Welcome to the CBIIT Speaker Series Wiki
This presentation will provide an overview of how CDER’s Computational Science Center (CSC) is integrating bioinformatics and analytics into the regulatory review environment. There are a number of components that work together to enable reviewers to utilize analytical tools to assist them in answering regulatory review questions and making decisions. These components include guidance and rule development, submission and use of standardized data, data validation, analytical tools that support data exploration from the reviewer perspective, and repositories to allow data integration. The CSC is a program that provides services to CDER, and review divisions to implement the components and facilitate analytical tool skill development.
April 16: James Lacey, Ph.D., Faster, Safer, Cheaper, Better: How CRM and Cloud Computing Can Help Studies Collect, Store, Use, and Share Data
Data drive research, but many studies use inefficient legacy technologies to manage their data. Better tools now exist for collecting, storing, using, and sharing data. For a large-scale new biobanking project within the prospective California Teachers Study cohort, we leveraged cloud computing and a Customer Relationship Management (CRM) system to build a novel data management system that provides real-time, on-demand access to all data, eliminates data silos, and reduces data management costs. We use mobile phones and tablets to ensure study-wide protocol compliance, guarantee high-quality data entry, and increase staff productivity. This presentation will describe why CRM and cloud computing are good for research and how we implemented our innovative system to achieve these results. We encourage other investigators to consider similar approaches and will discuss lessons learned from our experience.
April 2: Cheryl Marks, Ph.D., The Oncology Models Forum: An Interactive Platform for Collaborative Translational Research
The NCI Mouse Models of Human Cancers Consortium has provided a focus on animal cancer models for the last 15 years. However, the program ends in 2014, and a new entity is needed to extend the outreach and educational aspects of the Consortium to support new directions for translational applications of animal models. Dr. Marks will describe a new NCI program, an open Oncology Models Forum. The Forum will provide the cancer research community with a comprehensive resource for information to guide generating, validating, and credentialing new models, informing their practical uses, advancing modeling techniques, and providing catalogs of available models-related resources, programs, and services. The goal of the Forum program will center on effective, reliable use of mice, mouse models, and human-in-mouse models in translational cancer research. Key to the success of the Forum will be use of the HubZero® platform to enable collaborators from anywhere to work together on common problems that pertain to animal models.
March 19: Maxwell Lee, Ph.D., Integrated Studies of Breast, Esophageal, and Gastric Cancers Using High-Throughput Technologies and Computational Analyses
Cancer is a complex group of diseases with many causes. Genetic changes and epigenetic alterations in somatic tissues, as well as germ line mutations or risk alleles, all contribute to cancer development and progression. Dr. Lee will present integrated studies of breast, esophageal, and gastric cancers through collaborative research with many investigators in CCR and DCEG. He will discuss a broad range of topics: from GWAS to whole genome sequencing studies; from genomics to functional studies; from genes to signature studies; from experiments to computational analyses; and from data to knowledge discovery. Dr. Lee will talk about how interweaving high-throughput data with bioinformatics analyses enables us to gain a better understanding of cancer biology and etiology.