GENERICS. A STEADY COURSE IN A SEA OF CHANGE
EVENT PROGRAM
CONTENT
About GPhA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 GPhA Meetings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Sponsors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Agenda. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Program Speakers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Business Exposition. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Publication Partners . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Meeting Maps. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Special Events & Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 2009 Annual Meeting Photos. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
WELCOME Dear Industry Colleagues: Welcome to the GPhA 2010 Annual Meeting, as we usher in a new decade and this important year of change. Health-care costs and access promise to pose great challenges as well as opportunities in the years ahead. With this in mind, our industry represents A Steady Course in a Sea of Change, through our continued commitment to bring affordable medicine to countless millions of Americans. Each year, more than 500 attendees gather at our annual event to hear speakers from Washington D.C., Wall Street and across the globe. Our program offers insight into critical economic, regulatory and legislative issues impacting the generic industry and the pharmaceutical sector. We’re especially pleased that our 2010 agenda features a keynote address from Dr. Margaret Hamburg, Commissioner of the U.S. Food and Drug Administration. You won’t want to miss her unique perspectives on the regulatory and legislative arenas. In addition to our plenary sessions, we are once again hosting our popular Business Exposition, the only industry event of its kind for showcasing products and services before top industry decision-makers. While we have a full program agenda, we also understand the value of informal networking. This year, we host our annual evening reception and dinner party on Naples Beach. This event, along with two poolside receptions, a luncheon and networking breaks are sure to provide plenty of opportunities to network with colleagues in a relaxed, professional setting. I look forward to an exciting and informative Annual Meeting.
Kathleen Jaeger, President & CEO
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ABOUT GPhA Who we are GPhA members manufacture the vast majority of all affordable pharmaceuticals dispensed in the United States. Our products are used in more than two billion prescriptions every year. GPhA’s core purpose is to improve the lives of consumers by providing timely access to affordable medicines. Toward this end, GPhA advances the interests of our members through initiatives in the scientific, regulatory and state forums in the public affairs arena.
Staff Kathleen Jaeger President & CEO
Ashlee Koonce Associate Manager of Regulatory Affairs
Robert Billings Vice President of Policy
Rachelle Kosky Director of Finance and Operations
Shawn Brown Vice President of State Government Affairs
Jason Money Director of Federal Government Affairs
Cookie Cottrell Executive Assistant
Jennifer Nguyen Event Coordinator
Katie Dysart Senior Event Coordinator
Ted Piper Manager, Legislative Affairs
Bill Head Senior Vice President of Government Affairs
Michele Robinson Director of Media Relations
Gordon Johnston Vice President of Regulatory Sciences
Kathleen Wolff Senior Director of Events
MEETINGS AND EVENTS 2010 Meetings and Events GPhA 2010 Annual Meeting February 16 – 18, 2010 The Ritz-Carlton, Naples Naples, FL GPhA/ FDA Labeling Conference April 14, 2010 Marriott Bethesda North Hotel and Conference Center North Bethesda, MD GPhA/ FDA QbD Conference May 4 – 5, 2010 Marriott Bethesda North Hotel and Conference Center North Bethesda, MD GPhA/ FDA ANDA Basics Workshop June (TBD) Marriott Bethesda North Hotel and Conference Center North Bethesda, MD GPhA 2010 International Meeting August (TBD) Vancouver, Canada GPhA/Johns Hopkins Project RESTORE Charity Golf Classic September 27, 2010 Caves Valley Golf Course Owings Mills, MD GPhA 2010 Annual Policy Conference October 6 – 8, 2010 The Ritz-Carlton, Washington Washington, D.C. GPhA 2010 Fall Technical Conference October 19 – 21, 2010 Marriott Bethesda North Hotel and Conference Center North Bethesda, MD 13th Annual IGPA Conference December 8 – 10, 2010 Mumbai, India
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SPONSORS GPhA relies on the financial support of our members and allies whose generosity enables our Association to ensure that our Annual Meeting remains a vital educational and networking event. We gratefully acknowledge the outstanding demonstration of support for GPhA and our members through the contributions of our sponsors and patrons.
Platinum Sponsors
Gold Sponsors
Silver Sponsors
Bronze Sponsors
Patron Sponsors
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AGENDA Tuesday, February 16 8:00 a.m. – 7:00 p.m.
Registration – Main Ballroom Foyer
9:00 a.m. – 6:00 p.m.
GPhA Committee Meetings – Members Only
7:00 p.m. – 9:00 p.m.
Welcome Reception – Poolside
Wednesday, February 17 7:30 a.m. – 2:45 p.m.
Registration – Main Ballroom Foyer
7:30 a.m. – 8:50 a.m.
Breakfast – Business Exposition Hall PLENARY SESSION – Vanderbilt Ballroom
8:50 a.m. – 9:00 a.m.
Welcome and Introductions Kathleen Jaeger, President and CEO, GPhA
9:00 a.m. – 10:00 a.m.
Generic Industry CEOs Unplugged Moderator: Ron Insana, Senior Analyst, CNBC and Financial Industry Analyst • Paul Bisaro, President and CEO, Watson Pharmaceuticals, Inc. • Douglas Boothe, President and CEO, Actavis, Inc. • Heather Bresch, President, Mylan Inc. • Patrick Lepore, Chairman, CEO & President, Par Pharmaceutical, Inc. • William Marth, President and CEO, Teva North America
10:00 a.m. – 10:15 a.m.
Networking Break – Business Exposition Hall
10:15 a.m. – 11:00 a.m.
Health-Care Reform and the Impact on Older Americans John Rother, Executive Vice President of Policy and Strategy, AARP
11:00 a.m. – 12:00 p.m.
Looking Back: First Year of the Administration Coming Up: Mid-term Elections Paul Begala, Political Analyst and Commentator, CNN
12:00 p.m. – 1:15 p.m.
Luncheon/ New Chairman’s Remarks/ PAC Presentation – Center Court
1:15 p.m. – 2:00 p.m.
Health-Care Reform: What Are Its Prospects? Gail Wilensky, Ph.D., Senior Fellow, Project HOPE
2:00 p.m. – 2:45 p.m.
A View from Wall Street Randall Stanicky, CFA, Vice President, Global Investment Research, Goldman Sachs
2:45 p.m. – 4:30 p.m.
Annual Meeting Exhibitor Reception – Business Exposition Hall
5:30 p.m. – 6:30 p.m.
Networking Reception – North Beach
6:30 p.m. – 9:00 p.m.
Southern Barbecue Buffet and Entertainment – North Beach
Thursday, February 18 7:30 a.m. – 9:00 a.m.
Breakfast – Business Exposition Hall
8:00 a.m. – 9:00 a.m.
Membership Breakfast – Plaza Ballroom PLENARY SESSION – Vanderbilt Ballroom
9:00 a.m. – 9:45 a.m.
Keynote Address: FDA Perspectives and Priorities Margaret Hamburg, M.D., Commissioner, U.S. Food and Drug Administration
9:45 a.m. – 10:45 a.m.
Industry Business Trends Doug Long, Vice President, Industry Relations, IMS Health
10:45 a.m. – 11:20 a.m.
Fresh Perspectives on Economics Stephen Dubner, Journalist, Lecturer and CoAuthor of “Freakonomics”
11:20 a.m. – 12:00 p.m.
Product Liability Panel Session Moderator: TBD • John Duff, Director - Litigation, Actavis Inc. • Jennifer Levy, Partner, Kirkland & Ellis LLP • Michael Garofalo, Director, Aon Life Sciences, Aon Corp.
12:15 p.m. – 5:00 p.m. 6:00 p.m. – 7:30 p.m.
Golf Tournament/ Off-Shore Fishing/ Kayaking Farewell Reception – Poolside
*Times are subject to change.
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PROGRAM SPEAKERS Welcome and Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Kathleen Jaeger President and CEO, Generic Pharmaceutical Association
Kathleen Jaeger is the President and CEO of the Generic Pharmaceutical Association. Since assuming the helm of GPhA, the Association has established a strong presence in the halls of Congress and in state capitols across the country working to increase consumer access to safe, effective and affordable generics. Prior to joining GPhA, Jaeger was a partner at Kirkpatrick & Lockhart LLP, a Washington, D.C. law firm where she served as the national practice leader of its Food and Drug Practice Group. Jaeger’s roots in promoting consumer access to affordable medicines go back to her days working in her father’s family-owned community pharmacy. Jaeger received her B.S. in Pharmacy with a Minor in Chemistry from the University of Rhode Island and her J.D. from Catholic University Law School.
Generic Industry CEOs Unplugged. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Paul Bisaro President and CEO, Watson Pharmaceuticals, Inc.
Paul Bisaro is Chief Executive Officer and President of Watson Pharmaceuticals, Inc. Prior to joining Watson, Mr. Bisaro served as President and Chief Operating Officer of Barr Pharmaceuticals, Inc. and President of Duramed. Prior to joining Barr, he was associated with the law firm Winston & Strawn and its predecessor, Bishop, Cook, Purcell & Reynolds. Throughout his career he has served as a member of the Management Board of Pliva d.d., Director of Watson Pharmaceuticals, Director of Barr Pharmaceuticals and Independent Director of Forsyth Capital Mortgage Corp. Mr. Bisaro received his undergraduate degree in General Studies from the University of Michigan and a Juris Doctor from Catholic University of America.
Douglas Boothe President and CEO, Actavis, Inc.
Doug Boothe has extensive knowledge of the U.S. pharmaceutical industry. Working as the Chief Executive Officer at Actavis Inc. since August 2008, after serving as the company’s Executive Vice President and Chief Operations Officer from 2006 to 2008, he is responsible for all aspects of the company’s U.S. generics business,includeing sales, marketing, supply chain, quality, finance, legal, IT, regulatory affairs, human resources and intellectual property. Under his guidance, Actavis Inc., which has sales of greater than $600 million and includes Actavis Inc., Actavis Elizabeth LLC, Actavis Totowa LLC, Actavis Mid-Atlantic LLC, Actavis SouthAtlantic LLC and Actavis Kadian® LLC, has launched more than 50 products and filed over 100 ANDAs.
Heather Bresch President, Mylan Inc.
Heather Bresch is president of Mylan, the third largest generics and specialty pharmaceutical company in the world. She is responsible for the day-to-day operations of the company, which sells products to customers in more than 140 countries and territories. Previously, Bresch was Mylan’s chief operating officer, responsible for the company’s global commercial and technical operations, strategic planning, business development and international affairs. Throughout her 18-year career with Mylan, Bresch has held various positions including head of North American operations and chief integration officer.
Patrick G. LePore Chairman, President and CEO Par Pharmaceutical Companies, Inc.
Mr. LePore has served as Chairman, President and Chief Executive Officer of Par Pharmaceutical Companies, Inc., the parent company of Strativa Pharmaceuticals, since September 2006. He has been a director of Par Pharmaceutical Companies, Inc. since May 2006 and was named Chairman of the Board in August 2007. From 2002 to 2005, Mr. LePore was President of the health care marketing group at Cardinal Health, Inc. From 1984 until 2002, he was with BLP Group Companies, ultimately as Chairman, President and Chief Executive Officer, which was sold to Cardinal Health in 2002. Mr. LePore earned a BA from Villanova University in 1977 and an M.B.A. from Farleigh Dickenson University in 1984.
William S. Marth President and CEO, Teva North America
William S. Marth is the President and Chief Executive Officer of Teva North America and leads the Teva USA organization. He served as President and Chief Executive Officer of Teva USA from 2005 to 2008. Prior to that, he held the role of Executive Vice President of Teva USA from 2002 to 2005. From 1999 to 2002, Mr. Marth served as Vice President of Sales and Marketing for Teva USA. Prior to joining Teva USA, he served in various positions with the Apothecon division of Bristol-Myers Squibb. Mr. Marth received his B.Sc. in Pharmacy from the University of Illinois in 1977 and his M.B.A. in 1989 from the Keller Graduate School of Management in Chicago. Mr. Marth serves on various boards and committees, including the executive committee of the Generic Pharmaceutical Association, where he serves as Chairman.
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PROGRAM SPEAKERS Moderator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ron Insana Senior Analyst, CNBC and Financial Industry Analyst
A financial journalist who stands alone among his peers in having the experience of working for and running his own hedge fund, Ron Insana offers clear, unvarnished insights on the ever-changing status of the economy. Currently senior analyst for CNBC, Insana has access to all of the top financial players in Washington and on Wall Street and translates the market signals and political maneuvers into information everyone understands. His hands-on experience in the financial industry—through some of the markets’ most turbulent times—give an added depth of perspective that few analysts can match. He offers practical advice on what individuals and businesses can and should do now to protect what they have and to find opportunities in any type of market condition.
Health-Care Reform and the Impact on Older Americans. . . . . . . . . . . . . . . . . . . . . . . . John Rother Executive Vice President of Policy and Strategy, AARP
John Rother is the Executive Vice President of Policy and Strategy for AARP. He is responsible for the federal and state public policies of the Association and for formulating AARP’s overall strategic direction. He is an authority on Medicare, managed care, long-term care, Social Security, pensions and the challenges facing the boomer generation. Prior to coming to AARP in 1984, Mr. Rother served eight years with the U.S. Senate as Special Counsel for Labor and Health to former Senator Jacob Javits (R-NY), then as Staff Director and Chief Counsel for the Special Committee on Aging under its Chairman, Senator John Heinz (R-PA).
Looking Back: First Year of the Administration Coming Up: Mid-term Elections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Paul Begala Political Analyst and Commentator, CNN
Former President Bill Clinton described his longtime friend and former aide Paul Begala as, “a witty dynamo from Sugar Land, Texas…who brought energy, focus and credibility to our efforts.” Secretary of State Hillary Clinton says Paul, “embodies a passion for populism with a commitment to civility, no easy feat.” Now a political analyst for CNN, Begala served as counselor to President Clinton in the White House, where he helped define and defend the administration’s agenda, from the State of the Union address to the economic, domestic and international issues the White House faced each day. With his then partner James Carville, he was a senior strategist for the Clinton-Gore Presidential Campaign in 1992, and has helped direct the political strategy of numerous other campaigns across the country and around the world, including advising politicians in Europe, Latin America, the Caribbean and Africa.
Health-Care Reform: What Are Its Prospects? . . . . . . . . . . . . . . . . . . . . . . Gail R. Wilensky, Ph.D. Senior Fellow, Project HOPE
Gail R. Wilensky, PhD is an economist and a senior fellow at Project HOPE, an international health education foundation. From 2008 to 2009, she was President of the Defense Health Board (DHB). From 2006 to 2008, she co-chaired the Department of Defense task force on the Future of Military Health Care. In 2007, she was a commissioner on the President’s Commission on the Care of Wounded Warriors (Dole/Shalala). Dr. Wilensky was a commissioner on the World Health Organization Commission on the Social Determinants of Health from 2005 to 2008. From 1990 to 1992, Dr. Wilensky was the administrator of the Health Care Financing Administration, directing the Medicare and Medicaid programs. From 1992 to 1993, she served as deputy assistant to President Bush for Policy Development. From 1997 to 2001, she chaired the Medicare Payment Advisory Commission, which advises Congress on payment and other issues relating to Medicare; and from 1995 to 1997, she chaired the Physician Payment Review Commission.
A View from Wall Street. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Randall Stanicky Vice President, Global Investment Research Goldman Sachs & Co.
Randall Stanicky, Vice President, is the generics and health-care supply chain research analyst at Goldman Sachs. He leads an eight-person team of professionals with overall responsibility for 28 stocks across the generic pharmaceutical, drug distribution, pharmacy benefit manager and broader health care services sectors. Prior to joining Goldman Sachs & Co. in 2001, he worked in equity research on the buy side at Citigroup Global Asset Management supporting the investment decisions across healthcare.
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PROGRAM SPEAKERS Keynote Address: FDA Perspectives and Priorities. . . . . . . . . . . . . . . . . . . . . . . . . . . . Margaret A. Hamburg, M.D. Commissioner of Food and Drug Administration
Margaret A. Hamburg, M.D., was confirmed on May 18, 2009 by a unanimous Senate voice vote to become the 21st Food and Drug Commissioner. The second woman to be nominated for that demanding position, Dr. Hamburg is exceptionally qualified for her new job by her training and experience as a medical doctor, scientist and public health executive. In 1994, Dr. Hamburg was elected to the membership in the Institute of Medicine, one of the youngest persons to be so honored. Three years later, at the request of President Clinton, she accepted the position of Assistant Secretary for Policy and Evaluation in the U.S. Department of Health and Human Services (HHS). In 2001, Dr. Hamburg became Vice President for Biological Programs at the Nuclear Threat Initiative, a foundation dedicated to reducing the threat to public safety from nuclear, chemical and biological weapons. In that position, she has advocated broad reforms in public health infrastructure and policy, from local health departments to the national agency, in order to meet the dangers of modern bioterrorism as well as the threats of naturally occurring infectious diseases such as pandemic flu.
Industry Business Trends. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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.
Fresh Perspectives on Economics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Stephen J. Dubner Journalist, Lecturer and Co-Author of “Freakonomics”
An award-winning author, journalist and TV personality, Stephen J. Dubner is the co-author of the international bestseller FREAKONOMICS and SUPERFREAKONOMICS. Published in the U.S. in 2005, FREAKONOMICS instantly became a cultural phenomenon. Hailed by critics and readers alike, it went on to spend more than two years on the New York Times bestseller list, having sold more than four million copies around the world, in more than 35 languages. Dubner and his co-author, the University of Chicago economist Steven Levitt, have appeared widely on television and maintain the popular FREAKONOMICS blog, which can be found on the New York Times web site.
Product Liability Panel Session. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . John R. Duff Director of Litigation, Actavis, Inc.
Responsible for the management of Actavis’ commercial litigation in the United States which includes product liability litigation, pricing/ Average Wholesale Price litigation, employment litigation and other general commercial litigation. In addition, John proactively counsels the business on litigation risk mitigation strategies. Prior to joining Actavis, John was a litigation associate at Mayer Brown LLP in New York where he worked on a variety of litigation matters including pharmaceutical, securities, insurance and bankruptcy related matters.
Michael Garofalo Director, Aon Life Sciences
Mike has 31 years of experience as an Underwriter and Broker with extensive experience in the primary products, professional and excess disciplines. That experience has focused over the past 18 years on pharmaceutical, biotechnology, generic pharmaceutical, medical device, clinical trial product and supplement liability classes of business. Mike is the director of the Life Science Practice Group for the Chicago office and is a national resource for other Aon offices throughout the United States. He has also been a Director for the Surplus Line Association of Illinois.
Jennifer Levy Partner, Kirkland & Ellis LLP.
Jennifer Levy is a litigation partner in the Washington, D.C. office. She has appeared before trial courts and arbitration panels across the country and internationally. Jenny has litigated a wide variety of cases, which have included allegations of fraud and misrepresentation, breach of contract, business torts, product liability, antitrust and class actions. Her practice has involved a diverse array of subject matters including Medicaid/ Medicare fraud, allegations of antitrust violations on behalf of a generic drug manufacturer and product liability cases on behalf of manufacturers of automotive products, lead products, tobacco and pharmaceuticals.
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BUSINESS EXPOSITION
DBA US #2 Introducing the Pharmaceutical Training and Consultancy Experts. Based in Boston, MA, our customized training is used by the pharmaceutical industry worldwide to comply with regulatory expectations and maximize the contribution of their staff at all levels. Delegates leave our courses better informed about the subject area, better aware of their role and impact upon product quality and/or regulatory compliance and better motivated to improve their contribution.
Symbio #3 Symbio is a full service CRO and Phase I Unit specializing in generics and topical dermatology.
Harvest Moon Pharmaceuticals #4 Harvest Moon Pharmaceuticals develops complex generics in transplantation, injectables, transdermals, oral controlled release and biosimilars and licenses-out these complex pharmaceuticals in the USA and in Europe. The products are developed in our laboratories and manufactured in our facilities located in the USA, Taiwan and Japan. bioRASI #5 bioRASI is a Full Service Global CRO uniquely focused on clinical endpoint ANDA and 505(b)(2) programs. This experience and expertise allow bioRASI to facilitate obtaining FDA approvals by delivering high quality regulatory and clinical strategies, solutions and services, while saving their clients critical time. Knobbe Martens Olson & Bear, LLP #6 Knobbe Martens Olson & Bear, LLP is a law firm specializing in intellectual property law and has been servicing clients in the generic pharmaceutical industry for over 10 years. The firm has litigated more than 40 cases under the Hatch-Waxman Act and has the experience and technical resources necessary to service all facets of the generic drug process. A.J. Renner & Associates / Chubb Custom #7 A. J. Renner & Associates was founded in 1985 as an independent insurance broker specializing in Pharmaceutical Product Liability Insurance.
Halo Pharma #8 Contract Pharmaceutical Development of a wide range of Dosage forms. Contract Commercial Manufacturing.
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BUSINESS EXPOSITION Beckloff Associates, a Cardinal Health Company #9 Founded in 1976, Beckloff Associates, Inc., a Cardinal Health Company, assists companies with worldwide development of pharmaceutical, biotechnology and medical device products through regulatory and product development planning, total program management, regulatory authority interaction, regulatory documentation preparation (DMFs, INDs, NDAs, 505(b)(2), CTDs, ANDAs), regulatory publishing (eCTD and paper) and compliance programs.
MedXview #10 The solution you’ve been looking for & a partner you can trust! MedXview Inc. has come to the forefront as the leading provider of Regulatory Publishing Solutions and Services for International Generic Manufacturers. Our Premier software solution, eCentralô, provides an all-inclusive and user-friendly environment for document management, data management and collaborative eSubmission Publishing. We ensure that our clients benefit from low cost solutions and services that are easily implemented, adopted and maintained. The Power to Understand!
Intagras, Inc. #11 Intagras, Inc. is a Life Sciences software and consulting company that specializes in pharmaceutical labeling and regulatory compliance. Our products and services assist brand and generic pharmaceutical companies comply with the FDA’s SPL guidance for listing and registration.
Medmarc and The Hartford #14 Medmarc and The Hartford provide insurance protection and risk management solutions for manufacturers and distributors of generic medications. Our goal is to support the delivery of products that save and improve the quality of lives by ensuring the long-term availability of insurance for companies that provide these products.
Algorithme Pharma #15 As a worldwide leader in clinical research and bioanalysis, Algorithme Pharma provides a wide range of services in bioequivalence and early stage development (Phase I/IIa) studies to the pharmaceutical and biotechnology industries. Algorithme Pharma’s main success resides in the flexibility and commitment of its more than 600 dedicated and knowledgeable employees to deliver first-class service to each client.
Duane Morris #16 Duane Morris LLP, a full-service law firm of more than 750 attorneys, has a dedicated team of attorneys that represent global generic pharmaceutical companies in their quest to enter the U.S. market with new products. Our significant technical depth and ANDA litigation experience uniquely positions us to help clients find superior solutions to the industry’s legal and business challenges. For more information on the Generic Pharmaceutical and Intellectual Property groups, please contact Lew Gould at LFGould@duanemorris.com or 215.979.1282.
Thomson Reuters #17 Intelligent information to better manage the cost and quality of health-care and accelerate scientific research and innovation.
U.S. Pharmacist #18 U.S. Pharmacist is a monthly journal dedicated to providing the nation’s pharmacists with up-to-date, authoritative, peer-reviewed clinical articles relevant to contemporary pharmacy practice in a variety of settings, including community pharmacy, hospitals, managed care systems, ambulatory care clinics, home care organizations, long-term care facilities, industry and academia.
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BUSINESS EXPOSITION Ropack Inc. #19 Ropack offers turnkey primary and secondary pharmaceutical packaging services of solid oral dosages, tablets, powder, and encapsulation into blisters, pouches, bottles, and carded blisters. Our facilities are cGMP compliant and FDA certified. Ropack is competitive and flexible, supporting clinical trials, short run start-ups, commercial production and warehousing and distribution services.
Penn Bottle and Supply Company #22 Celebrating 90 years, Penn Bottle is the provider of ‘total packaging solutions’, plastic and glass containers and closures for your rigid packaging needs. Headquartered in Philadelphia, PA, and with four locations along the Eastern and Mid-Atlantic US, to provide many items from our inventory.
Aizant Drug Research Solutions (P) Ltd. #23 Integrated Drug Development Solutions.
Lexington Insurance Company #24 Lexington HealthcareSM provides reliable insurance protection and support services, including a comprehensive set of patient safety tools and incentives, to the health care industry.
Generics bulletin #25 Generics bulletin is the global generic industry’s essential source of news and views on product launches, company deals, regulatory changes and patent pricing and reimbursement issues. Two formats: a weekly electronic newsflash and a twice-monthly paper publication provide both immediacy and depth from a generics industry perspective. For further information please visit www.generics-bulletin.com or contact Val Davis at val. davis@generics-bulletin.com or call +44 (0)1564 777550.
GenericsWeb #26 GenericsWeb is a global patent intelligence provider completely dedicated to the generic pharmaceutical industry. GenericsWeb provides superior patent intelligence products through an intimate knowledge of Patent Searching, Legal and Regulatory affairs and In formation Science in the context of the generic pharmaceutical industry.
APCER PHARMA Solutions, Inc. #27 APCER PHARMA provides generic pharma companies cost effective safety & regulatory services. We know Compliance Matters ! We provide regulatory submission capabilities, complete safety & med-info case processing (24x7), e-submission and hosted solutions.
Nisaba Pharmaceutical Licensing #28 Compliance with state licensing requirements for manufacturers, distributors and wholesalers of pharmaceutical products is a big job. The requirements from state to state vary and the paperwork can be overwhelming. Consider Nisaba Licensing as your outsourcing solution for managing licensing and renewals.
Rexam #29 Rexam is the global leader in development, manufacturing, and supply of health-care plastic drug delivery solutions. Rexam’s global footprint allows us to produce a wide range of plastic products, from rigid plastic packaging to high precision, multi-component, complex drug delivery devices.
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BUSINESS EXPOSITION DDN #30 DDN has become the largest privately held provider of outsourced services to the life science industry by streamlining processes, reducing costs and improving efficiencies for emerging, mid-tier and market leading life science companies. By providing superior business processes and operations DDN frees manufacturers’ resources for R&D, acquisitions, and other core initiatives.
Healthcare Packaging Group / O.BERK Company #31 O.BERK Company Healthcare Packaging Group is a supplier of primary packaging components to the pharmaceutical industry. With 100 years of supplying packaging components, O. Berk company had developed the experience to provide guidance and service in every aspect of pharmaceutical packaging.
Aon Risk Services #32 Aon Corporation is the leading global provider of risk management services, insurance and reinsurance brokerage, human capital and management consulting. Aon’s Life Sciences Practice brings industryspecific solutions to generic manufacturer and distributors and a wide range of other pharmaceutical and life sciences companies Internationally, including ( i ) the intellectual property insurance product designed specifically for generic manufacturers to cover patent infringement liabilities associated with P4 “at-risk” launches under Hatch-Waxman, (ii) Product Liability and all Collateral Lines and International Clinical Trial / Bioequivilant Study coverages, and (iii) how to remove or “ring fence” risks in an M&A situation or technology transfer agreement.
Atlanta Center for Medical Research #33 ACMR is a dedicated 64 bed research facility, a full service provider that conducts bioequivalence / bioavailability clinical trials. We deliver timely and accurate results that ultimately meet the goals of our Sponsors.
PUBLICATION PARTNERS Be sure to visit the media table featuring publications from our media partners.
“The Pink Sheet”
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MEETING MAPS 1. 2. 3. 3. 2. 4. 5. 6.
Registration Technical Advisory Committee Government Affairs/ Policy Committee Small to Midsize Company Meeting Board of Directors Meeting Welcome Reception Breakfast Plenary Session
2/16 – 2/18 2/16 2/16 2/16 2/16 2/16 2/17 – 2/18 2/17 – 2/18
Main Ballroom Foyer Artisans Beach House Beach House Artisans Poolside Main Ballroom Vanderbilt Ballroom
3 2 8
7
5. 7. 5. 8. 8. 4.
Business Exposition & Networking Luncheon & Presentation Annual Meeting Expo Reception Beach Reception Southern Beach Barbeque Farewell Reception
5 1
2/17 – 2/18 2/17 2/17 2/17 2/17 2/18
Main Ballroom Center Court Main Ballroom North Beach North Beach Poolside
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SPECIAL EVENTS & ACTIVITIES As a part of the 2010 Annual Meeting, GPhA is proud to once again present a host of exciting special events, activities and professional networking opportunities. Registration for our Annual Meeting includes attendance at all of our social events, including the Southern Barbecue Buffet and Party on Wednesday, February 17. Registration also includes the Welcome Reception, Business Expo Reception, two breakfast buffets, our annual luncheon, meeting breaks and the annual Farewell Reception on Thursday evening. In addition, we offer several half-day activities on Thursday afternoon at the conclusion of our plenary session. Registration for these off-site events, including the golf tournament, fishing excursion and paddle tour, closes at 12:00 p.m. on Wednesday, February 17. Space is limited. NOTE: Please remember to carry your conference name badge with you at all times for admission into all Annual Meeting activities and events. You will receive your name badge upon check-in at GPhA’s registration desk.
Tuesday, February 16 Welcome Reception 7:00 p.m. We kick off our Annual Meeting with our Welcome Reception held at the hotel pool area. Prior to 6:30 p.m., please check in with the GPhA registration desk to pick up your name badge and other registration materials. For those arriving after 7:00 p.m., name badges are available at the entrance to the reception. Welcome packets and all other registration materials are available at the GPhA registration desk the following morning. Dress for the reception is resort casual.
Wednesday, February 17 Spouse / Guest Activity 9:00 a.m. This year’s Spouse/Guest activity is a tour of the Edison & Ford Winter Estates in neighboring Fort Myers. A tour guide takes you through the 20-acre estate which encompasses the homes, gardens and inventions of Thomas Edison and Henry Ford, two of the most productive and successful businessmen in American history. Participants on this tour learn about the lives and endeavors of these two neighbors and friends. The tour includes Edison’s botanical garden containing more than 500 varieties of plants imported from all over the world. Lunch and transportation are provided. Business Expo Reception 3:00 p.m. Immediately following the plenary session, meet your colleagues at the Expo Reception in the main ballroom. This lively reception includes music, beverages and light snacks along with a raffle with great prizes. Those entering the raffle must be present to win. Good luck! Southern Barbecue Buffet and Party 5:30 p.m. Networking Reception 6:30 p.m. Buffet Dinner and Entertainment Please join us as the sun sets on the Gulf of Mexico at our reception and Southern Barbecue Buffet and Party on Naples Beach.* By popular request, our annual gala has “gone casual” this year, to enhance the networking experience. Join your colleagues on the hotel’s beachfront property. A live dance band has been arranged for the event. Our beach party ends at 9:00 p.m., but restaurant and lounge times have been extended in the hotel to accommodate our group throughout the evening. *Weather backup location information provided as needed.
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SPECIAL EVENTS & ACTIVITIES Thursday, February 18 GPhA Annual Golf Tournament 12:30 p.m. Tee-off with industry colleagues on the beautiful Tiburon Golf Course. The golf course is just 10 minutes from the event hotel at the neighboring Ritz-Carlton Golf Resort. Please arrive at the beach resort lobby promptly at 12:20 p.m. for departure via the shuttle service. Tee off is at 1:00 p.m. Advance notice on pairing preferences is preferred. Last-minute pairing requests are handled on site by the golf pro. Of the two, championship 18-hole courses – Tiburon Gold and Tiburon Black – we are playing the Gold course. This offers a new experience for our returning golfers who played the Tiburon Black course in 2009. Fishing Excursion in the Gulf of Mexico 12:30 p.m. Our fishing excursion takes our attendees 5 – 10 miles offshore into the Gulf of Mexico aboard 30’ to 35’ charter boats for snapper, grouper and barracuda. This year’s fishing event is for small groups of up to four people. Please arrive no later than 12:15 p.m. to the hotel lobby for shuttle departure. All boats are fully equipped with state-of-the-art fish finders and creature comforts for a day on the water. Lunch and beverages are included. Fishing excursion tips: Cover-ups, cameras and sunscreen recommended. Tropical Bird Watch and Paddle Tour 1:00 p.m. Participants kayak serenely past mangroves and bird rookeries while a naturalist guide explains the fascinating ecology of the Everglades on this paddle tour. Birds are active at all seasons and you can expect to see osprey, ibis and a variety of egrets, and perhaps wild dolphin, manatees and other wildlife that inhabits the region. Your guide is a trained naturalist and certified kayak instructor. This two-hour tour is 30 minutes from the event hotel. Transportation and a boxed lunch are provided. Paddle Tour tips: Comfortable clothing and insect repellent recommended.
ANNUAL MEETING
See the photo key on the last page of the event program.
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Photos from page 27 Top left to right: GPhA 25th Anniversary Welcome Reception; Gary Buehler, Director, Office of Generic Drugs, FDA; GPhA’s 25th Anniversary Celebration; Annual Meeting Golf Tournament; Uwe Reinhardt, Ph.D., Professor of Economics, Princeton University, Christine Mundkur, President and CEO, Sandoz Inc.; Annual Meeting 2009 Business Exposition; Paul Bisaro, President and CEO, Watson Pharmaceuticals, Inc.; Robert Coury, Vice Chairman and CEO, Mylan Inc.; Daniel Movens, CEO and Director, Caraco Pharmaceutical Laboratories, Inc.; Bruce Downey, Former Chairman and CEO, Barr Pharmaceuticals, Inc.
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