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)