A packaging technologies provider sees demand for new package designs and clinical trial support.
Dr. Tracy Tsuetaki, president, Packaging Services group of Catalent Pharma Solutions
As president of the Packaging Services group (Philadelphia) of Catalent Pharma Solutions, Dr. Tracy Tsuetaki is responsible for three distinct lines of business: the contract packaging segment, the clinical packaging and supplies segment, and the printed components segment.
Dr. Tsuetaki joined Catalent last year from Quintiles Transnational Corp., where he was president of Quintiles Medical Communications and Consulting Group. Prior to leading that group, Dr. Tsuetaki served as senior vice president for global business development. His background includes positions as senior vice president for strategic planning and consulting at Kaiser Permanente and as an account executive with Ernst & Young’s management consulting group. Dr. Tsuetaki has a doctorate in optometry and a master of science in physiological optics from the University of California, Berkeley, and a master of business administration from Northwestern University’s Kellogg Graduate School of Management.
In a recent interview with PMP News, Dr. Tsuetaki says that core areas of focus for Catalent’s packaging services group are innovative packaging solutions that leverage design, continuous improvement in production quality and efficiency, and turnkey track-and-trace solutions.
What are the near-term growth prospects in outsourcing?
Though outsourcing is increasing, many of the large pharmaceutical companies are not seeing dramatic increases in new drug approvals, which impacts downstream commercial partners. While we would like to see new innovative products and treatments coming into the marketplace, patent expirations also create business opportunities for us. It prompts manufacturers to invest in R&D. As a result, growth in our clinical supplies business will equal and likely exceed the growth in commercial packaging.
With the globalization of clinical trials, how are clinical trial management services evolving?
Interest in adaptive clinical trials is one trend. Drug companies are asking whether outcomes are true outcomes based on appropriate patient use. Companies may be evaluating the drug in question at key intervals to establish more quickly that the drug is showing success. We have to be flexible if product isn’t showing likely outcomes.
We have developed systems to support rapid delivery of supplies, inventory management, return drug management and reconciliation, and quick turnaround on patient kits and label design.
We have added –20ºC storage capacity in our 400-pallet-size refrigerated space in Philadelphia in 2004. Since then, refrigerated-pallet capacity has been increased from 60- to 120-pallet-size-storage at our facility in Schorndorf, Germany. At our Bolton, UK, facility, a new temperature-controlled warehouse will house a 320-pallet refrigerator.
How are managed-care trends and government reimbursement practices affecting packaging?
With the drive for economies by moving care from the hospital to the home, package systems that assist patients with proper administration, while ensuring safety for children as well as for adults, will be favored, as will prefilled syringes. These are features demanded of commercial and clinical trial packaging.
Catalent has developed a number of new compliance packages that address also cost-effective manufacturing. How successful have they been?
Interest has increased tremendously in our innovative package designs, driven by manufacturers’ desire for improved patient compliance and the importance of patient safety. A top-five drug customer is using our HingePak.
How is Catalent supporting cost control?
We have been a leader in lean Six Sigma and continue our focus on improvements in this area. A big focus has been on improving changeover time on key packaging processes, so we can more efficiently utilize our equipment and respond to our customers more quickly.