While many of the core data protection responsibilities outlined in the GDPR are not new to organizations involved in research, the GDPR nonetheless will have significant repercussions for CROs. With the baseball season coming up and the GDPR effective date around the corner, here are the “starting nine” GDPR takeaways for CROs.
Today, pharma companies of all sizes have limited patience for delays in development and need to rapidly determine the relative risks of formulation decisions.
Vinita Kumar, VP of quality at Versartis, talks about how her philosophy on CMO collaboration has been field-tested. “Never does that importance of real collaboration reveal itself more than in hard times for your program when you need it most,” she says.
Current practices for specification-setting in the pharmaceutical industry have drifted from the intended purpose of specifications. There is growing recognition of this disconnect, resulting in a number of industry teams, regulatory initiatives, and conference sessions on the topic.
Outsourced Pharma Chief Editor Louis Garguilo talks about what makes this seventh edition of the Life Science Leader CMO Leadership Awards different from the previous years.
This year’s CMO Leadership Awards result from feedback obtained through four different contract manufacturing surveys — biologic API, biologic drug product, small molecule API, and small molecule drug product — conducted by Industry Standard Research.
Ray Sison, VP of pharmaceutical outsourcing and tech transfer at xCell Strategic Consulting, recounts how one of his tech transfers went bad and the five important points he learned as a result of the experience.
Small companies can often encounter situations in which contract organizations devote their best people to their larger sponsors. Therefore, to ensure you get the attention your small-company project deserves, you need to take some proactive steps.
A panel of supply chain experts share best practices and perspectives on what parameters to use in evaluating CMOs/CDMOs, how to address low performance partners, and how to meet growing FDA expectations.
A look at three scenarios that may impact the decision of virtual or in-house manufacturing, as well as key aspects to consider in the selection process and in forming a strong relationship between the company and CDMO.