BPN_Consultant_SOW_-_Final.pdf

NIH DRUG DISCOVERY AND DEVELOPMENT CONSULTING SERVICES

STATEMENT OF WORK

Background

The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people’s health and save lives.

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.

The NIH Blueprint for Neuroscience (BPN) Research, a consortium of 15 NIH Institutes and Centers that support neuroscience research, established the Neurotherapeutics Network as a pipeline between the typical endpoint of NIH-funded research and the beginning of industry drug development. The BPN provides neuroscience researchers with funding and access to a full range of industry-style drug development services and expertise. The program is intended for projects requiring medicinal chemistry optimization and contract research organization (CRO) support through phase I clinical testing. Each project is directed by a Lead Development Team (LDT) composed of the principal investigator (PI), industry consultants hired by NIH, and NIH staff. This team maps out a research strategy, including milestones, and oversees implementation by CROs. Bioactivity and efficacy studies are funded through an award to the PI; other research services are provided without cost to the PI through NIH contracts.

STATEMENT OF OBJECTIVE

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

SCOPE OF WORK

Each consulting contract will be specific to one or more areas of expertise as outlined in this Statement of Work, and will reflect the NIH time commitment needs for the specific areas of expertise.

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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.

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• 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

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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

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QUALIFICATIONS

General Experience

Consultants must have extensive experience in managing or being a senior leader in drug discovery and development projects in the biopharmaceutical industry. Experience with drug discovery and development for nervous system conditions is preferred. Broad experience across the entire drug discovery and development process is especially desired.

Consultants must be able to work in a virtual, cross-functional team environment and manage competing priorities.

Consultants must have strong interpersonal skills, an attention to detail, excellent organizational, writing, communication, presentation, and documentation skills as well as computer and software literacy.

Consultants must have knowledge and understanding of global regulatory regulations and guidelines.

Consultants must have experience working with multi-disciplinary teams at a senior level in the biopharmaceutical industry, especially teams with members from outside organizations and members at various management levels.

Experiences in team leadership, consulting, or service on strategic and advisory boards will be considered.

Specific Discipline Experience

The following educational and experience requirements are the minimum acceptable requirements.

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.

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• Experience with the oversight of regulatory document preparation for outside organizations is preferred.

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.

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

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.

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• 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

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.

Level of Effort

The NIH estimates that it will require the following labor hours for each of the specific disciplines as follows:

Year 1: Up to 800 hours Year 2: Up to 800 hours Year 3: Up to 800 hours Year 4: Up to 800 hours Year 5: Up to 800 hours

Year 2: Up to 800 hours Year 3: Up to 800 hours

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Year 2: Up to 800 hours Year 3: Up to 800 hours

Year 2: Up to 800 hours Year 3: Up to 800 hours

Year 1: Up to 2000 hours Year 2: Up to 2000 hours Year 3: Up to 2000 hours Year 4: Up to 2000 hours Year 5: Up to 2000 hours

Period of Performance

One base year with four subsequent option year periods.

Travel

Consultants may be asked to travel for one-day site visits for the launch of each project and for steering committee meetings for the Blueprint Neurotherapeutics Network. The consultant shall make his/her own travel arrangements. The COR shall assist the consultant in identifying a hotel at an acceptable rate, if an overnight stay is required.

The Government shall reimburse all reasonable travel costs. Airplane tickets must be purchased from a US carrier, at the coach/economy rate. The Government shall reimburse hotel costs for up to two nights per site visit, as well as food and incidental expenses. The consultant shall make a good faith effort to select travel options that are the most time and cost-effective, given the available options. The consultant shall make a good faith effort to keep food and incidental costs within the typical government per diem rate for the region. The consultant may bill up to 50% of travel hours to the Government, at the negotiated consulting rate.

Intellectual Property

Consultants who contribute to the creation of new intellectual property will be named as inventors according to US or prevailing patent law. Accordingly, consultants must complete negotiations with the principal investigator’s institution regarding assignment of rights and royalties distribution prior to advising on any activities. The consultant shall provide copies of all intellectual property agreements to the NIH COR, for documentation purposes.

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Confidential Treatment of Sensitive Information

The Contractor shall guarantee strict confidentiality of the information/data that it is provided by the Government or by persons or entities applying to or accepted to the Blueprint Neurotherapeutics Network during the performance of the contract. The Government has determined that the information/data that the Contractor will be provided during the performance of the contract is of a sensitive nature.

Disclosure of the information/data, in whole or in part, by the Contractor can only be made after the Contractor receives prior written approval from the Contracting Officer. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer.

Contractor agrees that it will not use the Confidential Information for any purpose except as set forth within this SOW, unless such time as such Confidential Information becomes public information through the efforts of participants in the Blueprint Neurotherapeutics Network.

IT Security Requirements

Please refer to the Combined solicitation synopsis for IT requirements.

The NIH anticipates awarding multiple consulting contracts under this solicitation.

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