CIRM and QuintilesIMS Kick Off Accelerating Center to Help Stem Cell Therapies Soar

You wouldn’t ask a goldfish to take flying lessons, right? The chances of success would be slim.

But in essence, that’s the predicament in which CIRM has found itself when asking top notch stem cell scientists to use the agency’s funding to carry their great cell therapy ideas into and through clinical trials. While these researchers are experts at developing therapies, knowing how to successfully navigate the complex regulatory requirements of the Food and Drug Administration (FDA) is another beast entirely. Many simply don’t have the experience to get those therapies off the ground by themselves.

This challenging scenario was the genesis of the $15 million CIRM Accelerating Center grant which was awarded to QuintilesIMS by the CIRM governing Board back in June. Last Tuesday, the QuintilesIMS and CIRM teams gathered to celebrate the grand opening of the Accelerating Center at QuintilesIMS’s San Diego office.

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CIRM President and CEO C. Randal Mills spoke at the grand opening of the CIRM Accelerating Center at the QuintilesIMS office in San Diego.

CIRM President and CEO, Randy Mills, spoke to the group and described the concept behind the center and how it will help accelerate stem cell therapies to patients with unmet medical needs:

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C. Randal Mills

“We were asking stem cell scientists to do something they don’t have experience doing. We thought about the answer to that and it was simply: why don’t we create a center for the world’s most brilliant researchers and innovators in cell therapy that gives them the tools they need to successfully navigate this regulatory system? That way, their transformative ideas can get into the clinic so that they can be tested and go on to help patients. We have stopped asking fish to take flying lessons. We’re telling fish to swim as fast as they can and we’ll help with the areas they don’t have as much experience in. That’s the concept behind the Accelerating Center and I’m so thrilled CIRM is a part of it.”

This first-of-its-kind center will provide researchers with the support and management services they need to increase the likelihood their clinical trials will succeed. As a leading integrated information and technology-enabled healthcare service provider, QuintilesIMS is just the company to carry out this task. CIRM’s clinical-related projects that are run through the Accelerating Center will not only benefit from QuintilesIMS’s deep experience and therapeutic expertise, but they will also be given a discount on their services.

Alan Metz, QuintilesIMS’s senior vice president of Global Therapeutic and Specialty Centers of Excellence also spoke at the grand opening about how this new endeavor hits close to home given his wife’s battle with multiple sclerosis:

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Alan Metz

“My family has a particular stake in the success of stem cell therapy, and I’m pleased and indeed privileged to be part of the collaboration with CIRM. I’m thrilled that Quintiles has the opportunity to participate in this ground breaking, really exciting field of research.”

Also in attendance was Scott Peters, the United States Representative of District 52 – an area that covers portions of San Diego including the QuintilesIMS office. As Peters cut the ribbon to officially kick off the Center, Mills gave a toast to the people all of this effort is directed toward:

“I just want to make a toast that we never forget why there is a life science industry, that we never forget why we’re here and never forget why CIRM exists: this is all about accelerating therapies to patient with unmet medical needs.”

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(Left to Right) C. Randal Mills, Representative Scott Peters,  Avi Kulkarni (SVP and Managing Director, QuintilesIMS) and Alan Metz cut the ribbon for the grand opening of the Stem Cell Accelerating Center in San Diego.

Accelerating the drive for new stem cell treatments

Acceleration

Acceleration is defined as the “increase in the rate or speed of something.” For us that “something” is new stem cell treatments for patients with unmet medical needs. Today our governing Board just approved a $15 million partnership with Quintiles to help us achieve that acceleration.

Quintiles was awarded the funding to create a new Accelerating Center. The goal of the center is to give stem cell researchers the support they need to help make their clinical trials successful.

As our President and CEO Randy Mills said in a news release:

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“Many scientists are brilliant researchers but have little experience or expertise in running a clinical trial; this Accelerating Center means they don’t have to develop those skills; we provide them for them. This partnership with Quintiles means that scientists don’t have to learn how to manage patient enrollment or how to create a data base to manage the results. Instead they are free to focus on what they do best, namely science.”

How does it work? Well, if a researcher has a promising therapy and approval from the US Food and Drug Administration (FDA) to start a clinical trial, the Accelerating Center helps them get that trial off the ground. It helps them find the patients they need, get those patients consented and ready for the trial, and then helps manage the trial and the data from the trial.

The devil is in the details

Managing those details can be a key factor in determining whether a clinical trial is going to be successful. Last year, a study in the New England Journal of Medicine listed the main reasons why clinical trials fail.

Among the reasons are:

  • Poor study design: Selecting the wrong patients, the wrong dosing and the wrong endpoint, as well as bad data and bad site management cause severe problems.
  • Poor management: A project manager who does not have enough experience in costing and conducting clinical trials will lead to weak planning, with no clear and real timelines, and to ultimate failure.

We hope our partnership with Quintiles in this Accelerating Center will help researchers avoid those and the other pitfalls. As the world’s largest provider of biopharmaceutical development and commercial outsourcing services, Quintiles has a lot of experience and expertise in this area. On its Twitter page it’s slogan is “Better, smarter, faster trials” so I think we made a smart choice.

When Randy Mills first pitched this idea to the Board, he said that he is a great believer in “not asking fish to learn how to fly, they should just do what they do best”.

The Accelerating Center means scientists can do what they do best, and we hope that leads to what patients need most; treatments and cures.


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