Our product portfolio reflects the true collaborative spirit of Regeneron, and end-to-end research and development capabilities power our clinical pipeline. Our Research and Preclinical Development team discovers promising new drug compounds. From there, Global Development brings these investigational candidates through the full clinical development process, from trial design to study execution and lifecycle management.
With approximately 35 investigational medicines in our clinical pipeline, including 12 in late-stage development, we are well-positioned to grow and to help millions of patients around the world.
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Regeneron’s senior vice president, development operations and portfolio management, discusses clinical trial accessibility.
Regeneron aims to be at the forefront of patient-centric clinical trial innovation, and we are making strides across three key areas:
Clinical trial design: Through remote data collection and decentralization we intend to relieve the burden on study sites so they can provide better care and make clinical trials more accessible to patients. Our patient-focused approach involves surveying patients to understand their needs and preferences, then applying that feedback to customize our approach to clinical trials.
Data collection: Digital biomarkers, collected using digital health technologies such as watches, insoles, eyeglasses and even home-based Wi-Fi boxes, can seamlessly amass more objective data. In 2023, we are scheduled to open a Digital Biomarker Lab housing specialized facilities and equipment for the verification, design, simulation and testing of wearable devices and non-contact sensors. These capabilities will allow us to accelerate the development of biomarkers and advance novel endpoints, potentially making trial data more robust, more reliable and less burdensome for patients. We are hosting a Digital Biomarker Summit where industry, technology companies, academia and regulators will share best practices, ongoing work with digital health technologies and digital biomarkers with the goal to propel the industry forward through education and collaboration. The Summit will showcase examples across a variety of domains, including motor function/mobility, cognitive function, sensory function and physiological measurement. Additionally, the Summit will demonstrate how design thinking methodologies play a key role in developing digital biomarkers and discuss regulatory guidance and frameworks to help the development and implementation of novel digital endpoints within clinical trials.
Data and advanced analytics: We are embarking on ways to allow study sites to reduce the burden of manual data entry and directly and securely transmit key information, with faster speed and lower error rates. Similarly, artificial intelligence and machine learning are improving our data granularity, revealing real-time insights. Patient privacy is of the utmost importance, and technology also helps protect privacy by encrypting patient identities for statistical analysis.
1 In collaboration with Bayer outside of the U.S.
2 In collaboration with Sanofi
3 In collaboration with Zai Lab in mainland China, Hong Kong, Taiwan and Macau
4 In collaboration with Alnylam
5 In collaboration with Intellia
This section contains investigational products not yet approved by regulatory authorities.
Biologics License Application (BLA) in wet AMD, DME
and diabetic retinopathy accepted for Priority Review by FDA
Reported that Phase 3 trials in wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME) met their primary endpoints
Reported that Phase 3 trial in eosinophilic esophagitis (EoE) in pediatrics (1 to 11 years of age) met its primary endpoint
Announced the primary and all key secondary endpoints were met in a Phase 3 trial in chronic obstructive pulmonary disease (COPD) with evidence of type 2 inflammation
Stopped one of the Phase 3 trials in chronic spontaneous urticaria (CSU) (in patients refractory to omalizumab) due to futility, based on pre-specified interim analysis
Initiated an additional Phase 3 trial in CSU (in biologic-naïve patients)
Presented positive data from the Phase 2 trial in neoadjuvant cutaneous squamous cell carcinoma (CSCC) at the European Society for Medical Oncology (ESMO) Congress 2022 and published in The New England Journal of Medicine
Presented positive data from the Phase 1 trial (in combination with Libtayo®) in advanced melanoma at ESMO Congress 2022
Presented positive initial data from the Phase 1 trial (in combination with Libtayo) in non-small cell lung cancer (NSCLC) at ESMO Immuno-Oncology Congress 2022
Presented positive initial data from the monotherapy dose escalation portion of Phase 1/2 study in platinum-resistant ovarian cancer at the ESMO Congress 2022
Reported preliminary data from the dose escalation portion of Phase 1/2 study (in combination with Libtayo) in prostate cancer
Presented positive initial data from the dose escalation portion of Phase 1/2 study in MET-altered advanced non-small cell lung cancer (NSCLC) at the ESMO Congress 2022
Presented positive data from two cohorts of pivotal Phase 2 study in patients with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) at the 2022 American Society of Hematology (ASH) Annual Meeting
Completed enrollment in pivotal Phase 2 study in multiple myeloma
Presented positive data from pivotal Phase 2 study in multiple myeloma at the ASH Annual Meeting
Reported positive interim data from Phase 1 trial in transthyretin (ATTR) amyloidosis
Reported preliminary data from the Phase 1 study in nonalcoholic steatohepatitis (NASH)
Reported results from a Phase 3 trial in children 5 to 11 years of age with HoFH met its primary endpoint
1 In collaboration with Bayer outside of the U.S.
2 In collaboration with Sanofi
3 In collaboration with Zai Lab in mainland China, Hong Kong, Taiwan and Macau
4 In collaboration with Intellia
We invent and research potential new medicines for a broad range of serious conditions. Learn more about our work to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases.
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