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, focused on the policies shaping US life sciences. The discussion explores intellectual property, drug pricing dynamics, regulatory balance, and how innovation ecosystems grow at the state and national level. The episode examines approaches to sustaining research and development while maintaining global competitiveness. It also considers the long-term implications of regulatory uncertainty and international competition.

Which policy issue do you think most impacts biotech innovation today?
How should decision-makers balance affordability and long-term R&D investment?
What does the US need to maintain leadership in life sciences?

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Timestamps:
0:00 Episode disclaimer 
0:17 Welcome to Making Medicine and episode overview
0:30 Why this conversation matters for 2026
1:24 Introducing Senator Thom Tillis
2:16 Building a life sciences ecosystem in North Carolina
3:43 Economic impact of biotech investment
4:27 Tax and regulatory strategy for innovation
7:52 Balancing reform and economic stability
9:58 Why intellectual property matters for life sciences 
12:18 Government involvement and innovation risks
13:51 Drug pricing policy and unintended consequences
17:05 R&D investment impacts and innovation trade-offs
20:26 Global competition and China’s growing role
22:55 Changing the narrative around life sciences
26:52 What’s next after public service
28:58 Closing reflections and future outlook

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

In this special holiday episode, the Making Medicine Podcast looks back at standout conversations since the show’s July relaunch, covering biotech innovation, research funding, and global competitiveness. Highlights include discussions with industry leaders on venture capital, R&D stability, manufacturing, and the importance of a connected life sciences ecosystem. The episode also revisits conversations on international competition, commercialization challenges, and how policy choices shape innovation outcomes. Together, these moments underscore why long-term investment and coordination across the value chain matter for patients and progress.

Which conversation stood out most to you this year?
What policy or innovation topic should we explore more deeply in 2026?
How do you see global competition shaping the future of biotech?

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Timestamps:
0:00 Show disclaimer and welcome
0:23 Holiday greeting and episode overview
1:00 Industry snapshot and biotech competitiveness
3:36 R&D funding, NIH, and innovation stability
5:36 Global competition and maintaining leadership
8:23 Risks and resilience of the innovation economy
8:46 Policy ideas to support US biotech
14:12 Global perspectives on commercialization and pricing
17:20 Integrating early innovators and large pharma
21:27 Policy, pricing, and innovation trade-offs
27:37 IP, R&D incentives, and unintended consequences
28:23 Closing reflections and looking ahead to 2026

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

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 innovation and patients. The conversation covers defense-related biotech priorities, healthcare affordability challenges, PBM reform efforts, and capital access for early-stage companies. We also preview new data on venture investment, emerging therapeutic areas, and AI-enabled drug development. The episode closes with a look at recent FDA approvals that highlight real progress reaching patients.
 
What stood out to you most in the 2025 biotech investment data?
How do you see policy shaping innovation and capital formation in the year ahead?
Which FDA approval gives you the most optimism for patients?

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Timestamps:
0:00 Disclaimers and welcome
0:23 Year in review overview: biotech, policy, and innovation
0:45 Congress wraps up the year and the FY2026 NDAA
1:32 Healthcare legislation and premium pressures
3:19 PBM reform efforts and legislative outlook
5:39 Capital access update and the Invest Act
7:32 2025 biotech investment data preview
8:00 Leading therapeutic areas and rare disease trends
8:41 Geographic investment highlights by state
9:21 Investment by congressional district
10:16 AI-enabled biotech investment trends
10:46 FDA approvals corner
12:31 Closing thoughts and year-end reflections

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

This episode breaks down how Congress is turning biotechnology into a core national security priority. John Stanford explains the biggest shifts in the 2025 defense bill, why China-focused guardrails are expanding, and how new investment rules could reshape biotech funding. We also cover a new bipartisan proposal to create a government-backed investment fund, and a high-stakes battle over ACA subsidies.

What NDAA change do you think will impact biotech most?
Should the U.S. invest directly in emerging biotechnologies?
How should policymakers balance security with scientific innovation?  

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Timestamps:
0:00 Disclaimers & Intro
0:23 NDAA Overview and Why It Matters
1:54 Biotech as a Strategic National Security Capability
2:54 Domestic Biomanufacturing & Supply Chain Priorities
3:19 DoD Bioindustrial Base & New Biotech Office
4:34 Data Standardization, AI Readiness & Security
5:07 Guarding the U.S. Biotech Ecosystem from China
7:09 Intelligence Community’s New Biotech Role
8:00 Outbound Investment Regime Explained
10:12 Implications for Investors & Biotech Leaders
12:42 The Independence Investment Fund Act
14:37 Why Congress Wants a Government-Backed Biotech Fund
14:40 Senate Showdown on ACA Subsidies & Healthcare Costs
17:36 Why Access and Innovation Are Interconnected
18:17 Closing Thoughts & Call for Questions

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

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 opens up about his relationship with President Trump, the impact of Most Favored Nation (MFN) drug pricing on U.S. innovation, and the forces shaping America’s biotech competitiveness. They discuss why predictable intellectual property and regulatory frameworks are critical for investment and how the U.S. can maintain a leading edge in life sciences. Don’t miss Tillis’s insights on why he chose not to seek reelection and what might come next for his career.
This is a must-listen for anyone interested in biotech policy, life sciences innovation, or U.S. global competitiveness.

What do you think about MFN-style pricing in the U.S.?
How can policymakers best support biotech innovation?
Which part of the life sciences ecosystem do you think needs the most attention right now?

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Timestamps:
0:00 Introduction to Making Medicine and Senator Thom Tillis
1:12 Tillis joins the podcast as the first sitting Senator
2:05 Early career and motivations in public service
4:20 Relationship with President Trump and MFN drug pricing
7:35 Potential impacts of MFN-style controls on U.S. innovation 
10:10 America’s global biotech competitiveness and China
13:50 Importance of IP and regulatory predictability for investment
16:25 Reflections on policy successes and challenges
18:40 Decision not to seek reelection 20:30 What’s next for Senator Tillis
22:00 Key takeaways on biotech policy and U.S. innovation
24:15 Closing thoughts and call to action

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

In this episode of the Making Medicine Podcast, John Stanford sits down with Daphne Zohar, Founder, CEO, and Board Member of Seaport Therapeutics to explore the forces shaping today’s biotech ecosystem. Daphne shares her entrepreneurial path from PureTech to Seaport, offering a rare inside look at building companies, catalyzing innovation, and scaling breakthrough science. The conversation dives into the Massachusetts biotech flywheel, competitiveness with China, U.S. policy risks like the pill penalty and MFN, and how regulatory uncertainty ripples through capital formation and patient impact. Daphne also highlights why she’s bullish heading into 2026 and offers tactical advice for founders gearing up for JPM.
 
What part of Daphne’s perspective resonated most with you?
Which policy issue do you believe will most affect biotech innovation in 2025?
What should we ask her next time she joins the show?

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Timestamps:
0:00 Welcome & Introduction
1:12 Daphne Zohar’s Path into Biotech
3:05 The Seaport Therapeutics Story
6:10 Biotech Hangout & CEO Sisterhood
8:42 Why Massachusetts Leads in Biotech
10:55 The M&A Flywheel & Metsera Deal
13:40 China’s Biotech Strategy & U.S. Competitiveness
16:20 Pill Penalty, EPIC Act & Drug-Pricing Distortions
18:55 MFN Proposals & Impact on Early-Stage Biotechs
21:30 FDA Uncertainty: Regulation, Capital & Patients
24:00 Positive Signals Heading Into 2026
26:15 JPM Outlook & Advice for Founders

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

In this special Tokyo edition of the Making Medicine Podcast, John Stanford hosts a powerhouse panel of biotech investors, founders, and industry leaders to break down Japan’s emerging life-sciences boom. Together, they explore Japan’s regulatory shifts, government incentives, and rising startup momentum. This episode unpacks how Japan is positioning itself as a global hub for regenerative medicine, gene therapy, and bioeconomy innovation. Whether you're a policymaker, entrepreneur, or simply curious about global biotech trends, you'll get a front-row seat to Japan’s life sciences ecosystem, and why the rest of the world is watching.

What part of Japan’s biotech ecosystem surprised you the most?
Do you think global biotech companies should be paying more attention to Japan? Why or why not? Where do you see the biggest opportunity for Japan to lead in biotech?

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Time Stamps:
0:00 Introduction: Why We’re Recording in Tokyo
2:45 Japan’s Biotech Vision: From Strategy to Reality
6:10 Role of Government & Public-Private Partnerships
9:20 Innovation Hubs: Shared Labs & Incubators
12:05 Investment Landscape: VCs, Funds & Incentives
15:30 Regenerative Medicine & iPSC Development
18:45 Gene & Cell Therapy Trends in Japan
22:00 Regulatory Reform & Drug Approval Acceleration
24:45 Global Biotech Partnerships: Japan’s Reach Abroad
27:10 Challenges: From Risk-Averse Culture to Commercialization
29:50 The Bioeconomy: Beyond Pharmaceuticals
32:15 What’s Next: Predictions for Japan’s Biotech Future

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

Former Sutro Biopharma CEO Bill Newell joins host John Stanford to discuss the realities of leading a biotech company through economic uncertainty, long development timelines, and a shifting policy landscape. Bill shares lessons from 16 years at the helm, raising over $1.6 billion, navigating clinical trials, and building partnerships with global pharma leaders. The episode dives deep into the challenges of price controls, intellectual property reform, and the importance of FDA consistency for innovation. A must-watch for anyone interested in how science, policy, and investment intersect to bring new medicines to life.

What surprised you most about the biotech development process?
How do you think policymakers should balance access and innovation?
Do you agree with Bill’s stance on price controls and IP reform?

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

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 the nation’s workforce. He contrasts this expansion with the recent closure of Arena BioWorks, raising questions about the balance between onshoring and sustaining innovation. The discussion also dives into major rumors of a potential Medicare-GLP-1 deal with Eli Lilly and Novo Nordisk and explores the possible implications of new CMS demonstration projects that could impact Part B manufacturers. Finally, John reflects on the growing pressure of tax and pricing policies that could reshape the biotech landscape. Do you think the U.S. is striking the right balance between manufacturing and innovation? How might Medicare coverage of GLP-1 drugs change the healthcare system? What policy signals should Congress send to protect early-stage biotech?

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0:00 Disclaimer and introduction
0:23 Welcome to the Making Medicine Podcast
0:57 FDA leadership shakeup and industry uncertainty
2:06 Arena BioWorks closure and policy contrasts
2:32 FDA predictability and regulatory challenges
3:28 Medicare and GLP-1 coverage discussion
4:08 New FDA guidance on biosimilars and gene editing
5:00 FDA moves to reduce biosimilar development costs
5:49 Gene editing progress and regulatory flexibility
6:53 Impact of pricing and revenue policies on innovation
7:48 Arena BioWorks shutdown and biotech investment climate
10:40 Virginia’s new manufacturing hub and workforce initiative
13:14 White House drug pricing rumors and CMMI demonstration projects
17:39 Closing thoughts and call for engagement 

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

In this episode of Making Medicine, host John Stanford unpacks the Senate HELP Committee hearing on “The Future of Biotech.” From China’s accelerating investment to U.S. policy uncertainty, he explores what’s needed to protect American leadership in life sciences. The episode also covers new White House biosimilar announcements, gene therapy market challenges, and early insights from Incubate Policy Lab’s investment analysis. With over $14 billion invested in early-stage biotech this year, the conversation turns to what’s next for U.S. innovation.

Do you think U.S. biotech can stay ahead of China? What policies would best support innovation? 
Should biosimilars have faster, simpler approvals?If you're new to the 

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Timestamps:
0:00 – Intro and disclaimer
0:23 – Senate hearing: “The Future of Biotech” overview
1:19 – China’s biotech rise and U.S. competitiveness concerns
2:10 – IP protection, FDA modernization, and investment flight
3:30 – NIH funding stability and bipartisan support
4:00 – PBM reform and patient access challenges
6:00 – John Crowley’s warning: U.S. could lose biotech leadership in 2–3 years
8:00 – Incubate Policy Lab report: “Red lights in the U.S., green lights in China”
10:00 – Policy solutions: pricing predictability and IP certainty
12:00 – White House biosimilars announcement explained
14:00 – Gene and cell therapy market struggles
15:30 – AI-driven biotech investments and top-performing states
17:00 – Incubate at JPM 2026 + FDA during government shutdown
18:12 – Closing thoughts and audience shout-outsDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

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 celebrates National IP Month with guest Joshua Kresh. We dig into criteria for the new wave of CNPVs, domestic manufacturing pushes (Augmentin XR and ketamine), and why some approvals matter for patients who’ve run out of options. John also unpacks the Orphan Cures Act debate, the latest CBO chatter, and what it all means for long-term innovation. Finally, Joshua explains why IP is the backbone of biotech and flags fixes on eligibility, injunctions, and PTAB. Tell us what you think and we may feature your comment next week.

What’s your take on the FDA’s new voucher selections - smart acceleration or risky subjectivity? 
Should Congress protect the Orphan Cures Act or revisit it in light of CBO’s estimates?

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Timestamps:
0:00 Disclaimers
0:23 Welcome & episode setup
0:46 Headlines: White House update & FDA Vouhcer program
1:20 FDA criteria & first recipients (overview)
3:00 Domestic manufacturing: Augmentin XR & ketamine
3:55 Approvals Corner: September FDA approvals
4:54 Orphan Cures Act: fix, CBO score & repeal talk
6:49 Tracking investor sentiment: life science & rare disease
8:05 National IP Month intro
8:47 Guest Joshua Kresh & IPI’s mission
12:36 The big IP issues: eligibility, injunctions (RESTORE), PTAB
24:49 Outro & call to action

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 breaks down Day 15 of the federal shutdown’s impact on health agencies, major pullbacks in cell & gene therapy, and the White House’s latest MFN-style deal with AstraZeneca following Pfizer. We’re joined by Incubate’s Policy Director John Guy to explain how “BIOSECURE” found new life inside the Senate’s NDAA and what that means for biopharma. We also cover investment trends, workforce concerns, and the new DoD Biotech Management Office mandate. Stick around to the end for how all this could reshape U.S. innovation and supply chains. 

How will MFN-style deals affect launch strategy and U.S. pricing? 
Do recent exits by Novo Nordisk and Takeda change your outlook on cell & gene therapy? 
What’s your biggest question about BIOSECURE's due-process path and NDAA timing? 

DOD 1260H List: https://media.defense.gov/2025/Jan/07/2003625471/-1/-1/1/ENTITIES-IDENTIFIED-AS-CHINESE-MILITARY-COMPANIES-OPERATING-IN-THE-UNITED-STATES.PDF 

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Timestamps:
0:00 Disclaimer
0:23 Welcome & agenda
0:47 Shutdown Day 15: CDC RIF confusion
2:29 Court injunction + earlier HHS/FDA/NIH cuts
2:49 Cell therapy pullbacks (Novo, Takeda)
3:58 Investment slump in cell & gene therapy
5:21 Policy clarity, China context & hope
6:00 AstraZeneca White House MFN deal vs Pfizer
8:07 NDAA intro & Biosecure refresher
9:40 Interview: What is Biosecure? (John Guy)
12:19 Biosecure 2.0 details: DOD 1260H list, OMB review & due process
14:43 NDAA path, DoD Biotech Office, workforce & wrap




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 reports from Boston - the beating heart of global biotech - with insights from investors, scientists, and executives shaping the future of life sciences. He breaks down what the government shutdown means for FDA operations, unpacks the White House–Pfizer deal, and shares key takeaways from conversations on U.S. competitiveness, biotech investment, and the next generation of talent and technology.

How do you see policy uncertainty affecting biotech innovation?
Are U.S. policies doing enough to keep the next generation of scientists here?
What biotech breakthroughs excite you most right now?

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Timestamps:
0:00 Disclaimer: Not medical or investment advice
0:23 Welcome from Boston - biotech capital of the world
1:11 Government shutdown and FDA operations
2:06 What’s paused at the FDA and why it matters
2:29 Understanding the White House–Pfizer deal
3:19 MFN pricing, TrumpRx, and tariff waivers
4:07 Pfizer’s $70B U.S. investment and industry implications
4:29 Key takeaways from Boston investor meetings
4:58 Policy uncertainty and its impact on biotech investment
5:29 Interest rate cuts and biotech’s comeback potential
6:07 The growing threat to U.S. scientific talent
6:33 The “brain drain” and its implications for America’s biotech future
7:22 Boston’s role in championing life sciences
7:50 Exciting new biotech modalities: gene therapy, RNA, and cell engineering
9:34 Policy clarity, workforce development, and scientific momentum
10:20 Closing thoughts: innovation across America
10:40 Outro and call to action 

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

This week, John Stanford breaks down the government shutdown and its impact on FDA, NIH, and biotech innovation. He also covers the surprising lapse of the SBIR program, what it means for early-stage biotech funding, and the fierce political debate around its future. Plus, we analyze President Trump’s deal with Pfizer on “Most Favored Nation” drug pricing and his latest tariff threats.

What does all this mean for the future of U.S. biotech competitiveness?
How should policymakers balance affordability and innovation in drug pricing?
Do you think the SBIR program will be quickly revived, or is this the start of bigger changes?
What impact will tariffs and MFN drug pricing have on biotech investment?

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Timestamps:
0:00 Welcome to Making Medicine
0:21 Government shutdown and biotech impact
1:05 FDA furloughs and regulatory slowdowns
2:00 NIH delays and research funding concerns
2:40 Investor confidence during shutdowns
2:57 SBIR & STTR programs expire
3:22 Political stalemate in the Senate
3:50 Why SBIR matters for biotech innovation
4:05 Trump & Pfizer announce MFN drug pricing deal
5:06 Trump RX website and drug access
6:05 Market reactions and industry uncertainty
6:36 Trump’s 100% pharma tariff threat
7:40 Section 232 investigations on drugs and PPE
7:59 Closing thoughts & audience Q&A


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 breaks down the White House autism event, the debate over shifting SEC reports to twice-yearly, and how MFN pressure is reshaping pricing strategy - before welcoming Endpoints News’ Max Bayer for a wide-ranging Press Pass on tariffs, GLP-1s, and China’s biotech surge. We unpack what “success” might look like for the administration’s drug-pricing push, why insurers could make or break any DTC effort, and how policy whiplash is hitting rare disease developers and investors. Max shares on-the-ground reporting about China’s rapidly built “Cambridge-like” ecosystems and the risks of restricting out-licensing. We also discuss the stakes for U.S. competitiveness if Europe becomes the default partner. Stick around to the end for how we’re tracking MFN and IRA signals across company filings.

Should SEC reporting shift to twice a year for biotechs, or does that cut needed transparency?

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Follow Max Bayer https://www.linkedin.com/in/max-bayer-20435179

Timestamps:
0:05 Welcome to Making Medicine
0:36 Headlines: White House autism event & fallout
1:34 SEC filings: quarterly to semiannual debate
2:13 Press Pass: Max Bayer (Endpoints News) joins
2:39 “Totality” of actions - MFN, tariffs, vaccines, China deals
4:10 Investor lens: regulatory continuity & rare disease shocks
6:01 MFN behavior shifts (e.g., UK pricing moves)
8:39 What counts as success? GLP-1 pricing & insurer role
12:11 China’s biotech surge & the out-licensing boom
15:03 Policy options: restrictions vs. U.S. competitiveness (Europe risk)
17:20 U.S. ecosystem headwinds: jobs, patents, visas, funding
23:51 Outro, subscribe, and where to send tips for Max DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

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?

If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPod https://www.instagram.com/makingmedicinepod/ https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true

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? 

📱If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPod https://www.instagram.com/makingmedicinepod/ https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true

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