In calendar year 2018, the FDA approved a record 62 novel drugs, with the Center for Drug Evaluation and Research (CDER) approving 59 and Center for Biologics Evaluation and Research (CBER) approving three cell therapies. The CDER classification breakdown was 40 chemical drugs and 22 biological drugs. It is notable that greater than 50% of the new drugs approved were biologics with many classified as immunotherapies. Industry surveys suggest this trend towards biologics in the pharmaceutical industry will continue with the percentage of biologics in the R&D pipeline between 25 to 50%. Associated with this change is the rapid growth in the field of gene and cell therapy products. Citing the 800 active INDs for cell therapy and gene therapy candidates and the expectation that it will be receiving more than 200 INDs each year by 2020, FDA Commissioner Scott Gottlieb, MD, in January 2019 outlined the FDA initiatives to support timely review and to enable the approval of 10 - 20 such therapies per year by 2025. Gottlieb announced that 50 new clinical reviewers would be added to the CBER staff to address this demand. What are the challenges ahead to bring cellular therapies to the market? “The key to making gene therapy accessible to patients will be better manufacturing processes”, Peter Marks, CBER Director, told attendees at the Galien Forum in New York City on Oct. 25, 2018, in a panel discussion on gene therapy. “At this point, the FDA has approved one directly-administered and two cell-based gene therapies”, Marks said, “but the Agency has received over 700 Investigational New Drug (IND) applications in the gene therapy field”. As the FDA points out, there is a large gap between R&D, clinical supplies production, and routine commercial production. Other key challenges include controlling costs, maintaining cell viability and potency and preventing potential microbial contamination. In this article, the author will explore the limitations in technical expertise especially in the field of microbiology within the biotechnology industry.

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• Biotechnology

• American Pharmaceutical Review

• 8/27/2019

• Article