Toxicology Testing Services with Unique Expertise in Predicting and Preventing Hypersensitivity (Infusion) Reactions
At SeroScience International©, we harness a network of international GLP compliant laboratories and world leading experts to tackle immune-related barriers to drug development at the R&D, Pre-Clinical, Clinical, and Regulatory Reporting levels.
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30 Brattle St, Harvard Square Cambridge, MA 02138
Immunotherapy Dosing Protocol
Played key role in the development of an FDA approved dosing protocol for the flagship product of a leading developer of immunotherapeutics struggling with issues surrounding infusion related hypersensitivity reactions to their lipid based delivery platform.
Medical Device R&D
Led tailored R&D program for a Fortune 500 medical device company after a toxicity assessment led to ground-breaking discoveries surrounding fundamental causes of hypersensitivity reactions to one of their main medical device product lines.
Provided expert testimony to senior management at a large pharma firm which dissuaded them from killing the program of a future block-buster drug in early pre-clinical trials due to severe toxicity in rabbits along a pathway irrelevant to human toxicity.