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About CIMSEPP

The mission of the CIMSEPP is to advance and promote fundamental understanding of the material properties and interactions between drugs and additives at molecular and particulate level as affected by manufacturing processes on product quality, performance, and stability.

This will facilitate Quality-by-Design (QbD) of drug products and afford smoother manufacturing scale-up, including transition to continuous processing from batch processing.  The overarching mission includes:

  • Advancing the fundamental understanding of structure-function-performance of drug products and process engineering, paving the way for enhancing drug product quality, drug bioavailability and stability
  • Cultivating a holistic environment for open-minded industrial/academic interactions for targeted industrially relevant research
  • Promoting translational research leading to innovations and intellectual property; and
  • Developing a diverse, well-trained workforce vital to maintaining US leadership in this field

CIMSEPP Academic Partnership

The team includes faculty from New Jersey Institute of Technology (NJIT, led by Raj Dave), University of Minnesota (UMN, led by Calvin Sun), and St. John’s University (SJU, led by Abu Serajuddin) with significant academic and industrial experience. Prof. Dave brings engineering training and physics based model predictive approach towards materials and process engineering, as well as experience in successful translation of his research to unmet industrial needs and commercialization/licensing of IP. Prof. Sun brings materials science training and mechanistic approach towards solving formulation and processing problems. Prof. Serajuddin has detailed understanding of problems facing pharmaceutical formulation design and manufacturing based on his work experience with pharmaceutical industry and subsequent extensive collaborations. This team also includes other prominent faculty researchers at each site.

CIMSEPP Structure

We are currently in the planning phase of this Industry-University Cooperative Research Center (IUCRC). If funded by NSF, the Phase I of the IUCRC will be for 5 years with NSF providing $450K/year ($150K/year per each of three sites); to be supplemented by $450K/year or more of industry membership funds. Indirect costs are limited hence > 90 % of the industry membership funds are directly used for pre-competitive research, results of which are shared by all members. Each proposed project is discussed by the faculty and industry members. Industry members will select about 10-12 total projects through voting; Full members ($50K/year) get 1 vote, Associate members ($25K/year) get 0.5 vote. Industry members may also support post-competitive bilateral projects with any site(s) under preferred terms.

CIMSEPP Value proposition

  • Pre-competitive scientific research portfolio valued at about $1.5M, representing significant 1:30 or higher leveraging of your individual membership funds
  • Members have access to the Center’s laboratories and available equipment and preferential arrangements for post-competitive research projects through individual member Research Agreements
  • Direct access to Center faculty with vast experience of 100+ man-years research, 500+ high-quality journal papers, dozens of granted patents
  • Members help determine the main research focus of the Center, and members select pre-competitive research projects
  • Members have advance access to all research papers and reports, including work in progress and in-house use of all IP generated during their paid membership
  • Semi-annual Industrial Advisory Board (IAB) meeting, members only seminars at no-cost, discounted attendance to public access conferences and workshops
  • Direct access to graduate students, postdocs and faculty through project mentorship program; opportunities for early, direct recruitment of highly trained students
  • Membership in a forum that synergizes interactions between academics and industrial for the purpose of advancing drug product design, manufacturing and regulatory aspects of current and emerging technologies