Utilizing Immune Monitoring in Next Generation Immunotherapy Trials

 

Kaitlin Searfoss:

Hi, everyone. Welcome to this podcast from Cambridge Healthtech 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, Tom Lawler, the Founder and Managing Partner of Baywyn Solutions. Thanks for joining us, Tom.

Tom Lawler:

Absolutely.

Kaitlin Searfoss

So you're speaking at the Outsourcing for Clinical Trials Conference on establishing a team atmosphere for creative problem solving. Can you give us a little insight into why this topic is so important?

Tom Lawler:

Drug development projects to me are just a series of issues that need to be resolved and no project team or partner is ever perfect so every time you embark on a development project you know you're going to have a bunch of issues in front of you. They're going to come up along the way. There's nothing more important to me as a project leader to ensure that I have a team that's going to be able to creatively come up with solutions for those problems and deal with them in a timely fashion and be able to keep things moving.

Kaitlin Searfoss:

So what are some examples of when teamwork was lacking and it resulted in tangible problems with the trial?

Tom Lawler:

I think a good example is a project that I was assigned to. It was an acquisitions project where the sponsor and the CRL had poor communications, poor team relationship and as a result of the acquisition, the CRL started to make assumptions about what the next steps were going to be for the partnership, for the relationship, and for the study and in the absence of strong communication what happened was the CRL actually started to be a little disengaged from the sponsor and the sponsor disengaged from the CRL. It came to a point where the progress on the program actually slowed down significantly because everyone assumed that this acquisition and the result of the acquisition was going to result in big changes to the program and to the team structure.

In fact that wasn't the case and the program actually had to be jump started again to get it back on track.

Kaitlin Searfoss:

Do you have any metrics for teams to use to measure their success or what advice would you give to struggling teams?

Tom Lawler:

I think the most important metric is very simple. It's delivery performance to plan. A team setting up goals whether it's an enrollment target or data cleaning or hitting a delivery of a document and then actually delivering to it. It's something that builds trust. It focuses the team on delivery, things that are important. It allows successes to be celebrated along the way during a project. I think when teams are having problems it's important for them to actually look at metrics like this one to focus on the short term. Try and build some wins in the next ten, twenty, thirty days.

By delivering on those promises and commitments to each other when teams are having problems that is a way to build trust and then also make progress on the project. Take things in small chunks and work through it that way.

Kaitlin Searfoss:

What are you most looking forward to seeing at the Clinical Trial Innovation Summit?

Tom Lawler:

I'm really looking forward to meeting new people. I always like networking and in particular I like to see how people are approaching some of the problems that we've had and we continue to have when it comes to drug development and clinical studies. I love to see how people are coming up with new solutions and new approaches to deal with these problems.

Kaitlin Searfoss:

Thanks so much for your time today Tom. I really appreciate talking to you.

Tom Lawler:

Oh you're very welcome.

Kaitlin Searfoss:

That was Tom Lawler the founder and managing partner of Baywyn Solutions. 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 key code, “podcast.”

I'm Kaitlin Searfoss. Thanks for listening.


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