Affordable Breakthrough Therapies

An Interview with Denis Bedoret of MaSTherCell

We recently sat down with Denis Bedoret, Chief BD Officier at MaSTherCell in Amsterdam at the Cell Therapy Manufacturing & Gene Therapy Congress conference to discuss the critical issues and opportunities present in the cell & gene therapy industry today.

Continue reading “Affordable Breakthrough Therapies”

No substitute for strong science: Breakthrough Therapy Designation success story

It has now been almost four years since the FDA introduced its Breakthrough Therapy Designation, and yet a certain air of mystery still surrounds it. Indeed, just this week, the FDA itself released a Q&A to “help readers understand not only the lingo, but also the implications of expedited reviews and approvals”.

At BioProcess International European Summit 2016, Merck Executive Director of Biologics Process Development and Commercialisation Gargi Maheshwari told of her experience of working on one of the biggest successes of the accelerated approval programme; KEYTRUDA.

The drug gained market approval a little over a year after being named a breakthrough therapy, and Dr Maheshwari highlighted how “the timelines that we had to work with were very different to the traditional pharma timelines of up to 10 years”, which inevitably created a lot of challenges.

Continue reading “No substitute for strong science: Breakthrough Therapy Designation success story”

FDA Breakthrough Therapy Designation List 2016-2017

With new FDA Breakthrough Therapy Designations constantly being granted, we keep an up-to-date list of every approval. Check back for all the latest news and information.

(Last Updated: 2 February 2017)

Continue reading “FDA Breakthrough Therapy Designation List 2016-2017”