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Re: lunatick post# 2498

Friday, 09/18/2015 8:02:34 AM

Friday, September 18, 2015 8:02:34 AM

Post# of 3108
STEM CELL MEETING ON THE MESA
Agenda
Day 1 Partnering Forum Wednesday October 7, 2015

"
MANUFACTURING & SCALE-UP WORKSHOP
7:00am – 9:00am | CONCURRENT WORKSHOPS
7:15am – 8:45am | Learning Theater
Sponsored by PCT, a Caladrius Company

As practitioners in the development of the regenerative medicine industry, we are often compared to those that came before us in the biologics industry. In fact, whilst the challenges to commercial success in this industry are real, just as in the industries that we are being compared to, solutions are forming along the lines of the unique challenges presented. That being said, are we really that different than our biologics industry predecessors? What lessons can we learn from how they solved the challenges of developing novel and game changing therapeutics that didn’t quite fit their predecessors in the small molecule drug development industry? As we contend with the key issues including dose finding, optimal route of administration and frequency of administration for our therapeutics, it is often said that, in regenerative medicine, traditional drug and then biologic paradigms of pharmacokinetic (PK) and pharmacodynamics (PD) modelling are difficult, if at all possible to directly apply. This session is intended to bring experts on the topic of how PK/PD models have been adapted to biologics to describe the relation between dosing, concentration and efficacy, in an attempt to inform the practices and approaches of today’s regenerative medicine development professionals.

Chair:
Robert Preti, Ph.D., Co-Founder & President, PCT, a Caladrius company; SVP, Development & Technical Operations & Chief Technology Officer, Caladrius Biosciences

Speakers:
Frank Borriello, M.D., Ph.D., VP, Head of Search & Evaluation, Baxalta
Andrew Weber, Investigator, Modeling & Translational Biology Group, GlaxoSmithKline"



also look at COMPANY PRESENTATIONS {Ballroom 1}

http://stemcellmeetingonthemesa.com/agenda/
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