Plenary Sessions Pave the Way for "Cure Not Treatment"

By: Brian Caine

Cell Therapy Bioprocessing & Commercialization got off to an exciting start as plenary speakers Marc Better PhD, Julie Alllickson PhD and Bruce Levine described the cell therapy landscape and their outlined progress.

More than 200 cell therapy professionals heard Dark Horse Consulting president and event chairperson Anthony Davies set the stage by reviewing the real progress and strides the cell therapy market has made while acknowledging the hard work that the industry is facing.

Marc Better, Phd, Vice President, Product Services at Kite Pharma kicked off the first of three presentations describing the market as "exciting and challenging". He outlined the general challenges faced by Kite Pharma and focused on the solutions it implemented to effectively and successfully engineer autologous T cell therapies.

Julie Allickson, PhD, Director, Regenerative Medicine Clinical Center, Wake Forest Institute for Regenerative Medicine said real commercialization would come as research moved to "cure, not treatment".

She provided attendees with Wake Forest’s approach to determine what process design, development, manufacturing, and technologies will best support their initiatives.

"Academic and industry must come together in order to be successful," she said to create "a manufacturing roadmap for TERM Technologies".

Allickson reinforced the need to create a consortium to develop infrastructure and resources to advance manufacturing and set a standards. She also noted that bio-printing is showing greta results and has a bright future.

Bruce Levine, PhD, Associate Professor in Cancer Gene Therapy, University of Pennsylvania detailed their approach to targeting tumors with CAR-modified T-Cells and reported on the positive short and long term results.

Join the conversation on Twitter by following #IBC_CTB15

Share this article with your social network, just click below to share now!

Share |

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...

Podcast | Transcript

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?"

Download the agenda | Register for the event 

We hope to see you in a few weeks!

Share this article with your social network, just click below to share now!

Share |