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Order a 2010 Digital Course 

Best Practices in Translational & Personalized Medicine 

Tuesday, February 2, 2010 ● 2:00 – 5:00pm ● Moscone North Convention Center, San Francisco, CA 

About this Product:
Award-winning speakers from the 2009 Bio-IT World Best Practices competition will give attendees an in depth look at cutting edge solutions and techniques for advancing translational medicine research. Going beyond the original entries, Best Practices winners will give updates, answer questions, and share the secrets to their programs’ success. This course provides you with an opportunity to “go behind the curtain” and see why our judges chose these entries as the best of the best.

Recorded at:
Cambridge Healthtech Institute’s 17th International Molecular Medicine Tri-Conference.

About the Conference:
Molecular Medicine Tri-Conference -- the flagship event of CHI –built this year's event around 6 scientific channels providing attendees more learning opportunities than ever before. Featured channels include diagnostics, chemistry, informatics, biologics, cancer and executive. This expanded program provides attendees a more in depth experience into each of the six areas of research and development. As the need for better information, new technologies, improved strategies and competitive intelligence becomes ever more acute, this event provides compelling research insight into the future of molecular medicine. In 2010, the event drew over 2,700 attendees, 1200 participating companies, 150 exhibitors, 100 posters, and representatives from over 38 countries.

Agenda At A Glance:

NCGR Schizophrenia Genome Project

Faye D. Schilkey, Associate Director, NM Sequencing Center, National Center for Genome Resources

Schizophrenia is a prevalent, disabling psychiatric disorder with a poorly understood genetic component. Second-generation sequencing has triggered a paradigm shift in the tools available to perform genomics studies in complex diseases like schizophrenia. The National Center for Genome Resources (NCGR) established the Schizophrenia Genome Project in 2007 to investigate the genetic basis of the illness and has successfully integrated high-throughput sequencing and analysis systems to support that effort. Using Illumina Genome Analyzers, NCGR’s internally designed Alpheus software system, and JMP Genomics, NCGR has developed a streamlined workflow for the acquisition, storage, analysis, organization, exploration and export of high-throughput sequencing data. Most importantly, recent publications authored by NCGR underscore the important evolution of second-generation sequencing studies beyond descriptions of sequence characteristics toward the exploration of important biological questions.

Biography: Ms. Schilkey is the Associate Director for the NCGR Genome Sequencing Center at the National Center for Genome Resources (NCGR). Her roles include operations, business development and ensuring collaborator and client success around the Center’s sequencing and analysis services. She is also the NCGR Principal Investigator for the NIH New Mexico IDeA network for biomedical research excellence. Ms. Schilkey received her B.S. degree in computer engineering in 1986 from Oakland University in Rochester, Michigan. She has been employed at NCGR since 1996 where she has held numerous technical and leadership positions producing various bioinformatics tools for genomics analysis. Before coming to NCGR, she worked for 10 years in the scientific software arena.

Biological Knowledge Management: Registration, Association, & Sharing

Jeremy Packer, Head of Bioinformatics, Abbott

Two of the world’s leading pharmaceutical companies joined with one of the world’s leading scientific software companies to collaborate on solving a critical business problem at a fraction of the cost of working separately. Although the difficulties related to IT infrastructure for registering and relating biological materials is not well known outside of the world of bench biologists and patent attorneys, it is a particularly acute challenge for knowledge management, and a significant drag on research innovation. Biological materials are notoriously complex entities, which require high levels of sophisticated understanding to define them uniquely. Through this industry consortium, a biological registration system has been developed which meets the needs across the pharmaceutical industry. Realizing economies of scale and utilizing an extensible SOA architecture and knowledge model, the system solves the current and future challenges related to IP protection and knowledge sharing among biologists.

Pediatric Knowledgebase

Jeffrey S. Barrett, Ph.D., FCP, Pediatrics Director, Pediatric Pharmacology Research Unit, The Children's Hospital of Philadelphia

Drug therapy in children is often based entirely on the knowledge of the caregiver and can be entirely empirical given the limited clinical investigation in pediatric populations. The Pediatric Knowledgebase (PKB) integrates hospital‐based electronic medical records (EMR) with drug and therapy‐based dashboards that provide patient and population views to current and historical data to guide individual medication use. The project brings together drug‐specific decision support generated by our clinical pharmacology experts and clinical caregivers with predictive models generated by our pharmacometric and informatics team. Drug dashboard prototypes for methotrexate (chemotherapeutic agent), tacrolimus (used to prevent organ rejection) and vancomycin (antibiotic) have been developed and are in clinical evaluation prior to production launch. The prediction engines and forecasting routines are transparent to the end‐user; emphasis on clinical outcomes including reduced medication errors and length of hospital stay have been used to demonstrate the ROI for individual dashboards.

Biography: Dr. Jeffrey S. Barrett, is a Research Associate Professor of Pediatrics, University of Pennsylvania, the Director of the Laboratory for Applied PK/PD in the Division of Clinical Pharmacology and Therapeutics at the Children's Hospital of Philadelphia (CHOP) and an Associate Scholar in the Center for Clinical Epidemiology and Biostatistics at The University of Pennsylvania. Dr. Barrett serves as the Principal Investigator for CHOP's Pediatric Pharmacology Research Unit and heads the Kinetic Modeling and Simulation core of the Penn/CHOP Clinical and Translation Science Award. He received his BS from Drexel University in Chemical Engineering and his Ph.D. in Pharmaceutics from the University of Michigan. Dr. Barrett spent 13 years in the pharmaceutical industry involved with PK/PD aspects of clinical drug development and was an early proponent of industrial pharmacometrics prior to joining CHOP. He is a Fellow of the American College of Clinical Pharmacology (ACCP) and the American Association of Pharmaceutical Scientists (AAPS) and received the Young Investigator and Clinical Pharmacology Mentorship Awards from ACCP in 2002 and 2007 respectively. He is a member of the FDA Clinical Pharmacology Advisory Committee and on the Board of Directors of the Metrum Research Institute. Dr. Barrett has co-authored over 90 manuscripts, 120 abstracts and has given over 75 invited lectures on PK/PD, clinical pharmacology and pharmacometrics. He joined the Editorial Boards of the Journal of Clinical Pharmacology in 2007 and the Journal of Pharmacokinetics and Pharmacodynamics in 2009. Dr. Barrett’s research interest is focused on investigating sources of variation in pharmacokinetics and pharmacodynamics applying clinical pharmacologic investigation coupled with modeling and simulation strategies to pursue rational dosing guidance. He develops pharmacometric approaches to advance PK/PD, medical informatics and disease progression modeling. Dr. Barrett also focuses on integrating model-based decision support systems with hospital electronic medical records.

Clinical Trial Portal (CTP)

Steven Beales, Vice President of Information Technology, ePharmaSolutions

The Clinical Trial Portal (CTP) was developed to streamline and accelerate workflow and collaboration between the stakeholders involved in conducting clinical trials. The CTP helps bio‐pharmaceutical companies accelerate and improve the site selection, activation, study training, trial management, adverse event management and patient enrollment process through a common technology platform that provides sites with one UserID, Passcode & URL for all of the studies they conduct. The CTP helps sites by reducing the number of credentials and redundant tasks that are associated with conducting clinical trials for sponsored studies. The CTP auto‐populates online feasibility surveys and regulatory documents with past responses, allows for digital signature completion of documents, delivers and track safety reports, tracks the completion of study training (GCP, SAE, eDC, etc.), and tracks recruitment in one portal. The CTP helps the regulatory agencies because it time stamps and tracks all user activity and is developed to integrate with the CRIX/FIREBIRD platform for electronic submission of regulatory documents. In summary, the CTP is the bridge between the internal and external stakeholders of a clinical trial to reduce the amount of credentials, tasks and paper used to conduct clinical trials today.

Biography: Steven is VP of Information Technology for ePharmaSolutions, where he heads development of the BIO-IT award winning Clinical Trials Portal, used by 180K clinical trials researchers in over 107 countries. He is a 19 year industry veteran with many years experience leading enterprise-wide Clinical Research IT implementations. Prior to joining ePharmaSolutions, Steven was chief architect at mdlogix where he developed the Johns Hopkins Clinical Research Management System, the Autism Speaks Interactive Autism Network, the Washington University Clinical Studies Management System, the Oracle Electronic Health Record Public Health System Prototype and many other clinical research and healthcare systems at Johns Hopkins, University of Pittsburgh, University of Pennsylvania and Tennessee Oncology. Steven is author of 10 papers and presentations on Clinical Research IT.

Individual $345
Site License $1380
Over 140 minutes
More than 177 slides