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by Alex Kesin and Matthew Pech
Life sciences, under the hood. Deep dives into the patent filings, regulatory gauntlets, and capital-risks that shape the business of biology.
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- Sep 18, 20263h 36m
Allergan: Botox, Rogue Scientists, and the Ultimate Beauty Franchise
The wild story of how a Cold War bioweapon became Botox — and how Allergan turned a sleepy ophthalmology drug into an enduring aesthetic franchise.Every part of this story looks nothing like your normal blockbuster drug. Botox started its development storyas a Cold War bioweapon so lethal the CIA was thinking of using it on Castro. Decades later, an eye surgeon in San Francisco mortgaged his house and managed to bootstrap his way to a BLA– no venture capital needed! After a contentious sale to a sleepy eye-drop company called Allergan, it turned Botox into one of the most durable, recurring-revenue franchises in the history of medicine. That cash cow provoked all sorts of financial battles– a hostile takeover attempt involving Bill Ackman, a tax-inversion scheme with Pfizer that united Bernie Sanders and Donald Trump in opposition, and a far-fetched plan to rent a Native American tribe's sovereign immunity to protect a different drug's patents.In this episode, we trace Botox from a 19th-century German sausage poisoning, through a Cold War weapons lab, an eye surgeon's garage-scale manufacturing operation, and into Allergan's decades-long reign — covering the science of why the drug still has no biosimilar, the "aesthetics stack" that turned it into a subscription business for faces, and the corporate finance drama (Valeant, Actavis, Pfizer and AbbVie) that followed. Along the way: exclusive interviews with Allergan's 95-year-old founding CEO, the scientist who helped manufacture the original drug substance in an academic lab, and the dermatologist who tried to repurpose Botox to treat depression.In this episode:How a Clostridium botulinum strain donated for free by a Harvard professor became the physical basis of a multi-billion-dollar drugWhy the FDA's insistence on unique nonproprietary names (onabotulinumtoxinA vs. abobotulinumtoxinA) created an accidental, unbreakable competitive moatHow Allergan built the "surround the ophthalmologist" sales playbook — and later applied the same tactics to the aesthetic space. The 2014 Valeant/Ackman hostile takeover attempt, and how Allergan fought backHow nearly every foundational piece of IP in the Botox story was given away for free by the academics who created itIs there a new aesthetic bundle to build around incretin-based weight loss products? Featuring quotes from: Gavin Herbert Jr. (Allergan founder and former chairman/CEO), Eric Johnson, PhD (Ed Schantz's research partner, University of Wisconsin), Eric Finzi, MD PHD (dermatologist and Botox-for-depression researcher), Brent Saunders (former CEO, Allergan/Actavis), and Amy Ingle, APRN (owner, Sweet Spot Medispo). BibliographySelected sources. Compiled September 2026.BooksHelveston, Eugene M. Death to Beauty: The Transformative History of Botox. Bloomington: Indiana University Press, 2023. iupress.orgBerkowitz, Dana. Botox Nation: Changing the Face of America. New York: New York University Press, 2017. nyupress.orgFinzi, Eric. The Face of Emotion: How Botox Affects Our Mood and Relationships. New York: Palgrave Macmillan, 2013. publishersweekly.comEssays and criticismShaywitz, David. “Botox: A Luminous Example of Field Discovery.” Timmerman Report, February 9, 2024. timmermanreport.comShaywitz, David. “‘Death to Beauty’ Review: The Birth of Botox.” The Wall Street Journal, February 12, 2024. aei.orgBusiness school case studiesPaine, Lynn S., Suraj Srinivasan, John C. Coates, and David Lane. “The Allergan Board Under Fire (A).” Harvard Business School Case 316-010. Boston: Harvard Business School, 2016 (rev. January 7, 2019). hbsp.harvard.eduPaine, Lynn S., Suraj Srinivasan, John C. Coates, and David Lane. “The Allergan Board Under Fire (B).” Harvard Business School Case 316-029. Boston: Harvard Business School, 2016 (rev. January 7, 2019). hbsp.harvard.eduPeterson, Randall S., and Lisa Duke. “David Pyott: The Battle for Allergan (A).” London Business School Case CS-16-001. London: London Business School, September 2018. Distributed by Harvard Business Publishing, no. LBS305. hbsp.harvard.eduForough
- Sep 14, 20263 min
What is Approved?
Approved tells the definitive stories behind the world's most interesting biotech ventures. Most people learn about the industry in a fragmented, ad hoc way-- an industry article here, a clinical trial readout there, some science twitter. In contrast, The Approved podcast tells comprehensive, definitive stories of how drugs are discovered, developed and sold. Whether we're tracking a single blockbuster drug's remarkable rise, or following a single startup’s decade-long path to approval, every episode we put out is an unvarnished look at how the biotech industry works. We break down what worked, what failed, and distill insights that you can apply to your own life science business. Every episode is accessible and entertaining, but ultimately designed for the life science professional. Hosted by Matthew Pech, PhD (cancer biologist and drug hunter) and Alex Kesin (biotech writer), every episode draws on hundreds of hours of research -- including Nature papers, corporate decks, SEC filings, and legal records. All that is supplemented with original interviews with the actual scientists, operators, and clinicians who brought the drugs to life. Season 1 HighlightsKeytruda: Featuring conversations with Roy Baynes and Greg Carven.Blueprint Medicines: Featuring Christoph Lengauer and Alexis Borisy.Botox: Featuring Gavin Herbert Jr. and Brent Saunders.Season 1 is wrapping up soon, with our upcoming episode on a drug worth 285 million times its weight in gold (guesses are welcome). Research for Season 2 is already underway...Subscribe on Apple Podcasts and Spotify, or visit approved.fm.
- Aug 4, 20262h 29m
Blueprint Medicines: Chasing Gleevec to a $9B Allergy Drug
Blueprint Medicines was built to find the next Gleevec-style cancer drug. It ended up pivoting to allergic disease instead, and selling to Sanofi for $9B. This is the platform, the pivot, and who got paid.Blueprint Medicines set out to be the natural sequel to Gleevec: a company founded by two of the scientists behind that landmark cancer drug, built to order by Third Rock Ventures' "venture creation" model, with a proprietary kinase-inhibitor library designed to drug the 517 other broken molecular switches Gleevec couldn't touch.A decade later, Sanofi paid roughly $9 billion for the company... just not for a cancer drug. Blueprint's blockbuster asset, avapritinib (AYVAKIT), found its real market almost by accident: indolent systemic mastocytosis, a debilitating, often-undiagnosed mast-cell disease that took patients years to get diagnosed and had no approved treatment.In this episode, we trace two threads at once: the science of designing truly selective kinase inhibitors, and the venture capital philosophy -- company creation, not just company funding -- that built Blueprint from a whiteboard sketch into a platform biotech. We cover the near-death Series B, the accidental discovery that opened up mastocytosis, the GAVRETO partnership that fell apart against a faster competitor, the Sanofi negotiation (CVRs and all), and the wide gap between what the venture firm and hired executives made versus what the founding scientists -- like Gleevec's co-inventor Nick Lydon -- walked away with. We end covering the efforts of Blueprint diaspora to create a new model of seed investing: Curie Bio. Featuring interviews with:Alexis Borisy: Former Blueprint CEO/Chairman; founding chairman, Curie.BioChristoph Lengauer: Founding CSO, Blueprint Medicines; Chief Drug Hunter, Curie.BioErica Evans: Former VP Biology, Blueprint Medicines; SVP, Curie.BioTim Guzi: Former Head of Medicinal Chemistry, Blueprint MedicinesDr. Charles Sawyers, M.D. — Academic co-founder, Blueprint MedicinesDr. Mariana Castells, M.D., Ph.D — Director, Mastocytosis Center, Brigham and Women's HospitalCREDITSCo-hosted by Alex Kesin and Matthew PechWritten, edited, and produced by Alex KesinMusic: “Food” by nerowski* Special thanks to the team at NFX for the use of their recording studio.* This episode is presented by JLL. Featuring Grant Dettmer on biotech real estate strategy.Sources1. Books and case studiesVasella, Daniel, with Robert Slater. Magic Cancer Bullet: How a Tiny Orange Pill Is Rewriting Medical History. HarperBusiness, New York, 2003. ISBN 9780060010300 · OCLC 50859163.Hamermesh, Richard G., Kathy Giusti, and Susie L. Ma. "Breakthroughs at Blueprint Medicines." Harvard Business School Case 820-001, June 29, 2020.Levin, Mark. "Mastering the Value Chain: An Interview with Mark Levin of Millennium Pharmaceuticals." Harvard Business Review, June 2001.2. SEC filingsBlueprint Medicines (CIK 1597264)Form S-1, March 23, 2015.Stockholders Agreement (Ex. 4.5), November 7, 2014.Investors' Rights Agreement (Ex. 4.4), November 7, 2014.Schedule 14D-9, June 17, 2025.Schedule 14D-9 Amendment No. 1, July 10, 2025.Schedule 14D-9 Amendment No. 3, July 18, 2025.Form 8-K — Roche immunokinase collaboration press release, March 18, 2016.Form 8-K —
- May 14, 20262h 7m
Keytruda: How Merck's Pembrolizumab Became the Best-Selling Cancer Drug of All Time
Keytruda is Merck's $31 billion a year PD-1 inhibitor and the best-selling cancer drug of all time. In Episode 3 of Approved, Alex Kesin and Matthew Pech trace the development of pembrolizumab , featuring interviews the scientists who drove the program forward : co-inventors Gregory Carven and Michel Streuli, and former Merck oncology CMO Roy Baynes.Topics include preclinical PD1 / CTLA-4 checkpoint biology that brought industry attention to the target (Jim Allison's CTLA-4 work and Tasuku Honjo's PD-1 discovery); how pembro started as a failed rheumatoid arthritis antibody program at a Dutch subsidiary of a paint company; the two mega-mergers that nearly killed the program; the biomarker enrichment trial design behind KEYNOTE-024 that let Merck break BMS's lead in lung cancer; the 41-patient Johns Hopkins MSI-H trial behind the first tissue-agnostic FDA approval, and the Jimmy Carter melanoma case that brought pembrolizumab to the public conscious. The episode closes on what comes next for Merck: the 2028 patent cliff, the Keytruda QLEX subcutaneous launch, and efforts to find the next blockbuster checkpoint inhibitor, including Summit/Akeso's PD-1 / VEGF bispecific ivonescimab.This episode is presented by JLL. Featuring Grant Dettmer on biotech real estate strategy.CHAPTERS 00:00:00 — Introduction: The Best-Selling Cancer Drug of All Time 00:02:15 — Part One — A Century of Failed Cancer Immunotherapy 00:04:17 — T Cells, CD28, and the Two-Signal Model of Immune Activation 00:06:25 — Jim Allison's CTLA-4 Discovery and the Path to Yervoy 00:12:03 — Tasuku Honjo Discovers PD-1: A Better Brake on T Cells 00:14:26 — Lieping Chen and the PD-L1 Tumor Evasion Hypothesis 00:16:26 — Part Two — Organon: The Dutch Paint-Company Subsidiary Behind Keytruda 00:19:48 — How Michel Streuli Caught the Solid-Phase Screening Artifact 00:22:09 — The Accidental Antagonist: From Rheumatoid Arthritis Drug to Cancer Drug 00:26:34 — Sponsor: Grant Detmer (JLL) on Biotech Real Estate Strategy 00:30:01 — Russian Nesting-Doll M&A: Schering-Plough Acquires Organon (2007) 00:31:43 — The $41 Billion Merck–Schering-Plough Mega-Merger of 2009 00:34:58 — Corporate Guerrilla Warfare: Four Scrappy Stunts That Saved Pembrolizumab 00:39:32 — BioNovion's Spite-Company Bid to Buy Pembro Back 00:42:10 — BMS at ASCO 2010: The Data Print That Revived Merck's PD-1 Program 00:45:55 — Part Three — Roger Perlmutter Joins a Bleeding Merck (April 2013) 00:50:48 — "Let Me Manage the Tigers": Ken Frazier Backs the All-In Bet on Pembrolizumab 00:55:22 — Breakthrough Therapy Designation and Eric Rubin's Adaptive Trial Design 00:58:25 — Keytruda's 2014 FDA Approval Erases BMS's Four-Year Lead 01:00:24 — The Lung Cancer Battlefield and the PD-L1 Biomarker Bet 01:02:19 — BMS vs. Merck: All-Comers vs. Biomarker-Enriched Trial Strategy 01:08:18 — KEYNOTE-024 vs. CheckMate-026: The Trial That Decided the Category 01:12:03 — Luis Diaz, MSI-H, and the Failed BMS Trial That Made Keytruda Tissue-Agnostic 01:17:18 — KEYNOTE-189: Perlmutter's Bet on Combining Keytruda with Chemotherapy 01:19:21 — Merck's Clinical Development Playbook: Basket Trials, Backwards March, External Collabs 01:25:29 — Part Four — The IO Graveyard: TIGIT, CD47, IDO1, LAG-3 and Tens of Billions Incinerated 01:30:23 — Why PD-1 Was the Only Checkpoint That Worked (Lieping Chen Revisited) 01:33:32 — Part Five — Inside the Best-Selling Drug of All Time 01:37:03 — "Build a Wall, High and Wide": Merck’s Commercial Strategy for Keytruda 01:43:44 — Part Six — The Patent Cliff and Loss of Exclusivity in Pharma 01:45:35 — Keytruda QLEX (Subcutaneous) and the Lifecycle Management Playbook 01:50:23 — PD-1/VEGF Bispecifics: Ivonescimab, Summit Therapeutics, and the Next Threat 01:55:31 — The Scorecard: Patient, Academic, and Financial Impact 02:01:19 — Who Actually Profited: Merck vs. Organon vs. the Scientists Who Built the Drug 02:05:54 — Epilogue: The Jimmy Carter DrugSourcesLast updated: May 2026Essential readingShaywitz, David. "The
- Mar 13, 20262h 22m
Episode #2: Geron
Listen on SpotifyListen on Apple PodcastsListen on YouTubeTABLE OF CONTENTS - Introduction - Hayflick Limit - Michael West & Founding of Geron - Early Science & IP Strategy - Cloning the Telomerase Gene - Embryonic Stem Cells & Political Context - Okarma, West’s Departure & Corporate Turmoil - Spinal Cord Injury Trial - Pivot to Blood Cancer - Clinical & Commercial Drama - Legacy & LessonsCREDITSCo-hosted by Alex Kesin and Matthew PechWritten, edited, and produced by Alex KesinMusic: “Food” by nerowski* Special thanks to the team at NFX for the use of their recording studio.SOURCESLast updated: March 2026I. BOOKSHall, Stephen S. Merchants of Immortality: Chasing the Dream of Human Life Extension. Houghton Mifflin, 2003.Williams, Tory. Inevitable Collision: The Inspiring Story That Brought Stem Cell Research to Conservative America.Mary Ann Liebert, Inc., 2014.II. KEY SCIENTIFIC PUBLICATIONSHayflick, L. & Moorhead, P.S. “The serial cultivation of human diploid cell strains.” Experimental Cell Research 25 (1961): 585–621.Kim, N.W. et al. “Specific association of human telomerase activity with immortal cells and cancer.” Science 266, no. 5193 (1994): 2011–2015.Feng, J. et al. “The RNA component of human telomerase.” Science 269, no. 5228 (1995): 1236–1241.Nakamura, T.M. et al. “Telomerase catalytic subunit homologs from fission yeast and human.” Science 277, no. 5328 (1997): 955–959.Meyerson, M. et al. “hEST2, the putative human telomerase catalytic subunit gene, is up-regulated in tumor cells and during immortalization.” Cell 90, no. 4 (1997): 785–795.Bodnar, A.G. et al. “Extension of life-span by introduction of telomerase into normal human cells.” Science 279, no. 5349 (1998): 349–352.Thomson, J.A. et al. “Embryonic stem cell lines derived from human blastocysts.” Science 282, no. 5391 (1998): 1145–1147.Asai, A. et al. “A novel telomerase template antagonist (GRN163) as a potential anticancer agent.” Cancer Research 63, no. 14 (2003): 3931–3939. Herbert, B-S et al. “Effect of the lipid modification of GRN163.” Nature: Oncogene 24 (2005): 5765–5772. Baerlochr, G. et al. “A pilot study of the telomerase inhibitor imetelstat for myelofibrosis.” New England Journal of Medicine 373 (2015): 908–919. Platzbecker, U. et al. “Imetelstat in patients with lower-risk myelodysplastic syndromes who have relapsed or are refractory to erythropoiesis-stimulating agents (IMerge).” The Lancet (2024).Lennox, A.L et al. “Imetelstat, a novel, first-in-class telomerase inhibitor: Mechanism of action, clinical, and translational science.” Clinical and Translational Science 17, no. 11 (2024).Scott, C. & Magnus, D. “Wrongful Termination: Lessons From the Geron Clinical Trial” Stem Cell Reports 3, no. 5 (2014): 721–723. III. REGULATORY & CLINICALPrescribing Information (Label) U.S. Food and Drug Administration. “RYTELO (imetelstat) for injection: Highlights of Prescribing Information.
- Jan 30, 20261h 46m
Episode #1: Amylin Pharmaceuticals
Listen on SpotifyListen on Apple PodcastsListen on YouTubeTABLE OF CONTENTS - Introduction - $50 of Dried Lizard Venom - Fax of Death - Sleeping Beauty Awakens - Carl Icahn Sends a Letter - Endgame - Postmortem & PlaybookCREDITSCo-hosted by Alex Kesin and Matthew Pech Written, edited, and produced by Alex KesinMusic: “Food” by nerowski* Special thanks to the team at NFX for the use of their recording studio.SOURCESLast updated: January 2026I. PRIMARY DOCUMENTSFDA Regulatory DocumentsSymlin (pramlintide acetate) - NDA 21-332* Approval Letter & Package (March 16, 2005)* Medical Review* Statistical Review* Clinical Pharmacology & Biopharmaceutics Review* Administrative Documents & CorrespondenceByetta (exenatide) - NDA 21-773* Approval Letter & Package (April 28, 2005)* Medical Review* Statistical Review* Clinical Pharmacology & Biopharmaceutics Review* Administrative Documents & CorrespondenceBydureon (exenatide ER) - NDA 22-200* Approval Letter (January 27, 2012)* Other Action Letters (Complete Response)* Summary Review* REMS* Administrative CorrespondenceSEC Filings & Financial Documents* Amylin 2005 Results Press Release (Ex-99.1, 8-K)* Amylin 2007 Results Press Release (Ex-99.1)* Amylin 2011 Form 10-K (Net Product Sales)* Carl Icahn SEC Filing (Schedule 13D)Proxy Fight & Legal Documents* Carl Icahn Letter to Amylin (April 15, 2009)* Amylin Response to Icahn (April 20, 2009)* Police Fund v. Bradbury (Amylin) Trial (May 4, 2009)* Lilly Litigation Ruling (May 25, 2011)II. ORAL HISTORY & INTERVIEWS* Howard Greene Oral History (UCSD Library, October 8, 2008) - Primary source for Hybritech founding, Ted Greene’s background, a
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Life sciences, under the hood. Deep dives into the patent filings, regulatory gauntlets, and capital-risks that shape the business of biology.
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