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

Hosted by The ERISA Industry Committee (ERIC)

This is a member-only webinar.

Please join us to discuss the Department of Health and Human Services (HHS) new final rule that rewrites the previous administration’s nondiscrimination rules as well as the Supreme Court’s recent decision in Bostock v. Clayton County, Georgia. On Monday, June 15, the Supreme Court ruled, 6-3, that Title VII of the Civil Rights Act of 1964 protects workers from discrimination based on sexual orientation or gender identity. During this webinar we will discuss the details of the case, the decision, and how it may impact the Trump Administration rules.

Attorneys from McDermott Will & Emery will present during the webinar. We look forward to your participation.