Identify and Prioritize Children’s Needs Using a Patient-Driven Approach
Many medicines that are currently used for children are compounded either by a health care provider or at home by their parents. Although today’s way of compounding provides access to many medications for the pediatric population, this is not without any challenges. As such, we aim to increase the availability of pediatric formulations with highest pharmaceutical grade standards, avoiding manipulation of adult formulations.
By increasing the number of medicines formulated for children, we aim to improve safety, efficacy and compliance of medicines used in children.
One of our priorities is to determine the medicines most in-need and find ways to make these medicines available commercially. As a first step, we are developing a national list of the most commonly compounded medicines in collaboration with pharmacists associated with Canadian pediatric academic health centres. This list is dynamic and will be updated periodically.
Partner with Pharmaceutical Companies to Develop Pediatric Formulations for Children
We are approaching pharmaceutical companies to seek partnership to facilitate the regulatory approval and commercialization of pediatric formulations for the currently compounded medicines most in need in Canada.
For the pharmaceutical partner, who will be the sponsor of the regulatory application, this will mean:
- Bringing to the Canadian market already existing pediatric formulations that are approved and available in other countries
- Developing pediatric formulations when they do not exist
Our business model is that we will partner with pharmaceutical companies to build a dossier to bring to regulatory agencies (e.g., Health Canada). The Centre will build a development plan, called a “PERFORM Plan”, for each drug of interest. The PERFORM covers the following aspects:
- Outline of clinical uses of the drug in pediatrics and formulation needs according to age groups
- Summary of published pediatric pharmacokinetic, efficacy, and safety data
- Systematic review and meta-analysis in the case of a submission relying on Third Party Data to Health Canada
- Description of existing pediatric formulation(s), if any, and indications for which they have been approved in other jurisdictions
- Identification of knowledge gaps, if present
If needed, the PERFORM plan may include the design of pediatric studies (including pharmacokinetic, bioequivalence, efficacy, and safety studies) needed in order to fulfill regulatory requirements for approval. The Goodman Centre can also take a leadership role in the undertaking of pediatric studies.
Our experienced team is available to attend meetings with regulators to support any regulatory applications.