Our program incorporates four cross-cutting themes that will enable effective translation of therapeutics at scale:
- T1. Biomanufacturing and Bioprocessing
- T2. Translation to Clinical Trials
- T3. Surveillance and Diagnostics
- T4. Knowledge Mobilization
T1. Biomanufacturing and Bioprocessing
CIEBH’s vision is that all biomanufacturing facilities associated with the hub will become part of a national biomanufacturing platform system to accelerate flexible, nimble, cost-effective biomanufacturing development in Canada, providing support for early-stage clinical trials.
Under this theme, CIEBH will consider forward-looking, innovative technology development projects such as digital and robotic solutions that address translational bottlenecks by:
- improving raw material/supply chain management,
- optimizing bioprocessing, or
- developing process analytical technologies.
In addition, the creation of new physical facilities for flexible, nimble, early-stage biomanufacturing to address critical gaps is envisioned.
Multidisciplinary research and training activities related to this theme are expected to involve applied scientists from chemical & biological engineering, manufacturing, and biomedical engineering, as well as engineering physics, electrical, and mechanical engineering (e.g., for process analytical sensors and automated device development). CIEBH encourages industry collaborations at an early stage, thereby leveraging profitable industry-leading technologies and processes that are designed for scalability. Importantly, CIEBH aims to serve as the seed for the eventual creation and growth of medium to large Canadian biotechs with profitable commercial therapeutics.
T2. Translation to Clinical Trials
Planning for clinical trials in the earliest stages of the pipeline is essential to an accelerated and equitable response. This theme is focused on key objectives critical for rapidly translating applied research findings into products that can be tested in humans, including:
- preclinical/investigational new drug (CTA/IND)-enabling studies (e.g., toxicology, pharmacology),
- clinical research and early-stage clinical trials, and
- regulatory sciences.
Recent trends in this realm include the shift toward first-in-human trials largely moving from the pharma sector to facilities within the academic health sector to minimize risks. In addition, collaboration among the NIH, FDA, industry and academia enabled regulators to accelerate approval processes in response to COVID-19, and it appears these changes are likely to be long-lasting—including potentially full digitization process from bench to bedside.
Proposals should draw on insights and innovations in regulatory sciences, clinical trial design, and Gender-Based Analysis Plus (GBA+) to identify opportunities to accelerate projects and ensure EDI in research design is at the forefront of decisions as products in our pipeline move through these key steps.
Proposals should also incorporate an ability to estimate the potential value of a proposed product for key stakeholders that will support the translation of new early-stage technologies from bench to bedside and inform additional research and development activities and enable commercialization decisions.
Activities under this theme will address a key gap in the pipeline by supporting capacity building for first-in-human clinical trials through infrastructure investments and training programs to provide the HQP necessary to support and maintain such capabilities. The creation of new physical facilities for early-stage clinical trials is envisaged in partnership with health authority partners.
T3. Surveillance and Diagnostics
Pathogen surveillance is critically important globally and locally to track the emergence of high-risk pathogens. More details on objectives related to surveillance coming soon.
Development of diagnostics for pathogen identification is of utmost priority for pandemic preparedness. With SARS-CoV-2 detection, PCR became the gold standard and required CAP-accredited laboratories to ensure quality and sensitivity with limited population testing capacity. Point-of-care testing has become urgently required to reduce the pressure on primary and secondary care, with several platforms receiving regulatory approval. CIEBH will work with partners to continue to commercialize rapid pathogen tests for laboratory use and point-of-care. Through partnerships within and between hubs, the objective will be to overcome the barriers that existed across Canada for the immediate approval and deployment of point-of-care diagnostics for SARS-CoV-2.
T4. Knowledge Mobilization
This theme will seek to address the public’s receptivity and uptake of new immune-based therapies and influence the equitable adoption at a population level of therapeutics developed under CIEBH’s priority areas. Acceptability is a particular challenge. Another key challenge is the interplay of legal, regulatory, and health technology assessment, which creates a complex system for innovators to navigate, yet requires innovators to engage early and often. There is an urgent need for strategies to enable two objectives:
- development of affordable drugs, vaccines, and diagnostics that can be rapidly and equitably deployed within Canada’s health systems and
- rapid and sustainable growth in Canada’s biotechnology sectors.
To ensure innovations have the greatest potential to succeed in building Canada’s future, CIEBH will prioritize projects that synthesize and integrate perspectives from diverse disciplines, methodologies, and knowledge systems. We encourage projects to prioritize engagement with a diverse range of stakeholders—including patients and the public, particularly those from equity-deserving populations—through diverse and inclusive approaches and methodologies to understand the appropriate blend of laws, policies, and business practices that support these two objectives.
Evaluations of the impact of regulatory reforms of advanced therapeutic medicinal products and mechanisms such as public health orders to accelerate regulatory approvals on research and development costs will also be supported. These regulatory reforms lower the evidentiary threshold for market authorizations with terms and conditions, requiring data and analytics systems to be implemented to longitudinally monitor products in clinical use. The evidence may be insufficient to support one-time health technology assessment for payers to determine safety, effectiveness, and cost-effectiveness. Therefore, we will also support the development and implementation of life-cycle health technology assessment, supported by legal frameworks of managed access agreements to ensure that ineffective therapies can be removed from the market.
Related:
- View the four priority research pillars