Therapeutic Categories of Interest: Key Examples of Conditions and Diseases
- Immunology & Inflammation, e.g., Asthma, Atopic Dermatitis, Chronic Obstructive Pulmonary Disease (COPD), Eosinophilic Esophagitis (EoE)
- Oncology, e.g., B-cell non-Hodgkin Lymphoma, Cutaneous Squamous Cell Carcinoma (CSCC), Melanoma, Solid Tumors
- Rare Disease, e.g., Fibrodysplasia Ossificans Progressiva (FOP), Myasthenia Gravis (MG)
We also welcome submissions for other Therapeutic Categories (Disease and Conditions), with threads set up in the Discusssions area for conditions where new medicines are being developed.
For additional disease areas of interest please review Regeneron’s drug development pipeline: Regeneron Pharmaceutical's Research and Development Pipeline
Track 1: RTM and RPM for RWD (Remote Therapeutic Monitoring and Remote Physiologic Monitoring for Real-World Data)
- Create a digital, scalable solution that brings patients and Healthcare providers (HCPs) closer by providing a modernized way to track and record symptom monitoring with remote monitoring and real-world data.
- RTM and RPM (remote therapeutic and remote physiologic monitoring) are poised to change the way patients and healthcare providers manage conditions. Additionally, with proper consent, the real-world data from these systems may change the landscape of clinical research.
- Submissions for Track 1 should clearly articulate and demonstrate how the solution achieves three main goals
- Use RTM or RPM to gather patient-reported outcomes and/or physiologic/sensor data to improve the monitoring of patients’ health, particularly in a way compatible with health insurance coverage. Therapeutic categories of interest are outlined below, and refer to the conditions and diseases where Regeneron is focused on developing new medicines.
- Gather data to be useful for real-world data (RWD) driven clinical research, particularly Patient Reported Outcomes (PROs) and digital sensor data beyond Electronic Health Record (EHR) and health insurance claims data. Example uses and contexts for RWD include Phase 4 post-approval understanding of how certain medications work in the real-world setting, and data used to develop digital biomarkers that correlate with and/or predict traditional disease progression measures.
- Do this in a way that is compelling for patients (adults and/or pediatric), caregivers, and healthcare providers
- Please see discussion board thread for Track 1 including trips, help and useful links for potential submissions and other helpful resources: https://regeneron.devpost.com/forum_topics/38325-track-1-remote-patient-monitoring-and-rwd-open-source-tools-and-resources
Track 2: Accelerating Clinical Trials
- Accelerating clinical trials means the process of speeding up the various stages of clinical trials, from design and patient recruitment to data collection and analysis. This can involve improving the efficiency of study design, enhancing patient recruitment and retention strategies, streamlining site selection and activation, and optimizing data collection methods. The goal is to reduce the time it takes to complete a clinical trial, thereby bringing potential new treatments to patients more quickly.
- Clinical Trials can be slow, expensive and resource-intense to run, placing potential new treatments further away from patients. For Track 2, submissions should focus on finding ways to accelerate clinical trials, from their inception in concept and study protocol design, to the monitoring and auditing of data gathered at clinical research sites.
- Please see discussion board thread for Track 2 including tips, help and useful links for potential submissions and other helpful resources: https://regeneron.devpost.com/forum_topics/38324-track-2-accelerating-clinical-trials-open-source-tools-and-resources
- The discussion board thread for Track 2 will have more examples of potential entry types that could help accelerate trials. These do not have to be patient-facing solutions, and indeed technology-enabled solutions can include predictive models (e.g. to predict the enrollment rate or success rate based on clinical trial design criteria), automatic search and summary tools to match and summarize clinical trial design elements for similar trials (e.g. inclusion & exclusion criteria; endpoints), and other more advanced trial-designer facing tools e.g. extracting details from unstructured clinical trial protocols, such as the Schedule of Events.
- Transcelerate Biopharma, a consortium of industry clinical trial sponsors, offers a Modernizing Clinical Trial Conduct process framework, for those who wish to learn more about the potential user journeys and needs to operate clinical trials, all the way from from concept to close-out. (External link to Transcelerate MCTC Process Frameworks)