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Agenda at a Glance
Agenda at a Glance
| September 20, 2010 | FULL-DAY SYMPOSIUM |
| 8:15 | Registration and Morning Coffee | 1:30 | Symposium Continues |
| 9:00 | Symposium Begins | 3:00 | 30-Minute Networking Break |
| 10:30 | 30-Minute Morning Networking Break | 4:30 | Symposium Concludes & Reception hosted by Quest Diagnostics |
| 12:00 | Networking Luncheon |
Industry Insights to Biomarker Development, Validation, and Deployment
According to a 2009 report by PhRMA, the biopharma industry is working on 861 medicines for cancer which are currently in clinical trials or under FDA review. The biopharma industry is fighting to beat the disease with technology, creative methods for using existing medicines, and innovative new products. This full day symposium brings together an esteemed group of oncology thought leaders ready to push the industry forward with cutting edge research.
Symposium participants obtain the tools to
- Optimize biomarker research and development in clinical development programs
- Identify proper de novo assay development techniques
- Select markers to yield data to enhance “go/No go” decisions
- Understand how to utilize biomarkers to assess target modulation
- Discuss opportunities and practices that bridge biomarkers into companion diagnostic development
Chairperson:
Terry Robins, Ph.D., Director, Biomarker Research & Development, Clinical Trials, QUEST DIAGNOSTICS
Leaders:
Marcia Lewis, PhD, Vice President, Biomarker Development, PGXHEALTH
Shabnam Tangri, Director, Clinical Sciences and Technology, BIOGEN IDEC
Heather R. Sanders, PhD, Principal Scientist, Oncology R&D, QUEST DIAGNOSTICS NICHOLS INSTITUTE
C. Hyung Park, PhD, former Director, Biomarker Outsourcing, Clinical Translational Medicine, PFIZER
Stephen Furlong, PhD, Senior Director & Science Safety Lead, ASTRAZENECA
| September 21, 2010 | MAIN CONFERENCE DAY ONE |
| 8:00 | Registration and Morning Coffee |
| 8:30 | Chairperson’s Welcome |
| Christine Brauer, President, BRAUER DEVICE CONSULTANTS, former scientific reviewer at the Center for Device Evaluation, FDA | |
| 8:45 | Transition to Central Lab East General Session Room |
| 9:00 | KEYNOTE PRESENTATION Prediction, Prevention and Detection – How the Patient will be the Game Changer in Personalized Medicine, Diagnostics and Clinical Drug Development |
| Thomas Goetz, MPH, Executive Editor, WIRED MAGAZINE Author, The Decision Tree | |
| 9:45 | Breaking News: Solutions to R&D Challenges – Tufts CSDD’s Annual Report on Drug Development |
| Kenneth I Kaitin, PhD, Director and Professor of Medicine, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT, TUFTS UNIVERSITY | |
| 10:30 | 45-minute Morning Break in Exhibit Hall, Transition back to Oncology room |
OVERCOME REGULATORY CHALLENGES TO FACILITATE DRUG APPROVALS FOR YOUR ONCOLOGY DRUG DEVELOPMENT PROGRAM | |
| 11:15 | Regulatory Roadmap for Drug Approvals Based Upon Biomarkers |
| Grant Williams, MD, WILLIAMS CANCER DRUG CONSULTING, LLC, former CDER Oncology Medical reviewer, Team Leader, Deputy Division Director, FDA | |
| 12:00 | Solutions Summit Meet & Greet |
| 12:30 | Networking Luncheon |
| Expert Exchange Luncheon, Network with the Faculty and Scientific Advisors | |
INSIGHTS TO COMPANION DIAGNOSTICS CHALLENGES & INDUSTRY IMPLICATIONS FOR DRUG DEVELOPMENT | |
| 1:30 | Uncover Novel Development and Regulatory Strategies for In Vitro Diagnostics |
| Christine Brauer, President, BRAUER DEVICE CONSULTANTS, former scientific reviewer at the Center for Device Evaluation, FDA | |
| 2:15 | Cutpoint Determination for a Continuous Valued Diagnostic Test and Implications for Drug Development |
| Howard Mackey, Senior Statistical Scientist, Clinical Biostatistics, GENENTECH | |
| 3:00 | 30-Minute Afternoon Networking Break |
BIOMARKER VALIDATION AND HOW TO OPTIMIZE ANALYSES | |
| 3:30 | Biomarker Assay Validity and Performance and Its Implications on Patients and Drug Development Programs |
| Abdel Halim, PharmD, PhD, DABCC-CC, DABCC-TOX, DABCC-MD, FACB, Director, Clinical Biomarkers, DAIICHI SANKYO PHARMA DEVELOPMENT | |
| 4:15 | Interactive Round Table Discussions |
| Table 1: Insights to selecting appropriate biomarkers and utilization strategies Table 2: How to bridging the gap with translational research Table 3: Clinical trial design considerations and PFS challenges | |
| 5:00 | TARGET Solutions Summit Discussion |
| Panelists: Summit Speaking Faculty | |
| 5:30 | Day One Concludes |
| September 22, 2010 | MAIN CONFERENCE DAY TWO |
| 8:15 | Morning Coffee |
| 8:45 | Chairperson’s Recap |
| Jason Hill, PhD, Director, Strategic Business and Operations, Oncology, QUINTILES | |
BIOMARKER CASE STUDIES AND LESSONS LEARNED – PRECLINICAL TO CLINICAL | |
| 9:00 | Developing A Biomarker Solution for P13K Signaling: From Validation To Global Deployment |
| Jason Hill, PhD, Director, Strategic Business and Operations, Oncology, QUINTILES | |
| 9:45 | Strategies for Developing Pharmacodynamic and Predictive Biomarkers to Target Cancer Stem Cell Agents |
| Ann Kapoun, PhD, Director, Translational Medicine, ONCOMED PHARMACEUTICALS | |
| 10:30 | 15 Minute Networking Break |
| 10:45 | Gene Expression Profiling as a Target Engagement and Safety Biomarker |
| Samuel C. Blackman, M.D., Ph.D., Associate Director, Experimental Medicine, MERCK | |
| 11:30 | TARGET Solutions Summit Discussion |
| Panelists: Summit Speaking Faculty | |
| 12:00 | Conference Concludes |