Abstract
Introduction
Pharmacogenomics (PGx) is an evolutionary-not a revolutionary-process. The
"blockbuster" business model is, of course, still relevant to the
pharmaceutical industry, but at the same time, companies must adopt
technologies that will enable them to develop better drugs-value-added drugs
that can command the prices capable of providing an acceptable return on
investment for the companies that develop them. Many companies, pharmaceutical
and diagnostic alike, have come to understand that they need to use PGx to
their advantage, a step that requires changing the status quo of drug
development to produce targeted medicines together with diagnostic tests.
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- The development of targeted medicines and PGx-based testing has been
slower than anticipated, and the promise of PGx is still largely to be
realized. Why? What is the key to unlocking the enormous potential of
personalized drug development?
- The industry needs to implement technologies that can be used to produce
safer and more effi cacious drugs. What are the challenges associated with
embracing the PGx model and the codevelopment of targeted drugs and their
companion diagnostic tests (RxDx codevelopment)? How will PGx improve this
process? Why is collaboration between pharmaceutical and diagnostic companies
so important?
- The pharmaceutical, diagnostic, and regulatory communities need to work
together effectively to develop more personalized medicines. What are the
bottlenecks delaying these interactions? What still needs to be done to make
this process work better?
- Pharmaceutical companies have come to recognize the current value and
future commercial potential of diagnostics, but they need a path to follow for
integrating PGx into drug development. How does a company begin? What is a
reasonable action plan to follow, and why is educating stakeholders so very
important?
Scope
- Industry experts: Twelve interviews and/or commentaries from
industry leaders who share their insights and experiences in implementing
personalized drug development and PDx testing.
- Targeted drugs and companion diagnostics: "personalized medicine"
targets the right patient for the right medicine; updating drug labels with
PGx information; the role of regulators in personalized medicine; complexities
in the underlying biology.
- Building a business case for RxDx codevelopment: a cultural change
for the industry; bottlenecks and stumbling blocks; evolving relationships
between big pharma and diagnostics companies; return on investment;
cost-benefi t analysis; clinical trial effi ciencies, value-added drugs;
raising the safety/ effi cacy bar.
- Pharmacodiagnostic test development: biomarker discovery and
research; CLIA-regulated versus FDA-approved tests; pricing/reimbursement
environment; CPT codes; clinical validity and clinical utility.
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