Samantha Conner

Former FDA; regulatory and CMC expert with extensive knowledge of regulations and policy related to CGT and beyond

Project Manager with experience in cell therapy, raw material supply, and production facility/cleanroom buildout

Cutting-edge CGT experience in gene modification and AAV for in vivo therapies

Former FDA; experience reviewing CGT CMC at CBER/OTP; also focus in cell & molecular bio, genomics, epigenetic, immunology, and virology

Extensive experience in global cross-functional program management, regulatory, and development strategy

John Ng joined DHC in 2023 as General Manager of Asia Pacific, responsible for growing and supporting the Asia-Pacific market.

Diverse experience with cell therapy regulatory writing, process development strategy, planning, and execution

Biotech quality assurance and systems experience with specialist knowledge in clinical trial oversight and computer system validation

CMC project manager with experience from R&D to clinical phase and commercial stages, including tech transfers

Engineer experienced in implementing development processes into GMP manufacturing: special interest in process equipment and raw materials

Experienced in CGT process development, GMP manufacturing and tech transfer, regulatory, quality, project management, and VOC

CGT expert with experience in stem-cell derived platforms; leads cross-functional teams towards successful early stage development programs

An established leader in business development, product development, manufacturing, and technical operations of cell-based therapeutics

Experience and thought leadership in the design and building of bespoke manufacturing equipment, instruments, and single-use consumables for use in the development and manufacturing of CGT

10+ years of biopharma experience: CDMO selection, plasmid and viral vector mfg, AAV process dev, analytical dev, regulatory strategy/writing, bioanalytical method dev for clinical-stage cell tx products.

Experience with contract development and manufacturing organization (CDMO); focus on program & alliance management

Decades of experience in overlap b/t device development & regenerative medicine; focus in engineering, operations, manufacturing, product development, regulatory, and quality