|
Day 2
Day Two: Tuesday, January 31
8:15 am Pharmaceutical Leaders’ Breakfast
MORNING PLENARY KEYNOTE SESSION
How Can We Make a Tangible, Positive Impact on Productivity?
9:00 am Chairperson’s Review of Day One
Nick Hughes, PA Consulting
 |
9:15 am Reducing the Cost of Attrition through Efficiencies in Discovery |
• Approximately 70% of technical attrition in new compound clinical trials stems
from the lack of appropriate efficacy, safety or pharmacokinetic properties
• Instituting measures to improve our knowledge in these three key attrition
categories while compounds are in the discovery phase of development
should potentially reduce clinical attrition
• At Millennium Pharmaceuticals we have initiated programs over the last three
years aimed at improving our ability to identify and eliminate compounds that
will fail to meet our expected product profiles.
• Our findings suggest that an integrated approach involving advanced animal
models, increased qualitative and quantitative information based safety and
PK coupled with closer interactions with translational clinical research
provides the best opportunity to impact productivity.
Joseph Bolen, Ph.D., Senior Vice President, Research & Drug Discovery, Millennium Pharmaceuticals |
 |
10:00 am Making Better Development Decisions with Early Imperfect Clinical Data |
• Is the current clinical development model sustainable?
w
A close look at where we fail and at what cost.
• If the thrust is not to improve quality early on, than what is it?
w The economic impact of failing smart and early.
• Early, imperfect clinical data - What opportunities exist?
w A cursory examination of where and what to procure.
• How can the use of imperfect information aid decision-making?
w The need for Bayesian revision has perhaps never been greater.
• What are the implications of terminating early?
w We'll get some of it right and some of it wrong but overall, it'll be better
than 'business as usual'.
Richard M. Bayney, Ph.D., MBA, Vice President, Portfolio Planning, PRD, Johnson & Johnson |
10:45 am Networking Coffee Break
 |
11:15 am Accelerating Discovery and Development Success with Enabling Technology |
•
Reducing late stage failure with Enabling Technologies
w Early identification and resolution of drug
safety issues with toxicogenomics
wAvoiding efficacy failures through ‘omics
technologies for target validation and biomarker discovery
• Improving drug discovery efficiency with Enabling
Technologies
wAttacking the unappreciated bottlenecks in
lead generation and lead optimization
James B. Summers, Ph.D., Divisional Vice President,
Advanced Technology, Abbott Laboratories |
12:00 pm Networking Luncheon
“Protein Tomography™ - Can it help us to make better decisions?”
|
sponsored
by |
A major dilemma in current drug discovery is the high number of late failures. The industry needs better methods for predic tion of the clinical outcome of a project. Protein Tomography™ can radically improve the predictive value of in vitro experi
ments. SET visualizes the disease event at a molecular level, in virtually any environment and biological context, thereby bridging the current gap between the test tube and human biology
Hans Johansson, CEO/President, SIDEC Technologies AB |
|
1:30 - 3:00 pm Interactive Breakout Groups A-D (Delegates can choose one)
The New Paradigm: Approaches to Reducing the Costs of Attrition
|
Session A:
Reducing the Cost of Development by
Conducting Tests in Asia |
Session B:
New Assays in Preclinical Development |
| 1:30 pm
|
|
Build, Buy or Partner: How Should We Leverage Emerging Capabilities in India and China to Solve the
Pharmaceutical Productivity Challenge?
• What are strengths, weaknesses,
opportunities and threats for
conducting R&D in India and China?
• What strategies are being used to
pursue these objectives?
• What is the five to ten year outlook in
the role of these two countries in
pharmaceutical development?
|
|
|
Sundeep Lal, Ph.D., MBA, Senior Director, External Scientific Affairs, Merck & Co.
|
2:15 pm Open Panel Discussion
Moderator: Eric Meyers, General Manager, Global Developer, Cambridge Healthtech Advisors |
|
|
|
|
| 1:30
pm |
|
Ernie Bush, Ph.D., Director, New Initiatives, Cambridge
Healthtech Associates (formerly Director, Preclinical
Toxicology, F. Hoffman La Roche)
|
|
2:15
pm Open Panel Discussion
Moderator: James Resch,Ph.D, Director, Strategic
Planning, Global Discovery Affairs, AstraZeneca
|
|
|
|
Session C:
Patient Stratification and Its Future Impact
on the Industry
|
Session D:
Reducing Attrition Attributed to the Market |
| 1:30 pm |
|
|
The Future Role of Rx-Dx Partnerships in the Development of New Drugs
• Discussion of four diagnostic/therapeutic pairings that are being launched during the time prior to the conference:
w Minimal Residual Disease flow cytometry
testing in CLL
with Campath therapy
w Abl mutations testing in CML for
Gleevec-resistance
w EGFR mutations testing in NSCLC with
Tarceva/Iressa;
w 5q deletion FISH testing in MDS for
Revlimid therapy
• Each represents a different type of diagnostic strategy and collaboration with a therapeutic and pharmaceutical company
• Joint commercialization efforts, successes and challenges will be discussed
|
| Glenn Miller, Ph.D., General Manager,
Analytical Services, Genzyme Genetics. |
2:15 pm Open Panel Discussion
Moderator:Dr. John A. Bilello, Chief Scientific Officer, Human Biomarkers Solutions |
|
| 1:30 pm
|
|
Key Components to Reducing Commercial Induced Attrition
• Recognizing, forecasting and factoring in marketplace demands earlier in the R&D process
• Seeking out and using competitive and marketplace intelligence in our decision-making processes
• Mitigating risk by collaborating early in the process with the following groups:
w Marketing
w Regulatory
w Medical
• Understanding the pressure of Wall Street on R&D decision-making
Linda Summerton, Ph.D., Director,
Strategy and Planning, Oncology & Infection Therapy Area Management Team,
AstraZeneca
|
2:15 pm Open Panel Discussion
Moderator: David Lester, Ph.D., NY Site Head, Global Clinical Technology Platforms, Pfizer, Inc.
|
|
3:00 pm Networking Refreshment Break
AFTERNOON PLENARY KEYNOTE SESSION
Large Molecule Drug Development: Will This Improve Our Productivity?
 |
3:30 pm Biologics in a Pharmaceutical R&D Environment - Advantages and Challenges of Building Biopharmaceuticals into Your Pipeline |
• Balancing small molecules and biologics in your portfolio
• Taking advantage of biotechnology expertise and broad therapeutic expertise
in building a pipeline with a higher probability of success
• Templates for aggressive timelines to clinical proof of concept
Thomas F. Bumol Ph.D., Vice President, Biotechnology Discovery Research & Applied Molecular Evolution, Lilly Research Laboratories |
| CASE STUDY |
 |
4:15 pm
Implementing the FDA's Critical Path Initiative through
Private-Public Partnerships (PPPs):
Reducing the Costs of Attrition Caused by Liver
Toxicity |
• The value of PPPs
• Opening the molecular black box of Liver toxicity
• The economic impact of improving the predictability of liver toxicity
• Reducing late - stage attrition by identifying and using biomarkers in early
animal safety studies
• Altering traditional approaches - conducting a systems biology comparison of
clinical and preclinical data
• The potential impact on R&D Productivity the cost per NME
Pieter Muntendam, M.D., President, BG Medicine |
 |
5:00 pm PANEL: Is the Current Business Model Delivering?
|
• Comparison of different R&D organizational and research models
• Leveraging size
• How well did the model work?
• Did it improve the drug discovery and development process?
Moderator: Matthew Bell, Ph.D., Director, Discovery Research Strategy, Wyeth Research
Panelists:
Richard M. Bayney, Ph.D., MBA, Vice President, Portfolio Planning, PRD, Johnson & Johnson
Thomas F. Bumol, Ph.D., Vice President, Biotechnology Discovery Research & Applied Molecular Evolution, Lilly Research Laboratories
Pieter Muntendam, M.D., President, BG Medicine
David Lester, Ph.D., NY Site Head, Global Clinical Technology Platforms, Pfizer, Inc. |
5:45 pm Networking Cocktail Reception
|
