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
Twenty years of experience in CMC for C>, including viral vectors, plasmids, and cell therapies.
Cell and gene therapy scientist with 15 years of experience leading research, preclinical, and process optimization for preclinical and clinical stage development programs in industry and academia.
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.
MASTER PRACTICE EXPERT, REGULATORY
CMC subject matter expert with over 25-years of US FDA-regulatory review experience that encompasses the life-cycle of regenerative medicine advanced therapy (RMAT) product development from pre-submission interaction with FDA through filing of market authorization applications.
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 a wide range of cell and gene therapy products.
Data-driven engineer and subject matter expert in cell cryopreservation, process optimization, scale-up, and technology transfer of cell therapies and clinical diagnostics.
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.
CMC project manager with 20 years of experience in the biopharmaceutical industry, from research & development to clinical phase and commercial manufacturing, including tech transfers of immunodiagnostic, personalized cancer immunotherapy, and C> products.
Process engineer with experience in cell therapy process optimization and technology development and deployment.
6+ years of gene therapy experience, spanning upstream, downstream and analytical process development. Lean Six Sigma Green Belt.
Bioengineer with 5+ years of experience focused on gene therapy viral vector process development as well as characterization and validation with an emphasis on AAV and lentiviral vectors.
Brings cutting edge cell & gene therapy experience in both gene editing and stem cells.
BUSINESS DEVELOPMENT MANAGER
Business development professional and analyst focused on the advanced therapy space, with a background as a strategy consultant and as business development manager in a CDMO.
Responsible for all DHC finance functions, select HR functions. 20+ years experience working as a Controller and CFO. Andrina holds an MBA with dual concentrations in Financial Business and Leading Organizations and will earn her MS in health care management in 2021.
SENIOR EXECUTIVE ASSISTANT
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.
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.
CONTRACTS ADMINISTRATOR and LEGAL ASSISTANT
Responsible for preparing and maintaining contracts and providing general support to the VP Legal Affairs. Cecilia has over 10 years of experience as a legal assistant in the biotechnology field.