What Makes ISPE Annual Meeting & Expo the Must-Attend Pharma Event of the Year?
As we start to populate and organize the education sessions for the 2018 ISPE Annual Meeting & Expo, I think back to my experiences at the 2017 ISPE Annual Meeting & Expo. We had exposure to global regulators and were able to hear about news and their priorities from a diverse global perspective in a townhall setting. Even more useful was the opportunity to mingle with those regulators during breaks to pick their brains on a variety of topics. This informal access to regulators is a unique opportunity.
We were also exposed to industry leading edge technology that is reshaping our businesses. This included continuous processing which seems to be gaining interest and momentum in many places but with significant issues yet to be institutionalized. There was a presentation by a firm that had converted an approved licensed small molecule from batch to continuous processing. In another session, opportunities to consider continuous processing of biotech large molecules reviewed typical unit operations and how each might go from traditional batch to a continuous step. One firm presented development data used to justify going to a continuous chromatography operation. This was an exciting peek into the future of pharmaceutical manufacturing game changers.
There also were sessions that provided guidance on efficiency gains. One session I attended focused on a true risk managed approach to quality deviations. This presentation addressed a common issue – lots of deviations that are treated with the same rigger, consuming lots of resources, with many closing near or at times beyond their deadlines. Using a quick checklist approach based on risk management principles allows firms to identify those that have the greatest potential for real product impact and to focus resources on those and set realistic target dates. Those with little to no impact can be closed in a more efficient manner.
Our goal is to continue to provide these and more exciting educational experiences at the 2018 ISPE Annual Meeting & Expo in Philadelphia, Pennsylvania USA in the fall. Submissions are coming in and the difficult job to evaluate and select the best has started. Come and network with the leaders in the Pharmaceutical industry and learn from those leading the way to the next evolution (Pharma 4.0).
The ISPE Annual Meeting & Expo is where the industry gathers to address top pharmaceutical priorities and drive innovation. Join us in Philadelphia for the 2018 ISPE Annual Meeting & Expo as we share best practices for navigating organizational and regulatory complexities that advance patient therapies.
