At the Heart of Bio Change and Investment are People
Darren M. Dasburg, P.E.
Maurice B. Parlane, B Tech MIT
It seems every year is a year of great change in the Biopharma industry and for me, I know the conferences are where I find my grounding. I look forward to ISPE conferences both local and international because I get to catch up with dozens of networked members who, like me, are constantly finding their next career move or benchmark/practice that can shape their current role. The 2019 ISPE Biopharmaceutical Manufacturing Conference is significant as it allows me to keep up with the newest molecular modalities and the challenges underlying their production. Everyone is learning about supply chains of single patients, gene editing and correction techniques that are one and done, regulatory realms stretching to keep up, vendors with new solutions and as mentioned, members moving and shaking among the unique fraternity of people who can make these complicated molecules.
This will be my fourth process validation specific ISPE event and I find, like Darren, they present tremendous value to me professionally both in terms of technical content and networking. Conferences like this one allow me to meet with many like-minded people and regulators who are all taking time out of their busy schedules to focus on an area of common interest. In my case Process Validation. This year I get double the value as I can participate not only in the 2019 ISPE Process Validation Workshop, but also attend the 2019 ISPE Biopharmaceutical Manufacturing Conference to learn even more and the two events have been planned to complement each other – both focusing on Biotech.
New products and modes of medicine are going to totally disrupt what we have traditionally practiced with PV and we really have to develop innovative ways to demonstrate quality and robustness of manufacturing without detracting from the patient’s outcome. The traditional batch and development paradigms are often not the basis for this type of product and there is no silver bullet solutions. Seeing case studies and presentations on how others are approaching this and more importantly having the opportunity to discuss this with these individuals and others helps me crystallise my own thoughts and really makes the trip worth-while.
With 906 global regenerative medicine companies and over 1000 molecules in clinical trials the return on investment in a conference like this one is easy to see among the $13.3B being invested in those 1000+ molecules. If the half-life of our education tends to be only four years out of college, then these recurring tune ups are great for continuous learning.
ISPE’s Advancing Pharmaceutical Quality (APQ) team and the University of St.Gallen Operational Excellence (OPEX) team have partnered to develop a comprehensive program for assessing and improving an organization’s Quality Management Maturity. ISPE is...
Although travel continues to be reduced or restricted across the world, there is an upside: The 2020 ISPE Asia Pacific Pharmaceutical Manufacturing Virtual Conference & Executive Forum has now pivoted into a fully virtual conference and virtual executive...