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 refined
The 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.
