by Lukas

95 percent of rare diseases still lack an FDA-approved treatment. Here is how recent policy changes are reshaping the future of rare disease innovatio...

FDA Chaos and Foreign Price Controls Are Collapsing American Innovation

19 Feb 2026

Contributed by Lukas

FDA reversals and price controls are handing biotech dominance to China. We expose the national security crisis in drug development.The FDA is facing ...

TrumpRx Explained: Cash Markets, MFN, and What This Moment Means for Drug Pricing

12 Feb 2026

Contributed by Lukas

TrumpRx has quickly become part of the broader drug pricing conversation, not as a new insurance program or pharmacy, but as a government website high...

Speed, Scrutiny, and Spending: How Washington Is Reshaping the Future of Medicine

05 Feb 2026

Contributed by Lukas

Washington is navigating a period of significant change in health policy, with implications for how new medicines are developed, reviewed, and paid fo...

Live From JPM 2026: Is This the End of American Biotech Leadership?

29 Jan 2026

Contributed by Lukas

The race is being won by someone else. While the headlines focus on the prestige of JPM 2026, a much quieter and more dangerous shift is happening...

How Global Competition and U.S. Policy Choices Are Reshaping Biotech

22 Jan 2026

Contributed by Lukas

Is the U.S. at risk of losing its edge in biotech innovation?Filmed live at JPM 2026, host John Stanford sits down with industry leaders who are deep ...

Innovation at a Crossroads | Live at JPM 2026 (Part 1)

15 Jan 2026

Contributed by Lukas

Filmed live at the JPMorgan Healthcare Conference 2026, this episode of the Making Medicine Podcast examines how global power shifts are reshaping the...

CMS Drug Pricing Proposals and What JPM 2026 Signals

08 Jan 2026

Contributed by Lukas

In this episode of the Making Medicine Podcast, John Stanford previews new CMS drug pricing proposals and explains how they could shape biotech invest...

How Policy Shapes the Future of Life Sciences

01 Jan 2026

Contributed by Lukas

In this New Year episode of the Making Medicine Podcast, we revisit a full-length conversation with U.S. Senator Thom Tillis of North Carolina, focuse...

Year in Review: Biotech Innovation, Policy, and Global Competition

25 Dec 2025

Contributed by Lukas

In this special holiday episode, the Making Medicine Podcast looks back at standout conversations since the show’s July relaunch, covering biotech i...

Biotech in 2025: Investment Trends, Congress, and Approvals

18 Dec 2025

Contributed by Lukas

In this year-in-review episode, we break down key biotech investment trends from 2025, major policy developments in Congress, and what they mean for i...

What the NDAA Means for the Future of Biotech

11 Dec 2025

Contributed by Lukas

This episode breaks down how Congress is turning biotechnology into a core national security priority. John Stanford explains the biggest shifts in th...

Inside Congress: Senator Thom Tillis on Drug Pricing, IP, and the Future of Innovation

04 Dec 2025

Contributed by Lukas

In this episode of Making Medicine, host John Stanford sits down with Senator Thom Tillis, the first sitting U.S. Senator to join the show. Tillis ope...

Making Medicine ft. Daphne Zohar. Biotech Flywheels, Policy Risks, and the Future of Innovation

25 Nov 2025

Contributed by Lukas

In this episode of the Making Medicine Podcast, John Stanford sits down with Daphne Zohar, Founder, CEO, and Board Member of Seaport Therapeutics to e...

Japan’s Life Sciences State of Play: The Takeaways You Can’t Miss

20 Nov 2025

Contributed by Lukas

In this special Tokyo edition of the Making Medicine Podcast, John Stanford hosts a powerhouse panel of biotech investors, founders, and industry lea...

Inside Biotech Leadership: Bill Newell on Innovation, Capital, and Policy at Sutro Biopharma

13 Nov 2025

Contributed by Lukas

Former Sutro Biopharma CEO Bill Newell joins host John Stanford to discuss the realities of leading a biotech company through economic uncertainty, lo...

U.S. Biomanufacturing Surge, Arena BioWorks Fallout & GLP-1 Rumors | Making Medicine Podcast

06 Nov 2025

Contributed by Lukas

In this episode, John Stanford breaks down the surge in U.S. biomanufacturing investments, including Virginia’s new $500B hub, and what it means for...

Is the U.S. Losing Its Biotech Edge to China? Senate Hearing & Innovation Outlook

30 Oct 2025

Contributed by Lukas

In this episode of Making Medicine, host John Stanford unpacks the Senate HELP Committee hearing on “The Future of Biotech.” From China’s accel...

FDA Vouchers, Orphan Cures & IP with Joshua Kresh

23 Oct 2025

Contributed by Lukas

In this week’s episode, John breaks down the White House headlines, the FDA’s new wave of priority review vouchers, and September approvals, then ...

Shutdown Fallout, MFN Deals & BIOSECURE Returns

16 Oct 2025

Contributed by Lukas

In this week’s episode, John Stanford breaks down Day 15 of the federal shutdown’s impact on health agencies, major pullbacks in cell & gene t...

Boston Biotech Pulse: Shutdowns, Pfizer Deal, and the Future of Innovation

09 Oct 2025

Contributed by Lukas

In this week’s episode, John Stanford reports from Boston - the beating heart of global biotech - with insights from investors, scientists, and exec...

Government Shutdown, SBIR Expiration, and Trump’s Pharma Moves | Making Medicine Podcast

02 Oct 2025

Contributed by Lukas

This week, John Stanford breaks down the government shutdown and its impact on FDA, NIH, and biotech innovation. He also covers the surprising lapse o...

China’s Biotech Surge, GLP-1 Prices, & MFN Deadline | Press Pass with Max Bayer

25 Sep 2025

Contributed by Lukas

In this week’s episode, John Stanford breaks down the White House autism event, the debate over shifting SEC reports to twice-yearly, and how MFN pr...

UK Pharma Challenges, DTC Ads Debate & 5 New FDA Approvals | Making Medicine

18 Sep 2025

Contributed by Lukas

This week, John Stanford dives into the UK’s pharmaceutical challenges, including ABPI’s warning about declining competitiveness and major compani...

Ending the Pill Penalty on 9/13, Tariffs & FDA Rare Disease Guidance | Making Medicine

11 Sep 2025

Contributed by Lukas

In this week’s episode, John Stanford reflects on Incubate’s own holiday, September 13th (9/13), and the ongoing fight to end the pill penalty thr...

MassBio’s 2025 Snapshot: VC Gravity, Policy & a Competitiveness Playbook | Kendalle Burlin O’Connell

04 Sep 2025

Contributed by Lukas

This week, John Stanford sits down with Kendalle Burlin O’Connell (CEO & President, MassBio) to unpack the 2025 Industry Snapshot - why Massachu...

Trump’s Tariffs, NIH Cuts, FDA Approvals & SBIR Debate | This Week in Making Medicine

28 Aug 2025

Contributed by Lukas

In this week’s episode, John Stanford breaks down the latest headlines across Washington, the FDA, NIH, and industry. We cover the Trump cabinet’s...

Ned Sharpless on Biotech’s Future, HHS Shifts, and Global Competition | Making Medicine Podcast

21 Aug 2025

Contributed by Lukas

This week, John Stanford sits down with Dr. Ned Sharpless - former NCI Director, Acting FDA Commissioner, and now venture capitalist at Jupiter Bio Ve...

FDA Shake-Ups & mRNA Funding Cuts | Industry Perspectives with Patrick Jordan

14 Aug 2025

Contributed by Lukas

In this episode, John Stanford dives into the latest policy and science headlines - from Dr. Vinay Prasad’s dramatic exit and return to the FDA, to ...

President Trump’s “Most Favored Nation” Drug Pricing Plan: Good Deal or Dangerous Gamble?

07 Aug 2025

Contributed by Lukas

This week on the Making Medicine Podcast, John Stanford dives into the “Most Favored Nation” (MFN) pricing concept, championed by President Trump,...

Listener Q&A: Drug Price Controls, EU Tariffs, and the August Recess | Making Medicine Podcast

31 Jul 2025

Contributed by Lukas

In this week’s special Q&A episode, John Stanford tackles your biggest questions from around the biotech and policy world. From the growing list...

Unpacking Uncertainty: Trump’s Health Policies & Future of FDA | Press Pass with Nyah Phengsitthy

24 Jul 2025

Contributed by Lukas

In this special Press Pass episode of the Making Medicine Podcast, John Stanford welcomes Nyah Phengsitthy of Bloomberg Law to break down the latest s...

Trump’s 200% Pharma Tariff? Timeline, Impacts, and What Comes Next | Making Medicine Podcast

17 Jul 2025

Contributed by Lukas

In this week’s episode, John Stanford breaks down the evolving story of President Trump’s aggressive tariff strategy—focusing on a potential 200...

Big Beautiful Bill Breakdown, Orphan Cures Win, and What’s Next | Making Medicine Podcast Relaunch

10 Jul 2025

Contributed by Lukas

John Stanford kicks off the official relaunch of the Making Medicine Podcast with a deep dive into the "one big beautiful bill" that’s shaking up Wa...

When Progress Gets Penalized: Biotech in the Age of IRA

18 Apr 2025

Contributed by Lukas

The path to new medicines is complex enough - policy doesn’t need to make it more difficult. But it does. In this episode, Thomas Kaiser, Co-Founde...

Bridging Science and Business: A Conversation with Professor Fred Ledley

13 Feb 2025

Contributed by Lukas

In this episode of The Making Medicine podcast, John Stanford sits down with Professor Fred Ledley, Director of the Center for Integration of Science ...

Can We Fix Healthcare? A Look Inside Our System

15 Oct 2024

Contributed by Lukas

The U.S. healthcare system is a puzzle for many.To fix it, we need smarter discussions and a deeper understanding of both the industry and the policie...

Protecting Innovation: Small Molecules and the Future of Medicine

13 Sep 2024

Contributed by Lukas

Science should lead our policy decisions—not the other way around. In this episode, Kirsten Axelson, Senior Policy Lab Advisor at Incubate Coalitio...

CEO Series Part 1: Sherine Chan, CEO & Co-founder of Neuroene Therapeutics

28 Jun 2024

Contributed by Lukas

As part of our inaugural CEO series, we're excited to welcome Sherine Chan, the CEO and Co-Founder of Neuroene Therapeutics.In this episode, Sherine s...

Dispelling Misconceptions in Biopharmaceutical IP Regulation

03 May 2024

Contributed by Lukas

On World IP Day, Kirsten Axelsen, Senior Advisor of the Incubate Policy Lab, joins host John Stanford to announce the newest whitepaper, delve into th...

When the Feds Come Marching In: A Deep Dive on The Bayh-Dole Act

11 Apr 2024

Contributed by Lukas

Joe Allen, Executive Director of The Bayh-Dole Coalition, was at the forefront of the Bayh-Dole Act back in December 1980, which allowed researchers t...

Beyond Medicine: Solving Disparities in Cancer Care

13 Sep 2023

Contributed by Lukas

How can we create better outcomes for cancer patients? That’s the big goal Mohit Manrao is aiming for in his work as SVP & Head of US Oncology a...

Balancing Access and Affordability in the Future of Healthcare

23 Aug 2023

Contributed by Lukas

Can we create a future healthcare system that is accessible and affordable for all patients?That’s the major question that Mary R. Grealy, CEO of He...

Making Patients the Center of U.S. Healthcare Reform

11 May 2023

Contributed by Lukas

With recent movement in healthcare including President Biden’s Cancer Moonshot and the Inflation Reduction Act, one thing is clear: American healthc...

Innovations in Women’s Health & Entrepreneurship

31 Mar 2023

Contributed by Lukas

Even though 80% of the household decisions around health are made by women, only 4% of research and funding goes towards women’s health research. In...

The Inflation Reduction Act: A Big Issue for Small-Molecule Medicine

24 Mar 2023

Contributed by Lukas

Runaway inflation and economic instability is terrible for just about everybody, but are efforts to tackle this problem creating more? To answer that,...

From the JP Morgan Conference: The Impact of the Inflation Reduction Act

23 Jan 2023

Contributed by Lukas

John was at the JP Morgan conference and is here to discuss the key takeaways of the Inflation Reduction Act: the small-molecule penalty, the value of...

Drug Investment Under the Inflation Reduction Act

12 Dec 2022

Contributed by Lukas

How will the Inflation Reduction Act affect life sciences startups, current and future revenues, and drug investment? What will happen to patients am...

The Three Pillars of Bio & Med Tech Investing and Industry Impact of DEI

28 Sep 2022

Contributed by Lukas

When you’re working to make good investments in bio and med tech there are three key pillars to consider: science, the management team and finance. ...

Understanding Health Equity w/ Dr. Jerome Adams

19 Jul 2022

Contributed by Lukas

Everyone wants to make healthy choices. But we don't always have an opportunity to make healthy choices. In today’s episode, we speak with Dr. Jero...

Addressing The Overlooked AMR Problem w/ Dr. Henry Skinner

24 May 2022

Contributed by Lukas

Investors are logical people. They invest in medicines that they expect will give them a return.Right now, there’s far too little investment in deve...

Pro-Patient Reforms: The Outlook for 2022

19 Apr 2022

Contributed by Lukas

We’ll be the first to say that the healthcare system is broken, especially in patient access complexity.However, we see three areas where we can exe...

How Better Data Fosters Health Equity w/ Kirsten Axelsen

05 Apr 2022

Contributed by Lukas

If we want data and clinical trials that meaningfully represent the population of people who take the drug, we’ll need to do more than just issue gu...

Winning the Drug Development Relay Race w/ Johannes Fruehauf

11 Feb 2022

Contributed by Lukas

Drug development is a relay race because you pass the baton to the next runner who will take it to the next level. You are proud to have made it onto ...

New Modalities: The Future of Drug Development w/ Jean-Francois Formela

21 Dec 2021

Contributed by Lukas

Drug policy debate today is like a wetland. It’s the heart of the ecosystem that has to be preserved at all costs — or else we lose the wetlands, ...

The Investor’s Paradox, Drug Development, & Price Controls w/ Peter Kolchinsky

02 Nov 2021

Contributed by Lukas

Today’s guest describes drug development in the American healthcare market with the analogy of mortgages and rents.People would rather pay higher mo...

MIT Takeover: A MedTech-VC Partnership Working to Reduce Parkinson’s Tremors

19 Oct 2021

Contributed by Lukas

How does an MIT senior year capstone project evolve into an early-stage biotech that creates wearable solutions for Parkinson’s tremors?Listen to Da...

Venture Capital Investors: The Underwriters of Innovation w/ Janis Naeve, Brian Bradbury, and Alan Brookhart

28 Sep 2021

Contributed by Lukas

As we follow innovation along the R&D value chain, we come across some compelling contributions to the healthcare ecosystem.Venture capital investors....

The Hidden Cost of Price Control Policies w/ Kirsten Axelsen

14 Sep 2021

Contributed by Lukas

The price control policies that are being discussed in Congress have the potential to harm innovation in the life science industry. But how, exactly?I...

You Cannot Make Medicine Alone: Relationships & Mentoring w/ Imran Nasrullah

27 Jul 2021

Contributed by Lukas

What goes into a bottle of new medicine is more than the proverbial 15 years and $2 billion. It takes great science, certainly, but it also takes 15 y...

Improving the Standard of Care w/ Patients in Mind

13 Jul 2021

Contributed by Lukas

High cost out-of-pocket drugs and obstacles to reduce those prices for patients plague the health industry. With patients in mind, organizations are l...

The Truth About Pharmaceuticals w/ Ravi Mehrotra

29 Jun 2021

Contributed by Lukas

As it turns out, many perceptions about the pharmaceutical industry are based without all of the facts.That’s why we’re sitting down to understand...

Valuing Inventors & Entrepreneurs: Changing the Dialogue of IP w/ Andrei Iancu

15 Jun 2021

Contributed by Lukas

Intellectual property (IP) rights have been the driving force behind innovation and entrepreneurship. However, IP has more recently been seen in a neg...

AMR: Challenges and Insight w/ Alfonso Chang

31 May 2021

Contributed by Lukas

The fight against Antimicrobial Resistance (AMR) is challenging due to financial, ethical, and legislative issues. Combating infectious disease can pr...

40 Years in Review: Bayh-Dole to 2021 w/ Joe Allen

15 May 2021

Contributed by Lukas

In 1980, the Bayh-Dole Act was enacted by U.S. Congress, which changed how ownership of an invention is pursued. Almost 40 years later, how has this a...

Making Medicine: An Origin Story

15 May 2021

Contributed by Lukas

From chance meetings to risky investments, Making Medicine explores the origin stories of life changing medication and how patients, corporations and ...