‘Manufacturing scientist’ believes in the machinery that powers Fred Hutch’s cell therapies

When most people think of cancer care, they rarely associate it with what goes on behind the scenes to create life-saving treatments.

For starters, developing cell and gene therapies is pricey, and maintaining the manufacturing technology and environment is equally challenging. Consider that numerous air exchanges are required each hour to filter out particles and impurities from a cell manufacturing facility. At the same time, the cell therapies that are scrupulously manufactured must be kept at specific, highly controlled temperatures in cold room storage or liquid nitrogen.  

Supervising the minutiae of the machinery that fuels the Therapeutic Products Program (TPP) at Fred Hutch Cancer Center falls to Folashade “Shade” Otegbeye, MBChB, MPH, an associate professor at both Fred Hutch in the Translational Science and Therapeutics Division and at the University of Washington School of Medicine. "I consider myself a manufacturing scientist,” said Otegbeye. “I oversee the manufacturing component of translational science.”

If you think about TPP as a cell factory churning out exploratory therapies, Otegbeye is the factory foreperson, responsible for maintaining quality control, compliance with regulatory standards and ensuring production schedules are met. “I’m a very precise person, a stickler for processes,” she said.

“Part of what we want to do is innovate processes in a way that recognizes the regulations and quality standards that govern the products we administer,” said Otegbeye, who is the facility director of TPP. “We want to make sure we keep up with innovation and can rapidly translate what researchers are doing in the lab to the bedside. If we have 10 investigators with strong potential products, we need to ensure we have robust enough infrastructure here to rapidly translate those ideas into the clinic so that ideas are not just waiting in the pipeline.”

Otegbeye will get an assist in her efforts to innovate as the new holder of the Fleischauer Family Endowed Chair in Cell and Gene Therapy Translation.

Elevating ‘manufacturing science’ at an academic medical center

Because it’s expensive to develop cell and gene therapy, support is needed to maintain existing infrastructure and comply with regulatory requirements, and more investment is needed for innovation.

Otegbeye, who is also an attending clinician treating Fred Hutch patients on the allogeneic stem cell transplant service and the cellular immunotherapy service, enjoys caring for her patients. But her true love is the cellular nuts and bolts of manufacturing therapies. 

Fred Hutch President and Director Thomas J. Lynch, Jr., MD, said Otegbeye has the exact qualities necessary to make Fred Hutch a leader in therapeutics. Lynch holds the Raisbeck Endowed Chair.

“Dr. Otegbeye’s eye for detail and precision is what allows Fred Hutch to be at the forefront of making groundbreaking therapies available to our patients,” he said. “But these therapies don’t just magically appear on the scene. We are fortunate that Dr. Otegbeye is on site, supervising the production of millions of cells that have the potential to save lives.”

Support from the endowed chair will help establish a platform for CRISPR gene editing. TPP has not yet used CRISPR, a gene editing tool that allows scientists to modify DNA, correcting or deleting faulty genes with extreme precision.  

Otegbeye leads a TPP project developing this technology to alter and transform T cells and natural killer cells. Some of the newest life-saving cancer treatments over the last decade involve white blood cells collected from cancer patients, which are then manufactured into cancer-killing cells using gene-editing tools.

“It will now be easier and faster to turn new ideas for immune cell engineering into treatments for our patients in clinical trials,” she said. “The endowed chair will help us continue evaluating, refining and developing the manufacturing processes and assays we need. It will also let us ask what else is out there, how can we keep up with it and how can we innovate on top of that?”

Otegbeye began working at Fred Hutch in 2021 after serving as medical director of Case Western Reserve University’s cell therapy facility. Born in Nigeria, she attended medical school in her home country but came to the United States for graduate school to access more bench science opportunities.

Fred Hutch is home to dozens of wet labs that do discovery work, amplifying the function of CAR T cells and T-Cell Receptor (TCR) T cells, for example, so that they more accurately target cancer using a patient’s own immune cells. The CAR T cells are tested in mouse models or cell cultures before they can find their way to clinical trials with patients. But before that happens, they must first be manufactured in a way that minimizes the risk of contamination or introducing infection. The task becomes even more daunting considering the number of cells required to treat a patient.

"For a clinical trial, we need to generate upwards of 100 million CAR T cells per patient, with reproducibility of the process and product for consistency across patients in the trial — the correct cell dose, with cells that are functional and potent every time," said Otegbeye. 

Endowed chairs provide sustained support and funding

The 47 endowed chairs at Fred Hutch are a way for donors to financially champion the work of scientists and clinicians through sustained, flexible support for groundbreaking research. Donors can choose to endow a chair for a faculty member with a gift of $2 million or more.

These endowments are a cornerstone of the Campaign for Fred Hutch, which is bringing together the community to raise $3 billion to radically increase the pace and scale of innovation.

"It's impossible to underestimate the value of endowed chairs to our mission," said Lynch. "They are a bedrock of permanent support that drives discovery and advances standards of care at Fred Hutch. Endowments offer our scientists and clinicians a smart and strategic path to future breakthroughs."

The Fleischauers will help further this goal by also directing the money they raised from fundraising for their Obliteride team to Otegbeye’s research efforts. Obliteride is a bike ride and 5K walk/run that connects and empowers people to help cure cancer faster by raising funds for Fred Hutch.

“Our goal is to get research ideas into clinical products – and even more importantly, to get those clinical products and resources to as many people as possible,” said Mark Fleischauer. “Safety, efficacy and accessibility are the watch words, and Shade is blessed with the talents to deliver on all those fronts for humanity.”