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
COO & MANAGING PARTNER
~20 years of C> operations experience, combining strategic vision and cross-functional technical leadership in the field.
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.
GENERAL MANAGER, DHC Europe Ltd. SENIOR PRINCIPAL
Cross-functional project leader in biopharmaceutical management of international clinical development, regulatory submissions, and development strategy.
Cell and gene therapy expert with over 15 years of experience in stem cell-based platforms. Leads cross functional teams towards successful preclinical development programs.
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.
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.
An established leader in the development and manufacturing of cell-based therapeutics with a strong technical/scientific background in stem cell biology and cell therapy CMC development and manufacturing.
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
10+ years working in academic, biotech and contract development and manufacturing organizations with a primary focus on manufacturing allogenic and autologous cell 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.
10 years of GMP Quality expertise supporting the manufacture, release and distribution of IMP, Drug Substance and Drug Product, with a focus on Quality System design and remediation.
Ten+ years experience across academic and industry in translational medicine, GMP manufacturing for viral vectors and various cellular products, as well as regulatory filing for clinical and commercial stage C> 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.
Corporate strategy, finance, and commercial operations expert with more than seven years experience supporting and leading teams in the Cell and Gene Therapy space.
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.
Bringing seven years of biotech experience focused on quality assurance, computer system validation, and clinical trial oversight.
Process engineer with 5 years of cell therapy experience including process, technology and device development, technology transfer and QA oversight of GMP manufacturing. Six Sigma Green Belt.
Process engineer with experience in cell therapy process optimization and technology development and deployment.
Extensive and diverse experience with cellular therapy process development strategy, planning, and execution.
Five years of experience across academia and industry, with expertise in immunobiology, clinical epidemiology and cell therapy process development and manufacturing.
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 10+ years of pluripotent stem cell biology know-how. Experience in tissue engineering, cell & gene therapies, tech transfer and validation.
SENIOR MANAGER, BUSINESS DEVELOPMENT
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.
Financial leader with experience in financial and accounting operations: emphasis on growth, operational efficiencies, and building scalable processes.
SENIOR EXECUTIVE ASSISTANT
Responsible for scheduling meetings, travel, onboarding, conferences, and other events as well as providing C-suite support.
BUSINESS OPERATIONS SPECIALIST
Oversees internal operations and resource management, as well as supporting business development functions.
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.
Responsible for providing administrative support across Dark Horse. Previous experience includes non-profit and arts administration as well as office management in Silicon Valley.