Think everything that can be automated has been automated? Think again. Look at the life sciences industry. All of the major automation companies are rapidly building expertise and bundling products and services in order to be ready when pharmaceutical manufacturers finally pull the trigger on major upgrades to their manufacturing systems.
The impetus for upgrading pharma manufacturing is mainly political, although competition probably is a factor as well. A mass of public opinion is building in reaction to increasingly high prices for drugs in the United States, while consumers see much lower prices in other countries. This swell of public opinion will soon reach critical proportions, resulting in some sort of political action. Part of the growing disenchantment with the way things are is increasingly coming from business leaders who are growing weary with ever increasing health care liabilities.
There is plenty of blame to go around. First, the current core competencies of pharma management consist of research and development and marketing. This is a financial model much like that of the software industry. The direct cost of the actual production is very small, but the costs to invent the product and market it are high. The way accounting rules work, the R&D is not counted as a direct cost. Therefore, the companies operate with huge gross margins, much of which must be plowed back into R&D. When you have proportionately huge gross margins, then manufacturing costs don’t really matter.
Another problem is that manufacturing processes are developed with the development of the drug. The company must produce drugs for the clinical trials. The production method is intimately related to the actual drug. So when the drug is validated, so is the manufacturing process. Drug companies view the challenge of re-validating an improved manufacturing process as daunting. Therefore, they have traditionally seen little incentive to improve the process.
In a rare case of “I’m from the government and I’m here to help you” working, the U.S. Food and Drug Administration (FDA) has been working with industry and academia to develop methods that would allow manufacturers to improve their manufacturing processes while maintaining the validity of the drug. Process Analytical Technology (PAT) is the resulting program. It holds out great promise for lowering costs and improving quality. And the automation industry will be at the center of the process.
Improve your skills
There are many ways that you can continue to learn new things that will improve your skills. This, of course, benefits both the company you work for and you personally.Reading magazines such as Automation World is a start. Attending conferences and trade shows is another.I’ve been trying to find other ways to provide information through my Weblog and my new Podcasts.
Automation World and one of its siblings, Packaging World, is providing another educational opportunity—the Packaging Automation Forum. I have attended many events. There are two things that I’ve discovered that have substantial benefit. One is intense technical training on the products you use or intend to use. The other is a gathering of peers where you can all share problems and solutions (non-proprietary, of course) and learn from each other.This latter is the idea behind our Forum.
We have gathered speakers with actual experience in packaging automation from companies including The Aagard Group, Clos du Bois Winery, Coors Brewing Co., Hershey, Miller Brewing Co., the OPC Foundation, Procter & Gamble and more. Plus, we’ve built in a lot of networking time for that informal learning that is so key to success. Join us on May 24 at the Chicago Marriott O’Hare. You can obtain further information or register at www.automationworld.com
Gary Mintchell Editor In Chief
[email protected]
