Welcome 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 Conor Hale, and we will feature it here at the end of each week.
FDA chief Scott Gottlieb steps down
FDA
Scott Gottlieb, M.D., will resign as commissioner next month.
At just shy of two years into leading the agency, the announcement of Gottlieb's sudden departure with no clear successor sent shock waves through the industry, not to mention precipitating a drop in the Nasdaq's biotech index.
Gottlieb has largely been seen as a friendly regulatory overseer, for good or ill—with the trade group PhRMA praising his "exemplary leadership" despite his efforts to combat rising drug prices by boosting generic competition, and his shaming of tactics used by certain makers of branded drugs to keep copycats off the market. He's also been prodigious: according to Jefferies, Gottlieb’s FDA published more than 200 guidance documents last year, while approving more new drugs with streamlined processes—including the agency's first cell and gene therapies. FiercePharma | FierceBiotech
Gilead loses oncology leader days into new CEO's stint
Gilead
Oncology leader Alessandro Riva, M.D., will leave at the end of the month.
Riva, who helped oversee the $11.9 billion takeover of Kite Pharma and pushed Gilead into CAR-T therapies, will leave the big biotech to serve as the CEO of Glenmark Pharmaceuticals' new unnamed R&D-focused spinoff. The news comes just days into the tenure of Gilead's new CEO, Daniel O’Day, who has begun the hunt for a successor to the crucial position. Whoever takes the baton will see pressure to boost Gilead's cancer sales, as O'Day has, with the company's hepatitis C revenues in decline. FierceBiotech | FiercePharma
Deciphera CEO to retire ahead of phase 3 data readout
Deciphera
Taylor—who is stepping down as the company awaits a phase 3 readout of its lead drug ripretinib—will be replaced by Deciphera board member Steve Hoerter, who has served as Agios Pharma's chief commercial officer for the past three years. Taylor will remain on Deciphera's board of directors and maintain an advisory role for the next six months, which should cover the release of data on the company's KIT/PDGFRα-targeted kinase inhibitor as a fourth-line or later therapy for gastrointestinal stromal tumors. FierceBiotech
DBV loses regulatory, R&D executives ahead of peanut drug refiling
DBV Technologies
COO Charles Ruban and CDO Laurent Martin, Pharm.D., are both set to leave their positions at the end of next week.
Two of DBV's leaders for regulatory and product development are set to leave the company by the end of next week, as the company gears up to refile its peanut allergy drug, Viaskin, for FDA approval. The company said Ruban is leaving to pursue new opportunities but offered no explanation for Martin’s departure, though DBV said the changes were a way to “flatten the organizational structure” as it evolves into a commercial-stage company. The company brought on Alexion Pharmaceuticals EVP Julie O’Neill at the start of the year to direct product development, manufacturing, supply chain, quality assurance and end-to-end process optimization. FierceBiotech
> The former president of Olympus' Medical Systems Group in the Americas, Todd Usen, has become the first CEO of Activ Surgical, a startup developing a surgery robot that can autonomously suture soft tissues. FierceMedTech
> Former Biogen executive Priya Singhal, M.D., M.P.H., has joined Zafgen as its new head of R&D. At Biogen, Singhal served as a senior vice president, global head of safety and benefit risk management and interim global co-lead and SVP of global development. FierceBiotech
> Ascletis Pharma is bringing on former MSD China global VP Zhengqing Li, Ph.D., to be its new chief medical officer and head of R&D. Li served as general manager of MSD China’s R&D operations since 2011 and is credited with helping the Merck & Co. unit gain Chinese approval for more than 20 product filings. FierceBiotech
> Vertex Pharmaceuticals CEO Jeffrey Leiden, M.D., Ph.D., and CCO Stuart Arbuckle will participate in a U.K. Parliament hearing on the price of its cystic fibrosis drug Orkambi and other precision meds, alongside officials from NHS England and the National Institute for Health and Care Excellence. FiercePharma
> Humacyte has appointed Chris Fang, M.D., as its chief medical officer. Fang was most recently managing partner at tech advisory firm Amaris Health, and also served as chief adviser for Acer's Asia healthcare business. He previously served as worldwide VP for strategic medical affairs and medical sciences for J&J's DePuy Synthes Spine and Trauma. Release
> Robert Kieval, V.M.D., Ph.D., joined bioelectronics developer FemPulse as its chief scientific and clinical officer. Kieval was previously founder and CEO at CVRx, a business development director at ProtoStar, and a divisional medical director at Medtronic. Release
> Kiadis Pharma has named Dirk de Naeyer as chief operations officer and Martine Nolan as head of quality assurance. de Naeyer first joined Kiadis from Janssen Pharmaceuticals in October 2018 as head of supply chain. He now takes over for Jan Feijen. Nolan joins from Amgen, where she served as regional head of quality operations covering sites in Dublin, Ireland, and Breda in the Netherlands. Release
> Cerevance has brought on Astex Pharmaceuticals' president of CNS drug development, Lee Dawson, Ph.D., to be its VP of neuroscience. Dawson previously spent six years at Eisai, within the company’s neuroscience innovation unit. Release