RFP Attachment 4_TORFP and TOSOW.pdf

Task Order Request for Proposal (TORFP) No. 75N95021R00043

IDIQ Contract No.: TBD IDIQ Contract Name: CRO Support for NCATS Regulatory Affairs Support and Related Services Task Order No.: TBD Task Order Name: Preparation of an Investigational New Drug (IND) application with Food and Drug Administration (FDA) for a treatment for Jansen’s Metaphyseal Chondrodysplasia Task Order Areas: Performance Areas 1 and 2

I. TASK ORDER INFORMATION

A. Task Order Title: Preparation of an Investigational New Drug (IND) application with Food and Drug Administration (FDA) for a treatment for Jansen’s Metaphyseal Chondrodysplasia

B. Requirements: See attached Statement of Work for requirement details.

C. Task Order Period of Performance: The anticipated base period of performance is 18 months.

The period of performance may be extended if an option is exercised in accordance with FAR Clause 52.217-7 and 52.217-9. The entire period of performance, including all options, will not exceed three (3) years.

D. Task Order Type: The Government anticipates award of a task order with both fixed price and labor hour line items. The Government anticipates the following contract types for the tasks specified in the Task Order Statement of Work:

Task A (base): Firm Fixed Price Task B (option): Firm Fixed Price Task C (option): Labor Hour

II. TASK ORDER PROPOSAL INSTRUCTIONS

A. Technical Proposal Instructions: Please follow the instructions in Section L.2.(c): PHASE II INSTRUCTIONS: TECHNICAL PRPOSAL. The same Technical Proposal Instructions apply to the task order Technical Proposal.

B. Task Order Business Proposal Instructions: Please follow the instructions in Section L.2.(d):

PHASE II INSTRUCTIONS: BUSINESS PRPOSAL.

The task order includes Tasks A, B, and C. Tasks A and B are Firm Fixed Price and Task C is Labor Hour. Business Proposals should reflect a Firm Fixed Price approach for Tasks A and B and should reflect a Labor Hour approach for Task C.

C. Submission Instructions: Task Order proposals must be included within in, and submitted with, proposals for Solicitation No. 75N95021R00008. Proposals must be submitted by the time specified in Section A of Solicitation No. 75N95021R00008 and in accordance with Attachment 2, "Packaging and Delivery of the Proposal."

III. TASK ORDER PROPOSAL EVALUATION

The major evaluation factors for this task order RFP include technical and cost/price factors.

Although technical factors are of paramount consideration in the award of the task order, cost/price is also important to the overall task order award decision. The Contracting Officer will issue a task order to the contractor whose proposal is most advantageous to the Government.

The Government may conduct discussions prior to awarding Task Order or award a Task Order without discussions. The Government reserves the right to cancel a TORFP any time prior to Task Order Award. Upon completion of evaluations, the Contracting Officer will issue a task order to the Contractor.

A. Evaluation Factors

Task order proposals will be evaluated using the following evaluation factors (see also Section M.4 of Solicitation No. 75N95021R00008):

1. Suitability, feasibility, and completeness of the technical approach, including the subtasks to be performed.

2. Feasibility and efficiency of the Offeror’s proposed timeline to ensure the project will meet its goals in a timely manner.

3. Clear delineation of Sample Task Order deliverables.

4. Appropriateness and adequacy of the experience, expertise and qualifications for all proposed personnel including proposed consultants and subcontractors.

B. Cost/Price Evaluation

Task Order proposals will be evaluated for price realism and reasonableness. For a price to be reasonable, it must represent a price to the government that a prudent person would pay when consideration is given to prices in the market. Normally, price reasonableness is established through adequate price competition but may also be determined through cost and price analysis techniques as described in FAR 15.404.

In accordance with FAR Clause 52.217-5, Evaluation of Options, (July 1990), the Government will evaluate proposals for task order award by adding the total price for all options to the total price for the basic requirement, except when it is determined in accordance with FAR 17.206(b) not to be in the Government's best interests. Evaluation of options will not obligate the Government to exercise the option(s).

Statement of Work

Title: Preparation of an Investigational New Drug (IND) application with Food and Drug Administration (FDA) for a treatment for Jansen’s Metaphyseal Chondrodysplasia.

A. BACKGROUND AND INTRODUCTION

The Division of Preclinical Innovation (DPI) at National Center for Advancing Translational Sciences (NCATS) conducts translational research in human therapeutics development. DPI is collaborating with an academic organization in the development of a peptide as a treatment for Jansen’s Metaphyseal Chondrodysplasia (JMC), an ultra-rare skeletal disorder. The disease has a low prevalence with approximately 35 cases been reported in the medical literature. There is no approved treatment, so there is an urgent treatment need for patients of JMC disease.

Jansen metaphyseal chondrodysplasia (JMC) is a rare disease of skeletal development and mineral ion homeostasis with onset during infancy and no effective treatment. Hallmarks of the disease include bone deformities, extremely short stature, and chronic hypercalcemia/hypercalciuria, which typically leads to chronic kidney disease, eventually necessitating kidney replacement. JMC is caused by activating mutations in the parathyroid hormone (PTH) receptor type 1 (PTHR1), a G protein-coupled receptor (GPCR) that regulates critical biological processes in cells of kidney, bone, and the growth plate chondrocytes. The activating mutations of JMC disrupt these processes and lead to abnormalities in bone development and mineral ion homeostasis. DPI, is developing a treatment by blocking receptor overactivity using a peptide. The peptide is being evaluated as a therapeutic candidate for JMC to support an Investigational New Drug (IND) application.

B. SCOPE AND OBJECTIVES

The scope of this TO is for the preparation, submission and maintenance of an IND application to the FDA to support the therapeutic candidate for JMC.

Specific objectives include, but are not limited to:

1. IND planning and regulatory strategy support

2. Prepare and file a complete IND

3. Provide post-IND filing regulatory support

C. GENERAL REQUIREMENTS

1. Project Management

The Contractor shall provide project management for its own core team to ensure planning, execution, delivery of reports, and accurate and timely communication with the Contracting Officer’s Representative (COR), Contracting Officer (CO), and other stakeholders.

The Contractor shall manage either face-to-face or telephone team meetings on a biweekly basis, to keep the COR and the project team apprised of project progress including any issues or problems. The meeting frequency may be altered at the direction of the COR. The Contractor shall be responsible for securing a physical location for the meeting or a suitable call-in number and passcode for the relevant participants and be responsible for moderating the meeting.

At least twenty-four hours prior to the team meeting, the Contractor shall submit a Pre-meeting Status Report that documents the efforts performed in the completion of each task.

Within forty-eight hours following the team meeting, the Contractor shall submit Post-Meeting Minutes that includes, at a minimum, a summary of any action items resulting from the meeting.

The Contractor shall create and maintain a file (government preference is excel table format but Contractor can also propose format to be approved by COR) documenting all applicable IND Modules and sections, and the status of each document (e.g., drafted, commenting, QC, publishing, etc.) under the corresponding Modules and sections. The Contractor will keep this file in shared location for the Government, and will update the document on a weekly basis, to keep the Government informed of the status of all IND documents.

In addition, the Contractor shall immediately contact the COR if there are any adverse results or difficulties with the study that would impact the project or timeline. The communications shall include proposed solutions.

2. Standard Operating Procedures

The Contractor shall follow all site-specific standard operating procedures (SOPs). If a deviation from an SOP is required, the Contractor shall notify the COR of the deviation and document as appropriate. At the request of the COR, the Contractor shall submit to the Government any SOPs, method descriptions, and references used in the implementation of studies. The Government will treat Contractor SOPs as confidential.

3. Record Retention

The Contractor shall document and provide all data, information, and records required for the writing of any documents (related to regulatory submissions or otherwise) used to support NCATS related programs.

The Contractor shall retain copies of all drafted documents for the Government; all communication exchanges with the Agency on behalf of the Government; and all communications with DPI. The transition/relocation of these documents should be addressed in the Transition Plan.

Upon study completion, the Government may require all study documentation be placed in secure storage for a period of up to seven years. During this period, the Contractor shall be responsible for the integrity and organization of the material and its confidentiality. At the end of the period, all such documentation will be transferred or disposed of at the direction of the COR.

4. Government-Furnished Data

The Contractor will have access to any data and materials available at NCATS or the NCATS partner related to the task order that the Government deems necessary to successfully perform under the task order. The Contractor will relocate/dispose of any Government-furnished data and materials at the end of each task order in accordance with the approved Final Transition Plan.

D. TECHNICAL REQUIREMENTS

In the performance of these tasks, the contactor shall ensure compliance with all applicable FDA IND regulations, policies, and procedures. Upon issuance of a task order, the Contractor will provide services related to the following:

1. Task A (Base): The contractor shall provide the planning and preparation for the IND. Specifically the contractor shall:

a. Conduct a Kick-off meeting within three weeks of task order execution where the contractor will present the plan for IND preparation to the Government. This presentation is to familiarize project team members with the project and shall include, at a minimum, the following topics:

i. Introduce contractor regulatory project manager and subject matter experts (SMEs) for the major disciplines (e.g., Pharmacology/Toxicology, CMC, and Clinical)

ii. Project Overview

iii. Project Schedule (high-level)

iv. Objectives and Definitions

v. Process

vi. Deliverables

vii. Roles and Responsibilities of the government and contractor team

viii. Resources

ix. Success Measures

x. Next Steps

xi. Questions and Answers (Q&A)

b. The contractor shall review the material provided by the government and present their assessment and any gaps in preparation for complete IND submission, including a timeline, to ensure that all key studies required for regulatory filings are included.

c. The contractor shall originate all draft documents for applicable sections of all IND modules.

After review by the government project team, the contractor shall finalize all IND documents, in compliance with electronic Common Technical Document (eCTD) format.

d. The contractor will assist in the writing of IND enabling preclinical proof of concept study reports (up to three) that were conducted in an academic laboratory.

2. Task B (Option): The contractor shall provide eCTD publishing capabilities for the IND submission, compliant with FDA eCTD regulations and guidance.

a. The contractor shall submit and file the finalized IND submission through FDA Gateway in eCTD format.

b. The contractor shall ensure functionality of document hyperlinking and usability across all IND modules in the eCTD submission.

c. The contractor shall be responsible for rectifying any non-compliance filling issues related to the eCTD submission of the IND submission.

d. The contractor shall maintain official FDA correspondence documentation and file.

3. Task C (Option): The contractor shall provide post-IND filing support. For the filed IND, the contractor shall provide regulatory support services for maintenance activities which may include but are not limited to the following:

a. During the initial IND 30-day FDA review period, the contractor shall provide regulatory support and strategy in response to any issued FDA request for information (RFI). In the event of a clinical hold, the contractor shall continue to provide regulatory strategy and support in addressing FDA issued Clinical Hold letter and comments, and the drafting of a Responses to Clinical Hold.

b. Preparation and filing of documents such as:

i. IND amendment, including but not limited to protocol amendments, responses to FDA issued RFIs.

ii. Documents required for the IND Annual Report.

iii. Meeting request and packages with FDA.

iv. Safety reports for all FDA reportable serious adverse events (SAEs).

ANTICIPATED LEVEL OF EFFORT FOR TASK C: 230 HOURS

E. TASK ORDER REPORT AND DELIVERY SCHEDULE

Satisfactory performance of the task order shall be deemed to occur upon performance of the work described in this Statement of Work and upon completion, delivery, and acceptance by the Contracting Officer, or duly authorized representative, the below listed deliverables. The deliverables shall be delivered F.o.b. Destination as set forth in FAR Clause 52.247-35, F.o.b. DESTINATION, WITHIN CONSIGNESES PREMISES (APRIL 1984) and in accordance with the specifications stated in Section D of the IDIQ contract.

All deliverables listed below must be submitted in the required format and in accordance with Agency regulations and requirements, as applicable.

Item Description Delivery Method

Delivery Schedule

Pre-meeting Status Report

Status report that documents the efforts performed in the completion of each task.

This shall include, at a minimum, the following information:

• Program status, to include objectives met, work completed, and outstanding work.

• Notable achievements.

• Issues or obstacles impeding progress and recommended solutions.

• Description of work completed and plans for next reporting period.

• Agenda for corresponding team meeting.

• Status of deliverables/milestones.

• Issues and resolutions.

• Resource planning/status.

Electronically to all team meeting participants

At least 24 hours prior to team meeting

Post-Meeting Minutes

Minutes that include, at a minimum, a summary of any action items resulting from the meeting.

Electronically to all team meeting participants

Within 48 hours after team meeting

HHS Contractor Non-Disclosure Agreements

A signed and witnessed non-disclosure agreement for each contractor/subcontractor employee

Electronically to the COR and CO

Prior to the employee performing any work under the task order

Project Kick-Off Meeting Presentation (Task A)

A project kickoff meeting presentation to familiarize project team members with the project. The presentation shall include, at a minimum, the following topics:

• Introduce contractor regulatory project manager and subject matter experts (SMEs) for the major disciplines (e.g., Pharmacology/Toxicology, CMC, and Clinical)

• Project Overview

• Project Schedule (high-level)

• Objectives and Definitions

• Process

• Deliverables

• Roles and Responsibilities

• Resources

• Success Measures

• Next Steps

• Questions and Answers (Q&A)

Electronically to the COR and CO

Once, within 3 weeks after task order execution. Note: The kickoff slides must be provided to the COR at least 5 working days prior to the presentation to provide sufficient time for the COR to review and provide input on the material and request revisions if necessary.

Communication and Management Plan (Task A)

The plan must cover the following at a minimum:

• Project Overview o Project Description o Project Scope o Assumptions o Constraints

• Project Organization o Project Structure o Roles and Responsibilities

• Project Timeline o Schedule for documents/drafts of IND sections/modules

• Work activities, methods and communication tools for project activities and documents

Electronically to the COR and CO

Once, within 6 weeks after task order execution.

IND Preclinical Study Reports (Task A)

IND enabling study report for each identified preclinical efficacy study identified by the Government in a format for IND submission. The Government

Electronically to the COR and CO

Within 3 months after study information provided anticipates up to three study reports will be needed.

IND (Task A) A complete and finalized IND regulatory package with all documents and forms in compliance with eCTD format, in addition to all final Microsoft word or pdf files used to generate eCTD files.

Note: the vendor may expect approximately three rounds of draft review and commenting by the Government before finalizing the IND package.

Electronically to the COR and CO

Within 2 months after all IND enabling study reports have been provided

IND filing with FDA Task B (option)

Electronic filing of the IND with FDA in eCTD format and providing any correspondence with FDA.

Electronically to the FDA, COR, and CO

TBD upon execution of option

Post-IND filing documentation Task C (option)

Formal IND amendments (e.g., responses to clinical hold, responses to FDA request for information, IND annual report, Serious Adverse Events (SAEs), etc.).

Electronically to the FDA, COR, and CO

TBD upon execution of option

Transition Plan A transition plan for an orderly and complete transition/relocation of the task order resources to a successor contractor or to the Government. This plan shall detail on the relocation/disposition of: all drafted documents for the Government; all communication exchanges with the Agency on behalf of the Government; unused materials and supplies; manuals and directories developed by the contract; all contract-developed database programs, entries, and file; and all other government property not listed.

Electronically to the COR and CO

At least 45 calendar days prior to task order expiration