Basking Ridge at Regeneron.

Jaclyn Patterson

With over two decades of hands-on experience in the industry, Jaclyn Patterson currently oversees clinical trial management for a portion of Regeneron’s clinical trial portfolio and is also site head at Regeneron’s office in Basking Ridge, New Jersey. Her key responsibilities entail approving operational strategies and designs for clinical trials, including sourcing models, vendors, countries, sites, timelines, and budgets.

Please tell our readers about your key roles and responsibilities in the organization.

My primary responsibility as ahead of clinical trial management at Regeneron is to provide leadership to a department of 200 clinical trial management staff. This involves overseeing the execution of Regeneron's clinical trial portfolio with a focus on early development and clinical experimental sciences, general medicine, and phase four real-world evidence. 

My role also involves advocating for my team and providing the necessary resources, processes, tools, and technologies to drive trial execution from early design to clinical study reports and submissions. 

As the site head for the Basking Ridge campus, I ensure cohesiveness within the campus and with other locations, particularly the headquarters in Tarrytown, New York. I focus on maintaining the continuity of culture and ensuring that the spirit of the headquarters is reflected in our New Jersey campus.

What are the challenges that you have observed in the industry?

As with any other industry, the clinical trials industry has its own set of challenges. We are facing challenges in adapting trial designs to meet the needs of patients, whether that is through decentralized clinical trials (DCT) or minimizing the burden of trial procedures. Despite efforts to improve trial designs, clinical trial execution remains complex. The challenge is to strike a balance between fully testing our investigational products and ensuring that we are not overburdening patients. Patient centricity is evolving with the use of AI in DCT, and we are seeing changes in the way clinical trials are designed.

What are recent trends prevailing in the industry?

The clinical trial industry is undergoing a technological revolution to enhance efficiency and optimize processes. As one of the heads of clinical trial management at Regeneron, I oversee the integration of these technologies in our clinical trials. Predictive data is being used to accelerate trial start-up timelines by providing historical performance indicators, and simultaneous activities are being conducted to reduce white space and create efficiencies. We are exploring the use of AI to automate manual processes, including metadata entry in TMF systems. Moreover, we are ensuring that clinical trials are data-inclusive by utilizing available data sources to supplement patient data and ensuring we are designing our clinical trials to collect only necessary data for informed decisions.

How do you envision the future of the industry?

The future of the industry is moving toward more collaborative partnerships between sponsors and CROs, with a focus on leveraging each other's strengths and expertise to execute clinical trials globally. We need to think differently about how we manage processes and technology to enable individuals to deliver successful outcomes. This may involve integrated approaches for delivery and reducing overlaps in roles. I see a trend toward making these partnerships more meaningful and successful through bi-directional benefits, requiring a pragmatic and out-of-the-box approach. Ultimately, this evolution in clinical trial management will lead to more efficient and effective trial execution, benefiting both patients and the industry as a whole.