The Regenerative Medicine & Entrepreneurship program is a new and exciting program here at the Case Western Reserve University School of Medicine. With this in mind, our alumni remain in the early stages of their careers, and we hope to aid them in their journey to becoming the scientists, practitioners, lawyers, and business men and women of tomorrow.
We invite our alumni to explore this webpage in order to learn more about the career paths, job offerings, and experiences available to them. Additionally, we also hope to utilize this page in order to highlight the success and the stories of our alumni as they progress towards their career goals.
Applying for a job? Considering higher education? Check out this webpage to learn more about the options available to you at Case Western Reserve University and beyond!
Check out the Case Western Reserve University School of Medicine's Admissions Youtube page to learn more about the process and what makes our program unique!
Check out the Case Western Reserve University Biomedical Scientist Training Program's Youtube page to learn more! This program features a variety of unique "areas of investigation" - including one in the regenerative medicine sphere!
Learn more about the Case Western Reserve University School of Law through their Youtube channel!
Alumni and Student Spotlight
Check back here to learn more about the exciting steps our alumni and students are taking in their careers as the future of regenerative medicine!
Meet Ashley Shay
Where would you say you are from (city, state, country)? Oak Harbor, OH, USA
Where did you receive your bachelor's degree? The Ohio State University
Before joining the RGME program what were you doing (i.e. student, research, industry role, internship)? I was working as a Research Assistant at CWRU, which I continued throughout the RGME program.
Why did you choose the RGME program? I chose the RGME program to continue to pursue my interests in genetics and regenerative medicine and for the opportunity to be connected with an internship in industry.
What was most important for you as you went through the program? The RGME program offers a lot of development opportunities, but optimizing growth requires being proactive so I prioritized being fully engaged and leaning into everything the program offers.
Did you participate in the internship or research project as part of the program? What did you take from that experience? What did that entail and what did you learn from it? I participated in an RGME 565 internship with Forge Biologics in the Regulatory Affairs Department. I gained new exposures in the development, manufacture, and regulation of gene therapies. My main project was authoring a European Medicines Agency Orphan Drug Designation application. I also participated in research through being awarded an ENGAGE research scholar award supported by the National Center of Regenerative Medicine. This award funded the grant application titled “Establishment and Characterization of Patient-Derived Organoids as Models of Small Cell Lung Cancer” and I was able to culture 3D organoids from 2D cell cultures.
What elective courses did you choose and why? I took: Molecular and Cellular Physiology to refresh my foundation in the subjects, Product and Process Design to gain insights into iterative product and process development principles, Polymers in Medicine because I enjoyed Molecular and Cellular Physiology, which was taught by the same professor, and Development of Interpersonal Skills for Managers to further improve my soft skills.
Now that you have graduated, what are you doing and what are your future plans/goals? I work full-time as a Regulatory Affairs Specialist at Forge Biologics, where I draw on my experiences from CWRU to support the development of life-saving gene therapies by contributing to FDA, EMA, and other global regulatory submissions. My next goal is to pursue RAC certification to demonstrate competency in the field after I have settled into my new role and gained more experience.
Meet Rachel Shaw
Where would you say you are from (city, state, country)? Cleveland, OH
Where did you receive your bachelor's degree? Ohio State University
Before joining the RGME program what were you doing (i.e. student, research, industry role, internship)? Before joining the RGME program, I was working in a research laboratory at CWRU studying Mycobacterium tuberculosis.
How did you hear about the RGME program? I heard about the RGME program while working at CWRU. I wanted to go back to school and get my master’s degree, but I couldn’t find a program that fit what I wanted. I found the RGME program on CWRU’s website and I knew it was exactly what I was looking for.
Why did you choose the RGME program? I chose the RGME program because I am fascinated with regenerative medicine and the concept of using the body’s own cells to repair organs, replace tissues and treat diseases. Because of powerful regenerative medicine tools, like stem cell therapy and gene-editing technology, people can live longer, healthier lives. Besides my interest in the science behind regenerative medicine, I was drawn to the RGME program because of its business component. I wanted a master’s program where I could learn about more than just the science of stem cells. The entrepreneurship classes taught me about the business side of science, which is something I had little knowledge of. Because of the uniqueness of the RGME program, combining both science and business, I feel confident in my ability to work in any area of the regenerative medicine field.
What was most important for you as you went through the program? The most important thing for me as I went through the RGME program was being exposed to a variety of areas of regenerative medicine. This program allows you to see all aspects of regenerative medicine from pre-clinical research to communicating with the FDA to building a start-up biotechnology company. It was important to me to learn about all aspects of regenerative medicine so I could choose the right career path.
Did you participate in the internship or research project as part of the program? What did you take from that experience? What did that entail and what did you learn from it? Since I knew I wanted to enter industry and I already had years of research experience, I decided to pursue an internship. I interned at Bristol Myers Squibb in the Global Regulatory CMC department. CMC stands for Chemistry, Manufacturing and Controls. Global Regulatory CMC professionals are responsible for ensuring every aspect of the manufacturing process meets the regulatory requirements for health agencies across the world. During my internship, I authored regulatory submissions for Abecma, one of the CAR T cell therapies Bristol Myers Squibb has on the market. I learned just how much I enjoyed the regulatory field and how applicable the material taught in RGME was to my work. For my internship, RGME 535 and 545 were particularly beneficial. I encountered the information covered in these two courses throughout my internship and regularly went through my lecture notes to review specific topics.
What elective courses did you choose and why? My science electives were EBME 451 (Molecular and Cellular Physiology) and PATH 416 (Fundamental Immunology). I took EBME 451 as a refresher course in cell biology. PATH 416 was the best elective course I took for the RGME program. I cannot recommend it enough to incoming students. The course was an in-depth overview of the immune system. The class was challenging, but I was incredibly prepared for RGME 535 because of the knowledge I gained from PATH 416. I use the information I learned from this course (plus RGME 535 and RGME 545) every single day in my job. My two business electives were EPOM 403 (Product and Process Design and Implementation) and MEM 475 (technology Marketing). Before joining RGME, I had very limited business experience. I wanted to take two electives that covered different aspects of entrepreneurship. I took EPOM 403 to get a better understanding of how to take medical technology from just an idea on paper to a tangible product. I took MEM 475 to understand the different marketing strategies medical technology companies use in a heavily regulated industry like regenerative medicine.
Now that you have graduated, what are you doing and what are your future plans/goals? After graduation, I took a remote job as a Regulatory CMC Specialist at Bristol Myers Squibb. I’m working in the same cell therapy department where I interned. Though I applied to a variety of jobs in the regenerative medicine field, I am very happy with my choice to stay at Bristol Myers Squibb. I love what I do. It is the perfect combination of science and business for me. Regulation surrounding the regenerative medicine field is challenging but also incredibly rewarding knowing I’m bringing life-saving therapies one step closer to the patients who need them.