I oversaw the development of clinical grade induced pluripotent stem cells (iPSCs) for therapeutic platform development as well as various engineered cell products derived from them. This work inherently involved activities relating to technology transfer, manufacturing, and analytical testing as well as regulatory submissions and interactions.
I was serendipitously recruited to Cellular Dynamic’s where I was tasked to lead and establish the iPSC platform technology in 2007. So, I would say this kicked off a chain of exhilarating opportunities in the field for me at a company founded by notable scientists James Thomson, Craig January, and Timothy Kamp from UW-Madison.
I had the privileged opportunity to lead the selection of appropriate Donor starting material and subsequent development of induced pluripotent stem cells (iPSCs) for therapeutic platform development at Fujifilm Cellular Dynamics International (FCDI). I directly participated and oversaw a significant portion of the development of processes to industrialize the production of iPSCs from derivation through Master and Working Cell Bank production, facilitate technology transfer, and support manufacturing efforts. This work afforded multiple opportunities to interface with both academic and commercial CDMO’s and inform various partnerships and collaborations that included Opsis Therapeutics. Coincident with these activities were opportunities to contribute to Regulatory Strategy and CMC-related content and correspondences spanning a range of jurisdictions including FDA, EMA, and PMDA. Subsequently, I went on to oversee development of iPSC-based therapeutic products including Century Therapeutic’s gene-edited, iPSC-based T cell platform.
Over the years I found myself increasingly engaged in cross functional activities within organizations in order to move a product from the research phase through development and manufacture. I came to appreciate the role each function played in making a clinical product successful and enjoyed the process and cross-functional interactions. There was also a service and support arm to the work that I did over the years which provided opportunities for client engagement. I was looking for opportunities to implement these skills in a way that would advance the field especially as it relates to stem-cell derived therapeutic products as well as broaden my exposure to additional exciting innovations in the field. DHC just seemed a natural fit.
I don’t even know if I really understood the range of opportunity inherent in a career as a scientist though I think many of the things I loved fell under the umbrella. I was curious and had a genuine love of learning and of animals. At one point, I thought I’d find myself at the interface of zoology and veterinary medicine. The only thing that stood in between a sleeve-length rubber glove and the backend of a horse was my queasy stomach. So, I married a veterinarian and took a job in the stables of Dark Horse instead.
The most significant experience that influenced my path was the valuable time spent as an undergraduate in Dr. Jeff Dangl’s laboratory studying disease resistance in mustard plants (Arabidopsis) at the University of North Carolina in Chapel Hill. I learned how to cross fertilize plants, isolate RNA, clone DNA, work with an incredible team of scientists, and present research findings in Europe. He was generous with his time and knowledge and constantly identified opportunities that would feed my growing curiosity and interest. I had no idea how my future would be shaped by the opportunities I had under his mentorship. This experience led me to graduate school at the McArdle Laboratory for Cancer Research with Dr. Bill Sugden who was equally as generous with his time and commitment to enriching education through his unwavering support and dedication. Therefore, I was very lucky to have such positive influences that shaped my professional career.
Hold on tight, get ready for a dynamic ride, and remain open to every opportunity to learn and extend our boundaries for what we think is possible! At the same time, take the time to reflect on past work to inform the path ahead and steer us away from repeated mistakes. Ultimately, there are many unknowns with respect to cell therapy which means tremendous opportunity for growth from both our mistakes as well as our successes.
The moment we can apply metrics to otherwise intuitive processes, the more successful the manufacturing outcome. It may be impossible to characterize a complex biological process completely but efforts to identify and measure critical process points are essential in order to gain control of the manufacturing process.
I really LOVE riding bikes anywhere including the road, gravel, and mountain. Cycling has been a gateway to so many inspirational things I would have never encountered without it from jobs, friends, and exciting places. I particularly love riding hills and am always in search of epic rides. I’ve crossed a few things off the list including a solo, multi-day ride along the coast of Ireland amongst the sheep, being dropped by helicopter with a bike onto the mountain ridges of New Zealand, and participating in the fantastic climbs of the notable bike race in Spain (Vuelta a España) during the week of the race that covers the hilliest sections of the Basque countryside.
Very much so. I like the adventure, the engagement, the sense of presence with the world around me and within myself. Perhaps it’s also an embodiment of life. I like the opportunity to push and challenge my expectations while meeting incredible people and places that shape my experiences along the way. I suppose I’ve sought one challenge after another and seen them as stepping stones towards refined versions of myself with potential for a positive impact.
Amanda Mack, an avid cyclist. sometimes participates in cyclocross racing in the fall. In this picture she’s leaping (effortlessly, it would appear!) over the barriers on the cyclocross obstacle course.