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Modeling Webinar Announcement

From: Ken Kowalski <ken.kowalski>
Date: Mon, 22 Mar 2010 09:21:47 -0400

Multi-Discipline Model-Based Drug Development to Improve "Accelerate/Go/No
Go" Decisions for New Products

 

These live webinars will show how modern modeling techniques can be used to
avoid incorrect drug development decisions, tackle costs, and assess value.
The expert speakers will survey the uses of model-based drug development,
particularly its role in improving decisions about accelerating, continuing
or canceling a drug's development.

 

To register, contact Shimon Cohen at 973-387-8655, or
shimon.cohen

 

Modeling is sometimes broken down into biological modeling (mechanisms),
statistical modeling (assessment), pharmacometric modeling (PK/PD and
clinical trial simulation), and economic modeling (value) and expert
speakers in each area will conduct the web-based instruction. The webinars
will be conducted during the weeks of April 26 and May 3. Each webinar will
be 90 minutes in duration with about 70 minutes of presentation and 20
minutes for Q&A.

 

The prerequisite to benefit from these webinars is knowledge of drug
development for regulatory approval. Mathematical knowledge is not a
prerequisite!

 

Target audience: Clinicians, pharmacologists, pharmacometricians,
statisticians, global marketers, and finance specialists working in clinical
development.

 

1. Modeling disease mechanisms - Matthew Onsum, Ph.D., Principal Scientist,
Merrimack Pharmaceuticals

2. Modeling for statistical study design and assessment - Alun Bedding,
Ph.D., Early Phase Consultant, Biostatistics Development Partners,
GlaxoSmithKline

3. Modeling for PK/PD and clinical trials simulation - Kenneth G. Kowalski,
President & CEO, A2PG - Ann Arbor Pharmacometrics Group, Inc.

4. Modeling product economic value - Sean Hu, MBA, Ph.D., Leader,
Personalized Medicine Strategy, IMS Health

Program chair - Michael Palmer, President, Adaptive Pharmacogenomics, LLC

 

Objectives
1. To survey case studies demonstrating the utility of modern model-based
drug development methods such as disease modeling, adaptive and Bayesian
study designs, prediction of study operating characteristics and results and
product valuation.

2. To give attendees the opportunity to hear from and ask questions of
experienced and well-respected experts in biological, statistical,
pharmacometric, and economic modeling. These are modeling methods used today
to rein in rising costs, maximize product value, and get relief from painful
clinical study failures.

3. To prepare attendees for interactions with the FDA, which is increasingly
pushing industry to adopt model-based drug development methods in order to
increase the efficiency of drug development and the reliability of marketed
medicines.


Dates and topics (all webinars will be from 11:30 a.m. to 1:00 p.m., Eastern
time):

April 26 -- Modeling disease mechanisms
April 27 -- Modeling for statistical study design and assessment

May 4 -- Modeling for for PK/PD and clinical trials simulation

May 5 -- Modeling product economic value

Cost
$1047 for the complete series of four webinars. Unlimited number of viewers
per login!

$349 for each webinar. Unlimited number of viewers per login!


Instructor bios

Matthew Onsum, Ph.D.

Principal Scientist, Merrimack Pharmaceuticals

Dr. Onsum received his B.S., M.S. and Ph.D. degrees in Mechanical
Engineering from the University of California, Berkeley, in 2000, 2002 and
2005, respectively. His doctoral work, under the supervision of Adam Arkin
and Kameshwar Poolla, used both computational and wet biology to study how
immune cells track and capture invading microbes. Additionally, he was a
member of the Alliance for Cellular Signaling where he developed models of
GPCR mediated calcium signaling and model validation software. He spent two
years at AstraZeneca R&D Boston, where he used model simulations to help
identify new drug targets. He is currently at Merrimack Pharmaceuticals
where he is using computational biology to identify predictive biomarkers
for oncology drugs.

 

Alun W. Bedding, Ph.D.

Director and Early Phase Consultant, Biostatistics and Programming
Development Partners, GlaxoSmithKline Research & Development

Alun Bedding has worked in the pharmaceutical industry for 20 years,
specialising in early phase development, Bayesian methodology and adaptive
designs. In his role at GlaxoSmithKline he acts as a consultant in early
phase development covering all therapeutic areas, as well as being an expert
in adaptive designs and Bayesian methodology. He has been involved in
industry wide initiatives looking at the implementation of adaptive designs
and Bayesian methods. He has contributed presentations to many
international conferences on Phase I studies, Bayesian methods and adaptive
designs, and has published several papers in these areas. Alun has a PhD
from Reading University.

 

Kenneth G. Kowalski, MS

President and CEO, A2PG - Ann Arbor Pharmacometrics Group, Inc.

Kenneth G. Kowalski, M.S., is a cofounder as well as President and CEO of
the Ann Arbor Pharmacometrics Group (A2PG), a consulting company providing
pharmacometrics services to the pharmaceutical industry. He received his
B.S. in Mathematics in 1980 and a M.S. in Statistics in 1982 from Northern
Illinois University. Ken has 28 years of experience working in the
pharmaceutical industry as a statistician and pharmacometrician. Prior to
joining A2PG, Ken was a Senior Director of Pharmacometrics at Pfizer R&D
based in Ann Arbor, MI. Prior to joining Pfizer he held various positions
within the Statistics Department at G.D. Searle and Company. He has
published over 50 articles, abstracts, and book chapters with a focus on
PK/PD modeling and clinical trial simulations. Ken is an editorial advisory
board member for the Journal of Pharmacokinetics and Pharmacodynamics. He
is a member of the American Statistical Association (ASA), American Society
of Clinical Pharmacology and Therapeutics (ASCPT) and the American
Association of Pharmaceutical Scientists (AAPS).

 

Sean Hu, MBA, Ph.D.

Leader, Personalized Medicine Strategy, IMS Health

Dr. Sean Hu has been with IMS Management Consulting for about five years,
and is currently leading personalized medicine strategy at IMS Health and a
member of the newly formed IMS Innovation Lab. Over the years, Dr. Hu has
advised pharma/biotech clients extensively on a variety of strategy related
topics, including corporate, portfolio, and drug / diagnostics development &
commercialization strategies, utilizing rigorous analytical and modeling
approaches. Prior to IMS, as part of his 18+ years experience in life
sciences Dr. Hu worked in a number of functional areas in both the pharma
and biotech industries, including business development, marketing & sales
services and R&D operations. Dr. Hu also holds a PhD in Genomics from New
York University, and an MBA from Wharton.

 

Michael C. Palmer

President, Adaptive Pharmacogenomics, LLC

Michael Palmer has been working with the U.S. Food and Drug Administration
(FDA) since 2005 on software tools to help assess the cost and complexity of
clinical trials. Michael graduated from the University of Michigan with an
MS in biostatistics in 1979 and has worked in clinical research and
development in the pharmaceutical industry since then. He and Cecilia A.
Hale, Ph.D. founded Adaptive Pharmacogenomics in 2007.

 

About Adaptive Pharmacogenomics, LLC

In 2005, Adaptive Pharmacogenomics, LLC scientists and software engineers
began working with the United States Food and Drug Administration (FDA) to
develop a pharmacogenomic clinical study design (PCSD) software tool. The
first version of that software was delivered to FDA in 2005 and an enhanced
version was delivered and evaluated at FDA the following year. Earlier, at
the beginning of FDA's Critical Path initiative, pharmacogenomics (PG) was
identified as a way to improve the safety and efficacy of medicines and to
reduce attrition in clinical development. FDA's sponsorship of the software
tool's development demonstrated their commitment to translating advances in
basic biomedical research into new drug and biologic products to improve the
health and well-being of Americans. In 2008, FDA signed a Cooperative
Research and Development Agreement (CRADA) with Adaptive Pharmacogenomics,
LLC and GlaxoSmithKline (GSK). The objective of the CRADA is to enhance the
PCSD tool with technology developed by GSK and Adaptive Pharmacogenomics and
to web-enable the tool.

 

To register, contact Shimon Cohen at 973-387-8655, or
shimon.cohen

 

 

Kenneth G. Kowalski

President & CEO

A2PG - Ann Arbor Pharmacometrics Group, Inc.

110 E. Miller Ave., Garden Suite

Ann Arbor, MI 48104

Work: 734-274-8255

Cell: 248-207-5082

Fax: 734-913-0230

ken.kowalski

 


Received on Mon Mar 22 2010 - 09:21:47 EDT

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