Open Door Salon

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/