| Corporate
Sponsor:
|
Presenting
Sponsor: |
|

|
"These
Pharmaceutical Strategy Series meetings have been quite
successful, both in terms of attracting quality speakers and
generating a good audience turnout from the pharmaceutical
industry." |
|
-
James Resch, Ph.D, Director, Strategic Planning,
Global
Discovery Affairs, AstraZeneca
|
|
Feature
Presentations |
|

|
Creating
a Desired Portfolio by Optimizing and Prioritizing
R&D Projects Based on Overall Corporate
Objectives
Rick
Bayney, Ph.D., Vice President, Portfolio Management,
Johnson & Johnson |
|

|
Categorization
of Biomarkers: Applications in Drug Development and
Registration
Thorir
Bjornsson, Ph.D., Vice President, Clinical Pharmacology,
Wyeth Pharmaceuticals |
|
The Predictive Value Of
Pre-Clinical Models For Decision-Making To Enter Clinical Trials
Christine Cioffe, Vice President,
Project Management, Merck & Co. |
|
|
|
|
Pre-Conference
Tutorial: Monday, November 17, 2003
How New Technologies Are Being
Used
to Make Better Decisions
Presented by Kevin Koch, Ph.D., President and Chief Scientific Officer,
Array
BioPharma Inc. |
|
|
|
For sponsorship and
speaking opportunities,
please contact Eric Glazer at 781-972-5442 or eglazer@healthtech.com.
|
|
|
Forum Participants include: |
Sharon
Baughman, Ph.D. Director,Pharmacokinetics and Drug
Metabolism, Amgen
Rick Bayney, Ph.D.Vice President, Portfolio Management, Johnson
& Johnson
Thorir Bjornsson, Ph.D.Vice President, Clinical
Pharmacology, Wyeth Pharmaceuticals
Daniel Chelsky, Ph.D.Chief Scientific Officer, Caprion
Pharmaceuticals
Christine CioffeVice President, Project Management, Merck
& Co.
Thomas FosterSenior Vice President, Cambridge
Pharma Consultancy
Christoph Hergersberg, Ph.D.Vice President, Research
Discovery Services, Amersham Biosciences Corp.
Sam Holtzman, Ph.D.Chief Executive Officer, Rosa
Pharmaceuticals
Kin-Kai Hwang, Ph.D.Director, US Drug Metabolism and
Pharmacokinetics, Aventis Pharmaceuticals
Charles Jaffe, M.D., Ph.D.Director of Medical
Informatics, AstraZeneca Pharmaceuticals
Kevin Koch, Ph.D.President and Chief Scientific
Officer, Array BioPharma Inc.
Walter A. Korfmacher, Ph.D.Director of Exploratory
Drug Metabolism, Schering-Plough Research Institute
Thomas Paterson, Ph.D.Chief Scientific Officer, Entelos,
Inc.
James Resch, Ph.D.Director, Strategic Planning,
Global Discovery Affairs, AstraZeneca |
|
|
PROGRAM
|
Day
One: Monday, November 17, 2003
|
|
Pre-Conference
Tutorial
How New
Technologies Are Being Used to Make Better Decisions
7:30
Pre-Conference Tutorial Registration and Coffee
8:00-11:30
Implementing New Technologies to Make Better Deciscions
Predictive
biomarkers for drug toxicity DNA to metabolites
Animal knock out models
Application of in silico technology
Early ADME prediction approaches
Applications of chemistry technology
Parallel optimization including in silico prediction of eADMET and in
vitro prediction for eADMET
Kevin Koch, Ph.D., President and Chief Scientific
Officer, Array BioPharma Inc.
Kevin Koch, Ph.D., received a Bachelor of Science degree
from State University of New York at Stony Brook with
majors in Chemistry and Biochemistry. After working at
Ciba-Giegy Corporation in the Chemical Process Research
Group, he studied at the University of Rochester where
he received a Ph.D. in synthetic organic chemistry
working with Professor Andrew S. Kende. He was awarded
both the Sherman Clarke Fellowship and Elon Huntington
Hooker Fellowship for his research. In 1988, Kevin moved
to Pfizer Central Research and was promoted to Senior
Research Investigator-Project Coordinator for the
Cellular Migration and Immunology Project Teams. In
1995, he joined Amgen Inc. as Associate Director of
Medicinal Chemistry and project leader for the Protease
Inhibitor and New Leads project teams. In 1998, Kevin
along with Anthony Piscopio, K.C. Nicolaou and David
Snitman founded Array BioPharma, a drug discovery
company integrating new technologies in the fields of
medicinal chemistry, biologic screening, structure based
drug design and information management. He currently
holds the position of President and Chief Scientific
Officer. In the field of organic synthesis, he has
published in the areas of the intramolecular ene
reaction of N-acyl imines, oxidative radical couplings
of phenolates and enolates, the total synthesis of the
anti-tumor antibiotic Lankacidin C, methods in palladium
catalyzed chemistry and combinatorial synthesis of
peptidomimetics. In the field of medicinal chemistry, he
has published in the areas of leukotriene antagonists,
macrolide immune-suppressant agents and
metalloproteinase inhibitors. He is the author or
co-author of over 40 publications and 16 patents. His
current research interests include combinatorial
chemistry, cytokine modulation, and kinase inhibition.
9:30-10:00am
Networking Coffee Break |
|
|
Main Conference
12:00 Main Conference
Registration
1:00 Chairpersons Opening
Remarks
|
FEATURE
PRESENTATION
|
1:15 Creating a Desired
Portfolio by Optimizing and Prioritizing R&D Projects Based on Overall
Corporate Objectives
Establishing decision rules to
manage a portfolio
Determining what you want to pursue and why
Implementing a process that establishes when to "Go" and
"No-Go"
Using criteria for first optimizing and then prioritizing
Examining the trade-offs between quantitative and qualitative assessments
for decision-making in your portfolio
Rick Bayney, Ph.D., Vice
President, Portfolio Management, Johnson & Johnson
|
|
2:15 First-in-Class Drugs from
Unprecedented Targets: Attrition in a High Risk, High Return R&D Portfolio
The availability of genomic information has given the pharma industry access
to numerous targets, offering the possibility of new first-in-class
therapeutics of high commercial value. However, the unprecedented nature of
these targets creates a higher risk of attrition due to lack of efficacy or
safety in clinical development. This high risk, high return situation presents
a challenge for companies with a heavy dependence on first-in-class targets.
Strategies to recognize and deal with this type of portfolio risk will be
presented.
James Resch, Ph.D., Director,
Strategic Planning, Global Discovery Affairs, AstraZeneca
3:00 Networking Refreshment
Break
3:30 What James D. Watson and
Francis Crick Have in Common with Enrico Fermi
Halting a $40 billion per year
hemorrhage (which is rapidly getting much worse)
How maximizing shareholder value fosters great waste and inefficiency
How to identify and cancel the 9 out of 10 programs that will never
yield valuable drugs
Sam Holtzman Ph.D., Chief
Executive Officer, Rosa Pharmaceuticals
4:15 Panel: Creating a
Corporate Culture that Enables Early Attrition
Addressing the emotion of
suspending a project
Incentives to kill projects early
From Wall Street to the lab: understanding the pressure of Wall Street
on R&D decision making
Communicating the benefits of reallocating resources of failed projects
throughout an organization
Gaining access to information on failures
Moderator: Andrew F. Branca,
Vice President and Senior Analyst, Cambridge Healthtech Advisors
Panelists:Rick Bayney, Ph.D., Vice President, Portfolio Management, Johnson
& Johnson
Charles Jaffe, MD, Ph.D., Director of Medical Informatics, AstraZeneca
Pharmaceuticals
Sam Holtzman, Chief Executive
Officer, Rosa Pharmaceuticals
5:30 Close of Day One
|
Day
Two: Tuesday, November 18, 2003 |
|
7:45
Morning Coffee
8:15 Hypothesis Management for
Novel Target R&D: Identifying the Most Important Experiments and Assays to
Guide Early Decision Making
Explaining the entire disease
phenotype with comprehensive and consistent hypotheses
Mapping knowledge gaps and testing the feasibility of alternative
hypotheses
Predicting novel target efficacy under multiple hypotheses
Identifying material knowledge gaps and the experiments/assays that can
resolve them
Realizing the value of improved decisions
Thomas Paterson, Ph.D., Chief
Scientific Officer, Entelos, Inc.
9:00 How Lead Optimization Can
Improve the Quality of Drug Candidates
Accelerating up cycle time
How to use drug metabolism to improve the quality selected candidates
Optimizing in vivo pharmacokinetics
Final quality checks so attrition rates are ultimately reduced
Walter A. Korfmacher, Ph.D.,
Director of Exploratory Drug Metabolism, Schering-Plough Research Institute
9:45 The Role of ADME and
Toxicity Prediction in Improving Success Rates
Kin-Kai Hwang, Ph.D., Director, US Drug Metabolism and Pharmacokinetics,
Aventis Pharmaceuticals
10:30 Networking Coffee Break
11:00 The Role of
Pharmacokinetics and Pharmacodynamics in Reducing Attrition Rates
What is the role of PK/PD in
research for molecule selection
How effective is animal PK/PD as a tool for predicting human results
How can PK/PD be used as a decision making tool for clinical trial
design and clinical go/no go decisions
Sharon Baughman, Ph.D.,
Director, Pharmacokinetics and Drug Metabolism, Amgen
|
FEATURE
PRESENTATION
 |
11:45 Categorization of
Biomarkers: Applications in Drug Development and Registration
Different uses of biomarkers
in drug development and registration
Definitions of biomarker objectives, expectations, timing of use,
and levels of informativeness
Development of utility-based biomarker categories
Biomarkers as clinical decision-making tools for go/no-go decisions
Development of biomarker strategies and biomarker plans
Thorir Bjornsson, Vice
President, Clinical Pharmacology, Wyeth Pharmaceuticals
|
|
12:45 Networking
Luncheon
2:00 Biomarker Analysis
as a Decision Making Tool in Drug Discovery and Development
Massively parallel
approach to novel target identification
Toxicity profiling for compound optimization or patient
selection
Compound mechanism of action
Patient stratification in clinical trials
Daniel Chelsky, Ph.D.,
Chief Scientific Officer, Caprion Pharmaceuticals
|
FEATURE
PRESENTATION
2:45 The Predictive Value Of
Pre-Clinical Models For Decision-Making To Enter Clinical Trials
What is the value and use of
genetic models
Which therapeutic areas benefit from preclinical animal models
What is the potential use of in silica models
Are there correlates of efficacy and safety between the preclinical
models and the clinical study results
Christine Cioffe, Vice
President, Project Management, Merck & Co.
|
3:30 Refreshment Break
3:45 Lessons to be
Learned from Failed Projects in Biotechnology and How To Improve
Attrition Rate in the Future
The importance of
direction and decision making
Decision tree organization as a means to stop and redirect
projects at the right time
Organizational improvements after "over organization"
delays decisions
Stakeholders and champions: how do they influence decision
making and attrition rate?
Bottom up or top down: optimizing the decision tree
Christoph
Hergersberg,Ph.D., Vice President, Research Discovery Systems,
Amersham Biosciences Corp.
4:30 Reallocating
Resources from Killed Projects
What development
governance needs to know
Why development governance doesnt know enough
How development teams can help kill projects and reallocate
resources
Where development teams do not have enough information to be
helpful
How human and non-human resources can be efficiently reallocated
Thomas Foster,
Senior Vice President, Cambridge Pharma Consultancy
5:15 Close of Executive
Forum |
|
|
|
Lead Sponsoring Publication: |
|
Sponsoring
Publications: |
 |
|
 |
 |
| Web Partner: |
|
|
|
|
|
Hotel Information
Park Hyatt Hotel
Broad and Walnut Streets
Philadelphia, PA 19102
T: 215-893-1234
F: 215-732-8518
Room Rate: $159 S/D
Cut Off Date: October 27, 2003
Please call the hotel directly to make
your room reservation. Identify yourself as a Cambridge Healthtech
Institute conference attendee to receive the reduced room rate.
Reservations made after the cut-off date or after the group room block
has been filled (whichever comes first) will be accepted on a
space-and-rate-availability basis. Rooms are limited, so please book
early.
Flight Information
Special Airline Discounts Available
Discounts fares are available on United, United Express, United code
share flights (UA*) operated by US Airways , US Airways Express A 5%
discount off the lowest applicable fare will be offered ONLY when you or
your travel agent call United's toll-free number 1-800-521-4041 and
refer to the Meeting ID Number 579YS. A 10% discount off the
unrestricted coach fares is available when purchased 7 days in advance.
An additional 5% discount will apply when you purchase your tickets at
least 30 days in advance of the your travel date.
Call for Sponsors
CHI offers a variety of conference sponsorships designed to bring
your company face to face with key executive decision-makers, position
your solutions/services and increase revenue opportunities in a highly
competitive marketplace. You will interact with Vice Presidents, Heads
of Departments and Directors of Pharmaceutical and Biotechnology
companies, who will attend this focused executive forum.
For details, please contact:
Eric Glazer at 781-972-5442email: eglazer@healthtech.com
 |
All
full paying registrants attending either the "Conference
& Tutorial" or "Conference Only" will be
issued a US Airways "Take Flight Certificate" good for
one free round trip airline ticket anywhere in the continental
United States where US Airways flies.
- Registration has to be paid in
full by October 3, 2003 to be eligible for free airline
ticket.
- Early bird discount
registrants are eligible
- Offer not good in conjunction
with any other Cambridge Healthtech Institute promotion
- "Tutorial Only"
registrants are not eligible.
- Take Flight Certificates will
be issued either at conference while supplies last or mailed
within six weeks following the conference dates.
- US Airways "Take Flight
Certificate" is good for one round trip ticket anywhere
in continental United States where US Airways flies.
Restrictions apply. For complete
US Airways Terms and Conditions, please visit www.healthtech.com/terms.asp
or call Eric Glazer at 1-781-972-5442 for additional
information. |
|