InTouch
November / December 2019
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.
Learn More about Biopharma Manufacturing3
- 1Rader, R., and E. Langer. “Top Trends In the Biopharmaceutical Industry and Bioprocessing for 2019.” Published 18 December 2018. https://www.bioprocessonline.com/doc/top-trends-in-the-biopharmaceutical-industry-and-bioprocessing-for-0001
- 2Marks, P. “FDA’s Efforts to Advance the Development of Gene Therapy.” 1 May 2019. https://www.fda.gov/news-events/ fda-voices-perspectives-fda-leadership-and-experts/fdase efforts-advance-development-gene-therapy
- 3International Society for Pharmaceutical Engineering. “Overview: Biotechnology Manufacturing Processes Training Course.” https://ispe.org/training/classroom/biotechnology-manufacturing-processes
