Investing in Biomedical Informatics for Drug Development and Health Care
|Event Date/Time: Oct 13, 2010||End Date/Time: Oct 14, 2010|
CRITICAL QUESTIONS INCLUDE:
1. How do we encourage participation in the clinical research enterprise? Is integrative biomedical informatics the key to maximizing the value of what is learned from clinical trials?
2. How do drugs in the same therapeutic class compare in terms of safety and eff ectiveness? What do we know about diff erences in comparative safety and eff ectiveness by patient subpopulations?
3. How much do we know about drug safety and eff ectiveness at the time of drug approval? How can analytics maximize continued learning post approval?
4. How quickly and accurately can we detect and understand new safety signals? What are the practical challenges of obtaining, integrating, and analyzing the necessary data?
5. What Risk Evaluation and Mitigation Strategies (REMS) would ensure that drug benefi ts outweigh risks while minimizing added health care costs and maintaining patient access?
6. Do key health care stakeholders have access to the right information, of the right quality, at the right time, to make the best-informed decisions?
THEME A â€“ Application of Biomedical Informatics to Health
Care and Pharma
â€¢ Semantic Web
â€¢ Clinical and Health Care Data Quality and Integrity
â€¢ Predictive Analytics
THEME B â€“ Policy of Biomedical Informatics in Health Care
â€¢ FDAAA and Comparative Eff ectiveness Research
â€¢ Technology & Data Standards in Public Health
â€¢ Meaningful Use of Electronic Health Care Records
â€¢ FDAAA: Sentinel Initiative
At the conclusion of this conference, participants should be able to:
â€¢ Describe usage of solutions, such as the semantic web, for the aggregation of disparate research, clinical and health care data.
â€¢ Describe methods for evaluating eff ectiveness of REMs.
â€¢ Identify the standards of interoperability across health care, pharma and basic research, e.g., HL7, CDISC and GO.
â€¢ Compare the eff ectiveness of clinical trial repositories, longitudinal studies, electronic patient records, and payor databases for biomarker identifi cation.
â€¢ Identify how data repositories can be utilized for analytics.
â€¢ Describe Health & Life Science opportunities enabled by analytics and public domain databases, such as DrugBank and ClinicalTrials.gov.
â€¢ Describe how the Sentinel Initiative will facilitate quality-based safety signal detection.
â€¢ Describe the â€œmeaningful useâ€ of Electronic Health Records as authorized by the American Recovery and Reinvestment Act of 2009.
â€¢ Identify predictive analytics tools that can be used to determine likely disease progression, e.g. supervised and unsupervised data mining approaches, modeling
â€¢ Describe how comparative eff ectiveness and outcomes research contributes to evidence-based medicine.
â€¢ Informaticians in health care and pharma
â€¢ Physicians in health care and pharma
â€¢ Safety/Pharmacovigilance professionals
â€¢ Data management professionals
â€¢ Health policy analysts
â€¢ Clinical pharmacologists
â€¢ Regulatory personnel
â€¢ Government organizations
â€¢ Contract research organization professionals
â€¢ Information technology professionals