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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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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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.