Sources Sought_Biologics.pdf

SMALL BUSINESS SOURCES SOUGHT NOTICE

1. Solicitation Number: NIH-NINDS-SBSSN-25-000977

2. Title: Biological Therapeutics Product Development Subject Matter Expert

Consultants to Support the Development of Therapeutic Biotechnology Products (Biologics)

3. Classification Code/Title: R499 – Support-Professional: Other

4. NAICS Code/Title/Size Standard: 541690 – Other Scientific and Technical

Consulting Services, $16.5 million

5. 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 the availability and capability of all qualified small business sources to perform a potential requirement.

This notice is issued to help determine the availability of qualified small business sources 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.

This requirement supports the NIH Biologics development projects under the NIH Blueprint Neurotherapeutics Network Biologics (BPN-Biologics) program, the NINDS Ultra-Rare Gene Therapy (URGenT) program, the Helping to End Addiction Long-term Pain Therapeutics Development Program (HEAL-PTDP), and other extramural or intramural NIH drug discovery and development programs.

The NIH Blueprint Neurotherapeutics (BPN) network is a consortium comprised of the NIH Office of the Director and 14 NIH Institutes and Centers (ICs) that support neuroscience research. BPN provides neuroscience researchers with funding and access to a full range of industry-style drug development services and expertise.

The program, originally focused on small molecules, was launched for projects requiring medicinal chemistry optimization, PK, PD, drug manufacturing and formulation, investigational new drug (IND)-enabling toxicological studies support through Phase I clinical testing and it is now being expanded to include the development of biological therapeutics for neurological diseases (BPN- Biologics). (https://neuroscienceblueprint.nih.gov/neurotherapeutics/bpn-biologics).

The URGenT program has been established by the NINDS to support the development and clinical evaluation of therapeutics to address ultra-rare genetically based neurological disorders. The network will provide neuroscience researchers with funding and access to a full range of industry-style biologics development services and expertise and in the future may expand to include other NIH institutes. The program is intended to rapidly advance patient-customized therapeutics through manufacturing, preclinical toxicology testing, and evaluation in Phase 1 clinical studies.

The HEAL-PTDP program is a multi-IC initiative that has been established by the NIH to support preclinical optimization and development of safe, effective, and non- addictive biologic therapeutics to treat pain. The goal of the program is to accelerate the optimization and development of promising small molecule and biologic hits/leads to Phase I clinical trials and readiness for the Early Phase Pain Investigation Clinical Network (EPPIC-Net) or other Phase II clinical studies. Applicants must have a promising biologic hit/lead, robust biological rationale for the intended approach, and identified assays for optimization of the agent. The scope of this program includes optimization and early development activities, IND- enabling studies, development of a PD/ target engagement biomarker, assembly and filing of an IND application and Phase I clinical testing.

This is a milestone-driven phased cooperative agreement program involving participation of NIH program staff in the development of the project plan and monitoring of research progress.

Additionally, NINDS has two (2) major Intramural Research Divisions with 52 labs that may require Biologics subject matter expertise.

The NINDS intramural divisions include:

1) The Basic Neuroscience Program (BNP), which pursues an understanding of the normal and abnormal structure and activities of the human research system.

2) The Clinical Neuroscience Program (CNP), which applies directly to disease detection, prevention, and treatment.

NINDS assesses and evolves the programs it supports over time, and consultants may be asked to support new Biologics drug discovery and development programs as needed across the period of performance in this contract. In all cases, the program would involve Biologics drug discovery and development to fall under the scope described here.

SMEs will be required on a part-time basis for individual projects and the level-of-effort is estimated at 20-405 hours per SME per year. The NINDS anticipates needing 1-2 vendors with a broad array of subject matter experts available to support active and future Biologics drug discovery and development projects.

Purpose/Objective: 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 that are needed to support NIH biologics programs, including NIH BPN-Biologics, URGenT, and HEAL PTDP.

The Contractor shall provide this support on an ad hoc basis or while serving on NIH Biologics Lead Development Teams (LDTs), 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 Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (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.

Specific 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 that are needed to support NIH biologics programs, including NIH BPN-Biologics, URGenT, HEAL PTDP, and NINDS Intramural labs. The specific consultant SME technical areas are outlined below.

1.1 Subject Matter Expert (SME) Consulting Services

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:

1) 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.

2) 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.

3) 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.

4) 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.

5) 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.

6) 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.

7) 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:

1) Knowledge of drug discovery and development process.

a. Demonstrated senior-level oversight of research and development efforts for therapeutic products

b. Broad experience across the entire biologics discovery and development process is especially desired.

c. 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.

d. 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.

e. 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.

2) Ability to analyze and evaluate milestones to manage a drug development program.

a. 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.

b. Reviewed, analyzed, and evaluated pre-clinical drug development data

c. 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.

3) Skill in applying Project Management tools to manage drug discovery and development programs.

a. Ensured that projects were managed and executed in line with the rules and governance of an organization and cognizant regulating bodies.

b. 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.

c. Has a track-record of successfully building and leading product development teams.

d. Defined project objectives; planned, executed, and finalized projects according to strict deadlines and within budget; oversaw quality control, assembled data, and managed program budgets.

4) Ability to communicate clearly, logically and persuasively on complex scientific issues.

a. Has attended and presented drug research findings at conferences and meetings with high ranking scientists in academia, industry, or government.

b. Developed and delivered progress reports, proposals, requirements documentation, and presentations.

c. 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.

d. Has experience in team leadership, consulting, or service on strategic and advisory boards .

e. A significant track-record of scientific accomplishment as evidenced by publications and/or contributions to the development of marketed products.

f. Must be able to work in a virtual, cross-functional team environment and manage competing priorities.

g. Must participate actively in project team discussions.

h. Must have strong interpersonal skills, attention to detail, excellent organizational, writing, communication, presentation, and documentation skills as well as computer and software literacy.

i. 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.

Education and Specific Work Experience

a) A MS, PhD, or MD in a relevant scientific discipline is preferred. A candidate without a PhD should have equivalent experience.

b) Must have at least 10 years of relevant professional experience.

c) Must have at least 10 years demonstrated experience in product development.

d) Must have at least 10 years of experience in managing or being a senior leader in product development projects in the biopharmaceutical industry.

e) SMEs supporting the URGenT program must also have at least 5 years of experience in supporting rare and/or ultra-rare biologics product development programs, including modalities such as gene therapy and/or oligonucleotides.

f) SMEs supporting BPN-Biologics must have at least 10 years of experience across broad biological therapeutics product development programs, including but not limited to proteins, peptides, antibodies, oligonucleotides, cellular therapy, gene therapy, and/or immunotherapy.

g) Experience with product development for nervous system conditions is preferred but not required.

h) Experience interacting with the FDA or other regulatory authorities preferred.

i) Extensive understanding of FDA or other regulatory agency requirements for

IND submissions and clinical trial execution (and when applicable for ultra-rare diseases) is preferred.

Project Management Plan: Contractors providing consulting services in more than one SME area shall develop and maintain a Project Management Plan to ensure that the Contractor has a well-defined plan in place for overseeing all of its consultant employees assigned to the contract.

The Contractor shall follow the work process flow, methodology, procedures, deliverables, and best practices that conform to the standards dictated by the Project Management Body of Knowledge (PMBOK) Guide, and Project Management Life Cycle defined and published by the Project Management Institute (PMI).

The Project Management Plan shall describe the Contractor’s understanding of its contract management responsibilities and the approach it will use to ensure risks are understood and managed and communicate with stakeholders in a timely manner. The Project Management Plan shall be kept current and updated throughout the contract period of performance and shall address, but is not limited to, team organization and responsibilities.

Capability statement /information sought. Respondents must provide clear and convincing documentation that they are capable of providing the consulting service(s) specified in this notice. This includes their ability to perform the specific requirements listed under the individual Performance Areas as well as their ability to perform under one or multiple Performance Areas.

Respondents must also provide their DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc., pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements.

Respondents must submit their response 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 an outline format that addresses each of the elements of the requirement and the capability statement / information sought paragraphs herein. A cover page and/or an executive summary may be included but are not required.

Responses are limited to a ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested.

Responses must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone numbers, and e-mail addresses.

All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer. Facsimile responses are NOT accepted.

All responses must be submitted to Shayna Simpson, Contract Specialist, via e-mail at shayna.simpson@nih.gov.

All responses must be received on or before the closing date of this notice and reference notice number NIH-NINDS-SBSSN-25-000977.

“Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in a 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 SAM, however, responses to this notice will not be considered adequate responses to a solicitation.

If a solicitation(s) related to this sources sought notice is issued, all offerors must be REGISTERED and have an ACTIVE System for Award Management (www.sam.gov) account at the time an offer/quote is submitted to the Government. All offerors registered in the System for Award Management (www.sam.gov) must be in full compliance with FAR 52.204-13 System for Award Management Maintenance to be eligible to submit an offer/quote. The Government cannot accept proposals/quotes from offerors who do not meet the SAM requirement.

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).”

mailto:shayna.simpson@nih.gov http://www.sam.gov/ http://www.sam.gov/