Explore every episode of the podcast Open Door Salon

Paul Uhrig is a healthcare lawyer and digital health executive, formerly Chief Legal and Digital Health Officer at Bassett Healthcare Network and Chief Administrative, Legal and Privacy Officer at Surescripts. Eddie Qureshi is founder and CEO of Rainfall Health, an AI platform that helps hospitals manage Medicare's TEAM model.

They explain what health system executives ask before they buy AI, why so many pilots never reach scale, and why only two or three priorities ever make a C-suite agenda. Then the patient side: people connecting their medical records to ChatGPT and Claude, why that data falls outside HIPAA, the consent screens nobody reads, the 30 days after surgery, and why ambient listening stuck with clinicians.

(00:00) The consent form nobody reads

(01:55) AI, bad actors and the threat closer to home

(04:13) Cybersecurity and the 100% landing rule

(07:14) What executives ask before they buy AI

(09:00) Why pilots fail to scale

(10:31) Pitch versus pain point

(14:54) Is every health system the same?

(16:56) Patients bring AI to the exam room

(20:19) Patient data in consumer AI tools

(23:29) HIPAA, the FTC and who educates patients

(26:56) The 30 days after surgery

(31:21) 85% of health systems use AI

(32:02) Why ambient listening stuck

(35:43) What inspired their career paths

(39:01) The hardest decision or challenge

Phil Vanek, PhD, is Chief Commercialization Officer of the International Society for Cell & Gene Therapy (ISCT), chair of the CGT Catapult Technology Advisory Board and founder of Redline Bioadvisors. David H. Crean, PhD, MBA, is founder and managing partner of Cardiff Advisory and the author of Dual Fluency.

They explain what a cell and gene therapy founder has to show before an investor conversation goes anywhere: a de-risked asset, evidence the biology is real, and a manufacturing plan that is not left to the appendix. They argue for writing the target product profile first, rank capital, reimbursement and manufacturing cost, compare how the US, the UK and Europe pay for advanced therapies, and explain why deals announced at JPM start many months earlier.

(00:00) What founders have to show before the conversation starts

(05:12) Target product profile: write the label first

(09:53) Show me the data: AI, fabricated evidence, and the three pillars ranked

(14:37) Who pays: reimbursement in the US, UK and Europe

(19:16) The four-legged stool and the aducanumab lesson

(25:10) Should you build to be acquired? Who really picks the asset

(31:40) Why JPM deals start nine months earlier

(36:06) Hardening the supply chain, and why science needs capital fluency

(40:56) Career lessons, and killing a program that works

(46:02) Mentorship and advice for emerging founders

Retired Air Force Brigadier General Chad Raduege spent 29 years in communications, IT and cyber operations, commanded the White House Communications Agency, and finished his career as Director of C4/Cyber and CIO for U.S. European Command. Today he is President of Cyber, Data & Communications at Elara Nova.

He explains why he sees biopharma data as a national security matter, how ransomware differs from espionage by advanced persistent threats, and why the CEO owns cyber risk at a 40-person biotech with no CISO. He describes what an adversary could learn from a venture firm's due diligence files, how he reads the summer's incidents at Amgen, Boston Scientific and McKesson, and why the industry should build security in and share what it learns.

(00:00) First to market, first breached, and meet Chad Raduege

(05:36) Taking the Oval Office anywhere: the White House Communications Agency

(09:45) EUCOM: Afghanistan, COVID and Russia's invasion of Ukraine

(14:24) Where biopharma sits on a nation-state target list

(19:17) Ransomware vs. espionage, and the 40-person biotech with no CISO

(25:50) VC diligence files, accountability and crown jewels

(33:14) Amgen, Boston Scientific, McKesson: an adversary mapping the industry

(37:40) Build it in, don't strap it on, and the path to 29 years

(43:59) Stop casting stones: ISACs and learning together

AI arrived in drug development carrying a very large promise. Nindhana Paranthaman, Vice President of Early Clinical Development at Bicara Therapeutics, and Paul Agapow, Chief Scientific Officer at Bayezian, work on opposite sides of that promise and agree on more than the marketing would suggest.

Paranthaman names the gains that actually arrived, all of them operational, and the one that did not: more drugs advancing into the clinic. Agapow explains why a trial completed inside a year is marketing, takes the digital twin apart on logical rather than technical grounds, and estimates that about a third of what the industry is building today will still be standing in five years. They close on target herding and what an investor should ask an AI-first company.

(01:24) What AI actually delivered in clinical development

(05:24) Whether a one-year trial is marketing spin

(10:30) Digital twins, and why a twin cannot replace a patient

(16:39) What survives five years, and the breakdown

(18:48) Protocols, amendments and the unglamorous gold

(29:29) Why biology breaks AI: discovered, not invented

(36:35) Target herding and the hundredth me-too drug

(39:09) Advice for VCs, family offices and private equity

Six hundred investable opportunities in a year. Five investments. Christian Schubert, Vice President and Global Head of AbbVie Ventures, walks Lori Ellis through where the other 595 fall out, and almost none of it is about pitch quality.

Mike Goguen joins him from the other end of the market. He spent twenty years as a general partner at Sequoia Capital before founding Two Bear Capital in 2019, and has served on more than eighty company boards.

Two investors, two entirely different mandates, one table. They cover what separates a funded biotech pitch from a passed one, what loses a pitch inside the first twenty minutes, whether warm introductions still move a founder to the front of the line, why the amount raised early was almost inversely correlated with success in Goguen's own look back at the data, and what makes a rejection useful instead of vague.

(00:40) Out of 600 opportunities, five investments

(02:46) The five to ten percent in the middle, where the work is

(03:31) Is the problem big enough? Why biotech is not tech

(07:04) Passion, resilience, and the North Star nobody else believes yet

(09:58) Sequoia in 1996: should we ever do life sciences again?

(11:53) The capital gap corporate venture is stepping into

(14:04) What is the fastest pitch you have ever lost?

(16:34) What loses a pitch in the first twenty minutes

(18:07) How much diligence goes into the team, not just the founder

(20:42) Social worker and fireman: what early stage leadership actually is

(26:50) When a founder should step aside, and who says it out loud

(28:08) Do warm introductions still move you to the front of the line?

(31:05) Why raising less money early correlates with bigger outcomes

(35:13) Groupthink: the biggest fallacy in venture capital

(38:31) What a fundable company looks like in 2027 and 2028

(43:58) The anatomy of a useful no

(49:24) The fund dynamics hiding behind a rejection

(53:48) The hardest questions: a random walk into venture

(56:38) Three billion lines of code in every cell

(01:00:30) The choice that lingers

(01:02:26) Venture capitalist, philanthropist, first responder. Pick one.

Mike Goguen is Founder and Managing Partner of Two Bear Capital.

https://www.linkedin.com/in/michael-goguen-23314/

Christian Schubert is Vice President and Global Head of AbbVie Ventures.

https://www.linkedin.com/in/crs79/

Episode page: https://opendoorsalon.com/what-gets-a-biotech-pitch-funded/

David Esposito has built biotechs to exit and taken biotechs into bankruptcy. Pavel Khrimian spent most of 2026 winding down the company he co-founded, after a pharma collaboration collapsed at the diligence stage. They talk about what the last ninety days actually look like, the three questions that separate a pivot from a closure, and the obligation to patients that outlives the company.

Lori asks about the ninety days before the decision rather than the day of it, and both answers land in the same place: the data was there earlier, and it did not arrive labeled. A manufacturing delay. A term sheet that was supposed to be a hundred million, drops to eighty, then oversubscribes to a hundred and twenty five. A program that is performing but is no longer the priority.

Khrimian reduces the closure decision to three questions. Do you have a credible hypothesis or asset. Do you have the cash to test it. Do you have the time and money to reach a realistic value inflection. Two answers of no and you are closing rather than pivoting. Esposito's version is structural: after a couple of rounds of capital a company has often prioritized itself into one swim lane, and the data then makes the decision for it.

Neither treats the people as a footnote. Patients on therapy have to stay on therapy, which turns a wind-down into an operational problem of narrowing sites and continuing to ship drug. Employees who did nothing wrong need somewhere to land.

(00:00) Why founders are drawn back to biotech

(00:38) How this sponsored episode worked

(02:04) Exits, launches, and companies taken into bankruptcy

(03:37) Letting go of the obsession with control

(06:04) Reading a new data point and deciding whether to pivot

(07:35) Pay attention to every data point, not just your own

(10:26) Build a base case, then watch it move

(11:26) The acute study, and the pivot to chronic indications

(12:31) Why it is always about the team

(16:06) Healthy tension between science, finance and strategy

(17:47) Doing everything right and still losing

(19:05) A word from Lab Thread

(19:28) The ninety days before the decision

(21:21) When a pharma collaboration collapses in diligence

(23:31) Optimism as a gear, measured against cash

(25:05) Pivot or close: the three questions

(26:54) The binary swim lane, and the calls that are never clear

(29:21) What the CAR-T pivot into autoimmune teaches

(30:52) You are not rewarded for a platform anymore

(31:57) Carrying the news

(33:14) Two hundred grand in the bank and no January calendar

(34:42) Investors, patients, and your team at the same time

(35:42) Take your own shoes off first

(36:42) The obligation to patients still on therapy

(39:20) Helping your team land somewhere good

(40:17) What inspired you to take this path

(44:12) The hardest decision you have had to make

(47:10) Thank yous

David Esposito is President and Chief Executive Officer of ONL Therapeutics.

https://www.linkedin.com/in/davidesposito2/

Pavel Khrimian is Co-founder and Chief Business Officer of Deka Biosciences.

https://www.linkedin.com/in/pavel-khrimian-3219935/

This episode was made possible by Lab Thread.

Nobody went into science for the admin. Lab Thread is the integrated lab management platform that scientists actually enjoy; Built to fit the way you work, from first idea to final report. Everything connected. Nothing lost. Never in your way.

Visit labthread.com to learn more, or book a demo

Episode page: https://opendoorsalon.com/biotech-wind-down-pivot-or-close/

Newsletter: https://opendoorsalon.substack.com/

An AI fabricated a scientific citation. When Raphaël Ognar pushed back, it apologized, saying it had not wanted to fall short by giving him an unsatisfactory answer. He told it that "I don't know" would have been better than lying, and stopped using it that day.

That anecdote opens a conversation that escalates. Ryan Cawood pastes in a DNA sequence he already knows the answer to and gets a confident, wrong one back. A cell line takes nine months to build and fails at the door of a GMP facility because a chain-of-custody record has a hole in it. And the FDA does not care where your data came from: submit it, and you own it.

Ryan Cawood, PhD, is Co-Founder and CEO of Lab Thread. Raphaël Ognar is President, CEO, Co-Founder and Chairman of NKILT Therapeutics, and carried two small molecules through to approval inside big pharma before leaving to build his own company.

Both run companies with AI in the workflow. Neither will put it in the pitch deck.

(00:00) "I don't know" is a good answer

(00:24) What happens when AI goes wrong in drug discovery

(01:40) The publication that did not exist

(03:41) The AI apologized for not wanting to disappoint

(05:02) The DNA sequence it read confidently and wrong

(06:51) Who is liable when the model is wrong

(10:01) What a mistake actually looks like in a lab

(12:06) Build checkpoints into the prompt, not just at the end

(14:47) Flawed data in, confident answer out

(16:29) Failure at big pharma versus failure at a small biotech

(21:01) Trials are designed for approval, not for the real world

(25:16) When you cannot show where the answer came from

(27:25) Nine months of chain of custody, recorded on paper

(30:20) Confidence is not accuracy

(32:34) Integrating AI instead of renting it

(35:24) Greed versus outcome in the AI bubble

(37:04) Who is really paying for your AI subscription

(39:33) The energy and water nobody prices in

(41:28) AI for AI's sake, and the colleague who rewrites your email

(43:31) The pitch deck with no mention of AI

(46:07) What inspired you to take this path

(50:20) The hardest decision

The A, B, C round path that funded biotech for thirty years is not currently available. Sara Jane Demy has just come out of her own Biotech CEO Summit, where that was the main topic. Jeremy Levin, who ran Teva Pharmaceutical Industries and sat on the executive committee at Bristol-Myers Squibb, has a specific answer about where the money went instead.

Host Lori Ellis asks them where biotech capital actually is now, why chief executives have changed their minds about Chinese clinical data, and what each of them regards as the hardest decision of their career. Levin's answer to that last question involves a resignation written on a napkin.

(00:00) There's no other industry like this

(00:30) Introduction

(01:17) The troops without supplies

(04:04) What the war does to the industry

(05:59) Hormuz: plastics, fertilizer and food security

(09:45) Is China gaining from the war?

(10:25) Why CEOs now trust Chinese clinical data

(12:58) The question isn't if China leads, it's when

(14:52) What disruption did to the US innovation engine

(17:13) Innovation won't stop, it will migrate

(19:57) What gets repaired and what doesn't

(23:05) The A-B-C round model isn't there anymore

(26:49) Back to basics: be fearless

(28:50) Advice for people still inside government

(33:52) Is the foundation still standing?

(35:33) The hardest decision of your career

(39:47) The resignation written on a napkin

Sara Jane Demy is Founder and CEO of Demy-Colton, which runs Biotech Showcase, BioFuture and the Biotech CEO Summit.

Jeremy Levin is co-founder and Executive Chairman of Ovid Therapeutics, the former President and CEO of Teva Pharmaceutical Industries, and a former chairman of the Biotechnology Innovation Organization.

Episode page: https://opendoorsalon.com/where-biotech-money-goes-venture-capital/

Newsletter: https://opendoorsalon.substack.com/

Alzheimer's science is finally moving. Two disease-modifying drugs are approved. Two blood

tests are approved. Biogen has taken an anti-tau drug into Phase 3. And early-stage

neuroscience companies still cannot raise money.

Lori Ellis sits down with two investors who fund brain health from opposite ends of the

capital stack and asks the question founders actually need answered: what has to be true

before you write the check?

They do not entirely agree, and that is the useful part. One says the caution was earned by

a track record of failure. The other says the ecosystem has already turned. Both are

specific about what they need to see, and blunt about what kills a deal.

Karen Harris is Executive Director of Mission-Related Investing and Finance at the

Alzheimer's Drug Discovery Foundation, where she leads the ADDF's venture-based investment

strategy. She came to the nonprofit world after more than two decades in finance, including

Global COO of global equity capital markets at UBS and investment banker at Merrill Lynch.

Mahesh Narayanan is Managing Partner and Founder of Neuvation Ventures, a Baltimore-based

seed fund backing deep tech, medtech, diagnostics and biotech innovation in brain health.

He spent fifteen years running life-sciences startups with two exits, and started investing

after his niece was diagnosed on the autism spectrum in March 2020.

(00:00) I can tell who's going to be a good CEO

(00:45) Why neuroscience became the hardest early-stage money to raise

(04:21) What changed: approvals, payer literacy, and neuroscientists becoming investors

(07:56) The payer and prescriber conversation founders start far too late

(12:48) Anthem covers a blood-based biomarker, and why that matters

(14:21) NIH, DARPA, ARPA-H, and the dual-use advantage in brain health

(18:07) Where private equity actually fits, and where it does not

(20:11) Venture philanthropy and venture capital: convergence and divergence

(25:04) What each investor needs to see from a founder

(30:02) Red flags: part-time CEOs and founders who will not be coached

(35:05) The caddie test

(38:24) What neuro founders should be doing right now and are not

(42:03) What inspired this career path

(46:56) The hardest decision

Watch the full conversation: https://opendoorsalon.com/why-alzheimers-startups-struggle-to-raise-money/

Karen Harris: https://opendoorsalon.com/honored-guests/karen-harris/

Mahesh Narayanan: https://opendoorsalon.com/honored-guests/mahesh-narayanan/

Most biotech CEOs assume nation-state hackers are a big-pharma problem. Raja Mikkili and Anne Elise Herold Li explain why the opposite is true: the small and mid-size companies doing the innovative R&D are the more interesting target, because they are the R&D labs the big companies shop from.

Continuing the conversation that started at BIO, they break down what a nation state actually wants from a biotech (the roadmap, not the ransom), why the West Pharmaceutical breach should have been an industry wake-up call, how far down the supply chain you now have to audit, what AI-versus-AI attack recon looks like, and the four-sentence clause buried in collaboration agreements that quietly gives your data away.

Raja Mikkili is Vice President, Core Technologies and Security at Arcutis Biotherapeutics, where he leads cybersecurity strategy, data analytics, AI, and technology initiatives. His 20-plus-year career spans aerospace and defense, pharmaceuticals, private equity, and construction, including DoD- and FDA-compliant security programs at EaglePicher Technologies and Zydus Pharmaceuticals.

Anne Elise Herold Li is Managing Partner of the New York office and Shareholder at Brownstein Hyatt Farber Schreck. A Chambers-ranked, first-chair IP trial lawyer focused on biotech, pharma, and medical devices, she holds an M.P.H. from Emory, teaches biotechnology law at Fordham, and is admitted to the U.S. Supreme Court.

CHAPTERS

00:00 The vulnerability no one reads

01:33 What nation states actually target in biotech

06:23 Why small biotechs are the bigger prize

10:23 The West Pharmaceutical wake-up call

14:51 Auditing your supply chain down to the roots

19:19 Honeypots, dummy data, and vendor firewalls

23:14 AI attacking AI: recon at machine speed

27:56 The new Cold War: China and the BIOSECURE Act

31:06 The COINS Act and who gets audited

32:54 Why anonymized data is exactly what they want

35:34 Career paths and hardest challenges

42:11 Data ownership: the four-sentence vulnerability

Open Door Salon is where global healthcare is discussed by the people who build, fund, and fight for it. Hosted by Lori Ellis.

Newsletter (seven key takeaways for every episode): https://opendoorsalon.substack.com/

Website: https://opendoorsalon.com/

LinkedIn: https://www.linkedin.com/company/opendoorsalon

Raja Mikkili: https://www.linkedin.com/in/rmikkili/

Anne Elise Herold Li: https://www.linkedin.com/in/anneeliseli/

Robert Califf is the only person to have served twice as Commissioner of the FDA. Vid Desai was the agency's first Chief Information Officer to report directly to the Commissioner. Both left in 2025. Host Lori Ellis asks them what the current turnover is doing to the agency, and they do not hedge.

Califf calls the situation calamitous, describes political oversight that "looks somewhat like a kleptocracy," and argues that any American strategy built on walling the country off from Chinese biotechnology is doomed. Desai explains why the FDA's Elsa AI tool ran into trouble for budgetary rather than technical reasons, and why China's research funding passing ours should concern every American.

GUESTS

Robert Califf, MD - Two-Time FDA Commissioner | Professor, Duke University School of Medicine

Vid Desai - First FDA Chief Information Officer | Former FDA Chief Technology Officer

CHAPTERS

(00:00) "You're sock puppets of industry"

(01:34) What leadership turnover does to an agency

(06:15) The rulebook, the referees, and the coach

(14:19) National priority vouchers and the administrative record

(18:17) Podium policy and what makes change stick

(20:22) Elsa, AI funding, and the money that runs out

(23:22) AI agents, human expertise, and the IKEA lesson

(28:33) Who is actually deciding now

(32:50) China, Operation TrialBlazer, and the missing US strategy

(41:57) What inspired their careers

(46:08) The hardest decisions of their careers

Get the seven key takeaways from every episode, free: https://opendoorsalon.substack.com/

Episode page: https://opendoorsalon.com/fda-turnover-china-clinical-trials-califf-desai/

Learn more about ISCT: https://www.isctglobal.org/home

The science works. Cell and gene therapies are curing diseases that had no answer. So why can't patients get them? Host Lori Ellis continues a conversation started at the ISCT meeting in Dublin with Bambi Grilley, President-Elect of ISCT and its former Chief Regulatory Officer, and Jaap Jan Boelens, Chief Medical Officer of ISCT, on access as the real bottleneck: why regulatory approval is only the beginning, how the reimbursement float and single-case agreements push patients to walk away from a cure they qualify for, the desperation economy of unproven stem cells, FDA turnover, the decade-plus road to in vivo gene therapy, and the Jesse Gelsinger case that nearly ended the field.

(00:00) The cold open: FDA turnover in one word

(01:21) Regulatory is the beginning, not the end

(05:40) The reimbursement float and patients walking away from a cure

(09:31) Speed versus safety: whose risk is it?

(15:53) Sick enough yet? Moving cell and gene therapy off the last line

(20:05) The desperation economy of unproven stem cells

(25:19) Navigating FDA turnover: "Bumpy."

(27:58) In vivo gene therapy: the decade-plus problem

(31:33) China, and what we don't know

(35:11) What inspired this career

(40:05) The hardest decision: the Jesse Gelsinger case

Guests: Bambi Grilley, President-Elect, ISCT (LinkedIn: https://www.linkedin.com/in/bambi-grilley-rph-cip-ccrc-ccrp-rac-076493114/). Jaap Jan Boelens, Chief Medical Officer, ISCT (LinkedIn: https://www.linkedin.com/in/jaapjanboelens/).

Open Door Salon is the life-sciences podcast hosted by Lori Ellis. Subscribe, and get the free quarterly briefing on Substack.

This episode is made possible by MedTech World: https://med-tech.world/

Medtech launches don't fail for one reason. They fail at the FDA, at the payer, or at the firewall. Host Lori Ellis continues a conversation started at MedTech World with Christian Espinosa, Founder and CEO of Blue Goat Cyber, and Edwin Lindsay, Principal Consultant and Managing Director at CS Lifesciences, on all three forces at once: why FDA cybersecurity deficiency letters are exploding, why vibe coding has no place in a regulated device, why China is a signal and not a verdict, and why reimbursement planning that starts after clearance is already too late.

(00:00) Where medtech launches actually break first

(01:52) 37 pages of FDA cybersecurity deficiencies

(03:44) The 180-day clock and what happens when companies miss it

(06:16) Why vibe coding fails FDA scrutiny

(08:00) The questions investors should be asking before they write a check

(10:05) Patient safety, not data protection, is the real cybersecurity question

(14:00) China, supply chains, and the CMS8000 backdoor

(20:41) A modified firmware chip and a very bad feeling

(22:20) What FDA readiness actually means in 2026

(25:27) The submission delay nobody saw coming five years ago

(26:45) Why "it's just a Docker container" isn't a defense

(29:49) When reimbursement strategy should enter product design

(32:20) The most expensive reimbursement mistake either of them has seen

(36:36) The hardest professional decision each of them has made

(40:25) What pulled each of them into healthcare

Guests: Christian Espinosa, Founder & CEO, Blue Goat Cyber (LinkedIn: https://www.linkedin.com/in/christianespinosa/). Edwin Lindsay, Principal Consultant & Managing Director, CS Lifesciences (LinkedIn: https://www.linkedin.com/in/edwin-lindsay-5a1980/).

Open Door Salon is the life-sciences podcast hosted by Lori Ellis. Subscribe, and get the free quarterly briefing on Substack.

Two wars, a pandemic threat, and a regulatory system under strain are hitting global health at the same time. Anna Titkova, who led clinical operations in Ukraine through the invasion, and Prashant Yadav of the Council on Foreign Relations, one of the world's leading voices on healthcare supply chains, join host Lori Ellis on Open Door Salon.

They cover what happened to clinical trials and patients when the war stopped shipments into Ukraine, why pharmaceutical supply chains push low- and middle-income countries to the back of the queue, the patients the market never sees, the erosion of confidence in the US FDA, China's very different model of health diplomacy, the global health funding gap, and why reform is not the same as dismantling.

(00:00) Intro — two wars, a pandemic, and a system under strain

(00:56) Clinical trials under fire: lessons from Ukraine

(04:28) Why supply chains push vulnerable patients to the back of the queue

(06:17) Inclusive research, or retreat to the safest places?

(08:24) Regulatory instability and the eroding confidence in the FDA

(12:40) Is the global community actually coming together?

(14:57) Ukraine's healthcare supply chains and Europe's response

(18:45) "The market doesn't see them"

(21:27) Can China fill the void? A different model

(25:16) Making care findable for displaced patients

(27:28) Entrepreneurs, young people, and reforming global health

(29:47) Reform is not the same as dismantling

(32:01) The hardest decisions, and what drives them

Guests: Anna Titkova, MD, PhD, MBA, Clinical Research Site Network Leader at Pratia (previously led clinical research operations in Ukraine); and Prashant Yadav, Senior Fellow at the Council on Foreign Relations.

Open Door Salon is the life-sciences podcast hosted by Lori Ellis. Subscribe, and get the free quarterly briefing on Substack.

New US rules are reshaping how pharma and biotech can do deals with China, and BIOSECURE was only the start. Theresa Campobasso, Senior Vice President at Aardwolf Global and a former US Marine Corps intelligence officer, returns to Open Door Salon to read the regulatory signals with host Lori Ellis.

They cover what the BIOSECURE Act actually restricts, why it's an early signal rather than the finish line, the likely next targets (APIs, raw materials, precursors), the USITC investigation into Chinese state subsidies, and the proposed COINS Act that would put US investment, licensing, and joint ventures in Chinese biotech under government review. Plus why existing deals may not be grandfathered in, the specific ways IP gets stolen, what the 28% concentration of top pharma deals in Chinese biotech means now, the medtech and hardware angle, and how to read where the regulation goes next.

(00:00) Intro — why China regulation matters now

(00:22) The China update: what just changed

(01:04) What the BIOSECURE Act actually covers (the 5 named companies)

(02:10) Why BIOSECURE is an early signal, not the finish line

(03:29) The next targets: APIs, raw materials, chemical precursors

(05:32) The USITC investigation + the COINS Act explained

(09:08) Does this hinder innovation? The window to act now

(10:35) Will existing China deals be grandfathered in?

(13:31) The different ways your IP actually gets stolen

(15:52) 28% of top pharma deals are China — now what?

(18:49) Medtech, counterfeit hardware, and the Warp Speed catch

(21:56) How to read where the regulation is headed next

Guest: Theresa Campobasso — SVP, Aardwolf Global; former US Marine Corps intelligence officer. LinkedIn: https://www.linkedin.com/in/theresa-campobasso-02b78b56/

Open Door Salon is the life-sciences podcast hosted by Lori Ellis. Subscribe, and get the free quarterly briefing on Substack.

China is on everyone's mind in life sciences, and the pharma supply-chain risk runs deeper than the BIOSECURE Act reaches. Theresa Campobasso, a former U.S. Marine Corps intelligence officer, explains where the real exposure hides.

Most companies vet a new partner, clear the third-party check, and call it done. Theresa Campobasso, Senior Vice President at Aardwolf Global Solutions and a former Marine Corps counterintelligence officer, explains why that is exactly where the risk begins. Hidden state ownership, Chinese military and government presence, and foreign ownership, control, and influence tend to live in tiers three through five of the supply chain, below where almost anyone looks.

In this first episode of our series on China and the life sciences, Theresa and host Lori Ellis get into what the BIOSECURE Act actually covers (federal contractors and a short list of named companies) and the commercial channel it leaves wide open, where a private pharma company can still license molecules, co-develop IP, and run discovery on Chinese AI platforms untouched by the law. They cover intellectual-property and patent theft, forced-labor exposure under the Uyghur Forced Labor Prevention Act, how the war in Iran and the closure of the Strait of Hormuz are handing China an energy-security opening, and the good news: why AI and agentic tools now make it possible to map a supply chain down to the raw material, something that was not feasible five years ago.

GUEST

Theresa Campobasso, Senior Vice President, Aardwolf Global Solutions; former U.S. Marine Corps intelligence officer (counterintelligence support to the DIA).

LinkedIn: https://www.linkedin.com/in/theresa-campobasso-02b78b56/

Aardwolf Global: https://www.aardwolfglobal.com/

HOST

Lori Ellis, Open Door Salon — candid conversations with the people who live inside, fight for, and fund healthcare.

Read the seven key takeaways from this episode, free on Substack: https://opendoorsalon.substack.com/

CHAPTERS

00:00 Cold Open — "China's regulatory environment is faster"

03:00 US-China Dynamics: Adversaries or Frenemies?

05:00 Third Party Risk Assessments, Why "Box Checked" Isn't Enough

07:00 Where You Find Hidden State Ownership

08:30 Covid Changed Supply Chain to Being National Security

11:00 Uyghur Forced Labor Protection Act

13:00 Digital Supply Chain with AI Tools and Intangible Risks

15:00 Iran and China, Energy Security and Regional Partners

17:00 Biosecure Act, What It Does and Doesn't Cover

20:00 Private Pharma Still Exposed — The Commercial Channel

We have to apologize for the video quality. Ali's recording corrupted.

GLP-1s hit $13 billion in sales last quarter — the highest-selling drug class globally. But a surgeon who still practices emergency medicine is seeing side effects the clinical trials didn't predict.

Ali Pashazadeh (Treehill Partners) is a surgeon-turned-banker who still works the ER. Jon Rees (MitoRx Therapeutics) is building next-generation obesity treatments that don't rely on appetite suppression.

Together they discuss:

• Why GLP-1s work — and why they're essentially a starvation response
• Atypical side effects: kidney stones, visual disturbances
• MitoRx: targeting mitochondria instead of appetite
• The personal moments that shaped their careers

Plus: Why Ali left full-time medicine after watching a team argue for 6 hours over a breast cancer patient's surgery. And what Jon wants on his gravestone.

SHOW NOTES

Ali Pashazadeh — Founder & CEO, Treehill Partners | Practicing Surgeon | Former Goldman Sachs, UBS, Blackstone🔗 LinkedIn: https://www.linkedin.com/in/ali-pashazadeh-8490b841/

Jon Rees — CEO & Co-founder, MitoRx Therapeutics🔗 LinkedIn: https://www.linkedin.com/in/jondrees/

🎬 YouTube: https://www.youtube.com/@OpenDoorSalon🍎 Apple: https://podcasts.apple.com/gb/podcast/open-door-salon/id1871280945🌐 Website: www.opendoorsalon.com

"There's probably about a 15 minute window on a certain Tuesday where you fit into the right window for an investor. You're too early. You're too late."

Edwin Stone is the CEO of Cellular Origins, building robotic manufacturing for cell therapy.

Erik Digman Wiklund is the CEO of Circio Holding, developing next-gen gene therapies. Both actually got funded in a market where almost no one does.

Two CEOs on why investors move in herds, why you can't do vaccines right now, and why China now has more cell therapy trials than the US.

In Today's Episode:

• "There's a 15 minute window on a certain Tuesday": the absurd reality of biotech funding
• Investors move in herds: in vivo CAR-T gets everything
• "You can't do vaccines right now": the political climate
• "Falling between the cracks": too early, then too late
• China now has the majority of cell therapy trials
• Platform vs asset: why platforms fell out of favor
• Cost of Phase 1 has gone up 4x in less than 10 years
• Europe is half the cost of the US
• What a well-funded company looks like in 2028

Timestamps:

(00:00) Cold Open: "The 15 Minute Window Becomes Five"(05:00) The Funding Environment: In Vivo CAR-T Gets Everything(10:00) Investors Move in Herds(15:00) "You Can't Do Vaccines Right Now"(20:00) Platform vs Asset(25:00) China Has the Majority of Trials(30:00) "Falling Between the Cracks"(35:00) The 15 Minute Window(40:00) What Well-Funded Looks Like in 2028(45:00) Europe Is Half the Cost

SHOW NOTES

Edwin Stone — CEO, Cellular Origins🔗 Cellular Origins: https://www.cellularorigins.com/

Erik Digman Wiklund — CEO, Circio Holding🔗 Circio: https://www.circio.com/

"AI is going to augment — it's going to allow things to work quicker, more efficiently. But it's not going to cut corners. It's not going to allow us to not do what's required to deliver the care people deserve."

Steve McWilliams is the VP and CIO at the Georgia Hospital Association. Richard Hicks is the CEO of Inspiredu, a nonprofit providing equitable access to technology and broadband education.

A hospital CIO and a community advocate on why the digital divide is a health divide.

In Today's Episode:

• "AI won't cut corners" — realistic expectations for healthcare AI
• "Your zip code dictates your future" — geography and health outcomes
• Technology deserts — when broadband access doesn't exist
• "Connectivity is like breathing" — the stakes of the digital divide
• Ambient listening and AI consent — the hot topic in healthcare
• "Check the bag" — how to validate what AI tells you
• The silver tsunami — aging population, shrinking workforce
• Consistency over confetti — building community trust
• "Enter to heal, depart to be well" — the mission

Timestamps:

(00:00) Cold Open — "AI Won't Cut Corners"(04:00) The Trust Gap — Why Patients Don't Engage(08:00) "Your Zip Code Dictates Your Future"(12:00) Technology Deserts — Broadband Access(16:00) Ambient Listening and AI Consent(20:00) "Check the Bag" — Validating AI(24:00) Cybersecurity Breaches and Trust(28:00) Hospital Economics(32:00) The Partnership Model(36:00) Consistency Over Confetti(40:00) The Silver Tsunami(44:00) "Enter to Heal, Depart to Be Well"

SHOW NOTES

Steve McWilliams — VP & CIO, Georgia Hospital AssociationVP and CIO at Georgia Hospital Association. Board member, Georgia HIMSS. Mission: shaping a healthier Georgia through advocacy, education, and communication.🔗 LinkedIn: https://www.linkedin.com/in/mcwilliamssteven/https://www.gha.org/Richard Hicks — CEO, InspireduCEO of Inspiredu, a nonprofit providing equitable access to technology, training, and broadband education. Background in technology, transitioned to nonprofit work in 2007. Focus: kitchen table issues, not nice-to-haves.🔗 LinkedIn: https://www.linkedin.com/in/richard-inspiredu/

Get Involved

https://www.iuatl.org/

"When you start to peel back the onion of what Iran provides to us, healthcare is at the very top."

A former CIA Chief and a former Microsoft VP on what the Iran war reveals about healthcare's hidden vulnerabilities.

Clinton West is the Former CIA Chief, Office of Supply Chain Risk Management — 20+ years at the agency including deployments in Afghanistan, Iraq, and Europe.

Mike Walker is CEO of Agentic Data Systems, Former Microsoft VP, Former Gartner VP — and he was nearly kidnapped in Cairo.

In Today's Episode:

• "I was nearly kidnapped in Cairo" — the dangers of global supply chain work
• Only 3% of pharma knows their supply chain end to end
• 70% of API comes from India and China — the hidden dependency
• "Supply chain doesn't collapse — it erodes slowly"
• What the Iran war reveals about healthcare vulnerabilities
• CIA tabletop exercises — "Let's play a game"
• The AI race — only two superpowers: US and China
• "What's an AirTag?" — meeting people where they are
• From Somalia at 19 to CIA Director — the personal journey

Timestamps:

(00:00) Cold Open — "I Was Nearly Kidnapped in Cairo"(04:00) What the Iran War Reveals About Healthcare Supply Chains(08:00) 70% of API Comes from India and China(12:00) "Supply Chain Doesn't Collapse — It Erodes Slowly"(16:00) Lessons from Afghanistan and Ukraine(20:00) Only 3% of Pharma Knows Their Supply Chain(24:00) How to Build a Supply Chain Risk Strategic Plan(28:00) CIA Tabletop Exercises — "Let's Play a Game"(32:00) "Family Counseling" — Emotional Intelligence in Risk(36:00) The AI Race — US vs China(40:00) What a Truly Resilient Supply Chain Looks Like(44:00) "What's an AirTag?" — Meeting People Where They Are(48:00) From Somalia at 19 to CIA Director

SHOW NOTES

Clinton West — Former CIA Director, Office of Supply Chain Risk ManagementPresident, Supply Chain Security Practice at Aardwolf Global Solutions. 20+ years CIA.LinkedIn: https://www.linkedin.com/in/clinton-west-jr/

Mike Walker — CEO, Agentic Data Systems | Former Microsoft VP | Former Gartner VPLinkedIn: https://www.linkedin.com/in/mikejwalker/

"Some of the best companies were founded during some of the worst times. It's almost Darwinian."

That's Mike Goguen — founder of Two Bear Capital, 20 years as a general partner at Sequoia Capital. With him is Rob Williamson — serial entrepreneur and 35+ years in drug development.

A 30-year venture capitalisst and a serial drug developer on surviving biotech's worst times, the AI bubble, and why founders should "beware the kindness of strangers."

In Today's Episode:

• "The best companies start in the worst times" — Darwinian survival
• "Where's the beef?" — spotting real AI vs window dressing
• Biotech can't compete for AI talent — half a million out of school
• Are we in an AI bubble? Lessons from multiple crashes
• Quantum AI — the revolution after the revolution
• "Thank you for giving me another Christmas" — why it's worth it
• "I've called it my vow of poverty" — why biotech over tech

Timestamps:

(00:00) Cold Open — "I'm Not Sure I Want to Say What I'm Really Thinking"(04:17) The Current Investment Landscape — Capital Efficiency Matters(08:00) Minimizing Dependence(12:00) First-Time Founders vs Experienced Operators(16:00) Product-Market Fit in Biotech — What Pharma Wants(20:00) M&A Is Slower Than Expected — Why Deals Are Stalling(24:00) The AI Revolution in Drug Discovery — What's Real(28:00) AlphaFold, Digital Twins, and the In Silico Loop(32:00) "Where's the Beef?" — Real AI vs Window Dressing(36:00) Biotech Can't Compete for AI Talent(40:00) Are We in an AI Bubble?(44:00) Quantum AI — The Next Revolution(48:00) "Thank You for Giving Me Another Christmas"(52:00) The Hardest Decision — Going All-In

SHOW NOTES

Mike Goguen — Founder & Managing Partner, Two Bear Capital20 years as General Partner at Sequoia Capital (1996-2016). Two Bear Capital invests at the intersection of tech and life sciences.LinkedIn: https://www.linkedin.com/in/michael-goguen-23314/

Rob Williamson — Founder & CEO, Traverse Therapeutics35+ years in drug development. Multiple drugs to market. Former BCG partner. AI-enabled drug delivery across the blood-brain barrier.LinkedIn: https://www.linkedin.com/in/robwilliamson/

Description

"Our transplant doctor at Hershey wrote us off and never spoke to us again. We signed her out against medical advice. And it saved her life."

Tom Whitehead is the co-founder of the Emily Whitehead Foundation and father of Emily Whitehead — the first pediatric patient in the world to receive CAR-T cell therapy. In 2012, when Emily was 6 years old and facing end-stage leukemia after two relapses, they defied medical advice, enrolled in an experimental trial at CHOP, and Emily became cancer-free 23 days later. She's now 21 and 14 years cancer-free.

Victoria (Tori) Lee was the 10th pediatric patient to receive CAR-T at CHOP. Diagnosed at 5, she went through four years of chemo and radiation before receiving CAR-T in 2013. Now 13+ years cancer-free, she's a health policy student presenting at ACRP on the bioethics of CAR-T access.

In Today's Episode:

• "We signed her out against medical advice — it saved her life"
• Only 20% of eligible patients get CAR-T — 80% don't
• "You're not sick enough yet" — when can patients get CAR-T?
• 45,000 lives saved — from one patient to tens of thousands
• Under $50K, under a week — manufacturing is advancing
• Trials leaving the US — patients going to Italy, Beijing
• Fighting insurance denials with AI
• "Emily is as famous as Taylor Swift to my daughter"
• "It's hard to talk about the worst days of your life"
• Advice for parents and patients seeking cell therapy

SHOW NOTES

Tom Whitehead — Co-Founder, Emily Whitehead FoundationFather of Emily Whitehead, the first pediatric CAR-T patient. Author of "Praying for Emily."

• Emily Whitehead Foundation (Co-Founder)LinkedIn: https://www.linkedin.com/in/tom-whitehead-08ba32102

Victoria (Tori) Lee — CAR-T Survivor | Health Policy StudentThe 10th pediatric CAR-T patient at CHOP. 13+ years cancer-free.

• Emily Whitehead Foundation (Patient Advocate)Story: https://www.emilywhiteheadfoundation.org/patient-stories/tori-lee/

Resources:Emily Whitehead Foundation: https://www.emilywhiteheadfoundation.org/CHOP Cancer Immunotherapy: https://www.chop.edu/centers-programs/cancer-immunotherapy-program"Praying for Emily" (Book): Free to patients and caregivers

✨ Support the Mission: The Emily Whitehead Foundation helps families find life-saving trials and advocates for wider access to cell and gene therapies.👉 Learn more or donate: https://www.emilywhiteheadfoundation.org/donate

Jim Kremidas spent 24 years at Eli Lilly and started the industry's first Patient Recruitment Department. Then he got bladder cancer — and couldn't find a clinical trial using the tools he helped build.

Elisa Cascade has 30+ years in clinical research technology. Former CPO at Science 37 and Advarra. Past Chair of ACRP. Built a 2.7 million patient community for direct-to-patient recruitment.

In Today's Episode:

• "Impossible to find a study" — even for industry insiders
• It took 6 people to connect Jim to a clinical trial
• ClinicalTrials.gov is wrong 80% of the time
• ChatGPT is now recommending clinical trials
• The hidden barrier: patient compensation varies wildly
• "I fell into clinical research" — time to reframe
• Why sites don't call patients back for 5 days
• The "Generations" study: how messaging changes everything

SHOW NOTES

Jim Kremidas — Executive Director, AMRC35+ years in healthcare. 24 years at Eli Lilly. Former Executive Director of ACRP. Bladder cancer survivor.

• AMRC (Executive Director)
• ACRP (Former Executive Director)LinkedIn: https://www.linkedin.com/in/jimkremidas/

Elisa Cascade — Chief Growth Officer, TrialScreen30+ years in clinical research. Former CPO at Science 37 and Advarra. Past Chair, ACRP. Wharton MBA.

• TrialScreen (Chief Growth Officer, Head of Americas)
• ACRP (Past Chair, Fellow)LinkedIn: https://www.linkedin.com/in/elisa-cascade/

Resources:AMRC: https://amrc.org/TrialScreen: https://www.trialscreen.org/CISCRP: https://www.ciscrp.org/

Sunitha Malepati is the Founder and CEO of the Buffalo Initiative. When her daughter was diagnosed with a rare neurogenetic condition, the doctor told them: "Go home and love your kid. There's nothing we can do." She refused to accept that answer.

Craig Lipset is a clinical innovation leader, former Head of Clinical Innovation at Pfizer, and co-chairs the Decentralized Trials & Research Alliance.

In Today's Episode:

• "Go home and love your kid" — what one doctor said after diagnosis
• Why pharma can't — and won't — solve ultra-rare diseases
• 7,000+ rare conditions with no treatments
• "Lemonade stands and bake sales" funding clinical trials
• The Buffalo Initiative: bundling and blending patient capital
• California leading state-level rare disease investment
• "This IS an investable proposition"
• Advice for biotechs, patients, and pharma

SHOW NOTES

Sunitha Malepati — Founder & CEO, Buffalo InitiativeAttorney turned rare disease advocate. Two-time Chan Zuckerberg Initiative grantee. Speaker at the White House Cell and Gene Therapy Forum.

• Buffalo Initiative (Founder & CEO)
• CACNA1A Foundation (Vice President)
• COMBINEDBrain (Governing Board)LinkedIn: https://www.linkedin.com/in/sunitha-malepati-5959952/

Craig Lipset — Clinical Leader, Buffalo Initiative | Co-Chair, DTRA20+ years transforming drug development. Former Head of Clinical Innovation at Pfizer.

• Buffalo Initiative (Clinical Leader)
• Decentralized Trials & Research Alliance (Co-Chair)
• Foundation for Sarcoidosis Research (VP, Board)LinkedIn: https://www.linkedin.com/in/lipset/

Resources:Buffalo Initiative: https://www.buffaloinitiative.org/DTRA: https://www.dtra.org/CACNA1A Foundation: https://www.cacna1a.org/

Jesús Zurdo is a scientist — molecular biology, drug discovery, manufacturing, company creation. Three and a half years ago, he was diagnosed with Philadelphia-positive acute lymphoblastic leukemia. 92% of his bone marrow was cancer cells. His donor was a stranger in Florida.

In Today's Episode:

• Diagnosed in one day — the UK system
• Nobody told me about brain fog — it stays for years
• Finding a donor: "He is my hero"
• "40% of us in this room will not make it"
• You go in with one disease, come out with two
• "I don't like when people talk about cures"
• Lisa — same diagnosis, didn't make it, survivor's guilt
• "This is my purpose in life — in neon letters"
• Scientists don't understand healthcare — until they become patients

Dr. Karla Loken is an OB-GYN who spent 20+ years in clinical practice before moving into industry. Three months ago, she was diagnosed with appendix cancer — 1 in 200,000. One month ago, she had major surgery. Now she's back to share what the system looks like from the other side.

In Today's Episode:

• Why she went public with her cancer
• The physician network that got her answers in hours
• Survivor guilt: "I'm lucky I had the network"
• Every patient is an N of one — there's no cookbook
• The waiting is the worst part
• What industry can do: the light side of the dark side
• "Your brain is still valuable" — advice for physicians facing illness
• Advice for patients: bring someone, write it down, find a navigator

Konstantina Katcheves is Chief Business & Strategy Officer at Acadia Pharmaceuticals. Former SVP at Bristol-Myers Squibb. Led BMS through the Karuna Bio and RayzeBio acquisitions in a single month. Now at Acadia building rare disease capabilities.

Daphne Karydas is President & CFO of Flare Therapeutics. Former CFO at Syndax, Head of Corporate Strategy at Allergan, and 15+ years on Wall Street. It took her 7 years to leave — she calls it "commitment phobia."

In Today's Episode:

• Why the CBO and CFO must be locked arms
• The ecosystem: large companies need small, small need large
• How long does it take? Years of relationship building before a deal
• You need an internal champion — often multiple
• M&A is actually cleaner — partnerships are harder
• "Every deal is bespoke" — no cookie cutter deals
• Advice: grit, resiliency, and trusted advisors

Jeff Fischer is Co-Founder and President of Longhorn Vaccines and Diagnostics — developing monoclonal antibodies that target chronic inflammation upstream, before it starts.

Steve Butts is Co-Founder and CEO of Arrivo BioVentures. His lead drug for depression works in women but not men. Then investors asked: "Is there really a market for that?"

In Today's Episode:

• Longevity isn't living to 120 — it's expanding healthspan
• SIRT6: DNA repair, mitochondria, glucose, inflammation
• Chronic inflammation: the upstream trigger most biologics ignore
• Why estrogen levels affect gut permeability and inflammation
• The depression drug that only works in females — and why that's a feature
• GLP-1s are tightening gut junctions — here's what that means
• Longevity for the few vs. longevity for the many

Tina Valbh, BS Pharm, RPh is a pharmacist with 28 years in life sciences — Managing Partner at Pharma Connect and founder of Tina's Warriors. She builds patient access programs. Then she got cancer — and discovered none of it worked the way the slide decks said.

Karla Loken, DO, OBGYN, FACOOG practiced OB-GYN for 20+ years before leading clinical development and medical affairs roles at Hologic, Roche, HerMD, and FEMSelect. She was diagnosed with appendix cancer 3 months ago. She's navigating the system she helped build.

In Today's Episode:

• The biggest gap right now: misinformation from TikTok to pharma
• "I got the same drug info 5 different ways — none of it matched"
• "I'm so tired of hearing 'we mapped the patient journey' — no you didn't"
• Clinical trial enrollment and the trust deficit
• "I got a denial yesterday. I haven't picked up the phone."
• Why reimbursement is 30% higher for the same surgery on men
• Advice to industry: fund the advocacy groups — it's the first line item cut

Matt Hewitt is CTO of the Manufacturing Business Division at Charles River Laboratories.

Jeff Holder is Partner and Managing Director at LEK Consulting, advising biopharma and investors on cell and gene therapy strategy since the first CAR-T approvals in 2017.

In Today's Episode:

• JPM 2026: Is cell & gene therapy interest real or cooling?
• Why manufacturing cost isn't the real barrier to adoption
• "Do boring better" — the 2026 investor thesis
• Should cell therapy be reimbursed as a procedure, not a drug?
• "The cheapest patient is a dead patient" — European payer realities
• Only 20% of eligible US patients get cell therapy (5% globally)
• The biologics benchmark: it took 12 years to get the first blockbuster antibody
• Why this space is "ADHD" — and why that's a feature, not a bug

Katie Schubert is President & CEO of the Society for Women's Health Research — 35+ years advocating for sex differences research. Former Capitol Hill staffer. Her goal: make women's health so mainstream that her organization goes out of business.

Joanna Stickler is VP of Health Policy & External Affairs at Roche Diagnostics. Former public health professional. Her mantra: we haven't even implemented A, B, and C before demanding X, Y, and Z.

In Today's Episode:

• What famines teach us about transgenerational health
• Why pregnancy sets the stage — but nobody's tracking it
• 1 in 5 women left or considered leaving their jobs due to menopause
• "Bikini medicine" and why women's health needs a rebrand
• Women weren't included in clinical research until 1993
• Endometriosis, PCOS, and the diseases we're ignoring
• The 9-minute primary care appointment isn't working

Frank Watanabe is the President and CEO of Arcutis Biotherapeutics, a dermatology biotechnology company based in Los Angeles. He's also the Vice Chairman of BIO. Frank spent 30 years in biopharma after a prior career in national security — he stumbled into the industry at Eli Lilly and stayed for the mission.

Josh Fessel is a physician-scientist who most recently served as Chief Medical Officer and Director of the Office of Translational Medicine at NCATS (National Center for Advancing Translational Sciences) at the NIH. He left federal service approximately 7-8 months ago after the landscape shifted in ways that conflicted with his values and oaths as a physician.

In Today's Episode We Discuss:

• Cash Is Oxygen: Advice for CEOs in a Tough Funding Environment
• The AI Bubble & Why It Popping Might Be Good for Biotech
• The 8-10 Year Divot in Basic Research That's Coming
• Brain Drain: Canada, France & Australia Are Recruiting US Scientists
• China's Rise & Why the Me-Too Strategy Is Dead
• State-Level Innovation: "50 Kids in a Trench Coat"
• Coopetition as a Survival Strategy
• The Hardest Decisions: Layoffs & Leaving Federal Service

Connect with Open Door Salon:LinkedIn I YouTube⁠ I Website

Andy Holt is the Chief Commercial Officer at Viralgen Vector Core, a company specializing in the contract manufacture of AAV gene therapies. A self-described "really bad molecular biologist" who moved to the commercial side, Andy has spent 18 years in cell and gene therapy, including a stint as VP at AskBio before its acquisition by Bayer.

Phil Vanek is the Chief Commercialization Officer at ISCT (International Society for Cell and Gene Therapy). Another former bench scientist who decided to "head into the business world," Phil has built his career in product development, innovation leadership, and investing on behalf of private equity.

In Today's Episode We Discuss:

• Why Clinical Adoption Isn't Keeping Up with Approvals
• CAR-T for $50,000 in India — Why Can't the US Do This?
• The $4 Million Problem: Employment-Linked Healthcare Breaks Everything
• First-in-Human Trials in Under a Year for Under $20 Million
• NIH Funding Uncertainty: Spend Every Dollar Like It's Your Last
• Why AI Is a "Shiny Object" Siphoning Capital
• Advice for Startups: "Hunt for Boring"
• Advice for Investors: "Don't Drink the Kool-Aid"

(00:00) Intro & Meet the Guests

(03:12) Why Clinical Adoption Isn't Keeping Up with Approvals

(06:44) Manufacturing Cost Is No Longer the Biggest Problem

(10:02) The Education Problem: Clinicians Are Learning Too

(14:20) Payers Think Like Investors — Here's What That Means

(17:46) The $4 Million Problem: Why Employment-Linked Healthcare Breaks Everything

(23:26) What Challenges Are Companies Facing Right Now?

(27:49) First-in-Human in Under a Year for Under $20 Million

(31:24) NIH Funding Uncertainty: Spend Every Dollar Like It's Your Last

(37:01) Instability Creates Opportunity — But Also Higher Risk

(42:08) Advice for Startups: Hunt for Boring

(44:25) Advice for Investors: Don't Drink the Kool-Aid

(46:38) Why They Chose This Industry

(52:37) Closing

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Colin Zick is a Partner at Foley Hoag, where he co-chairs both the Health Care Compliance practice and the Privacy & Data Security practice. With over 30 years of experience navigating healthcare regulation and cybersecurity, Colin has seen administrations come and go—and knows that the fundamentals of compliance never change, even when everything else does.

Anne Herold Li is a Shareholder at Brownstein Hyatt Farber Schreck, where she serves as Managing Partner of the New York office and co-chairs the Life Sciences practice. A former epidemiologist who was once the "Rat Queen of New York City," Anne pivoted to law after her brother suggested she might enjoy patent law—where someone pays you to learn the latest science every day.

In Today's Episode We Discuss:

• Supreme Court Tariff Ruling & What It Means for 300,000+ Companies
• The Biosecure Act Is Back — With Immediate Impact
• AI Regulation: US "Hold My Beer" vs. EU's Tricycle Approach
• Why Companies Actually Want to Be Regulated
• Effective Lobbying: Tell Your Story Like Hamilton
• The Boring But Critical: Tax, Insurance & Force Majeure

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#biotech #lifesciences #patent #biosecurity #tariffs #drugdevelopment #AI #healthcare #pharma #OpenDoorSalon #ODS

Chris Bardon is the Managing Partner at MPM BioImpact, a dedicated biotech investment firm working across private and public markets. A Harvard-trained physician who completed her residency at Brigham and Women's Hospital, Chris has spent over 20 years in biotech investing, including time at Fidelity before launching her own fund. She also serves on the board of the American Association for Cancer Research.

Elaine Hamm is a scientist turned operator who has spent her career moving between startups, academia, and venture capital. She currently manages a portfolio of pharmaceutical companies, serves as Executive in Residence at Tulane School of Medicine, and is Executive Director of the Alliance of Artificial Intelligence in Healthcare. She also owns a wine bar.

In Today's Episode We Discuss:

• Is the 2020 Biotech Bubble Hangover Finally Over?
• The AI Bubble in Life Sciences: Real vs. Hype
• China's Rise from CRO to Pharmaceutical Competitor
• Brain Drain & NIH Funding Threats
• What Makes Companies Fundable in 2026
• The #1 Red Flag That Kills Deals: Defensiveness
• Career Pivots: From Piano to Pharma

Connect with Open Door Salon:

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#investment #healthcare #biotech #lifesciences #AI #cancer