Chutes & Ladders—FDA's top 2 vaccine leaders to depart in the fall as questions loom over booster shots

                        Chutes and Ladders
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 Kyle LaHucik, and we will feature it here at the end of each week.

FDA's top vaccine leaders are departing the agency in late-fall as COVID-19 booster questions loom over the regulatory body, White House

Marion Gruber, Ph.D., will depart her post as director of the FDA Office of Vaccines Research and Review on Halloween.

Following her Oct. 31 departure, her deputy, Philip Krause, M.D., will also leave, sometime in November, the agency said Tuesday. Gruber and Krause are leaving the FDA as concerns loom over the White House's push for COVID-19 booster shots without the FDA's green light. Gruber spent more than 30 years at the agency and was pivotal in the United States' efforts around COVID-19 vaccines. The retirement announcement comes two weeks after Pfizer's Comirnaty vaccine was approved by the FDA, making it the first such nod for a COVID-19 vaccine in the U.S. The FDA's director for the Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D., will be the acting director of the vaccine unit as a search for Gruber's replacement takes wind.

A day after Gruber and Krause announced their departures, the FDA said it would review Pfizer's COVID-19 vaccine booster application on Sept. 17, three days before the Biden administration wants boosters available to Americans. Fierce Pharma

Teva Pharmaceutical snags former Moderna Chief Medical Officer Tal Zaks for its board

Teva Pharmaceutical
Tal Zaks, M.D., Ph.D., will be an independent director on the board of Israeli biotech Teva Pharmaceutical.

The appointment begins Oct. 1 and marks the first major move since Zaks left the now-famous COVID-19 vaccine maker in February. Zaks was CMO of the mRNA biotech for six years, leading clinical development and regulatory affairs as the company progressed toward making one of the first emergency use authorized vaccines for the pandemic. He had also served stints at Sanofi, GlaxoSmithKline and Cephalon. Zaks joins Teva as it struggles to beef up its innovative drugs portfolio after being a leading generics maker, with migraine and Huntington's disease drugs underperforming. Fierce Pharma

Galapagos CEO to depart once successor is chosen amid series of R&D flops for 22-year-old biotech

Onno van de Stolpe will leave his post as CEO after founding Galapagos in 1999. 

Van de Stolpe will leave after a tumultuous period at Galapagos in which the company's share price has fallen 80% and wiped out billions of dollars in value after a series of R&D setbacks. Van de Stolpe will depart once his successor is chosen. He leaves after flops for multiple programs. Filgotinib, once heralded as a potential blockbuster drug but failed in treating rheumatoid arthritis patients, then ziritaxestat failed a phase 3 trial in idiopathic pulmonary fibrosis and a SIK inhibitor program underwhelmed in its first clinical study.  Fierce Biotech

> Avidity Biosciences Chief Medical Officer Jae Kim, M.D., departed the company for personal reasons, sending the stock down 19%. Kim joined Avidity in July 2020 after a four-year stint at Alnylam. Fierce Biotech

> Kevin S. Boyle joins Ziopharm Oncology as CEO. Boyle joins the cell and gene therapies biotech from Kuur Therapeutics, where he was also CEO. Ziopharm also promoted Chief Medical Officer Raffaele Baffa, M.D., Ph.D., to the post of head of R&D. Adam Levy, Ph.D., was promoted to executive vice president of corporate development and investor relations. Fierce Biotech

> Brickell Biotech named Monica Luchi, M.D., its chief medical officer. Luchi will lead the development of a platform of assets acquired from Voronoi and joins from Sorrento Therapeutics, where she held the post of SVP of clinical research and development. Fierce Biotech

> Murray Stewart, M.D., will transition from Rhythm Pharmaceuticals chief medical officer to senior medical advisor. Linda Shapiro Manning, M.D., Ph.D., was promoted to fill the CMO role. Fierce Biotech

> Caladrius Biosciences hired Kristen K. Buck, M.D., as its chief medical officer. Buck joins the clinical-stage cell therapy biotech from ICON, a drug and device commercialization services provider, where she was chief medical officer. Release

> Avacta Group named Fiona McLaughlin, Ph.D., chief scientific officer of its therapeutics division. She was most recently vice president of new opportunities at Algeta ASA, a Norwegian biotech acquired by Bayer. Release

> Eisai's cancer genomics drug discovery subsidiary, H3 Biomedicine, promoted Ping Zhu, Ph.D., to president and chief scientific officer, and Ross Pettit to deputy president. Zhu was previously head of discovery and research and has been at the company since 2012, and Pettit was vice president of clinical operations. Release

> Alexander Brown will be chief operating officer of clinical-stage pharma Convergent Therapeutics. He joins the radiopharmaceuticals company from Sanofi, where he was the head of new product planning for the Big Pharma's global oncology unit. Release

> Jeff E. Knight was named chief operating officer of Crinetics Pharmaceuticals. He was previously at Poseida Therapeutics, where he led portfolio management and strategy. Release

> Chemomab Therapeutics appointed Dale R. Pfost, Ph.D., as CEO. He was previously CEO of Lodo Therapeutics. Founding CEO Adi Mor, Ph.D., will continue in her role as chief scientific officer. Release

> Edward G. Evantash, M.D., will be the chief medical officer of biomedical company Femasys. Evantash was previously CMO of Alydia Health and prior to that spent a decade at Hologic, including as medical director and VP of medical affairs. Release

> Radiopharmaceutical biotech RayzeBio made a string of hires. Susan Moran, M.D., joined as CMO after holding the same post at QED Therapeutics. Kimberly Ma will be senior vice president of clinical operations after serving in the same role at Odonate Therapeutics. And Nicholas Smith, Ph.D., becomes SVP of chemistry innovation after filling the same duties at Metacrine. Release

> Richard K. Murray, M.D., becomes Avisa Diagnostics' first CMO. Murray was previously a consultant to The Medicines Company, CMO of Spirehealth and, before that, vice president and deputy chief patient officer at Merck. Release

> Hanit Brenner-Lavie, Ph.D., will be vice president of clinical affairs at Check-Cap. The executive joins the clinical-stage diagnostics company from Alma Lasers, where she held the same post. Release

> Michael Didocha will serve as Americas chief financial officer for Telix Pharmaceuticals. He joins after a 16-year stretch at Roche, where he was most recently director of finance. Release

> Roberto Almodóvar Febles becomes Pharmaceutical International's head of aseptic operations. He has held stints at Baxter Healthcare, Amgen and iPR Pharmaceuticals. Release

> Neuromuscular diseases biotech PepGen promoted Jane Larkindale, Ph.D., as vice president of clinical science. Larkindale joined the company as senior director of clinical science in April after serving as executive director of a rare disease cures accelerator at Critical Path Institute. Release

> Preetam Shah, Ph.D., was named chief financial officer and chief business officer of Cidara Therapeutics after holding the CFO post at Brainstorm Cell Therapeutics. Cidara also snagged Shane Ward as chief legal officer and corporate secretary. Ward joins from Bellicum Pharmaceuticals, where he was chief legal and strategy officer. Release

> Gene therapy biotech Purespring Therapeutics named Ronny Renfurm, M.D., its CMO after stints as a consultant and previously group head of Astellas Pharma's nephrology unit. Julian Hanak was selected as chief development officer after being a senior vice president at NightstaRx Therapeutics, acquired by Biogen. Release

> Pillar Biosciences named Randy Pritchard its CEO as founder Gang Song, Ph.D., steps into the board chairman role. Pritchard joins from an 18-year run at Roche, where he was most recently senior vice president of U.S. diagnostics marketing. Release

> Chris Garcia was named CEO of health tech company GoodCell. Garcia comes from Remedy Partners, where he was CEO of the company, which was acquired by Signify Health. Release

> Jean-Christophe Pointeau was named president of Pfizer Biopharmaceutical's China unit. He previously led China operations for Big Pharmas Sanofi and Bristol Myers Squibb.

> Pyxis Oncology named Pamela Yanchik Connealy its chief financial officer. She was previously CFO and chief human resources officer at Immunovant. Release

> Jim Jogerst will be chief business officer of Rubius Therapeutics. He joins from Johnson & Johnson's Janssen, where he led licensing deals for the infectious diseases and vaccines business, a unit critical to the Big Pharma's COVID-19 jab. Release

> Oncternal Therapeutics named Steven Hamburger, Ph.D., as senior vice president of regulatory affairs and quality assurance. Hamburger joins from FerGene, where he was responsible for clinical regulatory affairs. Release