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• Highly respected pharmaceutical executive, corporate and non-profit Board member, precedent-setting litigator, and decorated former public official. • Transformative innovator with a unique multifaceted view of the biopharmaceutical industry built on decades of domestic and global public and private sector experience, including as FDA Deputy Commissioner and as Global Head of Regulatory Excellence and Global Head of Quality for top 25 pharmaceutical companies. • Worldwide regulatory, quality, legal, and policy knowledge and experience. • Adept at utilizing vast personal network in the public and private sectors globally, as well as legislative vehicles, industry lobbying, and other strategic mechanisms, to influence the regulatory environment and resolve complex issues.• Proven track record of devising and executing groundbreaking solutions to intractable problems.• Proficient at reconciling competing business and governmental priorities, sensitivities, and opportunities.• Proactive and results-driven leader of organizations of up to 5,000 people, accomplished at optimizing strategy and processes while building highly motivated teams.• Extensive public-facing experience, including through Congressional testimony, high profile media engagement, and technical and policy speeches.
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Chief Policy OfficerHims & HersWashington, Dc, Us
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Chief Executive OfficerHealthcare Innovation Catalysts Jan 2024 - PresentHIC was founded in 2022 to fill a gap in advisory services for the global life sciences industry. Our multidisciplinary team combines strategic and technical expertise in regulatory affairs, clinical advisory, quality, compliance, federal partnership, and strategic advisory services to help clients achieve their goals by delivering clear and actionable solutions to complex challenges. 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. -
Non Executive DirectorHims & Hers Nov 2024 - PresentSan Francisco, California, UsHims & Hers (NYSE: HIMS) is the leading health and wellness platform on a mission to help the world feel great through the power of better health.
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Non Executive DirectorAmneal Pharmaceuticals Jul 2022 - PresentBridgewater, New Jersey, UsAmneal Pharmaceuticals (NASDAQ: AMRX) is a fully-integrated essential medicines company, making healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals, primarily within the United States. The Company has a diverse portfolio of over 280 products in its Generics segment and is expanding across a broad range of complex products and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceutical products focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Serve on Audit and Conflicts Committees. -
Chair Of The Board Of DirectorsFda Alumni Association May 2018 - PresentUs -
Chief Executive OfficerAutor Strategies, Llc Jan 2022 - PresentConsolidate decades of wide-ranging, deep regulatory, public health, and government experience to guide a variety of organizations on highly sensitive strategic issues.
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Non Executive DirectorPardes Biosciences Jul 2021 - Sep 2023Pardes Biosciences, Inc. was a clinical stage, publicly-traded (NASDAQ: PRDS) biopharmaceutical company developing a potential direct-acting, oral antiviral drug to treat and prevent SARS-CoV-2 infections. Served on Nominating and Corporate Governance Committee & Science and Technology Committee.
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Scientific Advisory Council MemberCirs - Centre For Innovation In Regulatory Science, Ltd Jan 2020 - Dec 2021London, England, Gb -
Global Head Of Regulatory ExcellenceAstrazeneca Sep 2019 - Dec 2021Cambridge, Cambridgeshire, Gb• Led operations, policy, intelligence, CMC (chemistry, manufacturing & controls), and labeling for all AstraZeneca regulatory submissions globally.• Directed international regulatory strategy and acceleration of international regulatory submissions. • Oversaw divestments of AstraZeneca’s mature brands. • Drove policy and strategy for influencing regulatory landscape globally on groundbreaking issues such as digital health, real world evidence, novel clinical trial designs, and new regulatory partnerships. -
Advisory Board Member, Quality InstituteUs Pharmacopeia Jan 2017 - Jan 2019Rockville, Maryland, Us -
Board MemberAmr Industry Alliance 2018 - 2019Geneva, Geneva, Ch -
Head Of Strategic Global Quality & Regulatory PolicyMylan 2016 - 2019Canonsburg, Pennsylvania, Us• Influence global regulators and international organizations on high impact regulatory and quality issues through direct advocacy to governmental bodies, creating and driving industry coalitions, public speaking and engagement, and channeling trade association initiatives. • Shaped user fee implementation as one of four leaders chosen to represent entire industry and interface with FDA on an ongoing basis.• Implemented divergent global track and trace (serialization) requirements on over 100 packaging lines and oversaw implementation across extensive contract manufacturing network. -
Global Head Of QualityMylan 2013 - 2016Canonsburg, Pennsylvania, Us• Led Mylan’s largest function globally (5,000 people), overseeing the quality of 60 billion doses of medicine annually.• Devised and implemented a structure for quality system improvements across 50 manufacturing sites and dozens of regulatory systems.• Integrated three newly acquired businesses, creating synergies and assuring business continuity.
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Board MemberPda - Parenteral Drug Association 2015 - 2018Bethesda, Maryland, Us -
Deputy Commissioner, Global Regulatory Operations And PolicyFda 2011 - 2013Silver Spring, Md, Us• Oversaw all FDA inspections, criminal investigations, and international operations for human and veterinary drugs, biologics, medical devices, tobacco, and food. • Led a multi-disciplinary staff of over 4,500 and administered $1 billion annual budget.• Developed FDA’s Pathway to Global Product Safety and Quality strategy for confronting globalization and import safety.• Negotiated with Congress and industry to obtain stronger drug supply chain authorities, codified in the FDA Safety and Innovation Act of 2012.• Testified in Congressional hearings and conducted international negotiations, diplomatic missions, and briefings for the White House, Congress, Office of the Secretary of Health and Human Services, the Centers for Disease Control and Prevention, and the U.S. Departments of Defense and State. • Represented the administration in national and international print and television media, including New York Times, Wall Street Journal, USA Today, LA Times, Boston Globe, NBC, ABC, CBS, and CNN. -
Director And Associate Director, Office Of Compliance, Center For Drug Evaluation And ResearchFda 2001 - 2011Silver Spring, Md, Us• Led enforcement and policy making for compliance with all drug requirements, including: drug approval; current good manufacturing practices (GMP); human subject protection and bioresearch monitoring (GCP); import and export; and recalls.• Executed a groundbreaking initiative to eradicate marketed unapproved drugs, removing approximately 1,000 illegal drugs from the market.• Developed and implemented solutions in highly visible and controversial areas such as counterterrorism, Internet sales of pharmaceuticals, and heparin contamination.• Expert advisor to all levels of FDA and the federal government on complex legal issues, potential regulatory actions and compliance policies, and case development.• Provided executive leadership and technical direction to a staff of more than 300 doctors, lawyers, scientists, pharmacists, and engineers.
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Trial Attorney, Office Of Consumer LitigationU.S. Department Of Justice 1995 - 2001Washington, Dc, Us• First chair for dozens of civil and criminal cases under the Federal Food, Drug, and Cosmetic Act and other consumer protection statutes. • Conducted all court hearings, grand jury investigations, civil discovery, motions, and settlement negotiations. • Directed DOJ’s handling of over 200 civil seizures nationwide of adulterated and misbranded foods, drugs, and medical devices. • Set key precedent by winning the novel remedies of restitution and disgorgement for FDA violations.• Prosecuted massive network of pharmaceutical diverters, protected the government’s policy relating to anthrax vaccination of military personnel, and defended FDA’s authority to regulate cigarettes from the District Court, through all appeals, to the Supreme Court. -
AssociateWeil, Gotshal & Manges And Buc Levitt & Beardsley 1992 - 1995• Counseled clients in all areas of drug and device law, including clinical trials, product approvals, GMP, post-market reporting, and advertising.• Prepared clients for FDA advisory committee and scientific meetings for drugs, biologics, and devices, responded to Warning Letters, and led FDA investigation management.• Performed due diligence for initial public offerings.• Brought FDA-related shareholder derivative litigation.• Advised clients on compliance with Medicare fraud and abuse and anti-kickback rules. Represented clients in Federal Trade Commission and Consumer Product Safety Commission proceedings.
Deb Autor Skills
Deb Autor Education Details
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Harvard Business SchoolBoard Of Directors Program (Women On Boards) -
Northwestern University - Kellogg School Of ManagementExecutive Leadership Program
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Harvard Kennedy SchoolStrategic Management Of Regulatory And Enforcement Agencies
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Columbia UniversityBachelor Of Arts - Ba
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Boston University School Of LawDoctor Of Law - Jd
Frequently Asked Questions about Deb Autor
What company does Deb Autor work for?
Deb Autor works for Hims & Hers
What is Deb Autor's role at the current company?
Deb Autor's current role is Chief Policy Officer.
What is Deb Autor's email address?
Deb Autor's email address is de****@****bio.com
What is Deb Autor's direct phone number?
Deb Autor's direct phone number is +172448*****
What schools did Deb Autor attend?
Deb Autor attended Harvard Business School, Northwestern University - Kellogg School Of Management, Harvard Kennedy School, Columbia University, Boston University School Of Law.
What skills is Deb Autor known for?
Deb Autor has skills like Gmp, Life Sciences, Risk Management, Legislation, Government, Pharmaceutical Industry, Policy, Fda, Strategy, Leadership, Regulatory Affairs, Regulatory Requirements.
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