Inactive Total Small Business Set-Aside (FAR 19.5)

STATEMENT OF WORK (SERVICES) Pharmaceutics / Formulation / Chemistry Manufacturing Control Consulting Services Background Information and Objective The NIH is the nation’s leading medical research age... STATEMENT OF WORK (SERVICES) Pharmaceutics / Formulation / Chemistry Manufacturing Control Consulting Services Background Information and Objective The NIH is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people’s health and save lives. More than 25 million Americans suffer from chronic pain, a highly debilitating medical condition that is complex and lacks effective treatments. In recent decades, there has been an overreliance on opioids for chronic pain despite their poor ability to improve function. This contributed to a significant and alarming epidemic of opioid overdose deaths and addictions. Innovative scientific solutions to develop alternative treatment options for pain are thus critically needed. As part of the mission of the Helping to End Addiction Long-term (HEAL) Initiative, NINDS is working with other NIH Institutes and Centers to encourage the translation of basic research into new non-addictive pain treatments. This Initiative is intended to create a foundation to initiate the optimization and development of pain therapeutics and catalyze the development of partnerships between the academic and industrial sectors so that translational research in pain can flourish as a cooperative, iterative process leading to safe, effective, and non-addictive treatments for pain. Launched in April 2018, the NIH HEAL Initiative is an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. The Initiative advances research to reduce the risks of opioid use and misuse and improve pain management, thereby reducing reliance on opioids. NINDS is the lead Institute for pain research at NIH and leads the Executive Committee of the NIH Pain Consortium, which includes 23 Institutes and Centers. The NIH Pain Consortium’s mission includes improving the treatment of a variety of pain conditions. NINDS will focus efforts in the NIH HEAL Initiative in developing non-addictive pain treatments that may displace the need for opioids, and importantly, serve as effective treatments for acute and chronic pain conditions for which opioids are not effective. This work will be informed by partners from the government, industry, academia, and patients suffering from pain. The HEAL program will support preclinical optimization and development of safe, effective, and non-addictive small molecule and biologic therapeutics to treat pain. The goal of the program is to accelerate promising small molecule and biologic hits/leads towards clinical trials. The HEAL program will provide neuroscience researchers with funding and access to a full range of industry-style drug development services and expertise. The program is intended for projects requiring medicinal chemistry optimization and contract research organization (CRO) support through Phase I clinical testing. Each project is directed by a Lead Development Team (LDT) composed of the principal investigator (PI), industry consultants hired by NIH, and NIH staff. This team maps out a research strategy, including milestones, and oversees implementation by CROs. Bioactivity and efficacy studies are funded through an award to the PI; other research services can be provided without cost to the PI through NIH contracts. Purpose/Statement of Need The purpose of this solicitation is to acquire consulting services and technical recommendations in the areas of Pharmaceutics/Formulation/Chemistry Manufacturing Control (CMC). These services will support the NINDS’ HEAL Program and other NIH neuroscience-focused drug discovery and development programs. These services support the NIH HEAL Initiative’s aims to optimize non-addictive Therapies (Small Molecules and Biologics) to treat Pain. General Requirements Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government, as needed, to perform the Statement of Work (SOW). The Contractor shall provide this support while serving on NIH HEAL Lead Development Teams. Lead Development Teams (LDT) 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. The Contractor is expected to provide support services in a collaborative way. Lead Development Teams 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. Specific Requirements The Contractor shall provide consulting support services to the NIH HEAL program as follows: Pharmaceutics / Formulation / Chemistry Manufacturing Control (CMC) Pharmaceutics / Formulation/ CMC consultants will be expected to provide senior-level Pharmaceutics / Formulation/ CMC expertise and contribute feedback and guidance on projects to the NIH and to LDT members through conference calls and by email. The role of the Pharmaceutics / Formulation/ CMC consultant may include but is not limited to the following responsibilities and tasks: 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 that 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 Lead Development Team discussions via telephone and email regarding assigned drug metabolism and pharmacokinetics efforts. Level of Effort The required level of effort will vary depending on the quantity and complexity of the HEAL projects at any given time. It is anticipated that a minimum of 20 hours of consulting services will be required annually. A Not to Exceed (NTE) amount of up to 780 optional hours shall be exercised if needed, in accordance with FAR Clause 52.217-7 Option for Increased Quantity-Separately Priced Line Item. Government Furnished Information and Property No Government furnished property will be provided. Project data will be stored by NINDS. Project-related data required for performance of services will be provided to Contractor by NINDS on each occasion that consulting is requested. All data provided to the Contractor must be treated as confidential and not disclosed to any third party. Key Personnel The Contractor staff providing consulting services for this requirement shall be considered Key Personnel. Key Personnel requirements are as follows: Key Personnel - General Requirements Consultants must have extensive experience in managing, or being a senior leader in, drug discovery projects in the biopharmaceutical industry. Experience with drug discovery for nervous system conditions is preferred. Consultants must be able to work in a cross-functional team environment and manage competing priorities. Consultants must have strong interpersonal skills, attention to detail, excellent organizational, writing, communication, presentation, and documentation skills, as well as computer and software literacy. Consultants must have experience working with multi-disciplinary teams at a senior level in the biopharmaceutical industry, especially teams with members from outside organizations and members at various management levels. Must participate actively in LDT discussions. Must possess computer and software literacy. Key Personnel –Education and Work Experience Requirements A Ph.D. in a life or physical science discipline is required. A minimum of 15 years of experience in CMC activities. Experience in executing and managing drug development tasks, particularly for nervous system conditions. A track record of advancing projects into drug development. Measures of success include patents, Investigational New Drug (IND) applications, publications, and drugs brought to market. Experience in identifying and anticipating problems early in a project, overcoming technical difficulties, and making strategic decisions that make wise use of limited resources (including terminating projects that appear unlikely to succeed). Expertise leading CMC efforts performed by contract research organizations and managing drug project portfolios. Experience in small molecule and/or biologic therapeutics for pain relief is preferred. Key Personnel will be subject to the Health and Human Services Acquisition Regulation (HHSAR) Clause 352.237-75 Key Personnel as follows: The key personnel specified in the resultant contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract. If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days’ notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties. Travel The consultant may be required to travel within the contiguous United States to provide the services described in this statement of work. Travel reimbursement will be provided for such required travel. All travel arrangements must be made in accordance with Federal Travel Regulations and must be approved by the Contracting Officer and authorized by the Contracting Officer’s Representative prior to being finalized or invoiced. A Not to Exceed (NTE) amount of $1,500 annually for travel shall be exercised if needed, using FAR Clause 52.217-7 Option for Increased Quantity-Separately Priced Line Item. Contracting Officer approved and Contracting Officer’s Representative-authorized travel shall not exceed $1,500.00 annually. Approximately 8 hours of travel time are anticipated for this requirement. Please note that travel time may not be billed to the Government, in accordance with the Federal Travel Regulation. Data Rights The National Institute of Neurological Disorders and Stroke shall have unlimited rights to, and ownership of all deliverables provided for this requirement, including reports, analyses, recommendations, and all other deliverables, including those required as a result of modification of the governing contract. The definition of “unlimited rights” is contained in Federal Acquisition Regulation (FAR) 27.401, Definitions. FAR clause 52.227-14, Rights in Data-General, shall be incorporated by reference into any contract/order resulting from this solicitation. Intellectual Property Key personnel who contribute to the creation of new intellectual property will be named as inventors in accordance with U.S. prevailing patent law. Accordingly, consultants must complete negotiations with the principal investigator’s institution regarding assignment of rights and royalty distributions prior to advising on any activities. The key personnel shall provide copies of all existing intellectual property agreements to the NIH COR, for documentation purposes. Section 508 Compliance Section 508 of the Rehabilitation Act of 1973 requires that Federal agencies’ electronic and information technology (EIT) is accessible to people with disabilities. The FAR Final Rule on Section 508 (EIT Accessibility) can be found at https://www.section508.gov/manage/laws-and-policies. To provide services/support for this requirement, the Contractor must agree in writing to comply with the requirements of Section 508 or cite a justifiable reason for an exception. Non-Personal Services Statement Contractors performing services for this requirement will be controlled, directed, and supervised at all times by management personnel of the Contractor, if applicable. Actions of the Contractor may not be interpreted or implemented in any manner that results in any Contractor or Contractor’s agent creating or modifying Federal policy, obligating the appropriated funds of the U.S. Government, overseeing the work of Federal employees, providing direct personal services to any Federal employee, or otherwise violating the prohibitions set forth in Parts 7.5 and 37.1 of the Federal Acquisition Regulations (FAR). Confidentiality of Information Confidential Information means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization. Confidential Information or records shall not be disclosed by the Contractor without written authorization from the Contracting Officer. Whenever the Contractor is uncertain with regard to the confidentiality of, or property interest in, information as related to this requirement, the Contractor should consult with the Contracting Officer prior to any release, disclosure, dissemination, or publication. Collaboration Requirements It is required that all contractors involved with the NIH community work collaboratively with federal staff and other contractors towards the NIH mission and other affected organizations and follow the direction of the Contracting Officer’s Representative (COR), and/or the designated Federal Project Manager(s)/Lead(s). This collaboration includes day-to-day activities, support, development, knowledge transfer, and the creation and sharing of documentation when required. Period of Performance The required period of performance is a one-year base period, which shall start and end as specified in the contract/order, immediately followed by two (2), subsequent, one-year option periods. Place of Performance The primary place of performance shall be Contractor worksite. Conference calls and email shall be the primary mode of communication; however, the Contractor may be required to work at Government facilities or facilities of principal investigators, on an as-needed basis. Contract Type Labor-Hour Contract with Options to Extend the Term of the Contract and Options for Increased Quantity. Invoicing shall be in accordance with FAR Clause 52.212-4(g) and Attachment #3 – Invoice Submission Instructions. Payment of invoices shall be made via Electronic Funds Transfer (EFT). *Please see attachment "CSS_Pharmaceutics-Formulation-CMC" for additional information.*