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.
Innovation has always been a central component of the success that C-SOPS has had both organizationally and technically. Entrepreneurship brings additional energy to the Center, and is an intrinsic part of much of the leadership team’s character. As a result, the Center has continued to innovate, pushing technology towards commercial adoption and even challenging the traditional role of academic institutions when it comes to changing an industry, in an entrepreneurial manner. Through this the Center’s innovation ecosystem has flourished in recent years, and continues to grow.
In some ways the greatest increases in strength to our ecosystem has been driven by the increased level of interaction with the FDA and other government bodies. For the past three years, we have held one of our IAB meetings at a location close to the FDA to facilitate their ability to attend. During that time, we have seen our interactions and support from the agency grow. In 2015, our already very strong relationship with FDA has been further enlarged by two new grants, a $900,000 grant to NJIT focusing on oral films, and a $4,000,000 grant to Rutgers and Purdue to work on direct compression, representing the largest research grant ever provided by FDA to a University. In addition, we have been in communication with BARDA who is working closely with the FDA and their Emerging Technology Team to increase adoption of continuous pharmaceutical manufacturing. We hope to work closely with BARDA in the near future and have submitted a grant application to the FDA/BARDA program, focusing on developing standard manufacturing platforms for Continuous Manufacturing, involving all four core ERC partners. This large scale grant would have a significant effect on the innovation ecosystem as it would likely involve the creation of a shared use facility with the ability for companies to co-locate.
An additional component set to our ecosystem are the Center supported mini-consortia that we began launching in 2013. Each has a different focus and looks to address an aspect relevant to portions of the membership as well as outside companies within areas outside the core research program. Unfortunately, these efforts have had limited success until now. This year, H2Optx a non-ERC startup got involved in the Center through their connection with Pfizer. Using the mini-consortia model as usergroup was setup. The proposed research program for 2016/2017 has been funded and will involve researchers at Rutgers University and Shearbrooke University in Canada. Currently the usergroup members are Pfizer, H2Optx, Rutgers University, Shearbrooke University, BMS, and Janssen.
This past year another company was formed as a result of Center based activity that occurred over the past decade. Though no longer directly supported this past year members of the Test Bed 3 team formed PharmaPrinter LLC to further commercialization activities of the technology. Additionally, Integra Manufacturing Systems, the company started in 2013, completed a know-how license from the ERC and did begin work with their first client in late 2015. Integra will play an active role in the Center’s sustainability as it subcontracts work to the partner universities. Integra will provide engineering consulting services in the advanced manufacturing space and has a strategic plan that calls for subcontracting work to the continuous labs at Rutgers and Purdue. These are still currently some of the few places in the world where continuous manufacturing development and proof of concept work can be done.