SOURCES SOUGHT
B -- Biotechnology Products and Biologics Discovery and Development Consulting Services
- Notice Date
- 1/27/2015
- Notice Type
- Sources Sought
- NAICS
- 541690
— Other Scientific and Technical Consulting 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-SBSS-15-105
- Archive Date
- 2/26/2015
- Point of Contact
- Farrin Stanton,
- E-Mail Address
-
farrin.stanton@nih.gov
(farrin.stanton@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources, (2) whether they are small businesses; HUBZone small businesses, service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. The notice is strictly for research and information purposes only. The information requested will assist the Government in determining the appropriate acquisition method, including whether a small business social-economic set-aside, competitive or non-competitive method is possible, and to determine the availability of qualified companies technically capable of meeting the Government's requirement. ALL organizations with the capability and availability to perform the requirement under the applicable NAICS code are invited to submit a response to this notice. NORTH AMERICAN CLASSIFICATION SYSTEM (NAICS) CODE 541690 Other Scientific and Technical Consulting Services The National Institute of Neurological Disorders and Stroke (NINDS) is a part of the National Institutes of Health (NIH), conducting research into the causes, treatment, and prevention of neurological disorders and stroke. The NINDS mission is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease. NIH led by NINDS has given a high priority to increasing the predictive value of pre-clinical research due to the lack of reproducibility of pre-clinical studies and success in translating therapies to the clinic. In order to ensure Biotechnology Products and Biologics therapy projects are moving ahead for the right reasons NINDS seeks statistical advice. 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 · Biostatistics Consultant 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 (Cooperative Research to Enable and Advance Translational Enterprises for Biotechnology Products and Biologics), 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 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. Specific Discipline Requirements 1. Biologics Regulatory Affairs The role of the biologics regulatory consultant shall include, but is not limited to, the following responsibilities and tasks: · Advise NINDS staff on CDER and CBER regulatory guidelines, regulations, and requirements pertaining to the nonclinical and early clinical development of biologics · Review and assess data and project related proposals, and advise on study requirements to file an IND package for a range of potential biologics therapeutic modalities in nonclinical IND-enabling development – such as peptides, antibodies, recombinant proteins, oligonucleotides, cell and gene therapies - based on regulatory precedence and compliance to Common Technical Document (CTD) format requirements, including: o Review of administrative information (e.g. target product profiles, clinical protocols, and investigator information) o Review of animal pharmacology and toxicology study results to assess whether the product is expected to be reasonably safe for initial testing in humans o Determine if previous relevant human experience is available for similar biologics or research and report results from relevant clinical trials conducted both inside and outside of the US. o Review chemistry, manufacturing and control (CMC) nonclinical study plans and results pertaining to the composition, manufacturing, testing, stability and controls for a range of biologics to assess compliance to regulatory guidance. o Review clinical protocols and investigator information to assess adherence to investigational regulations and study protocols as it pertains to a biologic modality in each case. · Provide guidance to the preparation of pre-IND and IND Meetings or review FDA responses to recommend new course of action. · Identify and assess regulatory risks and gaps to IND-enabling research study plans and recommend solutions · Give oral presentations in area of expertise 2. Biologics Chemical Manufacturing and Controls (CMC) Development The role of the biologics CMC consultant may include, but is not limited to, the following responsibilities and tasks: · Provide guidance to NINDS staff on all CMC related requirements of the nonclinical and early clinical development of biologics (such as peptides, antibodies, recombinant proteins, oligonucleotides, and cell and gene therapies) in accordance with the US regulatory and the ICH guidelines. · Review and comment on the adequacy of biologic manufacturing including scale-up, analytical method development, and process development (upstream and downstream processing) approaches proposed by investigators · Provide expert advice, risk and gap analysis to team related to all CMC aspects such as proposed analytical strategy, QC release methods requirements, formulation development, stability testing, stage appropriate assay requirements such as potency and viral clearance · Provide guidance on delivery methods which may include complex formulations such as polymer, liposomes, and nanoparticles · Provide expert advice on master and working cell and viral bank development and testing · Give oral presentations in area of expertise 3. Biostatistics The role of the biostatistics consultant may include, but is not limited to, the following responsibilities and tasks: · Provide biostatistical review and advice to the team related to the design and evaluation of proposed nonclinical animal research models and plans and clinical research studies: o Consider and propose different design types to answer specific research question o Evaluate sample size and power calculations o Propose optimal randomization schemes o Employ hypothesis testing or parametric analysis using statistical techniques endorsed by regulatory agencies · Provide statistical considerations in the design and analysis of nonclinical and clinical research studies including study designs, clinical protocols, and review of statistical analysis plans · Provide general statistical guidance related to planning, review and analysis of nonclinical and clinical study proposals or data and data packages intended for regulatory submissions · Review process optimization and validation plans · Provide statistical analyses for and interpretation of study proposals or publications · Give oral presentations in area of expertise Specific Discipline Experience The following experience requirements are the minimum acceptable requirements for each consulting category: 1. Biologics Regulatory Affairs Consultant: · A minimum of 10 years’ experience in the biotechnology, pharmaceutical industry or regulatory industry is required. · A minimum of 7 years hands-on and in-depth consulting experience in nonclinical and clinical development of biologics · Demonstrate high-level expertise working with CBER and/or CDER pertaining to development of biologics · Familiar with FDA guidance documents pertaining to development of biologics · A good understanding of chemistry, analytics and pharmaceutical technology and in-depth understanding of the biologic therapeutic development process. · Proven track record of early recognition of potential regulatory risks especially with IND filings for biologics and proposing solutions · FDA interactions and experience reviewing of Pre-IND and IND applications for outside organizations. 3. Biologics CMC Development Consultant: · A PhD or equivalent in a biological science or chemistry degree preferred · At least 10 years of CMC experience; biotechnology products and biologics experience required · Previous hands-on experience in the preparation and/or review of the CMC sections of pre-IND, IND and/or BLA for biologics · A good understanding and track record of developing and advising clients on analytical assays and release assay development requirements for the nonclinical and clinical development of different biologic modalities · A good understanding of US regulatory requirements pertaining to nonclinical and clinical CMC development of different biologic modalities · Familiar with FDA guidance documents pertaining to CMC development of biologics 4. Biostatistics Consultant · A PhD or equivalent in a biostatistical discipline is preferred · At least 7 years biostatistical experience in the biotechnology or academic sector is required · Demonstrated experience in providing biostatistical advice related to the design and review of nonclinical animal research plans and/or analysis of nonclinical animal research results for IND-enabling studies. · Past experience in using statistical methods to optimize process and product development studies · Past experience in advising clients on the design of clinical trial protocols, innovative and adaptive designs, review of statistical analysis plans, and validations plans. · Past experience with interacting with regulatory agencies and presentation or defense of proposed study plans or study results, a plus · Past experience with statistical interpretation of published results or critique of scientific proposals · Past experience in providing statistical support to non-clinical and/or clinical development efforts CAPABILITY STATEMENT INFORMATION SOUGHT Respondents must provide, as part of their responses, clear and convincing documentation of their capability of providing the item(s) specified in this notice. Contractors that believe they possess the ability to provide the required must submit specific documentation of their ability to meet each of the project requirements to the Contract Specialist. Contractors must provide their Company Name, DUNS number, Physical Address, and Point of Contact Information. Interested organizations are required to identify their type of business, applicable North American Industry Classification System Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. All capability statements sent in response to this Sources Sought Notice must be submitted electronically (via email) to Farrin Stanton, Contract Specialist, at Farrin.Stanton@nih.gov in MS Word format by or before the closing date of this announcement. All responses must be received by the specified due date and time in order to be considered. The response must be received on or before February 11, 2015 11:00am, eastern time. CONCLUDING STATEMENTS Note: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After review of the responses received, pre-solicitation and solicitation notices may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. The solicitation release date is pending. The Government intends to negotiate a fixed-price purchase order. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-2/HHS-NIH-NIDA-SSSA-SBSS-15-105/listing.html)
- Place of Performance
- Address: 31 Center Drive, Bethesda, Maryland, United States
- Record
- SN03625684-W 20150129/150127234421-33a29cc0bd97064eedff04f7a6a13287 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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