CONTRACT KICKOFF MEETING AND PROJECT MANAGEMENT PLAN

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The purpose of this requirement is to acquire complex, specialized and strategic services to support National Institutes of Health (NIH) activities. The NIH requires a research organization to support the NIH biologics development projects for the NIH Blueprint Neurotherapeutics Network Biologics (BPN-Biologics) program, the National Institute of Neurological Disorders and Stroke (NINDS) Ultra-Rare Gene Therapy (URGenT) program, the Helping to End Addiction Long-term Pain Therapeutics Development Program (HEAL-PTDP ), as well as other extramural or intramural NIH drug discovery and development programs. This requires highly qualified and experienced personnel capable of providing a full range of specialized, strategic, technical and operational services to deliver the support that is critical to the broad range of NIH biomedical and clinical research activities in-process, planned and unanticipated. The objective of this contract is to support the BPN-Biologics, URGenT, HEAL-PTDP and other NIH programs by providing: A. Manufacturing services including, but not limited to: (1) Technology-transfer of an R&D laboratory scale process from a research facility to the contract manufacturing organization (CMO) (2) Biological therapeutics manufacturing process development (3) Chemistry, manufacturing, and controls (CMC) development (4) Small-scale manufacture, scale-up, and manufacturing under current Good Manufacturing Practice (cGMP) (5) Fill-finish, release testing, validation, stability testing, and other associated tasks (6) CMC study report documentation that will enable regulatory filing and evaluation of biological therapeutics in clinical trials for these NIH programs B. Nonclinical services including, but not limited to: (1) Efficacy testing in in vitro, in vivo or ex vivo models, including modeling neurological disease using patient derived pluripotent stem cells, or in animal models of disease, or in naïve animals, or in ex vivo tissue or small explant cultures (2) Absorption, distribution, metabolism, and elimination (ADME) studies (3) Pharmacokinetic (PK) and pharmacodynamic (PD) characterization (4) Toxicology studies including, but not limited to single-dose and/or repeat dose toxicology studies, and/or reproductive toxicology and/or carcinogenicity studies, and/or neonatal and juvenile toxicology studies (5) Nonclinical study report and documentation that will enable regulatory filing and evaluation of biological therapeutics in clinical trials for these NIH programs.