# Open Door Salon

> Life-sciences podcast where C-suite operators in pharma, biotech, and healthcare
> investment have unscripted conversations about drug development, biotech investment,
> AI in drug discovery, the BIOSECURE Act, women's health, cell + gene therapy, and the
> operator-level realities of healthcare innovation. Host: Lori Ellis, founder of Open Door Salon.

## About

- [About / homepage](https://opendoorsalon.com/): Show mission, format, and host
- [Lori Ellis on LinkedIn](https://www.linkedin.com/in/loriaellis/): Host profile
- [Open Door Salon on Substack](https://opendoorsalon.substack.com/): Weekly essay + episode takeaways (canonical owned audience)
- [The Q2 2026 Life Sciences Briefing](https://opendoorsalon.com/life-sciences-briefing/): Free quarterly briefing distilling every guest conversation from the quarter. The Q2 2026 edition covers nineteen life-sciences operators across eleven conversations in thirteen pages, organised as Access (six conversations), Capital (three), and Security (two).
- [Open Door Salon on Wikidata](https://www.wikidata.org/wiki/Q140412118): Canonical entity for the podcast
- [Lori Ellis on Wikidata](https://www.wikidata.org/wiki/Q140412144): Canonical entity for the host

## Episodes
- [Pivot or Close: What the Last 90 Days of a Biotech Wind-Down Look Like | Esposito & Khrimian](https://opendoorsalon.com/biotech-wind-down-pivot-or-close/): David Esposito (ONL Therapeutics) and Pavel Khrimian (Deka Biosciences) on the ninety days before a biotech closes, the three questions that separate a pivot from a closure, and the fiduciary obligation to patients that outlives the company.
- [AI in Drug Discovery: What Happens When the Model Is Wrong | Cawood & Ognar](https://opendoorsalon.com/ai-drug-discovery-when-the-model-is-wrong/): Ryan Cawood (Co-Founder & CEO, Lab Thread) and Raphaël Ognar (President, CEO, Co-Founder & Chairman, NKILT Therapeutics) on where AI earns its place in drug discovery, why an AI error in biology surfaces months after it is made, who is legally responsible for AI-generated data in an FDA submission, and why neither will put AI in a pitch deck.
- [Where Biotech Money Goes When Venture Capital Stops | Demy & Levin](https://opendoorsalon.com/where-biotech-money-goes-venture-capital/): Sara Jane Demy (Founder & CEO, Demy-Colton) and Jeremy Levin (Co-Founder & Executive Chairman, Ovid Therapeutics; former President & CEO, Teva Pharmaceutical Industries) on why the A, B, C venture round path is not currently available, the family offices now deploying directly into biotech, the hubs forming beyond Boston and San Francisco, and why chief executives have changed their minds about Chinese clinical data.
- [Why Alzheimer's Startups Still Struggle to Raise Money | Harris & Narayanan](https://opendoorsalon.com/why-alzheimers-startups-struggle-to-raise-money/): Karen Harris (Alzheimer's Drug Discovery Foundation) and Mahesh Narayanan (Neuvation Ventures) on why early-stage neuroscience remains the hardest money in biotech to raise, why reimbursement and prescriber strategy now belong in the pre-IND conversation, how venture philanthropy and venture capital divide the risk, and the two red flags that end a seed round.
- [Why Nation States Target Small Biotechs, Not Big Pharma | Mikkili — Herold Li](https://opendoorsalon.com/nation-states-small-biotech-cybersecurity/): Raja Mikkili (VP, Core Technologies and Security, Arcutis Biotherapeutics) and Anne Herold Li (Shareholder & NY Managing Partner, Brownstein Hyatt Farber Schreck) on why small biotechs are the real cyber target rather than big pharma, what nation states want from anonymized clinical data, the West Pharmaceutical breach, auditing sub-tier supply chains, and the data-ownership clauses that decide who keeps the crown jewels.
- [Former FDA Commissioner Robert Califf on RFK Jr., the FDA Exodus, and China | Califf & Desai](https://opendoorsalon.com/fda-turnover-china-clinical-trials-califf-desai/): Robert Califf (two-time FDA Commissioner, Professor at Duke University School of Medicine) and Vid Desai (first FDA Chief Information Officer) on leadership turnover at the agency, Operation TrialBlazer, AI in regulatory work, and why China is closing the gap on research spending.
- [Why Patients Walk Away From a Cure They Qualify For | Grilley & Boelens](https://opendoorsalon.com/cell-and-gene-therapy-patient-access-grilley-boelens/): Bambi Grilley (President-Elect, ISCT) and Jaap Jan Boelens (Chief Medical Officer, ISCT) on why approved cell and gene therapies still don't reach patients — reimbursement, single-case agreements, unproven stem cells, and in vivo gene therapy.
- [FDA, Payers & Hackers: The Three Forces That Make or Break a Launch | Espinosa & Lindsay](https://opendoorsalon.com/fda-payers-hackers-medtech-launch/): Christian Espinosa (Founder & CEO, Blue Goat Cyber) and Edwin Lindsay (Principal Consultant & MD, CS Lifesciences) on FDA cybersecurity, payer coverage, and hackers in medtech product launches.
- [When War Stops a Patient's Treatment | Anna Titkova & Prashant Yadav](https://opendoorsalon.com/clinical-trials-war-zone-global-health/): Anna Titkova (Pratia, Ukraine) and Prashant Yadav (Council on Foreign Relations) on clinical trials in a war zone, pharma supply chains in crisis, eroding regulator trust, and the patients the market never sees.
- [BIOSECURE Was the Start: The Rules for China Biotech Deals | Theresa Campobasso](https://opendoorsalon.com/regulatory-wave-reshaping-china-biotech-deals/): Former U.S. Marine Corps intelligence officer Theresa Campobasso on the regulatory wave reshaping China biotech deals: BIOSECURE's limits, the proposed COINS Act, how IP is stolen, and what regulators target next.
- [Why BIOSECURE Won't Protect Pharma From China | Theresa Campobasso](https://opendoorsalon.com/why-biosecure-wont-protect-pharma-from-china/): Ex-Marine intelligence officer Theresa Campobasso on hidden China supply-chain risk in tiers three to five, FOCI, the UFLPA, and the BIOSECURE Act's commercial-channel gap.

- ["Why Is CVS Selling Party Packs of M&Ms Alongside Ozempic?" | Pashazadeh & Rees](https://opendoorsalon.com/why-is-cvs-selling-party-packs-of-mms-alongside-ozempic/): Surgeon-banker Ali Pashazadeh (Founder & CEO, Treehill Partners) and MitoRx CEO Jon Rees discuss GLP-1 benefits and side effects, the $13B obesity market, and next-gen treatments beyond appetite suppression.
- ["There's a 15 Minute Window on a Certain Tuesday" | Stone & Wiklund](https://opendoorsalon.com/theres-a-15-minute-window-on-a-certain-tuesda/): Two CEOs who got funded when no one else could on why investors move in herds, why vaccines are unfundable, and why China has more trials than the US.
- ["AI Won't Cut Corners": A Hospital CIO and Community Advocate on the Digital Divide | McWilliams & Hicks](https://opendoorsalon.com/ai-wont-cut-corners-a-hospital-cio-and-community-advocate-on-the-digital-divide-mcwilliams-hicks/): A hospital CIO and community advocate on technology deserts, the silver tsunami, and why AI won't cut corners.
- [Cyberattacks and Closed Straits: Defending Pharma on Two Fronts | Clinton West & Mike Walker](https://opendoorsalon.com/cyberattacks-and-closed-straits-clinton-west-mike-walker/): A former CIA supply-chain risk official (Clinton West) and a Microsoft health & life-sciences digital-strategy leader (Mike Walker) on what the Iran war reveals about pharma's hidden supply-chain vulnerabilities. ~70% of API comes from India and China.
- ["The Best Companies Start in the Worst Times" | Mike Goguen and Rob Williamson](https://opendoorsalon.com/the-best-companies-start-in-the-worst-times-i-mike-goguen-and-rob-williamson/): 20 years at Sequoia, now betting on biotechs at Two Bear Capital. A VC's advice on surviving bubbles and building in downturns.
- ["We Signed Her Out Against Medical Advice." It Saved Her Life | Tom Whitehead & Tori Lee](https://opendoorsalon.com/we-signed-her-out-against-medical-advice-it-saved-her-life-tom-whitehead-tori-lee/): 45,000 lives saved by CAR-T. Only 20% of eligible patients get it. The father of Patient One and Patient Ten on why cell therapy access is still broken.
- [I Had Bladder Cancer & Couldn't Find a Clinical Trial. I Run Patient Recruitment! | Jim Kremidas & Elisa Cascade](https://opendoorsalon.com/i-had-bladder-cancer-and-couldnt-find-a-clinical-trial-i-run-patient-recruitment-jim-kremidas-elisa-cascade/): 80% of trials fail to recruit. ClinicalTrials.gov is wrong 80% of the time. Two industry insiders on why patients can't find trials.
- ["Pharma Is Not Coming." Patient Groups Are Now Drug Developers! | Sunitha Malepati & Craig Lipset](https://opendoorsalon.com/pharma-is-not-coming-patient-groups-are-now-drug-developers-sunitha-malepati-craig-lipset/): 7,000 rare diseases. No pharma interest. Patient groups are building their own drug companies. The Buffalo Initiative is changing rare disease funding.
- [92% of His Bone Marrow Was Cancer: A Scientist's Leukemia Journey | Jesús Zurdo](https://opendoorsalon.com/92-of-his-bone-marrow-was-cancer-a-scientists-patients-leukemia-journey/): Acute lymphoblastic leukemia, 92% of his bone marrow cancer. His donor was a stranger in Florida. A scientist on chemo brain, CAR-T, and survival.
- ["I'm Lucky I Had the Network": A Physician Becomes the Patient | Dr. Karla Loken](https://opendoorsalon.com/a-physician-becomes-the-patient/): Dr. Karla Loken on navigating cancer as a physician: the network that saved her, survivor guilt, and why patients need navigators.
- [Inside Pharma M&A: How Deals Get Done | Konstantina Katcheves & Daphne Karydas](https://opendoorsalon.com/inside_pharma_deals_katcheves_karydas/): How life-sciences M&A deals actually get done: valuation, diligence, and integration, from two dealmakers.
- [Why Men and Women Age Differently | Fischer & Butts](https://opendoorsalon.com/why-men-and-women-age-differently/): His depression drug works in women, not men. Investors asked if there's a market. Two CEOs on longevity, sex-based medicine, and gut health.
- [We Mapped the Patient Journey. No You Didn't](https://opendoorsalon.com/we-mapped-the-patient-journey-no-you-didnt/): Experts on the real complexity of the cancer patient journey and the misinformation patients navigate.
- [Why Only 20% of Eligible Patients Get Cell Therapy | Matt Hewitt & Jeff Holder](https://opendoorsalon.com/why-only-20-of-eligible-patients-get-cell-therapy-what-needs-to-change/): Only 20% of eligible US cancer and rare-disease patients get cell therapies. What's blocking access and what it takes to fix it.
- [What Happened to Your Grandmother Is Affecting Your Health | Katie Schubert & Joanna Sickler](https://opendoorsalon.com/what-happened-to-your-grandmother-is-affecting-your-health-katie-schubert-joanna-sickler-explain/): "Bikini medicine" and why women's health encompasses far more than reproductive issues in modern research.
- [Cash Is Oxygen: Frank Watanabe & Josh Fessel on Surviving Biotech's Chaos](https://opendoorsalon.com/biotech-survival-frank-watanabe-josh-fessel/): Arcutis CEO Frank Watanabe and former NIH physician-scientist Josh Fessel on biotech cash management, the NIH brain drain, and the coming 8-year pipeline gap.
- [The $50,000 Cure Problem: Why the US Can't Do What India Already Did | Andy Holt & Phil Vanek](https://opendoorsalon.com/why-the-us-cant-do-what-india-already-did-andy-holt-phil-vanek/): Why does sickle-cell gene therapy cost $50K in India and $4M in the US? Cell therapy pricing, manufacturing economics, and startup survival.
- [Everything Everywhere All at Once](https://opendoorsalon.com/everything-everywhere-all-at-once/): Healthcare attorney Colin Zick (Foley Hoag; co-chair, Health Care + Privacy & Data Security) and life-sciences attorney Anne Herold Li (Brownstein Hyatt Farber Schreck; NY Managing Partner + Life Sciences co-chair) on the regulatory chaos facing biopharma: tariffs, the BIOSECURE Act, and AI compliance.
- [We Are Trying To Cure Cancer](https://opendoorsalon.com/were-trying-to-cure-cancer/): MPM BioImpact Managing Partner Christiana Bardon, MD, and operator Elaine Hamm on deal red flags, China's shift from CRO to competitor, and AI reality in drug development.
- [A New Way to Talk About Healthcare](https://opendoorsalon.com/a-new-way-to-talk-about-healthcare/): Open Door Salon's debut episode, with Christiana Bardon, MD (Managing Partner, MPM BioImpact) and Elaine Hamm (Executive in Residence, Tulane School of Medicine).

## Honored Guests

Each guest has a dedicated profile page with a Person schema node (name, role, organization, sameAs) — the authoritative source for that person's appearance on Open Door Salon.

- [Ali Pashazadeh — Founder & CEO, Treehill Partners | Healthcare Investor, Surgeon & Former Banker](https://opendoorsalon.com/honored-guests/ali-pashazadeh/)
- [Andy Holt — CCO, Viralgen | AAV Gene-Therapy Manufacturing](https://opendoorsalon.com/honored-guests/andy-holt/)
- [Anna Titkova — Clinical Research Site Network Leader, Pratia | MD, PhD, MBA](https://opendoorsalon.com/honored-guests/anna-titkova/)
- [Anne Herold Li — Shareholder & NY Managing Partner, Brownstein Hyatt Farber Schreck | Co-Chair, Life Sciences Practice](https://opendoorsalon.com/honored-guests/anne-herold-li/)
- [Bambi Grilley — President-Elect, International Society for Cell & Gene Therapy (ISCT) | Cell & Gene Therapy Access & Regulatory](https://opendoorsalon.com/honored-guests/bambi-grilley/)
- [Christian Espinosa — Founder & CEO, Blue Goat Cyber | Medical-Device Cybersecurity](https://opendoorsalon.com/honored-guests/christian-espinosa/)
- [Dr. Christiana (Chris) Bardon — Co-Managing Partner, MPM BioImpact | Physician-Investor in Oncology & Biotech](https://opendoorsalon.com/honored-guests/christiana-bardon/)
- [Clinton West — President, Supply Chain Security, Aardwolf Global Solutions | Former CIA Supply-Chain Risk Leader](https://opendoorsalon.com/honored-guests/clinton-west/)
- [Colin Zick — Partner, Foley Hoag | Co-Chair, Health Care + Privacy & Data Security Practices](https://opendoorsalon.com/honored-guests/colin-zick/)
- [Craig Lipset — Founder, Clinical Innovation Partners | Co-Founder & Co-Chair, Decentralized Trials & Research Alliance](https://opendoorsalon.com/honored-guests/craig-lipset/)
- [Daphne Karydas — President & CFO, Flare Therapeutics | 20+ Years in Biopharma Finance & Dealmaking](https://opendoorsalon.com/honored-guests/daphne-karydas/)
- [David Esposito — President & CEO, ONL Therapeutics | Early-Stage Biotech Builder, Exits and Bankruptcies](https://opendoorsalon.com/honored-guests/david-esposito/)
- [Edwin Lindsay — Principal Consultant & Managing Director, CS Lifesciences | Regulatory, Quality & Clinical Compliance](https://opendoorsalon.com/honored-guests/edwin-lindsay/)
- [Edwin Stone — CEO, Cellular Origins | Automated Cell-Therapy Manufacturing](https://opendoorsalon.com/honored-guests/edwin-stone/)
- [Elaine Hamm — President & CEO, Ascend BioVentures | Executive-in-Residence, Tulane School of Medicine](https://opendoorsalon.com/honored-guests/elaine-hamm/)
- [Elisa Cascade — CGO, TrialScreen | AI & Patient Access in Clinical Research](https://opendoorsalon.com/honored-guests/elisa-cascade/)
- [Erik Digman Wiklund — CEO, Circio Holding | Circular-RNA Platform & Biotech Finance](https://opendoorsalon.com/honored-guests/erik-wiklund/)
- [Frank Watanabe — President & CEO, Arcutis Biotherapeutics | Vice Chair, Biotechnology Innovation Organization (BIO)](https://opendoorsalon.com/honored-guests/frank-watanabe/)
- [Jaap Jan Boelens — Chief Medical Officer, International Society for Cell & Gene Therapy (ISCT) | MD, PhD, Bone Marrow Transplant Physician](https://opendoorsalon.com/honored-guests/jaap-jan-boelens/)
- [Jeff Fischer — President & Co-Founder, Longhorn Vaccines & Diagnostics | Chronic Inflammation & Longevity](https://opendoorsalon.com/honored-guests/jeff-fischer/)
- [Jeff Holder — Managing Director & Partner, L.E.K. Consulting | Cell & Gene Therapy Strategy & Life-Sciences Enablers](https://opendoorsalon.com/honored-guests/jeff-holder/)
- [Jeremy Levin — Co-Founder & Executive Chairman, Ovid Therapeutics | Former President & CEO, Teva Pharmaceutical Industries](https://opendoorsalon.com/honored-guests/jeremy-levin/)
- [Jesús Zurdo — Biopharmaceutical Scientist & Innovation Leader | Leukemia Survivor & Patient Advocate](https://opendoorsalon.com/honored-guests/jesus-zurdo/)
- [Jim Kremidas — Executive Director, Association of Multisite Research Corporations (AMRC) | Patient-Recruitment Pioneer & Clinical-Trial Patient](https://opendoorsalon.com/honored-guests/jim-kremidas/)
- [Joanna Sickler — VP, Health Policy & External Affairs, Roche Diagnostics | Women's Health & Diagnostics Policy](https://opendoorsalon.com/honored-guests/joanna-sickler/)
- [Jon Rees — CEO & Co-Founder, MitoRx Therapeutics | Next-Generation Obesity & Metabolic Health](https://opendoorsalon.com/honored-guests/john-rees/)
- [Josh Fessel — Former CMO & Director, Office of Translational Medicine, NCATS, NIH | Regulatory & Science](https://opendoorsalon.com/honored-guests/josh-fessel/)
- [Karen Harris — Executive Director, Mission-Related Investing and Finance, Alzheimer's Drug Discovery Foundation | Former Global COO, Global Equity Capital Markets, UBS](https://opendoorsalon.com/honored-guests/karen-harris/)
- [Karla Loken — Founder, Loken & Associates | OB-GYN & Women's Health Medical-Affairs Leader](https://opendoorsalon.com/honored-guests/karla-loken/)
- [Katie Schubert — President & CEO, Society for Women's Health Research | Women's Health Policy & Advocacy](https://opendoorsalon.com/honored-guests/katie-schubert/)
- [Konstantina Katcheves — SVP & Chief Business and Strategy Officer, Acadia Pharmaceuticals | 20+ Years in Biopharma M&A & Strategy](https://opendoorsalon.com/honored-guests/konstantina-katcheves/)
- [Mahesh Narayanan — Managing Partner and Founder, Neuvation Ventures | Baltimore Seed Fund Investing in Brain Health](https://opendoorsalon.com/honored-guests/mahesh-narayanan/)
- [Matthew Hewitt — VP & CTO, Manufacturing Business Division, Charles River Laboratories | Cell & Gene Therapy Manufacturing](https://opendoorsalon.com/honored-guests/matthew-hewitt/)
- [Mike Goguen — Founder & Managing Partner, Two Bear Capital](https://opendoorsalon.com/honored-guests/mike-goguen/)
- [Mike Walker — Health & Life Sciences Digital-Strategy Leader | Former Microsoft Executive Director & Gartner Analyst](https://opendoorsalon.com/honored-guests/mike-walker/)
- [Pavel Khrimian — Co-founder & CBO, Deka Biosciences | Biotech Wind-Downs and Pharma Business Development](https://opendoorsalon.com/honored-guests/pavel-khrimian/)
- [Phil Vanek — Chief Commercialization Officer, International Society for Cell & Gene Therapy (ISCT) | Cell & Gene Therapy Strategist](https://opendoorsalon.com/honored-guests/phil-vanek/)
- [Prashant Yadav — Senior Fellow, Council on Foreign Relations | Pharmaceutical Supply Chain Expert](https://opendoorsalon.com/honored-guests/prashant-yadav/)
- [Raja Mikkili — Vice President, Core Technologies and Security, Arcutis Biotherapeutics | Cybersecurity, AI and Data Strategy in Biotech](https://opendoorsalon.com/honored-guests/raja-mikkili/)
- [Raphaël Ognar — President, CEO, Co-Founder & Chairman, NKILT Therapeutics | Allogeneic Cell Therapy](https://opendoorsalon.com/honored-guests/raphael-ognar/)
- [Richard Hicks — President & CEO, Inspiredu | Closing the Digital Divide](https://opendoorsalon.com/honored-guests/richard-hicks/)
- [Rob Williamson — Founder & CEO, Traverse Therapeutics | AI-Driven Blood-Brain Barrier Drug Delivery (Stealth)](https://opendoorsalon.com/honored-guests/rob-williamson/)
- [Robert Califf — Two-Time FDA Commissioner | Professor, Duke University School of Medicine](https://opendoorsalon.com/honored-guests/robert-califf/)
- [Ryan Cawood — Co-Founder & CEO, Lab Thread | AI in Laboratory Workflows](https://opendoorsalon.com/honored-guests/ryan-cawood/)
- [Sara Jane Demy — Founder & CEO, Demy-Colton | Biotech Showcase, BioFuture & the Biotech CEO Summit](https://opendoorsalon.com/honored-guests/sara-jane-demy/)
- [Steve Butts — CEO, Arrivo BioVentures | Sex-Based Medicine & CNS Drug Development](https://opendoorsalon.com/honored-guests/steve-butts/)
- [Steven McWilliams — VP & CIO, Georgia Hospital Association | Healthcare IT, Cybersecurity & Patient Access](https://opendoorsalon.com/honored-guests/steven-mcwilliams/)
- [Sunitha Malepati — Founder, The Buffalo Initiative | Fellow, Renaissance Philanthropy](https://opendoorsalon.com/honored-guests/sunitha-malepati/)
- [Theresa Campobasso — Senior Vice President, Aardwolf Global Solutions | Former U.S. Marine Corps Intelligence Officer](https://opendoorsalon.com/honored-guests/theresa-campobasso/)
- [Tina Valbh — Managing Partner, Pharma Connect | Founder, Tina's Warriors | Patient Advocate](https://opendoorsalon.com/honored-guests/tina-valbh/)
- [Tom Whitehead — Co-Founder, Emily Whitehead Foundation | Father of Emily Whitehead, First Pediatric CAR-T Cell Therapy Patient](https://opendoorsalon.com/honored-guests/tom-whitehead/)
- [Tori Lee — Pediatric CAR-T Survivor & Patient Advocate | Health-Policy Student](https://opendoorsalon.com/honored-guests/tori-lee/)
- [Vid Desai — First FDA Chief Information Officer](https://opendoorsalon.com/honored-guests/vid-desai/)

## Blog
- [What a Biotech Owes Its Team When a Program Is Cut](https://opendoorsalon.com/what-happens-to-employees-when-a-biotech-program-is-cut/): David Esposito (ONL Therapeutics) on cutting a program at a company that still has runway, what the leadership team owes the people who leave, and why active placement through the network is part of the job.
- [When a Biotech Shuts Down, What Happens to Its Patients?](https://opendoorsalon.com/what-happens-to-patients-when-a-biotech-shuts-down/): Pavel Khrimian (Deka Biosciences) on the fiduciary obligation to keep treating patients already on therapy after a company decides to close, and what meeting it costs in runway and logistics.
- [Pivot or Shut Down? The Three Questions Biotech Leaders Ask](https://opendoorsalon.com/when-should-a-biotech-pivot-instead-of-shutting-down/): A biotech co-founder reduces the pivot-or-close decision to three questions about hypothesis, cash and time, and explains what two answers of no means.
- [Warning Signs a Biotech Is Running Out of Money, Explained](https://opendoorsalon.com/warning-signs-a-biotech-is-running-out-of-money/): David Esposito (ONL Therapeutics) and Pavel Khrimian (Deka Biosciences) on the signals that appear months before a cash crunch and why they arrive unlabeled.
- [Should Startups Put AI in Their Pitch Deck? A CEO Says No](https://opendoorsalon.com/should-startups-put-ai-in-their-pitch-deck/): Raphaël Ognar (President, CEO, Co-Founder & Chairman, NKILT Therapeutics) and Ryan Cawood (Co-Founder & CEO, Lab Thread) on why Ognar leaves AI out of the pitch deck for a company that uses it every day, why he argues the claim does not survive a second question from an investor, Cawood’s objection to AI added for its own sake, and the test both apply: whether the tool changes a capability, a cost structure or a timeline, and if it does not, why the slide is decoration.
- [How to Prompt AI for Scientific Research, From Two CEOs](https://opendoorsalon.com/how-to-prompt-ai-for-scientific-research/): Raphaël Ognar (President, CEO, Co-Founder & Chairman, NKILT Therapeutics) and Ryan Cawood (Co-Founder & CEO, Lab Thread) on building milestones into a prompt so the work is inspectable in stages rather than judged only at the end, why good prompting means stating what two experts would normally leave implicit, why flawed input data defeats a well-written prompt, and why the FDA’s draft guidance is concerned with whether an output is demonstrably credible rather than with the technique used to obtain it.
- [Why AI Is So Expensive to Run, and Who Pays for It](https://opendoorsalon.com/why-is-ai-so-expensive-for-companies-to-run/): Ryan Cawood (Co-Founder & CEO, Lab Thread) and Raphaël Ognar (President, CEO, Co-Founder & Chairman, NKILT Therapeutics) on Cawood’s estimate that providers are underwriting roughly 90 percent of what it costs to serve an AI result, the ratchet of fewer tokens for the same subscription price, the risk of building a product on a subsidized input somebody else can withdraw, and Ognar’s argument that the energy and water cost sits outside the invoice entirely. US data center electricity use, about 4.4 percent in 2023 and projected to 6.7 to 12 percent by 2028, is cited from the Department of Energy’s December 2024 report.
- [AI Mistakes in Drug Development: Who Is Actually Liable?](https://opendoorsalon.com/who-is-liable-for-ai-mistakes-in-drug-development/): Ryan Cawood (Co-Founder & CEO, Lab Thread) and Raphaël Ognar (President, CEO, Co-Founder & Chairman, NKILT Therapeutics) on why the FDA holds the submitting company responsible for data regardless of where it came from, why chief medical officers carry that exposure personally, and why a model should be treated like a colleague rather than an oracle.
- [Why AI Errors in Biotech Surface Months Too Late](https://opendoorsalon.com/why-do-ai-errors-in-biotech-take-months-to-find/): Ryan Cawood (Co-Founder & CEO, Lab Thread) on why an AI error in biology is expensive because of WHEN it is found: a confident wrong answer at a desk in month one, a cell line that fails at the door of a GMP facility in month nine, and chain-of-custody records that cannot answer a question asked that late.
- [The Medarex Acquisition: How BMS Bet on CTLA-4](https://opendoorsalon.com/medarex-acquisition-ctla-4-bet/): Jeremy Levin (Co-Founder & Executive Chairman, Ovid Therapeutics; former President and CEO of Teva Pharmaceutical Industries) on the 2009 Bristol-Myers Squibb acquisition of Medarex at $16.00 per share, roughly $2.4 billion aggregate, whose lead candidate ipilimumab was approved as Yervoy in 2011, and on the internal resistance he says he overcame by writing a resignation on a napkin. The deal terms are verified against the BMS announcement; the napkin is Levin's own first-person account and is not independently corroborated.
- [New Biotech Hubs: Where Startups Are Building Now](https://opendoorsalon.com/new-biotech-hubs-united-states/): Jeremy Levin and Sara Jane Demy (Founder & CEO, Demy-Colton) on biotech company formation spreading beyond Boston and San Francisco to the Miami Collective, Houston and MD Anderson, and several Midwestern states, and on the cost pressures in the established hubs that are pushing founders to build elsewhere.
- [Family Office Biotech Investment: The New Capital Source](https://opendoorsalon.com/family-office-biotech-investment/): Jeremy Levin and Sara Jane Demy on family offices pooling into groups that now hold billions and stepping into the gap left by the traditional venture path, alongside grant money and collaboration dollars from patient advocacy and disease foundations, and what that changes for a founder raising capital today.
- [Are Clinical Trials in China Reliable? Investors Weigh In](https://opendoorsalon.com/are-clinical-trials-in-china-reliable/): Sara Jane Demy (Founder & CEO, Demy-Colton, which runs Biotech Showcase, BioFuture and the Biotech CEO Summit) on why biotech chief executives now treat Chinese clinical data as good and reproducible, what the industry believed ten to fifteen years ago and why it changed, the cost and time arguments driving trials there, why she attributes the shift to a deliberate build rather than cheap labor, and the explicit limit of the claim: this is what CEOs in her rooms report, not an audited comparison of trial quality across jurisdictions.
- [China's Biotech Strategy for 2035: What It Actually Says](https://opendoorsalon.com/china-biotech-strategy-2035/): Jeremy Levin (Co-Founder & Executive Chairman, Ovid Therapeutics; former President & CEO, Teva Pharmaceutical Industries) on the staged twenty-five-year industrial strategy behind China's biotech rise, what the published 2035 objective actually says against how it is usually paraphrased, how capital, education, clinical trials and the regulator were pointed at one destination together, the rise in Category 1 innovative drug approvals from 12 in 2019 to 46 in 2024, and why he argues the question is when China leads rather than whether.
- [What Is Venture Philanthropy in Biotech? A Working Guide](https://opendoorsalon.com/what-is-venture-philanthropy/): Karen Harris (Alzheimer's Drug Discovery Foundation) and Mahesh Narayanan (Neuvation Ventures) on the nonprofit funding model that invests in companies on investment terms and recycles returns into the mission rather than distributing them, the IND-enabling through phase 2A window it exists to cover, why it is complementary to venture capital rather than competitive with it, what a mission-driven funder asks that a VC does not, and why a foundation recycling returns can keep funding one hard disease for decades.
- [What Do Investors Look For in a Biotech Founder?](https://opendoorsalon.com/what-investors-look-for-in-a-biotech-founder/): Karen Harris (Alzheimer's Drug Discovery Foundation) and Mahesh Narayanan (Neuvation Ventures) on judging a founder by how they handle a negotiation rather than how they pitch, the caddie test Neuvation runs during diligence to see whether a founder can execute independently, the minimum viable product evidence bar at seed, the two red flags that end a deal (a team that will not go full time, and a founder who will not incorporate advice), and why the ADDF weighs whether a team can keep fundraising through years of ambiguous data.
- [Why Is Neuroscience So Hard to Fund? Investors Explain](https://opendoorsalon.com/why-is-neuroscience-hard-to-fund/): Mahesh Narayanan (Neuvation Ventures) and Karen Harris (Alzheimer's Drug Discovery Foundation) on the roughly fifty-year record of failures that made investors cautious about neuroscience, the two disease-modifying drugs and two FDA-approved blood tests that changed the last five years, how the Alzheimer's pipeline diversified so that amyloid, tau and inflammation or immune targets now each hold about a fifth of it, the prescriber and payer gate that can sink a drug after approval, and where the two investors disagree about how quickly capital follows a scientific turn.
- [Non-Dilutive Funding for Biotech Startups: The Brain Health Case](https://opendoorsalon.com/non-dilutive-funding-brain-health-startups/): Mahesh Narayanan (Neuvation Ventures) and Karen Harris (Alzheimer's Drug Discovery Foundation) on where federal money for brain health actually sits, NIH at roughly $3.9 billion a year for Alzheimer's and related dementias, the DARPA and ARPA-H programs and the 21st Century Cures work behind them, why nearly every brain-health company carries a dual-use component the defense agencies will fund, and why private equity is not competition at the seed stage.
- [Does Insurance Cover an Alzheimer's Blood Test?](https://opendoorsalon.com/does-insurance-cover-alzheimers-blood-test/): Karen Harris (Alzheimer's Drug Discovery Foundation) and Mahesh Narayanan (Neuvation Ventures) on Anthem covering blood-based Alzheimer's biomarker testing, the broader policy taking effect October 1 2026, why a blood draw that triages who needs a PET scan changes the economics of diagnosis, and what a coverage decision signals to diagnostics developers.
- [Is a Device With a USB Port a "Cyber Device" to the FDA?](https://opendoorsalon.com/is-my-device-a-cyber-device/): Christian Espinosa (Blue Goat Cyber) and Edwin Lindsay (CS Lifesciences) on why the FDA cyber-device bar turns on connectivity rather than complexity, why a single USB port is an attack vector, and why stripping Bluetooth to dodge testing usually breaks the product.
- [When Should Reimbursement Strategy Start for a Device?](https://opendoorsalon.com/medical-device-reimbursement-strategy/): Edwin Lindsay (CS Lifesciences) and Christian Espinosa (Blue Goat Cyber) on why reimbursement strategy belongs at the concept stage rather than after FDA clearance, the medtech company that assumed its device would fit an existing code and lost nearly six years waiting for one, and what a company does to survive the interim.
- [Does a Medical Device Made in China Pose a Cyber Risk?](https://opendoorsalon.com/china-medical-device-cybersecurity/): Christian Espinosa (Blue Goat Cyber) and Edwin Lindsay (CS Lifesciences) on why country of origin is a signal rather than a control, what the Contec CMS8000 backdoor actually proved, and why the unaudited sub-tier supplier is the real cyber exposure regardless of where a device is built.
- [Why Approved Gene Therapies Still Aren’t Available](https://opendoorsalon.com/why-approved-gene-therapies-arent-available/): Bambi Grilley (ISCT) and Jaap Jan Boelens (ISCT) on why FDA approval is not the same as patient availability, how manufacturing scale and treatment-center capacity gate real access, and why reimbursement decides whether an approved therapy reaches anyone.
- [What Is a Single-Case Agreement in Gene Therapy?](https://opendoorsalon.com/single-case-agreement-gene-therapy/): Jaap Jan Boelens (ISCT) on the patient-by-patient payer contract that gates access to an approved gene therapy, why it can take from two months to over a year, and why sickle cell patients walk away from a cure they qualify for while it is negotiated.
- [Why Gene Therapy Reimbursement Takes So Long: The Float](https://opendoorsalon.com/why-gene-therapy-reimbursement-takes-so-long/): Bambi Grilley (ISCT) on the gap between a payer agreeing to cover a gene therapy and the money actually arriving, the million-dollar float a hospital carries while reimbursement runs months behind a treatment the patient has already received, and why that delay decides which centers can afford to offer these therapies at all.
- [How Far Away Is In Vivo Gene Therapy? A Real Timeline](https://opendoorsalon.com/in-vivo-gene-therapy-timeline/): Jaap Jan Boelens (ISCT) and Bambi Grilley (ISCT) on why in vivo CAR for cancer is likely less than a decade away while in vivo gene therapy for genetic disease is more than a decade off, the dosing problem that has no lab step to control it, and the durability and shut-off questions that make years of monitoring non-negotiable.
- [Unproven Stem Cell Therapy: The Risks Families Face](https://opendoorsalon.com/unproven-stem-cell-therapy-risks/): Bambi Grilley (ISCT) and Jaap Jan Boelens (ISCT) on why a family with a rare disease and no approved option ends up at an unlicensed clinic abroad, the difference between a regulated trial and an unproven product that is nearly impossible to explain to a frightened parent, and the three risks that compound: no real treatment, unmonitored side effects, and the money.
- [Why Are Small Biotechs a Bigger Cyber Target Than Big Pharma?](https://opendoorsalon.com/why-are-small-biotechs-a-cyber-target/): Raja Mikkili (VP, Core Technologies and Security, Arcutis Biotherapeutics) and Anne Herold Li (Shareholder & NY Managing Partner, Brownstein Hyatt Farber Schreck) on why a small biotech holds concentrated, un-replicated IP on a fraction of the security budget, what the West Pharmaceutical breach revealed about the supplier tier sitting underneath the industry, and why data exfiltration rather than encryption is the strategic loss.
- [Why Is Anonymized Clinical Data a National Security Risk?](https://opendoorsalon.com/why-is-anonymized-data-a-national-security-risk/): Anne Herold Li (Shareholder & NY Managing Partner, Brownstein Hyatt Farber Schreck), an epidemiologist before she was a litigator, on why anonymizing patient data discharges the individual risk but not the national-security one: it is the population-level data set that a state actor wants, current rules protect the person rather than the population, and putting privileged material into an AI model waives the privilege.
- [What Do Nation-State Hackers Actually Want From a Biotech?](https://opendoorsalon.com/what-do-nation-state-hackers-want-from-biotech/): Raja Mikkili (VP, Core Technologies and Security, Arcutis Biotherapeutics) and Anne Herold Li (Shareholder & NY Managing Partner, Brownstein Hyatt Farber Schreck) on why a state actor is after the company roadmap rather than a ransom: the target set is the formulation, the manufacturing process, the clinical data set, the partner list and the map of where the company is weak, there is no transaction to announce the intrusion, and the strategic logic is an industrial catch-up play against a region rather than a competitive play against one company.
- [Who Owns the Data in a Biotech Collaboration Agreement?](https://opendoorsalon.com/who-owns-the-data-in-a-collaboration-agreement/): Anne Herold Li (Shareholder & NY Managing Partner, Brownstein Hyatt Farber Schreck) on the four-sentence provision buried deep in a joint development agreement that decides who owns the combined data set: collaboration contracts written before the last two or three years say almost nothing about it, the exposure has no remedy because a court can award damages but cannot un-train a model, and putting privileged material into an AI system waives the privilege.
- [What Should a Biotech Vendor Contract Require?](https://opendoorsalon.com/what-should-a-biotech-vendor-contract-require/): Raja Mikkili (VP, Core Technologies and Security, Arcutis Biotherapeutics) and Anne Herold Li (Shareholder & NY Managing Partner, Brownstein Hyatt Farber Schreck) on the vendor-risk lifecycle: tier vendors by the access they hold rather than by contract value, write in a right to audit and a breach-notification clause before signature, monitor continuously rather than once at onboarding, run a real off-boarding process that removes access, and follow the supply chain to its roots the way forced-labor compliance already does.
- [Can You Use Vibe Coding for Medical Device Software?](https://opendoorsalon.com/vibe-coding-medical-device/): Christian Espinosa (founder and CEO, Blue Goat Cyber) on why AI-generated code is fine for proving an idea and has no place in a final medical device, the IEC 62304 software standard the FDA recognizes, and the one question that exposes the risk to an investor.
- [What Is an FDA Cybersecurity Deficiency Letter? (2026)](https://opendoorsalon.com/fda-cybersecurity-deficiency-letter/): Christian Espinosa (founder and CEO, Blue Goat Cyber) and Edwin Lindsay (CS Lifesciences) on why FDA cybersecurity deficiency letters are surging, what a 37-page list and its 180-day response clock actually demand of a device team, and why roughly one in five companies has to file an entirely new submission.
- [Is the FDA the Clinical Trial Bottleneck? Califf Says No](https://opendoorsalon.com/is-the-fda-the-clinical-trial-bottleneck/): Robert Califf, the only two-time FDA Commissioner, on why the real clinical-trial delay sits with slow, expensive research sites rather than the agency, and what Operation TrialBlazer targets.
- [Has China Passed the US in Research Spending? What It Means](https://opendoorsalon.com/has-china-passed-the-us-in-research-spending/): Vid Desai (the FDA’s first CIO) and Robert Califf (the only two-time FDA Commissioner) on China’s research funding passing the US for the first time, why a phase-one trial runs a third the cost and six months faster there, and why walling the US off is a doomed strategy.
- [Why Government AI Projects Fail: The FDA’s First CIO](https://opendoorsalon.com/why-government-ai-projects-fail/): Vid Desai (the FDA’s first CIO) and Robert Califf on why government AI programs like the FDA’s Elsa tool stall on the funding cliff rather than the technology, and the question most executives ask wrong.
- [What FDA Reviewer Turnover Costs Drug Developers](https://opendoorsalon.com/fda-reviewer-turnover-impact-on-drug-development/): Robert Califf and Vid Desai on what FDA staff turnover costs sponsors: guidance you cannot bank on, lost institutional memory, and study designs re-litigated at the most expensive moment.
- [How China Is Reshaping Global Health](https://opendoorsalon.com/china-global-health-diplomacy/): Prashant Yadav (Senior Fellow, Council on Foreign Relations) on why China has the money and the speed to expand its health diplomacy, how its bilateral infrastructure-first model differs from the US and European system it would replace, and what the missing accountability and civil-society layer costs.
- [What Happens to Clinical Trials During a War?](https://opendoorsalon.com/what-happens-to-clinical-trials-during-a-war/): Anna Titkova (Pratia) and Prashant Yadav (Council on Foreign Relations) on trial continuity, patient access, and inclusive research when war disrupts clinical research.
- [Is the FDA Still the Global Gold Standard?](https://opendoorsalon.com/is-the-fda-still-the-gold-standard/): Prashant Yadav (Senior Fellow, Council on Foreign Relations) on why the FDA's 75-year standing as the world's gold-standard regulator is eroding, across party lines, and why that is a global-health problem.
- [Who Actually Funds Global Health?](https://opendoorsalon.com/who-funds-global-health/): Prashant Yadav (Council on Foreign Relations) on why the US still carries a disproportionate share of global-health funding, why wealthy and emerging economies have not raised theirs, and what fills the gap.
- [Why Don't Eligible Patients Get Cell Therapy? The 20% Gap](https://opendoorsalon.com/why-dont-eligible-patients-get-cell-therapy/): Matthew Hewitt and Jeff Holder on why only about 20% of eligible US patients actually receive cell therapy - the referral economics, clinician capacity, and data gaps behind the access problem.
- [How to Pay for One-Time Cell Therapy: The Payer Problem](https://opendoorsalon.com/how-to-pay-for-one-time-cell-therapy/): Matthew Hewitt (Charles River) and Jeff Holder (L.E.K. Consulting) on why US insurance, built for monthly refills, struggles to pay for one-time cell and gene therapies.
- [How to Map Sub-Tier Supply Chain Risk in Biotech](https://opendoorsalon.com/how-to-map-sub-tier-supply-chain-risk/): A practical guide to mapping biotech supply-chain risk past tier 1 into tiers three to five, from ex-Marine intelligence officer Theresa Campobasso (Aardwolf Global) on Open Door Salon.
- [The $50,000 Cure Problem: Why Cell and Gene Therapy Is So Expensive](https://opendoorsalon.com/why-is-cell-and-gene-therapy-so-expensive/): Andy Holt (CCO, Viralgen) and Phil Vanek (Chief Commercialization Officer, ISCT) on cell-therapy pricing and why India delivers at $50K what the US can't.
- [Why Won't Insurance Cover Gene Therapy? The Payer Problem](https://opendoorsalon.com/why-wont-insurance-cover-gene-therapy/): Andy Holt (CCO, Viralgen) and Phil Vanek (Chief Commercialization Officer, ISCT) on the employment-linked insurance problem that stalls one-time gene-therapy cures in the US.
- [Does the BIOSECURE Act Apply to Private Companies?](https://opendoorsalon.com/does-the-biosecure-act-apply-to-private-companies/): Theresa Campobasso (former U.S. Marine Corps intelligence officer, Aardwolf Global Solutions) on the commercial-channel gap the BIOSECURE Act leaves open for private pharma.
- [Are There Alternatives to Chinese Biotech Suppliers?](https://opendoorsalon.com/alternatives-to-chinese-biotech-suppliers/): Theresa Campobasso (former U.S. Marine Corps intelligence officer, Aardwolf Global) on whether the "China is the only option" assumption holds, and how to weigh alternative biotech suppliers.
- [What Is the COINS Act? A Guide for Biotech Dealmakers](https://opendoorsalon.com/what-is-the-coins-act/): Theresa Campobasso (former U.S. Marine Corps intelligence officer, SVP Aardwolf Global) on the proposed COINS Act, which would put US investment, licensing, and joint ventures in Chinese biotech under government review.
- [How Is Intellectual Property Stolen in China? Three Routes](https://opendoorsalon.com/how-is-intellectual-property-stolen-in-china/): Theresa Campobasso (former U.S. Marine Corps intelligence officer, SVP Aardwolf Global Solutions) on the three routes IP leaves a company in China biotech partnerships: cyber/partnership access, patent acceleration, and insider threat.
- [Will the BIOSECURE Act Be Expanded? What Comes Next](https://opendoorsalon.com/will-the-biosecure-act-be-expanded/): Theresa Campobasso (former U.S. Marine Corps intelligence officer, SVP Aardwolf Global) on why the BIOSECURE Act is likely to widen beyond its five named companies and federal-contractor scope, and what regulators target next.
- [Where Do US Drug Ingredients Come From? The China Risk](https://opendoorsalon.com/where-do-us-drug-ingredients-come-from/): Theresa Campobasso (former U.S. Marine Corps intelligence officer, SVP Aardwolf Global) on the concentration of active pharmaceutical ingredients and drug precursors in China, why that supply chain is largely unmapped, and how sourcing teams can test the "China is the only option" assumption.
- [Blog hub](https://opendoorsalon.com/blog/): Intent-targeted essays drawn from the episodes.

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