SOURCES SOUGHT
B -- DRUG DISCOVERY AND DEVELOPMENT CONSULTING SERVICES
- Notice Date
- 2/3/2015
- 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-15-106
- Archive Date
- 3/3/2015
- Point of Contact
- Farrin Stanton,
- E-Mail Address
-
farrin.stanton@nih.gov
(farrin.stanton@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION 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 NIH is seeking senior-level, industry-experienced drug discovery and development consultants with expertise in the following specific disciplines to provide leadership and technical guidance on drug discovery and development projects in the Blueprint Neurotherapeutics Network and possibly other NIH neuroscience-focused drug discovery and development programs. •Regulatory Affairs •Phase I Clinical Pharmacology •Business Development •Electrophysiology Assay Development •Medical Writing Statement of Work, and will reflect the NIH time commitment needs for the specific areas of expertise. Consultants hired under this requirement will not only make significant contributions to promising drug discovery and development projects that have been selected through a rigorous peer-review process, they will also help shape an innovative, high-profile program that may serve as a model for future NIH drug discovery efforts. Contract consultants will be expected to provide feedback and guidance on projects to the NIH and to Blueprint LDT members through conference calls and by email. Consultants may serve on an ad hoc basis or as members of LDTs. Consultants will be expected to offer input on project milestones, development strategy, study design, and data interpretation. Specific consulting responsibilities will depend on the expertise of the individual consultant and the needs of individual projects. The BPN currently has projects in the exploratory through preclinical safety stages. Some projects will proceed to the IND and clinical trial stages. Project continuation will depend on the achievement of project-specific milestones and portfolio management. Since 2011, fifteen projects have entered the BPN, and seven projects remain active. New projects are reviewed twice per year and the highest scoring projects may be incorporated into the program. General Requirements Consultants may serve on Blueprint LDTs, which require a regular time commitment of 3-10 hours per week, including meeting and preparation time. Each LDT meets for approximately 2 hours every 1-2 weeks by teleconference. Consultants may be asked to serve as co-chairs of LDTs. A consultant serving as an LDT co-chair shall facilitate LDT discussions, work with an NIH project manager by email and telephone to maintain and communicate the overall project strategy to other LDT members, and advise the PI on the preparation of milestone reports. Co-chairs for LDTs are selected based on breadth of expertise and previous experience serving in a comparable role. A teleconference call with all consultants is held twice per month to discuss programmatic issues of broad interest. Specific Discipline Requirements 1.Regulatory Affairs Regulatory Affairs consultants will provide leadership in support of regulatory affairs strategies for preclinical and clinical programs of the small molecules in development. Consultants may be asked to provide guidance on IND-enabling studies and programs to ensure that teams meet the guidelines and timelines of IND applications. Consultants will serve as the principal regulatory contact with NIH staff, PIs, regulatory agencies, and as the primary regulatory representative to the Food and Drug Administration (FDA). The role of the Regulatory Affairs consultant may include but is not limited to the following responsibilities and tasks: •Work within project teams to develop regulatory strategies, identify regulatory risks, and enable timely approval. •Advise NIH staff and project teams on issues related to regulatory strategy; identify areas of concern in regards to developing regulations. •Provide input on and review specifications, methods, SOPs, protocols, reports, labeling, etc. for regulatory compliance. •Develop and manage timelines for regulatory submissions. •Work independently to complete assigned projects. •Work effectively to coordinate the activities of CROs and other consultants in the preparation of regulatory submissions as necessary. 2.Phase I Clinical Pharmacology Phase I Clinical Pharmacology consultants will provide consultation and support to LDTs on the development of strategies for projects entering clinical trials and oversight on clinical trial conduct. Consultants will contribute to the planning, management, implementation, monitoring, and reporting of Phase I, first-in-human clinical trials. Consultants may be asked to join NIH staff on CRO evaluation visits and on-site monitoring visits. The role of the Phase I Clinical Pharmacology consultant may include but is not limited to the following responsibilities and tasks: •Assist investigators and NIH staff in the design of Phase I studies to support ongoing projects. Advise on outsourcing specifications for contractors. •In partnership with other consultants, contractors, and the NIH staff, advise and participate in the strategic planning of preclinical studies to inform clinical studies. •Serve as the Clinical expert in order to identify potential development and clinical challenges and suggest strategies to address these challenges. •Attend CRO site visits with NIH staff. •Provide clinical expertise to PIs in order to review protocols as part of LDTs. •In partnership with other consultants, contractors, and NIH staff, work with LDTs to develop regulatory strategies, identify regulatory risks, and enable timely approval for therapeutic assets. 3.Business Development Business Development consultants will engage in business planning and outreach coordination for projects and activities in BPN, including providing strategic guidance to academics and start-up companies, evaluating opportunities for new ventures, and leveraging NIH resources to provide information, intelligence, and insights that drive critical business decisions for research innovations. The consultants will be involved in developing effective scientific collaborations between federal agencies, industry including small businesses, the private sector, and academic investigators. The role of the Business Development consultant may include but is not limited to the following responsibilities and tasks: •Provide strategic advice to start-up companies, by evaluating opportunities for new ventures, and providing information, intelligence, and insights that drive critical business decisions for research innovations •Interface with private industry on the basis of specific technology areas to build partnerships for NIH funded advanced technology projects; •Foster effective collaborations with the NIH and private, non-profit, and other government entities 4.Electrophysiology Assay Development Electrophysiology Assay Development consultants may be required to evaluate electrophysiology assays and other bioactivity assays and recommend strategies and experiments to optimize and/or validate the assays for use in a medicinal chemistry campaign. The consultants may be asked to assist in the establishment of milestones related to assay optimization or validation. The NIH may seek guidance from the consultants on the design and interpretation of commonly used in vivo assays, such as cognitive and behavioral tests. Assay-related consultation services may be required on an ad hoc basis or on LDTs. The role of the electrophysiology assay consultant may include but is not limited to the following responsibilities and tasks: •In partnership with other consultants, contractors, and the NIH staff, advise, strategically plan, and manage programs to facilitate lead optimization, IND enabling, and clinical studies. •Serve as a resource to LDT members for assay requirements and logistics to conduct drug development activities for small molecule compounds from the preclinical stage through to the initial clinical stage •Serve as the assay expert in order to identify potential developmental challenges and suggest strategies to address these challenges. •Collaborate on design of investigative studies in support of development compounds. 5.Medical Writing Medical Writing consultants will be responsible for the preparation and submission of high-quality regulatory and other supporting documents for NIH projects. The consultants will coordinate with LDTs to prepare, edit, review, and submit documents to regulatory agencies (e.g., FDA) within project timelines. Documents may include but are not limited to clinical protocols, Investigational New Drug applications (INDs), Investigator Brochures (IBs), IND Amendments, Drug Master Files, and Statement of Investigators (Form FDA 1572). The role of the Medical Writing consultant may include but is not limited to the following responsibilities and tasks: •Work independently or as part of a team to gather, compile, write, and edit regulatory documents for submission to regulatory agencies. •Ensure that submissions meet format and content requirements applicable to FDA requirements in compliance with ICH guidelines. •Manage timelines for regulatory submissions. •Work independently to complete assigned projects •Maintain familiarity with current best industry practices and regulatory requirements that affect medical writing •Review and perform quality control (QC) on other documents as part of the overall clinical research process Specific Discipline Experience The following experience requirements are the minimum acceptable requirements for each consulting category: 1.Regulatory Affairs Regulatory Affairs consultants should demonstrate high-level expertise as follows: •An advanced degree (Master's or PhD) in a scientific discipline is required. •5 years' experience in the pharmaceutical or other related industry is required. •3 years hands-on Regulatory Affairs experience in the pharmaceutical industry dealing with drugs, biologics, medical devices, and/or combination products •Experience working directly with the FDA preferred •A good understanding of chemistry, analytics and pharmaceutical technology and in-depth understanding of the drug development process. •Proven track record of early recognition of potential regulatory issues especially with IND filings, distilling complex situations, sound risk assessment and overcoming hurdles. •Experience with the small molecule regulatory development process is required. •Neurotherapeutic experience desirable •Experience writing, editing, reviewing, and overseeing multiple IND filings and other regulatory documents. •Experience with the oversight of regulatory document preparation for outside organizations is preferred. 2.Phase I Clinical Pharmacology Phase I Clinical Pharmacology consultants should demonstrate high-level expertise as follows: •An advanced degree in a scientific discipline is required (MD or PhD). •5 years' experience in the pharmaceutical or other related industry with responsibility for early clinical trials is required. •3 years hands-on Phase I clinical experience in the pharmaceutical industry dealing both in-house and outsourced trials. •A good understanding of the drug development process. •Proven track record of early recognition of potential regulatory issues especially with IND filings, distilling complex situations, sound risk assessment and overcoming hurdles. •Experience with small molecule therapeutics is required. •Experience with the oversight of clinical protocol development for outside organizations is preferred. •Neurotherapeutic experience desirable •Familiarity with FDA regulations and International Conference on Harmonization (ICH) Good Clinical Practices (GCP) guidelines. 3.Business Development Business Development consultants should demonstrate high-level expertise as follows: •Bachelor's degree in life science, physical science, or related discipline; advanced degree preferred •At least 10 years of business development experience in the pharmaceutical or related industry •Working knowledge of the drug discovery and development industry •Experience facilitating start-up company formation and negotiating partnering agreements •Extensive biomedical technology development and commercialization experience •A proven track record of accomplishment in negotiating deals and partnering •Knowledge of regulatory aspects and business and product development expertise required to facilitate work across the science-business-regulatory interface •Experience in the small molecule area is preferred •Multidisciplinary biomedical research experience preferred 4.Electrophysiology Assay Development Electrophysiology Assay Development consultants should demonstrate high-level expertise as follows: •An advanced degree in a scientific discipline is required •Demonstrated electrophysiology expertise is required •Experience inventing high throughput cellular screening systems is required •Application of assays in industrial pharmaceutical discovery and development. •Application of automated technologies and robotics relevant to pharmaceutical assays. •Application of a diverse range of cellular techniques in pharmaceutical assays. •Self-organization, self-direction, critical thinking, and analysis skills. •Experience working with multi-disciplinary development teams at a senior level in the biopharmaceutical industry •Proven ability to take on a leadership role in a virtual, cross-functional team environment 5.Medical Writing Medical Writers should demonstrate high-level expertise as follows: •An advanced degree (Master's or PhD) in a scientific discipline is required. •A minimum of 5 years of direct regulatory and medical writing experience. •Experience with writing, editing, reviewing, and oversight of regulatory submissions, including but not limited to INDs, IBs, clinical protocols, and FDA response letters. •Excellent interpersonal, written, and verbal communication skills including the ability to effectively communicate with project teams and to lead virtual meetings to discuss documents. •Ability to effectively work in a virtual team environment. •Familiarity with Electronic Common Technical Document (eCTD) format •Familiarity with FDA regulations, ICH guidelines, and the drug development process •Experience with the oversight of regulatory document preparation for outside organizations is preferred. •Experience in the pharmaceutical/biotech industry or CRO environment preferred. 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 16, 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-15-106/listing.html)
- Place of Performance
- Address: 31 Center Drive, Bethesda, Maryland, United States
- Record
- SN03632246-W 20150205/150203235421-b1c7d0851791ef934a04e5978148977e (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 |