Events & Publications

Presentations

• “Drugs and Biologics: The Issues and Challenges for the Industry,” The University of Florida, College of Pharmacy,Pharmaceutical Outcomes and Policy Seminar, October 22, 2011
• “Life Cycle Management Considerations for the Biosimilars Market,” American Conference Institute, 12th Annual Maximizing Patent Life Cycles, October 4, 2011 (Panel Moderator)
• “Biosimilars Exclusivity,” American Conference Institute, 2nd Annual Conference, June 7, 2011
• “Strategic Considerations for the Biosimilars Market,” Food and Drug Law Institute 54th Annual Conference, April 5, 2011
• “Strategic Considerations for Biosimilars Market,” American Conference Institute, 11th Annual Maximizing Pharmaceutical Patent Life Cycles, October 6, 2010
• “Practical Implications for the Biosimilars Market under the New Regime,” American Conference Institute, Follow-on Biologics, June 21, 2010
• “Follow-On Biologics:  Interaction Between Patent and Regulatory Protections,” Yale School of Management MBA for Executives, November 20, 2009
• “Market Exclusivity for Pharmaceuticals,” Yale Economics Department, Health Economics and Public Policy Seminar and Yale School of Medicine, Healthcare Leadership Seminar, November 19, 2009
• Follow-On Biologics: Interaction Between Patent and Regulatory Protections, October 7, 2009
  • Session on Follow-On Biologics: Understanding the Role of Patents in Health Care Reform and Related Consequences for Life Cycle Strategies, 10th Anniversary Maximizing Pharmaceutical Patent Life Cycles (American Conference Institute), New York.
• Intellectual Property Supersession: Biotech Intellectual Property at the Crossroads, Biotechnology Industry Organization International Convention (BIO 2009), Atlanta, Georgia, May 18, 2009
• “Market Exclusivity for Pharmaceuticals,” American Conference Institute, Maximizing Pharmaceutical Patent Life Cycles, October 25, 2007
• “Market Exclusivity for Pharmaceuticals,” Yale School of Management MBA for Executives, April 13, 2007
• “Market Exclusivity for Pharmaceuticals,” Yale Medical School MD/MBA Program, April 12, 2007
• “Follow-On Biologics: The Challenge of Market Protection,” Harvard Law School, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, March 22, 2007
• “Market Exclusivity for Pharmaceuticals,” American Association of Pharmaceutical Scientists, AAPS 2006 Annual Meeting and Exposition, October 30, 2006
• “Non-Patent Market Exclusivities,” American Conference Institute, Maximizing Pharmaceutical Patent Life Cycles, October 24, 2006
• “Securing Exclusivity for Your Product,” Practicing Law Institute, Pharmaceutical Law 2006 Across the Product Life Cycle, October 4, 2006
• Moderator: “Politics in Healthcare,” AstraZeneca Capital Summit, April 20, 2006
• “Intellectual Property Consequences of Changing the Regulatory Standard for Follow-on Biologics,” Law Seminars International Advanced 2-Day Conference on Biotechnology: Strategies that Put you in the Winning Position, November 17, 2005
• “Working FDA-Related Issues into Your Collaboration Agreements,” American Conference Institute, Pharma and Biotech In-Licensing, Co-Development and Co-Promotion Agreements, November 15, 2005
• “FDA Issues in Collaboration Agreements, Preserving and Maximizing Value: Issues of Ownership of Access and Cooperation,” American Conference Institute, Pharma and Biotech In-Licensing, Co-Development and Co-Promotion Agreements, March 1, 2005
• “Perspectives on Clinical Trial Disclosures,” American Health Lawyers Association; Legal Issues Affecting Academic Medical Centers, January 27, 2005
• “Update on FDA Developments: Hatch-Waxman Reform and Drug Importation,” American Bar Association, Washington Healthcare Summit, December 7, 2004
• “Regulating Stem Cell Research in the United States,” Stem Cells Conference, James A. Baker III Institute for Public Policy, Rice University, November 20, 2004
• “Antitrust Considerations and Listing Controversies,” American Conference Institute, Maximizing Pharmaceutical Patent Life Cycles, October 5, 2004
• “FDA Regulation of Biotechnology,” BioFarmaceutica 2004, September 9, 2004
• “The Challenge of Market Protection for Biologics,” American Conference Institute: The Strategic Guide to Follow-on Biologics, June 25, 2004
• “The Prospects for Follow-on Biologics,” Law Seminars International: Biopharmaceuticals Conference, May 4, 2004
• “Pfizer v. Dr. Reddy’s: Two Critical Issues for the Pharmaceutical Industry,” Lehman Brothers, Seventh Annual Global Healthcare Conference, March 4, 2004
• “Beyond Sarbanes-Oxley: The Growing Scrutiny of Market Disclosures of FDA Developments,” BIO & CEO Investor Conference, Business Roundtable, February 25, 2004
• “The FTC and Orange Book Listings,” American Conference Institute, 4th National Maximizing Pharmaceutical Patent Life Cycles, January 27, 2004
• “Federal and State Regulation of Stem Cell Research,” American Health Lawyers Association 2004 Legal Issues Affecting Academic Medical Centers Conference, January 23, 2004
• “Research and FDA Related Issues,” American Health Lawyers Association, Fundamentals of Health Law, November 13, 2003
• “Antitrust and Intellectual Property Issues in the Pharmaceutical Industry,” National Bar Association, 78th Annual Convention & Exhibits, Commercial Law Section, August 6, 2003
• “The Hatch-Waxman Act and Proposed Reforms,” The New York Intellectual Property Law Association, July 25, 2003
• “The Threat of Generic Biologics: Lessons to Learn from the Implementation of the Hatch-Waxman Act,” BIO 2003, June 23, 2003
• “Regulation of Research on Human Embryos,” American Bar Association, Summer IPL Conference, June 20, 2003
• “Orange Book Listings: Controversies and Proposals for Reform,” American Bar Association, 2003 Summer IPL Conference, June 20, 2003
• “Introduction to Food and Drug Law – Federal Food and Drug Administration Jurisdiction,” American Health Lawyers Association, 2003 Legal Issues Affecting Academic Medical Centers, January 23, 2003

Publications

• Boosting Innovation in Antibiotics, National Law Journal, December 1, 2008
• The Influence of Market Exclusivity, August 3, 2007
• “Securing Exclusivity for Your Product Throughout Its Life Cycle,” Practicing Law Institute Pharmaceutical Law 2006: Across the Product Life Cycle Conference Handbook, October 2006
• “New CME Bias Standards Will Reduce Quality of Medical Education,” Washington Legal Foundation, (Legal Opinion Letter, June 6, 2003) (with Alan R. Bennett)
• “Hatch-Waxman Law Has Played Critical Role in Medical Advances,” Washington Legal Foundation, (Legal Backgrounder, June 7, 2002)
• “New Trends in the Regulation of Biologics,” The Journal of Biolaw & Business, Vol. 5, #1, 2002
• “Patent Thickets and Innovation Markets Reviewed: Antitrust Concerns Over the Life Sciences Sparked Recent Public Hearings,” National Law Journal, October 14, 2002
• “Impact of Hatch-Waxman Goes Beyond Generics,” National Law Journal, June 16, 1997
• “Exporters of Eco-Technology Seek IP Protection,” National Law Journal, July 8, 1996
• “The Strategic Implications of GATT for Pharmaceutical Patent Terms,” Spectrum Life Sciences (Decision Resources, Inc.), May 1995
• “U.S. Patent Law and GATT,” 1995(6) Regulatory Affairs Journal 1013
• “Potential Liability Associated with Restrictive Drug Policies,” 14 Seton Hall Legislative Journal 103 (1990) (with Bruce N. Kuhlik)