Ever get stuck behind a loud bore on an airplane? I had that misfortune last week. Eventually tuned him out, but couldn’t help but pity his quiet seat-mate, who didn’t know a peptide from a Pepsi, as he got sucked deeper and deeper into a one-sided verbal black hole, a diatribe about the axis of evil: the pharmaceutical industry and its “ally,” the FDA.

This bore was well-read, but essential bits of knowledge were missing from everything he talked about, from his description of peptides and how cox-2 inhibitors work to his characterization of the evil FDA.

Everyone keeps talking about how the industry is on the brink of great change….it’s the death of the blockbuster….the birth of…what?  The niche-buster? Personalized medicine? 

Just keeping up and fire-fighting may be difficult enough so it is tempting to be like Scarlet O’Hara, as in “we’ll just deal with those issues tomorrow.” 

The talk was all about convergence and mashups at this week's annual Rockwell Automation Fair in Nashville. In case you haven't heard, a mashup is a web application that combines data from more than one source into a single integrated tool--at least that's how Wikipedia defines it.

There is quite nothing like a trade show that provides complimentary lunch, snacks, and beverages to keep you charged as you plow the show floors. With an orange juice and muffin in hand I spent the morning at the Life Sciences Industry Forum of the Rockwell Automation Fair where manufacturing success was the topic of conversation.

Industry professionals spent the day discussing the ways in which integrating manufacturing and information systems can help achieve operational excellence in the life sciences.

Highlights:

Alan Thomas, vice president of Jacobs Engineering, began by addressing the recent global trends in life sciences manufacturing. He touched briefly on increased investment of manufacturing in particular India and China and the challenges the industry faces in terms of quality control with production handled in developing countries. Thomas also discussed the effect of fewer blockbuster drugs on the development and expansion of manufacturing facilities. Drug manufacturing facilities need to take an integrated approach to their new facilities and/or expansion of current plants, he said, and sustainability needs to be at the forefront of life science development.

Scott Sommer, automation technology manager at Jacobs Engineering followed with a presentation on automation trends that can optimize manufacturing. Sommer focused on measuring the value of each manufacturing application to determine its yield. Defining data requirements and utilizing "master data" in the initial production phases can help to assess an application's long-term value, he said. In regards to automation systems, Sommer discussed how maximization of value should bear far greater importance than minimization of cost. Value should be the factor by which all automation and manufacturing applications are measured for success.

MES was later discussed by Jim Labonty, associate director for automation and systems engineering at Wyeth Biotech. He warned of the dangers of using an MES solution on all process areas as a 'one size fits all' mechanism. Numerous automation systems must have varying levels of MES integration in order for the system to be profitable at each level, he advised. "Different Horses for Different Courses," he stressed (fittingly also the title of his presentation).

These presentations in full will be posted to PhM.com in the upcoming weeks.

On the show floor, companies such as burkert, Cognex Corp., Hoffman, Matrikon, Stratus, and many more displayed their latest and greatest. For product information from the show, please visit our New Product section.

MV

Hospira CEO and Chairman Christopher Begley urged lawmakers yesterday to pass legislation enabling the FDA to create an abbreviated regulatory pathway for “safe, pure and effective biogenerics.� In a keynote address at the Generic Pharmaceutical Association's (GPhA) Annual Policy Conference, Begley explained that the continual lack of an approval process is a critical policy issue. 

What I found interesting was the tact Begley used to try and convince people that these biogenerics need to be fast-tracked – these biosimilars will save the American people money. According to the press release, “Begley underscored the generic industry's eagerness and readiness to bring additional financial relief to the American people in the form of safe, effective, quality-driven biogenerics.� 

Something sounds fishy to me. The reason they want to make these biosimilars is to save people money – sure. I have seen reports stating that these drugs are not going to be that much cheaper for Joe Consumer. Begley did not provide any specifics to the pricing of his six biogenerics in the pipeline compared to the current costs of the non-generic biologics. He just railed on the current costs. “When life-saving drugs are not affordable -- regardless of their safety and efficacy -- they are irrelevant,� Begley said. What about 14 generic drugs doing the same thing – is that irrelevant? That is exactly what is happening for the drug Coreg (read the story). This is not a biologic drug but nonetheless. 

Begley also drew a comparison between these same issues back in the ‘80s regarding the idea of approving traditional or small-molecule generic pharmaceuticals. “Safety and savings were questioned, and the specter of stifled innovation was raised. None of these fears were realized.� 

It might have taken 20 years, but the pharma pipelines are getting pretty bare. This might not be the direct result of generic competition but I’m sure it is a contributing factor. Besides the fact that pharma companies are spending a lot of time reformulating old drugs to retain patents. 

I’m all for saving money. Somebody I know is taking these biologics and luckily she has very good insurance that is picking up the tab. 

But, is fast-tracking biosimilars the answer? I might be wrong, but it seems to me that biogeneric manufacturers just want to get their share of the pie that much faster. Therefore, the “save more money� approach is interesting to say the least. The jury is still out. 

BS

Last week, FDA approved an automatic home medication device, the Web based Electronic Medication Management Assistant or EMMA, designed to prevent medication errors.  It's designed to be an "electronic nurse, " linked to pharmacist and health care provider, to monitor and manage medication. 

Thinking about the number of medications my mother now has to take, I thought this was a particularly brilliant invention.  Then I remembered how much mom loves computers, the Internet, machines in general and touch screens in particular. (My mother is a brilliant woman, but she's the only person in the world who can make me feel smug about my IT skills. We spent hours getting her aol account, still untouched, going two years ago. I'll bet that there are many more target EMMA users just like her.)

John Mack was right to criticize the high cost ($200 per month) and general unwieldiness of the system. (For more, read here).  And, of course, what happens when something goes wrong with the device?

But this invention will likely be followed by smaller and more streamlined versions---just in time for tail-end Boomers and Generation X'ers  (only perhaps, by then, we'll have moved beyond tablets and capsules, to error-proof new dosage forms and combined drug devices).

FDA had issued a press release, but here is an update on how Emma works from Medical News Today.

Mention robotics and many people still envision 2001: A Space Odyssey.  If they don't think of HAL, chances are they think of automotive plants, but robots are finding increased use in pharma, in packaging applications but also in R&D areas such as sample preparation and high throughput screening.  Last year, the NIH described how it was applying robotics, while Robotics Online summarized some applications in this overview.

(Note - we're surveying our readers on their use of process control, automation and robotics.  If you work in the industry and can spare 5-10 minutes to take a brief survey and receive benchmarking results (and potentially one of five $100 Amex gift certificates), please click here).Click Here to take survey

Last week, the Automation and Robotics Show, sponsored by the Robotics Industry Association (RIA) in Chicagoland, highlighted many of the applications that robotics have, or could have,in pharma.  RIA also presented awards to the most innovative applications of robotics.  One of the winners was New York's Sloan-Kettering, which is using robots for high throughput screening.

RIA selected Memorial Sloan Kettering Cancer Center for its High Throughput Screening Core Facility at the center uses robots and machine vision to screen large chemical libraries against various cancer targets. The application has been successfully working in production since 2004. Among the key benefits provided by the system is the ability to discover novel and potential drugs for clinical use to fight a broader range of cancers, especially for those being neglected by the large pharmaceutical companies

"For economical reasons, many pharmaceutical companies aren't willing to research certain type of rare cancers," said Dr. Hakim Djaballah, head of screening at Memorial Sloan Kettering. "Thanks to this innovative application, we can now research these cancers using chemical screening techniques typically associated only with large pharmaceutical companies. We can investigate several cancer cell lines in forward and reverse time schedules, especially those primary cancer cells derived from patients, where we can correlate clinical observations to findings in the laboratory as to the response of these cancer cell lines to different therapeutic regiments," Djaballah explained.

The Memorial Sloan Kettering HTS system was designed internally and integrated by the laboratory automation and integration group at Thermo Fisher Scientific located in Burlington (Canada).

"Memorial Sloan Kettering has demonstrated that robots and vision technology can impact our lives in many ways we'd never imagined," said the RIA's Vincent. "Most people think of factory applications when they think of robotics, but this application shows just how diverse the uses of robots can be."

-AMS