september, 2015

10sep11:30 am1:00 pmABCs of the FDA – How to… Set a Preclinical Roadmap


Event Details

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 workshop will feature Michael Kelley, VMD, PhD, DABT, Senior Scientific Director with Janssen Research & Development. Mike has over 25 years of industry experience and has held leadership positions in both small and large biopharmaceutical companies.

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!

11:30am | Registration, Networking and Lunch
12:00pm | Presentation
12:30pm | Q&A
1:00pm | Close

Michael Kelley, VMD, Ph.D., DABT | Senior Scientific Director, Janssen Research & Development read bio»

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

JLABS @LabCentral
700 Main St
Cambridge, MA 02139

Speaker\’s Biography:
\'MichaelMichael Kelley, VMD, Ph.D., DABT | Senior Scientific Director, Janssen Research & Development
Mike is currently Senior Scientific Director/Head of Preclinical Projects & Submissions at the Janssen R&D site in Spring House, PA. As part of this role, he is responsible for a portfolio of discovery and development projects in the Oncology, Cardiovascular and Metabolism therapeutic areas. Mike is also the Janssen R&D preclinical scientific liaison to the Johnson & Johnson Boston Innovation Center. Mike has more than 25 years of preclinical experience working for small and large biopharmaceutical companies. He is a full member of the Society of Toxicology, Past-President of the Mid-Atlantic Chapter of the Society of Toxicology, and a Diplomate of the American Board of Toxicology. Mike received his BA and VMD degrees from the University of Pennsylvania, and his PhD in toxicology from Texas A&M University.


(Thursday) 11:30 am - 1:00 pm