6 December 2012
8.00 Registration, Coffee and Networking
8.50 Chair’s Opening Remarks
Using the Genome to Drive Drug Discovery
9.00 Accelerating the Drug Development Pipeline using Cancer Genome Sequencing
- A close look at the genomics approaches used to identify potential targets and biomarkers by Pfizer
- Real life successes that have guided patient care in the clinic
- An update on the consortium effort focusing on the most Asia-prevalent cancers
Mao Mao, Research Fellow, Oncology Research, Pfizer
9.30 Breast Cancer Prevention Through the Diagnosis and Treatment of Reversible Hyperplastic Intraductal Lesions
Steven Quay, Founder, Atossa Genetics
10.00 A Reliable and Accurate Method for Detecting Somatic Mutations in Next Generation Cancer Genome Sequencing
- An introduction to MuTect system developed at the Broad Institute
- Application of the technique for identification of somatic point mutations in NGS data of cancer genomes
- Real life examples of Mutect used in both drug development and the clinic
Kristian Cibulskis, Research Investigator, Broad Institute
10.30 Morning Refreshments & Networking
Translating the Cancer Genome into the Clinical Setting
11.00 Stratification of Clinical Trial Subjects Using Biomarkers Developed by Next Generation Sequencing
- Reviewing the applications of NGS for biomarker development and subject stratification
- Translating this information in effective clinical trial design and management
- The advantages and disadvantages of outsourcing versus internal NGS
Brian Dougherty, Translational Science, Oncology, Lead, AstraZeneca
11.30 Driving Early-Phase Clinical Trials using Clinical Tumor Genotyping
- Achieving patient stratification by using tumor genetic profile to optimize patient selection in early-phase clinical trial design
- Results from a 3,000 patient test which used a multiplex tumor mutation detection platform in a CLIA environment for genotype-directed clinical trials
Leif Ellisen, Clinical Director, Breast and Ovarian Cancer Genetics, Massachusetts General Hospital
12.00 Roundtable Master Mind Groups
A highly effective and energizing format for you to:
- Access the knowledge of fellow attendees
- Collaboratively predict future challenges in this space
- Review key learning points and set next steps
12.30 Lunch & Networking
1.30 Devising Methods for Intuitively Handling Huge Data Sets to Simplify Biomarker Discovery
Dongliang Ge, Director of Bioinformatics, Gilead Sciences
2.00 Accelerating Development of Targeted NGS Assays to Streamline Drug Trials and Improve Patient Care
- Learn the nuts and bolts of NGS panel development, from gene selection to annotation for knowledge base creation
- Similarities and differences between panel designed drug trials and clinical care
Seth Crosby, Director, Washington University
2.30 Approaches to Apply the Cancer Genome in the Clinic
- How will the cancer genome help us to inform treatment beyond simply disease prognosis?
- How can we speed up the transition from interesting research to clinical utility?
- Can the cancer genome be used routinely to improve patient treatment decisions?
Leif Ellisen, Clinical Director, Breast and Ovarian Cancer Genetics, Massachusetts General Hospital
Cameron Brennan, Surgeon and Laboratory Investigator, Memorial Sloan-Kettering Cancer Center
Michael Berger, Assistant Professor, Pathology, Memorial Sloan-Kettering Cancer Center
3.00 Afternoon Refreshments & Networking
Navigating the Regulatory Environment
3.30 Development of Next-Generation Sequencing as a Clinical Test and Requirements for Laboratory Standards
- Overcoming the hurdles to adoption of NGS in the clinical laboratory setting, including analytic validation of the test, CLIA/CAP certification, standards for reference material and proficiency testing
- Review of laboratory accreditation standards being developed
Nazneen Aziz, Director, Molecular Medicine, Transformation Program Office, College of American Pathologists
4.00 Navigating the Regulation of LDTs: The Laboratory’s Perspective
- An overview of the past actions of FDA with regard to Laboratory Developed Tests, including particular concerns that FDA regulation could pose for laboratories, from both a legal and practical standpoint
- Understand CLIA and how these two regulatory frameworks overlap
Peter Kazon, General Counsel, American Clinical Laboratory Association
4.30 Chair’s Closing Remarks
