The Power of Patient Samples

A Team Approach to Transform Samples into Cancer Research Insights

Seamless performance. Brave style. That’s how Cheryl Selinsky, PhD, vice president of Research Operations at the Parker Institute for Cancer Immunotherapy (PICI), describes her team.

“Seamless in a sense of having everything we do magically come together without our researchers and collaborators having to worry about it,” she said. “Brave style meaning we’re brave in the approach we take in managing more than 60,000 blood, tissue and stool samples as efficiently as possible.

“Our ultimate goal is to make our partners blissfully unaware of all that it takes to get a sample from a patient to a test tube to our BioTrust and then out to testing labs for analysis.”

Patient samples are not only the epicenter of everything the Research Operations team does, but they play a crucial role in all research efforts at PICI. In short, samples are cancer research gold.

Collecting patient samples from research studies and clinical trials and then turning them into data gives PICI researchers a comprehensive view into how a specific treatment is working for some patients and not others. And most importantly, provides deeper insights into why. In the end, this leads to better, more targeted treatments for patients in the future.

With a clear understanding of every detail that goes into collecting samples, Cheryl built the team from the ground up to manage each step seamlessly. They focus on the process – from ensuring the samples are collected correctly, shipped to the right location, and processed and stored appropriately, to getting the best samples to the right labs to be turned into data – all so researchers can focus on the science.

“Our top priority is to make sure the samples and data are clean so we can get them out of the BioTrust quickly to answer critical questions in immunotherapy,” said Christopher (Chris) Perry, associate director of biospecimen operations, who works with Cheryl to lead the day-to-day operations of the team.

“This ensures the samples aren’t sitting in the BioTrust for years, but instead, are turned into knowledge to accelerate research and improve treatments for patients.”

Meticulously Tracking Thousands of Samples for Quicker, Better Outcomes

How does the team keep track of the tens of thousands of samples that PICI collects?

Enter “Lord of the Dashboards” – a humorous name that Chris coined for more than 50 trackers that integrate data about every aspect of every single sample that comes into and out of the BioTrust. At any given time, it gives the team an extremely detailed look at where the samples came from, how they were collected, where they need to go, any issues reported and much more.

“I was drawn to the position because there is so much data, and we automate a lot of what we do to save time and reduce errors,” said Michael Gricoski, senior biospecimen specialist. “You don’t ever want to delay treatment for patients, and clean data makes it easier for us to find answers. The patient comes first in everything we do.”

Kristy Lagarde, MPH, biospecimen data specialist, and Lancelote (Lance) Leong, senior biospecimen data specialist, are charged with tracking and reconciling sample shipments from all PICI clinical trials and research projects. They ensure that the samples coming in match what is expected based on the study protocol, then identify gaps in the information, document any discrepancies and work with the team to resolve any issues.

“I try to have a good sense of where all 60,000 samples are or where they should be at a given time,” said Lance. “If things don’t match up, I do detective sleuthing work – a part of research operations that people may not know about.”

Cheryl adds that knowing where all the samples are at any given time is no small feat.

The team puts these meticulous data collection and tracking practices into play every day as they collect samples from PICI’s research studies and clinical trials to drive the best outcomes.

A Deeper Dive into Breast Cancer Research: TRIBUTE

In March 2019, the FDA approved the first immunotherapy combination treatment (the checkpoint inhibitor atezolizumab with the chemotherapy nab-paclitaxel) for metastatic triple negative breast cancer.

But this only raised more questions. Why does the treatment work for some patients and not others? How can we learn from the patients who do not respond to develop more effective treatments?

Seeing an opportunity in this breakthrough, PICI moved quickly, bringing together a thinktank of breast cancer experts across academia, industry and nonprofit organizations. The outcome: TRIBUTE, a research study to identify biomarkers that can predict which patients will benefit from immunotherapy and monitor whether the cancer is advancing.

Here’s where the seamless performance and brave style come in. Patrice Manning, biospecimen operations principal, and Kristy, worked closely with Cheryl to build a unique observational research study from the very beginning.

Synthesizing the conclusions from the thinktank, Cheryl partnered with the lead researcher on the study, Elizabeth Mittendorf, MD, PhD, of Dana-Farber Cancer Institute, and other PICI scientists to develop the observational study protocol. They submitted it to the institutional review board for approval within three months of the FDA approval of the drug combination.

Patrice took the lead on developing the sample management plan for collecting, processing and storing all the samples in the BioTrust. And on a parallel path, she thoughtfully designed the sample kits that include everything investigators need to collect the samples – a key component to ensuring PICI is collecting all samples in a standardized, efficient and comprehensive way.

“You have to think about creating the best kit to make things easy for our researchers,” said Patrice. “It must include the tools they need and also capture all the information correctly. There’s a lot of thinking behind creating a kit to ensure a smooth process. That’s the fun part.”

Kristy played an instrumental role in putting together the right documentation and creating the lab manual as the study began – a critical step in the process. When the kits are shipped to the research institutions, they include paperwork so the sites can correctly register the samples. In turn, this ensures an accurate account of everything the team receives in a single sample collection.

“We did everything so our investigators didn’t have to,” said Cheryl. “They could just step in, get started and focus on the research.”

“Working with Cheryl and her team has been nothing short of amazing. While our clinical team thought about the appropriate patient population and the clinically relevant questions, the PICI team took charge of proposing the best assays to use, and the optimal collection, processing and storage of samples to ensure the success of those assays,” said Dr. Mittendorf.

“They leveraged the PICI network so we can answer critical questions, and I can ensure patients that their samples will inform the care of future breast cancer patients,” she added.

Once the samples are collected, the team will work with PICI researchers and partners to comprehensively analyze them along with clinical data to improve outcomes for more patients.

“It’s exciting to see all the samples coming in and the real-time progress we’re making,” said Kristy. “And to connect it back to the larger purpose – turning the samples into a collection of valuable knowledge for cancer research.”

Getting samples into the BioTrust is only the beginning. The team is now moving into the next phase with our PRINCE clinical trial.

Transforming Samples into Data, Knowledge and Answers: PRINCE

PICI’s first in-house clinical trial, PRINCE, tackles pancreatic cancer with a new approach. An initial read out of results at the 2019 AACR annual meeting showed that combining immunotherapy agents with chemotherapy shrank tumors in a majority of advanced pancreatic cancer patients. The trial also completed enrollment for phase 2 in June 2019.

PRINCE set the stage for the expertise and tools the Research Operations team needs at the outset of all future trials and taught them which processes worked best.

Now they are on to the next phase: A set of samples has been selected, taken out of the BioTrust and will evolve into comprehensive data sets that are handed over to PICI’s Informatics team for integrated data analysis.

During this phase, Research Operations collaborates closely with PICI’s Translational Medicine and Informatics teams.

This process is driven by the translational analysis plan, which Theresa LaVallee, PhD, vice president of Translational Medicine and Regulatory Affairs, develops with a multi-disciplinary team at PICI. It’s a playbook for turning samples into data and knowledge. It outlines what questions the team wants to answer, what samples they want to use and which assays they will use to test their hypotheses.

“It is often overlooked and underappreciated how critical the preanalytical aspects of sample collection, processing and handling are for generating robust and reproducible translational data. The PICI Research Operations team has a passion and rigor for ensuring quality and attention to detail. It is absolutely essential for the translational team to deliver new insights for immunotherapy treatments for patients,” said Theresa.

The meticulous tracking comes full circle here. Lance works quickly and closely with Theresa and PICI’s Informatics team to select the best samples for the assays outlined in the plan.

“I’ve seen many of the samples as they come in and am aware of many of the variations that may affect the quality and integrity of the samples,” said Lance. “We’re using the best samples to generate the best data.”

At this point, much of the data from the trial has been delivered to the Informatics team. Along with looking at the clinical outcomes of the drug treatment combinations, they are conducting exploratory analyses to identify why the drugs work or don’t work, putting PICI’s mission into action.

“To turn difficult-to-treat pancreatic cancer into a curable disease, you first and foremost have to know the drugs are safe and effective,” said Cheryl. “But then we take it a step further to understand why. Our depth of samples, turned into a depth of data, allows us to do this.”

For example, the team has looked at the circulating tumor DNA sequencing information to see if it’s possible to find a blood test for pancreatic cancer patients. This would be a major win for patients because it could diagnose pancreatic cancer earlier, guide treatment decisions and is much less invasive than a tissue biopsy.

The end goal for the translational team is to aggregate all of the data to tell a story – to answer more questions, to improve treatment regimens over time and to generate new hypotheses that could lead to new clinical trials. A story that begins and ends with the patient.

What’s Next for the Team

Cheryl, Chris, Mike, Patrice, Lance and Kristy have created a comprehensive infrastructure that will be put to the test as PICI’s clinical trials and research studies evolve.

On the clinical side, they’ll use this infrastructure to support platform trials. These studies are built to enroll a small number of patients, conduct tests in real-time to show if a drug is safe and effective, and if so, expand the cohort to enroll more patients. The team will be tasked with tracking and managing the samples just as they have with other trials – but with more speed and agility.

For research studies, the team expects to see all the work they’ve put into AEROSMITH come to fruition. This observational study collects and analyzes clinical data and blood samples from patients during treatment to find answers about how autoimmune diseases develop after checkpoint therapy for some cancer patients. So far, the study has collected and processed blood samples from more than 800 patients toward a goal of 1,600.

Because of the number of samples and how well annotated they are, pharmaceutical companies have come forward to partner with the team, which is exactly the outcome they had hoped for.

“Working with more partners, researchers and institutions to share resources and analyze data gives us the opportunity to do even more research and drive the cancer immunotherapy field forward,” said Cheryl.

The Research Operations team has built a model that delivers on PICI’s mission. A model that accelerates cancer research – to save lives.

Meet the Team

Collaboration. Camaraderie. Diverse skillsets. Humor. The collegial spirit of the team is clear in the way they work together each day.

Cheryl Selinsky, PhD | Vice President, Research Operations

Background

• More than 20 years of experience in translational research and development
• Co-founded a biotech company that commercialized novel immunotherapeutics
• Served as COO of the Biodesign Institute at Arizona State University
• Worked at the Translational Genomics Research Institute and led the biospecimen repository for The Cancer Genome Atlas Project

Why PICI?

PICI is my dream job. It marries everything I’ve done in my career – I’ve managed a large-scale biobank, developed and validated clinical assays and worked on multiple clinical trials. I started my science career developing immunotherapeutic strategies for cancer patients, and then funding for the field dried up after a few failed clinical trials. PICI has brought me full circle. It brought me back to immunotherapy, which is my passion.

Christopher Perry | Associate Director, Biospecimen Operations

Background

• Supported the biospecimen management team and the acquisition of samples for R&D activities at Roche Molecular Systems
• Managed sample processing labs at UCSF, including the Clinical and Translational Science Institute

Why PICI?

I joined PICI because immunotherapy is cutting-edge and the mission is close to home for me. A lot of people in my life have been affected by cancer. Also, the framework and structure for the team were just starting to form. I was excited about the opportunity to help build this whole process from the ground up.

Michael Gricoski | Senior Biospecimen Specialist

Background

• Worked as a clinical research coordinator (CRC) to support patients through the clinical trial process from start to finish
• Has more than 12 years of experience in human subject research in psychology, ophthalmology, oncology and immunotherapy
• Served as the first clinical research associate at PICI, where he monitored clinical sites, verified data, developed internal processes and built strong relationships

Why PICI?

When I came to PICI I had onsite experience as a CRC, and I wanted to emulate best practices from what I had learned working on various clinical trials. While always keeping the patient in the forefront, I strive to develop and help implement efficient processes for clinical trials. PICI’s nonprofit, multi-institutional approach seemed to give me the best opportunity to improve inefficiencies in clinical trials while also keeping the focus on the patient.

Kristy Lagarde, MPH | Biospecimen Data Specialist

Background

• Studied public health in epidemiology at Emory University
• Worked at the American Cancer Society to support biospecimen and data management efforts for Cancer Prevention Studies

Why PICI?

I have always had an interest in cancer research and philanthropy, and being able to support that with my skillset has been very fulfilling. I was very involved in Relay for Life growing up, which is where my interest started. PICI was the perfect fit for my experience and my passions.

Lancelote Leong | Senior Biospecimen Data Specialist

Background

• Served as a lab manager at UCSF, where he learned from and collaborated with graduate students and post-doc scholars to develop a mutation panel that can detect and monitor prostate cancer, among other projects
• Managed post-award research grants for investigators in the Department of Epidemiology and Biostatistics at UCSF

Why PICI?

I am inspired by the innovative ideas of the Bay Area, and PICI is the product of many of them. The work PICI does is altruistic and its mission is tough to match. Few have been spared of this malicious group of diseases that affect their family, friends and/or themselves directly. I, too, am not immune. Ultimately, the people drew me in. Everyone is so collaborative and looks out for each other. It’s a great place to be.

Patrice Manning | Biospecimen Operations Principal

Background

• Worked as a lead technician at the Biospecimen Core Repository for The Cancer Genome Atlas Project, where she tracked and managed patient samples
• Studied ion transporters while managing a laboratory at the University of Cincinnati College of Medicine Molecular Genetics department

Why PICI?

It was exciting to have the opportunity to work in the field of immunotherapy. We’re on the cutting-edge of new discoveries. Everyone knows someone who has been touched by cancer – what we’re doing is hopeful.