For patients, the face of healthcare is often the doctor or nurse at the bedside. And those healthcare providers themselves may know the makers of medical devices primarily through sales, marketing, and customer support. But behind every new medical device, therapy, or drug that reaches a patient is a huge multiyear effort by a diverse, focused team.
At Terumo Blood and Cell Technologies, part of that team is the newly formed Terumo Research Institute, or TRI. That's the focus of our new blog series, launching today.
Read the Series: Transforming Insights Into Action
In this series, you'll read about how the TRI turns insights into action through a "team of teams" approach. Follow us for stories like these:
- Why the Alliance for Regenerative Medicine (ARM) tapped experts from the TRI for the chapter on cell collections in its just-published A-Cell, a comprehensive guidebook for best practices in cell-based therapies
- New evidence about the benefits modular automation may hold for cell health and quality
- How the product lifecycle depends on Global Medical Safety team support
- Discussions with experts in apheresis, cell collections, scientific communications, and more about using the company's knowledge core to help educate and lead in the industry
In this inaugural post, we take a deeper look at the TRI team.
It All Comes Down to Patient Care
"Everything we do starts and ends with patients," says Robert Cortes, MD, Vice President, Global Scientific & Clinical Affairs | Medical Safety. Dr. Cortes brings broad experience with research institutes at Schering-Plough, Novartis, the Fred Hutchinson Cancer Center, and two universities, and he now heads the TRI for Terumo Blood and Cell Technologies. "Patients are our passion and the reason we created the TRI. Ultimately, it will be a single voice for transformational patient care technologies across all Terumo companies. We'll bring top-level engineers, scientists, researchers, and clinicians together to develop new and exciting technologies and share them."
Today, Dr. Cortes describes the Terumo Blood and Cell Technologies segment of the TRI as a diverse but integrated team of teams.
- Scientific Affairs designs and executes scientific studies required to bring the company's devices to the market, supporting product development with scientific verification and validation studies, data analysis, and reporting. The team also represents thought leadership in the field through the scientific exchange of ideas related to the company's devices in forums such as peer-reviewed publications and webinars. Some recent highlights: publications about automated fill and finish for cell therapy products and expansion of memory T cells, as well as a Cell and Gene Therapy Insights webinar about automated cell expansion. The team's other roles include managing laboratory operations and coordinating procurement of blood for validation and verification testing of devices.
- While Scientific Affairs focuses on preclinical data in a lab setting, Clinical Affairs designs and executes all the company's clinical trials in close partnership with industry key opinion leaders, as well as primary investigators. In addition, this team supports investigator-initiated and collaborative studies.
Once a product receives a Conformité Européenne (CE) mark, allowing it to be sold in the European Union (EU), it retains that status through ongoing clinical evaluation, risk management, and post-market surveillance in accordance with the EU Medical Device Directive/Medical Device Regulation. The regulatory support arm of Clinical Affairs plays a critical role in the company's compliance and provides similar support for other markets, including China and geographies that leverage the EU CE mark.
- Medical devices are always designed for safety, but the Global Medical Safety team – with backgrounds in science, clinical medicine, blood banking, and apheresis – are entirely dedicated to patient, donor, recipient, and operator safety. They identify and review all clinical benefits and risks associated with the company's products and carefully weigh them against each other. They are also involved in, for example, risk assessment during complaint or field action evaluations, monitoring and evaluating reports of adverse events during a clinical trial, and assessing appropriate warnings and cautions for a device's instructions for use. Support begins when a product is just an idea and continues for its entire lifecycle.
Advancing Industry Excellence
Dr. Cortes emphasizes the TRI's role in giving back to the industry. "Terumo's mission is contributing to society through healthcare. We've got a team with tremendous talent and a wealth of experience in blood and cell technologies of all kinds. We don't want to keep that knowledge to ourselves – we want to share it, whether that means publishing articles, presenting findings at conferences and webinars, or bringing our experience to formal leadership opportunities in the industry."
Over the coming months, look for more stories about the TRI team and the work they do.
Next: Hear from Erin Goodhue, DO, MPH (Director, Clinical Development) and Dalip Sethi, PhD (Director, Scientific Affairs CTT/Innovation) about why it's so important to make cell collections part of the discussion about Quality by Design principles for cell therapies.