Faculty Directory
Brian Malkin

Brian
Malkin

The George Washington University 1988 B.A. Economics / Minor: Political Science Cum Laude with Special Honors in Economics

The George Washington University Law School 1991 J.D. Editor-in-Chief, The Advocate Administrative Advocacy Clinic

University of Maryland College Park 2004 B.S. Biochemistry

Brian Malkin is a practicing attorney with more than 23 years of food and drug law practice and over 12 years of intellectual property law practice. In particular, his practice includes the interrelation between patent law and food and drug law. Mr. Malkin’s regulatory experience includes a wide range of FDA-regulated products: drugs and biologics (including animal drugs and biologics), medical devices, foods and dietary supplements, tobacco products, and cosmetics. His intellectual property experience includes FDA and patent litigation for both innovator and generic companies, as well as patent prosecution for life science companies.

Mr. Malkin has been actively involved in promoting the biotechnology community locally, nationally and internationally to help stimulate a more active bioscience workforce and a more dynamic bioscience industry throughout Maryland, Virginia, the District of Columbia and beyond. He also currently mentors several health law students through a program coordinated by the Maryland State Bar Association's health law group. Nationally and internationally, he has worked with life science companies to promote new and innovative technologies, including emerging growth companies. In addition to his commitment to the life science community, Mr. Malkin has also been elected to a variety of premier editorial board and bar association leadership roles.

In his course Intellectual Property, Regulation and Compliance for Biotechnology at Katz, students will learn how to adapt and take on the challenges of starting a biotechnology company, understanding how new biotech products get approved by the FDA and other regulatory agencies, are protected by patents, are tested in clinical trials and priced taking reimbursement into consideration – all under effective management strategies for entrepreneurs. By pulling together a crucial understanding how new companies form to develop and obtain approval to market new biotechnology therapies, Mr. Malkin’s course will teach students what they need to know through practical, expert advice.

Mr. Malkin frequently speaks and write 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.

  • “Cannabis Law Update,” Summer 2018 Bridging the Gap NYC, New York State Bar Association, August 16, 2018
  • Speaker, “Balancing Unity and Individuality: Leadership Skills for Managing Culturally Divergent Clinical Teams,” DIA 2018 Global Annual Meeting (Boston, MA)
  • 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
  • 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

 

brian.malkin@yu.edu
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Intellectual Property, Regulation and Compliance for Biotechnology