OUR INDUSTRY PROGRAM
Industrial/ Practitioner Collaboration & Technology Transfer
As C-SOPS transitions from NSF funding to a self-sustained operational model the Center’s presence and impact within the pharmaceutical solid dose manufacturing industrial sector continues to grow. This further strengthens the Center sustainability post NSF ERC program support. The timing in many ways could not have been planned better. Over the course of the past year or so there have been numerous accomplishments that support this position. This year we have further strengthened our partnership with key industrial partners that now constitute a significant fraction of the overall program activity. In addition, crucial events within the industry, in particular the approval of the Janssen product Prezista co-developed by C-SOPS, are driving increased interest across the sector. Equally important and just as impactful is the continued development of strong interactions and even partnerships with regulatory and related groups such as the FDA and USP.
Program Vision, Goals & Strategy
The vision of C-SOPS with respect to its industrial/practitioner program is to provide a forum where stakeholders can share problems and ideas and explore solutions in a non/pre-competitive, collaborative environment. While this has not changed much over the years in which the Center has been in operation, the climate in which the Center is operating has. Today there are many more opportunities to engage companies in areas they are actively moving into like continuous manufacturing. With this increased attention and opportunity comes competition, particularly with regard to meetings. These must be effectively managed as the Center looks to balance capitalizing on existing opportunity with an eye (and a research program) toward the future.
Similar to the vision, the Center’s unchanged goal to identify problems important to practitioners, determine barriers to solutions (especially scientific gaps), cooperatively find the solutions, and enable the solutions to become part of industrial practice should be considered an ongoing success. In many ways the goal itself is a strategy that will continue to be employed long after NSF support.
As in each previous year, in 2015 the Center held two major IAB meetings. Our first 2015 IAB meeting was held in May at Purdue and focused on individual project working sessions, which were primarily led by a student or post-doctoral project coordinator.
Once again for the third year in a row, the Fall/Winter IAB Meeting was held in a location designed to maximize FDA participation. This year we met just a few miles from some of the FDA sites at the College Park Marriott Hotel & Conference Center. We had keynote addresses by both Dr. Janet Woodcock, Director of The FDA Center for Drug Evaluation and Research, as well as Dr. Lawrence Yu, the Acting Director for the Office of Pharmaceutical Science at the FDA. Both gave highly energetic talks that were highly supportive of the Center and what it is doing. More than 20 representatives from the FDA attended along with 50 or more people from industry. This meeting focused on continuous manufacturing and was at a higher level with plenary talks for each of the Thrusts and Test Beds.