Open Door Salon

Theresa Campobasso: The Regulatory Wave Reshaping China Biotech Deals

25 min · Gestern
Episode Theresa Campobasso: The Regulatory Wave Reshaping China Biotech Deals Cover

Beschreibung

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.

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Episode Theresa Campobasso: The Regulatory Wave Reshaping China Biotech Deals Cover

Theresa Campobasso: The Regulatory Wave Reshaping China Biotech Deals

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.

Gestern25 min
Episode China in Your Pharma Supply Chain: What BIOSECURE Misses Cover

China in Your Pharma Supply Chain: What BIOSECURE Misses

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

17. Juni 202620 min
Episode "Why Is CVS Selling Party Packs of M&Ms Alongside Ozempic?" | Pashazadeh & Rees Cover

"Why Is CVS Selling Party Packs of M&Ms Alongside Ozempic?" | Pashazadeh & Rees

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/ [https://www.linkedin.com/in/ali-pashazadeh-8490b841/] Jon Rees — CEO & Co-founder, MitoRx Therapeutics🔗 LinkedIn: https://www.linkedin.com/in/jondrees/ [https://www.linkedin.com/in/jondrees/] 🎬 YouTube: https://www.youtube.com/@OpenDoorSalon [https://www.youtube.com/@OpenDoorSalon]🍎 Apple: https://podcasts.apple.com/gb/podcast/open-door-salon/id1871280945 [https://podcasts.apple.com/gb/podcast/open-door-salon/id1871280945]🌐 Website: www.opendoorsalon.com [http://www.opendoorsalon.com]

3. Juni 202640 min
Episode "There's a 15 Minute Window on a Certain Tuesday" | Why Your Biotech Can't Get Funded Cover

"There's a 15 Minute Window on a Certain Tuesday" | Why Your Biotech Can't Get Funded

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

27. Mai 202647 min
Episode "AI Won't Cut Corners" — A Hospital CIO and Community Advocate on the Digital Divide | McWilliams & Hicks Cover

"AI Won't Cut Corners" — A Hospital CIO and Community Advocate on the Digital Divide | McWilliams & Hicks

"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/

20. Mai 202652 min