Q&A with Dr. Mike Pellini: the need for advanced software to scale cell and gene therapies
by Vineti | October 23, 2019
Mike Pellini, M.D., is a member of Vineti’s Board of Directors, a Managing Partner at Section 32, and the former CEO and Chairman of cancer genomics leader and trailblazer Foundation Medicine. He is a leading voice on how the life sciences will continue to evolve as we forge new approaches for serious diseases. We talked with with Dr. Pellini about the critical role of advanced software in the success of advanced therapies.
What do you see as the current greatest challenge in bringing these new personalized therapies, such as cell and gene therapies, to patients?
I often wondered both to myself -- and also aloud -- how we are going to manage the logistics of the entire cell and gene therapy and personalized vaccine processes from start to finish. It's one thing to be able to produce these therapies; while certainly complex, the manufacturing process is already part of pharma and biotech’s DNA. However, it's another thing to be able to perfectly manage the entire months-long process from start to finish - from the time the patient is identified, blood or tissue is obtained and transferred to the manufacturing site, the therapy is developed, then back to the provider’s location, and ultimately to the same patient - all with an infallible (i.e. perfect) Chain of Custody for the specimen and patient specific therapy. Frankly, biotech and pharmaceutical companies are not designed to manage overly complex logistics at scale; their focus is R&D, manufacturing, and commercial. This logistics game is a brand new puzzle, not just a new piece in a puzzle.
With regard to the challenge that you identified -- which is to say that these companies that are developing these therapies don't have the infrastructure and the technology developed to scale up like you've just described -- is that a challenge that everybody understands? Some people don't really identify the problem as being a problem and others really see it as a big issue. It seems that there's a lot of in-betweens as well. Do you think there's a need to communicate the challenge as much as there is one to communicate the solution?
Well, I suspect everyone involved in this space certainly understands the challenge at some level. However, I would be surprised if most understand the magnitude of the challenge. Industry is rightly focused on the R&D and manufacturing processes. And, in fact, that’s exactly where we want industry focused, namely on developing critical new therapies for patient care. Do we want them learning how to become logistics companies? Do we want academic centers worried about managing dozens of different logistics systems for their many pharma partners? I certainly don’t. We need to simplify the equation. If there was a plug-and-play solution to make the process relatively seamless, I believe they would sign up immediately.
We've had quite a few conversations around Vineti’s supply chain software. One of the consistent themes is the user experience. The ease of use and user experience seem to be particular aspects that matter most. Do you have a sense of other things that might be looked after or sought after when engaging with a company like Vineti?
Ease of use and adaptability are essential for the customer, but it also has to be comprehensive, highly secure, and I said earlier, essentially infallible. A robust, secure, user friendly, comprehensive, infallable solution is going to be critical. At least, that’s the starting point.
You've used the phrase ‘the UPS logistics of personalized medicine’ previously. Is that typically how you describe Vineti to people?
Yes, I use that analogy regularly, and I certainly hope the team doesn’t mind. I do mean it as a compliment. Vineti will ultimately be the software company that connects biotech and pharma companies to their providers and patients, and, in turn, the providers and their patients back to cutting edge treatment solutions. Everybody understands that UPS is not simply a delivery company. They are a complete logistics organization. I see Vineti as being the logistics leader in personalized medicine.
If Vineti works perfectly, no one should know they exist. The pharma and biotech companies (and scientists) should get the credit because they develop therapies. Physicians and their patients are the beneficiaries. What happens in between needs to be seamless. We only pay attention to the USPS, FedEx, Amazon, and UPS when something screws up. At times, one might think about the wonder of Amazon and how quickly something arrives at the doorstep, but I suspect you're not thinking about all the logistics that enabled Amazon to get it to you in 24 hours – at least until it fails. Well, in health care, it can’t fail when a patient is at the end the process.
There are keys to making this ecosystem work. Vineti is not manufacturing therapies. It’s not finding patients. It’s not educating the physicians. It’s not analyzing the tissue and the blood. Vineti is not doing any of that...but Vineti is enabling all of that crucial work. The Vineti solution will play a key role in streamlining and scaling personalized medicine.
Couldn’t each biotech or pharma build this kind of software for themselves?
I am firm believer in knowing what you do well and then doing it well. If every biotech company out there has to build a process like this from scratch, resources will be needlessly burned, and time will be wasted, neither of which is acceptable for a patient with a devastating disease. There are a ton of companies developing these therapies; they can't all go out and develop their own solution. First, it's going to take them forever to find and hire the right people. Second, their expertise is not, and should not be, in software development for logistical solutions. And let’s look at it from the provider’s prospective. If every clinical trial and provider site must integrate a separate solution for each company, they are going to be overwhelmed. Whereas if there's just one standard platform, the entire process is streamlined, and we expedite the roll-out of personalized medicine nationally and globally.
In addition to being a leader within Vineti’s Board of Directors, Dr. Pellini is Managing Partner of Section 32, a venture fund that invests in companies and inventors that are changing the way humans use technology and the way technology betters humanity. Previously, he served as CEO of Foundation Medicine (FMI) from May 2011 until he transitioned to Chairman in February 2017. He also serves as a member of the Board of Directors for Tango Therapeutics, Singular Genomics, Adaptive Biotechnologies, Octave BioSciences, Thrive Earlier Detection, Sema4, the Personalized Medicine Coalition, and the Mission Hospital Foundation. As a physician with more than 20 years of executive experience with companies at the forefront of clinical diagnostics and genomics, Dr. Pellini brings a breadth of understanding in personalized medicine, with a particular interest and focus on defeating cancer. Dr. Pellini is a member of the President’s Leadership Council at Thomas Jefferson University and Jefferson Health, as well as the Advisory Board for Mission Hospital’s Cancer Institute (Providence/St. Joseph Health).