Customized Program Planning for Opening IND Study
Virtual US Biotech Company developing a central nervous system (CNS) – targeted compound completed an initial Single Ascending Dose (SAD) study in the EU with limited preclinical data package and single dose patient study in Asia. Client required integrated program management of outsourced program to address regulatory gaps required for opening their US Investigational New Drug (IND) study designed to support further patient studies.
Integrated project team led by Celerion program director that assisted the client with planning the drug development program and designed/managed all outsourced studies within and external to Celerion, including subcontractor qualification.
Provided regulatory guidance, facilitated PreIND meeting with the FDA, and prepared IND documentation and subsequently coordinated the Scientific Advisory Board meetings.
- In Vitro drug-drug interaction elucidation of parent and metabolite with probes
- Synthesis of deuterated internal standards for parent and metabolite
- Develop and Validate human plasma assays for parent and metabolite
- IND opening food effect study
- Radioisotope tagging of parent compound for use in rat QWBA and human ADME study
- Rat Quantitative Whole Body Autoradiography (QWBA) and mass balance to determine complete human dosimetry
- Human ADME study for parent and metabolite analysis
Completed preclinical work and IND submitted within challenging investor-driven timelines. This involved the management of a complex program with numerous vendors, client representatives and external consultants, to ensure program remained on track:
- Alignment of the operational team and client management enabled the senior management to focus on investor activities following review of IND, resulting in successful initiation of the opening IND healthy normal food effect study
- Successful initial study allowed for Phase II program initiation in patients