21 Sep Team Spotlight: Jake Rome
Jake Rome is the Administrative Director of the FDA Regulated Research Oversight Program
PLEASE SHARE A BIT ABOUT YOUR PROFESSIONAL JOURNEY. HOW DID YOU ARRIVE AT YOUR CURRENT POSITION?
After graduating from law school, I worked at the UW’s Center for Patient Partnerships. There, I advised students who were teamed with clients to navigate issues the with their health and the health care system. From there I went to work at the UW’s Health Sciences IRBs Office, which interested me because of the regulatory and ethics nature of the position. In my time with the IRBs Office, I started to focus more on FDA regulated research and joined different FDA related groups on campus. When my current position as the Director of the FDA Regulated Research Oversight Program opened, I thought it was a great opportunity to both use and grow my knowledge of FDA regulatory requirements.
WHAT MOTIVATIONS FUELED YOUR CAREER PATH?
The primary motivation for my career path has always been my interest in health care access issues and medical ethics. In law school I focused my coursework on health law and that is part of what led me to the IRB. As I learned more about the FDA’s requirements for research, I found that working in the FDA regulatory field was a great and rewarding opportunity to assist investigators in navigating complex requirements as they seek to advance medical knowledge and treatment options.
WHAT ARE SOME PROFESSIONAL DEVELOPMENT TOOLS OR RESOURCES THAT YOU WOULD RECOMMEND TO OTHERS IN YOUR POSITION/FIELD?
For those interested in learning more about FDA requirements, the FDA provides a lot of good information on their training and continuing education website. The Regulatory Affairs Certification is also an option for individuals interested in drug and/or device development and regulatory requirements specifically.
HOW IS SUCCESS DEFINED IN YOUR FIELD?
For anyone submitting an application to the FDA, getting a “may proceed” letter or acknowledgement that a clinical trial may begin is a huge success. Submitting to the FDA takes a lot of work and it always impresses me how motivated, creative, and thoughtful investigators and their teams are when faced with the task of developing a clinical trial requiring an IND or IDE.
WHAT DO YOU LIKE MOST ABOUT YOUR ROLE?
What I like most about my role is seeing all the amazing work that is being done at the UW to promote health, grow knowledge of diseases and treatments, and provide patients access to potentially lifesaving products. Even though I play a small part in the process, I feel very lucky to be able to assist investigators and their teams in getting projects through the FDA approval process.
WHAT ARE SOME CHALLENGES YOU FACE IN YOUR ROLE?
Sometimes being an “Oversight Program” gives people the wrong impression that our primary focus is something other than providing support. It does not help that the FDA regulations are broad, so trying to explain why FDA rules need to be followed when there is no interest in commercial development of a product may add to that impression and can be a challenge. I really want everyone to know that the program exists to help support investigators and their research teams in meeting FDA requirements as an extension of their team. We are here to help, so please reach out if you have any questions!
HAVE ANY MENTORS IMPACTED YOUR PROFESSIONAL DEVELOPMENT? HOW DID YOU DEVELOP THESE RELATIONSHIPS?
The biggest impact that mentors have had on my professional development is by giving me access to opportunities and perspectives that are outside of my daily work. For example, allowing me to sit in on meetings or participate in discussions that are not directly related to what I do, but give me a broader understanding of where I can focus my growth, development, and interests. The key for me in developing these relationships has always been to show a genuine interest in developing and not be afraid to reach out to ask for guidance or to be involved in activities that are novel to me.
WHAT DO YOU WISH YOU HAD KNOWN WHEN YUOU STARTED YOUR CAREER PATH?
That it is not always clear where the path will take you, but that is okay. There are different components to every job so you will be able to find something that interests you and can use that to progress your career. I had no idea what an IRB was before I started working for one, but am glad I applied and was able to turn that into the FDA regulated focus I have today.
WHAT ADVICE DO YOU HAVE FOR SOMEONE PURSUING A SIMILAR CAREER PATH TODAY?
Take advantage of every opportunity you have to develop your regulatory knowledge, as there are many different paths you can pursue depending on what your specific interests are.
WHAT’S YOUR FAVORITE PART ABOUT WORKING WITHIN UW’S CLINICAL RESEARCH COMMUNITY?
All of the great people that I get to work with at this world class research institution. It is incredible to be able to work with the professionals in the Clinical Research Office and ICTR who are so driven to support researchers and their teams.