Alexander Varond

Publications & Speaking Engagements 

Mr. Varond frequently presents on topics related to drug and medical device law. Recently, he co-taught a course on medical device and drug regulatory law for the Department of Biomedical Engineering at The George Washington University and was a guest lecturer at the University of Maryland School of Law and IDC Herzliya’s Arison School of Business. He also trains in-house client teams on drug and biologic development, clinical trials, regulatory strategy and exclusivities, and FDA compliance. Mr. Varond’s speeches and presentations include:

• “Identifying and Comprehending Pre-Commercialization Concerns Relative to Small Molecules and Biologics,” Hatch-Waxman and BPCIA Essentials, American Conference Institute, October 2021.
• “Navigating the Approval Process for Drugs and Biologics,” FDA Boot Camp, American Conference Institute, 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,” Drug Information Association 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, Food and Drug Law Institute, 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,” Drug Information Association Annual Meeting, Boston, MA, June 2018.
• “What Can We Say About Combination Products? Labeling, Advertising and Promotion of Combination Products,” Drug Information Association Annual Meeting, Boston, MA, June 2018.
• “The Evolving Regulatory Landscape for Orphan Drugs,” Food and Drug Law Institute 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,” Drug Information Association Annual Meeting, Chicago, IL, June 2017.
• “Minding the Gap: Using Totality of Evidence to Support Regulatory Approval,” Drug Information Association 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,” Drug Information Association 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, Drug Information Association, July 2016.
• “Priority Review Vouchers: Past Experiences, Legislative Reform, and Tips for Sponsors,” Drug Information Association Annual Meeting, Philadelphia, PA, June 2016.
• “Life After Amarin and Pacira: Understanding Off-Label Promotion in 2016,” Drug Information Association 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, Food and Drug Law Institute, Washington, DC, April 2016.
• “Registration and Listing of Medical Devices,” Introduction to Medical Device Law, Food and Drug Law Institute, Washington, DC, June 2015.
• “Breakthrough Therapy Designation: An Analysis of FDA’s Precedents to Determine Eligibility Criteria and Their Value,” Drug Information Association Annual Meeting, Washington, DC, June 2015.
• “Introduction to Orphan Drug Development and Exclusivity,” New to Food and Drug Law Group, Food and Drug Law Institute, Washington, DC, July 2014.

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

• 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, Thomson Reuters, 2016.
• Commercialisation of Healthcare in the United States, Commercialisation of Health Care, Thomson Reuters, 2nd edition, 2015.
• Orphan Drugs, Bringing Your Pharmaceutical Drug to Market, Food and Drug Law Institute, 2015.
• Commercialisation of Healthcare in the United States, Commercialisation 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, Food and Drug Law Institute, 2010.