Wednesday, September 9, 2015

The 3 Biggest Challenges Facing Regenerative Medicine Developers

Dr. Julie Allickson, Director of the Regenerative Medicine Clinical Center, Wake Forest Institute for Regenerative Medicine and Wake Forest School of Medicine - also a keynote speaker at this years Cell Therapy Bioprocessing & Commercialization event - sat down with us for a podcast interview. During the interview, Dr. Allickson discusses the future challenges for regenerative medicine developers, how pharma companies that are developing regenerative medicine therapies can benefit from the academic model for translation, the regulatory hurdles that regenerative medicine developers face, the key differences between the industry in North America, Europe and Asia, as well as her talk at this years meeting. Below you will find a teaser from the interview...Interested in hearing more? Access the complete interview now...

Where do you see the biggest challenges facing regenerative medicine developers over the next five years?

I think there are several different challenges, but when I really try to add those up I feel that there is a lot that we need to develop yet to get a robust manufacturing process. I think there is a lot that goes into making sure that the product is safe and meeting all the requirements for the regulators. But also, as we are looking at scaling up, scaling out the products, I think that there are a lot of efforts that we still need to put into that.

The other piece would be looking at automation and really pushing the automation to decrease what I’m going to say is the “human factor”, which can bring error and, actually, it would be much more timely. So, I think that the field really needs to push for the automation to be able to get more of a robust manufacturing process.

We actually just published a paper in February in stem cells translational medicine with Josh Hunsberger as the primary author, but really looking at the roadmap for tissue engineering and regenerative medicine in the manufacturing space. I believe that that’s definitely one of the challenges, but I think, also, we have challenges in clinical trial design.

There is a lot of failure – I would say – in clinical trials as we are learning, but I think it is getting better. As we nail down the appropriate patient populations, we’re not so broad and incorporate control groups and also really being thoughtful as we are looking at the end points in clinical trials. It is very critical as we’re selecting what matches up with the potency of the product. I think that’s definitely key.

Then, I would say third would be regulatory considerations. As we move forward, we know it’s really a new paradigm – regenerative medicine – in healthcare and I think that gives us the opportunity to be able to voice our concerns, educate the regulators so that they really understand what we need.

So, I think it is definitely communication, educating the regulators and I think that the more opportunity that we have to facilitate those discussions, the better place that we’ll be in because there is such an opportunity for healthcare if we can accelerate the commercialization of some of these products.

Want to hear more from Dr. Allickson? Join her in Alexandria, VA for Cell Therapy Bioprocessing & Commercialization, September 30 - October 2, 2015 - where Dr. Allickson will have a keynote address titled "Academic Model for Translation of Regenerative Medicine Including Tissue-Engineered Products in the 21st Century: What are the Pathways? What are the Barriers?"

We hope to see you in a few weeks!

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