Reagent Generation for Bioanalytical Method Development for Biologics

Added: Oct 13, 2017 10:13 am Modified: Dec 07, 2017 3:30 pmTrack Changes This notice amends the solicitation to confirm that the development of bioanalytical assay reagents under this solicitation is a non-GLP/non-GMP activity (as stated in Attachment 3, Statement of Work), and removes the requirement in the Sample Task Order Request for Proposal (TORPF) (Attachment 4) that respondents show that facilities are appropriate for handling drug products under cGMPs.

Added: Oct 13, 2017 10:13 am Modified: Nov 28, 2017 8:52 amTrack Changes This notice amends RFP Attachment 4, Sample Task Order Request for Proposals (TORFP), and responds to formal questions submitted in response to the solicitation.

Added: Oct 13, 2017 10:13 am Modified: Oct 31, 2017 3:23 pmTrack Changes SUMMARY:

The National Center for Advancing Translational Sciences (NCATS), NIH, invites you to submit a proposal in response to RFP No. N01TR-18-2006, titled "Reagent Generation for Bioanalytical Method Development for Biologics."

REQUIREMENT AND TYPE OF SERVICE

The Division of Preclinical Innovation (DPI) at National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH), conducts translational research in the area of human therapeutics development.

The objective of this contract is to support the DPI drug development programs by generating reagents (e.g. polyclonal and monoclonal antibodies) that will be used in bioanalytical assay development to quantify concentrations of novel biologics and anti-drug antibodies(ADA) in biological samples (e.g. plasma, serum and tissue homogenate) collected from preclinical pharmacology, pharmacokinetic and toxicokinetic studies, as well as human pharmacokinetic studies in clinical trials.

Under this contract, novel biologics include but are not limited to the following: mAbs, recombinant human proteins, Fc-fusion proteins, bio-functional proteins, PEGylated or other engineered peptides, protein fragments, antibody-drug conjugates (ADC), engineered human genes and carriers, in plasma/serum, tissue homogenates, and CSF.

This RFP is a follow-up solicitation to NCATS RFP No. N01TR-17-2004, "CRO Support for NCATS Bioanalytical Method Development for Biologics," that was issued on January 26, 2017. In that RFP, the Statement of Work was divided into four technical areas: Technical Area 1: Reagent Generation; Technical Area 2: Bioanalytical Method Development for Novel Biologic Drugs; Technical Area 3: Bioanalysis of Novel Biologic Drugs in Biologic Matrices; and Technical Area 4: Determination of Anti-Drug Neutralizing Antibodies. To qualify for award, organizations had to demonstrate capabilities in at least one technical area.

NCATS received no responses in Technical Area 1, Reagent Generation. Therefore, it is issuing a new RFP soliciting responses to the reagent generation requirement.

NCATS anticipates making a single Indefinite Delivery/Indefinite Quantity-type award with individually negotiated cost reimbursement or fixed price task orders over a five-year ordering period. The guaranteed minimum for the awardee will be $5,000, and the program maximum is $696,028.

The ultimate goal of DPI and this planned project is to bring new drugs to market. To this end, the Government has issued 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 enables DPI contributors to retain control of their intellectual property, and 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.

This is a new requirement; therefore, no incumbent information is provided. The Government will select the proposal that is most advantageous to the Government in accordance with the basis of award included in the solicitation.

The anticipated award date for this action is around July 1, 2018.

ABOUT DPI AND NCATS

The Division of Preclinical Innovation (DPI) at National Center for Advancing Translational Sciences (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 such support will 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 scientific areas best suited for utilization of CROs and CMOs to conduct some or all parts of a given drug development program.

CONTRACTING OFFICE ADDRESS

National Center for Advancing Translational Science
NINDS R&D Contracts Management Branch
6001 Executive Blvd
Suite 3287, MSC 9531
Bethesda, MD 20892-9531*

*Use Rockville, MD 20852 for FedEx/USPS/Courier/Hand Delivery

Added: Oct 13, 2017 10:13 am SUMMARY:

This is a notice of a proposed contract action issued in accordance with FAR 5.203(a). The Government intends to issue RFP No. N01TR-18-2006, titled "Reagent Generation for Bioanalytical Method Development for Biologics," via FedBizOpps on or about October 31, 2017.

REQUIREMENT AND TYPE OF SERVICE:

The Division of Preclinical Innovation (DPI) at National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH), conducts translational research in the area of human therapeutics development.

The objective of this contract is to support the DPI drug development programs by generating reagents (e.g. polyclonal and monoclonal antibodies) that will be used in bioanalytical assay development to quantify concentrations of novel biologics and anti-drug antibodies(ADA) in biological samples (e.g. plasma, serum and tissue homogenate) collected from preclinical pharmacology, pharmacokinetic and toxicokinetic studies, as well as human pharmacokinetic studies in clinical trials.

Under this contract, novel biologics include but are not limited to the following: mAbs, recombinant human proteins, Fc-fusion proteins, bio-functional proteins, PEGylated or other engineered peptides, protein fragments, antibody-drug conjugates (ADC), engineered human genes and carriers, in plasma/serum, tissue homogenates, and CSF.

This RFP is a follow-up solicitation to NCATS RFP No. N01TR-17-2004, "CRO Support for NCATS Bioanalytical Method Development for Biologics," that was issued on January 26, 2017. In that RFP, the Statement of Work was divided into four technical areas: Technical Area 1: Reagent Generation; Technical Area 2: Bioanalytical Method Development for Novel Biologic Drugs; Technical Area 3: Bioanalysis of Novel Biologic Drugs in Biologic Matrices; and Technical Area 4: Determination of Anti-Drug Neutralizing Antibodies. To qualify for award, organizations had to demonstrate capabilities in at least one technical area.

NCATS received no responses in Technical Area 1, Reagent Generation. Therefore, it is issuing a new RFP soliciting responses to the reagent generation requirement.

RELEASE OF SOLICITATION:

The Government intends to issue a Request for Proposals on or about October 31, 2017. Proposals will be due 45 calendar days following release of the RFP.

The intended contract will be a single-award Indefinite Delivery/Indefinite Quantity (IDIQ) contract under this solicitation.

The ultimate goal of DPI and this planned project is to bring new drugs to market. To this end, the Government has issued 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 enables DPI contributors to retain control of their intellectual property, and 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.

This is a new requirement; therefore, no incumbent information is provided. The Government will select the proposal that is most advantageous to the Government in accordance with the basis of award included in the solicitation.

The anticipated award date for this action is around July 1, 2018.

ABOUT DPI AND NCATS:

The Division of Preclinical Innovation (DPI) at National Center for Advancing Translational Sciences (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 such support will 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 scientific areas best suited for utilization of CROs and CMOs to conduct some or all parts of a given drug development program.

CONTRACTING OFFICE ADDRESS

National Center for Advancing Translational Science
NINDS R&D Contracts Management Branch
6001 Executive Blvd
Suite 3287, MSC 9531
Bethesda, MD 20892-9531*

*Use Rockville, MD 20852 for FedEx/USPS/Courier/Hand Delivery