Serving academic research organizations, small to mid-sized private and public drug/device development companies working in early, clinical and late-stage development within the fields of regenerative medicine or immunotherapy.
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Our valued clients bring real questions . . .
“What level of drug product control and characterization is needed to conduct preclinical studies?”
-Discovery Scientist, Cell Therapy
“Should we be considering bridging studies?”
-CAR-T, VP of CMC Development
“When do we need to consider pediatric investigation plans?”
-EU-based Gene Therapy, CMO
"When should I worry about drug product potency assay?”
-Vector-based Science rare disease Head of R&D
“What are agency expectations for companion diagnostics (clinical inclusion criteria assays or safety/efficacy endpoint assays)?”
-Government Agency, Rare Disease Gene Therapy Unit
“How do I maximize clinical enrollment for rare disease?”
-Head of Clin Ops, HSCT Ex-Vivo Gene Therapy Company
“Is an adaptive design trial a good strategy for our program?
-Rare Disease AAV Gene Therapy, CMO
“What level of drug product testing is needed to initiate our Ph2 clinical study?”
-Oncology Drug Development, CEO