Manufacturing and Nonclinical Studies Support for the Development of Therapeutic Biotechnology Products (Biologics) for Neurological related Disorders

Status
Active
Published Date
June 10th, 2024
Response Deadline
July 8th, 2024
Notice Type
Solicitation
Solicitation No.
75N95024R00050

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNATIONAL INSTITUTES OF HEALTH NIDABethesda, MD, 20892, USA

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

PSC

HEALTH R&D SERVICES; HEALTH CARE SERVICES; APPLIED RESEARCH (AN12)

Summary

Presolicitation HEALTH AND HUMAN SERVICES, DEPARTMENT OF is planning to procure Manufacturing and Nonclinical Studies Support for the Development of Therapeutic Biotechnology Products (Biologics) for Neurological related Disorders. This service is typically used to support the translational development of therapeutic biotechnology products for neurological disorders. The procurement will include current Good Manufacturing Practices (cGMP) manufacturing and Good Laboratory Practice (GLP) nonclinical support services. The contractor will be responsible for executing studies, completing study reports, and providing documentation for regulatory filing and evaluation of biological therapeutics in clinical trials. The contract will also require project management support and coordination with federal staff. The manufacturing task area will involve the production of various biologics, including oligonucleotides, viral gene delivery vectors, purified proteins, peptides, antibody-based biologics, cell-based therapeutics, novel genome-editing modalities, and formulations of biological therapeutics. The nonclinical studies task area will include in vitro, in vivo, and ex vivo studies, as well as bioassay development and assay qualification or validation. Offerors must be registered in the System for Award Management (SAM) to be eligible for this procurement. The Request for Proposals (RFP) is anticipated to be issued on SAM.gov on or after March 14, 2024.

Description

View Changes

Amendment 3 is issued on June 10, 2024 to provide information and materials from the pre-proposal conference that took place on June 7, 2024. Attached is updated Questions and Responses that includes the questions asked during the conference, conference slides, and a transcript of the conference.

Amendment 2 is issued on May 31, 2024 to provide updated Questions and Reponses (see attached) and to provide the following information about a pre-proposal conference:

The Government will conduct a pre-proposal conference on Friday, June 7, at 3:00pm ET. The conference is expected to last no more than 60 minutes. The Government will provide an overview of the solicitation requirements, proposal submission requirements, and discuss program background. Questions will be accepted if time allows. Interested participants must register by submitting the following information to Kimberly Espinosa at Kimberly.espinosa@nih.gov no later than 3:00pm ET on Thursday, June 6:

Participant Name Participant Email Address and Phone Number Company Name Specific questions the participant would like addressed during the conference. The Government does not guarantee that all questions will be addressed during the conference.

Each participant must register individually even if multiple participants are attending from the same company. Receipt of the above information will be confirmed. All registered participants will receive a link via email to attend the conference.

Amendment 1 is issued on May 17, 2024 to include Questions and Responses. See attached.

Description

The National Institutes of Neurological Disorders and Stroke (NINDS) has a need for current Good Manufacturing Practices (cGMP) manufacturing and Good Laboratory Practice (GLP) nonclinical (preclinical) support services to support translational development of therapeutic biotechnology products (Biologics) for National Institutes of Health (NIH) drug discovery and development programs. To that end, several NIH programs are being implemented or expanded to provide support for academic and industry investigators developing medical interventions for neurological disorders.

This requirement supports the NIH biologics development projects for 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), as well as other extramural or intramural NIH drug discovery and development programs.

The Contractor shall provide support for both Biologics current good manufacturing practices (cGMP) manufacturing and GLP nonclinical services, including execution of the studies and completing study reports and documentation that will enable regulatory filing and evaluation of biological therapeutics in clinical trials for NIH drug development programs. These services may be provided through a combination of internally executed studies and subcontracted work. Throughout the contract ordering period and awarded task order (TO) periods of performance, the Contractor must maintain the technical capabilities, subcontractor network, minimum resources and organizational compliances with which to successfully perform the range of activities under both Task Area 1: Manufacturing and Task Area 2: Nonclinical Studies. Additionally, unless otherwise requested, any assigned research must be performed in compliance with all current Food and Drug Administration (FDA), and International Committee on Harmonization (ICH) policies, practices, procedures, guidelines and regulations specific to GLP and cGMP, as may be applicable. Data and documentation shall be prepared in a form acceptable to the FDA for inclusion in a Drug Master File (DMF), Investigational New Drug (IND) application, or New Drug Application (NDA).

In its own facilities and/or through its subcontractors, the Contractor shall conduct and/or oversee all manufacturing activities and nonclinical therapeutics evaluation and characterization in appropriate in vitro, in vivo, and/or ex vivo models, including cGMP manufacturing and preclinical IND-enabling and related studies. Nonclinical activities may include, but not are limited to, bioassay development, and/or efficacy studies, and/or absorption, distribution, metabolism, and elimination (ADME) studies, and/or pharmacokinetic (PK) and/or pharmacodynamic (PD) characterization, and/or GLP toxicology studies or other preclinical IND-enabling studies in support of requirements for IND applications. The Contractor shall provide Chemistry, manufacturing, and controls (CMC) and nonclinical study documentation to enable regulatory interactions, IND filing and evaluation of biological therapeutics in clinical trials for NIH drug development programs.

PLEASE NOTE: This solicitation is a Ramp-On re-opening and re-soliciting of Request for Proposals (RFP) No. 75N95022R00013 that was issued on January 25, 2022, with the purpose of adding one or more contractors to the existing Indefinite Delivery / Indefinite Quantity (IDIQ) contract pool supporting this program. The ordering period of the IDIQ contracts expire on September 29, 2030 and any new awards made under RFP No. 75N95024R00050 will have an ordering period that expires on September 29, 2030.

See attached Request for Proposals and attachments for complete information.

Contact Information

PrimaryKimberly Espinosa
kimberly.espinosa@nih.gov
SecondaryValerie Whipple
valerie.whipple@nih.gov
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Opportunity Lifecycle

Title
Type
Solicitation
Solicitation
Solicitation
Solicitation
Presolicitation
Presolicitation
Presolicitation

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