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Leslie A. Platt
Counsel
leslie.platt@pillsburylaw.com

Mr. Platt provides counsel and representation on policy, projects and compliance in the life sciences and health care, focusing on emerging medical technologies and harmonization of international standards.

Mr. Platt has worked in the biotechnology and health care fields for many years. He has served as in-house General Counsel of The Institute for Genomic Research, as Executive Assistant to the Director and Chief of Operations at the National Institutes of Health, and as a principal in global health sciences at Ernst & Young LLP. In 1980-1981, he served as Deputy General Counsel of the U.S. Department of Health and Human Services and as Counsel and Staff Director of the inter-agency White House Agent Orange Working Group. In the 1970s, Mr. Platt served as Associate General Counsel of the U.S. Department of Housing and Urban Development, where he drafted many bills enacted into federal law.

In policy matters, Mr. Platt has provided client counseling and representation on varied U.S. and international legislative and regulatory issues. His project experience includes work on research facilities and funding, including grants, contracts and alliance agreements. Additional work has included strategies, due diligence and transactions for intellectual property protection, technology transfer and commercialization.

In the compliance arena, Mr. Platt has worked on a range of regulatory issues, matters and investigations involving the conduct and reporting of research, covering human subject protections, clinical trial management, lab management, scientific fraud, grants and contracts fraud and abuse, corporate risk management, quality assurance and control, and organizational governance. He has worked with biotech, pharmaceutical and medical device companies, universities and academic medical centers, hospitals, government agencies, nonprofits, investors, insurers and others.
 
Mr. Platt is chairman of the board of directors of the Biojudiciary Project, a nonprofit organization that helps educate the federal bench, the bar and the public about biotechnology. He also chairs the Loudoun County, VA, Science & Technology Cabinet, and has taught legal and ethical aspects of bioscience management to graduate students at George Mason University. He is a frequent lecturer at industry conferences in the U.S. and internationally, with presentations given in Australia, Canada, Estonia, Germany, Japan, Norway and Sweden.



Education

J.D., New York University School of Law

B.A., The George Washington University


Admissions

District of Columbia


Affiliations

American Bar Association; Federal Bar Association; American Judicature Society

Selected Presentations

“Building Biotech: Global Issues and Trends In Bioscience Research & Development.” Biotech Forum at The Intellectual Property Institute of the University of Richmond School of Law, Richmond, VA (2007).

“The State of Healthcare & Medical Technology in 2020: Trends, Gaps, Needs and New Tools For the Future.” BIO IT Coalition, Carnegie Institution, Washington, DC (2007).

“Looking In & Looking Out: Protein Microscopes & Satellite Images.” Loudoun Science & Technology Cabinet, Leesburg, VA (2007).

“Caring Machines – Optimal Medicine.” Medical Automation 2006 International Conference, Lansdowne, VA (2006).

“Biotechnology: A Science Lesson for Generalists.” Program for Federal Judges, National Courts Building, Washington, DC (2006).

“Opportunities in India’s Emerging Life Sciences Sector: Key Considerations for Alliances, Technology Transfer, Resource Mobilization, and Barriers.” US-India High Technology Group, US-India Business Council, Washington, DC (2005).

“The Business of Life Sciences: The Future of Global Innovation.” The annual Technology Management Education Association Workshop, MIT, Cambridge, MA (2004).

“Public vs. Private Science: Who Wins?” Special Forum, XIX International Congress of Genetics, Melbourne, Australia (2003).

“An Ongoing Conversation.” Biojudiciary Project Inaugural Event, National Press Club, Washington, DC (2002).

“Compliance in Human Subject Research—Translating Theory Into Practice.” Annual Meeting of the New York State Bar Association, New York, NY (2002).

“Monetizing Research IP” and “Internationally Competitive Technology Transfer.” 1st Baltic Biotech Forum, Teterow, Germany (2001).

“Critical Elements of and Affecting Research IP Valuations.” Institute for Biotechnology Information, Conference on “Laws of Science 2001: Understanding Intellectual Property for the Life Sciences,” Research Triangle Park, NC (2001).

"Compromised Drug Research." Fourth Annual Health Industry Compliance Forum, Phoenix, AZ (2000).

"Upstream/Downstream Licensing and Transfer Problems and Solutions." BIO 2000, International Biotechnology Meeting & Exhibition, Boston, MA (2000).

 “Framework for Responsible Application of Genetic Medicine in Society.” 1999 Annual Meeting, American Association for the Advancement of Science, Anaheim, CA (1999).


External Publications

Insider Analysis: The Importance of “Who” in Medical Product Regulation, PharmAsia News, January 2008

Insider Analysis: Can Outsourced Clinical Trials Also Be The Best?: The Potential To Harmonize Best Practices in China, India and Globally, PharmAsia News, November 2007

Rewarding the Pharmaceutical Industry for Quality, The Spilker Report™, Vol. 2, No. 9: 6-7, October 2004

Realities at the Leading Edge of Research, European Molecular Biology Organization Reports, Vol.5, No.4: 324-329, Co-Authored by W. Alexander et al., April 2004

A Recipe For Restoring Investor Confidence: Zeroing In On Non-Financial Risk Exposures, J. BIOLAW & BUS., Vol. 6, No. 2, Co-Authored by Odell Guyton, 2003

Building A Mid-Atlantic BioMedTech Region, Washington Techway BioPulse Quarterly, Post Newsweek Tech Media, 2002

Securitization of Biotechnology Research Patents, Convergence, Ernst & Young's 14th Biotechnology Industry Annual Report, Millennium Edition, Co-Authored by W. Alexander et al., 2000