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.
Since the beginning, our basic strategy has been to collaborate with:
Finished goods suppliers from a number of industries (pharmaceutical, food, consumer products).
Technology providers to the finished goods suppliers (manufacturing and laboratory equipment, instruments, software, raw materials, and consulting services).
We have maintained a tiered membership structure to accommodate the needs and potential contributions of all sizes of companies, from the very small to the extremely large.
As has been the case during the majority of the Center’s lifetime, most of our members after 10 years of activity are associated with the pharmaceutical industry. This situation is a natural outgrowth of the strengths of the core partners and the needs of the industry. We expect this trend to continue into the future even though our emphasis on fundamental science has enabled us to consistently attract participants and associated projects from other industries.
Members at all levels enjoy numerous other benefits: early access to center publications, invitations to special presentations and workshops, access to new educational programs and materials, access to better trained graduate students and post-docs, and, perhaps most importantly, synergistic interactions with the FDA, peer companies, and potential customers.
Due to the fact that many of the membership benefits are enjoyed across all levels and come through the ecosystem, which has been purposely created, we have announced plans for a simplified single tier membership structure. This intention was announced at the winter 2015 IAB meeting along with a proposed post NSF research program. We will continue to implement this change throughout the course of 2016. The new memberships tier will be $50,000 per year, both cash and in-kind. Additional access for small companies and individual consultants will be managed through discounts or other exceptions.
Over the years we have come to learn what is most relevant to our members in terms of membership benefits and it boils down to three things. The first is the introduction and proof of concept demonstration of cutting edge scientific ideas both fundamental and applied. This provides the membership researchers the information they need to leverage the value of the Center and gain support for in-house research and development activities. We have seen many instances of this with TB 1 technology. The second benefit most often noted by the membership is the ecosystem itself. This is conveyed in a number of different ways, from the benefit of networking with other companies, to the access to potential students, to the ability to discuss openly and freely with regulators. The fact is that after 10 years many of the companies continue to be involved because of the industrial ecosystem which has been built around the science being done within the Center. Today that continues to be strengthened even further as regulatory support grows for the Center.
The third benefit, in some ways, is the most important and it is increasingly highlighted by senior management among our industrial partners: the strong relationship, and the open dialogue regarding emerging technology, that C-SOPS has created with FDA. This is highly appreciated by our industrial partners as a source of insights and as an opportunity to interact with FDA outside their usual regulatory relationship. Thus, we plan to build on this feature, both by continuing to pursue opportunities for interaction with and funding from FDA, and by expanding our efforts to include USP.