C-SOPS

Once again, and in our final year of NSF sponsorship, our academic/industrial partnership has continued to evolve and strengthen over the course of this year. As the strength and impact of our work permeates the industry, our reputation as a focal point for science-based development of structured organic particle-based products and their manufacturing processes has continued to grow. 

In 2015 our external funding exceeded peak NSF ERC program support for the first time.  This funding was led by major awards from Janssen and the FDA, with one of the award from the agency being of record level.  Additionally, fruition was realized in the approval of Prezista, the Janssen product for which the continuous manufacturing process was jointly developed and that began the increased commercialization momentum within and around the Center.  The recent success of the past few years has paved an undeniable path towards sustainability.  Still, this remains a time of transition, and obstacles remain. Perhaps one of the largest obstacles is the need for leadership to define a model that pursues a choice few of the many opportunities that are available. 

 

On the horizon there are many opportunities to be pursued including:

• Creation of a shared-use facility, likely in NJ, to aid in accelerating the evolution and adoption of CM technology

• Government/non-profit sponsored projects with organization such as FDA, BARDA, USP, and the Gates Foundation;

• Expansion of existing partnerships with Janssen & FDA

• Commercial development projects similar to the Janssen model

• Accelerating Innovative Research (AIR) grants, mini-consortia for equipment and instrument applications development with companies such as H2Optx and Pfizer

• Training programs, including “certified” training programs in conjunction with organizations like USP  

 

Expanding on the list above, the creation of a shared-use facility has been on the agenda for a few years as the issue of limited access to early stage GMP manufacturing capacity for continuous solid dose manufacturing technology adoption became evident. From our interactions with industry and government groups it seems clear that this is a need that would be supported from both sides.  As a result, this has become a high level strategic priority of the Center.  This is tied into or strongly aligned with most of the horizon opportunities including working with FDA/BARDA.   We have learned from our experiences with CpAML that facilities play a dual role of providing a forum for activities to occur within, as well as acting as public relations/advertising tool. As we gain further notoriety for our activities in the space we are playing a larger role in shaping the future of this technology by our collaboration with the agency. Leading a shared-use facility is the next step we as a Center can take towards reaching our vision stated to the ERC program at the onset of our program, that being, to become the national focal point for the science-based development of structured organic particle-based products and their manufacturing processes.

 

As we move beyond NSF support, other government and non-profit agencies have the potential to offset the core research funding once provided by NSF. One challenge with a post NSF sustainability model built on industrial projects is there is less pre-competitive elements as companies begin o work with proprietary materials.  To a large extent, funding from government or non-profit sources have lesser confidentiality provisions, and certainly in the case of FDA funding, are aimed at moving the technology forward for all. This is crucial because having meetings and other interactions with the industry where new work can be shown is critical to maintaining engagement and the health of the industrial ecosystem.  We have had good success in leveraging these sources thus far and will work to maintain current funding levels by expanding the pool of sources. This year, relationships were established with both the USP and Gates Foundation which we hope to grow in the future. 

 

The Janssen partnership has been one of our most successful and influential activities. This past year we established a new partnership framework aimed at furthering the collaboration.  Within this framework Rutgers and Janssen top leadership meet twice yearly at summit meetings. The overall activity is managed by a leadership working group that interacts on a frequent, approximately monthly, basis.  Day to day activity of the program and the activities of the individual project teams are overseen by a relationship manager on either side who meet on a weekly basis.   The second summit meeting that was recently held was highly successful, and while no additional funding was available for 2016 due to budget reasons, expansion plans for 2017 and beyond were enthusiastically discussed.

 

The success of the Janssen model has led to conversations on establishing similar relationships with other major companies.   The most in depth interactions in this area during the course of 2015 were with BMS. We plan to explore this model further with other major companies such as Abbvie, and AstraZeneca; two companies that want to get into continuous manufacturing faster than their infrastructure will allow or can be built up.   In doing this we will leverage the success of the Prezista approval as other companies seek the same.   

 

In recent years the AIR program has become a significant source of funding for translating ERC related technology into commercialization.  Moving forward, we will continue with the programs that have already been initiated as well as pursue others.  The first AIR award received by the Center focused on developing strategies for real time release methodologies.  Work from that program is now being put into commercial practice and should hopefully be part of FDA filings within the next year or two. This work was also instrumental in enabling a much larger grant ($4,000,000) from FDA.  Similarly, our efforts on developing predictive models for unit operation and integrated line assessment are now being utilized within the companies that were involved in the programs.  We look to build on these successes and continue to move the technology forward as we move into the future.  

 

During this past year we have explored a number of avenues to deploy training programs to serve a critical need as well as develop another area which could support Center sustainability.  We conceived different varieties of training to reach different audiences and cater to different user levels.   A proposal for a postdoctoral training program was submitted to the NSF.  We are currently launching a 2 week hands on short course as our first external standing training program.  This is being run through the Rutgers School of Engineering office of Continuing Education and Life Long Learning.   Recent discussions with the USP indicate a high level of interest in partnering in offering such courses in the future.  These sorts of partnerships will strengthen the Center’s position and reputation as the primary academic player in the space. 

 

From a membership perspective the plan for the next year will be to focus on fully installing the new membership structure and research program.  With this we plan to introduce a number of new membership benefits designed to engage the membership on a more frequent and ongoing basis.   Along with this we plan to be working on industrial coordination activities meant to move the entire community forward.  This will include items like the USP road mapping workshop, which will likely lead to further activities in the area of standardization and best practices.  Additional activities, such as those proposed to FDA/BARDA, would be aligned and further strengthen such efforts.