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Tuesday, February 11
7:00 am Registration and Morning Coffee
9:15 Refreshment Break in the Exhibit Hall with Poster Viewing
10:25 Chairperson’s Remarks
Manish Muzumdar, Senior Vice President, Products, Remedy Informatics
10:30 Translational Science Approaches to Reduce Phase III Attrition
Kalpana Merchant, Ph.D., CSO, Tailored Therapeutics, Neuroscience, Eli Lilly
Neurodegenerative, other neurologic and psychiatric disorders are syndromes that are defined by clinical instruments that do not have adequate specificity and sensitivity. Addressing the unmet needs of these chronic, debilitating disorders represents one of the most urgent areas of scientific research. However, these disorders are heterogeneous in their etiology, pathophysiology as well as progression course. Therefore, patient responses to marketed and investigational drugs are also heterogeneous and not predictable. This has led to failures of clinical trials of several investigational drugs. This talk will focus on translational science approaches directed at addressing gaps in key factors that contribute to clinical failures: (a) wrong therapeutic target, (b) wrong does/dosing regiment and (c) wrong patient population. Examples of recent successes utilizing genetic/genomic, imaging, physiological, or biochemical biomarkers will be discussed to demonstrate the impact of timely integration of translational science approaches into drug discovery and development.
11:00 Translational Safety of Immunostimulatory and ADC Cancer Biologics
Rakesh Dixit, Ph.D., DABT, Vice President, R&D; Global Head, Biologics Safety Assessment, MedImmune
With technological advances in generation of immune-stimulatory and armed biologics, the translational safety and toxicology predictions face unprecedented challenges. There is now renewed focus on a better understanding of translational immune-pharmacology associated toxicities (both on-target and off-target). Case studies with major considerations such as target distribution, target pharmacology, and systemic pharmacokinetics, early screening, both traditional and non-traditional (e.g., transgenic models), and in vitro safety assessments will be addressed.
11:30 Talk Title to be Announced
Kirk Bertelsen, Ph.D., Director, Clinical Pharmacology, Janssen Pharmaceutical R&D
12:00 pm Translational Value of Target-Based Risk Assessment
Alexander Fekete, Scientific Technical Leader, Novartis
Early safety risk assessment integrates data from pharmacology and ADME profiling, with later addition of pharmacokinetic experiments and efficacy models. One important element of this approach is target-based in vitro profiling for mapping off-target effects to clinical adverse reactions. Ultimately the goal is to produce safer medications for patients and to reduce late-stage attrition through effective translation of predicted toxicological effects.
12:30 Session Break
12:40 Luncheon Presentations (Sponsorship Opportunities Available) or Lunch on Your Own
1:40 Refreshment Break in the Exhibit Hall with Poster Viewing
2:15 Chairperson’s Remarks
Michael H.A. Roehrl, M.D., Ph.D., Director, UHN Program in BioSpecimen Sciences, University of Toronto
2:20 Use of Clinical Genetic Specimens to Support Clinical Drug Development
Rebecca Blanchard, Ph.D., Executive Director, Clinical Research; Head, Clinical Genetics, Merck & Co., Inc.
Many pharmaceutical companies maintain biorepositories of clinical specimens consented for and collected during clinical trials. This presentation will address common uses of biorepository samples to support clinical drug development, and will highlight challenges in specimen collection that impact ultimate utility of the specimen.
2:50 Use of NCI-Clinical Trial Network (NCTN) Bank Specimens to Support Biomarker Research
Irina A. Lubensky, M.D., Chief, Pathology Investigation & Resources Branch, Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, NCI, NIH
The NCI-Clinical Trial Network (NCTN) Biospecimen Banks collect well-annotated specimens from the large-scale, treatment phase 2-3 trials conducted by the NCI Clinical Trials Cooperative Group Program (reorganized into the NCI-National Clinical Trials Network-NCTN). This presentation will address successful uses of biorepository samples to support clinical biomarker validation and assay development, and will highlight challenges in specimen collection that impact research.
3:20 Best Practices for Management of Clinical Specimen to Support Clinical Drug Development
George Y. Tokiwa, Ph.D., Associate Principal Scientist, Clinical Genetics, Merck Sharp & Dohme Corp.
Many pharmaceutical companies maintain biorepositories of clinical specimens collected during clinical studies that are consented for future biomedical research. This presentation will focus on best practices to address the end to end clinical specimen management activities required to support optimal and compliant use of the specimens.
3:50 When Worlds Collide: Sharing A Vision for an Integrated Clinical Trial Management System
Hank Wu, Director, Translational Informatics, Remedy Informatics
Mr. Wu will discuss data strategies to facilitate a more efficient flow of information enterprise-wide between disparate, yet key players in life sciences research and healthcare—such as clinical trial teams, hospitals, labs, biobanks, and others—in order to deliver on and advance the promise of personalized medicine.
4:20 Valentine’s Day Celebration in the Exhibit Hall with Poster Viewing
5:20 Breakout Discussions in the Exhibit Hall
These interactive discussion groups are open to all attendees, speakers, sponsors and exhibitors. Participants choose a specific breakout discussion group to join. Each group has a moderator to ensure focused discussions around key issues within the topic. This format allows participants to meet potential collaborators, share examples from their work, vet ideas with peers, and be part of a group problem-solving endeavor. The discussions provide an informal exchange of ideas and are not meant to be a corporate or specific product discussion.
Translational Strategies to Support Combination of Cancer Immunotherapy with Chemotherapy and Radiation
Rakesh Dixit, Ph.D., DABT, Vice President, R&D and Global Head, Biologics Safety Assessment, MedImmune
Understanding the MOAs of potential combinations
How to select the best possible combinations to maximize efficacy and DFS
What combinations may work and may not work
PHC strategies and diagnostics
Preclinical studies to support combinations
How to conduct safety risk assessment for combinations
The Application of Next-Generation Sequencing as a Tool for Translational and Clinical Research
Philip Brohawn, Manager, Research & Development, Translational Science, MedImmune
With the declining cost of whole genome sequencing, what role is it likely to play as a clinical research tool?
With the boost in sensitivity for detecting low frequency mutations by NGS, will there be a practical update for currently existing molecular diagnostics based on mutation detection?
What is the promising aspect of next-generation sequencing as it applies to translational and clinical research?
6:30 Close of Day
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