Rene A. Braeckman, Ph.D.
Who Should Participate:
This course is well-suited to pharmacologists and chemists in discovery, and pharmacokineticists providing
discovery support.
Technical Platform
and Requirements:This
45-minute course is contained within a standard CD-ROM. Requirements
include a 486 or faster PC running Windows 9x, a CD-ROM player,
sound card, and speakers. Included on the disk is a copy of PowerPoint
97 Viewer, which is required to view the course content, and which
must be installed in the default directory in order to properly
utilize the menu-driven program. |
| About
the Course:
Traditionally,
potential drug candidates in the discovery phase are optimized for
pharmacological activity. It
is now generally recognized that early optimization for optimal human
pharmacokinetics (PK) is also very important, mainly because otherwise
failure due to poor PK in the later stages of drug development is high.
This 45-minute course outlines a practical strategy for the implementation and
integration of in vitro and in vivo preclinical testing for pharmacologic,
pharmaceutic, PK, and toxicologic drug characteristics, for a young, very
small pharmaceutical company. As
resources may be limited and most activities are outsourced, the “Small
Pharma” implementation uses a tiered approach where fast, cheap, in
vitro tests are done first, and more expensive, elaborate experiments
(mostly in vivo) are done later. Therefore,
particular attention is given to the sequence and the costs of
experiments. In addition, to
optimize decision making, selection characteristics of the ideal drug
candidate and go/no-go criteria are well defined at each stage.
About the Presenter:
Rene Braeckman, Ph.D., joined Pan Pacific Pharmaceuticals in June 2000 as Vice President, Drug Development. Dr. Braeckman is an expert in preclinical and clinical pharmacokinetics, pharmacodynamics, and drug metabolism, with broad experience in preclinical drug development, including areas such as pharmacology, toxicology, and regulatory affairs. Dr. Braeckman came from Ceptyr where he was Vice President of Pharmaceutical Development, responsible for leading and managing the planning, initiation and execution of preclinical development activities with new drug candidates.
Previously, Dr. Braeckman was Senior Director of Pharmacokinetics and Preclinical Development at Chiron Corporation. He served as a core member of several development teams, evaluated new drug opportunities, and contributed to the preclinical and clinical sections of several successful IND/CTX and NDA/PLA filings across a broad array of therapeutic areas including metabolic diseases, cancer, cardiovascular disease, thrombosis, sepsis, and CNS diseases. While at Chiron, Dr. Braeckman managed numerous in vitro, preclinical and early clinical development activities at contract research organizations.
Previous to joining Chiron, Dr. Braeckman held positions at Abbott Laboratories as a specialist in pharmacokinetics and pharmacodynamics, where he contributed substantially to preclinical and clinical regulatory filings.
Dr. Braeckman received his Pharmacy degree and a Ph.D. in Pharmaceutical Sciences from the University of Gent, Belgium. He also received specialist degrees in Industrial Pharmacy and Clinical Pharmacy. He has published more than 30 research papers and book chapters, and more than 60 abstracts in the field of pharmacokinetics, pharmacodynamics, and preclinical development, both for small molecule drugs and biologics.
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