2014 Archived Content

Cambridge Healthtech Institute’s Tenth Annual

Clinical and Translational Science

Strategies to Accelerate and De-Risk Clinical Development

February 10-12, 2014 | Moscone North Convention Center | San Francisco, CA


Day 1 | Day 2 | Day 3 |  Download Brochure 

Tuesday, February 11

7:00 am Registration and Morning Coffee

8:00 Plenary Keynote Session (Click Here For More Details)  

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 Enjoy 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 Biospecimen Sample Integrity and Validation of Biomarkers in Clinical Trials

Lokesh Agrawal, Ph.D., Program Director, Biorepositories and Biospecimen Research Branch (BBRB), Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute

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

Bruce Pharr, Vice President, Product Marketing Laboratory Systems, Remedy Informatics

Mr. Pharr 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

Day 1 | Day 2 | Day 3 |  Download Brochure 


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