July Event: Clinical Pharmacology –
Clinical Pharmacology – The Funner Science
Wednesday, July 17, 2019
Event Agenda:
Date: Wednesday, 17 July 2019
Time*:
5:15 – 6:00 PM Registration, Snacks, & Networking
6:00 – 6:05 PM Welcome and Announcements
6:05 – 7:05 PM Program Presentation
7:05 – 7:30 PM Q & A *Times are approximate.
Speaker:
Ronald J. Christopher, PhD, DABT, FCP
President
Parallel 33 Consulting, Inc.
Program Topic:
Clinical pharmacology captures the science that studies the characteristics, effects, properties, reaction and uses of drugs – especially their therapeutic effect in humans. The field focuses on drug action and incorporates a broad range of subjects including toxicology, safety, pharmacodynamics, pharmacokinetics and drug metabolism. The aim of this presentation is to provide an overview of the discipline of clinical pharmacology and its role as the quarterback in drug development from a scientific and regulatory perspective.
Currently, there are more than 150 reference products for biosimilars which offer promise of new, cost-saving competition despite the many manufacturing and approval challenges. From the regulatory perspective, a number of agencies have adopted principles from the US and/or the EU biosimilar guidances. However,specific guidelines are yet to be established for some major markets. A global development strategy is still evolving and, in time, it will determine how biosimilars will be regulated and marketed globally.
Key topics covered will include:
Introduction to Clinical Pharmacology
History of the field of Clinical Pharmacology
Overview of the development of a therapeutic and the integration of disciplines that comprise clinical pharmacology
Review of key regulations (US, EU, ICH) that impact clinical pharmacology testing
What constitutes clinical pharmacology content in a drug labelFuture innovations in the clinical pharmacologists’ toolkit
Speaker Biography:
Ron Christopher, PhD, D.A.B.T., FCP, is a full-time consultant and provides professional scientific and regulatory support in clinical pharmacology, toxicology, and DMPK in drug development, as specified by IND, BLA, and NDA requirements. His expertise lies in directing and managing nonclinical/early clinical development activities supporting development of small molecules, protein conjugates, monoclonal antibodies, cellular therapies, infectious disease and gene therapies in the pharmaceutical industry. Ron received his doctorate in Veterinary Toxicology from Texas A&M University and is a Diplomat of the American Board of Toxicology and Fellow, American College of Clinical Pharmacology. In his most recent role, he was Vice President, Drug Development at Arena Pharmaceuticals, Inc. (San Diego, CA). Prior to joining Arena Pharmaceuticals, Ron served in various management roles within the research and development industry, to include Takeda Pharmaceuticals, Johnson & Johnson, Schering-Plough, Bayer, and Ligand Pharmaceuticals.
Location:
Pfizer Inc.
10770 Science Center Drive (visitors center)
Conference Room #1110
San Diego, CA 92121
** Please make your reservation early. The pre-registration due date is Monday, 15 July 2019. Advanced registration is appreciated to assist in event planning.
** A photo ID is required to sign in at the venue.
** Space is limited for our monthly programs. Registration is capped at 85 participants. Register today to ensure your seat. Once our limit is reached, registration will close. Events with closed registration will not allow walk-ins.
Online registration (through Monday 15 June 2019 ): $15 SDRAN Member
$25 Non-Member
Onsite Registration: $25 SDRAN Member
$35 Non-Member
For Questions Email: programs@sdran.org
DIRECTIONS:
From the North:
I-5 South toward San Diego
Take Exit 29, turn left into Genesee Ave
Turn right onto Science Center Dr
CB2 Visitors Center is located at the end of the cul-de-sac
From the South:
I-5 North toward Downtown
Take Exit 29, turn right into Genesee Ave
Turn right onto Science Center Dr
CB2 Visitors Center is located at the end of the cul-de-sac
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