- IND Section Writing and Review
- Development Report Writing and Review
- Biologics Regulatory Strategy development and implementation
- Due Diligence Evaluations of In-Licensing Opportunities
- Identification of CMOs for Antibody and ADC Manufacturing
- Creation of Request for Proposal documents to facilitate comparative evaluations of potential CMOs
- Site visits to CMOs for technical audits of capabilities
- Development of systematic evaluation criteria for CMO ranking and evaluation
- Identification and Evaluation of Cell Line Development CMOs
- Process development for synthesis of a drug-linker molecule for an ADC program
- Process development for bioconjugation of drug-linker and antibody to form an ADC
- Establishment AND Management of CMO network to manufacture, formulate, fill and finish a monoclonal antibody for Phase I supply – We take care of everything from start to finish!
- Creation of detailed project timelines and budgets for Phase I ready programs – starting with tech transfer and ending with GMP manufacturing and clinical supply
- Preclinical asset portfolio evaluation and prioritization
- Research and White Paper creation for specific areas of interest – such as drug-linker technology platforms, orally available biologics and others.