Public procurement notice: Voluntary Ex Ante Transparency Notice
Published: 2019-01-11
Buyer: University of Birmingham
Country: UK
Contract type: Supplies
Procedure: Contract award without prior publication
CPV classification: 85121200: Specialist medical services
Estimated value: 393850 USD
Award criteria: Lowest price

Technical requirements: The University of Birmingham have a strong healthcare product development pathway for pharmaceuticals, medical devices and diagnostics and their translation into clinical trials. The Healthcare Technologies Institute currently hosts a pipeline of products designed to prevent scarring in range of tissues around the body and aim to take through phase 1 and 2 clinical trials. Key to these projects is the establishment of pre-clinical safety as part of the regulatory application process for clinical trial. We require the services of a pre-clinical safety Contract Research Organisation (CRO) to execute a set of in vivo studies on an ocular eyedrop-based product containing a biologic drug.
The University of Birmingham have a strong healthcare product development pathway for pharmaceuticals, medical devices and diagnostics and their translation into clinical trials. The Healthcare Technologies Institute currently hosts a pipeline of products designed to prevent scarring in range of tissues around the body and aim to take through phase 1 and 2 clinical trials. Key to these projects is the establishment of pre-clinical safety as part of the regulatory application process for clinical trial. We require the services of a pre-clinical safety Contract Research Organisation (CRO) to execute a set of in vivo studies on an ocular eyedrop-based product containing a biologic drug. Critically, we require these services to commence within the next 2 months and issue draft reports within 6 months of start of studies. Services include but not limited to:
The University of Birmingham engages with numerous CROs with the capability to design, execute and report such studies for a range of other projects in our pipeline. However, this particular package of work is very time critical. We require a package of work to bridge a knowledge gap at the request of the UK’s competent authority on pharmaceuticals, the Medicines and Healthcare Products Regulatory Agency (MHRA). The data required must form part of our final Clinical Trial Application (CTA) submission planned in 2019. The University intends to contract these activities to ITR Laboratories Canada Inc. Namely, they:
— have a demonstrated track record of designing, executing, and reporting of pre-clinical safety studies for topical ocular products,
ITR Laboratories Canada Inc. has built a reputation over the last 25 years for toxicology testing by providing access to specialist testing services for the biotechnology and pharmaceutical industries in North America, Europe and beyond. Furthermore, ITR is a small-medium scale CRO enabling it to operate with short lead times, quick adaptability, price point flexibility and timeliness of delivery.
University of Birmingham has attracted significant funding over the last 4 years to develop a set of pharmaceutical wound care technologies from concept to product and taking them through phase clinical trials. The UK’s competent authority on Investigational Medicinal Products (IMPs) — the Medicines and Healthcare Products Regulatory Authority (MHRA) is responsible for reviewing Clinical Trial Applications (CTAs) from entities wishing to run a clinical trial on their proprietary IMPs. Part of this process involves reviewing the supporting safety and quality aspects of IMPs before authorising progression to clinical trial or otherwise request further supporting data in order to make a more informed decision. There are international standard guidelines on establishing safety of an IMP (ICH M3 (R2) “Non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals”). However, for IMPs with significant novelty from products on the market, it is not unusual for the MHRA to request further supporting data. Acceptance of existing data in the public domain on similar products is at the discretion of the MHRA on a case by case basis. While the project team generated safety data around the current product, the MHRA requested further work to be included in a CTA. The required data must come studies on the product to be used in the clinical trial and hence utilising any data in the field on other “similar” products would not be acceptable.
The University gained funding to support the additional studies with conditions to maintain timelines towards the opening of the clinical trial and submit a CTA in Q3 2019. This requires completion of the work and reporting within 6 months. Engagement with other CROs has established there is typical lead time of several months before studies start. This mainly due to the volume of work major CROs attract from major pharmaceutical companies covering a huge range of product types. Unfortunately, this does not enable us to meet the imposed timelines on the project.
ITR Laboratories Canada Inc. is a small-medium scale CRO with strong expertise in pre-clinical testing of ocular products with short lead times, quick adaptability, price point flexibility and timeliness of delivery. Their ability to complete the work and report within the timelines within the limited budget of our funding sources has been confirmed and thus presents the best option for delivering this particular product to clinical trial.


Winner: ITR Laboratories Canada Inc.
Award value: 393850