Case Study
Accelerating a Novel Lupus Pipeline
During the COVID-19 pandemic, we collaborated with Eli Lilly and Company to identify and recruit 20 trial sites in under 30 days.
BUSINESS CHALLENGE
Lilly, a world leader in immunology, faced the challenge of accelerating a robust lupus pipeline and starting a Phase 2 clinical trial in a highly competitive environment and under the constraints of the COVID-19 pandemic.
SOLUTION
Lilly engaged Lupus Therapeutics to help prioritize its pipeline and accelerate a high-priority drug candidate into a clinical trial within our Lupus Clinical Investigators Network (LuCIN).
RESULTS
- We prioritized Lilly’s pipeline with input from LuCIN key opinion leaders
- We provided expert protocol review and design services to facilitate FDA approval for the Phase 2 trial
- We identified and recruited 20 trial sites within LuCIN for the study in under 30 days
- We facilitated and supported Lilly in study start-up activities that successfully shortened the timeline despite the pandemic
Prioritizing the Pipeline for Success
Lupus Therapeutics helped Lilly convene a scientific advisory board of expert key opinion leaders to evaluate the company’s pipeline of potential lupus drug candidates. Our advisors then vetted the candidates and provided recommendations for which to prioritize, along with a detailed overview of the specific patient populations needed to evaluate each one. These efforts not only helped Lilly focus on the most promising candidates, but also made the potential of Lilly’s pipeline visible and exciting to thought leaders in the lupus community.
Designing Patient-Centric Human Trials
Once we aligned on priority clinical trial candidates with Lilly’s senior leadership, we collaborated to design and ultimately obtain FDA approval on a Phase 2 clinical trial protocol.
Identifying Clinical Trial Sites at an Accelerated Pace
Upon receiving FDA approval for the trial protocol, we identified, prioritized, and engaged academic sites within LuCIN that would put the company in the best position for a rapid trial start-up. Despite the COVID-19 pandemic, we secured interest from and formally conducted feasibility with 35 LuCIN academic sites in just 30 days. This allowed rapid prioritization and identification of sites to engage.
Holding Investigators and Sites Accountable for Success
We implemented protocols that hold investigators and sites accountable for trial success and are currently working with Lilly to recruit and engage patients in the Phase 2 study.
Catalyzing Lupus Clinical Research Together
We help move research forward faster with our suite of medical and scientific consulting services and our expansive, proprietary network of clinical trial sites at leading academic research centers throughout North America, known as our Lupus Clinical Investigators Network (LuCIN).