|
Thursday, June 15: Day One
|
Pre-Conference Workshop:
Overcoming Organizational Challenges to Realize
Targeted Therapeutics Opportunities
Workshop Leaders: Dr. Waseem Noor and Dr William Leaf-Herrmann, Senior Members of Strategic Decisions Group’s Life Sciences
Practice
8:00am Pre-Conference Workshop Registration and
Morning Coffee
8:30 Pre-Conference Workshop Begins
If targeted therapeutics is a break from the traditional blockbuster
pharmaceutical approach, then there are clearly organizational
implications for those traditional players who want to adapt to harness
targeted therapeutics opportunities. Conventional behaviors, processes and
capabilities are unlikely to provide the winning formula to recognize,
pursue and execute on new value propositions in fast-changing scientific
and market territories which require very different business models. There
are several examples.
Pharmaceutical companies need to be internally
ready to create mutually beneficial relationships with new categories of
partners such as Philips, Kaiser Permanente and Microsoft. Horizontally
integrated life sciences firms need to find ways to better exploit
synergies between their therapeutics and diagnostics arms. Different
metrics and incentives are needed to orient teams towards the right
behaviors to create success where biomarkers slice blockbuster markets
into niche sub-populations.
• How should companies design and evaluate
development programs differently?
• In what ways do commercial, regulatory and R&D functions have to
interact in order to best
translate opportunities into successes?
•Pharmaceutical and diagnostics sales forces will require new
capabilities to overcome the
physician and patient education hurdles to
the adoption of new clinical
practices.
SDG will present an external assessment of the
organizational challenges to realizing targeted therapeutics opportunities
within pharma and diagnostics companies. Data will be shared based on
expert interviews and a rigorous survey of major industry players. We will
highlight role-model behaviors, processes and capabilities as well as
illustrate pitfalls as a prelude to suggesting some approaches to
addressing the hurdles.
12:00 Close of Workshop |
|
Main Conference
12:00pm Main Conference Registration
1:00 Chairperson’s Opening Remarks
Felix Frueh, Ph.D., Associate Director, Genomics, Office of
Clinical Pharmacology & Biopharmaceutics, CDER, FDA
1:15 The Future of Stratified Markets
• Can the pharmaceutical industry's mental model of market success
be changed?
• What will be the challenges in convincing consumers of the value of
these products?
• What are the likely barriers to physician adoption of this new
modality?
• How are payors thinking about the role of new diagnostics in
redefining appropriate utilization and reimbursement of focused
pharmaceuticals?
Johanna Allston-Griffin,
Ph.D., Board of Directors Member and Chair, Clinical Science Committee, Personalized Medicine Coalition and CEO, Beechwood Consulting
2:00 Targeted Therapeutics: First Stratify the
Disease!
• Patient Stratification: It’s more than genomics!
• Target evaluation: Opportunities and Challenges
• Clinical trials are not Clinical History
• Risk, Prevention, Early Diagnosis: Chronic Disease Populations
• Economics of the Approach- Save More, Spend Less!
Michael N. Liebman, Ph.D., Executive Director, Windber Research
Institute
2:45 Pharmacogenomics Impact on Chronic
Diseases; the Alzheimer’s Example
• Taking a hard look at the Alzheimer’s healthcare crisis
• Problem: Due to the anticipated increase in diagnosed Alzheimer's
cases over the next
several years, Medicare and Medicaid officials predict
many families are in danger of
bankruptcy.
• Strategic Options: Linking genes to Alzheimer’s Disease: a
Pharmacogenomics case study
Nadine Cohen, Ph.D., Head of Pharmacogenomics, Johnson&Johnson
Pharmaceutical Research and
Development East Coast and Europe
3:30 Networking Refreshment
Break
4:00 Selecting and Validating Biological
Markers in Early Drug Development
• Over the past decade there has been increased interest in the use of markers in Alzheimer’s
Disease research and these are currently being used to provide insight into disease
mechanisms.
• The development of therapeutic interventions aimed at slowing or reversing
neurodegeneration requires accurate and prospective markers, since conventional clinical
readouts lack specificity and sensitivity.
• Only reliable surrogate and PD markers (also time- and cost-effective) can enable decisions
in early drug development, by providing
- Evidence of mechanism of action at the molecular target
- Evidence of disease modification vs. symptomatic response
- Identification and stratification of the most appropriate patient population to include in
early efficacy trials
- Dose optimization
Vincenzo Libri, MD, Ph.D., Medical Director and Head of Exploratory
Medical Science, CPDM & NGI CEDD, GlaxoSmithKline
4:45 Translational Medicine in India: Update
from a Cohort Study in a Major Chronic Disease
• Cohort study design and objectives
• Status of bio-analytics capabilities in India
• Patient enrollment and study retention
• Business model and study design to address ethics and privacy issues
• Government policy considerations
• Future prospects for "translational medicine" in India
Gene Williams, CEO, Cambridge Healthtech Associates
|
|
5:30 FACILITATED ROUNDTABLE DISCUSSIONS
|
Roundtable 1:
Private/Public Partnerships- What Are the
Benefits of Us Working in Collaboration?
Facilitator: Cheryl L. Marks, Ph.D., Associate
Director, Division of Cancer Biology, Program Director, Mouse Models of Human
Cancers Consortium, National Cancer Institute
|
Roundtable 3:
How Do We Get from Interesting Research Findings
to Real Patient Treatment?
Facilitator: Michael Stocum, Ph.D.,
Managing Director, Personalized Medicine Partners
|
Roundtable 2:
How Are Companies Balancing the
Promise and Cost of Translational Medicine in Their R&D Activities?
Facilitator: Derek Hodkey, Chief
Operating Officer & General Manager, Pathways, Cambridge Healthtech
Associates
|
Roundtable 4:
Commercially Defining Targeted Markets: Issues
around Populations, Price, and Value
Facilitator: Malorye Branca, Editor-in-Chief,
Pharmaceutical Discovery
|
|
|
|
|
