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Smaller Pharma
Smaller Pharma
| Special sessions just for smaller pharmaceutical sponsors | |
| Monday January 26, 2009 | |
B1 Overcome Outsourcing & Operational Challenges for Smaller Companies | |
| 8:00 | Registration and Morning Coffee hosted by  |
| 9:00 | Workshop Begins |
| 9:00 | Best Practices in Outsourcing to Central Labs to Improve Efficiencies Gary Albert, Manager Clinical Operations, ALNYLAM PHARMACEUTICALS |
| 10:00 | Building the Checklists-Qualification, Selection, and Operating Tools to Save You Time |
| 10:30 | Morning Networking Break |
| 11:00 | OPEN SESSION |
| 11:45 | Going Global: Strategies for Success |
| 12:30 | Networking Luncheon |
| 1:45 | Navigating ECG RFPs and Maximizing the Continuum of Service Kristian B. Hubbard, Research, Grants and Contracts, Clinical Pharmacology, Translational Medicine, Biostatistics and Anti Infective, EISAI MEDICAL RESEARCH |
| 2:30 | Best Practices in Outsourcing to Imaging Core Labs VIRTUALSCOPICS |
| 3:15 | Afternoon Networking Break |
| Panel Discussion | |
| 3:45 | How to Reduce the Burden on Smaller Sponsor Clinical Team-The Cross Functional Approach Rhonda Benotti, Development Outsourcing & Contracts, GENENTECH TBA ACM LABORATORIES |
| Panel Discussion | |
| 4:30 | Working with a Central Laboratory to Help Control your Clinical Trial Costs Panelists: Marietta M. Henry, MD, Vice President, Medical Affairs and Global Laboratory Medical Director, COVANCE CENTRAL LABORATORY SERVICES Susan Martin, MD, Director, Medical Affairs, COVANCE CENTRAL LABORATORY SERVICES Maria Taboada, Associate Director, Global Logistics, COVANCE CENTRAL LABORATORY SERVICES Millie Marsh, Global Director, Site Support, COVANCE CENTRAL LABORATORY SERVICES |
| 5:15-6:45 | Networking Reception |
 Networking, Networking and More Networking!Please join us for the Partnering with Central Labs Welcome Reception Monday, January 26th, 5:15-6:45 Mingle with your colleagues and clients and have a drink on us! Join us as we welcome everyone and kick off our 7th Annual Conference. | |
| Tuesday January 27th, 2009 | |
| Track A: Central Lab Relationship Development | |
| 1:35 | Improve Patient Care, Transparency and Process Efficiency in Global Studies Solomon Babani, Director, CELTIC PHARMA DEVELOPMENT SERVICES Scott Sawicki, MA, Section Head, Central Laboratory & Diagnostic Services, CRO Management, NOVARTIS PHARMACEUTICALS CORPORATION Stephanie Talbott, Vice President, Global Business Development, ICON CENTRAL LABORATORIES Patrick Lindsay, Senior Vice President, Strategy and Business Development, UNITED BIOSOURCE CORPORATION - Invited |
| 4:45 | Development of Central Laboratory in China- Challenges and Opportunities Dr. James J Ho, MD, PhD, DABCC, Chief Executive Officer, PEKING UNION LAWKE BIOMEDICAL DEVELOPMENT LIMITED |
| Track B: Standardization in Imaging Studies | |
| 1:35 | Current Standardization Initiatives for Use of Imaging in Clinical Trials Mark Tengowski, DVM, PhD, Director Clinical Affairs, VIRTUALSCOPICS |
| Track C: Improving and Standardizing ECG and Cardiac Safety Studies | |
| 1:35 | Update on FDA Guidance for ECG Related Studies Jeffrey Litwin, MD, Chief Medical Officer & Executive Vice President, eRESEARCHTECHNOLOGY |
| 2:30 | New Equipment and Software Technology Landscape Moderator: Tim Callahan, Chief Scientific Officer, BIOMEDICAL SYSTEMS Panelists: Dr. Tosja K. Zywietz, CARDINAL HEALTH RESEARCH SERVICES |
| 4:15 | Using the MCC ECG Metrics Jeffrey Litwin, MD, Chief Medical Officer & Executive Vice President, eRESEARCH TECHNOLOGY Steve Asbury, Global ECG Coordinator, ELI LILLY & COMPANY |
| 4:45 | Hot Topics and Trends in Cardiac Safety Studies Moderator: Tim Callahan, MD, Chief Scientific Officer, Bio medical Systems Panelists: Matthew Spear, MD, Chief Medical Officer, Vice President, NEREUS PHARMACEUTICALS Invited |
| Wednesday January 28th, 2009 | |
| Track A: Central Lab Relationship Development | |
| 1:35 | Development of Central Laboratory in China- Challenges and Opportunities Dr. James J Ho, MD, PhD, DABCC, Chief Executive Officer, PEKING UNION LAWKE BIOMEDICAL DEVELOPMENT LIMITED |
| Track B: Standardization in Imaging Studies | |
| 2:15 | Building the Imaging Lexicon for Rate Cards to Improve Industry Consistency P. David Mozley, MD, Senior Director, MERCK & COMPANY |
| 3:00 | Imaging Regulatory Environment Shift Strategies George Mills, PhD, Vice President, Medical Imaging Consulting, Perceptive Informatics, PAREXEL INTERNATIONAL Beth Sabatino, Outsourcing Manager, BRISTOL MYERS SQUIB |
| Track C: Improving and Standardizing ECG and Cardiac Safety Studies | |
| 1:35 | Working Together to Develop Biomarkers for Safety Monitoring and Surrogate Endpoints Samir Khleif, Head, Cancer Vaccine Section Investigator, NATIONAL CANCER INSTITUTE, NIH William Wheeler, MD, Chief Scientific Officer, MDS PHARMA SERVICES Dr. Patrice Hugo Vice-President of Scientific Affairs, MDS PHARMA SERVICES |
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