MODIFICATION
B -- NINDS Biotechnology Products and Biologics Discovery and Development Consulting Services - Amendment 1
- Notice Date
- 3/16/2015
- Notice Type
- Modification/Amendment
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support/Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, Maryland, 20892
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SSSA-CSS-15-105
- Archive Date
- 4/28/2015
- Point of Contact
- Farrin Stanton, , Andriani Buck,
- E-Mail Address
-
farrin.stanton@nih.gov, andriani.buck@nih.gov
(farrin.stanton@nih.gov, andriani.buck@nih.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- revised combined solicitation/synopsis Amendment 0001 THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION WILL NOT BE ISSUED. This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The Solicitation Number for this acquisition is HHS-NIH-NIDA-(SSSA)-15-105 and is being issued as a Request for Proposal (RFP). The solicitation documents and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-80 effective March 2, 2015. This acquisition is a small business set aside. The North American Industry Classification System (NAICS) Code for this procurement is 541690 and the Small Business Size Standard is 14.0 million dollars; Other Scientific and Technical Consulting Services. STATEMENT OF OBJECTIVES The NINDS is seeking senior-level, industry-experienced discovery and development consultants with expertise in biotechnology products and biologics to assist NINDS program staff to vet and advance only the most promising therapeutic biologics through the development pipeline. Consultants with the following individual or combined areas of expertise are encouraged to propose their services: •Biologics Regulatory Affairs Consultant •Biologics CMC Development Consultant STATEMENT OF WORK The Cooperative Research to Enable and Advance Translational Enterprises for Biotechnology Products and Biologics (CREATE Bio) projects are funded through a cooperative agreement award mechanism, a collaborative team is formed between the principal investigators (PI) group with NINDS program staff participation in guiding the project plan. The PI's team performs all of the experiments while NINDS role is to establish performance milestones for each project to facilitate go/no-go decision making and then monitor research progress and achievement of project milestones. Each consultant is expected to provide technical guidance and advice pertaining to their area of expertise on advancing discovery and development projects through nonclinical development and submission of an IND or BLA package, and in some cases, design of early clinical protocol and launch of a first in human clinical trial. Consulting services will be for biologics-focused projects from the Cooperative Translational Research program such as CREATE Bio, Intramural NINDS projects or any other NINDS program with similar needs as outlined in the scope of this statement of work. Consulting contracts will include as many areas of expertise as possible as outlined in this Statement of Work, and will reflect the NIH time commitment and needs for the specific areas of expertise. Consultants will be expected to provide feedback and guidance on projects to NINDS staff through written documents, conference calls, and by email. The consultants' major responsibility will be in offering review, guidance and advice on projects. They will be expected to offer technical review and feedback on project milestones, progress reports, or development plans, study design, and data interpretation. Specific consulting responsibilities will depend on the expertise of the individual consultant and the needs of individual projects. On rare occasion, consultants may be asked to give oral presentations to NINDS staff or at an NINDS sponsored webinar, workshop or conference to provide training to investigators in their area of expertise. General Requirements Consultants will be asked to provide strategic and expert technical guidance for biotechnology products and biologic discovery and development projects. Consultants will serve as a resource to NINDS staff from the start of early discovery stage projects to structurally modify and optimize design characteristics of leads through IND-enabling activities necessary to advance potential development candidates through scale up and early phase clinical trials. Consulting advice and guidance shall be required to supplement NINDS program experience from the pre-application stage and then throughout the life of each project to review and monitor progress. Each project team is led by a PI and supported by NINDS staff with disease and therapy development expertise. The joint team establishes project milestones and monitors progress at least annually. The PIs conduct all of the research activities and report progress to NINDS. NINDS staff will interact directly with the PI and request assistance from consultants to review and provide expert advice on specific topics. Consultants shall directly advise NINDS staff, and in some cases communicate directly with the PI on team calls. The following attachments are provided to assist you in preparing your proposal responding to this solicitation. Attachment No. 1: Statement of Work Attachment No. 2: Invoice Instructions Attachment No. 3: Security Clauses
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-2/HHS-NIH-NIDA-SSSA-CSS-15-105/listing.html)
- Place of Performance
- Address: 31 Center drive, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03669238-W 20150318/150316235232-6fddc825b677bbaa079ffdb23aa7a57b (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |