| Agenda |
| |
08:00 | Registration |
| Plenary Talk |
| |
09:00 | | Keynote Presentation The Business of Bringing Biomarkers to the Clinic Anka Ehrhardt, Director, Clinical Cytometry, Bristol-Myers Squibb, United States of America
This presentation will focus on a few key considerations in the planning and execution of biomarker work when moving biomarkers from discovery into development, with a special emphasis on the requirements for clinical trials of increasing scale and complexity. With relevant examples, this presentation will illustrate the high impact which the right considerations in the right place will have on the success of biomarkers as business drivers. |
|
| Session I: Biomarkers In Early Phase Drug Development |
| |
10:00 | Biomarkers in Early Clinical Development – Selection and Utilization John Lambert, Chief Medical Officer, PAREXEL International, United Kingdom
|
10:45 | Biomarker Assessment in Clinical Phases of Drug Development Michael D Silva, Principal Investigator, BBRC- Syngene International Limited, India
This talk will focus on implementation of flow cytometry based biomarker assays into clinical trials to contribute in better understanding of target engagement, PK/PD activity, dose selection, safety/efficacy that enables patient stratification and potentially predict clinical outcome. |
11:30 | Coffee Break and Networking Session |
| Session II: Insights into Assay Development for Biomarkers |
| |
12:00 | | Keynote Presentation Biomarkers in Drug Discovery and Diagnostics Development Ramesh K Goyal, Executive Director (Research & Strategies), V ClinBio Labs Pvt Ltd, India
This talk will focus on various biomarkers like MIF and EGFR, for the development of newer anticancer drugs. It will also discuss about the application of various pharmacogenomic and cytokines panels and miRNA as biomarkers for the development of diagnostics for the prevention of progression of diabetes induced complications like foot ulcer, pregnancy-induced miscarriages etc. |
|
13:00 | Immunohistochemistry Based Assay Development of Clinical Biomarkers Malini A Venkata, Lead Investigator, Biocon Bristol Myers Squibb, India
This talk will discuss about IHC as a platform for sample analysis for development of IHC- based biomarkers. Further, it will mention how these predictive biomarkers guide the identification of new immunotherapeutic interventions. |
13:45 | Lunch Break and Networking Session |
| Session III: Taking Biomarkers from Research to Clinics |
| |
14:45 | Imaging Biomarkers – From Research to Clinical Practice Edwin van Beek, SINAPSE Chair & Director, Clinical Radiology & Clinical Research Imaging Centre, University of Edinburgh, United Kingdom
This presentation will give some highlights of areas of research where the methods like imaging and software tools for visualization are relatively advanced along with some examples where clinical and routine applications are being implemented. |
15:30 | POC Testing: Biomarkers from Research to Clinic Lakshmi V Ramanathan, Chief, Clinical Chemistry Service, Memorial Sloan Kettering Cancer Center, United States of America
This talk will address the challenges POC tests pose. Further, it will emphasize important factors like quality control, confirmatory testing, training of personnel performing the tests, regulatory guidelines compliance etc in order to provide the most accurate result to the patient. Specific examples will be discussed demonstrating the partnership between industry, the laboratories, point of care testing, and the clinical team in the ultimate care of the patient. |
16:15 | Fit-for-Purpose Gene Expression-based Clinical Biomarkers in Oncology and Immuno-Oncology: Why and How? Shashwati Basak, Lead Investigator & Head-Clinical Genomics, BBRC, Syngene Intl Ltd, India
This talk will discuss about development and use of RT-qPCR technology as a robust, accurate and reproducible method for biomarker assay qualification during early clinical phases. Key factors influencing assay performance such as sample matrix, sample preparation, experimental precision, reproducibility, sensitivity, specificity, dilution linearity and dynamic range and their impact on the assay outcome will be discussed. Based on these, recommendations for consideration and optimization of a qPCR-based biomarker assay will be put forth. Lastly, representative examples of safety/efficacy and pharmacodynamic biomarkers that have contributed to early decision making in Oncology and Immuno-oncology clinical trials will be demonstrated. |
17:00 | Coffee and End of First Day of Conference |