Manufacturing and Nonclinical Studies Support for the Development of Therapeutic Biotechnology Products (Biologics) for Neurological related Disorders
ID: 75N95024R00050Type: Solicitation
Overview

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)

Original Source

https://sam.gov/opp/2825f7a1c18e4e63b3e2556ce5ccd9d0/view
Timeline
  1. 1
    Posted Apr 26, 2024 12:00 AM
  2. 2
    Updated Jul 3, 2024 12:00 AM
  3. 3
    Due Jul 15, 2024 6:00 PM
Description

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.

Point(s) of Contact
Kimberly Espinosa
kimberly.espinosa@nih.gov
Valerie Whipple
valerie.whipple@nih.gov
Files
Title
Posted
75N95024R00050_Presolicitation QandA_Amendment 2.pdf
4/26/2024
75N95024R00050_Presolicitation QandA.pdf
3/28/2024
75N95024R00050_Presolicitation QandA.pdf
4/26/2024
Amendment 1_Questions and Responses_5.17.2024.pdf
5/17/2024
Amendment 2_Questions and Responses_5.31.2024.pdf
5/31/2024
Amendment 3_Questions and Responses_6.10.2024.pdf
6/10/2024
Pre-Proposal Conference_Slides.pptx
6/10/2024
Pre-Proposal Conference_Transcript.pdf
6/10/2024
RFP Att. 1_Packaging and Delivery of Proposals.pdf
4/26/2024
RFP Att. 10_HHS Subcontracting Plan Template.docx
4/26/2024
RFP Att. 11_Business Proposal Budget Template_TO_1.xlsx
4/26/2024
RFP Att. 12_Business Proposal Budget Template_TO_2.xlsx
4/26/2024
RFP Att. 13_Business Proposal Budget Template_TO_3.xlsx
4/26/2024
RFP Att. 14_Business Proposal Budget Template_TO_4.xlsx
5/17/2024
RFP Att. 15_Points-of-contact.pdf
4/26/2024
RFP Att. 16_Wage Rate Determination (2023).pdf
4/26/2024
RFP Att. 17_SF-LLL.pdf
4/26/2024
RFP Att. 18_Invoice Instructions NIH(RC)1.pdf
4/26/2024
RFP Att. 19_Invoice Instructions NIH(RC)2.pdf
4/26/2024
RFP Att. 2_Proposal Intent Response Form.pdf
4/26/2024
RFP Att. 20_DEC Acknowledgment.pdf
4/26/2024
RFP Att. 21_STO 1- Kickoff and Project Management Plan.pdf
4/26/2024
RFP Att. 22_STO 2 - AAV Manufacturing Task Order.pdf
4/26/2024
RFP Att. 23_STO 3 - ASO Manufacturing Task Order.pdf
4/26/2024
RFP Att. 24_STO 4 - BPN-Biologics PK and Tox Task Order.pdf
4/26/2024
RFP Att. 3_IDIQ Contract SOW.pdf
4/26/2024
RFP Att. 4_Section K RepsandCerts.pdf
4/26/2024
RFP Att. 5_Technical Proposal Cost Summary.pdf
4/26/2024
RFP Att. 6_Summary_of_Related_Activities.pdf
4/26/2024
RFP Att. 7_VAS Worksheet.pdf
4/26/2024
RFP Att. 8_Additional Technical Proposal Instructions.pdf
4/26/2024
RFP Att. 9_NIH 2043.pdf
4/26/2024
RFP No. 75N95024R00050_Cover Letter.pdf
4/26/2024
RFP No. 75N95024R00050.pdf
4/26/2024
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