CRO Support for NCATS Regulatory Affairs Support and Related Services

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. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. Please note that to qualify as an eligible small business for purposes of a small business set-aside, at least 50% of the cost of contract performance incurred for personnel must be expended for employees of the small business awardee (see FAR 52.219-14 Limitations on Subcontracting). Background The Division of Preclinical Innovation (DPI) at the National Center for Advancing Translational Sciences (NCATS) conducts translational research in human therapeutics development. DPI aims to move small molecule and biologic drug candidates forward in the drug development pipeline to predetermined milestones, at which point, DPI will hand off the drug candidate to external partner(s) to bring the novel therapy to patients. In addition to developing new candidate drugs, DPI seeks to advance the entire field of drug discovery and development by encouraging scientific and technological innovations aimed at improving success rates in the crucial pre-clinical stage of drug development. DPI's model is to operate as a full range small molecule and biologics drug development organization, moving drug candidates through each phase of the pre-clinical drug development process until an IND is filed with the US Food and Drug Administration (FDA), and, on a case by case basis, to continue into clinical development studies. DPI conducts drug development as collaborations through programs such as the Therapeutics for Rare and Neglected Diseases (TRND) and the Bridging Interventional Development Gaps (BrIDGs) programs. DPI drug development programs originate from academia, industry, non-profit foundations, or internally from NCATS and other NIH institutes, and its R&D operational strategy is to combine the capabilities of DPI in-house staff and DPI partners, who may be the drug originators. Each drug program operates in a multi-disciplinary, multi-partnership matrix team environment, and a DPI program officer is responsible for the overall planning, execution, and reporting of the program. Contract research organizations (CROs) and contract manufacturing organizations (CMOs) provide DPI with manufacturing, pharmacology, toxicology, regulatory, and clinical operations services to assist with drug development. Planning and execution of each individual drug development program includes identification of scientific and regulatory areas best suited for utilization of CROs and CMOs to conduct some or all parts of a given drug development program. One of the DPI program requirements is to support the development of projects throughout the phases of preclinical development and, in some cases, into clinical development. DPI has a need for both preclinical and clinical regulatory support so that projects can meet the regulatory requirements of the FDA and other non-US regulatory bodies. Therapies under development can cover a wide range of modalities, such as small molecules and biologics (e.g. antibody, proteins, and cell and gene therapy), and can be at different stages of pre-clinical or clinical development that requires varying levels of support. Project Requirements The objective of this contract is to support the DPI drug development programs by providing regulatory affairs services that can fully support drug development projects from pre-clinical through clinical phases to accomplish the requested tasks. Written capability statements should demonstrate your organization's in-house ability and related experience in all of the following Technical Areas: I. Technical Area 1: Regulatory Affairs Support and Strategy The Contractor shall provide services related to regulatory affairs for therapeutics under development. The Contractor shall work closely with the key stakeholders to ensure development of the best IND package for filing that will support the clinical plan of study. Activities may include, but are not limited to, defining a regulatory strategy; optimizing preclinical and clinical regulatory timelines and costs; ensuring that all key studies required for IND filing are included and strategically planned; ensuring regulatory compliance; and providing proven SOPs, templates, and industry best practice for regulatory services. II. Technical Area 2: pre-IND Regulatory Activities The Contractor shall provide services related to the pre-IND process such as the preparation of materials and meetings/interactions with FDA. Activities may include, but are not limited to, obtaining and reviewing preclinical and clinical information; preparing type B pre-IND meeting request letter; preparing and submitting pre-IND briefing package; working with FDA project managers; managing pre-IND meeting rehearsal; managing post-meeting communications; and conducing debriefing with program team. III. Technical Area 3: Preparation and Filing of IND The Contractor shall provide services related to the preparation and filing of IND. Activities may include, but are not limited to, conducting IND kick-off meeting; defining IND filing strategy; preparing all modules of the IND in eCTD format; providing all quality control during the process of reviewing, formatting, and publishing the IND in both electronic/hard copy and/or CD/DVD format in accordance with FDA requirements; providing post-IND filing support; and providing regulatory support for maintenance activities for filed INDs. IV. Technical Area 4: Regulatory Services for Clinical Studies The Contractor shall provide regulatory services for clinical studies if or when a development program's scope includes but is not limited to conducting human clinical trials, natural history studies, or patient finding studies. Activities may include, but are not limited to, interacting with US FDA, EU EMA, and regulatory agencies worldwide; plan and request additional FDA meetings; track and manage study related regulatory documentation; and providing clinical protocols and clinical trial consultants, reviewing, monitoring, and managing clinical studies and study material/data to ensure that the study is conducted, recorded, and reported in compliance with FDA Good Clinical Practice (GCP). V. Technical Area 5: Assisting in Regulatory Filings for Orphan Drug Designation and to other expedited regulatory pathways such as Breakthrough Therapy Designation, Pediatric or Neglected Disease Voucher, Fast Track, Accelerated Approval etc. for US and EMA, or other non-US regulatory bodies. The Contractor shall provide services related to preparing required documents and managing filing process for US and for non-US regulatory bodies (i.e., EU EMA, Health Canada, etc.). VI. Technical Area 6: Regulatory and Scientific Consulting Services and Subject Matter Expertise The Contractor shall provide scientific and technical consultants and subject matter expertise (Ph.D or MD level preferred) as required by the IND enabling and clinical studies being conducted in support of DPI therapeutic development programs (For example, in CMC services, toxicology, clinical etc.). Services may include, but are not limited to, designing studies; writing protocols; providing technical guidance; managing studies at CROs; reviewing data; and preparing and reviewing study reports and summaries. Additional Information It is anticipated that, for every task order issued under this contract, the contractor's responsibilities shall also include, but not be limited to, providing project management for its own core team and conducting biweekly teleconferences with NIH; providing all data, information, and records required for the writing and submission of Investigator's Brochures and Investigational New Drug, New Drug, and Biologics License applications; and ensuring an orderly, secure, and efficient transition of task order related materials and activities to the successor contractor or to the Government. Contract Type and Anticipated Period of Performance The Government anticipates making multiple Indefinite Delivery/Indefinite Quantity (ID/IQ) type contract awards under the future solicitation-with the eventual contract being administered and funded via Task Orders (TO). The Government anticipates awards will be made in the third quarter of FY2020. Required Information All capability statements must provide the following: (1) DUNS number; (2) organization name; (3) organization address; (4) point of contact; (5) point of contact title, address, telephone, and email address; and (6) size and type of business (e.g., 8(a), HUBZone, etc.) pursuant the applicable NAICS code. Submission Instructions and Due Date Written capability statements must be SUBMITTED ELECTRONICALLY NO LATER THAN 11:59 A.M. EASTERN DAYLIGHT TIME (EDT), THURSDAY, APRIL 18, 2019, to Jeffrey Schmidt, Contracting Officer, at jeffrey.schmidt@nih.gov with a copy to Kimberly Espinosa, Contract Specialist, at kimberly.espinosa@nih.gov. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in 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 a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. 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).