PHARMACEUTICS/FORMULATION/CMC CONSULTING SERVICES FOR NINDS HEAL PROGRAM

承包商应以合作方式提供药剂学/制剂/CMC咨询服务

The Contractor shall provide Pharmaceutics/Formulation/CMC consulting services in a collaborative manner to the NIH HEAL Program and to other NIH neuroscience-focused drug discovery and development programs while serving on HEAL Lead Development Teams (LDT). LDTs meet for approximately two hours every one to two weeks via teleconference and each LDT project may require between three and ten hours weekly, inclusive of meeting and preparation time. Lead Development Teams (LDT) to which the Contractor is assigned may work on a number of projects in the exploratory through preclinical safety stages. Some projects may proceed to investigational new drug (IND) and clinical trial stages. The Contractor’s responsibilities and tasks may include but are not limited to the following: • Provide senior level pharmaceutics/formulation/CMC expertise, feedback, and guidance on projects to HEAL Program staff and LDT members through conference calls and email. • Evaluate Pharmaceutics / Formulation / CMC activities for HEAL compounds under development in accordance with US regulatory and International Council of Harmonization for Registration of Pharmaceuticals for Human Use [ICH] guidelines. • Identify and assess regulatory risks for compounds under development and provide CMC guidance to HEAL program and LDTs. • Develop Pharmaceutics / Formulation / CMC strategies which accord with U.S. and international guidelines. • Provide recommendations for drug substance manufacturing, analytical method development, and process development for small molecules. • Provide pharmaceutical sciences expertise in chemical manufacturing, formulation, and product development for small molecules. • Assist in ensuring timely preparation, review, and submission of chemical manufacturing and controls documents to regulatory authorities including FDA, European Medicines Agency (EMA) and other national authorities, to support the conduct of clinical trials and marketing applications. • Provide expertise in activities related to active pharmaceutical ingredient (API) development. • Recommend dose form selection and API development strategies for HEAL efforts. • Develop plans to assist HEAL staff in strategically managing chemical manufacturing and control pharmacokinetic programs which facilitate assay development, exploratory chemistry, lead optimization, formulation activities, investigational new drug (IND) enabling, and clinical studies. • At the request of HEAL staff, accompany NIH staff or visit Contract Research Organizations (CRO) under contract with HEAL, inspect CRO facilities, and discuss appropriateness of CRO proposed methodology. Submit trip reports to HEAL staff. • Assist HEAL staff in designing investigative chemical manufacturing and controls pharmacokinetics studies, including study strategy and experimental design. Provide advice regarding recommended study milestones and prepare milestone reports as needed. • Facilitate LDT discussions via telephone and email regarding assigned drug metabolism and pharmacokinetics efforts. This study is part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to understand the basis of pain and enhance clinical pain management. It’s part of the program that establishes novel treatment options for a variety of pain conditions to improve quality of life and reduce opioid dependency. The program studies a broad range of pain conditions, including chronic overlapping pain conditions, chronic musculoskeletal pain, perioperative pain, and knee osteoarthritis.