FRANKLIN ADME CONSULT, LLC:1239158 [19-007544]

NIH RePORTER · NIH · N02 · $45,000 · view on reporter.nih.gov ↗

Abstract

Drug metabolism pharmacokinetics (DMPK) consultants provide senior-level DMPK expertise and contribute feedback and guidance on projects to the National Institutes of Health (NIH) and to lead development team (LDT) members through conference calls and by email. The role of the DMPK consultant may include but is not limited to the following responsibilities and tasks: • Offer input on project milestones, target product profiles, and testing funnels • Evaluate pharmacokinetics study protocols and data to identify potential drug discovery and development challenges. Recommend strategies to address these challenges. • In partnership with other consultants and contractors, develop plans to assist NIH staff in strategically managing pharmacokinetic programs which facilitate assay development, exploratory chemistry, lead optimization, formulation activities, investigational new drug (IND) enabling, and clinical studies. • Assist NIH Blueprint Neurotherapeutics (BPN) staff to design investigative pharmacokinetics studies, including study strategy and experimental design bearing budget constraints in mind. Provide advice regarding recommended study milestones and prepare milestone reports are needed. • Facilitate Lead Development Team discussions via telephone and email regarding assigned drug metabolism and pharmacokinetics efforts. • Analyze and interpret data for pharmacokinetics drug discovery, development, and translational projects. • Accompany NIH staff or visit, at BPN staff request, Contract Research Organizations [CRO] under contract to BPN. Inspect facilities and discuss appropriateness of CRO proposed methodology. Submit trip reports to BPN staff.

Key facts

NIH application ID
10361382
Project number
75N95019P00652-P00003-0-1
Recipient
Principal Investigator
ROBERT FRANKLIN
Activity code
N02
Funding institute
NIH
Fiscal year
2021
Award amount
$45,000
Award type
Project period
2020-09-20 → 2022-09-19