Our team of Cell and Gene Therapy professionals bring deep technical expertise to help you tackle the unique challenges of our exciting young field.
FOUNDER & CEO
Cross-functional project leader in biopharmaceutical management of international clinical development, regulatory submissions, and development strategy.
Nineteen years of experience in CMC for cell and gene therapies, including technology transfer, process development, quality by design, manufacturing, regulatory and facility design.
Over 25 years of experience in the development and commercialization of advanced therapeutics in multiple geographies, with particular focus on characterization, analytical development/validation, and quality control.
PRACTICE EXPERT, INTELLECTUAL PROPERTY and VICE PRESIDENT, LEGAL AFFAIRS
Intellectual property (IP) expert and registered patent attorney with over 10 years of combined experience in biologics and cell therapy patent prosecution and IP strategy at various stages of product development and commercialization.
PRACTICE EXPERT, QUALITY
EU Qualified Person and Practice Expert with 15 years of experience of IMP and commercial manufacture, quality, validation, clinical trials, regulatory submissions, and remediation activities.
14+ years of experience in in vivo and ex vivo gene therapies; combined with extensive CMC gap analyses and regulatory/development strategies for genetically modified cells for tissue regeneration, virally vectored gene therapy products, in vivo and ex vivo genome editing, genetically engineered immune cells targeting cancer cells and stem cell-based products.
Ten years supporting CMC activities in CG&T; including process development, technology transfer, risk assessment, regulatory strategy and filing authorship, along with Quality by Design based development and project management.
Responsible for all DHC finance functions, select HR functions. 20+ years experience working as a Controller and CFO across various industries, including financial services, biotech, and tech start-ups. Andrina holds an MBA with dual concentrations in Financial Business and Leading Organizations and will earn her MS in health care management in 2021.
BUSINESS OPERATIONS SPECIALIST
Responsible for maintaining databases and pipeline structure, administering inter-company contracts, acting as point of contact for corporate interactions, and shadowing in business development. Started at Dark Horse as Administration Coordinator to the CEO.
Responsible for scheduling meetings, travel, onboarding, conferences, and other events as well as providing C-suite support. Previous experience includes five years of research coordination and assistance in the finance sector as well as ~four years as water polo assistant coach at Harvard University.