Alexander Varond

Alexander Varond is a partner in Goodwin’s Technology and Life Sciences groups and a co-chair of the firm’s FDA Litigation practice. Alexander advises drug, biotech, and device clients on a wide range of cutting-edge FDA regulatory matters. He has extensive experience in medical device and drug development, Hatch-Waxman patent and exclusivity issues, and regulatory strategy. Alexander also counsels on advertising and promotional issues, defends companies during civil and criminal investigations on a variety of issues, including off-label promotion and GMPs, and regularly advises on corporate transactions. He has received wide recognition, including being named a Top Healthcare Lawyer by the Daily Journal and honored as a Top 40 under 40 lawyer in both California and Washington, DC.

Prior to joining Goodwin in 2017, Alexander was a senior associate at Hyman, Phelps & McNamara, PC. His perspective is bolstered by having worked closely alongside numerous in-house regulatory and legal teams through various critical projects, including NDA and BLA preparation, formal dispute resolutions, FDA meetings, regulatory strategy advisory meetings, and product launches.

Alexander serves as a board member of the Ogden CARES foundation, a rare disease patient advocacy group dedicated to supporting families with Ogden Syndrome. He is a member of several industry groups, including the Food and Drug Law Institute (“FDLI”) and the Drug Information Association (“DIA”). He serves on a number of FDLI committees. Alexander is also an active member of the Asian Pacific American Bar Association and the Asian American Bar Association.

Alexander's professional experience includes roles as a medical device engineer, operations manager, and deputy management representative to FDA in the medical device industry. He also served as an intellectual property law clerk at NuVasive, Inc.

In 2010, Alexander externed at the International Trade Commission’s Office of Unfair Imports and Investigations.

In 2023, Alexander was named a Top Healthcare Lawyer by Daily Journal, which honors the top healthcare and life sciences lawyers in California. He was also shortlisted for LMG Life Sciences’ Regulatory Attorney of the Year (FDA Pharmaceutical) Award. In 2022, he was named to Daily Journal’s Top 40 Under 40 List, which highlights the top up-and-coming lawyers across California. In 2021, Alexander received the National Law Journal’s Rising Star award, a distinction given to the Washington, DC region’s 40 most promising lawyers age 40 and under. In 2018, he received LMG Life Sciences’ U.S. Regulatory Rising Star Award.

Alexander has been recognized by The Best Lawyers in America Best Lawyers for his work in FDA Law 2022-2023. He is also recognized on the 2019-2023 Super Lawyers list of “Rising Stars” in Food & Drug Law. In addition, Alexander has been consistently recognized in The Legal 500 United States for his work in the life sciences industry, specifically in FDA law. In 2022 and 2023, The Legal 500 United States recognized Alexander as a “Next Generation Partner” in Healthcare: Life Sciences. Alexander was named to The Best Lawyers in America 2021: Ones to Watch. He is also listed as a “Rising Star” in Euromoney’s 2020-2022 Expert Guides.

In law school, Alexander placed second in the nation in the 2010-2011 National Giles S. Rich Intellectual Property Moot Court Competition. He was also named Best Overall Competitor and won the award for Best Brief for his efforts in The George Washington Law School's intellectual property moot court competition in 2011. In addition, he was a member of the Moot Court Board and Alternative Dispute Resolution Board.

Publications & Speaking Engagements

Alexander frequently presents on topics related to drug and medical device law. He has co-taught or lectured on drug and medical device regulatory law at graduate engineering, law, and business schools. He also trains in-house client teams on drug and biologic development, clinical trials, regulatory strategy and exclusivities, and FDA compliance. Alexander’s speeches and presentations include:

• “Key Regulatory Considerations for Oncology Companies in 2023,” MedInvest Oncology Investor Conference, Boston, MA, June 2023
• “Updates on Patent and Exclusivity Issues for Drugs, Orphan Drugs, and Biologics,” FDLI Annual Conference, Washington, DC, May 2023
• “Legal & Statistical Principles Underlying Drug Regulation of Cardiovascular Therapies,” 19th Global Cardiovascular Clinical Trialists Forum, Washington, DC, December 2022
• “FDA Approval is Coming: Part 1 – Securing Exclusivities and Maximizing Patent Term,” Goodwin Webinar Series, November 2022
• “Exploring the Link between the FDA Approval Process and the Patenting of Drugs and Biologics,” Hatch-Waxman and BPCIA Essentials, American Conference Institute ("ACI"), October 2022
• “FDA’s Expedited Programs: Understanding Which Program Best Suits Your Product,” FDLI Webinar, March 2022
• “Identifying and Comprehending Pre-Commercialization Concerns Relative to Small Molecules and Biologics,” Hatch-Waxman and BPCIA Essentials, ACI, October 2021
• “Navigating the Approval Process for Drugs and Biologics,” FDA Boot Camp, ACI, September 2021
• “Making the Most of Your FDA Interactions to Aid Preclinical or Other Preparatory Studies / Initial Clinical Development Strategies,” LSX CEO Forum, October 2020
• “Patient Voice and Its Role In Bringing Meaningfulness into Selection of Clinical Outcome Measures,” DIA Annual Meeting, June 2020
• “Generics, Biosimilars, and Hatch-Waxman Law,” Food and Drug Law Seminar, University of Maryland School of Law, Baltimore, MD, February 2020
• “The New Drug Approval Process: NDA Submission and Review,” Introduction to U.S. Drug Law and Regulation, FDLI, Washington, D.C., November 2019
• “Intersection of IP and FDA Law: Opportunities for Early-Stage Drug & Biologics Companies,” Goodwin, Boston, MA, October 2019
• "Regulatory Strategies to Employ When Your Study Doesn't Qualify for Breakthrough/PRIME," MassBio Forum, Boston, MA, September 2019
• “Cross-Labeling and Devices Referencing Drugs,” DIA Annual Meeting, Boston, MA, June 2018
• “What Can We Say About Combination Products? Labeling, Advertising and Promotion of Combination Products,” DIA Annual Meeting, Boston, MA, June 2018
• “The Evolving Regulatory Landscape for Orphan Drugs,” FDLI Annual Conference, Washington, DC, May 2018
• “Choosing the Right Drug Approval Pathway: Speedier Approvals with Less Risk,” FDAnews Webinar, February 2018
• “Effective Orphan Drug Development in a Challenging Regulatory Environment,” Regulatory Affairs Professionals Society’s Regulatory Convergence, Washington, DC, September 2017
• “Optimizing Early Clinical Strategies to Support Breakthrough Therapy Designation,” DIA Annual Meeting, Chicago, IL, June 2017
• “Minding the Gap: Using Totality of Evidence to Support Regulatory Approval,” DIA Annual Meeting, Chicago, IL, June 2017
• “Lessons Learned from the Sarepta Exondys 51 Approval: The Evolving Role of Orphan Drug and Subpart H Flexibility in Drug Approval,” DIA Annual Meeting, Chicago, IL, June 2017
• “Special Protocol Agreements,” FDAnews Webinar, October 2016
• “Evidentiary Standards for Rare Diseases: How Much Data is Enough?” Rare Diseases Webinar Series, DIA, July 2016
• “Priority Review Vouchers: Past Experiences, Legislative Reform, and Tips for Sponsors,” DIA Annual Meeting, Philadelphia, PA, June 2016
• “Life After Amarin and Pacira: Understanding Off-Label Promotion in 2016,” DIA Annual Meeting, Philadelphia, PA, June 2016
• “Dossier Considerations for Submissions Eligible for Expedited Review Programs,” Regulatory Operations and Submissions Conference, Philadelphia, PA, April 2016
• “Successful Orphan Drug Applications,” Regulatory Operations and Submissions Conference, Philadelphia, PA, April 2016
• “The New Drug Approval Process: NDA Submission and Review,” Introduction to Drug Law and Regulation, FDLI, Washington, DC, April 2016
• “Registration and Listing of Medical Devices,” Introduction to Medical Device Law, FDLI, Washington, DC, June 2015
• “Breakthrough Therapy Designation: An Analysis of FDA’s Precedents to Determine Eligibility Criteria and Their Value,” DIA Annual Meeting, Washington, DC, June 2015
• “Introduction to Orphan Drug Development and Exclusivity,” New to Food and Drug Law Group, FDLI, Washington, DC, July 2014

Alexander also frequently writes on drug and medical device matters. Prior to joining Goodwin, he frequently wrote for the FDA Law Blog. Alexander’s publications include:

• “Psychedelics & Drug Development – Key Considerations for Healthcare Industry and Life Sciences Companies as Congress Seeks to Tap Into Psychedelics’ Therapeutic Potential,” Goodwin Client Alert, May 2023
• “How FDA Really Works: Insights from the Experts – Navigating Alternative Pathways for Drugs and Biologics,” FDLI textbook, 2022
• “Compliance Considerations for Virtual Ketamine Clinics,” Law360 Expert Analysis, December 2022
• “Clinical Trial Diversity Planning for Sponsors: What to Know About FDA’s Recent Draft Guidance,” Goodwin Client Alert, April 2022
• "COVID-19: U.S., State Governments Expand Access to Telehealth Services; Reduce Other Barriers to Care," Goodwin Client Alert, March 2020
• "Conduct of Clinical Trials During the COVID-19 Pandemic: Recommendations from FDA," Goodwin Client Alert, March 2020
• "Patients (May) Know Best: Leveraging the Patient Experience from Development to Commercialization," Goodwin Client Alert, September 2018
• "Expanded Access Policy Disclosure and Federal Right-to-Try Law," Goodwin Client Alert, June 2018
• "FDA’s Flexibility in Subpart H Approvals: Assessing Quantum of Effectiveness Evidence," Food and Drug Law Journal, 2016
• "Promotion and Marketing of Prescription Drugs, Biologics, and Devices, FDA Deskbook: A Compliance and Enforcement Guide," Practicing Law Institute, 2016
• "Medicinal Product Regulation and Product Liability in the United States," Practical Law Thomson Reuters Life Sciences Global Guide 2016
• "Commercialization of Healthcare in the United States, Commercialization of Health Care," Thomson Reuters, 2nd edition, 2015
• "Orphan Drugs, Bringing Your Pharmaceutical Drug to Market," FDLI, 2015
• "Commercialization of Healthcare in the United States," Commercialization of Health Care, Thomson Reuters, 1st edition, 2013
• "Trends in Personalized Medicine," Regulatory Focus, 2013
• "The Regulation of Social Media: Whither FDA, Using Social Media in FDA-Regulated Industries: The Essential Guide," FDLI, 2010