June 11 Conference

 

The John F. Scarpa Center for Law and Entrepreneurship
at Villanova University School of Law


Presents the Second Annual Conference on


Current Topics in Life Sciences Law, Regulation and Business


June 11, 2015

Villanova University School of Law
299 N. Spring Mill Road
Villanova, PA 19085


Co-Chairs

Brian T. Gorman '01, Deputy General Counsel, AstraZeneca Pharmaceuticals LP
Kristin P. Kennedy '95
Senior Counsel, Branded Pharmaceuticals, Endo Pharmaceuticals Inc.

 

The John F. Scarpa Center for Law and Entrepreneurship 
at Villanova University School of Law


Presents the Second Annual Conference on


Current Topics in Life Sciences Law, Regulation and Business


June 11, 2015

Villanova University School of Law
299 N. Spring Mill Road
Villanova, PA 19085


Co-Chairs

Brian T. Gorman '01Deputy General Counsel, AstraZeneca Pharmaceuticals LP
Kristin P. Kennedy '95
Senior Counsel, Branded Pharmaceuticals, Endo Pharmaceuticals Inc.

Zane Memeger
Zane Memeger, U.S. Attorney for the Eastern District of Pennsylvania

 

The John F. Scarpa Center for Law and Entrepreneurship presented the second annual conference on Current Topics in Life Sciences Law, Regulation and Business on Thursday, June 11 from 8:00 a.m. to 12:30 p.m. in the Laurence E. Hirsch ’71 Classroom (Room 101) of Villanova University School of Law (299 North Spring Mill Road, Villanova). This year’s featured speaker Zane Memeger, U.S. Attorney for the Eastern District of Pennsylvania, discussed “Healthcare Fraud Enforcement & Business Compliance.”

This program was approved by the Pennsylvania Continuing Legal Education Board for 3.5 CLE substantive credits.  

 

Life Sciences Law Conference
Left to right: Brian T. Gorman '01, Danielle M. Lauzon '00 and Brian P. McVeigh

 

8:00 a.m. – 8:30 a.m.     Registration & Continental Breakfast

8:30 a.m.                         Welcome

Rufus KingDirector, John F. Scarpa Center for Law & Entrepreneurship

8:30 a.m. – 9:30 a.m.      Biosimilars: Regulation and Litigation

Biologic drugs have reached blockbuster status for a number of chronic and often fatal diseases. As patents covering the first generation of biologics near expiration, “biosimilar” versions of those drugs are coming to market raising new regulatory and intellectual property issues. So far, 2015 has been a landmark year for biosimilars in the U.S. On March 6, the Food and Drug Administration (“FDA”) approved the first biosimilar in U.S. history. Our panel of experts will tell you more about the regulatory and intellectual property issues surrounding biosimilars, including recent, pending and potential litigation.


Panelists:

Elaine Herrmann Blais, Partner, Goodwin Procter LLP
Sharada Devarasetty, Senior Patent Attorney, Boehringer Ingelheim
Duncan Greenhalgh
, Partner, Goodwin Procter LLP

 

9:30 a.m. – 10:30 a.m.    Recent Trends in Drug and Device Regulation

In a time of changing leadership at the FDA, new approval and enforcement priorities continue to emerge.  Our speakers will discuss some of the more pressing topics, including: priorities of the FDA Commissioner; new developments in the drug approval process; and trends from the Office of Inspector General relating to free drug and patient assistance programs.

Moderator: Bryant Lim '96, Chief Compliance Officer, Incyte Corporation

Panelists:

Isabel C. Duffy '97, Associate Vice President, Office of General Counsel, Merck Sharp & Dohme Corp.
Michael Labson, Partner, Covington & Burling LLP
Jeff Handwerker
, Partner, Arnold & Porter LLP

 

10:30 a.m. – 10:45 a.m.   Break

 

10:45 a.m. – 11:45 a.m.  Current Topics in M&A and Investments

Deal-making in the life sciences industry has continued at a furious pace in 2015.  In fact, pharmaceutical M&A has been one of the busiest sectors in 2015, accounting for roughly 11% of the overall M&A volume so far, with healthcare M&A representing another 15%.  In this session, our panel of experienced industry experts will consider topics such as: are big pharmaceutical companies moving towards investing in earlier-stage companies; what are the opportunities arising from the convergence of life sciences and technology; what are the trends in cross-border M&A; and how are recent legal and regulatory developments affecting deal structures and risk assessment.

Moderator: Spencer D. Klein, Partner, Morrison & Foerster LLP

Panelists:

Barry Frankel, Managing Director, Huron Life Sciences

Brian T. Gorman '01, Deputy General Counsel, AstraZeneca Pharmaceuticals LP

Danielle M. Lauzon '00, Partner, Goodwin Procter LLP

Brian P. McVeigh, Vice President, Worldwide Business Development Transactions and Investment Management, GlaxoSmithKline plc


11:45 a.m. – 12:30 p.m.  Focus on Enforcement

Featured Speaker: Zane Memeger, U.S. Attorney for the Eastern District of Pennsylvania

Healthcare Fraud Enforcement and Business Compliance”

Introduced by Gordon Cooney '84, Partner, Morgan, Lewis & Bockius LLP

 

Elaine Blais, a partner in Goodwin Procter's Litigation Department, focuses her practice on intellectual property litigation, particularly with respect to patent litigation. Blais has handled numerous patent infringement lawsuits in federal courts nationwide. She joined Goodwin Procter in 2001 and is currently a member of the firm's Hiring Committee and Partner Integration Committee. She also serves on the firmwide Women's Initiative Steering Committee, co-chairs the Boston Women's Initiative Council and is a member of the firm’s FinTech Practice. Blais has also served at various times on the firm's Alternative Billing Strategies, Renovations and Big Think Committees. Prior to joining Goodwin Procter, Blais was an associate at Jones Day, where she concentrated her practice on patent, trademark and copyright litigation. She is a member of the American Bar Association, the Boston Bar Association and the American Intellectual Property Law Association.

Sharada Devarasetty works as a Senior Patent Attorney at Boehringer Ingelheim at its corporate headquarters in Germany. In her current role, she works closely with company management to develop product launch strategies and advises management on patent issues that may arise. Prior to this role, she was a member of the Litigation Department at Proskauer Rose in its Boston office. Sharada received her JD, magna cum laude, and MS in molecular, cellular, developmental biology & genetics from the University of Minnesota Law School in 2007. She received a BA with distinction in biology and chemistry from Cornell University in 2003. 

Duncan Greenhalgh is a partner in Goodwin Procter's Technology Companies & Life Sciences Group. He has more than 17 years of experience advising life science companies, ranging in size from start-ups to public companies, and academic institutions on complex intellectual property matters and market exclusivity strategies. Greenhalgh also represents venture capital funds on intellectual property matters relating to their investments in life sciences companies, and investment banks on intellectual property matters relating to public and private financings. Greenhalgh has been recognized by Chambers USA: America’s Leading Lawyers for Business (2009-2014) and LMG Life Sciences (2012-2014) as an industry leader for his intellectual property expertise in life sciences. Prior to joining Goodwin Procter in 2005, Greenhalgh was a senior associate at Testa, Hurwitz & Thibeault LLP in the Patent and Intellectual Property Practice Group. He is a member of a number of professional organizations, including the American Intellectual Property Law Association, the American Bar Association, the Boston Bar Association and the Boston Patent Law Association.

Bryant Lim '96 is the Chief Compliance Officer at Incyte Corporation, a biotechnology company with an approved product for a rare type of cancer and several investigational compounds being evaluated for a variety of oncologic conditions. He also currently teaches a FDA course at Villanova Law, “The Law of Drugs and Biologics.” Prior to joining Incyte, he served as Associate General Counsel at ViroPharma Incorporated, which was acquired by Shire, plc in 2014. At ViroPharma, he provided legal advice on global regulatory and compliance issues across a broad range of issues relating to regulatory challenges, clinical trials, promotion, patient privacy, global anti-corruption/anti-bribery and drug safety. Prior to joining ViroPharma, Lim was Assistant Counsel at Merck & Co., Inc. where he focused his practice on FDA and other regulatory matters relating to promotion, sales and marketing. Prior to joining Merck, he was an attorney with Morgan, Lewis & Bockius LLP in Philadelphia.

Isabel Duffy '97 is an Associate Vice President in the Office of General Counsel at Merck Sharp & Dohme Corp. In this position, she is responsible for providing legal advice to the US Pharmaceutical business and the Merck Vaccine Division in the areas of the Anti-kickback Statute, the False Claims Act, Commercial and Government Contracting, Pricing and CIA support. With the exception of a three year period between 2008 and 2011, Duffy has worked at Merck since 2002 and has held positions of increasing responsibility throughout her tenure. Between 2008 and 2011, Duffy became Associate General Counsel at Auxilium Pharmaceuticals, a small biopharmaceutical company, where she was responsible for both FDA and commercial issues. Isabel is a graduate of Bucknell University and the Villanova University School of Law. Before Joining Merck, she was a law clerk for The Honorable Eduardo C. Robreno, Eastern District of Pennsylvania, and a litigation associate at the Philadelphia law firm of Drinker Biddle & Reath.

Michael Labson is a partner at Covington & Burling LLP. His practice spans the full range of pharmaceutical, biologics and medical device regulation. Labson provides strategic advice in dealing with the FDA and other agencies. He has litigated a variety of cases in the life sciences area and works actively on transactional and legislative matters. His recent work has involved issues such as clinical trial conduct; breakthrough therapy designation and accelerated approval; FDA dispute resolution; orphan drug, pediatric and Hatch-Waxman market exclusivities; product promotion; REMS; pharmacovigilance; drug samples; GMP and quality system requirements; FOIA; and Rx/OTC switches. He also has expertise on DEA and controlled substances issues, and child-resistant packaging requirements.

Jeffrey Handwerker is a partner at Arnold & Porter LLP and focuses his practice on pharmaceutical pricing and investigations, government contracts and commercial litigation involving the pharmaceutical, medical products and biotechnology industries. In the pharmaceutical pricing area, Handwerker regularly advises pharmaceutical and medical technology companies on pricing and contracting matters arising under, among other things, the Veterans Health Care Act, the Medicaid Rebate Act, the Deficit Reduction Act of 2005, the Medicare Prescription Drug, Improvement, and Modernization Act and the Patient Protection and Affordable Care Act. He also has advised pharmaceutical companies on some of the most important and cutting edge issues confronting the industry, including healthcare reform implementation, application of the First Amendment to pharmaceutical communications with healthcare professionals and novel issues under the federal and state Anti-Kickback laws. Handwerker represents clients in litigation matters, internal investigations, and government audits and investigations, including investigations initiated by the United States Attorney's Offices in Philadelphia and Boston, among others. He also has extensive experience litigating cases on behalf of pharmaceutical companies under both state and federal false claims acts.

Barry Frankel has over 35 years of experience in the life science industry, including investment research, strategic planning/M&A, marketing and strategy consulting. His expertise includes business strategies and business model evolution, R&D portfolio and technology assessments, market entry and geographic expansion commercialization strategies, new company formation and division spinoff creation and funding, and identification and valuation of acquisition, divestiture, licensing, and alliance candidates. His clients have spanned multinational and specialty pharmaceutical companies, emerging bio/pharmaceutical firms, device and diagnostic companies, industry intermediaries (including CROs and CSOs) and investment firms.

Brian T. Gorman '01 joined AstraZeneca in 2009 as Senior Counsel, Legal R&D, having previously worked for Wyeth Pharmaceuticals supporting the R&D and manufacturing divisions. He currently manages legal support for AstraZeneca's global development and portfolio & product strategy operating units. After graduating from Villanova School of Law, Gorman began his legal career in New York at Cleary, Gottlieb, Steen & Hamilton, advising multinational companies on a range of global litigation matters.

Spencer Klein is a partner at in Morrison & Foerster’s Corporate Department and serves as co-chair of the firm's global Mergers & Acquisitions Group. Klein focuses his practice on M+A transactions and related matters such as proxy contests and takeover defense counseling. He has advised on more than 150 successfully closed mergers, tender and exchange offers, stock and asset acquisitions, divestitures and joint ventures. He is also a veteran of numerous contested matters and regularly counsels corporate boards and committees in transactional and high-profile corporate governance matters. Klein frequently advises leading U.S. and multinational companies across multiple industries. His engagements include multi-billion dollar deals in health care and life sciences, financial services, technology, consumer products, manufacturing, retail, energy and entertainment and media. In addition to prominent corporate clients, he has represented some of the world's leading investment banks in their M+A transactions. Prior to joining Morrison & Foerster, Klein was a partner at O’Melveny & Myers LLP, McDermott Will & Emery LLP and Shearman & Sterling LLP. Klein received his B.A. from The Pennsylvania State University in 1986, and his JD from Hofstra University School of Law in 1989, where he served as Editor-in-Chief of the Hofstra Law Review.

Danielle Lauzon '00 is a partner in Goodwin Procter’s Technology Companies & Life Sciences Group. From 2007 through 2012, Lauzon was recognized as Massachusetts Super Lawyer “Rising Star” for her work representing private and public companies on general corporate and securities law and mergers and acquisitions. Lauzon also represents issuers in connection with the public offering and private placement of equity securities, and she has represented companies as well as venture capital and private equity firms in numerous venture capital financings and recapitalizations. Prior to joining Goodwin Procter, Lauzon was an associate in the Business Practice Group at Testa, Hurwitz & Thibeault in Boston. She is a member of the Massachusetts and Boston Bar Associations.

Brian McVeigh is the Vice President of Worldwide Business Development Transactions and Investment Management at GlaxoSmithKline (GSK). In this capacity he leads a global team of Business Development professionals responsible for GSK’s business development deals including in-licenses, out-licenses, research collaborations, co-development and co-promotion arrangements, joint ventures, product acquisitions, newco startups, equity investments and M&A deals. He also has responsibility for managing GSK’s portfolio of equity investments in R&D collaboration partners and GSK’s portfolio of LP investments in venture capital funds. McVeigh has held a number of positions of increasing responsibility within the R&D Finance, Marketing, Corporate and Worldwide Business Development organizations throughout his 20 year career with GSK. McVeigh has extensive business development experience, having successfully led a broad range of business development transactions including the acquisitions of Domantis, Praecis, Sirtris, and Genelabs, and the in-licensing of ambrisentan (Volibris®). McVeigh is a member of GSK’s Business Development Executive Committee, Transactions Leadership Team and the Technology Investment Board. He holds Bachelor of Science degrees in Accounting and Finance from LaSalle University, an MBA with a Concentration in Finance from Villanova University, a Post MBA Certificate in Pharmaceutical Marketing from Saint Joseph's University and a CPD from the Wharton Business School. He is a member of the Licensing Executives Society and is a Certified Public Accountant, Certified Management Accountant and a Certified Licensing Professional.

Zane David Memeger was appointed by President Barack Obama as the United States Attorney for the Eastern District of Pennsylvania on May 6, 2010, following confirmation by the United States Senate.  As the United States Attorney, Memeger has three statutory responsibilities: the prosecution of criminal cases brought by the federal government; the prosecution and defense of civil cases in which the United States is a party; and the collection of debts owed the federal government which are administratively uncollectible.

Memeger is currently serving a two-year term on the Attorney General’s Advisory Committee (AGAC), where he serves as Co-Chair for the Health Care Fraud Working Group. He also sits on the following AGAC subcommittees: White Collar/Fraud Subcommittee, Violent Crime and Organized Crime Subcommittee, LECC/Victim/Community Issues Subcommittee, Cyber Crime/Intellectual Property Subcommittee and the Racial Disparities Working Group.  Additionally, he serves on the Executive Board of the Philadelphia/Camden High Intensity Drug Trafficking Area Program (HIDTA), for which he served as Vice-Chair in 2011 and Chair in 2012.

Memeger leads an office of 126 attorneys where he served as an Assistant United States Attorney from 1995 to 2006, investigating and prosecuting a variety of cases including organized crime, government fraud, financial fraud, violent crime, narcotics, extortion and commercial bribery. As a result of his earlier work on behalf of the office, he received several commendations from FBI Director Robert S. Mueller, III, for investigating and prosecuting cases that involved public corruption and violent crime.

After 11 years serving the public as a federal prosecutor, Memeger returned to the private sector in 2006 where he became a partner with Morgan, Lewis & Bockius.  During that time his practice focused on white-collar criminal defense work and corporate investigations. He also published various writings on the topics of off-label marketing of pharmaceuticals and medical devices, corporate compliance and ethics, and corporate responses to government investigations.  Additionally, Memeger was very involved with Morgan Lewis’ pro bono program, handling cases as a member of the Criminal Justice Act Panel (CJA) for the Eastern District of Pennsylvania and supervising young attorneys handling matters for the Support Center for Child Advocates and the Education Law Center.

Memeger is a 1986 graduate of James Madison University, where he was a four-year letterman in men's gymnastics, and a 1991 graduate of the University of Virginia School of Law. Upon graduation from law school, he received the Robert F. Kennedy Award for Public Service for his work on behalf of federal and state prisoners. Memeger’s continued dedication to public service and fairness in the application of the law to all citizens has since been recognized by the Barristers’ Association of Philadelphia (2011 Honorable William F. Hall Award); the Peace Islands Institute (2013 Public Service Award); and the Citizens Crime Commission for the Delaware Valley (2013 Thomas Jefferson Award). Memeger was also recently recognized by the Legal Intelligencer (the oldest law journal in the United States) as the Pennsylvania Attorney of the Year for 2014.

Memeger is a member of the Penn Law Chapter of the American Inns of Court; the Philadelphia Bar Association; and The Philadelphia Barristers’ Association. Prior to his appointment as United States Attorney, Memeger served on the Board of Trustees for the People’s Light & Theatre Company, and as a member of the Regional Selection Committee for the University of Virginia Jefferson Scholarship Foundation.

 

Biosimilars: An introduction
Biosimilars: Regulation and Litigation
Recent Trends in Drug and Device Regulation
Current Topics in M&A and Investments