Toxicology Consulting Services

                                                                         COMBINED SYNOPSIS / SOLICITATION                                                                                            COMPETITIVESolicitation Number: NIH-NINDS-CSS-21-005337Project Title: Toxicology Consulting ServicesThis is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice.  This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.The solicitation number is NIH-NINDS-CSS-21-005337 and the solicitation is issued as a request for quote (RFQ).This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures; FAR Subpart 13.5—Simplified Procedures for Certain Commercial Items; and FAR Part 12—Acquisition

of Commercial Items, and is expected to exceed the simplified acquisition threshold.The National Institutes of Health (NIH) intends to make 1-2 awards resulting from this Combined Synopsis/Solicitation (solicitation). However, the NIH reserves the right to make a single award, multiple awards, or no award at all as a result of this Combined Synopsis/Solicitation.This solicitation and the incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2021-06, dated 06/10/2021.The associated NAICS code 541990 “All Other Professional, Scientific and Technical Services” has a Size Standard of $16.5 million.  Set Aside StatusThis acquisition resulting from this solicitation is 100% set aside for small businesses.                                                                                                                                                                                      STATEMENT OF WORK (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 NINDS’ HEAL program will support the NIH HEAL Initiative in 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 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 toxicology optimization and contract research organization (CRO) support through Phase I clinical testing.Each project in the NINDS’ HEAL Program is directed by a Lead Development Team (LDT) composed of the principal investigator (PI), industry consultants, 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 Principal Investigator (PI) through NIH contracts. Purpose/Statement of NeedThe purpose of this solicitation is to acquire consulting services and technical recommendations in the area of Toxicology. These services will support the NINDS’ HEAL Program and other NIH neuroscience-focused drug discovery and development programs in the area of Toxicology. 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.The Contractor shall provide toxicology consulting services to the NIH HEAL Program and to other NIH neuroscience-focused drug discovery and development programs. Consulting services include: Providing input on project milestones, target product profiles, and testing funnels.Providing feedback on chemical structures and processes proposed by a chemistry service contractor for each round of Structure-Activity Relationship (SAR).Evaluating SAR data as directed by the Contracting Officer’s Representative (COR).Toxicology Contractor(s) may be asked to evaluate the potential tractability (including surrounding IP space) of a chemical structure for toxicology. Specific consulting responsibilities will depend on the expertise of the Contractor and the needs of individual projects.In partnership with other consultants, contractors, and the NIH staff advise, strategically plan and manage toxicology programs to facilitate exploratory chemistry, hit-to-lead, lead optimization, IND enabling, and clinical studies.Serving as the toxicology expert in identifying potential drug discovery and development challenges, and suggesting strategies to address these challenges.Collaborating on design of investigative studies in support of NIH drug discovery and development projects.As required by the Contracting Officer’s Representative (COR), accompanying NIH staff on visits to Contract Research Organizations (CRO) under contract to the HEAL Program, inspecting facilities, discussing appropriateness of CRO proposed methodology, and submitting trip reports to HEAL program staff.Facilitating Lead Development Team discussions via telephone and email regarding assigned toxicology efforts.Level of Effort The required level of effort will vary depending on the quantity and complexity of the HEAL projects.  It is anticipated that an estimated minimum of 20 hours of toxicology consulting services, as described above, will be required annually. A Not to Exceed (NTE) amount of up to 780 optional hours will be exercised if needed, in accordance with FAR Clause 52.217-7 Option for Increased Quantity-Separately Priced Line Item.Government Furnished Information and PropertyNo Government furnished property will be provided.  Project data will be stored by NINDS. Project-related data required for the performance of services will be provided to the 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 PersonnelThe Contractor staff providing consulting services for this requirement shall be considered Key Personnel.  Key Personnel requirements are as follows: Key Personnel - General Requirements:  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.Must have experience working with multi-disciplinary teams at a senior level in the biopharmaceutical industry, especially with teams from outside organizations and team members at various management levels.Must have experience participating actively in LDT discussions.Must be comfortable working in a cross-functional team environment and manage competing priorities.Must have strong interpersonal skills, including attention to detail, organizational, writing, communication, presentation, and documentation skills.Must possess computer and software literacy.Key Personnel – Toxicology Education and Work Experience Requirements:Contractor must have a PhD degree in pharmaceutical toxicology or in a pharmacology-related, scientific discipline.Must have a minimum of fifteen (15) years of toxicology experience.Must have experience executing and managing drug development tasks, particularly for nervous system conditions.Must have 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.Must have 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).Must have expertise leading chemistry efforts performed by contract research organizations and managing drug project portfolios.Experience in small molecule and/or biologics 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 this 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.TravelThe key personnel may be required to travel within the contiguous United States to provide the services described above. Allowable travel costs for such required travel will be reimbursed.All travel arrangements must be made in accordance with the Federal Travel Regulations in effect at the time of travel, approved by the Contracting Officer, and authorized by the COR prior to being finalized and invoiced.A Not to Exceed (NTE) annual amount of up to $1,200 for travel shall be exercised if needed, in accordance with FAR Clause 52.217-7 Option for Increased Quantity-Separately Priced Line Item.Approximately eight (8) hours of travel time are anticipated to be needed for this requirement. Please note that travel time may not be billed to the Government per 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 PropertyKey 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 ComplianceSection 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 StatementContractor(s) 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 InformationConfidential 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 RequirementsIt 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 PerformanceThe 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 PerformanceThe primary place of performance shall be Contractor's site.  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 TypeLabor-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 "Amended CSS_Toxicology Consulting Services" for additional information.