CED Biotech Forum
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CED BIOTECH FORUM: CLINICAL RESEARCH ORGANIZATIONS AND CLINICAL STRATEGIES
When: May 20, 2013
5:30 - 8:00 PM
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North Carolina Biotechnology Center
15 T W Alexander Dr
Research Triangle Pk, North Carolina 27709
Vance Faulkner (firstname.lastname@example.org)
Online registration is available until: 5/20/2013
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Join a group of industry experts on May 20th as they discuss the benefits of - and concerns surrounding - working with Clinical Research Organizations. You’ll come away with an understanding of what causes a breakdown in client/vendor relationships and ways to prevent misunderstandings through real case studies. Hear from speakers on both sides of the relationship as they deal effective strategies for developing successful partnerships. You will glean applicable insights for your daily work as you participate in a discussion surrounding the strategic rationale for clinical development outsourcing among startups and large pharmaceutical companies.
5:00 - 5:30 PM - On-site registration and networking
5:30 - 7:00 PM - Program
7:00 - 8:00 PM - Reception and networking
CED Members - $20
Non-Members - $40
CED Members - $30
Non-Members - $50
Jeff Collins (Moderator), PhD, Executive-in-Residence, Pappas Ventures
Dr. Jeffrey Collins, a microbiologist with broad experience in virology, immunology and toxicology, is currently an Executive-in-Residence with Pappas Ventures, a life sciences-focused venture capital firm based in RTP. Prior to joining Pappas Ventures in 2002, Dr. Collins, who has extensive experience in project management and in the administration of basic and clinical research, served in senior management positions at global clinical research organizations (CROs), including PAREXEL International and ClinTrials Research. Before entering the CRO world,
Dr. Collins was at Glaxo Inc. and Glaxo Wellcome Inc. for nearly 11 years, where he directed a number of drug development programs in the anti-infectives and oncology areas, resulting in the submission and approval of one NDA and five sNDAs. Dr. Collins also spent 4 years with the National Toxicology Program at NIEHS in a research administration position (Project Officer) and nearly ten years at the Duke University Medical Center (DUMC), where he taught and conducted research in viral and tumor immunology, leaving as an Associate Prof. of Experimental Surgery and of Microbiology. Dr. Collins received his B.S. in Bacteriology from Cornell University and his Ph.D. in Microbiology and Molecular Genetics from Harvard University. Prior to his faculty appointment at DUMC, Dr. Collins conducted post-doctoral research in Cell Biology at the Imperial Cancer Research Fund Laboratories in Lincoln's Inn Fields, London, England.
John H Graham, Director, Head of Global Strategic Resourcing & Performance Analytics, Pharmaceuticals R&D, GlaxoSmithKline
John has worked for GlaxoSmithKline for over 10 years in a variety of roles in R&D in both Clinical Operations and Finance. In his current role as Director, Head of Global Strategic Resourcing & Performance Analytics, he leads a global team responsible for managing all strategic supplier relationships for clinical development including global CROs, functional providers, and central labs. In addition to the strategic relationship responsibilities, he leads the teams accountable for clinical resource forecasting and capacity management and clinical performance metrics and benchmarking. Prior to his current role, he led an initiative within Pharma R&D which resulted in the selection and implementation of the relationships with two Strategic CROs and has held various roles focused on resource capacity management and financial and performance analysis. Prior to joining GSK, John worked as a consultant with PricewaterhouseCoopers on process improvement initiatives primary for the Pharmaceutical industry. John has a BSc in Chemistry from The College of William and Mary and a MBA from Duke University's Fuqua School of Business.
Roger Hayes, PhD, Vice President and General Manager, Laboratory Sciences, MPI Research
Roger Hayes, PhD, is Vice President and General Manager, Laboratory Sciences at MPI Research. Dr. Hayes has held numerous leadership positions in the global life sciences industry and academia, leading teams in the development of state-of-the-art bioanalytical and analytical techniques, including mass spectrometry, chromatography, and automation in bringing medical and chemical products to market. For nearly two decades, he led strategic and research initiatives for large pharmaceutical companies that included both GLP and non-GLP preclinical studies as well as clinical trials. At Merck Research Laboratories (2000-2010), Dr. Hayes directed the regulated bioanalysis group in support of preclinical and clinical safety trials and also advanced efficiencies for method development and validation. At Parke-Davis Pharmaceuticals (1993-2000), he managed the instrumentation support department, headed the bioanalytical groups for both safety and discovery research, and did cutting-edge work as the leader of the drug metabolism mass spectrometry group. Prior to that, Dr. Hayes spent several years at Procter and Gamble, where he developed new analytical technology and processes. His career is rooted in academia, beginning at the University of Adelaide in Australia, where he received his PhD and performed innovative research in gas phase ion chemistry. From there, he went to the University of Nebraska-Lincoln, where he served as an assistant director/assistant research professor and continued his groundbreaking research, with an emphasis on advancements in the use of mass spectrometry. Most recently (2011), he served as President of Bioanalytical Operations, at Cetero Research where he focused on establishing overall corporate direction for bioanalytical and analytical services. Dr. Hayes has published extensively and has taught numerous aspects of LC/MS method development.
Steven Neilson, Senior Director, Clinical Operations, Chimerix
Steven Neilson joined Chimerix, Inc. (NASDAQ: CMRX), in 2011. As Senior Director, Clinical Operations, he heads up their clinical project management, vendor management, and corporate and operational development of new antiviral medicines for the treatment of life-threatening diseases. Prior to joining Chimerix, Inc., he spent eleven years at UCB Biosciences, Inc. (formerly Schwarz Biosciences, Inc.), where he served as Principal Clinical Project Manager with oversight of their CNS program for the transdermal treatment of Parkinson’s disease. Previously, Steven held middle management positions at two Clinical Research Organizations: Project Director at MDS Harris and Manager, Clinical Monitoring, at ClinTrials Research, Inc. Steven brings two decades of clinical research experience in Phases I-IV, including clinical project and operational management. Steven holds a Bachelor’s of Science and Certification in Health Care Administration and Planning from Tennessee State University and Meharry Medical College. In addition, he holds a Master’s of Science in Health Services Administration from the University of St. Francis.
Paula Brown Stafford, President, Clinical Development, Quintiles
Paula Brown Stafford joined Quintiles in 1985 as a biostatistician, and is currently the President of Clinical Development. Her global responsibilities cover all of Quintiles’ Phase I-IV services, including Clinical and Data Operations, Laboratory Services and Functional Resourcing.
Paula has held numerous positions during her 27 years with Quintiles including positions in Project Management in the United States and Europe, Business Development, Scientific Operations and General Management.
Paula holds a Bachelor of Science and a Masters in Public Health, both from the University of North Carolina at Chapel Hill, with her specialization in Biostatistics.
In addition to her role at Quintiles, Paula is the Board Chair of CDISC (Clinical Data Interchange Standards Consortium), member of the Foundation Board of the Gillings School of Global Public Health at UNC-Chapel Hill, member of the CTSA External Advisory Board of the School of Medicine at UNC-Chapel Hill, and member of the Board of Directors for Cenduit.
Paula was a 2011 recipient of the Triangle Business Journal’s Women in Business award for her significant contributions to Quintiles, and her dedication to making a positive difference in healthcare around the world.
Learn More: CED Biotech Forum