People in the News

Jeff Shuren, director of the FDA's Center for Devices and Radiological Health (CDRH), said this week that he will leave the agency later this year.

He said that on July 28 he will move to the Commissioner's Office as center director emeritus, and Michelle Tarver, the current deputy center director for transformation, will become CDRH acting director. Shuren will officially leave the agency later this year.

Shuren joined FDA in 1998 and has been CDRH director since 2009. Prior to 2009 he held a variety of policy and planning positions within the Office of the Commissioner.

Tarver joined FDA in 2009 as a staff fellow in CDRH's Office of Surveillance and Biometrics. She was previously an assistant professor at The Johns Hopkins University School of Medicine.

The US Food and Drug Administration confirmed Timothy Stenzel retired from his position at the agency as director of the Center for Devices and Radiological Health Office of In Vitro Diagnostics at the end of 2023. The agency is currently conducting a search for his successor. In the interim, Courtney Lias, director of the Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices, is serving in an acting capacity as director of the in vitro diagnostics office.

Stenzel joined FDA as director of the in vitro diagnostics office in 2018. Prior to that he was COO at San Diego-based cancer testing firm Invivoscribe. Stenzel was also CSO at Quidel, now called QuidelOrtho, and CMO and VP, R&D at Asuragen, now part of Bio-Techne, as well as an assistant professor of pathology and adjunct assistant professor of pathology at Duke University.

Roche subsidiary Foundation Medicine has appointed Dan Malarek as CEO replacing Brian Alexander, who will move to a senior leadership role in Roche's pharmaceutical research and development organization. Malarek has served in multiple roles within Roche Diagnostics, most recently as global head of marketing and customer insights. Before that, he served as general manager for Roche Diagnostics Norway.

Durin Technologies has appointed Mert Sahin as CEO.

Sahin previously led marketing for GE Healthcare's imaging business in the US and Canada and has also held roles at Roche Diagnostics, Eurofins Genomics, Thermo Fisher Scientific and Dalan Animal Health.

Octave Biosciences has named Doug Biehn president and CEO. Former CEO William Hagstrom is now chairman of the company's board of directors. Biehn previously held executive positions at companies including iRhythm Technologies, McKesson, AliveCor, Blue Shield of California, and Cala Health.

Aspira Women's Health has established a clinical advisory board and named Levi Downs, Nisha Garga, and Tamika Sea as its initial members.

Downs is director of gynecologic oncology at Park Nicollet Health Services in Minneapolis, Minnesota, and is the current president of the American Society for Colposcopy and Cervical Pathology.

Garga is a gynecologic surgeon with Phoenix-based Arizona Gynecology Consultants and an assistant clinical professor of obstetrics and gynecology at both the University of Arizona College of Medicine and at the Creighton University School of Medicine.

Sea is the founder and owner of Atlanta, Georgia-based Advanced Women's Care Center and has served as the chair of the department of obstetrics and gynecology at Piedmont Henry Hospital.

InterVenn Biosciences has appointed Joshua Stahl as CEO. Stahl was previously CSO and chief operating officer at ArcherDx. Following ArcherDx's acquisition by Invitae in 2020, he served as president of oncology of that company.

Roche has announced multiple changes to its board of directors and corporate executive committee, including the resignation of Bill Anderson, CEO of Roche Pharmaceuticals, and the proposal to appoint Mark Schneider and Akiko Iwasaki to the board. 

Anderson will resign effective Dec. 31, and Roche Diagnostics CEO Thomas Schinecker will take over as interim Roche Pharmaceuticals CEO on Jan. 1. The company previously announced that Schinecker will take over as the Roche Group's CEO from Severin Schwan in March, when Schwan will become chairman of the board. Matt Sause will become CEO of Roche Diagnostics on Jan. 1.

Anderson, who has served as CEO of Roche Pharmaceuticals since 2019, joined Roche subsidiary Genentech as SVP of the immunology and ophthalmology business unit in 2006 and then took over the BioOncology business unit. In 2013 he became the head of global product strategy and chief marketing officer for Roche Pharmaceuticals, and in 2016 he took over the North American operations for Genentech, later becoming CEO of the subsidiary.

Silke Hörnstein will become head of corporate strategy, secretary to the corporate executive committee, and will become a member of the enlarged committee in April. Hörnstein is currently the global head of strategy and transformation for Roche's diagnostics division. Hörnstein joined Roche in 2001 and has served as director of direct procurement, as well as diagnostics general manager for Denmark. She has also led multiple global programs for Roche, including digital transformation for the diagnostics business. 

The board of directors will propose at Roche's annual meeting in March that Mark Schneider and Akiko Iwasaki be appointed as new members. Schneider has served as CEO of Nestle since 2017 and was previously CEO of the Fresenius Group, a German healthcare company. Iwasaki is a professor of immunobiology and molecular, cellular, and developmental biology at Yale University. She is also an investigator at the Howard Huges Medical Institute, a nonprofit medical research organization.

Roche also announced that Annette Luther, secretary to the board of directors, will be appointed head of international government relations in April. Per-Olof Attinger, who is currently secretary to the corporate executive committee, will take over Luther's position. 

Caris Life Sciences has appointed George Sledge as its executive VP and chief medical officer. He will oversee the firm's medical affairs, research, and medical education, including the Caris Precision Oncology Alliance and the company's team of medical science liaisons. Prior to joining Caris, Sledge was professor of medicine in the oncology division at Stanford University School of Medicine. He was most recently co-director of the Stanford Cancer Institute's cancer therapeutics program and served as chief of the division of oncology from 2013 to 2020. He has also held various other positions, including chair of the Eastern Cooperative Oncology Group's Breast Cancer Committee, member of the US Food and Drug Administration's Oncology Drug Advisory Committee, member of the Integration Panel within the Department of Defense's Breast Cancer Research Program, and member of the National Cancer Institute's Clinical Trials Advisory Board. He is the past president of the American Society of Clinical Oncology.

Roche announced that Julie Brown will be stepping down as a member of the board of directors, effective immediately, after accepting the CFO role at pharmaceutical company GSK, starting in May. Brown was elected to the board in March 2016 and has been the chairwoman of the audit committee since then. Patrick Frost will be the interim chair of the committee until the general meeting in March 2023. 

Brown currently serves as chief operating and financial officer at fashion firm Burberry. She was previously group CFO at medical technology company Smith and Nephew. Brown also held multiple roles at AstraZeneca, including interim group CFO and VP of group finance, regional commercial VP of Latin America, and VP of corporate strategy.