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Team Spotlight: Diagnostic Development and Validation, R&D



When the Diagnostic Development and Validation (DD&V) Team at Foundation Medicine arrives for work each day, they are stepping into roles that epitomize the company’s value of collaboration. The team operates as a bridge between Product Development and Laboratory Operations through their focus on late-stage product development, validation, and transfer of knowledge. The team’s mission is to ensure that Foundation Medicine’s laboratory tests are safe and effective, enabling important diagnostic insights for partners and patients. Their collaboration with different partners across the company contributes to technical expertise within Foundation Medicine’s design and development process for new and existing products.

The leaders of the DD&V team came to Foundation Medicine from a variety of backgrounds, but consistent across the team is the way that the mission and the people drew them in. “I really wanted to work in a place where there was a lot of collaboration and openness, and that’s been the case here at Foundation Medicine,” Marbie, associate director, DD&V shared. “The team I interviewed with was collaborative, passionate, and smart,” added Haifa, associate director, DD&V. Both Marbie and Haifa have seen those qualities carried beyond the interview process and through all the work that the team does.

The team designs and implements processes and improvements into Foundation Medicine’s tests and uses that knowledge to validate our products, as well as to inform our Lab Operations teams. “I like to say that this is the purest implementation of the scientific method,” Brett, director, DD&V said. “The only way you fail in academia is if you get no data, versus in patient management, hypothesis testing and the rigorous process is critical – because the information from our tests is used to inform treatment decisions for patients.”

With such a complex portfolio of comprehensive genomic profiling tests, the DD&V team needs to make sure that they are not siloed in their work, and that they collaborate cross-functionally and communicate well across the company. They are essential to new approvals and improvements, from the launch of new products to companion diagnostic (CDx) approvals, and adjustments and improvements to our tests.

“We’re involved in new approvals from the very beginning, and at any given moment there are many of them. Completing projects for CDx claims and announcing them to the world to show how they can help patients is incredibly fulfilling,” shared Shannon, director, DD&V. “We have a lot of things we are working on that we hope are going to make a huge impact for patients,” he added.

“I’ve been here for over seven years, so I was here before we launched our FoundationOne®CDx product. The common thread from when I joined through now is the team spirit and people’s willingness to step in and help where help is needed, understanding the greater mission,” shared Joel, director, DD&V. “Working as a team to get things done ultimately helps the company. For the original FoundationOne CDx submission, everybody rallied to help where they could, and through the FoundationOne®Liquid CDx submission in 2020 where they did the same. I’m seeing the same commitment every day in DD&V as we work cross-functionally to achieve our goals.”

The team members have supported each other as they’ve been challenged by the many uncertainties of COVID, while adapting to the ever-changing nature of the work they are doing. Each of DD&V team’s leaders spoke to the way the team is constantly ready and eager to learn, adapt, and flex to the needs of the company. DD&V prides itself on the way they cross-train and support their team members, empowering them to build their skills and develop within their roles.


The team recently enjoyed an outing in Boston, taking turns driving during a Duck Boat Tour


While they are hard at work collaborating on their jobs, they also come together to celebrate one another outside of their work. The team is big on cake and pizza parties, and always takes a moment to have fun. “Half an hour a week can make a huge difference,” said Haifa, “Having fun is important for team building and for getting to know each other outside of our day-to-day jobs.”

DD&V is constantly innovating, and everyone is looking forward to continuing to impact the lives of cancer patients, while collaborating with partners both within Foundation Medicine and externally. “We come to work to be able to make a difference,” explained Haifa, “I think that’s what drives us, and I feel that our team does that on a daily basis.” 


Interested in joining the DD&V team? To see open job postings, click here. 

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