At the December 2009 PQRI Conference on Advancing Drug Product Quality and Development, the Institute awarded three individuals with Excellence in Research Awards for outstanding research contributions on behalf of PQRI .The awards were given to representatives of Regulatory Agencies, Industry, and Academia as all three perspectives are critical to the volunteer work that is routinely performed. The individual recipients and their accomplishments are described below:
Regulatory Representative: Rajendra Uppoor, R.Ph., M.Pharm., Ph.D. (FDA)
Dr. Rajendra Uppoor has been involved with PQRI for many years, serving as a driving force two working groups (Profile Comparisons WG and Specification Design and Life Cycle Management WG) and two Technical Committees (Drug Product Technical Committee and the Manufacturing Technical Committee). He also currently serves as an FDA representative to the Steering Committee, and has been instrumental in providing the critical FDA perspective. The Profile Comparisons WG evaluated the statistical method for comparing the Aerodynamic Particle Size Distribution (APSD) profiles using a chi-square ratio method as an in vitro bioequivalence test for inhalation drug products and also characterized the performance of a supplemental test based on a population bioequivalence approach for the impactor-sized mass, or PBE-ISM test. The Specification Design and Life Cycle Management WG proposed a new way to establish, approve, and manage drug component and drug product specifications consistent with the objectives in FDA’s Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century Initiative. Both of these working groups were instrumental in helping to change the regulatory paradigm.
In his role as Steering Committee representative, Dr. Uppoor has become invaluable to the group for his idea submissions, his continuous support of current projects, and solicitation of FDA representatives’ participation. Raj is very quick to offer insight into issues concerning the FDA in the pharmaceutical arena, and offer suggestions for how PQRI might get involved in developing solutions. His input and expertise is highly regarded and sincerely appreciated.
Industry Representative: Daniel Norwood, Ph.D., Distinguished Research Fellow, Boehringer Ingelheim (not pictured)
Dan Norwood worked with a team within IPAC-RS to develop a Leachables and Extractables (L&E) “Points to Consider” document for FDA. Central to this paper were proposals for: 1) reporting and qualification thresholds for leachables, and 2) a leachables qualification process. Based on the “Points to Consider” proposals and FDA’s response to them, a proposal to develop safety thresholds and examine best practices for leachables and extractables in Orally Inhaled and Nasal Drug Products was submitted to PQRI and initiated in 2001. The project was completed in 2006.
From the first days of the project, Dan Norwood showed himself to be a determined and thoughtful leader. He made sure that the FDA, academic, and industry representatives were fully engaged and committed to the team’s goal. He was also creative, realizing at the front end that the group, to be credible to all involved, would need to generate its own data. Almost immediately he began to seek out laboratories that would volunteer to help the team by testing and analyzing data. He led the team from the initial months of defining the problem and developing a work plan and study protocol development, to the later period, including laboratory and other scientific activities. In the fall of 2006, the team submitted to PQRI and the FDA its recommendations, “Safety Thresholds and Best Practices for Leachables and Extractables Testing in Orally Inhaled and Nasal Drug Products”.
In addition to its recommendations, the Working Group held a large public workshop and organized multiple “training courses” in the United States, Europe, and Canada. The group has also published two peer-reviewed scientific papers. The team is preparing a book on its safety threshold and qualification process for leachables and pharmaceutical development “best practices” for L&E. The L&E group’s work has been recognized by regulatory agencies and industry as ground breaking.
Academic Representative: Walter W. Stroup, Ph.D., Professor and Chair, Department of Statistics, University of Nebraska-Lincoln
Walt Stroup has been a member of the PQRI Stability Shelf Life Working Group from its initiation in 2006. As the Head of the Department of Statistics with the University of Nebraska-Lincoln, Walt has supported the Working Group’s efforts through his personal time and through his guidance of the graduate students that have been supported by PQRI and the Working Group.
As the PQRI Stability Working Group was forming in 2006, we knew we needed an innovative component to the group. With Walt’s set of expertise, he was an obvious choice. In addition, the Working Group recognized that we would have need for dedicated analysis support to help evaluate and quantify current practices and to develop the new and alternative methodologies for estimating shelf life that would define our objectives. Through Walt we were able to attract top graduate students to provide that support, and in doing so, we will have supported the awarding of two Ph.D. degrees in Statistics.
Walt’s input has both focused and directed many discussions which have allowed the Group to gain insight in our objective. In addition, Walt has initiated and contributed to a number of email discussions within the Working Group and has become one of the Group’s more prominent spokespersons within the pharmaceutical community. As evidence of Walt’s contributions, one only has to look at the numerous conference posters, presentations, panel discussions and a webinar in which he co-authored with members of the Working Group. His service has been extremely valuable to the overall success of the Working Group.
PQRI is very proud of our past accomplishments, and most particularly of our volunteers and their respective organizations, who allow them to serve on our research projects. We are looking forward to taking on new research projects in the upcoming months based upon feedback that we received from the attendees at our recent conference. For additional information about upcoming research projects and the call for volunteers, check out our website at www.pqri.org or email Product Quality Research Institute at PQRISecretariat@pqri.org.