Amanda Mack - Dark Horse Consulting

0

years of experience

0

years at DHC

Amanda

's Service Domains

CMC

Quality & Compliance

Regulatory

Business Analytics

Amanda joined DHC in 2021 bringing expertise in stem cell-derived platforms and products that include process and analytical development, technology transfer, and CMC-related regulatory strategy and submissions.

At DHC, Amanda has enhanced clients’ ability to understand their current state of clinical readiness by providing a framework intended to inform the client’s development strategy and maximize potential for successful regulatory engagement while balancing considerations linked to business objectives. For example, this may be an evaluation of readiness to file an IND based on existing development plans and supporting data. For early-stage developers, this often includes an assessment of their current program to identify gaps, assess risk, and share mitigation strategies to alleviate potential impact to timeline, budget, and regulatory interactions. Amanda primarily supports clients focused on cell therapies, both unmodified and gene modified, and particularly enjoys those that are pluripotent stem cell-based.

A significant achievement in Amanda's professional career was the opportunity to develop the technology and processes to manufacture induced pluripotent stem cells (iPSCs) for Cellular Dynamics, Intl (CDI) beginning in 2007. This capability advanced internal programs developing iPSC-derived products, catalyzed academic and industrial collaborations, and led to various award grants (NHLBI, CIRM). As a result, the increasing requests for iPSCs pressure tested Amanda's ability to identify forward looking strategies to address and anticipate current and future demand. Outcomes resulting from strategic initiatives Amanda led included established procedures to industrialize iPSC manufacture, technology transfer, banks of clinically-enabling iPSCs, and supporting dossiers for engagement across regulatory jurisdictions.

Amanda has experienced a dynamic range of environments from fast-paced, early start-ups through acquisition by a multinational conglomerate (FujiFilm, FCDI). Following acquisition in 2015, Amanda's role expanded to oversee development for both research and therapeutic, next generation platforms inclusive of gene modification for another 5 years. Her time at FCDI afforded cross functional interactions and visibility across a broad range of therapeutic programs that heightened her interest in supporting drug product development to first in human applications.

Amanda broadened experiences beyond platform development to pursue opportunities in cell therapy product development through roles with Opsis Therapeutics and Century Therapeutics. At Century Therapeutics, she was tasked to oversee the development of a range of CAR-engineered, T cell subtypes from gene edited iPSCs. In this role, Amanda led early development initiatives and built cross functional relationships with external vendors, quality, regulatory, and process development teams to create a collaborative infrastructure to support intra-dependencies in anticipation of future needs.