4th International Symposium on Continuous Manufacturing of Pharmaceuticals
Continuous Manufacturing for the Benefit of Patients: Accelerating Adoption and Breaking Barriers
November 9-10, 2020, Royal Sonesta Boston Hotel in Cambridge, MA, USA
Janet Woodcock,
FDA CDER,
Opening keynote speaker
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 the first symposium at MIT in 2014 organized by MIT and the Continuous Manufacturing and Crystallisation Consortium (CMAC) to accomplish this goal, and since then we repeated it in 2016 and 2018. The 2014 edition was a great success and culminated in a series of white papers. In 2016, we presented a number of case studies on continuous manufacturing, and in 2018 the symposium, which was held in London, included more business cases and presentations on supply chain impact of continuous manufacturing. This year, in 2020, the focus will be on patients and how we can accelerate adoption of continuous manufacturing by addressing specific implementation barriers. Dr. Janet Woodcock will be again our keynote speaker, in addition to Peter Marks, Director of CBER at the FDA and Rick Bright, Director of BARDA. 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.
Introductory Remarks
The symposium will bring together pharmaceutical company end users, suppliers, regulators and academics to look at accelerating adoption of continuous manufacturing for small molecules, biologic products and new modalities, and how they 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
Please join us at the 4th International Symposium on Continuous Manufacturing of Pharmaceuticals (ISCMP) to be held at the Royal Sonesta in Cambridge, MA, USA on 9th-10th November 2020.
Peter Marks,
FDA CBER
Rick Bright,
BARDA
Confirmed Keynote Speakers include Janet Woodcock, Director of CDER, Peter Marks, Director of CBER, and Rick Bright, Director of BARDA. Additional contributions from international top government officials and high-level executives from pharmaceutical and generic companies are also expected.
The webpage link with more information including registration will be up shortly, and we will send you a new email to initiate the registration process. Please stay tuned. Below is the vision statement of the meeting.
We are looking forward to welcoming you in November.
On behalf of the Organizing Committee:
Massimo Bresciani, Charles Cooney, Alastair Florence, Konstantin Konstantinov, Markus Krumme, Sau Lee, Salvatore Mascia, Moheb Nasr, Peter Richardson, together with Clive Badman and Bernhardt Trout (Co-Chairs)
Vision Statement of ISCMP 2020:
Continuous Manufacturing for the Benefit of Patients: Accelerating Adoption and Breaking Barriers
There is a general consensus in the pharma community that global implementation of continuous manufacturing of medicines would offer tremendous patient benefits. If we could have snapped our fingers to make it happen, we would have already realized these benefits, including improved patient access, enhanced supply chain security, agility to address emergencies, reduction or elimination of stock-outs, and enablement of personalized medicine. The current world-wide problems with the coronavirus have demonstrated the fragility of the pharmaceutical supply chain. Continuous manufacturing would provide a more agile and distributed and thus, more robust and reliable supply chain. In addition to benefits for existing modalities, there is also great opportunity in the adoption of continuous manufacturing for new modalities, including gene therapies, vaccines, biological nano-particles, and nucleotide-based medicines.
However, despite all of the benefits, the past decade has shown that barriers remain. In particular, companies tend to implement continuous approaches on a product by product basis, as opposed to creating an overall platform strategy. As a consequence, investment, while significant, is scattered in a given company and therein far from harvested to its potential. In addition, there is a lack of personnel expertise and training, and crucially, insufficient support at the corporate-level. In a recent white paper (J. Pharm. Sci., 108 (2019) 3521), we have proposed a way to accelerate adoption of continuous manufacturing. This will necessitate government supported incentives world-wide, including tax incentives and streamlining regulatory processes. The mission of this meeting is to bring together thought leaders including international top government officials and corporate-level decision makers to accelerate adoption of continuous manufacturing to realize expected global benefits for patients.