OneMedForum NY 2012 Sponsor Aptiv Solutions Educates the Market on Adaptive Clinical Trials

Aptiv Solutions is a full-service international CRO with proven expertise in supporting global clinical trials for biopharmaceutical and medical device companies. Their trials span the development lifecycle from first-in-human through regulatory approval and beyond. As a sponsor for OneMedForum New York 2012, the company’s corporate brand manager was interviewed by OneMedRadio and gives an overview of the clinical trial space and what makes Aptiv unique.

 

Click below to hear full audio interview and see transcript that follows.

Matthew Margolis:    Greetings from OneMedRadio, I’m Matt Margolis. Today, we’re with Phil Birch, corporate brand manager of Aptiv Solutions, a global CRO headquartered in Reston Virginia with a focus on adaptive clinical trials. Thank you for joining us, Mr. Birch.

Phil Birch:       Thank you, Matt.

MM:      So first, maybe you can give us a brief company overview of Aptiv Solutions.

PB:     Sure, I’ll be very happy to. Aptiv Solutions is a global CRO recently formed and focusing in two key areas, adaptive clinical trials and medical devices.

MM:     Maybe you can give me an idea of some company history. You mentioned it was recently formed, how did Aptiv come about?

PB:   Sure. It was created through a merger of several service companies, each with a track record of success, who all brought something different to the table and this included specific expertise and experience in adaptive clinical trials. We’ve taken those initial founding companies and added to them by recruiting some of the world’s leading experts in adaptive trials and we’ve put those people in what we call our innovation center, which is our centerpiece for helping clients develop novel approaches to develop their products.

MM:    So what are adaptive design trials and why are they important?

PB: Well adaptive design trials involve the timely collection of data in defined interim analysis steps, which provides the opportunity for the trial to adapt to the emerging data. So it’s a process that enables real-time learning. For example, if you’ve undertaken interim analysis, you can take a decision to change the sample size for the trial, you can stop the trial for futility, you can drop ineffective treatments and make a number of other changes to the trial. The important point is that these are not ad hoc changes, these are changes that are pre-specified and planned in advance so they’re preplanned design changes.

We’re passionate about adaptive clinical trials because they offer the potential to improve the efficiency of product development and we’re all aware of the issues facing product development at the moment.

MM:     Can you talk a bit about the idea of the importance of maintaining very strong client services?

PB:   Sure. You know, our approach that we take is unique. It’s different to other companies. We’re investing heavily in new methodologies and new technologies that are geared towards making the product development process more efficient and we’re offering our knowledge and our technologies to help companies design better clinical trials and the whole thesis behind is that an adaptive trial is a much smarter way of doing product development than the old traditional ways.

As I said earlier, we’re passionate about this because it’s going to go a long way to solving many of the issues facing industry today and those issues are declining in R&D productivity, increasing development costs and quite worryingly still high failure rates in late stage phase III development. We’ve invested heavily in the technology and the methodology that’s going to enable us to solve a lot of the problems that have been there in the past and we’ve coupled to that arms and legs traditional CRO to enable us to implement these trials, but importantly that’s supported by innovative thinking in trial design or execution. So effectively, it’s a CRO with a very solid brain on the top that enables us to have significant intellectual input into the design of these novel trials.

MM:    So it seems as though adaptive trials can be applied to various sectors but what areas are adaptive trials used more than others?

PB:    They can be pretty broad. Our experience to date has been, you know, we’ve done a significant number of trials in the respiratory area, in the GI area and the cardiovascular area, but they have broad application. We’re seeing a lot more interest now in doing CNS trials that can cover neuropsychiatric disorders or pain trials and also in oncology. In oncology, there’s a real need for an adaptive approach because they’re difficult areas to develop drugs in because of the heterogeneity in patient populations and the fact that individuals are on multiple therapies. Adaptive approach can really help identify what is the best drug for the best subpopulation of patients within that setting and that’s true for other therapeutic indications as well.

MM:  Now I want to circle back to something you touched on earlier, the idea that the clinical trial space and regulatory space is changing. I was wondering if you could talk a bit about what these changes are and how adaptive trials are becoming more necessary.

PB:      Sure. You know, adaptive trials are not new. They’ve been around for quite a while now. In fact, we’ve been running adaptive trials for over ten years, but they tended to be relatively simple adaptive trails where you’re making maybe one adaptation.

But what’s happened in the last few years is that the technology, so the technology platform to implement more complex adaptive trials has become available and this is now re-stimulating interest in the whole adaptive trial space. The important factor is that one can now design complex trials for instance in the phase II setting where you can ask a number of questions about your product development program. If you can answer those questions using an adaptive design then you can make much better informed decision making such that when you enter into your phase III confirmatory trial, you’re much more certain that you’re going to get a positive outcome. So being able to learn more using an adaptive approach at phase II is going to increase the success at phase III and that’s going to be very important for the industry. So we believe that adaptive trials are now enabling the dreams of biostatisticians in the past to become a reality. So they’re going to be able to really change the way that drug development has been done in the past.

MM:   Sure. So let’s jump back to your company profile a little bit, I was wondering if you could give our readers an idea of your global presence.

PB:  Absolutely, I’m very happy to do that. So we’re about 850 people at the moment, about 400 of those individuals are based in the US in various locations on the east coast and on the west coast and a similar number of individuals in Europe with a presence in most European countries and then a group of 50 based in Japan. In Japan, we focus specifically on oncology, that’s for historical reasons, and in other areas we are pretty broad in terms of the therapeutic expertise that we have. So we’re still relatively small, but we’re bringing something unique to the table and certainly finding that our offering and our technology and our approach is getting us through the door with a number of sponsor companies and they seem very interested in the adaptive approach.

MM:  One thing I’m particularly interested in is your ADDPLAN software. I was wondering if you could tell us what it is and why it’s important, what’s new with it.

PB:   Sure. So ADDPLAN is our proprietary software for designing confirmatory adaptive trials and it basically is a statistical design package that enables you to run a series of simulations of different trials, which then enables you to make a decision as to which is the best design for your study that you’re trying to initiate. So what’s new about it? Well we just launched some new software called ADDPLAN PE and PE stands for population enrichment. This is an adaptive approach that’s going to enable sponsor companies to run a trial and identify the subpopulation of patients that responds most effectively to their novel treatment. This has very important consequences for the whole area of personalized medicine and indeed pricing and reimbursement where these days the hurdles one has to jump over to get a successful health economics package are significant and this approach is also going to help in that area.

MM:       Sure. So touching on that idea of personalized medicine, from the CRO side of operation and development, I was wondering if you could talk a bit about this surge that we’re seeing in diagnostics and personalized medicine.

PB:   Sure. It’s been happening for quite a period of time. There’s a massive explosion in the identification of biomarkers and genetic markers. What we need to do now is use that information to development better drugs. The approach that we’re taking is going to enable companies to do that in a much smarter fashion. So it’s going to really be an enabling technology, an enabling methodology for running clinical trials and really identifying the patients that best respond to these novel treatments which is what personalized medicine is all about.

MM:    So as we wrap up here, I think the appropriate question is what is the future of Aptiv Solutions? What challenges and opportunities do you see going forward?

PB:   Our biggest challenge at the moment is to educate the market around the value and the benefit of adaptive trials and demonstrate to sponsor companies that one can implement these complex adaptive design trials in a broad setting in a number of different therapy areas. We’re finding that there’s quite a lot of knowledge about adaptive trials, but no real in depth understanding. So that’s really our challenge for the next 12 months is to help educate the marketplace effectively and we’re undertaking a number of activities, speaking at as many conferences as we can to get that message out there because as I said at the beginning we’re passionate about this because it really will make a difference to product development.

MM:   That was a company snapshot of Aptiv Solutions with Phil Birch, company corporate brand manager. This is Matt Margolis signing off.

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