Tissue Phenomics: From Biomarker Discovery to Clinical Diagnostic Assay Commercialization
Dr. Thomas Nifong, Executive Vice President, Diagnostic Tests, Definiens, Boston, Massachusetts, USA
Definiens’ Cognition Network Technology® (CNT) provides detailed tissue biomarker readouts from digital pathology slides, and enables the correlation of this information with clinical outcome and genomic data, an approach known as Tissue Phenomics. The manual approach to analyzing tissue provides mostly limited, qualitative information. However using CNT, thousands of quantitative,...
Tissue Quality and Clinical Data: The Bottleneck for Drug and Biomarker Development
Dr. Hartmut Juhl, Chief Executive Officer, Indivumed GmbH, Hamburg, Germany
Identification of drug targets as stratification and predictive biomarkers in patient populations by analyzing surgically resected tissues has become an important field in drug development. However, considerable research data demonstrate that RNA and protein expression level, including activation or inhibition of signaling pathways and their receptors can change significantly within...
Measurement of Target Engagement and Pharmacodynamic Response to Investigational Anti-Cancer Agents in Phase 1 Clinical Trials
Dr. Robert J. Kinders, Senior Principal Scientist and Head, Pharmacodynamics, Laboratory of Human Toxicology and Pharmacology, Frederick National Laboratory for Cancer Research, Frederick, Maryland, USA
Phase 1 Clinical trials of candidate anti-cancer agents are intended to establish the Maximum Tolerated Dose of the agent. In current practice, evidence of activity of the agent on the intended target is also a requirement in NCI-funded trials. The nature of these early clinical trial designs significantly impacts the...
Development of an Encapsulated Cell Replacement Therapy for Diabetes
Dr. Olivia G. Kelly, Director, Cell Biology, ViaCyte, Inc., San Diego, California, USA
ViaCyte Inc. is a clinical stage company developing a stem cell-based islet cell replacement therapy for treatment of patients with diabetes. The therapy is a combination product comprised of pancreatic progenitors, PEC-01™ cells, encapsulated within a retrievable delivery device, ENCAPTRAR Drug Delivery System. After implantation, encapsulated progenitor cells mature into...
Imaging and Analysis of RNA Biomarkers In Situ via RNAscope and SpotStudio
Dr. Xiao-Jun Ma, Chief Scientific Officer, Advanced Cell Diagnostics, Hayward, California, USA
RNA in situ hybridization (ISH) is a powerful tool for establishing spatial and cell type-specific gene expression in tissue. Traditional RNA ISH methods are technically challenging to perform and lack sufficient sensitivity and specificity for most clinically relevant biomarkers. RNAscope is a novel RNA ISH technology capable of detecting RNA...