Open Door Salon

The healthcare system is broken. Open Door Salon is a place where patients can find an easier way to navigate treatment—and where those working within the system can come together to solve the problems they hear about every day. Change starts with conversation.

Open Door Salon is a health podcast hosted by Unknown Host, with 27 episodes on record and a Required Pod Score of 80. PitchCentric scores this show on Booking Probability, Listen Score, and live audience signals refreshed every 24 hours.

Unknown Host hosts Open Door Salon, a health show with 27 episodes published.

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  Episode #28

  Why Alzheimer's Startups Still Struggle to Raise Money | Karen Harris & Mahesh Narayanan

  Aug 12, 202649 minS1

  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/

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  Episode #27

  Healthcare's Biggest Problem Nobody's Talking About

  Jul 29, 202645 minS1

  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/

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  Episode #25

  Former FDA Commissioner Robert Califf on RFK Jr., the FDA Exodus, and China

  Jul 22, 202653 minS1

  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/

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  Episode #24

  Why Patients Walk Away From a Cure They Qualify For | ISCT's Grilley & Boelens

  Jul 15, 202644 minS1

  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.

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  Open Door Salon

  The Three Forces That Make or Break a Launch: FDA, Payers & Hackers

  Jul 8, 202645 minS1

  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.

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