WEDNESDAY,APRIL 6
8:00 am Morning Coffee
8:25 Chairperson’s Opening Remarks
8:30 Results and Lessons Learned with the International Serious Adverse Events Consortium
Arthur Holden, Ph.D., Chairman and CEO, International Serious Adverse Events Consortium
An overview of existing pre-competitive biomedical consortium models will be presented. Operational characteristics of two highly successful consortia (i.e. the SNP Consortium and the currently running International SAE Consortium) will be used to provide lessons learned for encouraging success with such efforts. Key success factors associated with these efforts will also be discussed.
9:00 Integrating Academic Discovery and Commercial Drug Development: How One Non-Profit is Leveraging Its Position to Accelerate Research
Scott Johnson, President and Founder, Myelin Repair Foundation
Johnson will share the progress to date in demonstrating the MRF’s Accelerated Research Collaboration™ (ARC™) model. Covered widely in maintstream media, the ARC model may be the most holistic approach to date for addressing the barriers that are slowing or preventing progress across the entire value chain of medical research and drug discovery.
9:30 Five Years of Pharma Industry Collaborative Projects: What is Working, What is Changing and What We Learned
Ernie Bush, Ph.D., Drug Safety Executive Council
In order to improve the economics and effectiveness of pre-clinical safety assessment, CHA began organizing multi-company collaborations over five years ago. While the operating model has been optimized through several iterations, the fundamental vision of gaining more value from new technology evaluations through the “Wisdom of the Crowds” has not been altered. This presentation will review the various projects and programs that have leveraged this model and why the outcome has overwhelmingly been a win-win for all participants (i.e. both pharma companies and new technology tool venders), even when the technology did not perform as originally envisioned. Finally, the presentation will close with a discussion on the lessons learned during the past five years and areas for further enhancement of the paradigm.
10:00 Networking Coffee Break, Poster and Exhibit Viewing
10:40 The COPD Biomarkers Qualification Consortium: A Means to Make New Therapies Possible
William Mattes, Ph.D., Senior Director, COPD Biomarkers Consortium
Chronic Obstructive Pulmonary Disease will be the third leading cause of death in the U.S. by 2020. While several new targets for therapy are being explored, and many phenotypes of the disease evident, only one measure of the disease is currently accepted for registration of new drugs. The COPD Biomarkers Qualification Consortium was formed to pool clinical data collected by both industry and academic researchers and develop a dataset useful for formal FDA qualification of new biomarkers of the disease. Challenges and lessons learned from setting up this consortium will be presented.
11:10 The Pistoia SESL Project: A Pilot for a Biomedical Brokering Service
Bryn Williams-Jones, Ph.D., Pfizer
The current Disease Knowledge strategies within pharma companies result in not only a large duplication of effort, but also limits the access of this knowledge to public bodies who may be able to use it in innovative ways. Target selection and validation in the drug discovery process is compromised due to our limited understanding. Although these limitations are often due to a fundamental paucity of foundational knowledge about the disease mechanisms, difficulties in information access and integration are also a major block in awareness and understanding of existing knowledge by researchers. There is currently no single system for retrieving gene to disease relationships contained in both published and structure database content. This pilot aims to determine the feasibility of a ‘push model’ for biomedical knowledge access. The SESL project aims to engage multiple consumers, content providers and a single, public group to develop the necessary infrastructure to explore the standard required for the model to work in production. This service standard needs to be developed in the public domain where it will be of benefit to all and we can share costs and risks.
11:40 Panel Discussion
12:10 pm End of Conference