Our client, a USA-based mid-size Biotechnology Company with a breakthrough drug candidate that has a potential market value in excess of $15 billion, was seeking to capture that value through an initial public offer (IPO).
In order to realize the potential value of their drug candidate through an IPO, the Company must first successfully complete a one year Phase II clinical study of the drug involving 150 enrolled patients at 20+ investigator sites. In addition to achieving a successful outcome, the complex study also needed to be completed as fast as possible in order to conserve the Company’s existing capital, meet a milestone for an $70 million funding event and conduct the IPO within the planned timeframe.
However, the Company had serious concerns since about 50% of all Phase II studies fail and far more are delayed, and it had previously experiencing dissatisfaction with the norms of clinical services companies.
It was critical for the company to be able to kick-start the study as soon as possible, initiate the first 20 sites but maintain flexibility for global scalability if the patients are not enrolled fast enough.
Our cloud based platform DYNAMIKA was set up within 7 days and the first site initiated within 24h and just after 3 weeks from the initial conversation, the start was started. Due to the use of cloud based infrastructure, we were able to maintain live updates on the speed of the patient enrolment and QC, read and clean the data as it was coming in. 15 more sites were ended being engaged into the study to preserve the timeline. The Company was able to make this decision based on the reliable data.
In addition to a successful outcome, IAG’s norms resulted in the study being completed at least 90 days earlier than normal while maintaining 100% data quality. This time savings resulted from IAG’s focus on maintaining clean data throughout the study and eliminate the Company’s risk of lost or unusable data.
Under high pressure, budget constraints and tight timelines, the Company was able to meet its investors’ expectations and is currently thriving.
IAG is a strategic partner to bio-pharmaceutical companies developing new treatments to improve patients’ lives. Our dynamic Strategy, Trial Solutions and Bio-Partnering divisions work closely to meet critical needs of biotechnology companies: funding, clinical development and monetization of their assets. We fuse decades of therapeutic insights, risk-sharing business model and agile culture to accelerate novel drug development. IAG broadly leverages its core imaging expertise, proprietary technology platform DYNAMIKA and capabilities to support an objective early go no/ go decision and drive excellence for tomorrow’s innovative therapeutic agents with speed. www.ia-grp.com