Thursday, 26 May 2016 |
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. |
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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 |
Friday, 27 May 2016 |
Plenary Talk |
| | 09:00 | Health Technology Assessment of Biomarker Tests in Personalized Medicine
Franz Hessel, Professor, SRH University , Germany
This talk will discuss about the validity and feasibility of the fundamental principles of HTA and health economic evaluation for the evaluation of genetic biomarker tests in Personalized Medicine through careful adaptations of the existing guidelines. | |
Plenary Talk |
| | 09:45 | | 10:45 | Coffee Break and Networking Session | |
Session IV: Cancer Biomarkers |
| | 11:15 |  | Keynote Presentation Assessing Glioblastoma Tumor Burden by Cerebrospinal Fluid miRNA Profiling
Clark Chen, Co-Director, University of California-San Diego, United States of America
The talk will focus on using cerebrospinal fluid (CSF) derived exosomal miRNA signature as a liquid biopsy platform for assessing glioblastoma tumor burden. Issues pertaining to vesicle quantitation, normalization, optimal specimen storage condition, and influence of microenvironment will be discussed. |
| 12:15 |  | Keynote Presentation Genomic Approaches to Identify biomarkers for Esophageal Cancer in North East India
Sunita Saxena, Ex-Director & Consultant, National Institute of Pathology-ICMR, India
This Keynote talk will discuss about integrated genomic approaches under taken to understand molecular carcinogenesis of Esophageal Cancer (EC) and to identify biomarkers. Identification of five different genes COL11A1, FGF12, PAK1, DLC1 and NPHP4 using different bioinformatics tools along with other assays will be covered. It will further discuss about genome wide differential methylation profiling and integrome analysis of esophageal squamous cell carcinoma (ESCC) patients and their results. |
| 13:15 |  Technology Spotlight:
Understanding the Importance of Extracellular Vesicles
Namrata Jain, Product Technical Specialist- Nanometrics Bioscience, Malvern Aimil Instruments Pvt Ltd
In this talk, role of Malvern NanoSight Nanoparticle Tracking Analysis (NTA) system for enumerating and speciating Extracellular particles will be discussed. It will further mention how NanoSight has a growing role in biodiagnostics as an analytical platform of choice.
| 13:30 | Lunch Break and Networking Session | |
Session V: Biomarkers as Drug Targets in Brain Disorders |
| | 14:30 | Biomarker(s) for Prognosis of Brain Stroke
Rajpal Singh Kashyap, Senior Scientist (Medical) and Head, Central India Institute of Medical Sciences, India
This talk will discuss about biomarkers development for prognosis of acute ischemic stroke (AIS). It will specifically focus on evaluation of time course of inflammatory cytokines in AIS patients and their correlation with Inter-Alpha Trypsin Inhibitor Heavy Chain 4 (ITIH4), and outcome after AIS. | 15:15 | MicroRNAs as Biomarkers and Therapeutic Targets for Autism
Anitha Ayyappan Pillai, Associate Professor, Institute for Communicative and Cognitive Neurosciences , India
In this talk, the role & expression of miRNAs in the human brain and their dysfunction during Autism will be discussed. It will also discuss how miRNA-based therapeutics holds a great potential for genetically complex disorders such as autism. | 16:00 | Coffee Break and Networking Session | |
Session VI: Novel Biomarkers and Approaches |
| | 16:15 | | 17:15 | Is Urine a Better Biomarker Source than blood?
Youhe Gao, Professor, Beijing Normal University, China
This talk will discuss the advantages of urine over blood since blood has mechanisms to minimize changes and to keep the internal environment homeostatic while urine is more likely to reflect changes of the body and is a better biomarker source. It will also mention that due to information available only in blood, not urine, the researchers and/or companies in biomarker field may easily take advantage of the free information and try to validate them in urine. It will finally highlight disadvantage of urine due to complication involved. | 18:00 | End of Conference |
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