ABCs of the FDA – How to… Set a Preclinical Roadmap
When:
Tue, 10 November, 11:30am – 1:00pm
Where:
JLABS - 3210 Merryfield Row - San Diego, CA 92121
Description
For details, click here: https://www.google.com/url?q=https%3A%2F%2Fwww.eventbrite.com%2Fe%2Fabcs-of-the-fda-how-to-set-a-preclinical-roadmap-registration-17170272748&ust=1441873711930000&usg=AFQjCNHB-qwUDwD5_YRp2UEa9vrA2UZAsQ
Agenda
Translation is a team sport and NCATS wants to play
Program Overview:
Moving a program from Discovery through Development is an arduous task. Key among these challenges is designing a safe and druggable molecule that can withstand the rigors of preclinical testing in support of First in Human (FIH) trials, human Proof of Concept (POC), and finally global drug registration. This session will highlight design considerations to optimize drug disposition and safety characteristics in the Discovery phase, to ensure the preclinical road in Development is a smooth one. In addition, you will learn what startups need to know about preclinical requirements and resources to support early clinical trials through Human POC. This workshop is geared towards pharmaceutical and biotech startups.
Topics will include:
- Key drug metabolism, pharmacokinetic and toxicology characteristics that should be considered in molecule design
- Preclinical requirements to support FIH trials and POC
- Evaluating preclinical resources (consultants and CROs) to support your program
- Hiring your first Preclinical FTE The "How to... Workshop" series is dedicated to giving you the keys to a successful business, from creation to exit. As with all our events, the "How to... Workshop" is interactive and informal so bring your questions with you!
Agenda:
11:30am | Registration, Networking and Lunch
12:00pm | Presentation
12:30pm | Q&A
1:00pm | Close
Speaker:
Sandra Snook | Senior Director, Preclinical Development & Safety, Janssen Research & Development
Fees:
$35 General Public
$20 Student/Academic
$45 At the door
Speaker's Biography:
Sandra Snook | Senior Director, Preclinical Development & Safety, Janssen Research & Development
Sandra has been supporting the preclinical development of small molecules for 23 years. She is a DVM and board certified Veterinary Pathologist and after a stint in academics moved to GD Searle/Pharmacia where she worked for 11 years supporting late Discovery and Development small and large molecule projects. In 2003 she took on the mission to form the nascent Preclinical Development & Safety group for Janssen's La Jolla site. She has worked across therapeutic areas including infectious, metabolic and cardiovascular diseases, immunology, neuroscience and oncology. She has lead staff supporting toxicology and DMPK project support as well as laboratory animal medicine, investigative toxicology and molecular pathology. She and her team have extensive experience supporting innovative compound development from lead optimization through global registration; including managing the preclinical portion of external alliances and partnerships. Her team is frequently called upon to participate in critical due diligence reviews of potential licensing deals. For the last few years Sandra has also lead the Janssen Imbruvica preclinical development team, one of the first drugs to successfully navigate the Breakthrough Drug designation at the FDA. Sandra received her AB degree from The University of Chicago, a DVM from Iowa State University and served as a post-doctoral fellow in Comparative Pathology at Harvard University. She served on the faculty of The University of Chicago where she had independent research funding (NIDA) and ran a comparative pathology diagnostic laboratory supporting the LAMS organization in addition to the Lincoln Park Zoo and Shedd Aquarium. She is an author on 21 papers.
