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.
Industry interaction is key to understand and cope with the challenges of life during the pandemic. Collaboration (of the social distancing variety) can help manufacturers, consultants, and other members to stay informed and to share information.
ISPE has a new special interest group (SIG) to work on IT cybersecurity. The Special Interest Group was formed under GAMP®. A conversation with Jason Young of Silver Bullet Security, who heads the new group, provides details about the Special Interest Group.