The Drug Development Pathway
See how we can support your program in the field of cancer therapeutics - drugs and devices
Jyotsna Fuloria MD
Preclinical
Build the safety and efficacy evidence needed before human studies
-non clinical study planning
-safety and toxicology strategy
-IND enabling packet review
Phase 1
First in human studies to evaluate safety, tolerability and dosing
Site and CRO selection
Safety monitoring plans
Phase 2
Explore efficacy and define dose in the target patient population
Endpoint and population strategy
Adaptive design options
Go-no go decision support
Phase 3
Confirm safety and efficacy in large pivotal studies
Pivotal trial design
Study oversight and quality
Statistical Analysis Planning
Approval
Compile and submit the evidence for regulatory review and launch
Submission strategy and review
Agency meeting preparation
Post marketing planning