26 Feb Navigating the FDA Maze with Dr. Lynn Rose
The ITHS profile series is meant to shine a deserving spotlight on individuals or programs within ITHS doing critical work across the vast spectrum of translational science. For this installment, we sat down with Dr. Lynn Rose to learn more about her work and the services she provides through the ITHS Technology Development Center (TDC) and the ITHS Drug and Device Advisory Committee (DDAC). Dr. Lynn Rose currently serves as a regulatory consultant and advisor for the Technology Development Center where she supports researchers with the development of a regulatory strategy, clinical protocols and the creation and submission of Investigational New Drug and Investigational Device Exemption applications to the FDA.
Dr. Lynn Rose
Hi Lynn! How did you first get connected with ITHS?
Lynn: Back in 2007, I was working with Dr. Bonnie Ramsey at Seattle Children’s Research Institute in the Cystic Fibrosis Therapeutics Development Network. We had a consulting group there to guide companies developing cystic fibrosis treatments, covering everything from understanding the disease to regulatory requirements. That experience made me realize we could create something similar in a university setting, but for a broader range of diseases. So, when I joined ITHS, I brought that vision with me.
Tell us more about your role and your focus within the ITHS Technology Development Center (TDC)?
Lynn: My work is all about the requirements for regulatory approval: what tests, standards, clinical and nonclinical study designs, or other steps are required to move a new medical product forward. My colleagues, Teddy Johnson and Terri Butler, concentrate more on the commercialization side—whether the market needs this new product or not. I don’t focus on the market aspects as much; I’m here to make sure the team understands the regulatory path.
I don’t focus on the market aspects; I’m here to make sure the team understands the regulatory path.
How do you connect researchers with the right resources and mentors to advance their projects?
Lynn: It depends on their needs. For example, universities don’t typically have the kind of manufacturing facilities required to make products to FDA standards, particularly medical devices. Part of my job is to help researchers identify the right moment to hand off their projects to external manufacturing groups that can create clinical grade material or devices for clinical testing. Another key piece is documentation. In a lab, a lot of critical knowledge exists in researchers’ heads or their lab notebooks. But that won’t work when you’re transferring a process to a company. I help ensure their processes are documented in a way that’s reproducible and meets industry standards. So, helping researchers get connected with the right people truly depends on their need.
Why is your expertise so critical to researchers in the translational journey?
Lynn: The path to getting a new medical product approved by the FDA can be daunting—it’s a big, black box for most researchers. In science and medicine, people aren’t usually taught how this process works. I bring industry experience to the table, helping to demystify the FDA and make it less intimidating. This kind of expertise isn’t common in academia because people with my background don’t often return to academic settings to share what they’ve learned.
Who stands to benefit the most from working with you?
Lynn: Initially, it’s the researchers. By the time we’ve worked together, they should have a much clearer understanding of what they can accomplish within the university setting and when they need to hand off aspects of the project to outside contractors. But the long-term benefit? That’s for all of us. These new medical products won’t reach anyone if they don’t get FDA approval. So, I see my role as setting researchers up for success early and ensuring their ideas have a real shot at making it to the people who need them.
These new medical products won’t reach anyone if they don’t get FDA approval. So, I see my role as setting researchers up for success early and ensuring their ideas have a real shot at making it to the people who need them.
When should researchers or early career entrepreneurs reach out to you? Is it ever too early or too late?
Lynn: The earlier the better. As soon as they have a clear idea of what they want to accomplish, we should be talking. It’s never too early to start understanding the road ahead. Even if the team is years away from their first meeting with the FDA, getting that guidance early on their journey can help them reach those milestones faster.
Regulatory work can mean many things, but in our case, it’s about guiding researchers through the FDA approval pathway.
Are you supporting researchers navigating the IRB process too?
Lynn: Regulatory work can mean many things, but in our case, it’s about guiding researchers through the FDA approval pathway. I aim to get FDA feedback for the team as soon as is reasonably possible. This feedback is critical, not only for the team, but for future grant writing and funding opportunities. The IRB, on the other hand, comes into play much later in product development, when researchers are ready to initiate clinical studies. This often occurs many years after our first interactions. While we occasionally assist with IRB applications, it’s not our primary focus.
How can researchers get connected with you and the expertise you provide?
Lynn: One way is through the ITHS question portal located within the TDC webpage. But honestly, many researchers don’t know we exist, so outreach is a big part of what we do. We rely on word-of-mouth, referrals, and collaborations with groups like CoMotion and WE-REACH, who often direct researchers to us. Sometimes, researchers think it is too early to talk about FDA requirements and the medical need for their product, but that is rarely the case. The earlier they come to us, the more we can help. The TDC faculty is happy to speak with anyone about their project. If there is actual work to do on behalf of the team, then we set up a scope of work contract through the ITHS administration.
What strategies have been most effective in building and sustaining relationships between ITHS researchers and industry partners?
Lynn: We are early in the process and don’t necessarily deal with the spinouts, startups, or licensing—that’s CoMotion’s job. Our focus is more on helping researchers make their products in a way that can be tested safely, first in animals and then in people. To support this, we’ve built the Drug and Device Advisory Committee (DDAC), which brings together current and former industry professionals with expertise in everything from manufacturing to clinical testing. Developing a product is a team effort—it requires regulatory, clinical, non-clinical, and marketing expertise. By leveraging the DDAC, we ensure researchers are exposed to the full scope of product development.
What inspired you to co-found the ITHS Drug and Device Advisory Committee (DDAC) and how has this program evolved over time?
Lynn: When Dr. and I started the DDAC in 2008, we were building on our experience with the CF Therapeutics Development Network and invited our friends in the biotech industry to participate. Initially, we thought drugs would be our primary focus, but we quickly realized that the University of Washington was also a medical device powerhouse. That was a major shift for us. Over time, we brought in experts in engineering and quality systems to better support device development. DDAC has grown into a diverse group of professionals who guide researchers on everything from clinical testing to manufacturing . The DDAC is now led by Dr. Terri Butler who serves as the Director of Research Partnerships.
Who do you think would most benefit from reading this article?
Lynn: Researchers developing new medical devices or therapeutics — especially those who don’t realize how early they should start thinking about the FDA requirements. If they take one thing away, it should be to reach out to us sooner rather than later.
Thank you, Dr. Rose, for taking the time to talk to us!
Working on developing new medical devices or therapeutics? Connect with ITHS Technology and Development Center to breeze through the maze of startup formation, clinical studies, FDA clearance, fundraising, and market entry.
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