Latest / Becker’s Healthcare Podcast / Diane M. Simeone on Transforming Cancer Clinical Trials

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Diane M. Simeone on Transforming Cancer Clinical Trials · Becker’s Healthcare Podcast

• 0:02
  - There's a small circle of people who truly
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  - understand what it takes to lead a health
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  - Becker's fourteenth annual CEO and CFO roundtable
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  - executive level attendees
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  - workforce strategy, and the leadership questions that don't
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  - have easy answers.
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  - Join us November second through the fifth in
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  - Chicago.
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  - For the agenda and event details,
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  - visit beckershospitalreview.com
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  - and click on the events tab in the
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  - upper right.
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  - Hello, and thank you so much for tuning
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  - in to the Becker's Oncology Leadership podcast.
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  - I'm Elizabeth Gregerson,
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  - a reporter here at Becker's. And today, I
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  - am talking to doctor Diane Simeone.
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  - Doctor Simeone is the director at the Moores
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  - Cancer Center and the Komen Family presidential director's
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  - chair at UC San Diego Health. He's also
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  - cochair
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  - of the
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  - Association of American Cancer Institutes and National Cancer
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  - Institute steering committee, which is focused on streamlining
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  - efficiencies and accelerating
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  - time to activation for clinical trials.
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  - Doctor Simeone, thank you so much for joining
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  - me on the podcast today.
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  - Wonderful to be here today.
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  - Perfect. And before I dive into my questions,
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  - could you share just a bit about your
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  - background and your roles at Moores and UC
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  - San Diego for our listeners?
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  - Sure.
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  - My background is I'm a
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  - surgeon scientist. I've spent
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  - thirty years focused on,
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  - tackling pancreatic cancer from basic science discovery all
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  - the way to innovations in clinical trials and,
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  - driving innovation
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  - in early detection.
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  - Of course, now I have a much larger
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  - role, at UC San Diego where I've been
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  - the cancer center director for
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  - a little over two years, where we look
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  - at driving
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  - impact for patients,
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  - from scientific
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  - discoveries to even findings,
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  - at the bedside and bringing them back to
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  - the bench, really, all patient centric.
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  - Amazing. Thank you. And I'd love to kind
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  - of kick off my first question.
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  - With the work that you're doing at Moores
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  - and UC San Diego,
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  - what's been the biggest
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  - shift you've made in your cancer program strategy
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  - and maybe around the last twelve months, and
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  - what prompted it?
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  - Well, it's we have a unique
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  - environment here in UC San Diego in that
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  - we're embedded in,
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  - what has, I've come to known as called
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  - Bio Tech Beach. So we're actually the third
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  - largest biotech sector
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  - in The United States. And it's it's also
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  - unique in that
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  - the epicenter is all within about a ten
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  - minute drive of where I'm sitting right now
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  - in the middle of the cancer center.
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  - So taking advantage
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  - of
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  - partnering
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  - with companies
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  - that are in the business of making new
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  - oncology drugs and thinking how we can best,
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  - leverage that for the benefit of our patients,
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  - not only here in San Diego and across
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  - the country,
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  - is something we've given a lot of thought
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  - to.
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  - And so
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  - one of the areas we focused on is
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  - transforming
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  - how we do clinical trials here at our
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  - own institution,
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  - driving down
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  - time to activation for clinical trials,
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  - but also just looking at what's happening at
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  - the national landscape
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  - and can we all collectively
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  - do better,
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  - not only for the benefit of our patients,
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  - but,
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  - to have,
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  - a thriving
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  - drug development,
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  - to first in human trial enterprise in The
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  - United States.
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  - Thank you. And I'd love to know too,
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  - is that kind of maybe the biggest gap
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  - you've
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  - seen, or is there something else with that's
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  - standing between, you know, what's possible with these
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  - new cancer therapies and what patients actually have
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  - access to?
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  - Well, one of the things I realized of
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  - my career, which has spanned from, you know,
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  - doing bench work and then some some of
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  - my own work going into clinical trial is
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  - there's so many
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  - exciting,
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  - advances happening,
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  - in drug design and understanding biology, large scale
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  - genomics,
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  - and omics technologies, but actually clinical trial
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  - design and execution
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  - has really lagged behind.
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  - And if we're gonna
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  - look at that continuum from doing,
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  - science to having something that has an impact
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  - for patients,
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  - that piece of the continuum
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  - really
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  - needed a lot deeper look
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  - at how we can do it much more
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  - efficiently,
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  - faster,
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  - of course, safer for patients, but also for,
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  - it to be economical.
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  - And,
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  - I think now the time is right to
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  - really dig into that, as in parallel, it
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  - is
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  - a priority
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  - of the new,
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  - director of the National Cancer Institute, Tony LaTai.
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  - So I think there's an opportunity
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  - to revisit
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  - how we do clinical trials and to perhaps,
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  - redefine a national strategy.
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  - That's the perfect segue,
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  - to my next question,
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  - which focuses more on your work with the
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  - committee,
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  - with AACI and the NCI.
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  - What has been the single
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  - biggest bottleneck
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  - your committee has found when it comes to
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  - getting cancer clinical trials from that design phase
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  - to the actual enrollment
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  - phase?
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  - Well, I I think one of the big
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  - issues is there's a lot of hands in
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  - the pot, right, for to to get from
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  - concept of a trial to successful execution.
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  - And if we were to set a goal
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  - that
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  - all,
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  - cancer centers could open up trials,
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  - in sixty days or less, what would that
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  - look like? What would the key stakeholder
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  - investment
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  - need to be?
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  - So it involves,
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  - of course, cancer centers. It involves
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  - pharma companies. It involves,
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  - the National Cancer Institute and the NIH, and
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  - it also involves the FDA.
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  - And so
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  - can we have an opportunity to get everyone
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  - at the table agreeing
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  - on the goal
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  - and then work backward
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  - to put in place the steps to execute
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  - that goal.
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  - And it's particularly pertinent right now because a
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  - lot of our clinical trials are actually going
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  - to China
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  - where there's a big effort
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  - to get a, what I would call, a
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  - first in human signal. Does,
• 7:08
  - a drug,
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  - have the potential to be positive? So getting
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  - that very early information is really critical.
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  - And,
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  - there's also a lot of movement of clinical
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  - trials to Australia, again, because processes are quicker
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  - and less expensive.
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  - So now
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  - we have to take an opportunity to look
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  - at how we're doing this in The United
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  - States,
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  - and we have always been leaders in innovation,
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  - and we should, now step up to the
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  - plate to rethink how we're gonna do clinical
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  - trials to make them much more efficient.
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  - Thank you for laying that out. And I,
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  - you know, I I can just hear the
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  - voices of the oncology leaders that I've connected
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  - with recently just echoing, you know, that desire
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  - and that kind of drive to streamline this
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  - process because they know how life changing these
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  - clinical trials are for patients and, you know,
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  - for the industry at large.
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  - Are there any specific changes coming out of
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  - the committee's work that you expect cancer centers
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  - to be adopting
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  - sooner than later, maybe within the next year
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  - or two?
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  - For sure, there will be changes that are
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  - coming. We have four different committees that are
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  - working on
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  - looking at,
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  - pretrial,
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  - processes
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  - to streamline
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  - them, to focusing on,
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  - improving contract negotiations,
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  - budget negotiations,
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  - coverage analysis.
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  - And then, of course,
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  - are we in a position that we can
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  - use AI tools to streamline the whole thing?
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  - And
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  - if we can put all the pieces together
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  - to have the whole thing streamlined
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  - such that, again, I'm I'm trying to,
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  - advocate that we have a sixty day, time
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  - frame to open up trials, remove redundancies.
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  - If we
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  - have central IRB
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  - IRB processes in place, we don't need to
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  - have every single institution,
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  - reinvent the wheel. So I think it's looking
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  - at all aspects of this, including the regulatory
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  - part,
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  - to have things streamlined.
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  - And, so it's an exciting time. I think
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  - now there's a recognition that we
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  - we really need to step up to the
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  - plate and do this.
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  - Mhmm. And everybody
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  - is interested in in having this be effective.
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  - So
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  - I think we need to run with it
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  - and push it as much as we can.
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  - And, you know, from a physician standpoint, as
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  - someone that has taken care of patients with
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  - a
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  - very challenging type of cancer, pancreatic cancer,
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  - we know that sometimes the best chance for
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  - cure for a patient is going to be
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  - a clinical trial.
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  - And so it's time to really pay attention
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  - to that.
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  - The other aspect is how do we get
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  - exciting new treatments,
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  - in the clinical trial setting out into
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  - rural communities
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  - where,
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  - there's more challenging access. So there is an
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  - opportunity to rethink what the models
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  - look like so that we can
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  - accomplish the results we seek.
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  - Perfect. Yeah. I'll you know, was just thinking
• 10:25
  - of all the articles I've seen in this
• 10:27
  - past week of about the FDA approval for
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  - the pancreatic cancer drug and, you know, how
• 10:32
  - you said
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  - with patients clinical trial was, you know, their
• 10:36
  - best chance for a cure. And and I
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  - can only hope that with the success of
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  - this pancreatic,
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  - you know, cancer drug that received FDA approval
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  - that
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  - people will notice how important these clinical trials
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  - are and continue, you know, elevating
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  - the necessity, like you said, to be a
• 10:52
  - leader when it comes to innovation there. And
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  - I really appreciate you kind of, sharing your
• 10:57
  - expertise with us when it comes to this
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  - subject.
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  - I'd love to switch to
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  - you as an individual,
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  - as a leader in oncology,
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  - for anyone else who's listening.
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  - When it comes to your own career,
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  - what's a decision you've made that you would
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  - tell other oncology leaders or even health care
• 11:19
  - leaders at large to either copy or to
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  - avoid?
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  - Well, I can't profess to know all the
• 11:26
  - answers, but the thing I would say reflecting,
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  - where I am at my career now is
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  - I'm doing things I never envisioned I'd be
• 11:34
  - working on.
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  - Mhmm.
• 11:37
  - Sometimes you really want to go where there's
• 11:39
  - an unmet need and a new problem to
• 11:42
  - solve.
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  - And sometimes it takes,
• 11:46
  - a fresh set of eyes on how to
• 11:48
  - develop a new strategy.
• 11:50
  - So I love the idea of really
• 11:54
  - making sure that we have people from different
• 11:58
  - disciplines coming together
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  - to look at a problem
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  - and rethink
• 12:04
  - if we're having an effective approach to it.
• 12:06
  - If the strategy is working, then we should
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  - definitely stick with it. But if the strategy
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  - isn't working,
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  - then we should really rethink what is the
• 12:16
  - strategy.
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  - And I think that kinda gets back to
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  - this clinical trial piece. And,
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  - you know, I wasn't formally trained in doing
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  - clinical trials early on. I was a clinician
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  - and operate on patients with pancreas cancer and
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  - ran a basic science laboratory. But as my
• 12:32
  - own work started to go into clinical trials,
• 12:35
  - I realized that the advancements happening in clinical
• 12:37
  - trial space were were lagging behind.
• 12:41
  - And because it was so important for us
• 12:43
  - to get better drugs to patients with pancreas
• 12:46
  - cancer, we had to
• 12:48
  - derisk clinical trials. We needed to make sure
• 12:51
  - the pathways to getting these drugs to patients
• 12:53
  - were accelerated.
• 12:55
  - And so that's what led me,
• 12:57
  - into this space. So
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  - I think,
• 13:01
  - we all have career evolution
• 13:03
  - over time and,
• 13:04
  - I think, you know, keeping
• 13:07
  - your eyes open
• 13:08
  - and options open,
• 13:10
  - to to work on
• 13:13
  - problem solving that's gonna be helpful to patients.
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  - That that makes you very excited about getting
• 13:18
  - up and going to work every day.
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  - I love that. And I think it's so
• 13:22
  - applicable, you know, not just for health care
• 13:24
  - leaders, but for anyone.
• 13:26
  - That's such excellent advice. I'm so grateful that
• 13:29
  - you were able to share that with our
• 13:31
  - audience today. Doctor Simeone, thank you so much
• 13:34
  - for coming on the podcast
• 13:35
  - and
• 13:36
  - talking to me and answering all my questions.
• 13:38
  - I hope you get a chance to connect
• 13:39
  - again soon.
• 13:41
  - My pleasure. Great talking to you. And thank
• 13:43
  - you to our listeners for tuning in to
• 13:45
  - Becker's Oncology Leadership podcast.
• 13:48
  - Invite everyone to check out even more Becker's
• 13:51
  - healthcare podcasts at beckers podcasts
• 13:54
  - dot com.
• 13:55
  - Thank you again to doctor Cimione for joining
• 13:58
  - me and to our listeners. Have a great
• 13:59
  - day.