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Indefinite Delivery Contract HHSN271201700020I
Award Date
7/26/17
Last Date to Order
7/31/24
Overview
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Activity
Contract IDVs
Contract Awards
8
Transactions
7
Price Lists
Opportunity Stack
2
Funding Federal Agency
National Center for Advancing Translational Sciences
Contracting Federal Agency
National Institute on Drug Abuse
Awardee
Societal Cdmo San Diego, LLC
Ultimate Awardee
Irisys, Inc.
NAICS Category
325412 - Pharmaceutical Preparation Manufacturing
PSC Category
AN11 - Health R&D Services; Health Care Services; Basic Research
Set-Aside Type
No Set-Aside Used
Federal Contract Vehicle
NCATS Drug Product Development Studies 2017-2022
Pricing Type
Order Dependent (IDV only)
Legislative Mandate
Not listed
National Interest Action
None
Award Type
Multiple
Primary Consortia Member
Not listed
NCATS Drug Product Development Studies 2017-2022
Master IDIQ
HHSN271201700020I
Indefinite Delivery Contract
8
Federal Contract Awards
Description
CRO SUPPORT FOR NCATS DRUG PRODUCT DEVELOPMENT, MANUFACTURE, AND STABILITY STUDIES
Posted 7/26/17, 12:00 AM
Mod #
Description
Reason For Modification
Federal Obligation
(Click to sort descending)
Date
(Click to sort ascending)
P00009
CRO SUPPORT FOR NCATS DRUG PRODUCT DEVELOPMENT, MANUFACTURE, AND STABILITY STUDIES
Other Administrative Action
$0
7/11/23
P00008
CRO SUPPORT FOR NCATS DRUG PRODUCT DEVELOPMENT, MANUFACTURE, AND STABILITY STUDIES
Novation Agreement
$0
2/1/23
P00007
CRO SUPPORT FOR NCATS DRUG PRODUCT DEVELOPMENT, MANUFACTURE, AND STABILITY STUDIES
Supplemental Agreement for work within scope
$0
4/25/22
P00006
EO14042 - CRO SUPPORT FOR NCATS DRUG PRODUCT DEVELOPMENT, MANUFACTURE, AND STABILITY STUDIES
Other Administrative Action
$0
3/28/22
P00004
CRO SUPPORT FOR NCATS DRUG PRODUCT DEVELOPMENT, MANUFACTURE, AND STABILITY STUDIES, ORDERING PERIOD 8/1/2017 - 7/31/2022.
Other Administrative Action
$0
4/19/21
Name
Description
Awardee
Potential Value
(Click to sort descending)
Award Date
(Click to sort descending)
Completion Date
(Click to sort descending)
Updated At
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Delivery Order HHSN271201700020I-75N95021F00003
The National Center for Advancing Translational Sciences of the National Institutes of Health awarded a $2 million delivery order contract to Societal Cdmo San Diego, LLC for dosage form development, manufacture, and stability studies of NES-100 nasal spray. Societal Cdmo San Diego is a division of Recro Pharma, Inc., the prime contractor. The award is issued against the NCATS Drug Product Development Studies 2017-2022 master IDIQ contract vehicle. Performance will take place in San Diego, California over a four-year period ending in September 2025. The firm fixed price contract supports the NIH's work to facilitate translation of basic scientific discoveries into new and better patient treatments through pre-clinical and clinical studies.
Societal Cdmo San Diego, LLC
$2.0m
9/24/21
9/23/25
7/20/23
Delivery Order HHSN271201700020I-75N95021F00002
Societal Cdmo San Diego, LLC was awarded a $702,848.85 firm fixed price delivery order against the National Center for Advancing Translational Sciences Drug Product Development Studies 2017-2022 master indefinite delivery/indefinite quantity contract by the National Institutes of Health's National Institute on Drug Abuse. Under this contract, Societal Cdmo will provide dosage form development, manufacture, and stability studies of R-VK4-116 from June 1, 2021 through May 31, 2025 in San Diego, California. As the prime contractor, Societal Cdmo will leverage its expertise in drug product development to support the National Institute on Drug Abuse's mission of advancing science on the causes and consequences of drug use and addiction and applying that knowledge to improve individual and public health.
Societal Cdmo San Diego, LLC
$702.8k
6/1/21
5/31/25
12/20/23
Delivery Order HHSN271201700020I-75N95021F00001
EXTENSION OF STABILITY STUDIES OF METARRESTIN (ML246), PERIOD OF PERFORMANCE 1/28/2021 - 3/31/2021.
Societal Cdmo San Diego, LLC
$32.6k
5/25/20
3/31/23
1/27/21
Delivery Order HHSN271201700020I-75N91024F00001
The Department of Health and Human Services' National Institutes of Health National Cancer Institute awarded a $711,750.00 Firm Fixed Price Delivery Order contract to Societal CDMO San Diego, LLC (doing business as Irisys Inc.) for Metarrestin cGMP manufacturing and stability testing services. This contract is under the NCATS Drug Product Development Studies 2017-2022 indefinite delivery, indefinite quantity (IDIQ) contract vehicle. Societal CDMO is a self-certified small disadvantaged business and has previously provided drug product development, manufacturing, and testing services to federal agencies including the NIH, National Cancer Institute, National Center for Advancing Translational Sciences, and Department of Veterans Affairs.
Societal Cdmo San Diego, LLC
$711.8k
5/23/24
5/22/28
5/23/24
Delivery Order HHSN271201700020I-75N95022F00001
This is a task order awarded to Societal CDMO San Diego, LLC (doing business as Irisys Inc.), a self-certified small disadvantaged business, to provide dosage form development, manufacture, and stability studies of the drug ORC-13661 for a Phase II clinical trial. The task order, valued at $760,749.00, was issued under the National Center for Advancing Translational Sciences (NCATS) Drug Product Development Studies 2017-2022 Indefinite Delivery/Indefinite Quantity (IDIQ) contract. NCATS, a component of the National Institutes of Health (NIH) within the Department of Health and Human Services (HHS), is the funding agency for this award. The task order does not have a set-aside designation and is for a firm fixed-price contract with a period of performance through July 31, 2027.
Societal Cdmo San Diego, LLC
$760.7k
9/27/22
7/31/27
9/9/24
Name
Description
Solicitation Number
Federal Agency
Type
Posted Date
(Click to sort descending)
CRO Support for NCATS Drug Product Development, Manufacture, and Stability Studies
Awarded contract HHSN271201700022I to Purdue University for 14444775 on 2017-08-01.
N01TR-17-2003
Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse
Award Notice 2/2
8/1/17, 9:02 AM
CRO Support for NCATS Drug Product Development, Manufacture, and Stability Studies
This is not a Request for Proposals (RFP). This is a Pre-solicitation Announcement only. RFP No. N01TR-17-2003, titled "CRO Support for NCATS Drug Product Development, Manufacture, and Stability Studies," will be issued via fedbizopps on or about August 7, 2016.The Division of Preclinical Innovation (DPI) at National Center for Advancing Translational Science (NCATS) conducts translational research in the area of human therapeutics development and aims to move small molecule and biologic drug candidates forward in the drug development pipeline to predetermined milestones, at which point, DPI will hand off the drug candidate to external partner(s) to bring the novel therapy to patients. In addition to developing new candidate drugs, DPI seeks to advance the entire field of drug discovery and development by encouraging scientific and technological innovations aimed at improving success rates in the crucial pre-clinical stage of drug development. DPI's model is to operate as a full range small molecule and biologics drug development organization, moving drug candidates through each phase of the pre-clinical drug development process until an IND is filed with the US Food and Drug Administration (FDA). For certain drug development programs, DPI will support its candidate's development up to human Phase IIB studies if and when determined by DPI management team as necessary to achieve DPI's mission. DPI conducts drug development as collaborations through programs such as the Therapeutics for Rare and Neglected Diseases (TRND) and the Bridging Interventional Development Gaps (BrIDGs) programs. DPI drug development programs originate from academia, industry, non-profit foundations, or internally from NCATS and other NIH institutes, and its R&D operational strategy is to combine the capabilities of DPI in-house staff and DPI partners, who may be the drug originators. Each drug program operates in a multi-disciplinary, multi-partnership matrix team environment, and a DPI program officer (PO) is responsible for the overall planning, execution, and reporting of the program.Contract research organizations (CROs) and contract manufacturing organizations (CMOs) provide DPI with manufacturing, pharmacology, toxicology, regulatory, and clinical operations services to assist with drug development. Planning and execution of each individual drug development program includes identification of technical areas best suited for utilization of CROs and CMOs to conduct some or all parts of a given drug development program.Approximately one-half of ongoing and recently completed TRND and BrIDGs projects involved compounds to be administered by routes that require sterile dosage forms (e.g. intravenous, subcutaneous, intramuscular, inhalation of atomized solutions, and ophthalmic drop applications). The remaining projects involved the development of solid oral dosage forms, primarily capsules. In addition to these sterile and solid dosage forms, and because a number of TRND projects explore treatment of certain genetic conditions that initially present in young children, future projects may involve the development of orally administered solutions or suspensions.The objective of this contract is to support the DPI drug development programs by providing services related to the development, manufacture, and conduct of stability studies for non-sterile and sterile pharmaceutical dosage forms.To accomplish this objective and ensure adequate CRO and CMO support is provided to DPI, and out of a recognition that it is unlikely that a sufficient number of contractors will have capabilities for both sterile and non-sterile dosage forms, this solicitation is divided into three technical areas. Technical Area 1: Administrative Reporting Requirements sets forth the required services for the overall administration of the contract. Technical Area 2: Non-Sterile Dosage Forms sets forth the anticipated activities related to the development, manufacture, and stability studies for non-sterile drug products. Technical Area 3: Sterile Dosage Forms sets forth the anticipated activities related to the development, manufacture, and stability studies for sterile drug products. To qualify for award, organizations must have capabilities in Technical Area 1 and at least one other technical area. If an organization has capabilities in Technical Area 2 and Technical Area 3 and wishes to be considered for award under those technical Areas, the organization must respond fully to all three technical areas.The Government anticipates awarding multiple Indefinite Delivery/Indefinite Quantity (IDIQ) type contracts under this solicitation.The ultimate goal of DPI and this planned project is to bring new drugs to market. To this end, the Government will seek a Determination of Exceptional Circumstances (DEC) to deviate from the Federal Acquisition Regulation clauses at 52.227-11 Patent Rights and 52.227-14 Rights in Data. The deviated language will enable DPI contributors to retain control of their intellectual property, will be included in the RFP, and incorporated in any resultant contract. Prospective Offerors are advised that agreement to the terms of these FAR clauses deviations will be a condition for contract award.Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons may identify to the Contracting Officer their interest and capability to satisfy the Government's requirement with a commercial item within 15 days of this notice. Contracting Office Address: NINDS R&D Contracts Management BranchNCATS Section6001 Executive BoulevardSuite 3287, MSC 9531Bethesda, Maryland 20892-9531* *Use Rockville, MD 20852 for Fed-Ex/USPS/Courier/Hand-Delivery
N01TR-17-2003
Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse
Pre-Solicitation 1/2
7/21/16, 11:21 AM