ARM Member Profiles

Hybrid Concepts International (HCI) is a niche consulting and advisory firm serving the fields of cell therapy, ex vivo modified cell therapies (gene or non-gene modified), in vivo gene therapy, other advanced therapies & regenerative medicines, tissue engineering, and cell-based drug discovery. Specific discipline expertise (current team of 6) for the aforementioned fields include global regulatory affairs strategy and content (especially FDA), CMC, Process Development and cGMP-compliant manufacture, translational R&D (e.g., IND-enabling studies), technical/product/platform/regulatory diligence activities, and related QA, QC, and regulatory publishing/eCTD support. HCI primarily serves start-ups and innovative biotechs. HCI also serves larger more established biotech and pharma alike, multi-disciplinary diligence for Wall Street (especially VCs), subcontracts for other consulting firms, and contracts with government organizations. HCI can fulfill both i) project-specific, hourly rate consulting contracts, and ii) longer-term, more largely scoped, part-time, titled advisory contracts. HCI operates for clients all around the world.

Partnering Objectives: Interact and work with industry, academia, government, and other stakeholders internationally in the aforementioned fields so our Hybrid Concepts can help accelerate their goals. HCI supports the development of potential cures instead of daily prescription drugs.