Andrew Kolodziej
- Role
- Senior Director, Regulatory Toxicology at Corbus Pharmaceuticals
- Location
- Cambridge, MA, US
- LinkedIn followers
- 500 followers
About Andrew Kolodziej
Specialties: Early stage discovery through Phase 2 development. Scientific leadership in…
Experience
Senior Director, Regulatory Toxicology
Jul 2020 — Present
Program lead for mAb-based oncology program targeting avb8 integrin • Lead toxicologist for Lenabasum and Corbus’ pipeline of cannabinoid (CB) receptor modulators, responsible for completing NDA-enabling toxicology studies, regulatory submissions to FDA/EU authorities (e.g. DSUR, orphan drug, IB updates) • Review PK data, SAP, and TFLs for ongoing clinical safety studies (TQT, renal and hepatic impairment), and assess DDI risk for enrollment candidates. • Discovery team leader for peripherally restricted CB1 receptor inverse agonist program for weight loss and diabetic nephropathy indications.
Skills
- High Throughput Screening
- Molecular Biology
- In Vivo
- Computational Chemistry
- Clinical Development
- Fluorescence
- Gpcrs
- Pharmaceutical Industry
- Protein Chemistry
- Biochemistry
- Technology Transfer
- Medicinal Chemistry
- Cell Biology
- Assay Development
- Small Molecules
- Biomarkers
- Immunology
- Biomarker Discovery
- High-Performance Liquid Chromatography (Hplc)
- Cancer
- Biopharmaceuticals
- Animal Models
- Lead Change
- Hplc
- Nmr
- Biology
- CRO
- Pharmacology
- In Vitro
- Drug Design
- Adme
- Enzyme Kinetics
- Purification
- Drug Development
- Chemistry
- Biotechnology
- Analytical Chemistry
- Oncology
- Lifesciences
- Life Sciences
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