Chutes & Ladders—FDA's Janet Woodcock set to retire in early 2024

 Chutes and LaddersWelcome to this week's Chutes & Ladders, our roundup of hirings, firings and retirings throughout the industry. Please send the good word—or the bad—from your shop to Max Bayer or Gabrielle Masson, and we will feature it here at the end of each week. 

Editor’s note: We won’t be publishing Chutes & Ladders next week on Nov. 25 due to the Thanksgiving holiday, but will be back to our regular schedule the following week.

FDA pillar Janet Woodcock set to retire in early 2024

Food and Drug Administration

Headshot of FDA Deputy Commissioner Janet Woodcock
Janet Woodcock, M.D. (FDA)

The FDA has long been plagued by turnover, given the lucrative industry salaries that can lure career regulators away from Washington. But Janet Woodcock, M.D., has been an outlier, a stalwart leader of the organization who’s worn almost every hat in the drug development arm of the agency. That nearly 40-year career is coming to an end, however, with Commissioner Robert Califf, M.D., confirming her plans in an all-staff email posted by the agency’s spokesperson.

Califf said Woodcock will depart early next year, though an exact timeline wasn’t mentioned. His message came after reports of her retirement broke. 

“While no one can fill Janet’s shoes, I’ll share news about her successor in the future,” Califf wrote. 

Woodcock’s career began in 1986 as director of the Division of Biological Investigational New Drugs at the Center for Biologics Evaluation and Research (CBER) before leading the center’s Office of Therapeutics Research and Review. In 1994, Woodcock was named the director of CBER’s sibling, the Center for Drug Evaluation and Research. She also at one point served as interim commissioner of the agency, from January 2021 to February 2022. The list of her accomplishments and contributions could be kept in a scroll. Califf called her a “legend in every sense of the word.” Tweet

Madrigal swiftly names new CCO with potential launch imminent


New Madrigal CEO Bill Sibold has landed on a commercial chief, bringing on a former colleague at Sanofi who helped lead the launch of blockbuster Dupixent. Carole Huntsman has taken the gig a little more than a month after Remy Sukhija departed shortly after Sibold’s arrival.

Her arrival gives Sibold a critical executive partner with the FDA set to decide on the company’s nonalcoholic steatohepatitis (NASH) drug, resmetirom, by the middle of March 2024. And Huntsman is a familiar face, having worked with Sibold at Sanofi as SVP and head of speciality care, U.S. and North America lead. She directed some 2,600 employees on the rollout of numerous drugs, including Dupixent. The unit she led was responsible for more than $10 billion in net sales in 2022, just what Madrigal wants to hear and see as it plans to debut the first approved NASH treatment.

Before joining Sanofi in 2012, Huntsman was SVP of U.S. neurology and rheumatology at EMD Serono and VP of U.S. marketing for the neurology unit at Serono. Source

Alkeremes cancer spinout launches with $275M and a couple seasoned development execs

Mural Oncology

Alkermes has formally unveiled its new cancer spinout, Mural Oncology, equipped with $275 million in committed capital and interleukin-2 (IL-2) candidate aimed at solid tumors. The move has been in the works for about a year.

Leading Mural will be a couple of veteran clinical artists, with Caroline Loew, Ph.D., set to take the CEO mantle and Vicki Goodman, M.D., hired as chief medical officer. Loew was previously the CEO of Glympse Bio and before that was head of R&D strategy and planning at Bristol Myers Squibb. Goodman was the chief medical officer at Exelixis after working at Merck for almost two years. Goodman and Loew overlapped at BMS for about three years, during which Goodman was a vice president.

The two’s top priority will be nemvaleukin alfa, the asset atop Mural’s pipeline. The company says registrational trials are ongoing with initial readouts slated for the first quarter of 2025. Source

> Two former Amgen scientists are joining Halia Therapeutics’ leadership team, with Lisa Shamon, Ph.D., taking on the role of VP of regulatory affairs and Xianne Penny, Ph.D., as senior medical director. Before joining Halia, Shamon held various roles across Alza Corporation, Exelixis, Aeglea BioTherapeutics, FivePrime Therapeutics and Amgen, while Penny served as Amgen’s senior principal clinical immunologist for more than five years. Release

> Nereid Therapeutics has named Michael Kauffman, M.D., Ph.D., to serve as president and CEO, taking the reins from Apple Tree Partners venture partner and acting CEO Spiros Liras, Ph.D. Most recently, new Nereid leader Kauffman served as longtime CEO and co-founder of Karyopharm. Release

> Wendye Robbins, M.D., will be taking the top spot at Incendia Therapeutics. With more than 20 years of industry experience under her belt, Robbins continues to also serve as an independent director for Rapt Therapeutics. Release

> Memo Therapeutics has tapped Erik van den Berg to helm the antibody-focused biotech. Van den Berg joins from AM-Pharma, where he was CEO for 12 years, and succeeds Karsten Fischer, who led Memo for five years. Release

> Nucleome Therapeutics has nabbed Stephen Harrison, Ph.D., to serve as chief scientific officer. Before joining Nucleome, Harrison held executive leadership positions at Engine Biosciences, Relypsa (divested to Galencia), Nektar Therapeutics and KAI Pharmaceuticals (acquired by Amgen). Release

> Theseus Pharmaceuticals is shrinking its head count by 72%, including R&D head William Shakespeare, Ph.D., although he will continue to support the biotech in a consulting role until the end of June 2024. Fierce Biotech

> Melissa Faris has departed GSK to take up a spot as OMass Therapeutics’ chief business officer. Faris spent years with the Big Pharma, most recently serving as VP and head of immunology business development. Release

> 1910 Genetics has promoted SVP and Head of Chemistry Bridget Cole, Ph.D., to chief scientific officer. Before 1910, she served as Nocion Therapeutics’ SVP of drug discovery, and has held past roles at Axial Biotherapeutics, Flatley Discovery Lab, Surface Logix and Pfizer. Release

> Noema Pharma has chosen Robert Lasser, M.D., to serve as the company’s chief medical officer. Most recently, Lasser served as an executive leader for Sage Therapeutics and has held past leadership roles across Medday Pharmaceuticals, Roche, Shire Pharmaceuticals (acquired by Takeda), Johnson & Johnson and Novartis. Release

> IMIDomics is building out its leadership team, tapping Eric Perakslis, Ph.D., to serve as SVP and chief technology officer, and Ramon Felciano, Ph.D., to serve as strategic adviser in biomedical artificial intelligence and data science. Perakslis has held leadership roles at the FDA, Datavant, Takeda and Johnson & Johnson, while Felciano is the founder and CEO of Digital Alchemy. Release

> Affini-T Therapeutics, an immunotherapy company planning an IPO in 2024, has appointed Kathy Bergsteinsson as chief financial officer. Bergsteinsson most recently served as managing director and head of healthcare equity capital markets for Morgan Stanley. Release

> Attorney Graham Owens has been tapped to serve as executive director of the Rare Disease Company Coalition. Owens also serves as regulatory and oversight counsel for the Senate Small Business Committee. LinkedIn

> Former venture partner at Versant Ventures and CEO of Inception Therapeutics Jeremy Caldwell, Ph.D., has joined Red Tree Venture Capital as a partner. Release

> Ori Biotech is preparing for the commercial launch of its cell therapy manufacturing platform, tapping Gillian Bonthron to be chief financial officer and John Machulski to be chief operating officer as well as promoting Thomas Heathman, Ph.D., from VP of commercial operations to chief commercial officer. Bonthron joins with experience at Healx and Perspectum under her belt, while Machulski joins from Catalent and has past experience at Lonza, GE Life Sciences (now Cytiva), Sanofi, Pfizer and Johnson & Johnson. Release

> Sofinnova Partners is bolstering its medtech leadership team, bringing on Mano Iyer as a partner and promoting Cécile Dupont to partner. Iyer is the founder of ReCor Medical, and Dupont has been with Sofinnova since 2019. Release