When it comes to partnering with a contract research organization (CRO), many pharmaceutical and biotech companies, particularly small ones, have no choice but to outsource. I caught up with Bob Paccasassi, VP of quality and compliance operations, and Mandy Clyde, VP of operations at BioRestorative Therapies for their insight on the best strategies for selecting and partnering with a CRO.
Rapid changes in the biopharma industry are making it increasingly difficult to launch new products successfully. In this article, we review the five key levers for biopharma launch success and explain how they inform the creation of a high-performing product launch framework.
VIA Freeze controlled-rate freezers are compact electrical systems that do not require liquid nitrogen for freezing cells. Conduction-based cooling enables consistent cryopreservation of cells, including those in umbilical cord blood.
A GMP manufacturing suite was developed from its inception by AES, which included a custom-designed and constructed clinical manufacturing cleanroom core for producing PENN Medicine's cell and gene therapy candidates.
FDA/CMS Summit 2019 draws the highest leadership at the FDA and CMS and through an outstanding speaking faculty composed of 38 regulatory, policy, and industry leaders delivers the best available information on FDA and CMS priorities, policy changes, evidence-based practice, federal review processes on various areas of biopharma such as CDER, CBER, CDRH, and the most cutting-edge advances in healthcare and technology.