Managing Precision Medicine Clinical Trials

Mana Chandhok:
Hi everyone. Welcome to this podcast from Cambridge HealthTech Institute for the Scope Summit, which runs January 24th to the 26th in Miami, Florida. I'm Mana Chandhok, and associate producer. We have with us today one of our speakers from the Managing Precision Medicine Trial Symposium, Dr. Brenda Yanak, who is a director of clinical innovation at Pfizer. Brenda, thank you for joining us.

Brenda Yanak:
Hi, thanks for having me.

Mana Chandhok:
How challenging has it been to apply the concept of precision medicine to clinical trials?

Brenda Yanak:
I would say that it's really a two part response. First, scientifically the level of difficulty really depends on the therapeutic area. In some therapeutic areas more may be known about the disease or the mechanism of disease, so it may be a little easier to apply concepts there. Whereas in other therapeutic areas less may be known, and therefore there could be a lot more exploratory work that needs to be done for a successful application.

Second, operationally speaking because we're on the leading edge of precision medicine most companies don't yet have standardized operations related to trial activities in this area. You'll find a wide variety of processes in place from therapeutic area to therapeutic area. What we've done is try to understand commonalities across therapeutic areas so that we can harmonize operations that way so that we do have a standard approach in place as we apply precision medicine in trials. What we're doing is we're going from variability to harmonization where that harmonization can be achieved.

 

Mana Chandhok:
What sort of trends, either technological or otherwise, should we be aware of for precision medicine trials?

Brenda Yanak:
There's actually a lot of activity in this space, so I think this is a great question. From a protocol perspective there's an effort to divide the common protocol template. In the industry we have a consortium called Transcelerate which is comprised of several different companies, and they're actually working on a common protocol template. A lot of activities that are around precision medicine you can actually find within the consent management, specimen tracking, and bio-banking spaces as well.

Within consent management what we see is that there are several software and service companies that are now offering consent management capabilities, either in their software or as a service. We have small companies that are now offering e-consent or consent by video, and I've even seen some mobile app development occurring. I've also seen companies using text mining through natural language processing to mine consent allowances within their consent documents to try to reduce the complexity and manage the information.

In addition, within the specimen management space, similarly we see software and service companies now offering specimen tracking capabilities directly from point of collection through central labs, analytical labs, and storage spaces. We see partnerships forming between small companies and large labs and CROs to manage the specimen tracking challenges in this area. In addition, I'm pleased to say that bio-banking is finally becoming recognized as a key player in clinical trial planning versus being considered simply as a large freezer for specimens at the end of trials.

I think it's a really good thing that there's recognition that bio-banking is one of the foundational aspects of precision medicine architecture, and that specimen collection and storage consideration are analyzed during clinical trial set up versus at trial closure. Furthermore, in looking at the environment and trends, what I see in the future is that bio-banks may be considering not only offering specimens and specimen sets, but may also be offering data generation services to their clients as well, and I see patient advocacy groups partnering with bio-banks or companies to offer specimen sets or data sets as part of collaborations.

Mana Chandhok:
What can we hope to take away from your presentation and scope during the Managing Precision Medicine Trial Symposium?

Brenda Yanak:
I think that the key message is that precision medicine can be done in a skilled fashion within companies while still allowing therapeutic areas to maintain autonomy and decision making. We can reap the benefits of standardization while still allowing for these variations therapeutic area to therapeutic area so that they are able to apply precision medicine as they see fit within their particular trials.

Mana Chandhok:
Brenda, thank you for your time and insights today.

Brenda Yanak:
Thanks for having me.

Mana Chandhok:
That was Brenda Yanak from Pfizer. She'll be speaking at the Managing Precision Medicine Trial Symposium at the upcoming Scope Summit, which runs January 24th to the 26th in Miami, Florida. If you'd like to hear her in person go to www.scopesummit.com for registration information, and enter the key code podcast. I'm Mana Chandhok. Thank you for listening.