Clinical trial framework for Patients with Crohn’s Disease & Permanent Ileostomy

1. Background Information

The University of Western Ontario (Western), the third largest university in Ontario, has a full and part-time enrolment of more than 45,000 graduate and undergraduate students and includes three affiliated University Colleges.  The Western campus covers 481 hectares and is located about 4 km north of the centre of London. Western’s campus has one main campus with over 100 buildings. In addition, Western has several offsite locations, including but not limited to, the Institute for Chemicals and Alternative Resources (ICFAR) located on Wonderland Road north and the Advanced Manufacturing Park (AMP) located off the Veterans’ Memorial Parkway, north of Highway 401 near Bradley Avenue. There are approximately 3,800 full-time faculty and staff.  An additional 5,000 part-time staff and faculty represent approximately 3,800 full-time equivalents.
 

2. Context

This Advance Contract Award Notice (ACAN) is aimed at communicating Western’s intention to issue a Purchase Order for the development of a framework for testing therapies in clinical trials for Patients with Crohn’s Disease(CD) and Permanent Ileostomy(PI) to Alimentiv located at 100 Dundas Street, Suite 200, London, Ontario, Canada.  However, before the contract is awarded, Western would like to give suppliers the opportunity to prove that they can meet the requirements set out in this advance notice by presenting a Statement of Capabilities during the posting period of 25 calendar days.
 

3. Statement of Capabilities

This document does not constitute a call for tenders.

Suppliers who consider themselves wholly qualified and who are available to meet the specified requirements may present a written Statement of Capabilities to the contracting authority named in this advance notice, by no later than the notice closing date. The Statement of Capabilities must clearly prove that the supplier has the necessary qualifications, capabilities, capacity, experience and resources to meet the deliverables set out in the advance notice.

If other potential suppliers present a Statement of Capabilities during the posting period and prove that they meet the requirements set out in the ACAN, Western will initiate a full tendering process through Bonfire and MERX public tendering service.

If no supplier presents a Statement of Capabilities meeting the requirements set out in this ACAN by the closing date and Western’s internal approvals, a purchase order will be awarded to Alimentiv.

4. Application

Most patients with Crohn’s Disease (CD) require at least one surgery over their lifetime due to consequences of uncontrolled inflammation, which include the development of complications such strictures, fistulae or abscesses. This increases their risk for formation of a permanent ileostomy (PI). Although progress has been made in controlling intestinal inflammation with several new drugs, we recently reported that patients with CD and PI have been universally excluded from all clinical trials evaluating new treatments.1 This is concerning as up to one-third of patients with PI can develop disease recurrence in the small intestine proximal to the PI, which typically requires medical therapy; furthermore 16% experience significant recurrence needing additional surgery.2 Evidence is lacking in this group of patients to guide optimal medical therapy. The pharmaceutical industry is poised to enter this area and multiple drugs are available due to the huge investment that has been made to treat luminal CD. However, without the necessary measurement tools to include patients with CD and PI into clinical trials, such as valid and feasible clinical trial endpoints, efficacy of new drugs cannot be evaluated in patients with PI. To address this challenge, we have assembled an international expert team with specific interest and expertise in the management of CD, evaluative instrument development, and clinical trials.

The overall goal is to build a drug development pathway for patients with CD and PI through creation and adoption of clinical trial endpoints that will enable inclusion into clinical trials of novel therapeutic agents.

A framework for testing therapies in clinical trials for patients with Crohn’s Disease (CD) and Permanent Ileostomy (PI).

 

5. Deliverables

The framework will involve the following deliverables:
 

1. A consensus process to provide a framework for optimal clinical care pathways for patients with CD and PI
2. A patient priority setting exercise to identify top research priorities for patients with CD and PI
3. Development of an Ostomy patient reported outcome measure
4. Development of an Ostomy Endoscopy Index
5. A global expert consensus to inform the optimal configuration of clinical trial endpoints and design for patients with CD and PI

6. Budget Limit

The available pre-tax budget for the Testing Therapies Framework, including shipping and training, is $1,750,000 CAD.
 

7. Deadline

Statement of Capabilities must be received by Western no later than December 22, 2023 12:00PM.
 

8. Statement of Capabilities Submission Instructions

All submissions and accompanying documents must be uploaded electronically at https://uwo.bonfirehub.ca.  Hardcopy submissions will NOT be accepted.
Suppliers are solely responsible for the delivery of submissions in the manner and time described.
 

1. Requested Files:

Organize your submission into the following individual files (note the required file types):
Statement of Capabilities Response- MS Word or PDF

Each file has a maximum size of 1000 MB. You will upload each file individually.
 

2. Technical Support:

Western is using a BonfireHub public portal for the submission process. Please contact Bonfire at Support@GoBonfire.com for technical questions related to submitting your documents. You can also visit their help forum at https://bonfirehub.zendesk.com/hc.
 

9. Submissions Must Be Submitted on Time at Prescribed Location

Statement of Capabilities submissions must be submitted in the method set out above on or before the Deadline. 

When submitting through Bonfire electronic bid submission, please note that submissions will be time stamped with the time at the end of the upload process not the beginning.

Submissions to Bonfire after the specified deadline will be rejected.
 

10. Western Primary Contact: Scott Roth sroth6@uwo.ca

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