CRO Support for NCATS Drug Substance Development and Manufacture

This is not a Request for Proposals (RFP). This is a Pre-solicitation Announcement only. RFP No. N01TR-17-2001, titled "CRO Support for NCATS Drug Substance Development and Manufacture," will be issued via fedbizopps on or about April 6, 2016.

The Division of Preclinical Innovation (DPI) at the 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, at which point, DPI will hand off the drug candidate to external partner(s) to bring the novel therapy to patients.

The overall goal of this proposed project is to support the DPI drug development program by contracting for Chemistry, Manufacturing, and Control services. Specifically, this proposed project is designed to ensure DPI receives Active Pharmaceutical Ingredients and formulated Drug Product of sufficient quality and quantity to support IND-enabling, pre-clinical, and clinical studies.

To accomplish this goal, the Government plans to solicit proposals from offerors having in-house capability in one or more of the following technical areas: (1) Manufacture and Analysis of Small Molecules; (2) Manufacture and Analysis of Synthetic Peptides, Oligonucleotides, and Related Substances; and (3) Manufacture and Analysis of Biopharmaceuticals.

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.

This is not a Request for Proposals (RFP). This is a Pre-solicitation Announcement only. RFP No. N01TR-17-2001, titled "CRO Support for NCATS Drug Substance Development and Manufacture," will be issued via fedbizopps on or about March 31, 2016.

The Division of Preclinical Innovation (DPI) at the 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, at which point, DPI will hand off the drug candidate to external partner(s) to bring the novel therapy to patients.

The overall goal of this proposed project is to support the DPI drug development program by contracting for Chemistry, Manufacturing, and Control services. Specifically, this proposed project is designed to ensure DPI receives Active Pharmaceutical Ingredients and formulated Drug Product of sufficient quality and quantity to support IND-enabling, pre-clinical, and clinical studies.

To accomplish this goal, the Government plans to solicit proposals from offerors having in-house capability in one or more of the following technical areas: (1) Manufacture and Analysis of Small Molecules; (2) Manufacture and Analysis of Synthetic Peptides, Oligonucleotides, and Related Substances; and (3) Manufacture and Analysis of Biopharmaceuticals.

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.

This is not a Request for Proposals (RFP). This is a Pre-solicitation Announcement only. RFP No. N01TR-17-2001, titled "CRO Support for NCATS Drug Substance Development and Manufacture," will be issued via fedbizopps on or about March 17, 2016.

The Division of Preclinical Innovation (DPI) at the 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, at which point, DPI will hand off the drug candidate to external partner(s) to bring the novel therapy to patients.

The overall goal of this proposed project is to support the DPI drug development program by contracting for Chemistry, Manufacturing, and Control services. Specifically, this proposed project is designed to ensure DPI receives Active Pharmaceutical Ingredients and formulated Drug Product of sufficient quality and quantity to support IND-enabling, pre-clinical, and clinical studies.

To accomplish this goal, the Government plans to solicit proposals from offerors having in-house capability in one or more of the following technical areas: (1) Manufacture and Analysis of Small Molecules; (2) Manufacture and Analysis of Synthetic Peptides, Oligonucleotides, and Related Substances; and (3) Manufacture and Analysis of Biopharmaceuticals.

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.