Capabilities
We can help with all aspects of your drug discovery programs; preclinical development; transitioning pre-clinical programs to clinic; early clinical development and proof-of-concept studies.
Small Molecule Drug Discovery
Provide guidance on all phases of drug discovery:
Hit Identification
Hit Evaluation / Expansion
Hit-to-Lead
Lead Optimization
Pre-clinical Development
Clinical Candidate Selection
Manage outsourcing activities at domestic or international CROs:
Identify the right CRO
Price negotiations
Manage all aspects of Chemistry, DMPK, in-vivo pharmacology, etc. activities
Manage collaborations:
Interface with KOLs, academia, and/or partnering companies to ensure information and data flow
Participate in patent-related activities:
Help develop patent strategy
Review patent applications
Write experimental procedures
Participate in business development activities: Evaluate partnering opportunities for in-licensing / out-licensing programs
Review slide decks for partnership opportunities, meetings, and conferences
Provide scientific feedback
Help with presentations:
Review / edit / prepare presentations for conferences / meetings
Provide guidance on presentation skills
Overall program management:
Manage / lead / chair drug discovery programs at all phases
Early Clinical
Development
Help transition pre-clinical programs to the clinic:
Review pre-clinical program, evaluate clinical candidate
Help develop scientific rationale for the study
Assist in writing / review regulatory documents (IND filing, Investigator's Brochure, Protocol, etc.)
Identify clinical sites; engage PIs for the study
Perform site qualification / initiation visits, protocol trainings
Educate the clinical team on key pre-clinical information (toxicology, PK, dose, dosing regimen, etc)
Overall program management:
Analyze / interpret patient data for response, efficacy, adverse events, time on study, etc.
Manage / lead dose escalation / expansion programs through PoC
Chair weekly TCs with PIs and study teams
Coordinate information and data flow between clinical sties and sponsor
Help with presentations:
Review / edit / prepare presentations for conferences / meetings
Provide guidance on presentation skills
Manage collaborations:
Interface with KOLs and/or PIs on study at investigator's meetings, key conferences, committee meetings
Assist the MSL team; participate in booth duties at conferences