By Ed Miseta, Chief Editor, Clinical Leader
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By Ed Miseta, editor, Outsourced Pharma and Clinical Leader
At this year’s Quality Consortium Summit, hosted by pharma consulting firm The Avoca Group, Chris Hilton, VP of Development and Clinical Alliance Management for Pfizer Inc., shared his a-ha moment on the importance of quality. “It was the week I became head of operations and received an FDA warning letter just seven days later,” he said. “It caused me to look at things very differently. There is no question we need to build transparency between everyone involved in the clinical trial process. For most of us it will involve a different way of looking at the world.”
In today’s pharma industry everyone wants to talk about quality, and “culture of quality” seems to be the new buzz phrase. The consensus at the conference seemed to be the need for better communication and more transparency between drug sponsors and their outsourcing partners. The work of The Avoca Quality Consortium is in helping companies optimize their approaches to proactive quality management with an emphasis on bringing sponsors and CROs into greater alignment through the acceleration of best practices and industry standards for proactive quality management. The team at The Avoca Group would like everyone to do more than talk, and is hoping their second Quality Summit will get more companies to take action.
Patricia Leuchten, president, The Avoca Group
The summit, held on May 8th and 9th in Princeton, NJ, focused on three main aspects of clinical trials: effective oversight, risk assessment/risk management, and creating a culture of quality. Bringing together representatives from drug sponsors, CROs, the FDA, and consulting firms, the sessions were intended to open communication between all involved and begin the process of creating greater transparency. Avoca Group president Patricia Leuchten acknowledged the process will not be easy, pointing to pressures everyone in the industry is facing trying to balance the goals of lowering costs, meeting deadlines, and maintaining high quality standards.
In addition to Hilton, speakers at the event included Michael D. Jones of Eli Lilly, Stephen Cutler of ICON Clinical Research Services, Harris Koffer of Research Pharmaceutical Services, and John Potthoff of Theorem Clinical Research, to name just a few. Ann Meeker-O’Connell, Acting Division Director, Good Clinical Practice Compliance, US FDA provided the group with her insights on strategies for ensuring effective oversight of outsourced clinical trials as well as risk assessment and risk management of these trials.
All agreed more needs to be done to change the culture within organizations if true advancements are to be made in eliminating problems arising with cGCP, FDA compliance, and product quality. Cutler noted that when it comes to defining roles and responsibilities, everyone needs to be more open AND transparent. “Pharma needs to start treating CROs as trusted partners, and the CROs will need to focus on showing more ownership and accountability,” he says. “The only way everyone involved will be able to do this is with a change in culture.”
Along with trust and transparency, there will need to be improvements in technology. Jones believes this is a stumbling block for many firms in the pharmaceutical industry. “Unfortunately, when it comes to technology, pharma has always been slow to get in the game,” he said. “There are great technologies available to us, yet we are still writing and typing. We need to get over this reluctance to readily adopt available technologies.”
Over the next few weeks I will post additional articles based on the work of the Quality Consortium following the Summit. The purpose is to get everyone thinking more about the subject, and sharing their ideas with each other. If you have thoughts relating to the subject and what needs to be done by all involved, please share them with me. I would like to include as much input as possible.