Annie is an experienced C> professional that has worked in both academia and industry to lead the manufacture of autologous cell and gene therapies. She joined Dark Horse in January 2022, bringing her expertise in manufacturing and technical operations including cell processing and enrichment, gene modification and final fill methods, technology transfer and resource planning.
After nearly 10 years as a bench scientist in academia and the non-profit sector, Annie joined the C> field in 2013 at the University of Pennsylvania. She supported the manufacture of CAR-T cell products for early phase clinical trials at Penn’s Clinical Cell & Vaccine Production Facility (CVPF), a cGMP service center facility manufacturing autologous and allogeneic cell and gene immunotherapy products under academic and industry supported INDs.
Annie led the team in the successful manufacture of >100 drug products per year for first-in-human, Phase I and Phase II clinical trials. In addition, with the support of her team, she led the successful technology transfer of NPI from Process Development to Manufacturing for academic and industry-sponsored INDs and proactively managed the implementation of platform and technology improvements. Annie also supported the development of technical documents, SOPs, and regulatory dossiers.
In 2020, Annie joined Rocket Pharmaceuticals, a clinical-stage company with a cell and gene therapy platform for rare childhood diseases. As the CMC Associate Director at Rocket Pharma, Annie supported external manufacturing activities with CMOs based in the US and internationally including technical review of executed clinical and engineering batch documents to support the timely release of manufactured drug products. She also led laboratory set-up to enable internal process development activities for the cell processing platform and process FMEA-based risk assessments as a technical expert. With the support of her team, she managed internal and external process optimization, technology transfer of NPI to commercial CMO partners and the development of technical and regulatory documents.