Clinical Research Focus - Candy Bermingham, Arcus Biosciences

Summary

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Podcast Summary: Blood, Sweat and Smears

Episode: Clinical Research Focus – Candy Bermingham, Arcus Biosciences

Host: Violet Votin (sitting in for Dr. Brad Lewis)
Guest: Candy Bermingham, Vice President, Head of Clinical Science, Arcus Biosciences
Date: January 20, 2026

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Main Theme / Purpose

This episode spotlights the intricacies of modern clinical research from the perspective of a seasoned leader in oncology drug development. Guest Candy Bermingham provides insights into challenges, innovations, and operational realities facing clinical science teams at biopharmaceutical companies, especially in the context of cancer trials and the rapidly advancing CAR T cell therapy space.

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Key Discussion Points and Insights

1. Challenges of Leading Clinical Science in Biopharma

[01:12 - 04:23]

• Role Overview: As VP, Head of Clinical Science, Candy oversees scientists translating research into patient treatment. Her team ensures scientific integrity, guides study design, and interprets data to enable patient-centered decisions.

• Complex Juggling Act:

  • Balancing scientific rigor with practical strategy and people management.
  • Working with diverse teams—statisticians, regulators, safety experts—requiring strong communication and clarity despite different “languages.”

• Uncertainty is the Norm:

  • Clinical trials rarely offer complete information.
  • Early data may be “messy,” biology is unpredictable, and decisions have significant patient impact.
  • Teams must stay focused and motivated through frequent changes and unexpected issues, e.g., varying drug efficacy, safety signals, enrollment delays.

• Human Dimension:

  • Every participant is a patient, often with limited options.
  • Studies must be designed with safety, fairness, and respect for volunteers.

Notable Quote:

“Leading a clinical science team really means navigating scientific complexity, coordinating huge functional efforts, and communicating clearly, but always keeping patients at the center.”
— Candy Bermingham [03:52]

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2. Selecting and Collaborating with Specialized Laboratories

[04:23 - 06:23]

• Role of Specialized Labs:

  • Central to measuring endpoints and generating critical clinical markers (pharmacodynamics, pharmacokinetics, imaging).
  • Labs are chosen for niche expertise, advanced technology, and reliable, high-quality output.

• Operational Excellence:

  • Labs must not only excel scientifically but also demonstrate strong, dependable processes that ensure data is operationalized quickly and effectively.

Notable Quote:

“In clinical research, both the science and operational rigor matter, because really, the decisions we make ultimately affect patient care.”
— Candy Bermingham [06:11]

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3. The Crucial Importance of Turnaround Time

[06:23 - 07:33]

• Real-World Example:
  • In non-small cell lung cancer trials, delayed central testing for PD-L1 status meant patients waited weeks without treatment; such delays may force patients to redo screenings or become ineligible, impacting both care and trial progression.

Notable Quote:

“When you’re thinking about the patient, they are now going weeks without treatment. So in this scenario, the patient turnaround time could be crucial for the patient.”
— Candy Bermingham [06:56]

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4. Criteria for Choosing Assays and Lab Partners

[07:33 - 11:42]

• Assay Decision-Making:

  • First, clarify the intended use: early research, clinical trial, diagnosis, etc.
  • Rising stakes and regulatory expectations as drug development advances from early to late phase.

• Early Development:

  • Flexible, fast development prioritized.
  • Focus on detecting early signals of efficacy; assays might not be fully validated but must be sensitive and adaptable.
  • Partners: Need translational expertise, ability to operate with small samples and quick turnarounds.

• Late Development:

  • Emphasis on accuracy, reproducibility, regulatory compliance, and defined cutoffs.
  • Partners: Must have impeccable quality systems, compliance records, global execution capability.

Notable Quote:

“Early stage assays are built for flexibility and speed. … Late phase trial assays… must be accurate, precise, reproducible across sites and stable over time.”
— Candy Bermingham [09:54, 10:54]

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5. Recent Innovations in the CAR T Cell Therapy Field

[11:42 - 14:53]

• Current State:

  • CAR T is transformative but slow, complex, and costly due to autologous (patient-derived) requirements.

• New Frontiers:

  • Allogeneic CAR T: Sourced from healthy donors—potentially faster and cheaper, but with persistence and rejection challenges.
  • In Vivo CAR T: Genetic reprogramming of T cells directly inside the patient using nanoparticles or viral systems. Could drastically shorten treatment timelines and reduce complexity, increasing accessibility.

• Solid Tumor Advances:

  • Next-generation CAR Ts are showing promising results in traditionally hard-to-treat cancers (glioblastoma, gastric cancer).

Notable Quote:

“You can imagine the potential for this… treatment can happen in days instead of weeks. There’s no custom manufacturing, so there’s reduced costs... It will increase access to CAR T therapies.”
— Candy Bermingham [12:44]

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6. Bonus Advice for Aspiring Clinical Scientists

[15:00 - 15:55]

• Let Data Drive Decisions:
  • Build studies with clear endpoints.
  • Plan interpretation frameworks upfront.
  • Be objective, avoid fitting data to preconceived hypotheses, and remain open to surprises.

Notable Quote:

“Stay open to what evidence is actually showing you, and when the data [reveal] something unexpected, follow it with curiosity rather than trying to force it to [the] original narrative.”
— Candy Bermingham [15:27]

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Memorable Moments & Quotes with Timestamps

• On Leading Clinical Science Teams:
  “[It’s] about connecting the dots, really turning complex data into a clear, trustworthy story that everyone can understand and rally around.” — Candy [02:11]

• On Operational Excellence in Lab Partners:
  “We don’t just need partners who excel scientifically… we’re also looking for those partners who can operationalize.” — Candy [05:32]

• On the CAR T Future:
  “CAR T isn’t just a niche cancer therapy anymore. In fact, it’s a rapidly evolving therapy that may soon redefine how we treat many diseases and not just blood cancers.” — Candy [14:38]

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Important Segment Timestamps

• Challenges in Clinical Science: [01:12] – [04:23]
• Lab Selection and Criteria: [04:23] – [06:23]
• Turnaround Time in Trials: [06:23] – [07:33]
• Assay Selection: [07:33] – [11:42]
• CAR T Cell Innovations: [11:42] – [14:53]
• Advice for Clinical Scientists: [15:00] – [15:55]

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Episode Tone and Takeaway

Candy Bermingham brings a clear, patient-focused, yet deeply pragmatic voice to complex clinical research topics. Her approach highlights both the scientific and human elements inherent in clinical development, advocating for rigor, adaptability, cross-disciplinary communication, and unrelenting focus on patient outcomes.

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Transcript

[A]

Hello and welcome to Blood, Sweat and Smears, your Macheon Diagnostics podcast with tag team hosts, including Our medical director, Dr. Brad Lewis, senior director Bjorn Stromses. That's me. And other guest hosts. We hope you find these podcasts interesting and informative. Thank you for listening. And away we go.

[B]

Hi, my name is Violet Votin, one of our scientists sitting in for Bjorn. For our Series 5 questions. In this episode, we are turning our questions toward clinical research. Today I'm joined by Candy Birmingham, Vice president, head of Clinical science at Arcis Biosciences, a clinical stage global biopharmaceutical company developing differentiated molecules and combination medicines that may have the potential to help people with cancer live longer. Candy has been in the industry for over 25 years, most of that time in clinical development.

[C]

Thank you so much for helping me, copilot.

[B]

Okay, on to our five questions. First question is, what is the main challenge in your role as vp, Head of Clinical Science, working for a growing therapeutics company?

[C]

In my role as a vice president of clinical Science, I actually oversee a group of clinical scientists who help turn scientific research into real treatment for patients. So if you think about it, the clinical scientists are really the guardians of scientific integrity within our clinical study. What we do provide is guidance in study design, in interpretation of data, and we ensure trial ultimately supports better decisions for patients. So now, leading a clinical science group is really one of those roles where you're constantly juggling science strateg as well as people. At its core, the job is about figuring out whether or not a new treatment is safe and effective and designing trials that actually answer those questions. But really, here's the tricky part. You almost never have all the information you want. Early data is very messy, biology is unpredictable, and every decision feels really high stakes because it really affects real patients. So another thing about being on a clinical study team is that you're working with a large number of experts. You're working with statisticians, physicians, regulatory teams, safety teams, and all those experts within a team really kind of speak a different language. So a lot of leadership role is about connecting the dots, really turning complex data into a clear, trustworthy story that everyone can understand and rally around. And another thing about clinical trials is the uncertainty. If you think about it, clinical trials can take years and sometimes unexpected things happen. And actually in most cases, it does happen. So, for instance, you know, your drug might work better in one population than any other. Maybe a safety signal pops up, maybe your enrollment slows down because patients are not meeting eligibility criteria. So as a clinical Leader, what you really need to do is really stay calm and make decisions, even if you have imperfect information. And it is your job to keep the team focused and motivated for, really, all those twists and turns. Now, on top of that, the really important thing is you have to keep in mind that there is a human dimension to this, because every clinical trial, our patients who are often sick, they sometimes have no other treatment options. So it is really our responsibility to make sure clinical studies are really designed in a way that is safe, that is fair and respectful of the patients who volunteer to participate. So when you put it all together, leading a clinical science team really means navigating scientific complexity, coordinating huge functional efforts, and communicating clearly, but always keeping patients at the center. But at the end of the day, it could be incredibly meaningful, because if you do it well, you're helping bring new therapies to patients who need them the most.

[B]

Thank you. One part of this complex process is finding and hiring a specialized lab, for example, to provide a service. What is the greatest challenge in that process? As the sponsor, when do you decide on the lab, and when do you recommend a lab to your CRO?

[C]

No, of course. Now, in clinical trials, every step we take is guided by very specific endpoints. So these are kind of markers that help us decide what to do next. So in my experience, specialized labs plays a critical role in generating those markers. We often rely on them for, for instance, pharma dynamic assessments, which essentially tells us what the drug is doing to the body, and pharmacokinetic analysis, which show how our bodies absorbs, processes, and clears the drug. So in oncology studies, particularly in lay phase studies, we also use dedicated imaging labs, evaluate tumor growth or shrinkage. So these assessments need to be consistent and highly accur, which is why we specialize in imaging teams that are so valuable. So specialty labs are chosen for a few key reasons. Sometimes it's because they offer niche tests that aren't available elsewhere, or because they use advanced technologies that give us deeper or more reliable insights. So just as important, though, is the expertise inside the organization. What we're looking for is that we really don't just need partners who excel scientifically. We obviously need partners who produce high quality and trustworthy results. But what we're also looking for is those partners who can operationalize so those that operate well with strong dependable processes. So in clinical research, both the science and operational rigor matter, because really, the decisions we make ultimately affect patient care and the success of the trial.

[B]

And of those criteria for a lab, how important is Turnaround time. And how important is that to the success of your trials?

[C]

I can tell you, I can actually give you an example of how critical turnaround time could be. Let me give you an example. We had a study in non small cell lung cancer that can only recruit patients with PD L1 high status.1 of the requirements in the protocol is that we do a biopsy. We have to send the samples for central PD L1 test. So in the meantime, the patients are there waiting, wondering if they can be on this clinical study. Now, if the samples come back late, the patients may have to redo other screening procedures because they're now outside their screening window, which are usually around kind of three weeks to four weeks, something like that. Now, when you're thinking about the patient, they are now going weeks without treatment. So in this scenario, the patient turnaround time could be crucial for the patient. And of course, it is important for the successful clinical trials to make sure that patients who are eligible come on the study quickly.

[B]

That's interesting how the turnaround time of one test might affect other tests in the screening process. When you choose a particular assay, how do you make that decision? What criteria do you use? Does it depend on the intended use of the assay, for example, inclusion and trial exploratory markers, safety markers, efficacy, so on?

[C]

Oh, absolutely. Now, you know, before you choose an assay or a partner in this case, you have to know what decisions the assays will support. So is it going to be for early research? Is it for an early or late phase clinical trial, or is it even for patient diagnosis? And one thing to keep in mind is that as you go each step in the development ladder, there is an increase in requirements for scientific rigor, reproducibility, compliance, and of course, risk management. So I'm going to talk a little bit more about clinical assays for drug development and I'm going to really start off with early drug development. So in the early drug development space, it's really about seeing early signs that you are on the right path. You're kind of really often looking at novel drug or novel mechanism. And in this case made with older assays are especially important as this is how teams detect the first hints of biological activity. Now, early efficacy, start with mechanism. You're looking for proof of mechanism by looking at target engagement, you're looking at pathway modulation and for immunotherapies, immune activation. So then made to order assays at this early stage is really how you can see hints of a biological signal before you can see efficacy. And those Assays then and the results really help us with clinical decisions. For example, it may help you with choosing the right dose. To that end, the early stage assays are built for flexibility and speed. The focus of your data again is to support go or no go decisions. That's why the assay themselves really need faster development times. So to that end we may prioritize sensitivity, for example over long term robustness. Some of the assays we may not have defined an exact cutoff. And another thing about kind of developing an assay at this stage of early development is that the clinical assays are still allowed. How to evolve as you understand more of the biology. And so in terms of finding the right partner for an early stage trial, you need a team who have a translational background. So they need to know understand the pre clinical biology and they need to understand the preclinical biology doesn't always translate perfectly to people. And they should understand what regulators expect, but isn't required yet. And operationally they need to know how to deal with small samples and fast turnaround times. Now, if you contrast early clinical development with late phase development, late phase trial assays for something like phase two, free registrational studies, at this point you kind of really have to have a focus on regulatory evidence. You know, the assays may support a primary or secondary endpoint, it may depend on which patients get treated, it may justify a label came or become a companion diagnostic. So at this point, clinical assays must be accurate, precise, reproducible across sites and stable over time. And at this stage you really need to have defined cutoffs. And the validation of assay is much more formal now. They have to be comprehensive, aligned with regulatory expectations. So when we choose a partner for late stage development, we really need ones who are credible. They have a regulatory track record, they have to have mature quality systems, are audit ready and they can execute globally without surprises. So that's really kind of a difference between late development and early development.

[B]

Thank you. And I noticed that CAR T has been one of your interests as it is for matrian diagnostics. What is the biggest innovation in the last few years in the CAR T space?

[C]

Oh, absolutely. Now I was involved with clinical development of CAR TS back in my Pfizer days and of course I still have a continual interest. I really believe CAR T therapy is one of the most powerful cancer therapies. But it is slow, complicated and expensive. The proof treatments to date, what's known as autologous CAR T's where you have to take a patient's T cells out of the body, Genetically re engineer them in a lab so that they recognize, canc, Grow millions of them and infuse them back to the patients. So this process itself takes three to six weeks. And it's a long wait for patients with rapidly growing disease. And of course, those patients must be first treated with chemotherapy or lymphodepleted before receiving fusions where you can create kind of a much more ideal environment for the car T cells to expand. So for a number of years now, Researchers have looked at how we can optimize this process. For example, some companies have developing allergenic cartes. So this where CAR T's are made from healthy donors. So it should be faster, cheaper, and more accessible. But the problem here is that t allergenic CAR T don't expand or persist as well as patient divide car T therapy. And there's also potential for rejection for graft versus host disease as well. So in terms of exciting development in CAR T space, I think one of the most exciting development is in vivo car t. So instead of engineering cells outside the body, and the CAR T gene is packed into lipid nanoparticle or modified virus system that is designed to target T cells specifically. So what you have is a patient's own immune cells Are then reprogrammed inside the body to become target cells. You can imagine the potential for this. I mean, this innovation could be huge. Treatment can happen in days instead of weeks. There's no custom manufacturing, so there's reduced costs. You can imagine that it will increase access to CAR T therapies. But of course, the data is still very early. Currently, CAR T therapy has really transformed treatment of blood cancers. But it's really exciting now to see data coming out in solid tumors as well. There is next generation CAR T trials now in solid tumors that are posting real responses. For instance, there's a trial in glioblastoma that saw tumor shrinkage in 62% of Valabo patients. And another CAR T trial in gastric GJ cancer that reported extended survival by about 40% over standard therapy. There is a lot of development in this space. These are all kind of new technologies that are pushing the field forward. So you can imagine that CAR t isn't just a niche cancer therapy anymore. In fact, it's a rapidly evolving therapy that may soon redefine how we treat many diseases and not just blood cancers.

[B]

That's very exciting. Finally, our bonus question is, what is something you'd recommend? And it can be anything.

[C]

Oh my goodness. Now, as a clinical scientist, I have to think. The one most important thing to think about is really about letting the data guide the decision so early, objectively and without assumptions. So really what that means is build studies with clear, meaningful endpoints that truly answer the clinical question. You have to plan up front how you interpret the data before you see it and avoid falling in love with the hypothesis. Stay open to what evidence is actually showing you, and when the data reviews something unexpected, follow it with curiosity rather than trying to force it to original narrative. I think this approach protects the scientific integrity, really accelerates good decisions and ultimately leads to better outcomes for patients.

[B]

Thank you for joining us today, Candy. I was glad to have met you when we were at a recent networking event and you spoke on a panel here in the Bay Area where we're both based. Thank you so much.

[C]

Thank you so much, Violet. Nice to be here.

[A]

That's it for us here at Blood, Sweat and Smears, a podcast produced by Matrion Diagnostics, your reference lab and CRO specializing in thrombosis, hemostasia and rare disease. Thank you for listening and if you have a question or comment or there's a topic you'd like Dr. Lewis to speak to, please send us an email to blood sweatandsmearsachriondiagnostics.com that's M A C H A O N diagnostics.com you can follow Matrian at Twitter ationdx. Be sure to subscribe to Stay in the know. Share this podcast with clinicians you think might appreciate it, and we hope you'll join us next time here at Blood, Sweat and Smears.