PK/PD-based Development of Anti-infective Agents
by
Hartmut Derendorf, PhD
University of Florida, Gainesville
February 13, 2012
1:00 - 2:00 pm EDT
It is my pleasure to announce that that Dr. Hartmut Derendorf will start the
2012 Rosa Impact Webinar series by presenting PK/PD-based Development of
Anti-infective Agents on February 13, 2012 at 1:00 pm EDT (GMT -5:00).
The cost of drug development has exploded in recent years and risen to a
level that soon will no longer be affordable to society. The public
expectation of drug safety and guaranteed therapeutic success has become
unrealistic. As a result, the number of new drug approvals can be expected
to go down in the near future, a trend that is already noticeable in drug
classes with low market potential due to short term therapeutic use, e.g.
antibiotics. One reason for the high cost of drug development is the many
unnecessary studies, where the results could have been predicted with
reasonable certainty. PK/PD modeling is a tool that can be used to collect
and integrate all the available information about a drug candidate and its
class in order to make rational decisions on studies that will decrease the
uncertainty of the compound. It is based on quantitative data on drug
exposure and response, and it is particularly well suited to address the
question of dose determination and optimization. In the drug development
process, it bridges the complete cycle, from discovery to clinical use. The
advantage of this approach is to define objective go/no-go decision criteria
for the development process, rather than relying on subjective empirical
decisions. There is no way that, today, all developing questions can be
answered by experimental evidence; modeling and simulation is a powerful
alternative approach. This modeling and simulation approach is of particular
need in the field of new anti-infective agents, where the rise of resistance
has become an international threat to society. However, very few drug
companies are currently developing new antibiotics, due to the poor
prospects of return on investment. However, the cost of anti-infective drug
development can be dramatically lowered by applying pharmacometric concepts
and selecting some key experiments based on pharmacokinetic/pharmacodynamic
(PK/PD) concepts. Using microdialysis, it is currently possible to measure
local exposure at the infection site in both animals and humans. This PK
information is much more useful than traditional serum pharmacokinetics.
Furthermore, pharmacodynamic activities can be captured more precisely by
analyzing time-kill curves, rather than simple minimum inhibitory
concentrations (MICs). Examples from various classes of antibiotic drugs
will be presented, where these concepts are applied and illustrated.
Application of these concepts will help to develop new anti-infective
treatments at low cost to combat resistance development with optimum
efficacy and safety. The purpose of the "Impact" series is to foster the use
of M&S activities in all phases of drug development by illustrating the
advantages and enhancing the applicability of M&S in product discovery,
development, and marketing programs. The series is intended for drug
development project team members from discovery to phase 4 clinical trials.
This includes pharmacologists, ADME scientists, PK/PD modelers, clinical
pharmacologists, clinical development team members, regulatory affairs
specialists, and other interested professionals.
Register for this free webinar at www.rosaandco.com/webinar. After
registering you will receive a confirmation email containing information
about joining the webinar. More information about the webinar series, an
archive of past webinars, and a list of future webinar speakers may be found
at www.rosaandco.com/webinar.
Please allow 5-10 minutes for a Java applet to be installed on your computer
prior to joining our webinar series for the first time.
Toufigh Gordi, PhD
President, PK/PD and Clinical Pharmacology Services
Rosa & Co. LLC: www.rosaandco.com http://www.tgordi.com/
E-mail: [email protected] <mailto:[email protected]>
Tel.: 408-480-7314
Fax: 408-370-9810
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