Frede Vinther NNE Pharmaplan A/S presented on this challenge. His agenda: Background Needs and Obstacles Alignment and Discrepancy – The Human Factor Manufacturing Scheme Manufacturing Operations Management Standards Path Forward People and Governments spends more and more money on Healthcare; The more wealthy the more money are spend. PwC has forecasted that economy growth as: G7 will grow 40% E7 will triple (300%) Global Pharma market for medicines was in 2004: $518 billion With Proportional growth, this be: $800 billion in 2020 Pharma spends lots of money and effort on developing and producing drugs But; There are no real increase in the number of NMEs approved! Governments in both the Developed and Developing World will not continue to accept this increasing price for Healthcare Needs and Obstacles: Lower price for Medicine Faster development and approval of new Medicine Medicine for higher count of People Higher “hit” rate in Pharma development; More NMEs approved Better understanding of Diseases and Patients Knowing and Utilizing knowledge on Disease sub-types Knowing and Utilizing knowledge on sub-populations Legislation to enable a much more Globalized thinking in relation to drug development and disease fighting Legislation makes development of new drugs inefficient. Dr. Scott Gottlieb, the FDA’s Deputy Commissioner for Medical and Scientific Affairs, recently noted: The highly empirical, statistical method that currently predominates is inflexible; it restricts innovation and results in “overly large” trials that yield information “about how large populations with the same or similar conditions are likely to respond to a treatment. But doctors don’t treat populations, they treat individual patients.” Alignment and Discrepancy-- The Human Factor The globalizing world and its demands for medicine will foster a dramatically change Medicine will have to be developed for: disease subtypes targeted towards different patient subpopulations only test them on patients who suffer for those conditions The era of Big Pharma searching for blockbusters will have to end Mass Production of medicine to market will end Production to Order will be key in the future Utilizing and sharing all knowledge that exists Globally Inside and outside individual companies (Pharma) Legislation exceeding the borders of Countries and Regions (Globalized)
•With proper legislation the development process of the future will be much more refinedThe most important single obstacle is humans. “Our” way of in a persistent sociological, corporate or institutional culture to avoid using already existing products,research or knowledge because of its different origins. NIH = Not Invented Here! Manufacturing Scheme Traditionally, we have had "build to order" processes. In the future, we need new completely modular process modules. Process Modules are VPEs and all COTS “Self-contained” Mechanical, Instrumentation and Controls for the specific Process Functionality e.g. Chrom, Centrifuge, Reactor … Pre-validated Basically no interface between Process Modules Product Movement No piping Bags, IBCs and other types of product containers Flexible Product Storage by use of Farm Modules Capable of: Controlling and Maintaining product and environmental conditions Interfacing to overall MOM General: Up to daily product changeovers Different product in different units of same facility/train Unclassified space Unrestricted substitution of Process Modules (VPEs) Using identical “skid-stations” where Process Modules are hooked up Process Modules physically isolated yet Procedurally Connected 10-100 products per facility Currently product changeovers might take as long as 100 days. In the future, we should expect to see as much as 40% reduction in Time to Market delay. Product Change Over Facility utilization increased from 65% to 95 due to reduction in Downtime for product changeover Requires Pre-configured modules Pre-validated modules Plug-n-Play methodology for changeover High flexibility for Procedural Control Agile Systems and People We have not yet come to a point where we've created a standard that addresses these issues in a good way. Going Forward What can we as “Automation and Batch practitioners” bring to the table? Shift into a much higher gear on standardization work With the visionary Pharma companies, other forums like ISPE and other people to analyze and establish a Business Model for the new way of doing Medicare Create a common standard for 88 and 95 areas or redefine the 95 standard to defining the complete Manufacturing Operations Management as a generic business and software model that is not specifically targeted towards Batch, but that will also accomplish the task of Batch Control Investigate and explore technologies and standards used in other IT areas to create a basis for understanding how to enable integration across systems and software platforms and technologies Extend the current work done by Make2Pack and create a real compliance standard for integration of VPEs to the MOM (the Plug-n-Play standard) Secure the “buy-in” from Automation and IT vendors, as without them we can do nothing And finally, we should stop NIH.