According to research data specialists, 79% of their time is spent finding and organising data. The FAIR (Findable, Accessible, Interoperable, Reusable) data guiding principles were created to save researchers time and help to maximise the impact of health data.
Practical implementation of these principles, however, is easier said than done. Join us for our virtual series: Driving FAIR in Biopharma and hear the lessons learned from implementation and benchmark how you can improve FAIRification programmes in your organisation.
In this 3-part series we're joined by FAIR champions implementing these principles to better govern data across the R&D value chain.
In this upcoming session, we will look into how drug discovery related data flows from CROs to pharma to regulatory agencies. We will discuss how the data flow is affected by FAIR data and its applications.
Ellen Berg Ph.D. is an entrepreneur and scientific leader in drug discovery technology innovation.
She is Chief Scientific Officer, Translational Biology for Eurofins Discovery and a principal at Alto Predict LLC. Dr. Berg was the lead inventor of BioSeek’s BioMAP platform of human primary cell-based disease models, now successfully commercialized by Eurofins and serving the pharmaceutical and consumer products industries to deliver safer and more effective products.
In previous positions, Dr. Berg was co-founder and CSO of BioSeek, Inc. and led a research team at Protein Design Labs, Inc.
She received her Ph.D. from Northwestern University and was a postdoctoral fellow at Stanford University School of Medicine, where she was a fellow of the American Cancer Society and a Special Fellow of the Leukemia Society of America.
She is currently focused on working with industry, academic, and government stakeholders to incorporate non-animal, human-based in vitro and in silico predictive models into the drug discovery process and helping to promote the adoption of these platforms by regulatory agencies.
Dr. Berg holds several patents in the field of inflammation, and has authored over 80 publications.
Isabella Feierberg, Ph.D. has over 15 years of experience as a computational chemist in drug discovery.
After her Ph.D. in computational studies of biomolecular structure-function relationships at Uppsala University in Sweden, she joined AstraZeneca where she supports the early drug discovery pipeline.
Her research ranges from individual drug discovery projects to method development for High Throughput Screening analysis, assay informatics, pre-competitive collaborations, and FAIR data.
Being an end-user of experimental data for analysis, modeling and decision making, she relies heavily on high-quality data and metadata.
Dr. Feierberg is currently involved with the Pistoia Alliance to plan a pre-competitive collaboration on high-quality curation and FAIRification of public domain assay protocols with public ontologies.
Dr. Callahan obtained his Ph.D. in Chemistry from the University of Chicago. He was previously employed at FDA, NIH and the U.S. Pharmacopiea (USP). He has been involved in Nucleic Acid, HIV, tuberculosis research and the development of analytical methods for biotechnology-derived products. He also has been responsible for the management and development of chemical/biological databases for the National Institute of Allergy and Infectious Disease (NIAID), National Library of Medicine (NLM), National Cancer Institute (NCI), and the Food and Drug Administration (FDA).
Dr. Callahan is currently responsible for the development and management of the FDA Global Substance Registration System (G-SRS). The goal of the SRS is to define all substances in FDA regulated products and assign a Unique Ingredient Identifier (UNII) to each substance and create meaningful relationships between substances. These relationships include impurities, metabolites, metabolic enzymes, transporter and target proteins along with specifications for active substances and LADMER data for substances and products. The G-SRS also links substances to products, applications clinical trials and adverse events.
Dr. Callahan and Dr. Frank Switzer were the primary editors of the ISO 11238 Standard for defining substance and with Dr. Herman Diederik of the Dutch Agency and the EMA are the primary editors of ISO TS-19844 document which is the implementation guide for defining all substances in medicinal products. Dr. Callahan is also the FDA lead on the Global Ingredient Archival System (GInAS) project, which attempt to integrate regulatory, toxicological, and clinical information on all substances in medicinal products.