IN VITRO STRATEGIES LIMITED LIABILITY COMPANY:1198212 [16-014035]IGF::CL::IGF

In Vitro Strategies, Llc, Flemington NJ

Investigators

Abstract

Consultants hired under this requirement will not only make significant contributions to promising drug discovery and development projects that have been selected through a rigorous peer-review process, they will also help shape an innovative, high-profile program that may serve as a model for future NIH drug discovery efforts. Contract consultants will be expected to provide feedback and guidance on programs and projects to the NIH and to BPN LDT members through conference calls and by email. Consultants may serve on an ad hoc basis or as members of LDTs. Consultants will be expected to offer input on project milestones, development strategy, study design, and data interpretation. Specific consulting responsibilities will depend on the expertise of the individual consultant and the needs of individual projects and programs. The BPN currently has projects in the exploratory through preclinical safety stages. Some projects will proceed to the Investigational New Drug (IND) and clinical trial stages. Project continuation will depend on the achievement of project-specific milestones and portfolio management. Since 2011, fifteen projects have entered the BPN, and five projects remain active. New projects are reviewed twice per year and the highest scoring projects may be incorporated into the program. General Requirements Consultants may serve on BPN LDTs, which require a regular time commitment of 3-10 hours per week, including meeting and preparation time. Each LDT meets for approximately 2 hours every 1-2 weeks by teleconference. Consultants may be asked to serve as co-chairs of LDTs. A consultant serving as an LDT co-chair shall facilitate LDT discussions, work with an NIH project manager by email and telephone to maintain and communicate the overall project strategy to other LDT members, and advise the PI on the preparation of milestone reports. Co-chairs for LDTs are selected based on breadth of expertise and previous experience serving in a comparable role. A teleconference call with all consultants is held once or twice per month to discuss programmatic issues of broad interest. Specific Discipline Requirements 1. Bioactivity Assay Bioactivity Assay consultants may be required to evaluate bioactivity assays and recommend strategies and experiments to optimize and/or validate the assays for use in a medicinal chemistry campaign. Bioactivity Assay consultants may be asked to assist in the establishment of milestones related to assay optimization or validation. The NIH may seek guidance from consultants on the design and interpretation of commonly used in vitro assays, such as biochemical and cell-based assays. Specific consulting responsibilities will depend on the expertise of the individual consultant and the needs of individual projects. Assay-related consultation services may be required on an ad hoc basis or on LDTs. The role of the Bioactivity Assay consultant may include but is not limited to the following responsibilities and tasks: ? In partnership with other consultants, contractors, and NIH staff, advise, strategically plan, and manage programs to facilitate lead optimization, IND-enabling studies, and clinical studies. ? Serve as a resource to LDT for assay requirements and logistics to conduct drug development activities for small molecule compounds from the preclinical stage through to the initial clinical stage ? Serve as the assay expert in order to identify potential developmental challenges and suggest strategies to address these challenges. ? Collaborate on design of investigative studies in support of development compounds. 2. Drug Metabolism and Pharmacokinetics Drug Metabolism and Pharmacokinetics (DMPK) consultants may be required to evaluate PK study protocols and data, assist with study design, and advise NIH staff on the establishment of milestones related to DMPK. Specific consulting responsibilities will depend on the expertise of the individual consultant and the needs of individual projects. DMPK-related consultation services may be required on an ad hoc basis or on LDTs. The role of the Drug Metabolism and Pharmacokinetics consultant may include but is not limited to the following responsibilities and tasks: ? In partnership with other consultants, contractors, and the NIH staff, advise, strategically plan, and manage pharmacokinetic (PK) programs to facilitate assay development, exploratory chemistry, lead optimization, formulation activities, IND enabling, and clinical studies. ? Serve as the PK expert in order to identify potential drug discovery and development challenges such as lead identification and lead development and suggest strategies to address these challenges. ? Collaborate on design of investigative PK studies, PK/PD strategy, experimental design, data analysis and interpretation for discovery and translational projects in support of NIH drug discovery and development projects.