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

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.

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]

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]

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]

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]

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]

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]

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]

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]

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.