Michael Barbella, Managing Editor04.05.24
Healthcare Innovation Catalysts Inc. (HIC) has named former U.S. Food and Drug Administration (FDA) Deputy Commissioner Deborah M. Autor as its first CEO.
With more than 30 of experience at the highest levels of government and regulated industry, Autor possesses a range of expertise across regulatory, quality, compliance, business strategy, policy, and law. Her government career spanned two decades, culminating in the role of Deputy FDA Commissioner where she managed all inspections and international operations. Her FDA tenure also included a stint as director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research, where she led enforcement and policy making for compliance with all requirements relating to pharmaceuticals. Before the FDA, Ms. Autor was a decorated federal prosecutor at the U.S. Department of Justice, and FDA was her client.
“We are honored to have Deb take the helm as our first CEO,” HIC Executive Chairman Michael Singer said. “She brings a wealth of experience to HIC as a leader, strategist, and technical expert. Because she has played so many different roles in and around the life sciences industry, Deb brings a valuable perspective that will enable us to further leverage H.I.C.’s technical bench to achieve meaningful results for our clients. She is highly regarded, widely recognized, and deeply connected.”
In addition to her wealth of government experience, Autor has also been a hands-on leader of key functions in both the brand and generic pharmaceutical industries. She ran multiple regulatory functions for all AstraZeneca products globally and led Global Quality at Mylan, overseeing the quality of 60 billion doses of medicine annually across 50 manufacturing sites and dozens of regulatory systems.
“I am delighted to join HIC’s team. In its short year and half, HIC has produced amazing results for its clients and grown to be a catalyst for healthcare innovation,” Autor stated. “I look forward to bringing my vision, knowledge, and government and industry know-how to HIC, with the ultimate goal of finding solutions to clients’ needs in areas such as product development, compliance, post-approval support, and federal partnerships.”
Since 2018, Autor has chaired the FDA Alumni Association, and she is also a Non-Executive Director of Amneal Pharmaceuticals Inc. She has testified in Congressional hearings and appeared in national and international print and television media, including the New York Times, Wall Street Journal, USA Today, LA Times, Boston Globe, NBC, ABC, CBS, and CNN.
Healthcare Innovation Catalysts Inc. was founded in 2022 to fill a gap in the advisory services available to the global life sciences industry. The organization includes experts from government, industry, and academia across disciplines, including regulatory affairs, clinical advisory, biostatistics, quality, compliance, and federal partnerships. The company has brought drugs, biotech products, and medical devices through the clinical development and approval processes; audited clinical trials, manufacturing sites, and labs; developed federal partnerships; and resolved significant compliance problems.
With more than 30 of experience at the highest levels of government and regulated industry, Autor possesses a range of expertise across regulatory, quality, compliance, business strategy, policy, and law. Her government career spanned two decades, culminating in the role of Deputy FDA Commissioner where she managed all inspections and international operations. Her FDA tenure also included a stint as director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research, where she led enforcement and policy making for compliance with all requirements relating to pharmaceuticals. Before the FDA, Ms. Autor was a decorated federal prosecutor at the U.S. Department of Justice, and FDA was her client.
“We are honored to have Deb take the helm as our first CEO,” HIC Executive Chairman Michael Singer said. “She brings a wealth of experience to HIC as a leader, strategist, and technical expert. Because she has played so many different roles in and around the life sciences industry, Deb brings a valuable perspective that will enable us to further leverage H.I.C.’s technical bench to achieve meaningful results for our clients. She is highly regarded, widely recognized, and deeply connected.”
In addition to her wealth of government experience, Autor has also been a hands-on leader of key functions in both the brand and generic pharmaceutical industries. She ran multiple regulatory functions for all AstraZeneca products globally and led Global Quality at Mylan, overseeing the quality of 60 billion doses of medicine annually across 50 manufacturing sites and dozens of regulatory systems.
“I am delighted to join HIC’s team. In its short year and half, HIC has produced amazing results for its clients and grown to be a catalyst for healthcare innovation,” Autor stated. “I look forward to bringing my vision, knowledge, and government and industry know-how to HIC, with the ultimate goal of finding solutions to clients’ needs in areas such as product development, compliance, post-approval support, and federal partnerships.”
Since 2018, Autor has chaired the FDA Alumni Association, and she is also a Non-Executive Director of Amneal Pharmaceuticals Inc. She has testified in Congressional hearings and appeared in national and international print and television media, including the New York Times, Wall Street Journal, USA Today, LA Times, Boston Globe, NBC, ABC, CBS, and CNN.
Healthcare Innovation Catalysts Inc. was founded in 2022 to fill a gap in the advisory services available to the global life sciences industry. The organization includes experts from government, industry, and academia across disciplines, including regulatory affairs, clinical advisory, biostatistics, quality, compliance, and federal partnerships. The company has brought drugs, biotech products, and medical devices through the clinical development and approval processes; audited clinical trials, manufacturing sites, and labs; developed federal partnerships; and resolved significant compliance problems.