Industry/Regulator Communication is Linchpin in Addressing Cell/Gene Therapy CMC Challenges, Experts on Both Sides Are Affirming

Industry and agency experts engaged with advanced therapies are stressing that the communication process between them is critical in clearing the CMC pathway for development of the products and that this communication needs to happen as early and as openly as possible to help sponsors navigate around the many pitfalls that lie along the journey.

As experience with cell and gene therapies (CGTs) grows, so does the recognition that the complexity of the CMC challenges involved, the difficulty in making clinical/quality connections and informed risk assessments, the lack of CGT-specific standards, and the severe consequences of missteps, make this industry/regulator communication process a linchpin in their development.

At key forums, through agency initiatives, regulations and guidance, in public/private partnerships and association task forces, and directly between sponsors and reviewers, the doors to this needed communication are being pushed open in recognition of the possibilities that lie on the other side.

The boundaries of what is considered “pre-competitive” space are expanding, and the partnering arrangements are finding new forms to address the complex supply, manufacturing, analytical, distribution and patient delivery problems involved.

ISPE Biomanufacturing Conference Sheds Light on CGT CMC Challenges

The concluding session at this year’s ISPE Biopharmaceutical Manufacturing Conference in San Francisco in December shed a lot of light on how the diversity of products and processes being developed in the advanced therapy/personalized medicine arena necessitates a much more intensive sharing of ideas and expertise than may have been the case in other contexts.

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