The Future of Biopharma: What Does the Industry Want & Need?
What Does the Industry Want and Need?
Eric S. Langer, President and Managing Partner, BioPlan Associates, Inc., shared these most-needed cell and gene therapy manufacturing improvement, systems, platforms, and infrastructure from his company’s research1 at the 2019 ISPE Biopharmaceutical Manufacturing Conference (as indicated by the percentages of survey respondents who chose these options):
FDA Forges Ahead to Support Cell and Gene Therapy
The FDA is working to streamline the review and safety reporting requirements for gene therapy protocols.2
NIH’s Recombinant DNA Advisory Committee (RAC) will transition to become the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC), focusing on evaluating new biotechnologies and emerging applications.
Eric J. Staib Vice President of Compliance Genpact ISPE’s newest Special Interest Group (SIG) will work on the emerging areas of artificial intelligence (AI) and machine learning (ML). The Artificial Intelligence Special Interest Group was formed under GAMP®. A conversation with Eric Staib, Vice...
ISPE will introduce a new platform this fall for online Communities of Practice (CoPs) that will make the Communities of Practices more useful and user-friendly. Participating in a Communities of Practice by posting a question or responding to a post is a great way for ISPE members to meet...