Industry Expert Q&A with Gerard Creaner

A Q&A with Gerard Creaner, president at GetReskilled

Together with cut-e, GetReskilled has developed the Behavioral Positioning System, designed to assess the characteristics and behaviors required to drive quality in pharmaceutical development and manufacturing environments.

PharmTech: What made you set up the joint venture with cut-e and develop the Behavioral Positioning System?

Creaner: One of the challenges [the pharma industry has] been facing is an increasing number of quality problems with our products. Pharmaceutical companies and the industry have been driving more cGMP training programs and emphasizing cGMP-compliant procedures to a greater extent than ever.  Yet, the results do not reflect this emphasis. We’re getting a divergence in quality rather than a convergence. This challenge led me to ask whether there might be another way to approach the problem by addressing the people factor. People want to do the right thing, but we realized they didn’t have the necessary quality behavioral traits (QBTs) to do it right all the time--conscientiousness, compliance, and discipline for example. If we could find a way of measuring and strengthening these QBTs, then we could get ahead of the curve and become proactive in addressing manufacturing quality issues before they happen.

Behavioral scientists have broken human behavior down into categories based on behavioral traits, and developed huge databases with millions of responses, to study specific behaviors that impact performance. This combination of pharmaceutical science and behavioral science came together around the same time that the industry began to grapple with drug shortages and [began] discussing the need for a quality culture. At this point, more professionals asked whether anything might be underpinning manufacturing and quality problems that we weren’t getting at. The partnership between GetReskilled and cut-e looks at measuring critical behavioral traits, and having an intervention program in place, with a view to strengthening them when that is needed.

PharmTech: How important is the idea of tracking changes over time?

Creaner: That is an important part of the system. What is needed is a combination of being able to assess and measure critical behavioral traits and having a customized training program that can be delivered online in a practical manner that works around operations department needs and the practicalities of manufacturing. Then you can follow pre-intervention performance by post-intervention analysis and track the changes in operators’ and technicians’ performance. If we can assess and measure critical behavioral traits, such as conscientiousness, and deliver a customized online program that can be delivered in bite-sized pieces over an extended period of time, we can help drive behavioral change. Then, we measure performance again at the far end. This approach can drive a cultural change, focusing on the behavioral side of the equation, and on the goals and results that matter for the industry and the patient.