Chutes & Ladders—FDA nod for Biogen's Aduhelm sees trio of AdComm members hit the exit

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                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 Fraiser Kansteiner, and we will feature it here at the end of each week.

Former Ogilvy Health head Schirmer lands at Syneos pharma and healthcare agency GSW New York

Andrew Schirmer takes the reins as president.

From art director to executive creative to general manager and DTC pioneer, GSW New York's new president Schirmer has run the gamut at healthcare and pharma companies. He comes on board at the Syneos Health agency from Ogilvy, where he helmed the ship as president and CEO of North America for Ogilvy CommonHealth. Right before that, he was president of McCann Global Health and founded its direct-to-consumer offering, McCann HumanCare. After taking a brief post-Ogilvy sojourn, Schirmer answered the Syneos call. Now, he's returning to his roots in creative and strategy at GSW. He's set up two agency mandates. First, the work needs to be surprising, and it can't just be more noise. “In the day and age of limitless messaging and limited attention, you can’t communicate unless you engage,” he told Fierce Pharma. His second decree is to make sure creativity comes from all parts of the agency, not just the so-called creative department. Fierce Pharma

AdComm members quits over FDA approval of Biogen's Aduhelm

FDA's Peripheral and Central Nervous System Drugs advisory committee
Joel Perlmutter, M.D., and David Knopman, M.D., have quit the committee.

The FDA's decision on Biogen's controversial Alzheimer's disease med aducanumab, now christened Aduhelm, was bound to draw ire no matter which way the regulator swung. Now, in the aftermath of an approval, three members of the advisory committee that recommended rejecting the drug have quit. First up was Perlmutter, a neurologist at Washington University School of Medicine in St. Louis, who left left “due to this ruling by the FDA without further discussion with our advisory committee.” The neurologist, who went on to co-author a JAMA paper arguing against aducanumab, warned there was a "huge danger in approving something that turns out not to be effective" at November's advisory committee meeting. Not long after Perlmutter's exit, Mayo Clinic neurologist Knopman followed his AdComm compatriot out the door. “I was very disappointed at how the advisory committee input was treated by the FDA,” he said, adding, "I don't wish to be put in a position like this again.” As a site investigator for the drug's Engage study, Knopman wasn’t part of the panel that debated and rejected it last Fall. Aduhelm failed to reduce clinical decline in that study, but Biogen tried to use the results to validate the findings of its other phase 3 trial by doing a post hoc analysis of high-dose patients. As of Friday, a third member, Harvard University professor Aaron Kesselheim, M.D., had quitFierce Biotech

Inogen snags BD diabetes VP for CMO to help expand line of home oxygen devices

Stanislav Glezer, M.D., will come on board as chief medical officer.

2021 is shaping up nicely for Inogen, maker of a line of at-home and portable oxygen concentrators. The company has a new chief executive, its revenues are on the rebound and now, it's brought new chief medical officer Glezer into the mix. Armed with decades of experience at medtech and life sciences juggernauts like BD, Novo Nordisk and Sanofi, Glezer will start helming Inogen's medical affairs, clinical research and regulatory branches on June 21. The company is currently questing to broaden its foothold in the oxygen device market expand its product line. The company has five separate systems in its arsenal: three portable concentrators, one for at-home use, and the Tidal Assist Ventilator, which connects to oxygen tanks and concentrators to increase oxygen flow. Glezer comes straight from BD, where he was vice president of global medical affairs in the company's diabetes care business. Fierce Biotech

> Ovid Therapeutics' announced the metamorphosis of its chief business officer's title. Jeffrey Rona is expanding his role to include chief financial officer at the neurological disease biopharma. Rona's life sciences track record includes stints as chief business officer at GlobeImmune, chief financial officer at AlgoRx Pharmaceuticals, CFO at Great Basin Scientific and director of investment banking at UBS. He joined Ovid from Danforth Advisors, where he was the Western region managing director. Release

> Strata Oncology has tapped former Abbot executive Mark Szewczyk as chief commercial officer in the latest boost to its commercial team following the appointment of Trey Regalo as vice president of sales and Rob Manor as VP of commercial partnerships. At Abbot, Szewczyk served as VP of global commercial operations for the company's molecular diagnostics unit, plus its general manager. He spent time at Philips Healthcare as general manager of diagnostics imaging systems, and he also had a run as general manager of the Cleveland Clinic Home Care. Release

> Icosavax has summoned Thomas Russo into the role of chief financial officer. He joins the infectious disease vaccine developer from clinical-stage biotech Assembly Biosciences, where he occupied the same post. He spent a seven-year stretch at Gilead Sciences before that, including as its vice president, head of commercial finance. Meanwhile, Russo's time at Merck & Co. should come in handy as Icosavax advances its pipeline of respiratory disease vaccine candidates, which run the gamut from RSV to COVID-19. He climbed the ranks within the Big Pharma's manufacturing division, where he was particularly focused on vaccines. Release

> Ocugen has set its sights on Michael Shine to fill the role of vice president of commercial. Shine has held top posts at companies like Novapharm Therapeutics, Colgate Oral Pharmaceutical and Pfizer Vaccines and previously held the title of chief marketing officer with Thomson Reuters. While at Pfizer, Shine led the launch of the company's Prevnar pneumococcal vaccine franchise. He also helped get the shot included in key national immunization programs, spurring sales of more than $2 billion. Release

> Monte Rosa Therapeutics has enlisted Filip Janku, M.D., Ph.D., as its first chief medical officer. At Monte Rosa, Janku will help propel the Boston-based biotech's pipeline of precision medicines toward the clinic. The company is developing drugs that degrade disease-causing proteins. Janku comes over from The University of Texas MD Anderson Cancer Center, where he filled several roles, including center medical director for the Clinical and Translational Research Center, associate professor and medical oncologist in its Department of Investigational Cancer Therapeutics. Release

> Fledgling Aurion Biotech, which recently emerged on a mission to cure blindness using advanced therapies for ocular diseases, was in need of a leader. Now, it's putting Greg Kunst in charge as chief executive officer. Kunst joins by way of Glaukos Corporation, where he spent six years leading global marketing, market access, reimbursement, health economics and outcomes research, government affairs and business development teams. He launched four new products there and operated in the role of global franchise director over the glaucoma surgery and retina pharmaceutical businesses at Novartis' Alcon before that. Release

> Chinook Therapeutics, working on precision medicines for kidney diseases, has sent two of its own up the ladder. Chief Business Officer Tom Frohlich has been promoted to chief operating officer, and Andrew King, D.V.M, Ph.D., the company's head of renal discovery and translational medicine, has been bumped up to chief scientific officer. Co-founder Frohlich will now be in charge of business development, CMC, quality, new product planning, program management and program team leadership functions, Chinook said in a release. For his part, King, who worked at Ardelyx before joining Chinook in May 2019, will mange discovery research, non-clinical development and translational medicine teams. Release

> Pyxis Oncology has called upon Steve Monks, Ph.D. as chief technical officer and Ritu Shah, PMP, as chief operating officer. It's also grown its scientific advisory board by two, adding Christoph Rader, Ph.D., and Anthony Tolcher, M.D.. Before joining Pyxis, Monks was SVP of development at Aura Biosciences and served on the executive team at Agenus before that. For her part, Shah most recently held the role of VP of business operations and program management of Levo Therapeutics. Release

> Clinical-stage immunotherapy biopharma CARISMA Therapeutics has hired on Richard Morris as its chief financial officer. He comes over from Passage Bio, where he also wore the CFO mantle. He played an "instrumental" role in Passage's metamorphosis from private start-up to a public development-stage company. Prior to that, he was executive vice president and CFO for Context Therapeutics. Release

> Umoja Biopharma, developing next-gen immunotherapies against solid tumors and blood cancers, has named David Fontana, Ph.D., chief business and strategy officer. He comes over from pharma heavyweight Bristol Myers Squibb, where he was a cell therapy franchise exec and a member of the lymphoma disease strategy team. Specifically, he led development for the company's recently approved CAR-T therapy Breyanzi. Release

> Advanced cell therapy company Gamida Cell has tapped Vladimir Melnikov as senior vice president, global operations and manufacturing. He signs on with an arsenal of experience in biologics manufacturing, operations, engineering and technology transfer, and will be based at the company's commercial manufacturing facility in Israel. Melnikov's most recent posts were general manager at Johnson & Johnson's Omrix Biopharmaceuticals, as well as biologic technical operations lead at Ethicon Biosurgery. Release

> PepGen is welcoming drug development expert Niels Svenstrup, Ph.D., to the team as SVP of chemistry, manufacturing and controls, plus well-versed financial leader David Pelissier, CPA, who joins as VP of finance. Svenstrup will be tasked with overseeing the R&D process of the company’s EDO platform. His latest tenure before PepGen was at Cydan as SVP of development. Pelissier, meanwhile, served as vice president and controller of gene therapy player Avrobio. Release

> Oxular tapped Friedrich Asmus as its new chief medical officer. He enters the fold shortly after Oxular raised $37 million in financing, while Marc de Smet, who was working as CMO in a part time capacity alongside his private clinical practice, will continue to serve with the company as senior medical adviser. Asmus will lead all medical, clinical and regulatory functions to advance the company's lead asset, OXU–001, in diabetic macular edema. Release

> Solid Biosciences, working on therapies for Duchenne muscular dystrophy, welcomed Iman Barilero as chief regulatory officer June 1. She most recently served as a senior adviser to Innouvo, where she also offered regulatory guidance. Prior to that, she held top spots in regulatory affairs and pharmacovigilance at Agenus and Poxel in Boston and previously was VP, global head regulatory science & policy at Lundbeck. Release

> DTx Pharma is bringing Jill Howe into the fold as chief financial officer. She joins from Gossamer Bio, where she operated in a similar capacity as treasurer and vice president of finance. Howe was also the internal project lead for the company’s initial public offering as well as follow-on and debt offerings. Before that, she held controller and director of finance roles at Amplyx Pharmaceuticals, Receptos and Somaxon Pharmaceuticals. Release

> Kinnate Biopharma, working to ID and develop small-molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, has ushered Neha Krishnamohan into the role of chief financial officer and executive vice president, corporate development. She comes over from a 12-year stint at Goldman Sachs, where she most recently held the role of vice president in the Healthcare Investment Banking Group and was a member of the Mergers and Acquisitions Group within the Investment Banking Division. Release

Intercept Pharmaceuticals is bolstering its executive roster by two. On Monday, the company announced that Andrew Saik would come on board as chief financial officer. Just two days after that, the biopharma, which focuses on development and commercialization of new therapeutics to treat progressive non-viral liver diseases, called on M. Michelle Berrey, M.D., M.P.H., as its president of research and development and chief medical officer. Saik joins the team with more than two decades of biopharma finance know-how. He previously served as CFO of Vyne Therapeutics, where he led a buildout of the company’s finance department in the U.S.. For her part, Berrey most recently served at Chimerix, where she was president and chief executive officer. Earlier in her career, she was Pharmasset's chief medical officer, prior to the company's $11.2 billion buyout by Gilead Sciences. 

Editor's note: This story was updated to include an announcement from Intercept.