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.
The second guide in ISPE’s Advancing Pharmaceutical Quality (APQ) series provides a systematic and proactive approach to quantitatively assessing and advancing leadership systems by evaluating the management responsibilities highlighted in ICH Q10 as well as other key leadership components.