First to Proof-of-Concept
Get accurate data for key decisions in half the time, and cut costs 10% in the process.
There’s a standard process for taking a drug from single ascending dose (SAD) to multiple ascending dose (MAD) and then to proof-of-concept: sequentially. In many cases one or more studies is needed before the proof-of-concept study. Therefore, the standard timeframe from the SAD study to proof-of-concept is 45 weeks.
Cetero leads the industry in experience combining the four sequential studies into a single study design, and can deliver results in 14 to 18 weeks. The single-study design also generates efficiencies that can cut costs, on average, more than 10%. The approach is complex to design, plan and execute correctly, and varies according to each compound’s risk assessment.
The first step, the single ascending dose study, examines the safety and tolerability of the compound after a single dose. The multiple ascending dose study does the same after multiple doses. This is where time savings begin in the First to Proof-of-Concept study design.
The MAD study can be started while the SAD study is ongoing. From this point on, in fact, all the remaining stages through proof-of-concept can be accelerated: SAD, MAD, interaction studies and proof-of-concept all overlap. Cetero precisely times each overlapping cohort to maximize both participant safety and learning from earlier cohorts. We also provide dedicated clinical resources to ensure that overlapping recruitment and confinement can be scheduled without delays.
Staff training time and costs are streamlined as well, because instead of having to train four teams to administer four separate studies, the same team manages the combined study from start to finish.
In addition, we design one comprehensive study protocol instead of four separate ones which means there is only one document for regulatory approval, instead of four. Cetero has mastered the subtleties of designing protocols that are both precise enough to satisfy regulatory requirements and flexible enough to allow the lessons learned in each step to be applied to subsequent cohorts.
Cetero has both the experience and resources to deliver as promised on these extremely complex, overlapping studies. Our ability to quickly recruit both healthy volunteers and patients is critical to delivering on-time start-up and on-track adherence to the timeline straight through to the final report writing. We also have extensive experience conducting complex proof-of-concept studies to collect efficacy measures, which is especially difficult when the symptoms are subjective.
Go/no-go decisions are critical at every stage of a compound’s development, but the earlier you reach a decision, the sooner you can reallocate resources to optimize the development of your portfolio. And you can start saving time right now. Contact Cetero today.
For a recent article on ways to remove the speed bumps between first-in-human and proof-of-concept, click here.
