Capabilities
Specialized Areas of Expertise and Experience
- Primary Expertise: Inhalation toxicology and respiratory pharmacology
- Other Indications: Inflammatory, Cardiovascular, Gastrointestinal, Ophthalmology and Arthropathies
- Routes of Administration: Inhalation, intranasal, intra-articular and intravitreal administration
- Modalities: Recombinant and engineered proteins, oligonucleotides, antibodies, peptides, small molecules, PEGylated molecules and drug-device combinations
Pharmacology and Toxicology Strategy and Development
- Develop toxicology strategies from IND to registration
- Design, implement, monitor and interpret nonclinical studies
- Identify, select, initiate and oversee CRO studies
- Define and manage animal model & safety pharmacology programs
- Perform nonclinical due diligence for acquisitions
Document Preparation and Review
- Regulatory quality (GLP) reports
- Regulatory submission preparation
- Investigational brochures
- Board or partnering presentations
- Manuscripts and white papers
