Preliminary Program - American Association of Pharmaceutical ...

72
2009 AAPS Annual Meeting and Exposition
AAPS Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM) Programming
9:00 am – 11:00 am
Translational Challenges in PK/PD/TD
of Biotechnology-derived Products
Roundtable
The unique complexities associated with the PK
and PK/PD of biotechnology-derived products
including immunogenicity, species specificities,
and target/immune-mediated clearance pose
special challenges in translation of PK/PD/TD from
preclinical to clinical domain. In preclinical safety
assessment, a loss of exposure of humanized
antibody due to neutralizing immune response
may prevent appropriate end-organ toxicity or
safety margin estimation and may not have human
relevance. Translation of safety biomarkers from
early to late stage of clinical development.
Moderator
Anis A. Khan, Ph.D.
Merck & Co, Inc.
PK/PD Translational Issues with Biologics
Anis A. Khan, Ph.D.
Merck & Co, Inc.
Translation of Safety Biomarkers from Early to
Late Stage of Clinical Development
Joy A. Cavagnaro, Ph.D., D.A.B.T., R.A.C
AccessBio
WEDNESDAY AFTERNOON ROUNDTABLES
2:00 pm – 4:00 pm
In Vivo Animal Models for Prediction of
Drug-drug Interactions
Roundtable
With the advent of polytherapy it has become
prudent to minimize, as much as possible, the
potential for drug-drug interactions. Conducting
drug-drug interaction studies is expensive and there
is great emphasis to proactively minimize potential
for drug-drug interactions. Towards this end, the
metabolic and transporter pathways involved in the
disposition of a drug candidate (phenotyping) are
evaluated in vitro employing available human tissue
and specific reagents. Likewise, in vitro screening
for inhibition and induction of drug-metabolizing
enzymes and transporters is conducted also. Such
in vitro human data can be made available prior to
human dosing and enable in vitro to in vivo-based
predictions of clinical outcomes. Despite some
success, however, in vitro systems are not dynamic
and sometimes fail to predict drug-drug interactions
for a variety of reasons. In comparison, relatively
less effort has been made to evaluate predictions
based on data derived from in vivo animal models.
The focus of this roundtable is to provide examples
where animal models can be used to predict
cytochrome P450-and transporter-based drug-drug
interactions. Following brief presentations, there
will be discussion surrounding caveats in employing
these animal models and their utility in conjunction
with in vitro-in vivo extrapolation methods. Such
an integrated data set can be used to select drug
candidates with a reduced drug interaction potential.
Moderator
Punit H. Marathe, Ph.D.
Bristol-Myers Squibb
In Vivo Animal Models for Prediction of CYP
Inhibition-mediated Drug-drug Interactions
Cuyue Tang, Ph.D.
Merck and Co., Inc.
In Vivo Animal Models for Prediction of CYP
Induction-mediated Drug-drug Interactions
Michael Sinz, Ph.D.
Bristol-Myers Squibb
In Vivo Animal Models for Prediction of
Transporter-mediated Drug-drug Interactions
Gary Bowers, Ph.D.
GlaxoSmithKline plc
WEDNESDAY AFTERNOON SYMPOSIA
funded by a grant from
2:00 pm – 4:30 pm
Mechanism-based PKPD Modeling: Its
Role in Discovery and Early Development
of Biologics
Symposium
Pharmacokinetic-Pharmacodynamic (PKPD)
modeling is being increasingly applied early on in
the discovery and development of all therapeutics.
This technology has even higher relevance for
biologics such as antibodies, because of their
unique PKPD properties. The increase in computing
power and higher resolution in analytical techniques
for measuring cellular reactions has prompted
increased confidence in in silico approaches such
as computational systems biology in the design
of therapeutics with optimal PKPD properties. The
regulatory environment has also changed in recent
years and PKPD modeling using preclinical data may
be required to support first-in-human trial designs
for “high-risk” biologics such as some antibodies.
This symposium will discuss the importance
of early investment in a PKPD modeling and
simulation platform, discovery through preclinical
development, and support the optimal progress of
biologic programs.
Moderators
Ellen Q. Wang, Ph.D.
Pfizer Global Research & Development
Joseph P. Balthasar, Ph.D.
University at Buffalo, The State University
of New York
Integration Not Isolation: The Role of
Computational Systems Biology on the
Discovery of Antibody Therapeutics
John Burke, Ph.D.
Boehringer Ingelheim Pharmaceuticals, Inc.
PKPD Modeling of Preclinical Data Using a
Surrogate Antibody to Underwrite Reprotoxicology
Safety
Saileta Prabhu, Ph.D.
Genentech, Inc.
PKPD vs. Toxicology-based Approach to
Starting Dose Selection in First-in-Human
Trials
Balaji M. Agoram, Ph.D.
Pfizer Global Research & Development
Application of Mechanistic PKPD Modeling for
Predicting Human PKPD Response
Philip Lowe, Ph.D.
Novartis Pharma AG
2:00 pm – 4:30 pm
Microdialysis Role in the Development
and Optimization of Drug Topical
Delivery
Symposium
The rapid and efficient development and evaluation
of topical delivery systems is still a challenge,
particularly when new approaches or devices
like iontophoresis are tested. In vivo cutaneous
microdialysis allows studying drug delivery and
pharmacokinetics as close as possible to the site of
action and provides a tremendous tool for a better
understanding of how the formulation affects drug
PK into the skin. The proposed symposium will start
with an overview of the microdialysis technique
as applied to skin issues and will compare it with
the other methods used to study PK in skin or
skin layers. Then some of the available studies
that utilized MD in skin will be presented and
discussed. An expert from the U.S. Food and Drug
Administration (FDA) will also be invited to provide
insights into the regulatory aspects of the technique.
The symposium will provide the attendee with the
opportunity to evaluate the contribution of MD to
improve our understanding of skin delivery.
Moderators
Carryn Purdon, Ph.D.
Nycomed
Chinmay Shukla, Ph.D.
U.S. Food and Drug Administration