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Keynotes
Disruptive Drug Development: Driving the Necessary Innovation and Change to Pioneer the Next Frontier
Craig Venter, Founder Celera Genomics, The Institute for Genomic Research, J.Craig Venter Institute
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J. Craig Venter, Ph.D., is regarded as one of the leading scientists of the 21st century for his numerous invaluable contributions to genomic research. He is Founder, Chairman, and President of the J. Craig Venter Institute (JCVI), a not-for-profit, research organization dedicated to genomic research and the exploration of social and ethical issues in genomics. Dr. Venter is also Founder and CEO of Synthetic Genomics Inc., a privately held company dedicated to commercializing genomic-driven solutions to address global needs such as new sources of energy and next generation vaccines. Dr. Venter and his team at the Venter Institute continue to blaze new trails in genomics. He is also one of the most frequently cited scientists, is the author of more than 250 research articles
Changing Your Game – How Clinical Executives Can Succeed in the New Leaner Life Science Industry by Increasing Global Competitiveness and Driving Revenue and Profit Growth with Innovation
Ram Charan, Author, The Game-Changer: How You Can Drive Revenue and Profit Growth with Innovation Execution
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Dr. Ram Charan is a highly sought after business advisor famous among senior executives for his uncanny ability to solve their toughest business problems. For more than thirty-five years, Dr. Charan has worked behind the scenes with top executives at some of the world's most successful companies, including GE, Verizon, Novartis, Dupont, Thomson Corporation, Honeywell, KLM, Bank of America, and MeadWestvaco.
Crowdsourcing Clinical Development and Medical Innovation
James Suroweiki , Columnist for The New Yorker, Author, The Wisdom of Crowds
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James Surowiecki is the foremost authority on how to harness the collective wisdom of your organization for competitive advantage. He has written a well-received book on the theory and practice of The Wisdom of Crowds—Why The Many Are Smarter Than The Few And How Collective Wisdom Shapes Business, Economies, Societies And Nations. In The Wisdom of Crowds, Jim describes systematic ways to organize and aggregate the intelligence available in your organization in order to arrive at superior decisions—often better than those that individuals would make, even if they are 'experts'. The book and Jim's presentations based on the book are full of insights into how groups operate that are invaluable to business leaders. He also offers practical methods, tailored to his audience, for leveraging people and technology to learn what you need to know and make decisions that really serve the organization's goals. Jim writes a twice-monthly financial column for The New Yorker that is typically pegged to current events and incorporates the kind of insights from economics, sociology, and business history
Capture and Navigate New Markets – Reset your Compass for Business Transformation by Profitably Tackling the Challenge of Entering New Markets, Wherever They Are
Steve Wunker, Author, Capturing New Markets
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In addition to his entrepreneurial and corporate venturing experience, Steve was a long-term colleague of the leading innovation authority Harvard Business School Professor Clayton Christensen in building up his consulting practice, Innosight. Steve has co-written two articles with him and helped to put together his most recent book, The Innovator's Prescription. Since 2009,Wunker has led New Markets Advisors, which is dedicated to helping companies find, enter, and win in new markets. Before his entrepreneurial career, Steve was a strategy consultant at Bain and Company. Additionally, he worked at the United Nations to finance alternative energy and energy efficiency projects in emerging markets and lived around the global, including the US, UK, Netherlands, Japan, Ecuador, and Zambia.
Women Leading Change with Impact
Moira Forbes, Vice President and Publisher, ForbesWoman
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Moira Forbes is Vice President and Publisher, ForbesWoman and Associate Publisher, ForbesLife magazine. She is also the host of Success with Moira Forbes, a weekly video series featuring candid, one-on-one interviews with today's top women leaders. ForbesWoman is a multi-media platform serving successful women in business and leadership. This effort, launched by Forbes Media in 2008, includes a robust website, a digital community and a variety of content-rich live forums and events. Across these diverse media, ForbesWoman examines the unique experiences of professionally successful women, affirms their ambitions and achievements, and sets the agenda for purposeful discourse on the topics that matter most to them.
Beating the Odds – Not Only Living with Cystic Fibrosis – Rocking It
Emily Schaller, CF Patient, Clinical Trial Participant, Marathon Runner and Founder Rock CF Foundation
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Take one look at this native Detroiter and it's plain to see. Emily Schaller does not take guff. Equal parts spark and wit, Emily is claiming her victories against cystic fibrosis having launched Rock CF Foundation in summer of 2007. Today Emily's battle against this deadly genetic disease is printed in magazines and posted on websites, her greatest victories being raising $250,000 for cystic fibrosis research. She is a super teacher and a speaker. Emily teaches parents, patients and audiences in the CF world about the effects of cystic fibrosis and improvements being made to the treatments. She is a super athlete. Emily has ran over 1,000 miles, 6 half marathons and biked over 3,500 to keep healthy and raise funds for Rock CF. She is a super musician. Schaller organizes and rocks out at rock 'n roll CF benefit concerts.
"I am inspired and motivated to keep plugging away because I know for a fact that the money we raise is indeed helping to improve the lives of cystic fibrosis patients."
Mr. Zummo is Co-Head of J.P. Morgan Alternative Asset Management and Chief Investment Officer. He is head of the Portfolio Management Group and a member of the JPMAAM Investment Committee. Mr. Zummo co-founded JPMAAM in 1994. Prior to that, Mr. Zummo served as the manager of retirement plan investments for the Interpublic Group of Companies from 1992 to 1994, where he was responsible for analysis, asset allocation and manager selection. From 1990 to 1992 he worked at the former Chase organization as an investment analyst and consultant for institutional clients of the Chase Consulting Group. Mr. Zummo received a B.S. from the State University of New York at Albany and an M.B.A. from New York University. He holds the Chartered Financial Analyst (CFA) designation and is a member of the CFA Institute.
Deirdre Bevard, Vice President, Development Operations, Endo Pharmaceuticals View bio
Deirdre BeVard is Vice President, Development Operations at Endo Pharmaceuticals. In this capacity she is responsible for the operational execution of clinical development of Endo's pipeline. This includes the clinical trial management, data management, clinical outsourcing and clinical quality control for study execution in support of Endo's key therapeutic areas. Endo utilizes a semi-virtual model for clinical development which retains key design, decision and oversight responsibilities while leveraging external partners to accommodate scalability, allowing the organization to continuously drive toward operational excellence. Deirdre is also actively involved in the business development activities that support the strategic therapeutic diversity of the organization through collaborative business partner relationships.
Prior to joining Endo, Deirdre was Vice President, Clinical Services at ClearTrial, where she was responsible for the clinical services function supporting clinical trial operations planning and forecasting for client companies. Previous to that Deirdre developed a clinical site network as the Executive Director, Clinical Research for the Physician Alliance for Clinical Research (PACR).
Deirdre was also Senior Director, Clinical Operations at Otsuka Pharmaceutical where she was responsible for global clinical trial operations, business process development and training, and clinical outsourcing. During her career at Otsuka she also had responsibility for other functions including Investigational Materials, Document Management and Meeting Planning. She has worked for a leading CRO, where she developed the company's first regional monitoring network, was responsible for project resource allocation, and the management, training and development of project staff in the US and Europe.
Deirdre is a recipient of the 2010 HBA Rising Star Award and was selected as part of Endo's Accelerated Leadership Development Program. She has served on the Advisory Board for the IIR Partnerships Conference since 2006, was a member of the 2011 DIA Annual Meeting Program Committee, serves on advisory boards for other industry initiatives, and presents in multiple public courses and conferences in clinical development.
John Hubbard, SVP, Worldwide Head Development Operations, PFIZER INC
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Summit & Track Chairs
Christina Bodurow, PhD, Senior Director, External Sourcing, Development Center of Excellence Eli Lilly
Craig Lipset, Head of Clinical Innovation, Pfizer Inc.
Deirdre Bevard, Vice President, Development Operations, Endo Pharmaceuticals
Jeff Nau, MMS, VP, Medical & Clinical Affairs, NeoVista Incorporated
Joe Popowicz, Director, Clinical Operations, Stryker John W. Hubbard, Senior Vice President, Worldwide
Head Development Operations, Pfizer Inc.
Jorge Guerra, Senior Vice President, Global Clinical Operations, Biogen Idec
Joseph Kim, Director, Clinical Operations, Shire Pharmaceuticals
Megan Weaver, Director of Global Clinical Operations, Biogen Idec.
Ross Horsburgh, VP & Head of Clinical Development Asia Pacific Nycomed
Mariette Boerstoel-Streefland, VP for Global Drug Safety, Forest Research Institute
Meredith Smith, Senior Scientific Director – Risk Management, Abbott Labs
Mitchell Katz, PhD, Executive Director, Medical Research Operations, Purdue Pharma Steve Whittaker, President and Independent
Consultant, PharmaPM Consulting, LLC
Pharma/Biotech/Medical Device Speakers
Anne Harcarik, Director Clinical Operations, C.R. Bard
Ann Wang, Vice President, Clinical Operations & Data Management, Human Genome Sciences, Inc.
Bernard Munos, Chief Apostle, breakthrough innovation, InnoThink Center for Research in Biomedical Innovation
Brenda Crowe, PhD, Research Advisor, Global Statistical Studies, Eli Lilly
Bryant Wales, Vice President, Strategic Sourcing, ImClone Systems
Carol Lewis-Cullinan, BC, FNP, Senior Director, Clinical Operations, AMAG Pharmaceuticals Inc.
Chris Davis, Director, Global Strategic Sourcing, Eli Lilly Craig Coffman, Sr. Director, Clinical
Business Operations & Outsourcing, Endo Pharmaceuticals
Christina S. DiArcangelo, Chief Executive Officer, Armonia Clinical Research, LLC
Cristina Damatarca, MD, Senior Safety Science Leader, GENENTECH-ROCHE
Daniel Jacob, Medical Director – Global
Pharmacovigilance, Baxter Healthcare
David S. Reasner, Senior Vice President, Data Science - North America, Sunovion Pharmaceuticals Inc.
David Tripi, Head of Healthcare Innovation, Janssen
Donna Jarlenski, Head of Clinical Operations, Momenta Pharmaceuticals Donna Jarlenski, Head of Clinical Operations, Momenta Pharmaceuticals
Ed Campanaro, Vice President of Clinical Operations, Cubist Pharmaceuticals, Inc.
Frances Grote, Senior Director, Clinical Outsourcing Millennium
Graeme Currie, Head, Clinical Project Management and Operations, Regeneron Pharmaceuticals Graeme Currie, Head, Clinical Project Management and
Operations, Regeneron Pharmaceuticals
Hakan Sakul, Executive Director & Head of Diagnostics, Pfizer
Ira Spector, Senior Vice President Global Development
Operations, Allergan Inc. Janelle Sabo, PharmD, RPh, CA-AM, Sr. Director, Global Clinical Trials Materials Services, Eli Lilly
James Cai, VP of Clinical Development, aTyr Pharma
Jessica Lee, MPH, Senior Director Clinical Development, Inovio Pharmaceuticals Inc.
Jill Robinson, Senior VP for Global Patient Safety and Risk Management, Genzyme
Johann Proeve Head Global Data Management Bayer Vital GmbH, Germany
John L. LaMattina, PhD, Former President, Pfizer Global Research and Development and Senior Vice President, Pfizer Inc., Senior Partner Puretech Ventures John Lewis, Vice President of Public Affairs, Association of Clinical Research Organizations
Justin Zamirowski, Director of Project Management, Otsuka Pharmaceuticals
Kamal Shah, Head of Global Trials Safety Surveillance, Celgene
Karen Brennan, Vice President, Clinical Development Operations, Millennium Pharmaceuticals
Kenneth G. Olovich, R.Ph, MBA, Chief Procurement and Financial Officer Chorus
Kevin Fain, Associate Chief Counsel for Drugs, former FDA
Ron Corey, PhD, MBA, Vice President, Clinical and Project Management Asubio Pharmaceuticals, Inc.
Lauren Goldsmith, Senior Manager, Purchasing & Strategic Outsourcing, MannKind Corporation Larry Blankstein PhD, Senior Director Clinical
Development, Genzyme Corporation
Lauren Meyers, Global Alliance Director, Genentech
Lee Shieble, Strategic Sourcing Consultant, Eli Lilly
Mario R. Ehlers, MD, PhD, Deputy Director, Clinical Trials Group, Immune Tolerance Network
Mark Milberg, Senior Contract Manager, Clinical Contracting, Medtronic
Mark Travers, PhD, VP, RCSM America, Regional Global Clinical Operations, Sanofi-Aventis
Mary Rose Keller, Vice President Clinical Development and Operations, Sangart Matthew Emmens, Chairman and CEO, Vertex Pharmaceuticals
Melanie Goodwin, Global Trial Optimization, Manager, Merck
Michael Cox, Senior Manager, Outsourcing, MedImmune
Miguel Orri MD, Senior Director, Pfizer Pharmaceuticals
Nancy Widener, Executive Director, Clinical Science and Operations, Bristol-Myers Squibb
Nina Spiller, Sr. Director, Global Clinical Development, OPDC, Otsuka Pharmaceuticals
Peter Aurup, Senior Vice President, Global Research, Merck
Peter de Veene, MD, European Qualified Person for Pharmacovigilance, Roche
Peter Dibiaso, Senior Director Clinical Planning & Performance, Vertex Pharmaceuticals
Ratan Ratnesh, Associate Director - Strategic Sourcing, Novartis
Rehbar Tayyabkhan, Executive Director, Global Clinical Development, Bristol-Myers Squibb
Rebecca Noel, Dr, PH, Research Scientist, Global Patient Safety, Eli Lilly
Rene Sluijter, Global Head Outsourcing, Abbott
Robert Walsh, MD, MBA, Senior Medical Director, Boston Scientific
Scott Sawicki, Director, Clinical Contracting & Category Management, Novartis
Stephen Porter, CEO, VDDI Pharmaceuticals
Soloman Babani, Vice President, Alliance Management at Celtic Pharma & Celtic
Therapeutics
Songlin Xue, MD, PhD, Senior VP and Global Head of Pharmacovigilance, Takeda Pharmaceuticals International
Stafford O’Kelly, President, Abbott Molecular
Susan Gould, Senior Director, Clinical and Medical Affairs, Baxter Healthcare
Theresa Musser, Vice President, Development Operations, Rigel Pharmaceuticals
Todd Rich, SVP Development Innovation, Genentech (Roche)
Zili Li, Head of Emerging Market Regulatory Strategy, Merck
Academics and Sites
Adam Larabee, Director, Rochester Clinical Research Center
Charles Weinbar, Participant Recruitment Services Program Manager, UCSF and Participant, MS Clinical Trials
Jeffrey Rosen, Medical Director, Clinical Research of South Florida
Mitchell D Efros MD, Principal Investigator, Acumed Research Associates
Nariman Nasser, Director, Participant Recruitment Service, UCSF
Prof. Stan Kachnowski, Chair, HIT Lab, PI,
CUMC, Fellow, ROYAL SOCIETY OF MEDICINE
Other Industry Experts
Amy Tenderich, Founder, DiabetesMine
David H. Windley, CFA, CPA Managing Director - Healthcare Equity Research, Jefferies & Company, Inc.
David S Zuckerman, President, Customized Improvement Strategies LLC
Eric Coldwell, Managing Director at Robert W. Baird & Co.
Felix Frueh, President, Medco Research Institute, Medco Health Solutions
Guy Mascaro, President, Metrics Champion Consortium
Jonathan Leff, Managing Director, Warburg Pincus LLC
Linda Sullivan, VP Operations, Metrics Champion Consortium
Lisa McKay, Executive Director, Relationship and Project Management, The Avoca Group(Moderator)
Michael A. Martorelli, CFA, Managin Director Fairmount Partners
Patricia Leuchten, President and Founder, The Avoca Group
Seth Ginsburg, President, Global Health Living Foundation
Tony Coelho, Chairman, Partnership to Improve Patient Care
CROs and Other Outsourcing Providers
Allison Holland, Senior Director Alliance Management, Covance
Dan Perlman, CEO & Chairman, RPS
Debra Marshall, Vice President, Clinical Programs and Site Monitoring, RPS
Jeff McMullen, CEO, PharmaNet
Harris Koffer, PharmD, President & COO, RPS
Jeff Cohen, CEO, HRP Consulting
Kai Peters, Partner, Gordon & Rees LLP
Kimberly Glen, Vice President, Strategic Programs, ICON Clinical Research
Nagaraja Srivatsan, SVP and Head of Life Sciences, North America, Cognizant Technology Solutions
Suzanne Collins, Director of Operations, Trifecta Multimedical
Weihong Hsing, Patent Attorney, Panitch Schwarze Belisario & Nadel LLP
Julie Ross, Senior Vice President, Global Strategic
Services, PharmaNet/i3
William Sharbaugh, Chief Operating Officer, PPD, INC.
Michael O’Brien, President & CEO, BEARDSWORTH CONSULTING GROUP, INC.
Shantal Feltham, President and CEO, STIRIS RESEARCH INC.
Larry Poli, Vice President, Business & Product
Development, TTC. LLC
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