Operations

Industry Viewpoints: Examining the Challenges of Conducting Early Phase Trials

Operations

16:29, July 13 2017

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David Hinds, Tioma Therapeutics, speaks to CTA Editor Henry Kerali about the challenges of working within the oncology space

In this Industry Viewpoint, Clinical Trials Arena sat down with David Hinds who’s the Vice President of Clinical Operations at Tioma Therapeutics.

David Hinds’ current area of focus is oncology, in particular, early phase trials. Some of the main outsourcing challenges he faces working within a small company center around when to involve vendors and staying relevant. For Hinds, it’s important to understand who’s doing what where and what the competition is at any given time.

When it comes to building the team and deciding which vendor’s right for the company, Hinds feels it’s the people and how they work together as a team that’s important.

In this interview, Hinds speaks to CTA editor, Henry Kerali, about some of the challenges he faces working within the oncology space.

Clinical Trials Arena: What are the keys to developing an effective outsourcing strategy for early phase trials?

David Hinds: For a sponsor, I think it’s critical to determine what they want to do. The sponsor has to be clear about their expected goals as well as their outcomes. Small companies, especially start-ups, really need to clear about the answers they want to receive from their programs, so that when you go to vendors, they understand what they’re looking for and that will help tailor who can help you get there.

CTA: Why is it important to involve a vendor from the early stages before a trial gets underway?

DH: Well, I believe we’re only as good as what we’ve experienced up to the present day. One of the wonderful things about vendors is that they have the volume of experience that’s incorporated into their institutional knowledge. The goal therefore should be to involve them early enough to avoid major problems they may have been through. So it’s really important to understand what you’re going into, develop a strategy that factors in how they’ve dealt with certain issues in the past.

Often as a sponsor, you may have done something a year ago, six months prior, even a month ago, and you may find things have changed. This is a really dynamic landscape, so having in place a group of vendors, ideally on board as early as possible really helps you sufficiently for when problems arise.

CTA: How do you deal with instances whereby a vendor hasn’t met their expectations?

DH: This is an art – remedying situations when your vendor hasn’t fulfilled what’s expected of them. Unfortunately, people that do this for a living have unrealistic expectations – we demand perfection, but we never get it, so we’re always striving towards it. I think with that as a framework, it’s all about how you establish your team communications as well as your working relationship. I’ve always been a long game player – I believe in establishing relationships that can take you through the ups and downs, highs and lows. So it’s vital sponsors get to know their vendors as individuals and as organizations, and I think those are two important distinctions. The people are the ones who will get you over major hurdles, the organizations can help get the right people in place.

What’s inevitable is that you’re going to have friction points; try to eliminate them for the people on the ground. Have levels of escalation that can quickly be drawn upon that don’t alienate one another. For instance, if I’m a start-up and a single person in a department, I can leverage an organization without alienating a primary partner on a day-to-day basis. It is an art, and admittedly not one that I’ve perfected by any means!

CTA: Do you find it beneficial to work with the same partners to gain that level of understanding?

DH: There is certainly a lot to be gained by working with the same partners over time. There is significant cost to establishing and building new relationships both in terms of dollars and lost productivity. This can be avoided in large part by partner continuity. This is felt more substantially, of course, in a small company. My general approach is to constantly evaluate the state of a relationship with an eye towards the future. If the partner is performing well and are they seeking to adapt and evolve, my preference would be to continue to work with the partner. I think this is the most natural way to establish preferred providers. It also helps to reinforce a feeling of shared ownership of the development of the molecule. If this shared ownership can be established, it is a very powerful tool for the team. If all is going well with current vendors, it remains critical to stay connected to industry innovation and seek disruptive options that can advance your unique objectives.

CTA: What advice would you give fellow professionals working in early phase trials?

DH: To me, early phase trials are the discovery point – the point where we learn everything. Validation comes later. This is where you need to put your experimental mindset on and be willing to look at the challenges ahead of you with a very broad range of potential outcomes. It’s important to think through how you can mitigate those simultaneously, such that none will be lacking in their preparations. To me, it’s one of the most fun things you can do to go about solving new problems. And this is the place to do it, you solve the issues early before expanding on to later phase trials.

Ultimately, when you find good people, lock them down and stick with them. Have as broad an outreach as you can have to really be integrated into the business. We’re moving at the speed of light with the integration of new technology, so stay in the mix and be relevant, and seek counsel from as many partners as you can get.