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1. Title: Medical Writing Consultant Support Services

1. Classification Code/Title: R499 – Support-Professional: Other

1. NAICS Code/Title/Size Standard: 541690 – Other Scientific and Technical Consulting Services, $16.5 million

1. 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 the availability and capability of all qualified small business sources to perform a potential requirement.

This Notice is issued to help determine the availability of qualified small business sources 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 award a contract. Responses will not be considered as proposals or quotations. 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. This Notice is for research and information purposes only.

1. 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 apply that knowledge to enhance health, lengthen life, reduce illness and disability, and conduct, support, and make medical discoveries that improve people’s health and save lives. The National Institute of Neurological Disorders and Stroke (NINDS) is an institute within the NIH that conducts research into the causes, treatments, and preventions of neurological disorders and stroke. The NINDS mission is to seek fundamental knowledge about the brain and nervous system and use that knowledge to reduce the burden of neurological disease.

The NINDS intends to issue a solicitation seeking three, part-time Medical Writing Consultants to provide technical recommendations to support the translational development of neurological and pain therapeutics for NIH’s Blueprint Neurotherapeutics Network (BPN) drug discovery and development programs. Several such programs are being launched or expanded to provide support for investigators developing medicinal interventions for neurological disorders. The Medical Writing Consultants will support BPN’s Small Molecule and Helping to End Long-term® Addiction (HEAL) Pain Therapeutics Development Program (PTDP) by providing consulting services for candidate small molecule or biological therapeutics development.

The Early Phase Pain Investigation Clinical Network (EPPIC-Net) is a part of the NIH Helping to End Addiction Long-termSM (HEAL) Initiative. The HEAL Initiative is an aggressive, trans-NIH effort to speed scientific solutions to the current opioid crisis by improving prevention and treatment strategies for opioid misuse and addiction and to enhance pain management, via the development of effective, non-addictive treatments. EPPIC-Net is a sophisticated clinical trial network established to design and execute early phase (focused on Phase 2) clinical trials of promising non-addictive pain therapies in well-characterized patient cohorts with pain conditions of high unmet need.

EPPIC-Net accepts applications from academic and industry investigators with promising pain therapeutic assets, including drugs, biologics, and devices; proof-of-concept testing and validation of potential biomarkers may also be considered. Assets are reviewed in a three-stage application process: Stage 1: preliminary application, Stage 2: dossier application and Stage 3: protocol application. The preliminary application stage is open to all applicants; stages 2 and 3 are by invitation only. For selected assets, EPPIC-Net designs and conducts the clinical trial at no cost to the asset owner. Funding for selected protocols is provided to the EPPIC-Net infrastructure for conduct of the trial; ownership and intellectual property rights remain with the asset owner.

Each Medical Writing Consultant will be required to provide expert-level consulting on a part-time basis for assigned projects. The level of effort required of each Consultant is estimated at 20 - 800 hours per calendar year.

1. General Requirements:

The Contractor shall provide this support while serving on NIH BPN Lead Development Teams. Lead Development Teams (LDT) meet for approximately two hours every one to two weeks via teleconference and each LDT project may require between three and ten hours weekly, inclusive of meeting and preparation time.

Since members of the LDT may lack drug discovery and development experience it is essential the consulting services be provided in a manner that is both informative and collegial. The Contractor is expected to provide support services in a collaborative way. BPN Program Director or staff might want to discuss the program with candidates. The Contractor may be assigned to work on a number of projects in the exploratory through preclinical safety stages. Some projects may proceed to investigational new drug (IND) and clinical trial stages.

The Contract shall support EPPIC-Net. The Contractor shall work with invited applicants at the second stage of the application process to prepare a dossier document based on a template provided by NIH. The dossier shall include detailed information on the asset, such as that on drug pharmacology, device specifications, and preclinical and clinical safety/efficacy data, as applicable, based on information provided by the asset holder and, as needed, gathered by the Contractor independently. The Contractor is expected to participate in a one-hour introductory call and other calls, as needed, with the asset holder and/or EPPIC-Net staff to work on the dossier. The completed dossier, as approved by the applicant, should be provided to the applicant for submission to NIH within three weeks of the Contractor receiving the assignment from NIH.

1. Specific Requirements:

1. Medical Writing

Medical Writing consultants shall be responsible for the preparation and submission of high-quality regulatory and other supporting documents for NIH projects. The consultants shall 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) and drug dossiers. 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.

2. Drug Dossier Development

Drug Dossier Development consultants shall be responsible for the preparation and submission of high-quality Drug Dossiers for EPPIC_net. The Consultants shall coordinate dossier development with the Asset holder. The role of the Drug Dossier development 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 drug dossiers for submission to Asset Holder for onward submission to EPPIC-Net.

• Manage timelines for dossier submissions.

• Work independently to complete assigned projects.

• Maintain familiarity with current best industry practices and regulatory requirements that affect drug dossier development.

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