Notice ID 75N95024Q00099
Description
This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations.
The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition.
Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice.
This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only.
Background:
The National Institutes of Health (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 apply that knowledge to enhance health, lengthen life, reduce illness and disability, and conduct, support, and make medical discoveries that improve people’s health and save lives. The NINDS is an institute within the NIH that conducts research into the causes, treatment, and prevention of neurological disorders and stroke. The NINDS mission is to seek fundamental knowledge about the brain and nervous system and use that knowledge to reduce the burden of neurological disease.
The NINDS has a need for biological therapeutics development subject matter expert (SME) consultants to provide technical recommendations and advice that will support the translational development of novel therapeutics (Biologics) for NIH drug discovery and development programs. The support included in this contract will cover all aspects of drug discovery and development through the Phase 1 clinical trial, including but not limited to chemistry, manufacturing, and controls (CMC), assay development, pharmacokinetics and pharmacodynamics (PK/PD), absorption, distribution, metabolism, and excretion (ADME), toxicology, regulatory affairs, regulatory operations, medical writing, biostatistics, and quality assurance/quality control (QA/QC), and first-in-human trial planning and design. The NINDS is seeking vendors who can supply a broad array of Biologics subject matter experts, including all modalities and cell and gene therapies.
Purpose and Objectives: The purpose of this requirement is to acquire high-level subject matter expert (SME) support for translational product development at the National Institute of Neurological Disorders and Stroke (NINDS). This requirement provides support that is critical to the broad range of NINDS translational product development activities that are in-process, planned, and evolving.
Specific requirements:
The NINDS has regular needs for expert consultants in specific areas as different projects join the NINDS product discovery and development pipeline. Programs supported by these experts include all NINDS Intramural programs, NINDS Extramural programs, and trans-NIH efforts such as Helping End Addiction Long-Term (HEAL), Brain Research Through Advancing Innovative Neurotechnology (BRAIN), Blueprint Neurotherapeutics (BPN) Small Molecules, BPN Biologics, and Ultra-rare Gene-based Therapy (URGenT).
The Contractor shall provide this support on an ad hoc basis or while serving on NIH Biologics Lead Development Teams (LDTs) or URGENT Multi-Disciplinary Project Teams (MPTs) which include both SME consultants and NIH staff. These teams will map out a product development and clinical evaluation research strategy, including milestones, and oversee manufacturing and nonclinical study services by CROs.
SME consultants will be expected to provide feedback and guidance on project milestones, development strategy, study design, and data interpretation through in-person meetings, conference calls, and email. Specific consulting responsibilities will depend on the expertise of the individual consultant and the needs of individual biologics projects and programs. Consultants may be involved in multiple projects.
SMEs will be required on a part-time basis; hours will vary depending on the needs of the projects to which they are assigned. The NIH estimates 20-405 hours per year per SME.
The broad areas requiring SMEs include, but are not limited to, chemistry, controls, and manufacturing (CMC), pharmacokinetics/pharmacodynamics (PK/PD), absorption, distribution, metabolism, and excretion (ADME), toxicology, assay development, regulatory affairs, medical writing, biostatistics, quality assurance, and first-in-human study planning and design. These areas of expertise can be in all Biologics modalities and cell and gene therapy. Consultants in all areas are expected to:
- Serve as the expert in their area to identify potential product development challenges and suggest strategies to address these challenges, provide expert advice in their area of expertise on study designs and approaches for product development, serve as a resource for requirements in their area of expertise (e.g., requirements for bioassay development, characterization of quality attributes for release testing, etc), assist in developing endpoints and milestones for projects, provide expert advice on necessary activities from the preclinical stage through the initial clinical stage (including medical writing and regulatory submission requirements), provide feedback on the potential tractability of a proposed product in the market.
- Review and provide feedback on methods, reports, regulatory filings, milestones, study protocols, standard operating procedures, statistical analysis plans, statistical analysis results, and site audits in their area of expertise.
- Collaborate in designing investigative studies in support of therapeutics development projects, including manufacturing and preclinical testing studies, collaborate in designing investigative new drug (IND)-enabling experiments, develop or collaborate in developing regulatory submissions and materials for regulatory agency meetings, prepare for and run regulatory agency meetings, develop statistical analysis plans, and develop and explain statistical analysis protocols and contingencies.
- Assist in analyzing, interpreting, and evaluating data in their area of expertise for quality assurance checks, deviation assessments, and study results. These evaluations may be written or communicated in meetings.
- Accompany NIH staff in visiting contract research organizations (CROs) and contract manufacturing organizations (CMOs) under contract to the NIH. Assist in inspecting facilities and discussing appropriateness of facilities and proposed methodology.
- In partnership with other consultants, contractors, and the NIH staff, advise, strategically plan, and manage preclinical evaluation and safety testing, and IND submission and provide strategic guidance for the continued development and improvement of the NIH therapeutic development programs.
- Facilitate discussions at all meetings and via email related to their area of expertise.
All SMEs are expected to meet the following criteria and demonstrate how they meet these criteria:
Knowledge of drug discovery and development process.
- Demonstrated senior-level oversight of research and development efforts for therapeutic products
- Broad experience across the entire biologics discovery and development process is especially desired.
- Have managed a portfolio of comprehensive, milestone-driven pre-clinical drug development biologics-based therapeutics projects; planned, organized and directed inter-disciplinary drug research or development team efforts; developed policies, program directions, and procedures surrounding the administration of drug research programs.
- Managed milestone-driven research and development projects in the area of biologics-based therapeutics, which require well-defined goals and objectives achieved with greatest efficiency. Developed and implemented quantitative and qualitative reviews of milestones to determine if they appropriately translated into accelerated progress of therapeutic candidates toward Investigational New Drug (IND) applications to the FDA, and provided clear indicators of a project’s continued success or emergent difficulties.
- Managed a portfolio of preclinical drug discovery and development projects (e.g., cooperative agreements) in the area of biologics-based therapeutics (including but not limited to e.g. peptides, proteins, antibodies, oligonucleotides, gene and cell therapies) with responsibility for all aspects of administration (i.e., organizing and managing). Secured and implemented scientific advice from senior leaders and colleagues and applied drug discovery and development expertise.
Ability to analyze and evaluate milestones to manage a drug development program.
- Developed project plans and associated communications documents. Managed the day-to-day activities of assigned Programs and Projects; directed and managed project development from beginning to end; and estimated the resources needed to achieve Program and Project goals. Managed key relationships internal and external to an organization.
- Reviewed, analyzed, and evaluated pre-clinical drug development data
- Provided an in-depth review, analysis, evaluation, and recommendation of milestones at the beginning of a funding year or funding cycle (depending on the Program or Project) to support a determination as to whether a project should be continued. This in-depth review included assessment and recommendations to ensure that individual projects were competitively evaluated against the broader research landscape.
Skill in applying Project Management tools to manage drug discovery and development programs.
- Ensured that projects were managed and executed in line with the rules and governance of an organization and cognizant regulating bodies.
- Prepared a variety of routine and special reports as requested by senior management. Researched and prepared reports, briefing materials, and other compilations of Program and Project activities and policies for use in policy development, program planning, evaluation and implementation, and presentation to senior advisors. Researched and wrote scientific review presentations, position papers, talking point papers, and briefing materials for senior staff as requested.
- Has a track-record of successfully building and leading product development teams
- Defined project objectives; planned, executed, and finalized projects according to strict deadlines and within budget; oversaw quality control, assembled data, and managed program budgets.
Ability to communicate clearly, logically and persuasively on complex scientific issues.
- Has attended and presented drug research findings at conferences and meetings with high ranking scientists in academia, industry, or government.
- Developed and delivered progress reports, proposals, requirements documentation, and presentations.
- Has built, developed, and grown relationships vital to the success of a Program or Project to establish worldwide collaborative relationships among government, academia, and industry that are focused on the search for therapeutic interventions and treatments for neurological disorders.
- Has experience in team leadership, consulting, or service on strategic and advisory boards .
- A significant track-record of scientific accomplishment as evidenced by publications and/or contributions to the development of marketed products.
- Must be able to work in a virtual, cross-functional team environment and manage competing priorities.
- Must participate actively in project team discussions.
- Must have strong interpersonal skills, attention to detail, excellent organizational, writing, communication, presentation, and documentation skills as well as computer and software literacy.
- Must have experience working with multi-disciplinary teams at a senior level preferably in the biopharmaceutical industry, especially teams with members from outside organizations and members at various management levels.
Anticipated period of performance:
Base Period: March 15, 2024 – March 14, 2025
Option Period One: March 15, 2025 – March 14, 2026
Option Period Two: March 15, 2026 – March 14, 2027
Capability statement /information sought.
Companies that believe they possess the capabilities to provide the required services should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements separately. Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Capability statements must also include the Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses.
Interested companies are required to identify their type of business, applicable North American Industry Classification System (NAICS) Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number.
One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2” x 11” paper size, with 1” top, bottom, left and right margins, and with single or double spacing.
The information submitted must be in and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required.
The response is limited to ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested.
All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer. Facsimile responses are NOT accepted.
The response must be submitted to Evan Feely, Contract Specialist, at evan.feely@nih.gov.
The response must be received on or before January 25, 2024 at 5:00 pm Eastern Time.
“Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.
Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a presolicitation synopsis and solicitation may be published in www.sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation.
Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).”
