Mountaineer Bio
The journey of discovering, developing, and commercializing a new medicine is a long and sometimes arduous one. Mountaineer Bio LLC helps sponsors navigate the challenging terrain associated with advancing novel treatments, primarily for infectious diseases and immunological disorders.
Core Specialty Services
Mountaineer Bio provides specialty services supporting discovery, development, and life cycle management of treatments for infectious diseases and immunologic disorders.
Translational Research
- Integrated, strategic approach to supporting Investigational New Drug Applications (IND)/Clinical Trial Authorizations (CTA) to New Drug Application (NDA) or Biological Licensing Application (BLA)
- Study design and oversight of in vitro and preclinical efficacy models
- Novel endpoints, biomarkers, and companion diagnostics in early and late phase clinical trials
- Contract Research Laboratory/Organization (CRL/CRO) selection and study design
- Engagement with funding agencies
Business Strategy
- Target Product Profile (TPP) and Asset Product Profile (AAP)
- Development and optimization of R&D organization and governance processes
- Due Diligence Reviews
- Scientific engagement with Medical Affairs and Commercial organizations to augment Life Cycle Management
Authorship, Data Interpretation & Integration
- Nonclinical Pharmacology and Clinical Efficacy sections of INDs, CTAs, Clinical Investigator Brochures (CIBs), NDAs, and BLAs
- Response to Regulatory Authorities
- Primary research manuscripts
Mountaineer Bio will provide other types of project support as needed.