Sessions include:
Are biomarkers the
new requirement for dealmaking?
Big Pharma
and Big Biotech companies say they won't collaborate on the development of new drugs
unless the dossier contains biomarker data — biochemical evidence that the compound
is hitting and modulating its target. Top business development executives talk about
how biomarkers are driving value in today’s dealmaking environment.
How to incorporate biomarkers
into a drug development program
Biomarkers
can be used as a pharmacodynamic tool, to enrich patient populations for clinical
trials, to help prioritize a drug portfolio, and in some cases, as companion diagnostics.
This panel will discuss the critical factors in designing and implementing a biomarker
strategy.
Clinical case studies: drug
development
When are biomarker data compelling? Can they be sufficient
to make a go/no-go decision about advancing a drug development program? Experts
in translational research talk about their experiences using biomarkers to expedite
their firms' R&D programs.
Clinical case studies: diagnostic
development
Despite the
intuitive appeal of using diagnostics to get the right drug to the right patient
at the right time, the notion of developing a companion test in tandem with a drug
program remains problematic. A consistent theme heard from diagnostics firms and
their backers is the importance of preserving autonomy from pharma — either by developing
tests that focus on a drug class or a broad set of pharmacologically-relevant characteristics,
or by using biomarkers to identify a drug to bring in-house for development. Are
some drug classes better than others for this type of development effort? Which
tests, using which types of markers, have been most successful, and why
How can payors use
biomarkers in decison-making?
Biomarker data has the potential to influence the adoption
and reimbursement of a given medicine, and payors may be the most logical partners
for start-ups interested in developing novel and potentially costly diagnostics.
How can biopharma firms demonstrate to payors that biomarker testing lowers their
overall health care costs? How do the payors view the pharmacogenomics boom? This
panel will explore how health insurers can incorporate biomarkers into their coverage
decisions and provide insights into why they are or are not prepared to pay for
testing.
Is there a business
model for companion diagnostics?
A biomarker may ultimately become linked to a diagnostic
product opportunity — as a predictive test to select patients more likely to respond
to a drug or class of drugs, or as a way to monitor a response to one. But diagnostics
development costs are soaring with greater demands for validation from prospective
clinical trials, and pharma companies have been reluctant to support these efforts.
Where are diagnostics companies turning for support and funding? Which high-value
opportunities can sustain a business? Is collaboration the answer, and if so, in
what form?
Where is the investment
opportunity?
Biomarkers are an important
drug development tool, but can the knowledge be used to create profitable personalized
medicine start-ups? A panel of VCs discusses the pros and cons of pharmacogenomic-based
companies and their criteria for picking potential winners.
Don’t miss this unprecedented opportunity to join other senior-level executives in discussing the business case for and against biomarker technologies, and helping determine the future application of biomarkers in this competitive environment of commercializing new products.