Advancing a Novel Lupus Pipeline in Breakneck Speed

Despite an active pandemic, Lupus Therapeutics identified and recruited 20 trial sites in 30 days.

Advancing a Novel Lupus Pipeline in Breakneck Speed

Despite an active pandemic, Lupus Therapeutics identified and recruited 20 trial sites in 30 days.

Partnering with Eli Lilly and Company from pipeline prioritization to clinical trial site recruitment

Business Challenge
Prioritize, rapidly advance a robust lupus pipeline, and start up a Phase 2 clinical trial within a highly competitive environment during a global pandemic.

Solution
Lilly, a world leader in immunology, engaged the full suite of Lupus Therapeutics services to help prioritize its pipeline and quickly advance a high-priority drug candidate into a clinical trial utilizing its Lupus Clinical Investigators Network (LuCIN).

Results

  • Prioritized pipeline with input from North American lupus key opinion leaders
  • Provided expert protocol review and design services to facilitate securing FDA approval for Phase 2
  • Identified and recruited 20 trial sites within LuCIN for study inclusion in less than 30 days
  • Facilitated and supported Lilly in study start-up activities decreasing trial start-up timelines despite global pandemic

Detailed overview

Prioritizing the pipeline for success 
Lilly’s initial engagement with Lupus Therapeutics included convening a scientific advisory board of expert key opinion leaders to evaluate the company’s drug development pipeline of potential lupus drug candidates. Lupus Therapeutics’ advisors vetted and assisted Lilly with a prioritized list of candidates, along with a detailed overview of specific populations of patients among which to evaluate the therapeutic candidates. This initial engagement not only helped to focus on the most promising candidates, but engaged and excited the lupus thought-leader community on the potential for Lilly’s pipeline.

Designing patient-centric human trials 
Once the candidates were prioritized and agreed on with Lilly senior leadership, Lupus Therapeutics collaborated with the company to design a Phase 2 clinical trial protocol that was both scientifically sound and patient centric. Lupus Therapeutics supported Lilly in obtaining FDA feedback and approval on this protocol.

Identifying clinical trial sites at an accelerated pace
Once FDA approved the trial protocol, Lilly tapped Lupus Therapeutics to identify, prioritize and engage academic sites from within LuCIN that would best position the company for a rapid trial start up. Despite the active COVID-19 pandemic, within 30 days, Lupus Therapeutics secured interest and formerly conducted feasibility from 35 academic sites within LuCIN. This led to the rapid prioritization and identification of sites to engage.

Holding investigators and sites accountable for success
Additionally, Lupus Therapeutics put in place protocols to ensure sites are performing to the level of agreement and are responsible for holding each site and investigator accountable to trial success. Lilly is actively working with Lupus Therapeutics to recruit and engage patients in the Phase 2 study.

Discover our solutions

A research innovation accelerator dedicated to improving lupus treatments and advancing research toward a cure, ONLY Lupus Therapeutics has a track record of successfully collaborating with more than a dozen top global pharmaceutical companies working on lupus clinical studies.

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