How will cell therapy change in the next five years?

Joining us in this Cell Therapy Bioprocessing & Commercialization Podcast is Anthony Davies, President of Dark Horse Consulting. Anthony discusses key industry challenges he is seeing, the evolution of the field in the next five years, some exciting new initiatives he is working on, regulatory issues and much more. Below is a brief excerpt from the podcast, be sure to click on the links below to access the complete podcast.

Listen to the Podcast | Access the complete transcript

How do you see the field of cell therapy changing in the next five years? 

I believe strongly that the next five years will bring the first significant drug approval. This will be a transformative moment for the field. A lot of players who are sitting on the wings will move in and there will be a big acceleration. Who will benefit from that the most are the organizations and the entities which have spent the difficult, recent years preparing and positioning themselves the best. 

I think we would do well to look around at this point because it will – in a sense – be the calm before the storm. The companies which are working fervently now preparing themselves to be able to take their drugs all the way to commercialization are the ones who are going to step in to the fast lane when the first big approval comes. And as I said, I do think that the next five years is a very realistic timeframe for this to occur.

[The above was a brief excerpt from the podcast]

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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.

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.

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