ISAP Symposium on PK/PD in drug development and registration

ISAP International symposium (Birmingham, U.K., July 3d-4th, 1999)

Pharmacodynamics and Pharmacokinetics as a Way to accelerate Drug Discovery, Development and Registration

An official satellite meeting to the 21st International Congress of Chemotherapy

Organizers: G.L. Drusano (Albany, NY) & Paul M. Tulkens (Brussels, Belgium)

Pre-meeting Introduction (goals and objectives)

The slides presented by the some of the speakers at this workshop are available on this site as "Web slide shows". To view them, click on the title of the lectures. These slides, which reflect the views of their authors and should not be taken as being endorsed by ISAP, are for information purposes only. They cannot be reproduced or used for any form of presentations without the autorization of their author and of ISAP. Please, contact the ISAP Webmaster for further information.

! only a few presentations are available as slides right now. More will come. Please, call again !

ISAP Welcome and Introduction (P.M. Tulkens, Cathol. University of Louvain, Belgium)
Use of pharmacodynamic principles in the drug discovery process (M. Zeckel, Lilly Research Laboratories, USA)
Use of PK/PD principles in drug selection and development: activity issues (G. L. Dusano, Albany Medical College, USA)
In vitro pharmacodynamic models as a way to accelerate and fine-tune the development of new antiinfectives(A. MacGowan, Bristol Center for Antimicrobial Research and Evaluation, UK)
In vitro toxicodynamic models to accelerate drug selection and safety assessment (F. Van Bambeke, Cathol. University of Louvain, Belgium)
Lab to Phase II Trial: Use of Microbiology, Animal Model Data and Phase Data for Dose Selection of antibiotics (W.A. Craig, Middletown Memorial Veterans Hospital,, Madison, USA)
The definition of the mutation preventing concentration (MPC) and its use to define the clinical dosing of antibiotics (X. Zhao, Public Health Research Institute, New York, USA)
The pharmacodynamics of intracellular antibiotics: beyond drug accumulation ? (P.M. Tulkens, Cathol. University of Louvain, Belgium).
Mathematical models as a tool to predict (and prevent ?) emergence of resistance during antiinfective commercial life (A. Baquero, Ramon y Cajal Hospital, Madrid, Spain)
Have PK/PD concepts really been incorporated in the most recent development of antibiotics ? (Axel Dalhoff, Bayer AG, Wuppertal, Germany)
Pharmacokinetics and Pharmacodynamics in the Process of Drug Registration: Regulatory position / Regulatory concerns (B. Aronsson, EMEA, London, UK)
Pharmacokinetics and Pharmacodynamics in the Process of Drug Registration: A Present View from the the US regulatory agency

Microbiological aspects (S.S. Altaie, FDA, Rockville, USA)
Pharmacological aspects (P. Colangelo, FDA, Rockville, USA).

Goals and objectives

Over the last ten years, our understanding of the pharmacodynamics of antiinfective chemotherapy has markedly improved and has reached the point where this science may, and even must, be taken into consideration for the proper development of new agents. By using such information researchers, regulators and clinicians can achieve the goal of maximal therapeutic effect while reducing the risks of encountering drug exposure-related adverse events.

What is perhaps even more important, is that a proper understanding of the pharmacodynamics of antiinfectives may greatly reduce the risk of creating bacterial or viral resistance to the new drugs. This is becoming of paramount importance since we now know that bacterial and viral genomes indefatigably "imagine" ways of avoiding antiinfective actions and that the inappropriate use of antibacterials and antivirals create conditions for selecting resistant strains.

The goal of this workshop is to bring to the attendees current information and thoughts about in vitro model systems, animal model systems, and clinical trial analysis which link drug exposure to outcomes for anti-bacterials, anti-fungals and anti-virals. The meeting will focus on the interrelationship between pharmacokinetics and pharmacodynamics in (i) orienting the discovery process in a most effective fashion, (ii) determining the most favourable dosing regimens for moving from in vitro to in vivo and from animal to clinical trials, and (iii) finally to come to registration with dosage recommendations that will maximize efficacy and reduce the risks of losing drugs because of toxicity or fast emergence of resistance.

The focus of the programme is on a real interrelationship between Academia, Industry and Regulatory Bodies. ISAP indeed ran two recent "Discussion workshops" with both the US FDA (see <http://www.isap.org/Rockville-1999.htm>) and the European EMEA (see <http://www.isap.org/Uppsala-1999.htm>) in which the PK/PD concepts which will be presented at the meeting were discussed. Ther was a general agrrement that these concepts are useful and could be implemented in the future processes of drug evaluation and registration by these agencies.

Credits:

The ISAP Web site and ISAP diffusion list are kindly and generously housed on the INTERNET Server of the Faculty of Medicine of the 'Université Catholique de Louvain' in Brussels, Belgium, with the expert help of Benoît Debande, MD. All comments and queries should however be sent exclusively to the ISAP Webmaster.
The other pictures and logos are from the WEB sites to which they are linked (21st ICC, International Society of Chemotherapy, British Society of Chemotherapy, City of Birmingham,)

last significant update: July 27th, 1999