Introduction (Text Version)
Joel Nowak; Malecare
I would like to welcome everyone this morning—to this morning’s session. My name is Joel Nowak and I’m with Malecare. The process of basic research—our—our topic is the process of basic research all the way through to Phase 3 trials and I promise you that you’re going to find this a most interesting session. I want everyone to know including our speakers that we are very tight on time and so we’re going to ask if you can keep to the time limits.
Clinical trials are the backbone of the advancement for treatments for prostate cancer. And in this session we are going to discuss the prostate cancer clinical trials consortium, which is a network of 13 leading cancer centers across the country working to facilitate the rapid movement of new therapies for prostate cancer all the way through Phase 1, Phase 2, Phase 3 trials, and ultimately onto clinical practice. Through the joint support of the Prostate Cancer Research Program and the Prostate Cancer Foundation, in only 5 years the consortium has enrolled more than 2,500 patients in over 83 clinical trials and has invested in 50 drugs, 8 of which are currently in the advanced stage of Phase 3 trials. Those are pretty amazing statistics.
We will learn about the formation of the consortium and the effect it had—it has had on the accelerating pace of clinical research. We will be provided with an update on the current condition of the consortium and their clinical trials and their initiatives that are in the pipeline. Additionally, two key drugs under clinical investigation by the consortium will be discussed in detail. The first Ipilimumab, which is an immunotherapeutic, which has advanced to stage three trials—we heard a little bit about it in the earlier presentation; the second drug which we’ve also heard about, Abiraterone is an androgen synthesis blocker that has already demonstrated significant survival benefits.
Abiraterone will be discussed as an example of an accelerated drug development that’s been done by the consortium enabling a Phase 3 trial to start significantly earlier than we would have otherwise been. We will also hear about the discoveries that have led to clinical testing of novel products that affect the androgen receptor. Additionally, we will also find—we will also learn about other axes of treatment such as MDV3100 and ARN509.
And at this point I would like to introduce Dr. Howard Soule, who is my co-moderator. He is the Executive Vice President and Chief Science Officer for the Prostate Cancer Foundation. He’s responsible for the coordination of global academic government via pharmaceutical sector research activities, as well as being responsible for the implementation of the PCF research strategies. He’s also a member of the PCRP Integration Panel. Dr. Soule is going to give us a history and share the news of the growth of the consortium as well as the growth of the institutions that have participated.
Howard Soule; Executive Vice President and Chief Science Officer, Prostate Cancer Foundation
Good morning. It’s a pleasure to—to be a co-moderator of this session which we actually could call where the rubber meets the road because if—if our discoveries don’t get to the clinic well they can still be important discoveries but they’re not going to help patients.
Before I give a brief of history of the consortium I want to make a global statement about this excellent conference. And—and make a—make a request that Dr. Best and I have been talking about. This is a unique conference with many—many patient survivors in the auditorium. And it would be most helpful and appropriate if—if each of you not just in this panel but—but throughout this conference whether it’s a poster session or another podium talk would take one or two sentences at the end of your talk to really nail what this means for patients, because that’s why we’re here. We’re here for the patients. We’re here to—to see new therapies move forward and—and you know even if it’s a basic science presentation that might have translational properties going out a few years, really putting it into the context of the patient, we want these people to go home energized and ready to—to help be really intelligent advocates for this program. So I think that would be a very good thing to do and I will be taking notes.
By way of background, the Prostate Cancer Foundation around 1996 which pre-dates my—my work there by—by about 9 months made the decision that there was a real unmet medical need in the prostate cancer clinical research community. When—when these investigators do clinical trials and this is really heavy lifting; this is one of the hardest things to do in medicine is to prosecute a really important clinical trial strategy—the problem is there’s the infrastructures were lacking. Companies come and companies go; ideas come and ideas go. But left behind are principal investigators, informatics systems, nurses, fellows, all of the—all of the—the bricks and mortar of clinical trials that nobody seems to want to pay for but everybody just expects that it falls from heaven and that it exists. It’s extremely expensive. The people have the—some of the most unique skill sets anywhere. And nobody wants to pay for them.
So we made a decision in 1996 with six major cancer centers to create a—a consortium where we wouldn’t fund clinical trials but we would make a—an annual donation if you, write down on one piece of paper how you’re going to spend the money, but we’re not going to tell you how to spend it. Let us know how you’re going to spend it, just—just for your infrastructure. And it worked well and we had some expansion. Sloan-Kettering was the—and Dr. Scher who will be speaking this morning was the—essentially the titular leader.
And then as my—my role in the Prostate Cancer Research Program Integration Panel matured, I had the opportunity to propose a number of years ago, I believe in 2004-2005 time frame that the DOD should—should also partner in this clinical consortium which they did which caused everything to go competitive. There was a competition for the coordinating center. There was a competition for at that time 10 study sites and that got into place. Sloan-Kettering was the recipient of the coordinating center, and I’m not going to name the centers. They’ll be—they’ll be shown in—and perhaps Maha will be showing them in just a moment.
But it—it has really matured now to—to a 13-center consortium with—with very high-bar metrics if you will that as you will see is not just the clinical trials machine but more of a treatment sciences machine. And by that I mean there’s scientific rationale as well as regulatory science. By scientific rationale, you’re going to learn this morning about an immunotherapy program, and we all know that immunotherapy is emerging as a major treatment now for advanced prostate cancer and you’re going to learn about the androgen axis from—from the experts in that area and how science integrated into clinical trials with the perspective on what’s next; what—if you’re going to do a Phase 1 trial the question of how this is going to eventually lead to an integrated Phase 3 program with regulatory approvable end points has to be established. So this was really a first. And as you’ll also see, it cuts down on time and bureaucracy and it has accelerated the development of many potentially lifesaving therapies at responsible but—but extremely fast speeds. And you’ll learn about that too this morning.
So you know speaking both as—as a Prostate Cancer Foundation executive as well as a member of the—of the DOD Prostate Cancer Integration Panel, it’s just been wonderful to see this program mature scientifically and clinically and I think arguably it’s—it’s opened a horizon and has sped the development of new drugs for the treatment of this disease, which is why we’re here and for no other reason.