All nmusers who are interested are encouraged to attend:
The Use of Physiological, Mechanistic Models in Drug Development:
Introduction, Case Studies, Impact, and Ideas for Applications
Jeff Barrett, PhD, FCP, Research Professor, Lab. for Applied PK/PD,
Children's Hospital of Philadelphia
Dean Bottino, PhD, Head, Modeling and Simulation - Oncology, Roche
Melissa Hallow, PhD, Senior Modeler, Novartis
Mike Reed, PhD, Vice President, Rosa & Co. LLC
Jim Bosley, PhD, Moderator
Physiological, mechanistic models are different than PopPK models that many
AsoP members are expert in. What are they? How can they help your
company's research programs? Four experts will discuss specific cases in
which physiological models were used, emphasizing the positive program
impact and insight delivered. A roundtable, to address your questions,
follows.
Abstract
Pharma/Biotech must deliver higher R&D yield (more and better candidates
that will show efficacy and safety in human trials) with lower costs
(failing flawed drugs early in trials) if research-based drug development is
to survive, flourish, and continue to provide new therapies to patients in
dire need.
Clinical pharmacology has made great advances in improving the decisions we
make using human data. Gaps still exist, though, in support for earlier
decisions. For example, we must decide which compounds to promote to human
trials before human data are available, and animal models aren't always
predictive. Another gap exists in our ability to understand the huge and
growing mountain of data available, especially when we are facing complex
diseases such as diabetes, cancer, and cardiovascular derangements. Human
variability and differences between individuals, population groups, the
sexes, and adults and children make the gap seem even wider.
To face this gap in a rational, scientific way, many companies are now using
physiologically-based, mechanistic models to integrate and understand data,
and to better predict human outcomes sooner. These models allow more data to
be used in a quantitative manner and generate hypotheses that are testable.
The models and underlying assumptions that go into them can be documented.
Such models account for the complexity of disease, and the variability and
uncertainty surrounding subjects and data.
In this session, four experts will summarize challenges, describe approaches
used, and report outcomes for a specific challenge faced. Ideas for future
application of these models will be shared.
Event Details
Date: Thursday, February 2, 2012
Location: Bridgewater Manor, 1251 Route 202/206, Bridgewater, NJ 08807
- Reception (with cash bar) 5:30-6:45 pm
- Presentation 6:45-8:00 pm
- Dinner 8:00-9:00 pm
Costs:
ASoP members receive a discount! Not yet a member? Become an ASoP member at
http://www.go-asop.org/events http://www.go-asop.org/events before you
sign up for this event.
- Event only: $30 ($25 for ASoP members)
- Event and dinner: $55 ($45 for ASoP members)
Notes about the price:
* As we must give final numbers to the hotel on Monday, Jan 30, please
sign up before this date. A $10 late fee will be added on to any
registration after this date!
* If you sign up, please show up! If you can't, please cancel your
registration by clicking on the link in your confirmation email - there will
be a $2 processing fee for cancellations.
* There will be no refunds starting 24 hours before the event as we
will have already paid the venue. Thanks for your understanding.
Submitted to NMUSER list on behalf of the ASOP Steering Committee, by
James R. Bosley, Jr. PhD, PE
[email protected] | Direct: +1.610.347.0149 (Philadelphia) | Mobile:
+1.610.299.4981 | Fax: +1.610.347.0142
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