Day 1 | Day 2
Leading drug discovery and development companies are increasingly reorganizing their drug development process and programs to take advantage of new tools and techniques to make more effective go/no-go decisions as early as possible in the drug development process to concentrate resources on the best candidates, accelerate development and reduce later-stage attrition. Learn from leading practitioners how to:
Build a More Effective Drug Discovery and Development Process
Reduce Risk and Later-Stage Attrition
Case Studies of New Proof-of-Concept Approaches and Programs
Measure Targets, Pathways and Impacts
Implement New Drug Development Process Models
Discover the Latest Early Proof-of-Concept Approaches, Techniques and Technologies
Scientific Advisory Committee:
Terri A. Roberson, MT (ASCP), M.B.A., Manager, Chorus Operations, Eli Lilly and Company
Stephen Donahue, M.D., Senior Vice President, Clinical Development, Ore Pharmaceuticals, Inc.
8:30-9:00 am Short Course Registration and Morning Coffee
Morning Pre-Conference Short Course
9:00 am to 12:00 pm
Predicting Outcomes in Pre-Clinical Development
John Arrowsmith, Ph.D., Executive Director and Head, Competitive Intelligence, Pfizer Global Research and Development and Philip Miller, CMR International, Thomson Reuters
The course will explore some of the fundamental factors that go into a POC decision. It will analyze the underlying science that drives those decisions and how to influence investments and behaviors to make more of the right choices and fewer wrong choices.
This interactive short course will cover:
• Introduction to the general idea of attrition, pointing out obvious productivity and economic impacts.
• Investigate causes of attrition.
• Focus on Phase II attrition specifically and the importance of POC.
• Group discussion on defining a POC and how far in advance of a POC the decision criteria need to be agreed.
• Discuss how and why things go wrong when a POC fails.
• Novel and non-novel POC's, the Proof of Mechanism and translation from pre-clinical to clinical for safety and efficacy measures.
• Types of risk being taken on at POC, since all are not are born equal.
• Group discussion around planning and executing POC's.
• Leveraging benchmark data and use after action reviews.
• Final wrap up discussion and Q&A.
*Separate Registration Required
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12:00-1:25 pm Main Conference Registration
Main Program
DAY ONE: TUESDAY, OCTOBER 13, 2009
1:25 Chairperson’s Opening Remarks
Terri A. Roberson, MT (ASCP), M.B.A., Manager, Chorus Operations, Eli Lilly and Company
1:30 Eli Lilly’s Chorus Program: The Continuing Evolution of Accelerated Drug Development
Joel Scherer, M.D., Managing Director, Chorus
Chorus was created in 2002 as a strategic early phase R&D pilot focused on improving productivity (virtual development, limit parallel processing, cutting edge IT platform), and has evolved into an alternative R&D engine to move molecules through the LRL early phase pipeline. The group now numbers approximately 30 and handles about 20% of the Lilly early development portfolio. The challenges of managing the growth and maturation of this unique group while maintaining its productivity advantages and identity will be discussed.
2:00 Moment – Coordination of the Work in a Distributed Environment
Neil Bodick, M.D., Ph.D., Chief Operating Officer, Flexion Therapeutics
As the organizational model for pharmaceutical innovation evolves beyond the monolithic institutions that dominated the modern industry, and as early stage partnering takes on greater significance in value generation, there is an associated redistribution of the work of pharmaceutical development within and particularly across organizations. As large R&D organizations reconfigure internal operations and become more involved with external relationships, a need emerges for a common representation of work that serves to both maintain the integrity of the workflow in a distributed environment and provide bases for portfolio-wide optimization. In the past, pharmaceutical companies have made large investments in both enterprise management systems and project management technologies. And while these systems undoubtedly confer benefit, they do not, by enlarge, provide deep representation of the work itself. MomentTM is a novel management system developed at Flexion Therapeutics that does provide a deep representation of the work. In particular:
The data model underlying Moment comprises a set of abstractions that relate strongly to the fundamental elements of work;
The system explicitly represent the absorption of risk as a product of work and as such provides a basis for portfolio optimization;
Moment is anchored in time with the capability to rapidly reconfigure plans with the emergence of new data;
The Moment accountability model may be distributed over multiple organizations;
Provision is made for communication or sequestration of proprietary materials among multiple organizations.
The data model underlying Moment will be described and the operation of interface will be demonstrated.
2:30 Networking Refreshment Break with Exhibit and Poster Viewing
3:10 Sponsored Presentation (Opportunities Available)
3:40 Predicting Outcomes in Pre-Clinical Development at Pfizer
John Arrowsmith, Ph.D., Executive Director and Head, Competitive Intelligence, Pfizer Global Research and Development
Phase II survival is the weakest link in the development continuum and is a key driver of the low industry wide R&D productivity that Pharma is currently experiencing. Despite increasing Phase I and Phase II portfolios over recent years, the industry struggles with the conversion of these into Phase II starts. Benchmark data showing a greater than twofold increase in the number of compounds failing at the POC hurdle over that last 3-5yrs. Pfizer has implemented a simple process to harvest learning’s from positive and negative POC decisions that has led to key insights that will significantly increase the POC success rate and avoid the expenditure of resources on projects that would inevitably have failed.
4:10 Pharmacology Guided Drug Development: An Innovative Approach for Earlier Go/No-Go Decisions
Albert Bellibas, M.D., President, Pharmahelpline International
No matter what NME we are trying to develop, we are either interacting with a receptor, a drug transporter or an enzyme activity in the biological systems. Therefore, even before a desired therapeutic effect is achieved, there is a pharmacological change or a “response” that has occurred. Monitoring these responses at the cellular or molecular level can provide guidance in order to understand the likelihood of success for any NME before conducting expensive and time consuming large clinical trials. This pharmacological approach coupled with an understanding of the pathophysiology of targeted disease and advanced biomarkers/imaging techniques will be discussed and case studies will be presented.
4:40 Effective Use of Translational Imaging for Early Indication of Treatment Response in Oncology
Patrick McConville, Ph.D., Director, Global Discovery Imaging, Discovery and Imaging Services, Charles River
Imaging technologies are being increasingly adopted in the pharmaceutical industry to accelerate drug discovery. The effective use of imaging technologies can enable early, more predictive endpoints that are also clinically translatable. This presentation will focus on key in vivo imaging technologies, such as 18-FLT PET, diffusion MRI, and 1H magnetic resonance spectroscopy (MRS), and the critical advantages they offer for oncology research and drug discovery. Optimization of their effectiveness in pre-clinical imaging will be a key part of the presentation, including study design, data analysis, and data interpretation issues.
Sponsored by
5:10 Networking Reception with Exhibit and Poster Viewing
6:10 Close of Day One
For more information, please contact:
Christina Lingham
Cambridge Healthtech Institute
250 First Avenue, Suite 300
Needham, MA 02494
Phone: 781-972-5464
Fax: 781-972-5425
E-mail: clingham@healthtech.com
For partnering and sponsorship information, please contact:
Arnie Wolfson
Business Development Manager
781-972-5431
awolfson@healthtech.com