Abstract
Introduction
Biomarkers play an increasingly important role in drug discovery and
development. A large number of companies have emerged that provide various
biomarker-related tools and services. The various stakeholders in the
biomarker industry-specifi cally, biopharmaceutical companies, biomarker
developers, and research institutions and universities-will need to devise
specifi c strategies to access an array of agents and technologies that are
constantly changing.
Get the Answers You Need to Shape Your Strategy
- Biopharmaceutical companies must carefully consider their options when
seeking to access specifi c biomarker technology. What single principle
should biopharmaceutical companies adhere to when seeking to secure successful
deals with potential clients in order to increase the chances of fi nding a
suitable partner?
- In today' s environment of M&As and the anticlimactic results of the
Roche-Ventana and GE Healthcare-Abbott deals, large in vitro diagnostics (IVD)
companies need to clarify their biomarker research strategies. How should a
large IVD company' s choice of commercial partners change with the company' s
goals?
- Research institutions and universities that have patented technology will
continue to rely upon licensees or commercial partners to further refi ne the
technology and perform the advanced testing that allows commercial use of the
technology. What aspect of licensing agreements do research institutions
need to be particularly wary of when negotiating agreements with commercial
partners?
- Because the bulk of new biomarker research is driven by research
institutions and universities, these parties need to continue to secure
funding for their research efforts. Why is reliance on biopharmaceutical
licensing partnerships as a source of funding for these institutions
particularly risky in today' s biomarker environment?
- Partly because of the costs associated with biomarker development, several
consortia have been set up to address biomarker use for drug discovery and
development. What specifi c biomarkers are some of these consortia seeking
to develop?
Scope
- Advantages of biomarkers across the health care value chain: benefi
ts for diagnostics companies, biopharmaceutical companies, life sciences
research tools companies, patients, caregivers, and health care payers
- Accessing biomarker technology: sources of biomarkers; determining
biomarker access strategies; validation and qualifi cation requirements
- Research institutions and universities: goals of outlicensing
biomarker technology; the transference of technology to the private sector;
patents, royalties, liabilities, and milestone payments; commercialization of
biomarker technology; importance to emerging diagnostics and biotechnology
companies
- Biopharmaceutical and diagnostics companies: the use of biomarkers
as tools for improving drug discovery and development; association with
diagnostics testing companies; biomarker licensing activities by in vitro
diagnostics companies
- Smaller companies: the role of testing laboratory companies and
biomarker research tool and service companies
- Licensing agreements: a series of 5 tables detailing more than 170
biomarker agreements
- Outlook: the engine for new biomarkers; providing critical funding;
consortia to the rescue
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