Brian J. Malkin Additional Speaking Engagements

Given his particular experiences, Brian frequently is asked to speak on numerous FDA- and intellectual-property-law issues, including clinical trials and new product development for complex and challenging products, such as biotechnology products, orphan drugs, generic drugs, 505(b)(2) new drug applications, patent-term restoration under the Hatch-Waxman Act, biosimilar products, tobacco products, patent-term adjustment, risk management and due diligence.

Brian has presented a variety of programs for a Korea-Maryland USA Bio Expo in Rockville, Maryland, on the following topics: (1) current good manufacturing practice (cGMP) and its role in regulatory drug quality, (2) current drug shortages and orphan drug disease pharmaceutical development, (3) innovative strategies for new drug development/biobetters; and (4) dietary supplements and functional foods. View Brian’s pre-McDermott speaking engagements below.

• Moderator, “FDA Law for IP Lawyers – Tips for Effectively Integrating FDA Regulatory Law Into an IP Law Practice” Webinar, DC Bar Intellectual Property Law Community; April 29, 2020 (online)
• Speaker, Intellectual Property Issues Impacting High Schoolers, DC Bar Communities Melvin R. Wright Youth Law Fair; March 31, 2020 (online)
• Speaker, “Legal Perspective: Regulatory Landscape & Use of CBD in Food Products,” Q1 Productions Food Labeling: Evolving Regulatory Compliance Conference; February 11-12, 2020 (Alexandria, VA)
• Panelist, “Part II: What is FDA’s Role in the Regulation of Cannabis?,” FDLI Legal and Practical Issues in the Evolving World of Cannabis Regulation; November 18-19, 2019 (Washington, DC)
• Keynote Speaker, “New Challenges of In Vitro Diagnostics,” Michigan Institute for Clinical & Health Research Medical Devices in Academic Research Symposium; October 16, 2019 (Ann Arbor, MI)
• Speaker, “Regulatory Compliance During Study Conduct,” AdvaMed Investigational Device Exemption Submissions Workshop; October 9, 2019 (Washington, DC)
• Panelist, “Drug Pharmacovigilance Under CDER,” FDAnews Post-Market Surveillance Conference; June 28, 2019 (Washington, DC)
• Speaker, “FDA and DEA Regulation of Opioid Drugs and the Opioid Drug Crisis” CLE Course, DC Bar; June 19, 2019 (Washington, DC)
• Speaker, “Hot Topics in Cannabis Law: CBD Rulemaking,” New York State Bar Association; May 6, 2019 (New York, NY)
• Speaker, “Top Ten Intellectual Property and Regulatory Issues for Biotechnology Startups” Webinar, Yeshiva University’s Katz School of Science and Health; May 6, 2019 (online)
• Moderator, “Orphan Drug and Rare Disease Developments,” FDLI Annual Conference: Exploring Advanced Topics in Food and Drug Law; May 3, 2019 (Washington, DC)
• Speaker, “Regulatory developments in orphan drugs,” Venture Café Cambridge BIO Connect; April 25, 2019 (Cambridge, MA)
• Speaker, “Violations, Enforcement and International Issues,” FDLI Introduction to Biologics and Biosimilars Law and Regulation; April 3, 2019 (Washington, DC)
• Guest Lecturer, “Global Drug Law & Regulation,” Georgetown Law School, March 22, 2019 (Washington, DC)
• Moderator, “Concerns Establishing Single Shared ETASU REMS, Waivers and Generic Blocking,” ExlEvents 11th Risk Evaluation and Mitigation Strategies Summit; January 28, 2019 (Arlington, VA)
• Speaker, “The Biosimilar Action Plan – Clarify FDA’s Guidance,” CBI’s 14th Annual Biosimilars Summit; January 22, 2019 (Alexandria, VA)
• Speaker, “Hot Topics in FDA Law,” New York State Bar Association; January 17, 2019 (New York, NY)
• Speaker, “Hot Topics in Cannabis Law 2019: What Lawyers Need to Know,” New York State Bar Association; January 15, 2019 (New York, NY)
• Speaker, “Practical Implications of Decriminalized Marijuana for the Legal Practitioner,” New York State Bar Association; October 3, 2018 (New York, NY)
• Speaker, “Balancing Unity and Individuality: Leadership Skills for Managing Culturally Divergent Clinical Teams,” DIA 2018 Global Annual Meeting; June 25, 2018 (Boston, MA)
• Speaker, “Cannabis Law Update,” Summer 2018 Bridging the Gap NYC, New York State Bar Association, August 16, 2018 (NewYork, NY)
• Speaker, “Launch an Expanded Access Program That Effectively Supports Patient Needs and Compliantly Enhances Drug Development,” World Congress Life Sciences Market Access & Oncology Summit; February 5, 2018 (Philadelphia, PA)
• Moderator, “Embracing the Continuum of Risk: CTP Builds Policy on Product Standards and Tobacco Flavoring, and Reassesses Regulatory Priorities in Aftermath of the Deeming Rule,” NYSBA Food, Drug & Cosmetic Law Section Meeting; January 25, 2018 (New York, NY)
• Guest Lecturer, “Health Law and Regulation –LAWG-2076-09, LAWJ-2076-09 Fall,” Georgetown Law School, October 6, 2017 (Washington, DC)
• Speaker, “Violations, Enforcement, and International Issues,” FDLI Introduction to U.S. Biologics and Biosimilars Law and Regulation, October 5, 2017
• Panelist, US Roundtable Discussion and “Explore How the New Trump Administration Affects the Future of Pre-Approval”, IQPC Pre-Approval Access Programs, September 26, 2017
• Speaker, “Quality Systems Regulation,” ACI Fifth Annual FDA Boot Camp: Devices Edition, July 28,2017
• Moderator, “The Animal Drug Compounding Debate,” FDLI Annual Conference, May 4, 2017
• Speaker, “Wearable Health Trackers, FDA’s ‘General Wellness’ Classification, and Patent Protection, Oh My!” ACI Advanced Summit on Medical Device Patents, March 1, 2017
• Host/Moderator, “Reciprocity Issues for New York-Admitted Lawyers,” NYSBA Holiday Networking Event, December 14, 2016
• Moderator, “Executive Roundtable – Life Sciences Industry Update” and “Business and Legal Issues for Early Stage Companies,” 8th Annual Pharmaceutical and Medical Device Conference, November 10, 2016
• Moderator, “Deconstructing the New Guidance on Expanded Access and Update on Legal Developments,” Expanded Access: FDA’s New Regulatory Process How Compassionate Use Fits into Proposed Reforms, October 13, 2016
• Speaker, “Animal Biologic Development: The Continuing Debate Between Cure and Cost” and “Revisiting the Animal Drug Compounding Debate,” ACI’s 2nd Annual Legal, Regulatory, and Compliance Forum on Animal Health: Veterinary Drugs, Therapeutics, and Animal Food, September 13-15, 2016
• Speaker, “Develop Strategies to Successfully Implement the New Guidance Determine Potential Compliance Obstacles and Financial Penalties to Avoid Unanticipated Delays,” The Pharmacovigilance Finale Rule Summit on IND Safety Reporting, August 16-17, 2016
• Speaker, “High-Risk Devices-Parsing the Premarket Approval Process (PMA)” and “Quality System Regulation,” ACI’s 4th Annual FDA Boot Camp, July 20-22, 2016
• Speaker, “Amarin,” 2016 FDLI Annual Conference, May 5, 2016
• Speaker, 2016 Danish Biotech Conference, April 12-13, 2016
• Speaker, “The Impact of the Evolving US Biosimilar Regulatory Policies on Bringing Biosimilars to Market,” CBI 11th Summit on Biosimilars, January 29, 2016
• Moderator, “FDA Update – Recent Developments and New Initiatives Including a MDUFA Update” and “Off-Label Promotion in the Wake of the Amarin Decision,” 7th Annual Medical Device and Life Sciences Conference, November 19, 2015
• Moderator, “Amarin and the Future of Off-Label Promotion,” FDLI, November 16, 2015
• Panelist, “Foreign Corrupt Practices Act and Corporate Accountability,” Pennsylvania Bar Institute 21st Annual Meeting, November 4, 2015
• Speaker, “Developments in Global Intellectual Property,” International Generic Pharmaceutical Alliance (IGPA) 18th Annual Conference, September 17, 2015
• Panelist, “Drug Compounding in the Animal Drug Industry: Assessing Fair and Foul Practices,” ACI Legal, Regulatory, and Compliance Forum on Animal Health, Veterinary Medicines and Therapeutics, September 10, 2015
• Speaker, “Develop Strategies to Continue Building Successful Benefit-Risk Assessments,” CBI Benefit-Risk Assessment & Decision Making Summit, August 8, 2015
• Speaker, “Protecting Both Innovation and Competition: Finding Compromise Within Federal and State Biosimilars Substitution Laws,” ACI’s 6th Annual Summit on Biosimilars, June 2, 2015
• Panelist, “Breakout Session: Center for Drug Evaluation and Research (CDER),” FDLI Annual Conference, April 20, 2015
• Panelist, “Biosimilars Patent Litigation,” European Generic Medicines Association (EGMA) 11th Legal Affairs Forum, March 27, 2015
• Panelist, “FDA, LDT and IVD: The ABC’s of Clinical Lab Test Development,” New York State Bar Association Food, Drug and Cosmetic Law Section Annual Meeting, January 29, 2015
• Panelist, “Analyze the FDA’s Newly Released REMS Standardization Report” and “Highlight Key Consideration to Collaborate Successfully in a Single Shared REMS,” ExL Pharma 7th Risk Evaluation and Mitigation Strategies Summit, January 22, 2015
• Speaker, “Insights into Developing the Best Regulatory Pathway for Your Venture and Methods of Designing an Efficient and Productive Clinical Trial,” Climbing the Regulatory Summit, December 10, 2014
• Speaker, “FDA Update: Recent Developments and New Initiatives,” 6th Annual Medical Device and Life Sciences Conference, November 18, 2014
• Co-Speaker, “Regulations – The Good, the Bad, and the Ugly,” Food Safety Challenges in an Era of Change: How to Better Protect Your Food and Beverage Company, Your Customers, and Yourself, October 9, 2014
• Moderator, “Issues Concerning Development of Rare Disease and Special Population Medical Devices,” AdvaMed 2014 The MedTech Conference, October 7, 2014
• Panelist, “The Case for Small Markets with Large Returns: Orphans/Rare Disease Panel,” Life Science Nation: Redefining Early Stage Investments, September 17, 2014
• Panelist, “Pre-Conference Primer: Biosimilars 101: Comprehensive Deep Dive into the Relevant Legal, Regulatory, and Scientific Factors Companies Must Know,” ACI 5th Annual Conference on Biosimilars, June 4, 2014
• Speaker, “Breakfast Breakout: Career Opportunities in Food & Drug Law,” 2014 FDLI Annual Conference, April 24, 2014
• Guest Speaker, “Safety v. Competition (Federal Trade Commission Follow-On Biologics Workshop: Impact of Recent Legislative and Regulatory Naming Proposals on Competition February 4, 2014 Overview),” BioCentury This Week, February 16, 2014
• Speaker, “Biotechnology Roundtable: Innovative Strategies for New Product Development,” Montgomery County Department of Economic Development, February 5, 2014
• Speaker, “FDA Regulation: The Intersection of Policy and Politics, The Opportunities and Challenges for Innovation – Perspectives from Two Former FDEA Officials,” New York State Bar Association Food, Drug and Cosmetic Law Section Annual Meeting, January 30, 2014
• Speaker, “Understand the FDA Report [Risk Evaluation and Mitigation Strategies (“REMS”;) Standardization] and the Impact on the Industry,” ExL Pharma 6th Risk Evaluation and Mitigation Strategies Summit, January 28, 2014