DNAsolve...making better drugs
You know your product best, but DNAsolve can help you get and keep your programs off the ground by participating in your product development program as part of your management or project team, or both.
Contact us by phone (832-419-3785) or email to learn the ways that we may be able to assist you in your product development programs.
SERVICES WE PROVIDE:
- Strategic planning and program and project design services
- Design and optimization of viral vectors to maximize protein production per cell
- Engineering retrovirus, lentivirus, Adenovirus, vaccinia etc. for clinical use
- Integrated Project team development and leadership
- Planning, content and participation in meetings with the US FDA, including:
- pre-pre IND and pre-IND meetings
- End-of-Phase 2 meetings
- Pre-NDA and pre-BLA meetings
- Other types of ad hoc regulatory and scientific advice and review meetings
- Biomarker program development
- Identification of pharmacodynamic correlates of efficacy
- Identification of prospective versus predictive biomarkers
- Correlation between molecular, histological and clinical biomarkers
- Selection of targeted patient populations to minimize study size
- Toxicology, pharmacokinetic and animal tumor models
- Strategic planning and customized study designs
- Selection of GLP contract organizations and study placement
- Data review and interpretation
- Study report preparation, review and finalization
- Preparation, review and finalization of IND and NDA/BLA summary sections
- Coordination of CMC activities, including process development, scale-up, analytical sciences and cGMP manufacturing with the nonclinical and clinical programs
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