BIONAVIGEN CONSULTING SERVICES
Real world drug development experience-based consulting services for biologics (e.g., antibodies, peptides, recombinant proteins, bispecifics, antibody drug conjugates (ADC), oncolytic virus, gene editing and gene delivery) viral, cell and gene therapy), small molecule pharmaceuticals, therapeutic peptides and medical devices.
Discovery and Preclinical Development
- Discovery, target nomination, target safety, pharmacology, development of target product profile
- Nonclinical toxicology and pharmacology consulting (e.g., non-GLP and GLP study design, CRO monitoring, report review, pre-IND and IND support).
- All therapeutic areas, including oncology, cardio-renal-metabolic, respiratory, autoimmune, oncolytic viruses and vaccines
- Special expertise in ADC and immune-oncology drug development
Translational Sciences and Early Clinical Development
- Development of translational medicine enriched Phase I protocol
- Advice on biomarkers and personalized medicine strategy
- System pharmacology, PK-PD modeling and assessment
- First time in human dose selection and phase I protocol development
Regulatory Sciences and Due Diligence
- Guidance on nonclinical and clinical regulatory strategy on all biopharmaceutical products
- Expert advice on orphan drugs designation, break-through therapy, accelerated approval, ANDA and 505(b)(2) submissions
- Conduct scientific and business centric due diligence assessments (on-site and/or electronic) of new drugs and acquisition