Online Documentation
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General Session |
| Break From the Pack–and How to Compete in a Copycat Economy Oren Harari, PhD, Business Visionary, Best-selling Author, Renowned Academician, Professor, Graduate School of Business, UNIVERSITY OF SAN FRANCISCO |
Track A |
| Scope of Work and Change Orders: Getting it Right the First Time Panelists: Marisa F. Bower, CCOG Manager, Vendor Outsourcing Division, WYETH RESEARCH Helen Chavez, Clinical Outsourcing Manager, GENENTECH Mark Harvill, President and Chief Operating Officer, PARAGON BIOMEDICAL |
| Understanding and Streamlining the RFP Panelists: Mark Sanders, Director, Site Lead - Contracts & Outsourcing, PFIZER Christina S. DiArcangelo, Associate Director, Clinical Contracts and Outsourcing, FIBROGEN Tiffany Sizemore Cherry, JD, MBA, Chief Executive Officer, KONTRAX CONSULTING, LLC Mike Minor, Vice President, Proposals and Business Information, ICON CLINICAL RESEARCH |
| Becoming a CRO Partner of Choice: Preferred: Providers and What to Do When You're Not on "The List" Moderator: Mandi Walters, Senior Director, Business Development, PHARMANET Panelists: Robert P. Stevens, MBA, Associate Director, US Medical Outsourcing, US Clinical Development, NOVARTIS PHARMACEUTICALS CORPORATION Solomon Babani, Director, Outsourcing and Vendor Management, CELTIC PHARMA DEVELOPMENT SERVICES Cynthia Russeau, Assistant Director, Strategic Outsourcing, Global Pharmaceutical R&D, ABBOTT LABORATORIES |
| Making the Most of Your Functional Service Provider (FSP) Relationships – An Emerging Trend in Outsourcing John Covin, Head, Global Grants and Contracts, GLAXOSMITHKLINE Terri Ellis, Executive Director, Contracts, Grants and Administration, CHILTERN |
| The Collaboration of Procurement & Clinical Outsourcing to Develop and Maintain Good Supplier Relations Moderator: Vanessa Cooke, Global Head of External Supplier Management, BAYER PLC Panelists: Fredrick L. Naids, PhD, Senior Strategic Sourcing Director, Clinical R&D, SHIRE PHARMACEUTICALS Samuel L. Dowell, MBA, CPM, Senior Director of Development Procurement, PFIZER Jay Joyce, Associate Director, R&D Services Governance, PROCTER & GAMBLE PHARMACEUTICALS |
| Standardization: The Holy Grail? Moderator: Mac McElroy, M.Ed., Vice President, Corporate Development, CHILTERN Panelists: Douglas Peddicord, PhD, Executive Director, ASSOCIATION OF CLINICAL RESEARCH ORGANIZATIONS (ACRO) Deirdre BeVard, Senior Director, Clinical Services, CLEARTRIAL, Formerly Sr. Director, Clinical Ops, OTSUKA Redge Santos, RN, BSN, MBA, Operations Project Leader, Pharma Development Operations Leadership, HOFFMAN-LA ROCHE INC Shannon Brome-Ward, MPH, Head of Global Strategic Sourcing Consumer Healthcare Development, BAYER HEALTHCARE PHARMACEUTICALS |
Track B |
| Wall Street's Forecast and Analysis of Outsourcing Trends: How is Pharma Doing? Moderator: John Kreger, Equity Research Analyst, WILLIAM BLAIR & COMPANY Panelists: David H. Windley, CFA, CPA, Managing Director, Healthcare Equity Research, JEFFRIES & COMPANY Eric W. Coldwell, Director & Senior Research Analyst, Healthcare Distribution & Services, ROBERT W. BAIRD & COMPANY Derek Gustafson, Senior VP Corporate Finance Division, MACQUARIE SECURITIES (USA) INC. |
| Defining and Measuring the Value Achieved through Outsourcing & Offshoring KEYNOTE: Arie Y. Lewin, PhD, Professor of Business Administration and Sociology, FUQUA SCHOOL OF BUSINESS, DUKE UNIVERSITY; Director of the Center for International Business Education and Research (CIBER) Panelists: Daniel M. Perlman, CEO and Chairman of the Board, RPS, INC Steven Whittaker, Director of Operations and Project Management, CV/Acute Care Platform Team, ELI LILLY& COMPANY |
| Determining Core Competencies and Adapting to the Right Sourcing Model for Your Organization Moderator: Jay Turpen, Director, Medical Sourcing, ELI LILLY& COMPANY Panelists: Frances Grote, Director of Global Development, Strategic Sourcing, BRISTOL-MYERS SQUIBB John Kurtz, Senior Director, Clinical Services Outsourcing, JOHNSON & JOHNSON Edwina Wyatt-Knowles, Senior Director, Clinical Operations, CEPHALON, INC |
| Outsourcing Strategies for Virtual Organizations Moderator: Allan M. Cohen, Director, Legal Services, CELTIC PHARMA DEVELOPMENT SERVICES Panelists: David Reasner, Senior Vice President, Clinical Operations and Data Analysis, SEPRACOR Solomon Babani, Director, Outsourcing and Vendor Management, CELTIC PHARMA DEVELOPMENT SERVICES Patrick S.G. Lindsay, Executive Vice President and General Manager, Strategic Clinical Solutions, UNITED BIOSOURCE CORPORATION Michael O'Brien, President & CEO, BEARDSWORTH® |
| Sourcing Strategies for Successful Portfolio Management Moderator: Samir Shah, Vice President, Strategic Development, RPS, INC Panelists: Kevin Skare, Senior Director, Global Clinical Operations, PROCTER & GAMBLE PHARMACEUTICALS Fredrick L. Naids, PhD, Senior Strategic Sourcing Director, Clinical R&D, SHIRE PHARMACEUTICALS |
| Supporting the Sourcing Model – The Case for Change in Development Operations Lynne Germsheid, Director, Clinical Development IT, MERCK & COMPANY |
Track C |
| Partnerships with Investigators: Implementing an Effective Site Development Program to Improve Site Performance, Productivity, and Satisfaction Moderator: Kyle Given, Executive Director, Clinical Programs, RPS Panelists: Ernesto Aycardi, MD, Senior Director, Global Clinical Research Operations, Global Medical Organization, MERCK & COMPANY Jennifer Hofecker, Regulatory Coordinator, NEVADA CANCER INSTITUTE Deidra Poucher, Independent Consultant, D. POUCHER CONSULTING |
| Resource Relationship Management: Instilling Loyalty and Longevity in Clinical Teams Shelby Morgan, Project Manager, Clinical Operations, CHILTERN Kathleen Billman, Director, Scientific Affairs, ALIMERA SCIENCES, INC |
| Successfully Partnering with CROs to Ensure that Clinical Success Results in Commercial Success Luis Gutierrez, President, Commercialization, COVANCE Gergana Zlateva, Director, Global Outcomes Research, PFIZER Martin Zagari, Executive Director, Global Health Economics, AMGEN |
| Explore Both Sides of the CRO - Pharmaceutical Partnership to Build a Strong Unified Project Team Moderator: Patricia Leuchten, President and CEO, THE AVOCA GROUP Panelists: Michael Brooks, Executive Director, Project Management, Hematology/Oncology, PPD, INC Christopher Logel, Associate Director, Contracts & Outsourcing, PFIZER Wayne Alves, PhD, Senior Director, Corporate Project Management, CADENCE PHARMACEUTICALS Patricia A. Mosher, Executive Director, Infectious Disease Division, PHARMANET |
| Establish Building Blocks Toward a Successful Partnership James Trammel, Principal Biostatistician, i3 Scott Patterson, PhD, Senior Director of Statistical Science, Vaccines and Infectious Disease, WYETH RESEARCH & DEVELOPMENT |
| Hurry, Hurry....Wait: How CROs Can Manage the Changing Environment within Sponsor Companies Panelists: Anthony J. Santicerma, Director of Strategic Alliance and Global Marketing, QUEST DIAGNOSTICS CLINICAL TRIALS Ariette Van Strien, VP, Sales, Contracts and Marketing, MDS PHARMA SERVICES Patrick S.G. Lindsay, Executive Vice President and General Manager, Strategic Clinical Solutions, UNITED BIOSOURCE CORPORATION |
Track D |
| Strategies and Technology for Streamlining and Expediting Data Collection and Reporting Moderator: David W. Hanaman, Chief Sales & Marketing Officer, Co-Founder, C3I, INC. Panelists: Alistair Macdonald, Senior Vice President, Global Data Services, INC RESEARCH Graham Bunn, VP, Global CRO Partnerships, MEDIDATA |
| Governance Building to Drive Real Team Results Between a Pharmaceutical Company and CRO Anthony Carita, Director, Clinical Outsourcing, OTSUKA PHARMACEUTICAL DEVELOPMENT & COMMERCIALIZATION Wayne Langlois, GM & VP, Americas Region, Late Stage Development Services, COVANCE |
| Transform While You Perform: Next Generation Clinical Operations Nagaraja Srivatsan, Head of Life Sciences, North America, COGNIZANT Marissa Volpe, Acting Neurology Line Manager, UK Clinical Operations, BIOGEN Ann Wang, Vice President, Clinical Operations and Data Management, HUMAN GENOME SCIENCES |
| Strategic Approaches to Rapid and Effective Patient Enrollment Moderator: Tammy Ice, Associate Director, Active Recruitment Management, INC RESEARCH Panelists: Tinna Kwan, PhD, RN, Clinical Study Manager, ALLERGAN James Dodson, President & Creative Director, QD SOLUTIONS, INC. David Heck, Senior Director, CENTERWATCH James Kremidas, Global Enrollment Optimization, ELI LILLY & COMPANY |
| Data, Data Everywhere, Not a Byte to Use Carol Smith, MBA, MT (ASCP), Director, Clinical Documentation, CEPHALON, INC Jack Lawler, Associate Director, Clinical Information, CEPHALON, INC |
| Using Feasibility Studies to Proactively Identify the Best Sites and Predict Resource Requirements to Better Manage Costs, Patients and Timelines Moderator: Debbie Kerr-Leathem, Director, Clinical Logistics, Data Generation Division, ORTHO-MCNEIL JANSSEN SCIENTIFIC AFFAIRS Panelists: Michelle Jones, Sr, Director, Information Modeling, Operational Strategy & Planning Group, Late Stage Development Services, COVANCE INC. Michael Schwartzman, Associate Director, Global Strategic Outsourcing, DAIICHI SANKYO Sharon Wyatt Moore, MD, MBA, MPH, Vice President, Medical Affairs and Quality, CHILTERN Anne Brillouet, Global Studies Leader, HOFFMAN-LA ROCHE |
| Oversight of Transferred Obligations: Breaking the Micromanagement Habit Panelists: Karole Sutherland, Vice President, Clinical Operations, ALLON THERAPEUTICS Debbie Profit, Associate Director, Global Clinical Development, OTSUKA |
| Flexibility and Agility: The New Outsourcing Paradigm Steve Cottrell, Sr. Vice President, Business Development, INVENTIV CLINICAL SOLUTIONS Todd Fears, VP of Data Management, INVENTIV CLINICAL SOLUTIONS |
| Single-Sourcing Central Lab and CRO Services: Benefits and Opportunities Agostino Fede, PhD, Senior Vice President, Global Central Labs Services, PPD, INC. Richard Scaife, Director of Outsourcing on EU and Global Projects, DAIICHI-SANKYO (UK) |
Track E |
| Strategies to Successfully Leverage Emerging Markets for Global Clinical Trials Moderator: Andrew Fleming, Executive Director, Business Development, Emerging Markets, PHARMANET DEV. GROUP Panelists: Ian B. Holmes PhD, Senior Vice President, Corporate Development, PHARMANET DEV. GROUP William Egan, Vice President, PHARMANET CONSULTING Douglas Peddicord, PhD, Executive Director, ASSOCIATION OF CLINICAL RESEARCH ORGANIZATIONS |
| Outsourcing Clinical Trials in Emerging Regions Moderator: Mark Lanfear, Regional Manager, KFORCE Alliance, ROCHE Panelists: Luis Meza, MD, Managing Director, Latin America Operations, RPS, INC Karen Chu, Executive Director, International Clinical Operations, PAREXEL INTERNATIONAL Priya Pawar, Vice-President, Business Development, SIRO CLINPHARM, USA Viq Pervaaz, Vice President, Global Project Management, Global Central Lab, MDS PHARMA SERVICES |
| Novel Technologies to Provide Global Project Excellence Tenley Koepnick, Director, Site Support Services, PARAGON BIOMEDICAL Marianne Plaunt, PhD, VP, Global Operations, PARAGON BIOMEDICAL |
| Benefits of Global Feasibility Assessments James Kyle Bryan, MD, Executive Medical Director, Global Drug Development, PPD, INC James Kremidas, Global Enrollment Optimization, ELI LILLY & COMPANY |
| Patient Recruitment in Global Trials: Accessing Research Subjects in Developing Regions Panelists: Nancy A. Sacco, PhD, Sr. Dir, Head, Clinical Operations, TAKEDA PHARMACEUTICALS Eileen Harvey, VP Operations, PRA INTL Thomas B. Smith, MD, Vice President, Medical Affairs, KENDLE |