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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 Chairperson’s 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 doesn’t 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


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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.

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