Sources Sought Notice.pdf

SMALL BUSINESS SOURCES SOUGHT NOTICE

1. Notice Number: NIH-NINDS-SBSS-75N95025Q00003

2. Title: Biological Therapeutics Product Development Consultant Support Services

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 award a contract. Responses will not be considered as proposals or quotations. 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 for research and information purposes only.

6. 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 National Institute of Neurological Disorders and Stroke (NINDS) is an institute within the NIH that conducts research into the causes, treatments, and preventions 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 chemistry, manufacturing, and controls (CMC) for gene therapies.

NIH Drug Development Programs Involving Biologics

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 (https://neuroscienceblueprint.nih.gov/neurotherapeutics/blueprint-neurotherapeutics-bpn-https://neuroscienceblueprint.nih.gov/neurotherapeutics/blueprint-neurotherapeutics-bpn-network 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, pharmacokinetics (PK), pharmacodynamics (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 (https://www.ninds.nih.gov/Current-Research/Research-Funded- NINDS/Translational-Research/urgent-network) 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 (https://heal.nih.gov/) 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.

The NIH anticipates needing a single consultant during this time. The NIH estimates requiring up to 40 hours of work during the period of performance.

7. 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 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 and HEAL Lead Development Teams (LDTs) and 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 Contract https://neuroscienceblueprint.nih.gov/neurotherapeutics/blueprint-neurotherapeutics-bpn-network https://neuroscienceblueprint.nih.gov/neurotherapeutics/bpn-biologics https://www.ninds.nih.gov/Current-Research/Research-Funded-NINDS/Translational-Research/urgent-network https://www.ninds.nih.gov/Current-Research/Research-Funded-NINDS/Translational-Research/urgent-network https://heal.nih.gov/

Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs).

SME consultants shall 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.

The NIH estimates requiring up to 40 hours of work during the period of performance.

8. Specific Requirements:

The contractor shall provide consulting services in the following Performance Area.

Performance Area 1: Chemistry, manufacturing, and controls (CMC) for gene therapies

Subject matter experts in drug discovery and development for gene therapies focusing on preclinical and early clinical CMC (through Phase I). Consultants shall be expected to provide senior-level expertise gene therapies and contribute feedback and guidance on CMC aspects of projects to the NIH and to LDT members through conference calls and by email.

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 level.

Capability statement /information sought.

Respondents to this Notice must provide clear and convincing documentation demonstrating their capability to provide the consulting service(s) specified in this Notice.

This includes the ability to perform the specific requirements listed above.

Respondents must include the following in their response: respondents’ technical and administrative points of contact, including names, titles, addresses, telephone numbers, e-mail addresses, organization DUNS number, organization name, organization address, organization’s business type (e.g., 8(a), HubZone, veteran-owned, etc.) under NAICS Code 541690, and any other information that may aid in developing or finalizing the acquisition requirements.

The response must address each of the elements in the “Specific Requirements” section (above). A cover page and/or an executive summary may be included but are not required.

Responses may not exceed ten (10) pages. The 10-page limit does not include a cover page and executive summary.

Respondents must submit their response in Microsoft Word or Adobe PDF format using 12-point font, 8-1/2” x 11” paper size, with 1” top, bottom, left and right margins, and with single or double spacing.

All responses to this Notice must be submitted to Shayna Simpson, Contract Specialist, via e-mail at Shayna.simpson@nih.gov. Facsimile responses will not be accepted.

All responses must be received on or before the closing date of this Notice and reference Notice Number NIH-NINDS-SBSS-75N95025Q00003.

“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 the 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. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in SAM; however, responses to this Notice will not be considered as responses to a solicitation or request for quotation.

If a request for quotation related to this Notice is issued, all offerors must be REGISTERED and have an ACTIVE System for Award Management (SAM) (www.sam.gov) account at the time a 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 a quote. The Government cannot accept 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/