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.
Interestingly, 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.
Sign up for email updates
Check us out on LinkedIn
|
Share this article with your social network, just click below to share now!
|
|
|
No comments :
Post a Comment