POTOMAC, Md.--(BUSINESS WIRE)--Healthcare Innovation Catalysts, Inc. (HIC), a leading provider of regulatory affairs, clinical advisory, quality, compliance, federal partnership, and strategic advisory services to global life sciences organizations, announced today that Deborah M. Autor, former Deputy Commissioner of the U.S. Food and Drug Administration (FDA), has joined the firm as its first Chief Executive Officer. In this role, Ms. Autor will build on HIC’s deep bench of cross-functional technical expertise, furthering the company’s role as a sought-after advisor in both the private and public sectors.
With over 30 of experience at the highest levels of government and regulated industry, Ms. Autor brings an unparalleled range of expertise across regulatory, quality, compliance, business strategy, policy, and law. Her government career spanned two decades, culminating in the crucial role of Deputy Commissioner of FDA where she oversaw all inspections and international operations. Her FDA tenure also included distinguished service 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 FDA, Ms. Autor was a decorated federal prosecutor at the U.S. Department of Justice, and FDA was her client.
In addition to this wealth of government experience, Ms. 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.
“We are honored to have Deb take the helm as our first CEO,” stated Michael Singer, Executive Chairman of HIC. “She brings an unparalleled 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 uniquely valuable perspective that will enable us to further leverage H.I.C.’s technical bench to achieve meaningful and groundbreaking results for our clients. She is highly regarded, widely recognized, and deeply connected.”
“I am delighted to join HIC’s tremendous team. In its short year and half, HIC has produced amazing results for its clients and grown to be a formidable technical force and catalyst for healthcare innovation,” said Ms. Autor. “I look forward to bringing my vision, knowledge, and government and industry know-how to HIC, with the ultimate goal of finding elegant solutions to clients’ needs in areas such as product development, compliance, post-approval support, and federal partnerships.”
Ms. Autor has been a visible expert for many years. Since 2018, she has served as Chair of the FDA Alumni Association, where she continues to work to support the agency’s mission. She is also a Non-Executive Director of Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX). 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.
About Healthcare Innovation Catalysts, Inc.
Healthcare Innovation Catalysts, Inc. (HIC) was founded in 2022 to fill a gap in the advisory services available to the global life sciences industry. Because we unite strategic and technical expertise with deep connections and knowledge, HIC is uniquely suited to help our clients envision and reach daunting goals and overcome appreciable obstacles. We are a catalyst for healthcare innovation. Rather than stopping at the surface or drowning in the weeds, we unify multiple levels of analysis to create clear, actionable deliverables, enabling our clients to meet otherwise elusive goals and solve intractable problems pre- and post-market. Our organization includes experts from government, industry, and academia across disciplines, including regulatory affairs, clinical advisory, biostatistics, quality, compliance, and federal partnerships. Among many other things, we have brought novel 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.
