Summary
Peter Marks, M.D., Ph.D. has discussed the wide range of products that fall under the umbrella of cellular therapies, from simple cell therapies used for local treatment of wounds to more complex products such as cellular products laid down on scaffolds.
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He has also discussed the progress made in cell and gene therapy, the potential for innovation in clinical development, and the need for collaboration in chemistry, manufacturing, and controls.
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As the director of the Center for Biologics Evaluation and Research (CBER) at the FDA, he is responsible for assuring the safety and effectiveness of biological products, including vaccines, allergenic products, blood and blood products, and cellular, tissue, and gene therapies.
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He has also discussed the need for regulatory clarity to innovators and the potential for regenerative therapies to be more effective in treating a variety of diseases.
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Currently, there are three approved products: two cell-based gene therapies for cancers of the blood and one directly-administered gene therapy for an inherited disorder of the retina of the eye.
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Summary
In an interview conducted by BCG's Michael Choy, Peter Marks, the head of the FDA's Center for Biologics Evaluation and Research (CBER), discussed key areas of progress in cell and gene therapy, ways to streamline regulatory review, and more. He discussed the exciting areas of CGT today, such as cell-based gene therapies and directly administered gene therapies, and the potential for innovation in clinical development. He also discussed the need for collaboration in chemistry, manufacturing, and controls, and the potential for regenerative therapies to be more effective in treating a variety of diseases.
Peter Marks Discusses the Road Ahead for Cell and Gene Therapy
bcg.com
Summary
is the director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. The center is responsible for assuring the safety and effectiveness of biological products, including vaccines, allergenic products, blood and blood products, and cellular, tissue, and gene therapies.
Peter Marks | FDA - U.S. Food and Drug Administration
fda.gov
Summary
In this interview, Peter Marks of the US Food and Drug Administration discusses how the FDA has contributed to the broader innovation ecosystem of cell and gene therapies. He outlines the drivers of success to date, the challenges of manufacturing vectors in a scalable fashion, and the potential bottlenecks to continue innovation in the field. He also emphasizes the importance of providing regulatory clarity to innovators, and the need for more focus on product concepts that will drive the next wave of innovative therapies.
Regulating the rapidly evolving field of cell and gene therapies | McKinsey
mckinsey.com
Summary
There are now three approved products: two cell-based gene therapies for cancers of the blood ( Kymriah and Yescarta ) and one directly-administered gene therapy ( Luxturna ) for an inherited disorder of the retina of the eye.
FDA's Efforts to Advance the Development of Gene Therapy
fda.gov
