17th ANNUAL IGPA CONFERENCE - Generic Pharmaceutical

17th ANNUAL IGPA CONFERENCE
19-21, NOVEMBER 2014 | THE RITZ-CARLTON KEY BISCAYNE, MIAMI
Program Speakers
Shawn Brown, Esq.
Vice President, International
Government Affairs, Actavis, plc.
Nick Cappuccino, Jr., Ph.D.
Vice President and Head of Global
Quality, Dr. Reddy’s Laboratories, Ltd.
Shawn Brown is the Vice President of International
Government Affairs for Actavis Inc. Mr. Brown formerly
served as Vice President of International Government
Affairs and State Government Affairs at the Generic
Pharmaceutical Association (GPhA). From 2005 until
2008, he served as Director of Policy for the Association. Prior to joining GPhA, he worked at the Food and
Drug Law firm, Hyman, Phelps & McNamara, in Washington, D.C. From 2006 to 2014, Mr. Brown served as an
advisor to the Department of Commerce and United
States Trade Representative on intellectual property,
trade and pharmaceuticals as a member of the Industry
Trade Advisory Committee for Chemicals, Pharmaceuticals, Health/Science Products and Services (ITAC 3).
Mr. Brown received his Juris Doctor from the University
of North Carolina, Chapel Hill, where he served as an
Articles Editor for the North Carolina Law Review. He
received his M.A. and B.A. in English from the University of Maine. Before entering the field of law, Mr. Brown
studied and worked in Japan as an English teacher, and
previously taught literature and writing at the University of Maine.
Dr. Cappuccino is currently the Vice President and
Head of Global Quality for Dr. Reddy’s Laboratories,
Ltd. based in Hyderabad, India. Dr. Cappuccino has 30+
years of experience in the pharmaceutical industry. He
has held Senior Management roles in generic companies such as Apotex, Sandoz, Andrx, and Watson prior
to Dr. Reddy’s. He is currently Chair of the International
Generic Pharmaceutical Alliance (IGPA) Science Committee. Nick was a member of the ICH Expert Working
Groups for ICH Q1A, Q1D, and Q1E and has served as
an Observer to the WHO Expert Committee on Specifications for Pharmaceutical Preparations when many of
their Stability guidelines were established and revised.
Nick holds a PhD degree in Organic Chemistry from Stevens Institute of Technology in Hoboken, NJ.
Trevor Cook, Esq.
Partner, Wilmer Cutler Pickering Hale
and Dorr LLP
Trevor Cook is an English qualified solicitor who focuses
his practice on transnational intellectual property litigation matters and is also active in the area of life sciences.
Mr. Cook has more than 35 years of experience in global
patent litigation, particularly in Europe and Asia. He
has acted in many of the leading patent infringement
cases that have come before the English courts, most
of which have concerned pharmaceuticals and biotechnology, and also in many of the leading cases regarding the protection of regulatory data. Mr. Cook joined
WilmerHale at the beginning of 2014 in their New York
office from Bird & Bird LLP in London, where he had
been a partner in the Intellectual Property Group and
co-head of the International Life Sciences Sector Group.
He was for several years president of the UK Group of
the International Association for the Protection of Intellectual Property (AIPPI), is Chairman of the British Copyright Council and is on the World Intellectual Property
David Buchen
Executive Vice President, Commercial
North American Generics and
International, Actavis, plc
David Buchen is Executive Vice President Commercial,
North American Generics and International of Actavis
plc. Prior to assuming this global commercial role in
July 2014, Mr. Buchen served in a number of leadership
positions, most recently as Chief Legal Officer – Global
and Secretary to the Board of Directors. Prior to joining Watson Pharmaceuticals (now Actavis) in 1998, Mr.
Buchen was Corporate Counsel at Bausch & Lomb Surgical (formerly Chiron Vision Corporation) and was an
attorney with the law firm of Fulbright & Jaworski, LLP.
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different positions mainly in the field of drug and food
regulation. From 2008 to 2013, he was Executive Director
of Japanese Association of Vaccine Industries. Since July
2013, he is Director General of Japan Generic Medicine
Association.
Organisation (WIPO) List of Arbitrators. Mr. Cook is a prolific author, having written numerous articles and books
during his career. His most recent include A Users’ Guide
to Patents (3rd edition - Bloomsbury 2011), International
Intellectual Property Arbitration (Wolters Kluwer 2010), EU
Intellectual Property Law (Oxford University Press 2010)
and Pharmaceuticals Biotechnology and the Law (LexisNexis Butterworths 2009).
Ronny Gal, Ph.D.
Senior Analyst
Sanford C. Bernstein & Co.
Aaron (Ronny) Gal is the Senior Research Analyst covering the specialty pharmaceutical industry at Sanford C.
Bernstein, providing research and investment insights
on specialty and generic pharmaceutical stocks to institutional clients around the world. His work is recognized
in third-party surveys, including those conducted by
Institutional Investor and Greenwich Associates. Prior
to joining Bernstein, Mr. Gal spearheaded Canon’s business development in life sciences. He also spent six years
with the Boston Consulting Group, advising clients in the
pharmaceutical and healthcare delivery sectors. Mr. Gal
was awarded a PhD from the Massachusetts Institute of
Technology and holds a BSc from Emory University.
Jeremy Desai, Ph.D.
President & CEO, Apotex Inc.
Jeremy was born in London, UK and gained a Pharmacy
degree in 1981 followed by a Ph.D. in 1985. He has spent
close to 30 years in progressively senior roles in the pharmaceutical industry. In August 2014, he was appointed
as President & Chief Executive Officer, Apotex based in
Toronto, Canada. He served for seven years on the Board
of Directors of Cangene Corporation, one of Canada’s
largest biotechnology companies and holds the designation ICD.D from the Corporate Institute of Directors.
David Gaugh, R.Ph.
Senior Vice President, Sciences &
Regulatory Affairs, Generic
Pharmaceutical Association (GPhA)
Vivian Frittelli, M.B.A, ACIS, FCIBM
CEO, National Association of
Pharmaceutical Manufacturers (NAPM)
Vivian Frittelli has worked in the pharmaceutical industry for the past 27 years. He headed Roche’s Marketing
and Sales Division in Southern Africa before doing a stint
of three years in Saudi Arabia. Upon his return to South
Africa, he took up a position with Sandoz and thereafter
joined the National Association of Pharmaceutical Manufacturers as its Chief executive.
David Gaugh has over 25 years of leadership experience
in the Healthcare and Pharmaceutical business and has
been an outstanding contributor to the industry over
the years. He has been employed by GPhA since February 2012 as the Senior Vice President for Sciences and
Regulatory, where he is responsible for the science, regulatory and professional liaison functions between member companies, agencies of the US Government and
Legislative bodies. Prior to joining GPhA, David was the
Vice President and General Manager of Bedford Laboratories, a Division of Ben Venue Laboratories (a wholly
owned subsidiary of Boehringer Ingelheim). David was
responsible for Strategic Planning, Financial Management, Business Development, Marketing and Sales for
a $500 million multi-source injectable business. Prior to
joining Ben Venue, David was Senior Director, Pharmacy
Contracting and Marketing at VHA/Novation; the largest
Tamaki Fushimi
Director General, Japan Generic Medicines
Association (JGA)
Mr. Tamaki Fushimi, a pharmacist, has bachelor’s and
master’s degrees from Kyoto University in pharmaceutical science. He worked for Ministry of Health, Labor and
Welfare, Government of Japan, where he experienced
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17th ANNUAL IGPA CONFERENCE
19-21, NOVEMBER 2014 | THE RITZ-CARLTON KEY BISCAYNE, MIAMI
Group Purchasing Organization in the US. Prior to Novation, he was System Director of Pharmacy for St. Luke’s
Health-System, a tertiary-care hospital in Kansas City,
MO. David is a registered pharmacist and a graduate of
the University Of Wyoming School Of Pharmacy. He is
engaged in several pharmacy-related activities such as
the ASHP Education and Research Foundation Board
of Directors and various Pharmacy Internship and Residency Programs.
maceutical Association (CGPA), the organization representing Canada’s generic pharmaceutical industry. Mr.
Keon graduated from Trent University. He subsequently
received his M.A. in Economics from Queen’s University.
Prior to joining the Association in 1994 (he became President in 1998), he held senior positions in the federal government and was directly involved in international trade
negotiations for the FTA, NAFTA and the WTO, as well as
Canada’s inter-provincial trade negotiations. Mr. Keon is
the Chair of the Management Committee of the International Generic Pharmaceutical Alliance (IGPA), which
promotes the interests of generic drug makers around
the world.
Peter Goldschmidt
President of Sandoz US and Head of North
America, Sandoz Inc.
Since July 2013, Peter Goldschmidt holds the position
of President of Sandoz US and Head of North America.
He joined Sandoz from Novartis Pharma where he was
Country Group Head for the Philippines, Singapore and
Indonesia, and then became Head of Central and Eastern
Europe. A German national, Peter first joined the Novartis Group in 1990 in Germany and held a number of progressive roles in marketing, sales, strategic planning and
general management.
Eugenia Costanza Laurenza, J.D.
Senior Associate Lawyer
Fratini Vergano–European Lawyers
Ms. Eugenia Costanza Laurenza is a senior associate lawyer at FratiniVergano - European Lawyers in Brussels,
Belgium (www.fratinivergano.eu). Her practice focuses
on international trade law (i.e., WTO law, dispute settlement and trade negotiations in the areas of agriculture,
services and non-tariff barriers such as sanitary and
phytosanitary measures and technical barriers to trade,
trade-related aspects of intellectual property rights,
trade remedies, subsidies and regional integration). Ms.
Laurenza has extensive experience in advising Governments and private parties on WTO matters and multilateral/regional/bilateral trade negotiations. She is one of
the primary authors of the Report on Trade Principles for
the Generic and Biosimilar Medicines Sector for Inclusion
in International Trade Agreements, which was completed
in 2014. Ms. Laurenza is admitted in Italy (Rome) and is a
member of the Brussels’ bar (E list). She graduated in law
at the University of Rome La Sapienza in 2001, obtained
an Erasmus Diploma at the Universitat Autònoma de Barcelona, and completed an LL.M in European and International Trade Law at the Universiteit van Amsterdam with
distinction. Ms. Laurenza publishes frequently on issues
of WTO and EU law.
Nick Haggar
Head of Western Europe, Middle East &
Africa, Sandoz International GmbH
Nick Haggar is responsible for Western Europe/Middle
East Africa for Sandoz International and is a Member of
the Sandoz Executive Committee. In January 2014, Nick
expanded his responsibility further to include the German organization of Hexal, 1A and Sandoz. Nick has
worked for twenty seven years in the Pharmaceutical/
Healthcare industry. Nick joined the EGA (European
Generics medicines Association) as a board member in
2006 while leading Ranbaxy in Europe and assumed the
Presidency of the EGA in October 2013.
Jim Keon
President, Canadian Generic
Pharmaceutical Association (CGPA)
Jim Keon is President of the Canadian Generic Phar9
the company’s operations. He also serves on Mylan’s
board of directors. Malik’s responsibilities as president
include overseeing research and development (R&D),
business development, regulatory affairs, manufacturing, quality, supply chain, and medical affairs, as well as
the sales and marketing of Mylan’s generics business. He
also is responsible for helping lead Mylan’s expansion
into emerging and other new commercial markets, such
as the company’s commercial launch in India in 2012.
Malik has held important leadership positions at Mylan
since January 2007, when the company acquired a controlling stake in Matrix Laboratories Limited (now Mylan
Laboratories Limited), one of the world’s largest suppliers of active pharmaceutical ingredients. At the time of
the acquisition, Malik was Matrix’s chief executive officer.
Among his earlier contributions at Mylan, Malik played
a key role in significantly expanding and diversifying
the company’s global product portfolio, pipeline and
manufacturing footprint. In partnership with Mylan’s
leadership team, he played a significant role in leading
the integrations of Mylan and Matrix and Mylan and the
generics business of Merck KGaA to leverage the benefits
of global scale and vertical and horizontal integration.
He also helped establish Mylan as a leader in antiretroviral medicines, particularly in developing markets. Malik
has approximately 30 years of experience in the global
generic pharmaceutical industry. Prior to joining Matrix
in 2005, Malik was head of Global Development and
Regulatory at Sandoz. He started his R&D career at Ranbaxy Laboratories, rising to head of Generics R&D. Malik
earned his master’s degree in pharmaceutical technology from Punjab University, India, and has more than 60
process patents to his credit.
Yehudah Livneh, Ph.D.
Vice President, Global Policy, Asia and
EMIA, Teva Pharmaceuticals
Dr. Yehudah Livneh is the VP, Global Public Policy, Asia
& EMIA at Teva Pharmaceutical Industries, Ltd., a global
Israeli-based pharmaceutical company which develops,
manufactures and markets generic and specialty human
pharmaceuticals and active pharmaceutical ingredients.
Previously, Yehudah was the General Patent Counsel and
VP Corporate IP and Legislative Affairs at Teva. Yehudah
is a registered Patent Attorney in Israel, as well as a registered Patent Agent in the USA. He holds a Ph.D. in Biochemistry from Brandeis University, Massachusetts, USA,
and a B.Sc. in Chemistry from the Hebrew University of
Jerusalem, Israel. Yehudah is the Chairman of the Intellectual Property Committee of the International Generic
Pharmaceutical Alliance (IGPA), Chairman of the Patent
Committee of the Manufacturers Association of Israel
and a member of the Secretariat of the Israel National
Group of the AIPPI. Yehudah is also a member of the Editorial Board of the Journal of Generic Medicines. Yehudah’s other interests include triathlons, bicycling and
long distance running.
Doug Long
Vice President, Industry Relations
IMS Health
Doug Long is Vice President of Industry Relations at IMS
Health, the world’s largest pharmaceutical information
company. Mr. Long, who has been with IMS Health since
1989, focuses on securing data for all existing and new
databases supported by IMS Health, managing supplier,
manufacturer and association relationships, and developing information for data partners. He has considerable
experience with, and unique perspective on, the changing U.S. and global health care marketplace and pharmaceutical distribution.
Osama A. Nabulsi
Vice President, Business Development &
Alliance Management
Hikma Pharmaceuticals PLC
Mr. Nabulsi is a pharmaceutical & biotechnology professional with more than 20 years of industry experience,
and strong commercialization, development and management expertise. He urrently serves as the Vice President of Business Development and Alliance Management
at Hikma Pharmaceuticals. Prior to that, he served in
various management positions at Abbott, Amgen and
Genentech with responsibility for research, market-
Rajiv Malik
President, Mylan Inc.
Rajiv Malik is Mylan’s president, and is responsible for
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17th ANNUAL IGPA CONFERENCE
19-21, NOVEMBER 2014 | THE RITZ-CARLTON KEY BISCAYNE, MIAMI
Conference on Civil Rights (the nation’s oldest and largest coalition), as President and CEO of the nonpartisan
People For the American Way, and as a chief counsel in
the U.S. Senate, first to Senator Edward W. Brooke (R-MA)
and then to Senator Dave Durenberger (R-MN.). Neas
earned his B.A. from the University of Notre Dame and
his J.D. from the University of Chicago Law School. Neas
has also taught at the University of Chicago Law School,
Georgetown University Law Center, and Harvard’s Kennedy School of Government.
ing, business analytics, and strategic planning. Recent
accomplishments include various high profile negotiations; joint venture; and acquisitions of strategic assets
in areas of oncology, cardiovascular, CNS, anti-infective
and biotechnology/biosimilars. Additionally, Mr. Nabulsi
made significant contributions to the successful launch
of key blockbusters, including Aranesp®, Sensipar® and
Nutropin®, and the development of various company
commercialization strategies. He has a Masters in Molecular Biology from California State University-San Bernardino and an MBA from Pepperdine University.
Sergio Napolitano
Legal Affairs and Trade Manager
European Generic medicines
Association (EGA)
Allan Oberman
President and CEO, Teva Americas Generics
Allan Oberman became President & CEO of Teva Americas Generics in November 2012 after serving as the head
of the North America Generics division. Prior to his role
in the Americas, he served as President of Teva EMIA,
where he had responsibility for Eastern Europe, Middle
East, Israel and Africa. Allan joined Teva in 2000 as the
President and CEO of Novopharm, which is now Teva
Canada. While at Teva Canada, he led the transition of
the company from a family-owned business to that of
a successful subsidiary of Teva, ultimately regaining the
Canadian generic market leadership position. Allan also
served as the Chief Operating Officer of the Teva International Group. Before joining Teva, he was President of
Best Foods Canada Inc. Allan holds an MBA from Schulich
School of Business, York University and a B.A. from University of Western Ontario. He also served as Chairman
of the Canadian Generic Pharmaceutical Association
(CGPA) from 2007 – 2008.
Sergio Napolitano is Legal Affairs and Trade Manager
at the European Generic medicines Association (EGA).
Before joining the EGA, Sergio Napolitano worked in the
Directorate General for External Policies of the European
Parliament where he was part of the Secretariat of the
Committee on International Trade (INTA). In 2012, he
authored a report of the European Parliament on “The
Role of the Congress in Shaping the US Trade Policy”. He
previously worked in the Trade Policy Department of the
Permanent Representation of Italy to the EU on multilateral, plurilateral and bilateral trade negotiations, EU
investment policy, IPR, etc. Sergio Napolitano is qualified
for mediator certification in most American states. He
holds a degree in Law from the University of Naples Suor
Orsola Benincasa and a LL.M. on EU and European Public
Law from the University College of London (UCL).
Clive Ondari, Ph.D., MBA, BSc.
Coordinator, Medicines Access and
Rational Use, World Health Organization
(WHO)
Ralph G. Neas
President and CEO, Generic
Pharmaceutical Association (GPhA)
Ralph G. Neas is the President and CEO of the Generic
Pharmaceutical Association (GPhA). Prior to joining
GPhA, he was the President and CEO of the National
Coalition on Health Care (NCHC), a nonpartisan centrist
coalition of more than eighty national organizations.
For more than 30 years, Neas focused principally on civil
rights, civil liberties, health and consumer issues, serving
as the Executive Director of the nonpartisan Leadership
Clive Ondari has over 20 years of experience in pharmaceutical policies and programmes, having worked for the
Government of Kenya and WHO on various assignments.
He holds a Doctorate in Pharmaceutical Sciences and
Master of Science in Business Administration. He started
his career in academia and regulatory affairs in Kenya
where he was Associate Professor of Pharmaceutics and
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Head of Department at the University of Nairobi and
Chairman of the Pharmacy Board (Committee on Registration of Medicines) for over 10 years. For over seven
years, he was the Coordinator for Medicines Access and
Rational Use, and in the last year has been leading the
WHO Team on Safety and Vigilance.
research monopolistic practices, growth and competitiveness, foreign investment, legal argument, publicity,
intelligence, among others. He has worked in various
federal government agencies, including the Procuraduría General de la República (PGR) (Attorney General’s
Office), in which he performed duties of legal analysis
and international cooperation in law enforcement with
Europe, Latin America, the United Nations and other specialized agencies. He has worked in the Federal Competition Commission, where he served as General Director
of the Directorate General of Regulated Markets, Competition Commission, where he served as Deputy Director General for Research of Monopolistic Practices, and
Managing Director of Proceedings of the Procuraduría
Federal del Consumidor (PROFECO) (Federal Consumer
Protection), as head of the department in charge of the
processes of punishment for false advertising and violations of the Federal Consumer Protection Law. In March
2011, Julio Sanchez y Tépoz joined the Comisión Federal
para la Protección contra Riesgos Sanitarios COFEPRIS
(Federal Commission for the Protection against Sanitary
Risk) as Chief of Staff of the Federal Commissioner since
July 2012 and serves as a Commissioner of Health Promotion in COFEPRIS in Mexico.
Frederick Rein, Esq.
Partner, Goodwin Proctor LLP
Frederick Rein, a partner at Goodwin Procter LLP, is a U.S.
registered patent attorney with 25 years of experience
in intellectual property law. He is a graduate of Rensselaer Polytechnic Institute, New York University and Boston College Law School and served as a law clerk at the
U.S. District Court for the Central District of California. Mr.
Rein is also the U.S. case reports editor for the Journal
of Generic Medicines and has frequently written about
pharmaceutical patent matters.
Nawel Bailey Rojkjaer
Senior Director, International Affairs
Office of Global Policy, Mylan Gmbh
Hanan Sboul
Secretary General, The Jordanian
Association of Pharmaceutical
Manufacturers (JAPM)
Nawel Rojkjaer is the Senior Director of International
Affairs at Mylan. Responsible for international trade policy, Nawel has worked to increase Mylan, and the industry’s, engagement on trade policy at a global level. She
is a graduate of McGill Law with a focus on Intellectual
Property, and worked as an IP litigator in the pharmaceutical sector for years, before moving into IP policy and
government relations. She is the current Chair of the EGA
Trade Committee.
Hanan J. Sboul was appointed as Secretary General of
the Jordanian Association of Pharmaceutical Manufacturers (JAPM) since 2003. Prior to that, she has worked
at Jordanian Food and Drug Administration (JFDA). Ms.
Sboul holds an MBA degree and a bachelor degree in
pharmacy; she is also a certified association executive
(CAE) by the American Society of Association Executives.
Julio Sánchez y Tépoz
Commissioner of Health Promotion in
COFEPRIS
Randall Stanicky, CFA
Managing Director, Equity Research
RBC Capital Markets
Julio Sanchez y Tépoz has a degree in law from the
Escuela Libre de Derecho de Puebla, and A.C. Master in
Development Economics at the Complutense University
of Madrid, Spain. It has several specialized studies in foreign trade, economics of regulation, competition policy,
Randall is currently Managing Director, RBC Capital Markets and lead analyst of the specialty & generic pharmaceuticals research team in New York. He has more
than 14 years of experience covering several healthcare
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17th ANNUAL IGPA CONFERENCE
19-21, NOVEMBER 2014 | THE RITZ-CARLTON KEY BISCAYNE, MIAMI
sectors on both the buy and sell-side, most recently at
Canaccord|Genuity and Goldman Sachs. Prior to becoming a sell-side analyst, Randall followed healthcare stocks
on the buy side at Citigroup Global Asset Management.
He is a regular Wall Street speaker at international conferences and is a regular contributor to mainstream print,
radio and TV media, presenting his views on the industry.
Randall received a bachelor’s degree in commerce from
the University of British Columbia and he is a CFA charter
holder. Randall is also a Board Member of TherapeuticsMD and the Children’s Tumor Foundation.
Beata Stepniewska, M.Sc., Pharm.
Deputy Director General, Head of
Regulatory Affairs, European Generic
medicines Association (EGA)
Beata Stepniewska is Deputy Director General, Head of
Regulatory Affairs of the European Generic medicines
Association (EGA) in Brussels. In this position, she is
responsible for coordinating the EGA’s regulatory and
scientific activities, covering a variety of EU and international regulatory developments. Having worked with the
EGA since early 2002, Beata has been involved in expressing the position of the generic medicines industry to the
European Commission, Parliament and Council as well as
the CMDh, the EMA and National Competent Authorities
on a number of pieces of legislation and on many regulatory guidelines covering the operational aspects of marketing authorization. Before joining the EGA, Beata was
Head of the Regulatory Affairs Department of PLIVA Krakow (currently a part of the TEVA group) and Regulatory
Intelligence Manager for the PLIVA Group. Before joining
the generic medicines industry, she worked as a University researcher and lecturer at the Faculty of Pharmacy
in Krakow (Poland) as head of Department of Pharmaceutical Law and Pharmacoeconomics. She is a qualified
pharmacist.
Adrian van den Hoven
Director General, European Generic
medicines Association (EGA)
Adrian van den Hoven was appointed Director General of the European Generic and Biosimilar medicines
Association (EGA) on 1 September 2013. Before this, he
was Deputy Director General of BUSINESSEUROPE with
responsibility for the International Relations and Industry departments. He worked as an International Relations
researcher and adjunct professor in Italy (EUI), France
(Nice) and Canada (Windsor) prior to joining BUSINESS­
EUROPE in 2003. He received his doctorate in Political
Science from the University of Nice, France in 2000.
Yi-Yun (April) Wang
International Affairs Committee, Taiwan
Generic Pharmaceutical Association
(TGPA)
Yi-Yun (April) Wang is the current chair of the International Affairs Committee of TGPA. Since 2008, she has
served as the manager of the legal department at Yung
Shin Pharm. Ind. Co., Ltd. where she oversees the company’s legal matters, including litigation, Paragraph IV matters, contracts, legal analysis and mergers & acquisitions.