|
Exhibit
& Keynote Pass is FREE until May 14th!
Click
here to register for the World Pharma
Congress Exhibit & Keynote Pass
SCHEDULE
OF EVENTS
MONDAY, MAY 12
8:30am OPENING KEYNOTE: New
Targets for Chronic Pain Therapy: Challenges and Opportunities
Catherine Abbadie, Ph.D., Senior Research Fellow,
Department of Pharmacology, Merck & Co., Inc.
Pain is a major unmet medical need but drug discovery
remains challenging. There is a need for new therapies that
provide more predictable effi cacy in all patients with
improved tolerability. Over the last decade, understanding the
basic mechanisms contributing to the generation of neuropathic
or infl ammatory pain in pre-clinical animal models has
greatly improved. The complexity of pain processing in
clinical pain conditions and in animal models has revealed
many time-related changes and an abundance of molecular drug
targets. There continues to be insecurity, however, about new
target validation in clinical pain and thus most analgesia
development is of high risk for evolving new pain therapies.
This presentation will review the rationale behind a number of
these mechanism-based approaches and discusses specifi c
challenges that they face.
Novel and Emerging Techniques in
Pain Management
Eugene Viscusi, M.D., Director of Regional Anesthesia
and Acute Pain Management, Department of Anesthesiology,
Thomas Jefferson University
Current pain management needs remain unmet. In spite of
the tremendous emphasis on patients’ rights to pain control
and position statements and guideline by societies and
accrediting bodies, large numbers of patients suffer
unrelieved pain. Older drugs and technologies fall short or
satisfying the needs. Novel and emerging technologies must
focus on ease-of-care, reduced abuse liability, improved side
effects and reduction in analgesic "gaps."
3:00pm - 4:40pm - Grand Opening of
the Exhibit Hall
5:10pm - 6:10pm - Cocktail Reception in the Exhibit Hall
TUESDAY, MAY 13
10:10am - 10:50am - Coffee Break,
Exhibits, & Poster Viewing in the Exhibit Hall
1:55pm KEYNOTE PANEL DISCUSSION: Drug Safety: A 20/20
Vision
Medical Product Development:
Addressing Scientific Hurdles Through Strategic Partnerships
with Stakeholders
Wendy R. Sanhai, Ph.D., Senior Scientific Advisor,
Office of the Commissioner, FDA
To make medical product development more efficient (in
time and cost), new paradigms for leveraging resources and
intellectual capital toward mutually beneficial goals, while
still preserving incentives for commercializing these
products, must be developed. Under the Critical Path
Initiative, the FDA has embarked upon a number of
collaborative efforts, with multiple stakeholders, focused on
addressing common hurdles in bringing commercially viable
medical products to the market and to patients. Outlines and
priorities for some of these efforts will be shared for
discussion. They will include efforts on biomarker development
and clinical validation, cardiac safety, medical
device/diagnosis and nanotechnology.
Patient Safety: Opportunities,
Challenges, and Possible Evolution
Charles M. Beasley, Jr., M.D. FFPM, Chief Scientific
Officer, Global Product Safety, Eli Lilly & Co.
As illustrated by post-approval product withdrawals, there
are ample opportunities for evolution in methods and
procedures applied to the understanding of the effects of
pharmaceuticals in order to enhance patient safety. What is
not recognized by all stake holders and interested parties is
the inherent limitations of pre-approval controlled clinical
trials with respect to the ascertainment of pharmaceutical
effects that infl uence safety. These limitations will be
illustrated with a specific example. Therefore, there are many
opportunities for the evolution of the post-approval study of
pharmaceuticals. Several evolving methodologies and possible
future developments will be enumerated.
The Unintended Consequences of
Safety
Peter J. Pitts, President, Center for Medicine in the
Public Interest
How are the issues of creeping anti-incrementalism, risk/benefi
t balance, comparative effectiveness, the unintended
hyper-focus on drug safety and the dangers of the
precautionary principle endangering the hope of personalized
medicine and a truly 21st century FDA.
3:45pm - 4:30pm – Refreshments,
Exhibits, & Poster Viewing in the Exhibit Hall
4:30pm PLENARY KEYNOTE:
Pharmaceutical Research: From Productivity to Sustainability
Charles T. Gombar, Ph.D., Vice President, R&D
Strategy & Business Improvement, Wyeth Research
The global pharmaceutical industry is facing new and
unprecedented challenges that may alter the framework for how
companies operate. For pharmaceutical companies to sustain
research and development investments at traditional levels new
products must succeed commercially, yet the evolution of the
pharmaceutical environment is making commercial success
increasingly difficult. Regulatory hurdles have never been
higher, reimbursement is difficult to secure, and pressure
from generic competition is eroding markets. In this session
Charles Gombar, Ph.D., Vice President, R&D Strategy and
Business Improvement, Wyeth Research, will present a
perspective on the current industry challenges, and a panel of
experts representing these major stakeholders will discuss the
issues and potential solutions.
Panel Discussion: Facing the
Challenges in the Pharmaceutical Industry
-
How Pharmaceutical Companies Need
to Evolve to Succeed
-
Meeting the Challenges in
Licensing, Reimbursement, and Generic Competition
-
Regulatory Issues and Insights
Panelists:
Charles T. Gombar, Ph.D., Vice President, R&D Strategy
& Business Improvement, Wyeth Research
Wednessday, May 14
10:10am - 10:55am - Coffee Break,
Exhibits, & Poster Viewing in the Exhibit Hall
2:30pm - 3:10pm - Refreshment Break (Final Viewing of
Exhibits & Posters)
View
the Exhibitors to Date!
|
