BIO 2015 Dispatches: Data Transparency Initiatives Could Deter Industry Investment, Attorney Says
This article was originally published in The Pink Sheet Daily
Executive Summary
Covington partner Richard Kingham says early disclosure of clinical data could impede sponsor efforts to secure patents, driving away potential investors in the process. But EMA's Hans-Georg Eichler says investors should welcome the initiatives because they will bring greater efficiency to drug development.
You may also be interested in...
J&J’s Clinical Data Disclosure Strategy Focuses On Collaboration With Yale University Group
In what appears to be the most expansive policy to date on release of clinical trial data, J&J will use an existing outside group and will share full clinical study reports and patient-level data regardless of when the studies were conducted.
FDA Proposes Clinical Data Disclosure; Argues Sharing Will Improve Trial Design
The agency suggests making masked clinical trial data available to outside parties for further analysis, saying access may enable researchers to overcome drug development hurdles, such as identification of primary endpoints or potential biomarkers.
Rare Diseases: CBER Looks To ‘Lean Into’ Accelerated Approval, Align More With CDER
US FDA biologics center officials spoke about their efforts to increase collaboration and harmonization with the drugs center, and to internally involve more review disciplines in evaluating biomarker evidence, during a Reagan-Udall Foundation meeting that weighed potential use of accelerated approval for neuronopathic mucopolysaccharidoses disorders.