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Translational sciences can help increase not only the speed at which a drug reaches the clinic, but also the efficacy of the drug, the safety profile of that drug and the treatment population. Cambridge Healthtech Institute's Eighth Annual Translational Science conference at the 2012 Molecular Med Tri-Con will bring scientists from academia, industry and government together to discuss the role of translational science in drug discovery and development. While remaining in the forefront of pharmaceutical development news, translational science has become an integral component of modern drug discovery, starting with target validation and continuing through post-market surveillance. The role of the translational scientist may vary from organization to organization, but the underlying need to better understand and utilize the knowledge from both clinical and pre-clinical endeavors is crucial to reducing pharmaceutical attrition. What is the impact of having a pharmacodynamic vs. a prognostic biomarker? Can you implement a translational approach in a drug-diagnostic co-development project? What is the modern role for in vivo models in translational science? Learn from the experts and contribute to the conversation by bringing your experience to the forefront through interactive roundtables, moderated panel discussions and networking breaks. Case studies (from both small molecule and biologics) will be presented with an emphasis on the role of translational science in the success or failure of the compound. What are the lessons learned from the successes? Learn how these results are already translating back to pre-clinical research for similar targets.
RECOMMENDED SHORT COURSES:
Tuesday, February 21
7:00 am Registration
9:40 Grand Opening Refreshment Break in the Exhibit Hall with Poster Viewing
11:00 Chairperson's Opening Remarks
Theresa LaVallee, Ph.D., Director, Research & Development, MedImmune
11:10 Impact and Translational Opportunities of Pre-Clinical Imaging in Biomarker Discovery and Drug Development
Paul McCracken, Ph.D., Director, Imaging, Eisai Research Institute
Review of pre-clinical imaging modalities - applications of SPECT, PET, MRI, and CT, including integration with and utilization of molecular biomarkers to drive imaging development, selected neuroscience and oncology discovery imaging examples, and translational opportunities.
11:40 Integrating Imaging in Early Drug Development: Lessons Learned from the VEGFR TKI Experience
Glenn Liu, M.D., Associate Professor, Medicine, Carbone Cancer Center, Wisconsin Institute for Medical Research, University of Wisconsin
Anatomic imaging is commonly used to assess treatment efficacy in late-phase cancer clinical trials; however, this assumes that the therapy will result in anatomic tumor shrinkage (cytotoxic) and predict survival. Advanced quantitative functional imaging methods can be used to assess early treatment response.
12:10 pm Translational Imaging for De-risking Pharmaceutical Pipelines
Anthony M Giamis, Ph.D. , Head of Radiochemistry / Radiopharmaceutical Sciences, Translational Sciences - Advanced Technology, Abbott
12:40 Luncheon Presentation
Use and Validation of Image Based Biomarkers of Drug Response: a CRO Perspective
Patrick McConville, Ph.D., Chief Scientific Officer/COO, Molecular Imaging, Inc.An overview of the use of multiple preclinical imaging modalities for image-based biomarker assessment of disease progression and drug response will be provided. Special attention will be given to biomarker validation, and examples using probe facilitated imaging will be discussed.
12:55 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
1:45 Dessert in the Exhibit Hall with Poster Viewing
2:15 Chairperson's Remarks
Theresa LaVallee, Ph.D., Director, Research & Development, MedImmune
2:20 PET Imaging as a Quantitative Biomarker in CNS Drug Development: Illustration by Examples
Yiyun Henry Huang, Ph.D., Associate Professor, Co-Director, PET Center, Department of Diagnostic Radiology, Yale University
Results from these PET imaging studies for novel CNS therapeutic agents have been shown to be critically important to inform the go/no-go decision in drug development.
2:50 Use of Biomarkers and Translational Science to Improve and Accelerate Oncology Drug Development
J. Carl Barrett, Ph.D., Vice President, Translational Medicine, AstraZeneca
3:50 The JAX Cancer Consortium: Changing the Course of Clinical Advancement
Brandy Wilkinson, Ph.D., In Vivo Study Director, The Jackson Laboratory-West
The JAX Cancer Consortium has established a publically available patient derived xenograft (PDX) resource. This presentation will highlight the diverse library of solid and liquid PDX models available to further drug discovery programs.
4:20 Reception in the Exhibit Hall (Sponsorship Available)
5:20 Breakout Discussions in the Exhibit Hall
Concurrent problem solving breakout discussions, open to all attendees, speakers, sponsors, and exhibitors, provide a forum for discussing key issues and meeting potential collaborators. Plan to take part and explore these topics in-depth. Please pick a topic of your choice, find your table and join in.
The Use of NGS in Cancer Diagnostics – Challenges in Moving from Research into the Clinic
Jeffrey M. Otto, Ph.D., M.B.A., National Director, Catholic Health Initiative's Center for Translational Research
- Is there demonstrated clinical evidence suggesting an improvement over existing alternatives?
- Who should pay for the test? Payors? Patients? Providers?
- 85% of cancer care is delivered in community hospitals – how to drive adoption when existing molecular diagnostics are under-utilized?
- Is NGS, while a strong research tool, not a viable platform for routine molecular diagnostics?
Use of Retrospective and Prospectively collected samples for the discovery nd validation of Biomarkers
Rao Mulpuri, Ph.D. M.B.A., Director of Scientific Operations, Catholic Health Initiative's Center for Translational Research
a) Ethical, Privacy and consenting challenges
b) Challenges in using previously collected samples – how to normalize the data for sample quality
c) Clinical and genomic data integration challenges – define best practices
How do you Facilitate Excellence in Translational Research in an Academic Setting?
Michael Kalos, Ph.D., Director, Translational and Correlative Studies Laboratory, University of Pennsylvania School of Medicine
How Can We Define the Appropriate Patient Population Early in Drug Discovery?
Joerg Heyer, Ph.D., Director, Genetic Models, Translational Research, AVEO Pharmaceuticals
• Effects of translational medicine on increasing patient population knowledge
• Informatics approaches
• Pharmacogenomics, clinical data, and more
Scale up of Translational Preclinical Imaging Biomarker Assays for Decision Making in Drug Discovery and DevelopmentPatrick McConville, Ph.D., CSO, Molecular Imaging, Inc.
• How are imaging biomarkers validated in preclinical testing?
• What level of validation is required in order for an imaging biomarker to be used confidently in decision making?
• Is clinical validation a pre-requisite for preclinical use?
• What is the ‘sweet spot’ for decision making with imaging biomarkers?
• Once an imaging biomarker is validated, how is scale up achieved and what are the challenges
6:20 Close of Day
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