ABCs of the FDA - How to... Set a Preclinical Roadmap

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10/11/2015 12:30 10/11/2015 14:00 America/Los_Angeles ABCs of the FDA - How to... Set a Preclinical Roadmap JLABS , 3210 Merryfield Row , San Diego , CA 92121 JLABS San Diego false DD/MM/YYYY
November
10
Event

ABCs of the FDA - How to... Set a Preclinical Roadmap

JLABS , 3210 Merryfield Row , San Diego , CA 92121

November 10, 2015 from 12:30 PM to 14:00 PM (PDT)

$10 - $35


JLABS SAN DIEGO EVENT 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 read bio»

Fees:
$35 General Public
$20 Student/Academic
$45 At the door

Location:
JLABS
3210 Merryfield Row
San Diego, CA

Speaker's Biography:
Sandra Snook 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.


JLABS San Diego

Johnson & Johnson Innovation, JLABS (JLABS) is a global network of open innovation ecosystems, enabling and empowering innovators to create and accelerate the delivery of life-saving, life-enhancing health and wellness solutions to patients around the world. JLABS achieves this by providing the optimal environment for emerging companies to catalyze growth and optimize their research and development by opening them to vital industry connections, delivering entrepreneurial programs and providing a capital-efficient, flexible platform where they can transform the scientific discoveries of today into the breakthrough healthcare solutions of tomorrow. At JLABS we value great ideas and are passionate about removing obstacles to success to help innovators unleash the potential of their early scientific discoveries. JLABS is a no-strings-attached model, which means entrepreneurs are free to develop their science while holding on to their intellectual property. JLABS is open to entrepreneurs across a broad healthcare spectrum including pharmaceutical, medical device, consumer and digital health sectors. The JLABS flagship opened in 2012 in San Diego at Janssen's West Coast Research Center, and since then has grown to eight locations including the Bay Area, Boston & Lowell, MA, Houston, Toronto and a ninth location, New York City, launching in 2018. For more information please visit jlabs.jnjinnovation.com.

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