Discovery/Medicinal Chemistry
- Medicinal chemistry and organic synthesis support
- Structure based drug design
- Hit to Lead
- Lead Optimization and candidate selection
- Coordination of outsourced pre-IND activities
- Vendor identification and management
- Med Chem optimization of molecules for transdermal delivery using patches or bases
CMC/Manufacturing
- Gap Analysis
- CMC Strategy for Pre-IND through commercial
- ID and qualification of CDMOs and vendors
- Vendor management
- CMC Problem solving
- Focus on API manufacturing
Project Leadership
- Identify lead molecules and programs
- Get your molecule from Lead Optimization to Phase 1
- Development problem solving
- Preparation of scientific papers and posters
Opportunity Assessment
- Prioritizing R and D pipelines
- Opportunity Review
- Market opportunity check on existing programs
- Patent analysis
- In licensing opportunities
Clinical/Regulatory
- Regulatory filing preparation
- FDA meetings
- Clinical Operations Support
- Protocol and IB preparation
- Orphan Drug Applications
- Clinical Study Reports
- Statistical Support (with CGI).
Virtual Company Mentoring
- Advice and guidance on managing a virtual company
- Identification of key skilled consultants
- Identification of academic research labs as collaborators
- Building a virtual research network to support MOA and LO activities