Tuesday, June 17, 2014

See What's "Long Overdue" in the Field of Cell Therapy

In cell therapy, the Target Product Profile (TPP) is the preferred document used to record the aspirational attributes of a therapeutic.  Anthony Davies, Ph.D., President of Dark Horse Consulting, is a leading expert on TTPs and will be presenting on the specifics of authoring a TPP at this year’s Cell Therapy and Bioprocessing Conference.  He was able to shed some light for us on the current state of TTPs in the field:  

Are Target Product Profiles being increasingly adopted as development and as a mode of regulatory communications?

Anthony: Yes, they are and this is also long overdue. The TPP was introduced by the FDA quite some time ago as a way of capturing your expiration or profile of your product. It is, at last, being adopted more widely by industry. This is much appreciated by the regulatory agencies. It is a very good tool for two purposes.

First of all, from the first interaction the product ever has with a regulatory agency, this enabled the agency to frame the complete trajectory of product development all the way through to commercialization and gives them a tremendous perspective on what they are trying to do in developing these drugs. It’s repeated provision for the agency as the drug moves out of development product and keeps everything on track and keeps everybody realistic about where the drug is meant to be at each stage of development.

Cell Therapy Target Product ProfilesInterestingly, it’s also being adopted by biotech companies and pharmaceutical companies as an internal method of tracking the progression of the drug development. The use in both the external, regulatory view of the drug and the internal corporate view of the drug development is a really nice harmonizing tool. I’m very happy at the Conference to be giving a presentation on the nitty gritty of how to fill out a TTP for cell therapy. I hope it will be very useful for the attendees.

Anthony’s full interview can be found in this year’s brochure.  

You can hear more from Anthony and other leaders in the space at this year’s Cell Therapy Bioprocessing Conference.  Join us September 15-16 in Arlington, VA.  Save $100 as a reader of this blog when you register to join us and mention code XB14189BLOG.

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