Kaitlin Searfoss:

Hi everyone, welcome to this podcast from Cambridge Health Tech Institute for the Outsourcing for Clinical Trials Conference taking place April 25th and 26th 2017 as part of the Clinical Trial Innovation Summit. I'm Kaitlin Searfoss, conference producer. We have with us today one of our speakers, Vatche Kalfayan who is the senior director of clinical operations at Pfizer. Thanks for joining us, Vatche.

Vatche Kalfayan:

Thank you, Kaitlin. Thanks for having me.

Kaitlin Searfoss

First question. As someone with experience in both the CRO world and in pharma, what would you consider the biggest challenge in outsourcing?

Vatche Kalfayan:

Kaitlin, I should mention that even though I work for Pfizer and I am a consumer of CRO services there, my opinions on this podcast and ultimately at the conference are mine and based on my experiences. The biggest challenge in the relationship is setting expectations. I think a lot of times we're focused on, from a sponsor standpoint, the scope of the offerings from our CROs, their experience, and certainly their skills, and those are all valid. Where the pitfalls lie is that somehow it is not uncommon for both parties to come to disagreements on expectations after the fact, after the contracted arrangements are made. That's because I think sometimes sponsor companies believe that some of it's implied, and I don't think that's the case. I think from the CRO side, and again not surprisingly, CRO is interested in securing the contract, securing the bid, and I think they should be a little bit more in tuned with what expectations are and if they're not getting clarity, they should be seeking clarity at the time they're doing their initial contract with a sponsor.

Kaitlin Searfoss:

What are some lessons learned from your experiences at Pfizer, and at Aris Clinical?

Vatche Kalfayan:

Well, they're distinctly different experiences. Aris Clinical is a small, clinical trials management services CRO and it's a specialty organization, and so it provides certain services and specializes in certain areas. From that perspective, I think it's a matter of you're a CRO and you fall into that category. If you don't and you're a bigger CRO, it's identifying what you are for clarity for purposes of the sponsor, knowing what they're getting, not trying to be something that you're not. That's a big lesson for most CROs; don't try to sell, eventually it'll come back on you, something that you can't provide.

This is both sides, planning to be a partner with your client and ensuring that expectations are met. Then, of course on the sponsor side and the Pfizer side specifically, the scope of the projects that we do are so varied, the CRO needs are anything from smaller transactional support maybe regionally, to global multi-national studies. The challenges there again is, I'm going to stay on this theme, expectations to be very clear about not only what service offerings you're expecting, but where do you want to land, where do you want to arrive at the end. That's really the beginning, the foundation of a relationship with any CRO, whether it's a small company like Aris or a big multi-national company.

Kaitlin Searfoss:

Where is the field of outsourcing headed next? What projects are you working on to move Pfizer in that direction?

Vatche Kalfayan:

Well one, more than ever the marriage between CROs and sponsors is something that needs to be nurtured, that needs to be acknowledged by both parties it's going to be a long term arrangement. I think there was a time many years ago; I've been doing this for well over 20 years, where most sponsor companies, certainly large pharmaceutical companies had a lot of their own clinical trial management infrastructure, a lot of that has been outsourced. Now we are in a coexistent state with CROs. I think that the future, number one, is that we both acknowledge that we're there together and we have to succeed together.

I also think that one of the challenges going forward is going to be about how unique some of our studies are. We have the phase one through three paradigm where if we build an outsourcing model, we may say we need a certain kind of support for phase one studies, two studies, and phase three studies. Well, it's gotten much more complicated than that. We've got, of course, indication specific needs. We also have precision medicine, accelerated approval pathways and orphan drugs, all of which are examples of where you need a different kind of specialized support. I think some companies out there, some CROs out there could be providers of that kind of niche support.

Then there's other things to consider. Technology is playing a big role in how we're going to capture data, how we're going to move information. We'll be able to find tremendous efficiencies going forward and that's going to impact offerings, and then things like risk-based monitoring, which should probably change the way that we monitor all studies eventually.

Kaitlin Searfoss:

What are you most looking forward to seeing at the Outsourcing for Clinical Trials Conference?

Vatche Kalfayan:

I'm looking forward to hearing everybody's different opinion. I think there's going to be a wealth of experience there. I've seen the agenda. I know that there's at least one presenter that's going to be talking about transactional models for CRO services, which I think right there is one of the many approaches, and a very valuable one. I'm interested in hearing that presentation.

I'm interested in hearing questions at the panel discussion, because you learn a lot about what people are thinking and where the industry is going. You know, we're going to have folks from both sides, both sponsor and CRO. I think pluralism is really important. We should be open to hearing how everybody's doing it. We can learn from each other. There's a lot of people that I work with in the current setting at Pfizer [inaudible 00:05:04] I'm fortunate. I get the influence from a lot of subject matter experts, but that's just one organization. I'm really interested in hearing all the different opinions from the attendees.

Kaitlin Searfoss:

Well thank you so much for your time today, Vatche. It's been great talking to you.

Vatche Kalfayan:

Thank you, Kaitlin.

Kaitlin Searfoss:

That was Vatche Kalfayan, who is the senior director of clinical operations at Pfizer. He'll be speaking at the Outsourcing for Clinical Trials Conference at the Clinical Trial Innovation Summit, taking place April 25th and 26th 2017 in Boston. If you'd like to hear him in person go to clinicaltrialsummit.com for registration information, and enter the keycode podcast. I'm Kaitlin Searfoss, thank you for listening.