Making Medicine

This week, John Stanford dives into the UK’s pharmaceutical challenges, including ABPI’s warning about declining competitiveness and major companies pausing investment. We also explore the debate over direct-to-consumer drug advertising in the U.S. and how it ties into investment decisions and the pill penalty. Finally, we close with August’s FDA approvals, celebrating breakthroughs for rare diseases and cancer patients.

What do you think?
Can the UK become Europe’s life sciences hub by 2030?
Should the U.S. rethink DTC advertising, or does it play a vital role in innovation?
Which of this month’s FDA approvals excites you most? 

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Timestamps:
 0:00 Welcome to Making Medicine
0:28 UK pharma outlook and ABPI report
1:37 Weaknesses in UK drug investment
2:24 Companies pausing UK investments
3:08 U.S. vs UK drug access and pricing
4:08 Global pressure for fair drug pricing
4:33 MFN pricing concerns in the U.S.
5:09 Debate over drug advertising
6:09 How DTC ads affect biotech investment
7:26 Connection to the pill penalty
7:48 FDA Approvals Corner – August highlights
8:17 Jazz Pharmaceuticals – Modeyso approval
8:36 Boehringer Ingelheim – Hernexeos approval
9:17 Other rare disease drug approvals
10:23 Closing thoughts & FDA wins 

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

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 through the EPIC Act. He also covers the latest developments on tariffs, HHS hearings, FDA’s new rare disease principles, and the future of the SBIR program. We close with new research on how the IRA is affecting biotech investment.

What are your thoughts on the pill penalty?
Do you think FDA’s new rare disease guidance will accelerate innovation?
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Timestamps:
0:00 Welcome to Making Medicine
0:32 9/13 and the pill penalty explained
1:37 Incubate’s advocacy: EPIC Act and campaigns
2:31 Life Science Investment Tracker: discontinued drugs & programs
3:02 Trump tariffs and pharmaceutical exemptions
4:06 Japan deal and Most Favored Nation strategy
4:22 RFK Jr. Senate hearing on vaccines, IRA, and drug pricing
5:37 The trap of list prices in policy debates
5:39 FDA’s new Rare Disease Evidence Principles (RDEP)
6:34 Why clarity matters for rare disease companies
6:36 SBIR program renewal and uncertainty ahead
7:09 NPC survey on the IRA’s impact on investment
7:51 Closing thoughts & call to action

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

This week, John Stanford sits down with Kendalle Burlin O’Connell (CEO & President, MassBio) to unpack the 2025 Industry Snapshot - why Massachusetts still attracts 22% of U.S. biotech VC and how advanced modalities keep the state at the cutting edge. We dig into the “flywheel” of the bioeconomy, from NIH and SBIR to FDA uncertainty, tariffs, and MFN. Kendalle lays out a unifying policy roadmap - a comprehensive competitiveness package - to keep the U.S. leading in life sciences. We also talk capital concentration, China’s rapid rise, and what it will take to avoid losing our edge in the next 2-5 years. Stick around for a candid, optimistic close on how the ecosystem rebounds.

What stood out to you most from MassBio’s 2025 Snapshot?
Do you agree the U.S. needs a “comprehensive competitiveness package”- and what should be in it?
How are funding cuts or regulatory uncertainty affecting your team right now?If you're new to the

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https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps:
0:00 Intro music & welcome
0:15 Guest intro: Kendalle Burlin O’Connell, MassBio CEO
1:24 2025 MassBio Snapshot: why it matters now
2:12 Key stats: 22% of U.S. VC & advanced modalities lead
3:45 “Massachusetts works”: optimism amid a gloomy market
5:03 The biotech flywheel: how uncertainty stalls the ecosystem
6:59 Funding pipeline: NIH cuts, SBIR reauth, FDA/tariffs/MFN
9:58 Why biotechs need big pharma; price controls’ ripple effects
12:45 Capital crunch: venture down & late-stage concentration
14:51 Why NIH & ARPA-H can’t be replaced by private capital
16:56 The fix: a comprehensive competitiveness package
19:09 China’s rise & the 2-5 year warning
22:23 MA bioeconomy impact, optimism, and outro*We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.”*We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.”

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 tariff-drug pricing push, BARDA’s funding of vaccine research following recent pivots away from mRNA vaccines, a hopeful return of biotech IPOs, and NIH program cuts. Plus, we debut the FDA Approvals Corner celebrating new medicines reaching patients, and spotlight the looming September deadline for the SBIR and STTR programs.

What do you think about tariffs being tied to drug pricing?
Should Congress extend SBIR funding as-is, or rethink the program? Which FDA approval from July do you think will have the biggest impact?

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Timestamps:
0:05 Welcome to Making Medicine
0:38 Trump cabinet links tariffs & drug pricing
2:24 BARDA shifts vaccine funding away from mRNA
3:36 First biotech IPO in 6 months: LB Pharmaceuticals
4:56 Policy headwinds in SEC filings & MassBio snapshot
5:17 NIH cuts minority biomed research program
5:43 Launch of FDA Approvals Corner
6:25 July FDA approvals roundup
7:45 Policy Spotlight: SBIR & STTR programs
8:46 The Innovate Act and foreign risk concerns
9:42 Extension vs. compromise for SBIR reauthorization
10:27 Closing thoughts & call for comments *We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.”

This week, John Stanford sits down with Dr. Ned Sharpless - former NCI Director, Acting FDA Commissioner, and now venture capitalist at Jupiter Bio Ventures. From the challenges of biotech funding, regulatory uncertainty, and the Inflation Reduction Act to the rise of China in biotech, IP battles, and the hype around AI, Ned offers candid insights you won’t hear anywhere else.

What do you think about the current funding environment in biotech?
How should the U.S. respond to China’s scientific rise? 

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Timestamps:
0:00 Welcome to Making Medicine
0:12 Guest introduction: Dr. Ned Sharpless
1:03 Launch of Jupiter Bio Ventures
3:31 The tough biotech funding environment
5:27 Regulatory uncertainty, IRA, and FDA challenges
8:02 Leadership turmoil at FDA, NIH, and HHS 10:18 RFK Jr.’s vision and impact on health policy
13:05 Morale, recruitment, and expertise at federal agencies 15:20 How NIH, FDA, and CMS work together 
19:00 NIH funding freezes and Congressional outlook 23:36 FDA’s new priority review voucher program
28:02 Public skepticism, politics, and FDA trust
30:02 The “pill penalty,” EPIC Act, and IRA fixes
34:04 Why small molecules still matter for cancer 35:40 IP protections, march-in rights, and investment risks
39:20 The debate over Most Favored Nation drug pricing
43:12 Direct-to-consumer pricing as a potential solution 
44:38 AI in biotech-hype vs. reality
46:46 China’s rise in biotech and global competition
50:11 Closing thoughts and optimism for science

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 HHS’s $500M cut in mRNA research, to looming pharmaceutical tariffs. Then, we debut our new "Industry Perspectives" segment with NovaQuest Capital’s Patrick Jordan, exploring how regulatory uncertainty, populist pricing policies, and global market dynamics impact biotech innovation.

What do you think about HHS’s decision to pull back on mRNA research? 
Could foreign reference pricing harm small biotech companies more than big pharma? And how should the FDA navigate leadership instability to keep innovation on track? 

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This week on the Making Medicine Podcast, John Stanford dives into the “Most Favored Nation” (MFN) pricing concept, championed by President Trump, and what it could mean for drug pricing, innovation, and patients in America. Could aligning U.S. drug prices with those abroad actually save patients money, or would it crush innovation and access? John unpacks the trade-offs of MFN, the global free-riding problem, the role of PBMs, and the rise of direct-to-patient drug models. The episode explores whether America already is the most favored nation in pharmaceuticals and what bold moves are next.

What do you think: Should the U.S. demand lower prices from drug companies or protect innovation at all costs?
Would a direct-to-patient model work better than today's broken system?

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Timestamps:
0:00 The History of Most Favored Nation
1:06 Trump Brings MFN Back into Focus
1:22 Welcome to Making Medicine
2:19 Why Drug Pricing Became the MFN Battleground
3:04 Trump's Push for MFN & the Pharma Letter
4:02 The Personal Story Driving Trump’s Policy
5:00 The Appeal and Simplicity of MFN
5:19 Industry Pushback & Potential Consequences
6:02 America’s Role in Global Drug Innovation
7:06 Why MFN Could Damage U.S. Biotech
7:25 The Costco Analogy & Why It Fails
8:20 Global Free-Riding and What Other Nations Don’t Pay
9:00 The U.S. Middlemen Problem (PBMs)
10:03 Global Solutions and Missed Opportunities
11:01 Generics: The Hidden Strength of the U.S. System
12:43 What Happens If Generics Vanish?
13:14 Trump's Unclear Path Forward
13:46 Direct-to-Patient Sales: A Better Path?
14:42 Is the U.S. Already the Most Favored Nation?
15:30 Final Thoughts on MFN & What Comes Next

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 of drug price controls under the IRA to the newly announced 15% EU tariffs on medicines, there's a lot at stake for patients, companies, and innovation. John also breaks down the temporary NIH funding freeze, what it means for research, and why August recess matters more than you think.

What impact do you think drug price controls will have on innovation?
Should medicines be included in international tariff negotiations?
What policies should Congress prioritize this fall?

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Timestamps:
0:00 Tech setup and behind-the-scenes
3:37 Welcome to the Making Medicine Podcast
4:16 Breaking news: FDA's SBER director steps down
4:58 Are we moving toward more price controls on drugs?
7:47 New EU trade deal and tariffs on pharmaceuticals
10:08 How the IRA continues to impact the investment environment
12:31 Did the White House freeze NIH funding?
15:10 What is August recess and why it matters
16:53 Final thoughts and call for listener questions

In this special Press Pass episode of the Making Medicine Podcast, John Stanford welcomes Nyah Phengsitthy of Bloomberg Law to break down the latest shifts in drug pricing, FDA policy, and the unpredictable pace of the Trump administration. They explore the Medicare drug price negotiation program, new FDA leadership under Dr. Makary, and the industry’s reaction to rapidly changing executive orders. Nyah also shares her approach to filtering meaningful policy changes from political noise. Plus, they dive into how upcoming guidance may reshape the role of physicians in Part B drug distribution and what that means for innovation in medicine. How should industry leaders respond to policy announced via social media posts? Will the new FDA leadership redefine efficiency and access in drug approval? What worries you most (or excites you) about the future of drug pricing policy?

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Timestamps:
0:00 There's a lot going on
0:36 Welcome to Making Medicine
1:00 Introducing Nyah Phengsitthy and Press Pass
1:40 Top trends in drug policy under Trump
2:52 Uncertainty and industry response
3:57 How Nyah filters news vs. noise
5:29 A changing FDA and its new direction 
6:49 Stakeholder engagement and Makary’s listening tour
7:51 Industry frustration over vague policy
9:00 Medicare drug negotiation: Trump’s first take
10:47 Fixed dose combos and Orphan Cures Act in new guidance
11:50 Part B dynamics and physician involvement
12:56 Listening sessions and future guidance
13:19 Final thoughts and wrap-up

In this week’s episode, John Stanford breaks down the evolving story of President Trump’s aggressive tariff strategy—focusing on a potential 200% tariff on pharmaceuticals. From a historical look at Trump’s decades-long affinity for tariffs to the current Section 232 investigation into pharmaceutical imports, we explore what these actions could mean for national security, drug prices, and innovation. Could this policy lead to onshoring more drug manufacturing—or just higher prices for patients? And what exactly is “Liberation Day”? What are your thoughts on a 200% pharma tariff?

Is this a smart way to strengthen domestic manufacturing—or a policy that could backfire? 📱If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:
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Timestamps:
0:00 Welcome and Overview
0:33 Why Tariffs? A Trump Trade Philosophy
1:32 Trump’s History with Tariffs
2:32 The 2025 Tariff Timeline
3:59 Liberation Day and the Global Tariff Shock
4:53 August 1st Deadline and Market Reaction
5:27 Trump Floats 200% Pharmaceutical Tariff
6:03 Section 232 Investigation Explained
6:56 Incubate’s Response and Global Supply Chain Concerns
7:50 National Security, APIs, and the Commerce Department
8:56 Trump’s Endgame: Manufacturing Medicines at Home
9:44 What the Industry Should Expect
10:26 Why We’re Still in the Dark
10:50 Next Week’s Preview: The Press Pass Segment