Supply chain management has advanced rapidly over the past decade, evolving from what was once dubbed “materials management” into the essential glue that binds all aspects of a business’ internal and external collaborations.
The changes in the economic landscape and pipelines over the last 10-15 years have resulted in drug developers in companies of all sizes to take a hard look at their strategy and operations.
As part of their risk-based monitoring strategy, many sponsors and CROs are using remote techniques to conduct source data review and verification (SDR and SDV).The best implementations out there actually streamline activities at both ends, both for sponsors/CROs and for study sites.
Developing a dermal NCE generally follows the same path as other small molecule NCEs administered orally or systemically, except that the dermal route is used in a non-rodent model.
By John Zehmer, PhD, Senior Scientist and Study Director at BioReliance
Conducting a viral clearance study is an important step on the road toward getting your biomolecule into the clinic and on its way to becoming a drug. However, since most companies do not have the systems in place to support a regulated virological study of this kind, this will likely mean engaging a contract research organization (CRO) as a partner. The keys to meeting your goals are solid planning and good communication between your group and your CRO partner. This article provides a high-level review of these processes and will aid in planning for a successful study.
OMEICOS Therapeutics, a biopharmaceutical company developing first-in-class small molecule therapeutics for the prevention and treatment of cardiovascular diseases including atrial fibrillation, recently announced the approval of an approximately €1.7M grant by the German Ministry of Education and Research (BMBF)