Director, Preclinical Affairs at PDS, Inc
Dr. Laura Kaufman is a board-certified toxicologist (DABT) with extensive nonclinical pharmaceutical, biotech, and biodefense drug development experience. She earned her PhD in anatomy (neuroscience) from the University of Pennsylvania and completed a post-doctoral fellowship at The Rockefeller University, where her research centered on estrogenic modulation of muscarinic receptors in rat hypothalamus. She served as department head of nonclinical safety, exploratory toxicology, and cardiovascular safety pharmacology in large pharma (Wyeth) and in smaller biotech companies (Enzon, Elusys). Her experience spans large and small molecule development across most therapeutic areas, and she has played pivotal roles in designing novel ways to screen compounds for safety, resulting in several marketed products. Dr Kaufman's current interests center on standardized electronic formats for nonclinical data (SEND or Standard for Exchange of Nonclinical Data) and how they can be leveraged to facilitate drug development. She is an active member of PhUSE and CDISC and co-chair of several FDA/PhUSE working groups, including the Nonclinical Study Data Reviewer's Guide Working Group.
Live Sessions Not Found.
Are You Ready For The FDA's Mandate Requiring Electronic Submission Conformance to SEND and SDTM?
In this course, we will examine the 'why' behind the mandate and how it can change the way therapies are being developed, leading to faster market delivery of better drugs. We will explore FDA's vision of having electronic access to all submission data in ways that are not currently feasible. The electronic standards for exchange of nonclinical data (SEND) and clinical data (SDTM), developed by CDISC, will be discussed, focusing on SEND.
Get life time access for one participant with download option!
SUBSCRIBE TO NEWSLETTER
Get industry updates and exclusive deals on offers!