In 2014 Janet Woodcock, Head of CDER at the FDA, has asked us to set up a symposium to align on making continuous pharmaceutical manufacturing a reality! Thus, we set up a symposium at MIT on May 20-21, 2014 organized by MIT and the Continuous Manufacturing and Crystallisation Consortium (CMAC) to accomplish this goal. The 2014 edition was a great success and cumlinated in a series of white papers, which are also available on the ISCMP 2014 website. This year we are organizing a 2nd edition on September 26-27 in Cambridge, MA with a focus on case studies of implementing continuous manufacturing. Note: the symposium is by invitation only and space is extremely limited, but if you would like to apply to be invited, please click here.
The symposium will bring together pharmaceutical company end users, suppliers, regulators and academics to look at accelerating adoption of continuous manufacturing for both small molecules and biologic products and how research groups, globally, might collaborate more to help drive this. This is an enormous opportunity to guide the way in which new technologies and new approaches in the pharmaceutical industry can transform quality, cost and service for the benefit of the patient.
Schematic Vision of Continuous Manufacturing of Pharmaceuticals
Spring-boarding from our successful 1st International Symposium on Continuous Manufacturing of Pharmaceuticals (ISCMP), sponsored by CMAC and MIT/Novartis on May 27-28, 2014, we are planning a follow-up symposium, September 26-27, 2016, at the Royal Sonesta Hotel in Cambridge, MA, near MIT. This venue provides a pleasant and convenient site and allows us to expand the number of participants. As before, it will be by invitation only with the aim of getting representatives from a broad stakeholder comminity.
Based on feedback from the 2014 symposium, we plan to have a tangible output, with case studies, identification of technology gaps, proposals for addressing those gaps, and a draft document that can help inform future regulatory guidelines. We will form working groups with key stakeholders and post draft documents to the website to collect for input from the community. Panel sessions with representatives from academia, industry and regulators will continue this interaction during the symposium. The objectives of the symposium are summarized below.
Thanks for your engagement!
Clive Badman, Salvatore Mascia and Bernhardt Trout
For the Conference Organization Team
Continue and accelerate implementation based on progress made since 2014 Symposium
Provide practical guidance based on real cases studies
Identify remaining gaps and develop appropriate solutions and next steps
Continue to engage key stakeholders (academic, industry and regulators)
2014 White papers and 2016 symposium output can lay the foundation of a future ICH guideline