Support of CMC to IND for Novel First-in-Class Small Molecule Drugs

Case Study

US biotech company requiring integrated program management of outsourced program including drug synthesis, formulation, stability, Investigational New Drug applications (IND)-enabling preclinical studies and writing of First-In-Human (FIH) study for first lead compound and follow up compound
Collaboration with client leadership team in managing internal team dynamics of medical, clinical, PK/PD and chemistry leads
Support for the organization, storage, planning and scheduling of IND
Required short time frame for filing of IND to meet required financial milestones

Integrated project team led by Celerion program director
Assisted the client with planning of drug development program and managed all outsourced studies within and external to Celerion
Weekly teleconferences with the client leadership team to assure alignment with team approach
Regular program team meetings, including monthly on-site meetings
Tracking of required deliverables through rigorous planning to meet milestones
Supported chemistry completion and outsourcing of synthesis to a GMP facility
Audited non-Celerion vendor sites on behalf of client
Reviewed all preclinical study designs and final reports and oversaw the development of bioanalytical assays
Provided regulatory guidance, facilitated PreIND meeting with the FDA, and prepared IND documentation
Coordinated the Scientific Advisory Board meetings

Completed Chemistry and Manufacturing Controls (CMC) and preclinical work and IND submitted within challenging investor-driven timelines
Managed a complex program with numerous vendors, client representatives and external consultants, to ensure program remained on track
Supported the alignment of the operational team and client management enabling the senior management to focus on investor activities following review of IND, FDA allowed initiation of FIH study with patient arm
Exceeded client expectations and began additional program for second generation compound