For She's a Regulatory Fellow, Which Nobody Can Deny
"I don't look at this [fellowship] in terms of what it can do for me, I look at it to see how my experience can help benefit the Warfighter," said U.S. Air Force Maj. Monika Lunn, Regulatory Affairs Fellow at the U.S. Army Medical Materiel Development Activity, Fort Detrick, Maryland.
As the recipient of the first Advanced Development Acquisition Fellowship in Regulatory Affairs at USAMMDA, Lunn has quite an interesting road ahead of her. Over the next year, she will be working closely with both the Division of Regulated Activities and Compliance, and the Clinical Services Support Division to gain extensive knowledge on the U.S. Food and Drug Administration regulatory process, to apply this experience to the development of products specific to the Air Force Medical Service.
Recently, I sat down with Lunn to discuss her new assignment, including her past, present and future in the military, and was struck by a recurring thought throughout our conversation: she not only wants to serve her country, she is truly excited about it.
"My dad served in the Army for many years, and my mother is a retired Army civilian who worked over 30 years with the MWR [Morale, Welfare and Recreation] program, so I was always pulled toward public service, and wanted to give back for the life experience I was afforded as an Army brat," said Lunn. "I really like the idea of Americans serving their country, and I think everyone should at least consider it at some point."
Although the Regulatory Fellowship is only a one-year assignment, Lunn hopes to receive a two-year follow-on assignment to sharpen her skills by applying this knowledge to the regulatory process. She views this particular mission as an extension of her recent biomedical science work at Wright-Patterson Air Force Base in Ohio.
"I applied for this position because I really felt it could bridge the gap with the research I had been involved with at Wright-Patterson – to connect the initial R&D [research and development] to actually fielding completed products to our Warfighters," said Lunn. "This was appealing to me – I really was interested in learning more about taking a concept through the entire acquisition process to fielding.
"It will be very important for me to look at the clinical aspect, and the quality components, and to see how documents are written and compiled for submission to the FDA," she added. "I am really excited about working with the DRAC office, and rotating through CSSD, to see how each group functions and how they work together."
In a nutshell, the offices of DRAC and CSSD are tasked with ensuring that all sponsor responsibilities regarding product development are fulfilled in accordance with the policies set forth by the U.S. Army Medical Research and Materiel Command, USAMMDA's higher headquarters. The USAMRMC's mission is to create, develop, deliver, and sustain medical capabilities for the Warfighter; as a USAMRMC subordinate command, USAMMDA remains the premier developer of military medical solutions worldwide.
In light of this, it appears that Lunn certainly chose the right organization with which to share her talents. However, this collaboration is one of many within the USAMRMC that join together the Army, Air Force and Navy in a unified effort to produce and deliver medical products for our country's Warfighters. And this appealing multi-Service environment attracted Lunn to USAMMDA.
"As the first person entering as the Regulatory Fellow at USAMMDA, I hope to show the continued value of having an Air Force member serve alongside Army personnel to help advance critical products to our Servicemen and -women in the field, regardless of their branch," said Lunn. "We're all working together to keep our country safe and our Warfighters healthy, and that's our main focus."
Not only is Lunn happy to be working at USAMMDA, her team leaders are equally excited to have her onboard as well.
Said Dr. Robert Miller, DRAC director, "Maj. Lunn's willingness to participate as the first USAMRMC Regulatory Affairs Fellow here at USAMMDA is a great credit to her in helping to overcome the challenges of joint military medical product development for all Service Members."
Serving as Lunn's preceptor is Lisa Borek, chief of USAMMDA's Medical Devices and Diagnostics Branch. Borek will act as co-mentor to Lunn along with Miller during the year-long assignment, and she is looking forward to adding Lunn's talents to MD&D, which performs a critical role throughout the medical device product lifecycle, and the acquisition cycle from concept through post-market.
"We are very pleased to welcome Maj. Lunn as a member of our regulatory team, as she will add much experience and an outstanding educational background to our group," said Borek. "During her fellowship, we will build upon this foundation to foster key professional regulatory skills and expand her knowledge base to support and expedite the development of safe and effective medical devices and diagnostics across the Services."
While Lunn remains very enthusiastic about the prospects of this new challenge, she also is visibly passionate about her life as an Air Force officer, which she detailed for me.
"I had intended to serve only one tour, and I had a direct commission in the Air Force because of my bachelor's degree [in medical technology]," said Lunn. "But within a short time, I was really enjoying my work, and doing things in the military that I would never have experienced as a medical technologist in the civilian world.
"I am very happy to be here at USAMMDA, and happy to be in the military," she added. "Life in the military brings something new every few years, and even within each assignment there are always new challenges, which keep me on my toes!"
After serving 14 years to date, and earning a master's degree in micro/molecular biology during this time, Lunn has recently been chosen for promotion to the rank of Lieutenant Colonel (O-5), which forges her legacy in the Air Force. However, Lunn said that her eventual military retirement will not be the end of her work in the field.
"Actually, after I retire, I would like to extend my stay and follow on as a civilian or a contractor," said Lunn. "I would never have thought this early in my career, especially since I thought I would only do one tour in the Air Force, but now I have a great connection to this work, and I really would like to remain involved in some capacity later on – this is home to me now."