Chutes & Ladders—Novavax taps Machielse to head manufacturing in lead-up to approvals


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

Novavax hires new manufacturing chief to take COVID-19, flu vaccine hopefuls across the finish line

Ben Machielse will join as executive vice president of chemistry, manufacturing and controls .

Machielse, a veteran of rare disease company Vtesse and MedImmune, will bring his more than 25 years of pharmaceutical experience to help Novavax take the leap from the clinical to commercial stage, CEO Stanley Erck said in a release. Machielse's appointment comes just weeks after Novavax appointed AstraZeneca veteran Filip Dubovsky as its chief medical officer, signaling the company's push for its first FDA approval and amid a fundraising spree that's yielded more than $500 million for its vaccine development. Dubovsky and Machielse will serve in complementary roles as Novavax angles for approvals, with the former tasked with overseeing development of the company's COVID-19 candidate and the latter putting the manufacturing apparatus in place to pass regulatory muster and successfully scale production. FiercePharma

British cell therapy biotech Rexgenero nabs life science veteran as CMO

Gilbert Wagener, M.D., Ph.D., has been tapped as senior vice president and CMO.

Wagener will be tapped to lead cell therapy development, clinical and medical activities, and regulatory strategy. Rexgenero is currently working on an late-stage cell therapy, known as REX-001, for critical limb ischemia (CLI) that causes burning pain in the feet as a result of blocked arteries in the lower limbs. Patients often get ulcers that can lead to amputation of the affected limb. A year after initial diagnosis, around 12% of patients have had an amputation. Five years after diagnosis, the situation is even worse with mortality at 50%, rising to 70% after 10 years. The biotech started two phase 3 tests late last year in the U.K. known as Salamander, specifically in diabetic patients with CLI. FierceBiotech

EMA picks WHO's Cooke to replace Rasi as executive director

European Medicines Agency
Emer Cooke has been nominated as the new executive director.

Cooke, who works at the World Health Organization, will replace Guido Rasi later in the year if she comes through the remaining steps in the hiring process. Thursday, the EMA management board selected Cooke as the next executive director after talking to the shortlisted candidates. EMA is yet to share details of the subsequent vote, but Cooke needed to secure the backing of two-thirds of the 36-person board to win the nomination. The next step is for Cooke to make a statement to a European Parliament committee. Assuming the European Parliament supports the appointment, EMA will issue a contract to Cooke, positioning her to take up the executive director position. Rasi is set to step down as EMA executive director Nov. 15. FierceBiotech

> Mereo appointed John Lewicki, Ph.D., as its new chief scientific officer and Ann Kapoun, Ph.D., as senior vice president of translational R&D. Both worked at cancer biotech OncoMed before, now merged into Mereo, with both also having worked on anti-TIGIT oncology hopeful etigilimab before the 2019 union. FierceBiotech

> Cambridge, Massachusetts-based Avrobio has named Kim Raineri as chief manufacturing and technology officer. Raineri will replace Kim Warren, Ph.D., who will be retiring at the end of July. Raineri most recently served as VP of operations for Nikon CeLL innovation Co. Ltd, a Japanese CDMO. Release

> Cambridge, Massachusetts-based eGenesis has hired Peter Hanson, Ph.D., as chief operating officer. Hanson was most recently chief development operations officer at Centrexion Therapeutics. Release

> Swedish biotech Oncopeptides has named Marty Duvall as CEO, replacing Jakob Lindberg. Lindberg will assume the role of CSO, replacing Christian Jacques, M.D., who has held the position since 2018. Jacques will continue as a senior adviser. Release

> Czech oncology biotech Sotio has tapped Richard Sachse, M.D., Ph.D., as CMO. Sachse most most recently served as deputy chief medical officer at Sotio and previously worked as chief scientific officer at Neovii Pharmaceuticals. 

> New York-based Lodo Therapeutics has promoted Steve Colletti, Ph.D., to the role of CSO and Brad Hover, Ph.D., to VP of discovery research and platform technology. Release (PDF)

> Salt Lake City-based Sera Prognostics has tapped Thomas Garite, M.D., as VP of clinical sciences. Garite most recently worked as director of research and education for Obstetrix. Release