Deb Autor Email & Phone Number

Washington, DC, US

HIC 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.

San Francisco, California, US

Hims & 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.

Bridgewater, New Jersey, US

Amneal 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.

US

Consolidate decades of wide-ranging, deep regulatory, public health, and government experience to guide a variety of organizations on highly sensitive strategic issues.

Pardes 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.

London, England, GB

Cambridge, 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.

Rockville, Maryland, US

Geneva, Geneva, CH

Canonsburg, 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.
• 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.

Canonsburg, 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.

Bethesda, Maryland, US

Silver 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.
• 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.

Silver 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.
• 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.

Washington, 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.

• 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.

Board Of Directors Program (Women On Boards)

Executive Leadership Program

Strategic Management Of Regulatory And Enforcement Agencies

Bachelor Of Arts - Ba

Doctor Of Law - Jd