Open Door Salon

Theresa Campobasso and Clinton West return to Open Door Salon. Campobasso is chief strategy officer of Reinaert and a former U.S. Marine Corps intelligence officer. West is Reinaert's president of supply chain security and logistics operations and a former CIA supply chain risk leader.

They discuss the Beam Therapeutics lawsuit and the insider risk signals that could catch a case like it earlier, how a faster foreign patent office lets stolen research win the patent race, why IP theft cases rarely reach court, the due diligence investors skip, and what a breach at a venture firm exposes.

Theresa Campobasso | Chief Strategy Officer, Reinaert

Theresa Campobasso is chief strategy officer of Reinaert, a service-disabled, veteran-owned firm that provides security, logistics and mission support to government and commercial clients. A former U.S. Marine Corps intelligence officer, she served overseas in support of special forces in Afghanistan and later helped stand up the Defense Intelligence Agency's first Acquisition Risk Task Force. Before Reinaert she was SVP for strategic accounts at Exiger and a partner and SVP at Aardwolf Global Solutions. She is a Certified Insider Threat Program Manager and holds degrees from the University of Notre Dame and Georgetown University.

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

Clinton West | President, Supply Chain Security and Logistics Operations, Reinaert

Clinton West is president of supply chain security and logistics operations at Reinaert, a service-disabled, veteran-owned firm that provides security, logistics and mission support to government and commercial clients. He spent more than two decades at the Central Intelligence Agency, where he led the Office of Supply Chain Risk Management. Earlier he served in the U.S. Navy and at the National Reconnaissance Office. Before Reinaert he led the supply chain security practice at Aardwolf Global Solutions. He traces his interest in supply chain security to moving cargo in Somalia early in his career.

LinkedIn: https://www.linkedin.com/in/clinton-west-jr/

(00:00) The Beam Therapeutics case and three insider risk signals

(04:05) How a faster foreign patent office wins the race

(07:10) Why IP theft cases are so hard to win in court

(10:29) Sources and methods, and the diligence companies skip

(14:34) When an investor withholds capital: economic statecraft

(20:53) When a VC's portfolio company is breached

(27:01) Congress, Treasury and Section 1260H compliance

(33:56) What this career asked that they did not expect

(38:10) What the career cost them

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: http://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/