Roche Discuss Impact of FDA Breakthrough Designation Therapy on Technical and BioProcessing Departments

We spoke to BioProcess International Europe Summit keynote speaker, Niklas Engler, Head of European Technical Development for Biologics, about the impact of the FDA’s Breakthrough Designation on bioprocessing and technical support teams, a key theme of this year’s BPI Europe conference in Düsseldorf, 14-15 April 2015.

“One of the biggest challenges we face is how technical teams support variations in clinical trials”

“The big challenges we face at the moment are not necessarily protein production, that is fairly well understood, it’s how technical teams support variations in clinical trials, whether it’s an accelerated programme such as FDA Breakthrough Therapy Designation, or heavily gated programmes where you don’t do any technical support for a long time and then have to catch up very quickly.”

FDA Breakthrough Designation

“The speed in which the FDA worked with us was really impressive”

In November 2013 Roche’s monoclonal antibody, Gazyva, became the first medicine approved through the FDA’s Breakthrough Designation Therapy Designation, triggering a flurry of activity in the area. FDA’s Breakthrough process intends to expedite the development and review of drugs for serious or life-threatening conditions.

“The FDA’s Breakthrough Designation has created a direct dialogue between sponsors and the agency. For Gazyva, which attacks targeted cells both directly and together with the body's immune system, we had weekly exchanges; the speed in which the FDA was working with us was really impressive,” says Dr Engler.

Cost and resources are also key. “Obviously, the financial and personnel investments are huge for such as product so you have to make sure you have the right product in place and all the departments are aligned - technical, clinical and non-clinical development.

Because once you jump on that train you accelerate very quickly. If you are not prepared you can really slow down any accelerated advantage you once had. My presentation at BioProcess International Europewill report some recent experiences and strategies to prepare for the acceleration (link here).

Being able to supply the market is also key: “If you want to go for a large indication like the PD-1 and PDL-1 markets, you need to make sure everything in place to supply. This is a big topic for the FDA, they don’t want difficulties in supply.”

“There haven’t been any new computers for a decade but the capabilities and power has been increasing all the time. We see this trend in bioprocessing in terms of speed and scale.”

So what of the future of bioprocessing? “I think the biomanufacturing industry has come of age. A lot of the technical challenges have been solved in terms of titre and productivity. Now it’s more about speed and gating. Compare it to the computer industry. There haven’t been any new computers for a decade but the capabilities and power has been increasing all the time. We see this trend in bioprocessing in terms of speed and scale.”

“The key is avoiding any quality discussions by using the right technologies and analytics. It’s more about speeding up and avoiding the hiccups. It’s more important to avoid the slip ups than ever before. In previous years it was like a rally. You could afford to lose ground because you knew you could make up it later. This options isn’t available anymore. Now it’s like a Formula 1 race – if you slip up you could be out of the race completely.”

Niklas Engler will be speaking at this year’s BioProcess International Europe Summit in Dusseldorf, on Tuesday 14 – Wednesday 15 April 2015.