FDA Friday - Cristin G. Welle, PhD

This #FDAFriday series consists of mini-interviews with former FDA regulators. Our goals are twofold: (1) help students and professionals interested in Regulatory Affairs see what career paths are possible, and (2) talk about some of the various roles at FDA to demonstrate the diversity of responsibilities at the Agency. If you are a former FDA employee and would like to participate, please email us at info@acknowledge-rs.com.


Finding an opportunity to work at the FDA is a fantastic way to learn the inner workings. I’d recommend that if you know anyone at FDA, send them your CV. It may wind up getting in the right hands!
— Cristin G. Welle
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Cristin graduated magna cum laude from the College of William and Mary before receiving her Ph.D. in neuroscience from the University of Pennsylvania. She joined FDA as a postdoc, and shortly thereafter began work as a Principal Investigator, focused on the safety and reliability of medical devices that interface with the nervous system. Cristin is currently an Associate Professor at the University of Colorado, Denver, in the Departments of Neurosurgery and Bioengineering. Her lab seeks to understand how invasive neural devices impact the nervous system, with the aim of informing novel device solutions for patients.

 

Tell us a little bit about your time at FDA.

I worked in the Center for Devices and Radiological Health (CDRH) as a Biologist, and my primary position was in research, within the Office of Science and Engineering Labs, where I ran the Neurological Devices Lab. However, I also served as a consulting reviewer for questions relating to animal testing, early clinical testing, electrical stimulation safety, biocompatibility and neural interfaces, and worked on 100's of files across multiple branches in the Office of Device Evaluation (ODE). I was able to become involved in a few extra projects as well, including playing a role in the Innovation Pathway, which became the Entrepreneur in Residence program, the Neurotoxicology Working Group, and the Early Feasibility Study Committee. In addition, I emphasized communication with the scientific community, worked with officials in other government agencies to promote education on FDA policies, and organized the FDA Public Workshop on Brain Computer Interface devices, resulting in the publication of a white paper.

What past experience or trait do you think helped you be a successful regulator at FDA?

My basic science training and subsequent collaborative efforts with investigators funded through the Department of Defense's Defense Advance Research Projects Agency (DARPA) gave me unique insight into the challenges that come from developing novel technology that pushes boundaries. I think this gave me a different lens through which to consider the testing protocols required for approval, particularly for early human studies. Certainly, I shared with many reviewers the ability to delve into vast amounts of scientific data and try to ascertain the most critical components. Reviewers are remarkable at digesting volumes of complex data very quickly, and I truly admired my peers for their ability to do so.

What are you up to these days?

Right now, I am an Assistant Professor at the University of Colorado, running a research lab that aims to improve the brain/electrode interface, and maximize the capabilities of modulating the brain's performance through electrical stimulation. I direct a group of 5 - 7 excellent scientists, who do the real work, to be honest! I haven't left my FDA life completely behind me though, and I have developed a comprehensive curriculum on FDA Regulatory Affairs that I teach to the university's bioengineering students. Also, I am in the process of developing a certificate program in FDA Regulatory Affairs with both coursework and an internship. So get in touch if you would like motivated, talented regulatory interns! Finally, I do dabble in some regulatory consulting, as I can't stop being interested in how Regulation and Innovation intersect!

What's something that you learned from FDA that helped you in your current position?

Regulatory decisions are extremely complex, and require integrating information from so many different sources. The ability to research an idea from many different angles, and then make a concrete decision, is highly valuable. In addition, regulators become familiar with so many different device areas. Working as a consultant reviewer stretched my boundaries of what I could understand to new limits. I use both of these abilities - pulling a central message out of diverse information sources and stretching to learn about new concepts - all the time in my current role. In addition, I've also learned quite a bit about what it takes to develop new, innovative medical devices. I'm engaged in some early stage development efforts with some collaborators, and am looking forward to putting all that FDA knowledge to use. Finally, I certainly couldn't teach the course that I teach without my FDA experience. It helps to engage the students to talk about how things 'really' work at FDA, aside from just what is printed on the website.

What do you think is a common misconception about FDA reviewers?

FDA reviewers may be more receptive to a dialogue than you think. FDA reviewers and sponsors approach the conversation with different expertise; FDA reviewers have a wide breadth of knowledge in many areas, and may be able to draw on other experiences to help shape the review of a submission, while sponsors come with a deep expertise in their particular product. Expressing healthy respect for what everyone brings to the table, but also pushing back in areas where you may have more experience than others, leads to a productive dialogue, and hopefully a satisfying solution.

What is some advice you can give to a person interested in regulatory affairs?

Finding an opportunity to work at the FDA is a fantastic way to learn the inner workings. I'd recommend that if you know anyone at FDA, send them your CV. It may wind up getting in the right hands!


More about Cristin G. Welle, PhD

For more information about Cristin, please visit the BIOElectrics Lab, or her LinkedIn page.