Biomedical Engineering Reference
In-Depth Information
For the drug development industry, the competitive space is focused on the
marketing of proprietary therapeutic agents that meet with regulatory approval
for on-label treatment, as such the opportunity to share the cost and risk of
upstream research affords the pharmaceutical companies a precompetive
opportunity. Of course, the IP constraints associated with the precompetitive
effort must be carefully considered so as to not create a barrier for down-
stream commercialization.
Since the commercial benefi t of diagnostic and biotechnology companies is
further upstream than the pharmaceutical companies, the ability to create
precompetitive opportunities is more challenging. However, the goal of deter-
mining relevant precompetitive opportunities for any company is to identify
mechanisms for discovering or developing fundamental knowledge and out-
comes that drive a net positive return on investment for the company's com-
petitive products.
The concept of precompetitive collaboration has been recognized as a suc-
cessful strategy for accelerating drug development by U.S. and European regu-
latory agencies through their participation in several initiatives. For example,
the FDA is a founding member and active participant in several precompeti-
tive consortia, including the Critical Path Institute (C-Path), Predictive Safety
Testing Consortium (PSTC), and the Biomarkers Consortium (BC) (see
Section 3.4 for the details of each initiative). In May 2010, the FDA and the
European Medicines Agency (EMA) concluded the fi rst joint precompetitive
qualifi cation process for biomarkers.
More particularly, this FDA-EMA initiative involved a joint effort to con-
sider use of renal toxicity markers proposed by the PSTC and involved the
participation of 16 pharmaceutical companies. This unprecedented sharing of
data by multiple pharmaceutical companies has served to test a joint FDA-
EMA data submission process to receive, review, and approve new methods
as qualifi ed for use in drug development. Through the joint process, the PSTC
submitted a single (preclinical) biomarker data application to both regulatory
agencies and then met jointly with scientists from both the FDA and EMA to
discuss the details of the submission and to address any scientifi c questions
posed by the regulators. Each regulatory agency then reviewed the application
and made independent decisions on use of the new biomarkers.
The leveraging of contributions and risks with appropriate partners
improves the chances for positive outcomes and reduces the risk of invest-
ment. As such, there is likely an opportunity for most commercial stakeholders
to fi nd benefi ts in the precompetitive space, though it may take some looking.
3.4
EXAMPLES OF SUCCESSFUL LARGE - SCALE PARTNERSHIPS
The emergence of large-scale partnerships exemplifi es the industry's recogni-
tion that the “old model” for conducting scientifi c research needs to be recon-
sidered. Whether done in a precompetitive fashion or using a controlled
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