Amanda Mack, Ph.D.

Amanda joined DHC in 2021, bringing 15 years of experience in the use of stem cells as a platform for differentiation into a range of cell types destined for therapeutic application. She has served as a cross-functional leader directly engaging teams involved with research, process development, quality, technology transfer, manufacturing, and regulatory towards successful, preclinical programs in both industry and academia. Her diverse experience is enriched with perspectives from fast paced, small companies through acquisition, to large internationally-recognized organizations.

Amanda formerly served as a Senior Director at FUJIFILM Cellular Dynamics, Inc (FCDI) where she spent over 12 years shaping and carrying out a vision to position the company as a leader and provider of high-quality induced pluripotent stem cells (iPSC). She began in 2007 where she led research efforts to derive the company’s first iPSCs, constituting a critical part of FCDI’s patent portfolio. She also oversaw analytical development and quality control activities related to the release of iPSCs for compliance with regulatory standards. Following significant process improvements, she worked with teams to centralize and standardize internal policies governing iPSCs for clinical application. This was done to ensure existing and future production of dependable, high-quality material for therapeutic platform development for both internal programs and external partners. She has been an advocate for presenting information via publications, regulatory submissions and conferences in order to improve standards in response to client feedback, regulatory feedback, and the evolving CG&T landscape. While implementing FCDI’s vision for iPSCs, Amanda also embraced a range of additional opportunities from managing differentiation and gene editing projects to leading the search for GMP CDMO partners while supporting business efforts to build CDMO services internally.

Amanda has formerly served as a Director for both Opsis Therapeutics, LLC and Century Therapeutics, Inc. where she worked collaboratively with senior leadership to provide strategic input in the development of preclinical programs. In her role at Opsis, she oversaw the selection and production of master and working cell banks across sites to support the production of ocular cells for therapeutic application. Additionally, she oversaw the production of autologous iPSCs and technology transfer to the National Eye Institute and Department of Transfusion Medicine in order to advance the development of ocular therapies at the NIH. At Century, Amanda led a team of scientists to develop an immune cell platform derived from engineered iPSCs for eventual clinical application. She collaborated closely with colleagues to oversee the coordinated hand-off of materials across internal research teams and built cross functional relationships with external partners, quality, regulatory, and process development teams to create a solid infrastructure in anticipation of future intra-dependencies.

Amanda’s tenure in the cell therapy field has afforded opportunities for her to author sections and review CMC content for regulatory submissions for iPSC-derived products spanning ocular, cardiac, immune, neural, and mesenchymal cell types, to name a few. Additionally, she has contributed to and submitted Drug Master Files, participated in INTERACT and pIND meetings, and has been responsible for compiling content in response to inquiries from a range of agencies including the FDA, PMDA, and EMA.