Just read Mina Kime's enlightening account of the J&J McNeil quality disaster in Fortune. Forget about the fact that the adulterated products did not and most likely would not have harmed consumers, the problems cited are very serious and go straight to the heart of GMP's. 

Every so often, one gets a major reminder of the strategic importance of manufacturing and the largely invisible "CGMP set" to the drug industry and, yes, its bottom line. Former FDA chief Mark McClellan gave pharma a good one years ago with his famous "potato chips and soap flakes"  comment, immortalized in a Wall Street Journal piece. Typically, manufacturing continues to be thought of something that will get done....quietly, invisibly, wherever and by whomever.

Did anyone miss President Obama's recent announcement that he plans to put an end to corporate tax loopholes (a mainstay for every major pharma and biotech company in the world....)More from Bloomberg and the President himself. 

Busy and eventful week.  Michele's on her way to Ireland to visit biotech and pharma labs, and Paul had nice interviews with AstraZeneca's CEO David Brennan and former House majority leader Dick Gephardt. 

I spent yesterday afternoon at the Forum for Medical Innovation in downtown Chicago, hosted by the Council for American Medical Innovation and moderated by former U.S. House of Representatives majority leader Dick Gephardt. The event also featured AstraZeneca CEO David Brennan as a guest speaker. David Brennan

I don’t know about you, but the relentless drum beat of negative news has been getting to me lately.  Every day seems to bring news of some drastic four-figure layoff...er, restructuring, whether in pharma or other industries.

At a meeting at DIA in Boston yesterday, Mike Svinte, President of Global Life Sciences at IBM provided a sneak peek and insights into a new report probing CEO challenges and concerns and their implications. The report, which is due to be released next month, will distill interviews with more than 1,100 CEOs from around the world, 40 of them heading life sciences companies, including mid-sized companies, in North America, Europe and Asia. Not that their individual names can or will be disclosed, but the CEO’s appeared very willing to engage in open dialogue and creative discussion of issues. "The interviews were a bit like therapy for some,” Svinte said.

Nearly a quarter of the life sciences CEOs interviewed admit that they have had no, or only minimal success at managing change within their organizations.  At the same time, IBM analysts found, they are hungry for change.  The study suggests that CEOs need to “seed” their organizations with challenges and to gain inspiration by examples from other industries that have already undergone transformation. They will then need to convince their companies that change is necessary, and cultivate enthusiasm for it

IBM’s research shows that life sciences companies’ financial performance tends to be better when CEOs encourage change and invest in new areas, Svinte said. The questions are where to invest and why, and how will pharma’s industry model and business model need to change for the future. Will pharma companies be the "dinosaurs" predicted years ago---holding companies that outsource all key functions?

Not enough CEO’s have actively wrestled with these questions, the survey suggests.

Talent shortages top the list of their concerns---63% of pharma CEOs named this the major problem (compared with 48% in other industries. Regulatory issues, as one might expect, came in second (53% vs. 45% for other industries).

One factor driving change, CEO respondents say, is a better informed consumer, who demands more as he or she pays more."We’re experiencing increased pressure related to environmental initiatives,” wrote one anonymous CEO from
North America.“Transparency is being driven by the government as well as by consumers. There is great risk in not focusing on rising consumer expectations."

As pharma moves from the old multinational model to a globally integrated one, Svinte said, issues of global regulation, intellectual property protection and talent shortages in India, China and other regions of the world may pose risk but more CEO's say they are investing there.

Three quarters of pharma CEOs are pursuing innovations in business models. More than half are focused on enterprise model innovation or reconfiguring the breakdown between what work is done inhouse and what is outsourced. Only 17% were focused on new industry model innovations, including those that will involve diagnostics and targeted or personalized medicine, and will require new revenue and enterprise models.  Among blue sky possibilities discussed was the concept of consumers paying for a therapy only if it worked.  (Ha! Don’t hold your breath waiting for this to happen – brief editorial interjection)

62% of the life sciences CEOs surveyed also see rising expectations of corporate social responsibility as a positive, rather than a negative one. But nearly a quarter of respondents don’t expect such work to have any impact on their corporate bottom lines. IBM analysts suspect that new dimensions of corporate responsibility may not yet have reached pharma CEOs’ radar screens.Pharma CEO’s may recognize the drug industry’s duty to “do no harm,” but they may not be able to measure the footprint that pharma has on society, analysts suggest, pointing to the issue of drug residues in the world’s municipal water supplies.

Knowledge management and the drive to turn data into information are becoming more important to a growing number of CEOs, the study found, since these establish a framework for more collaboration and cross-functional product development.

Manufacturing and supply chain management are becoming a priority for more CEO’s, Svinte said, although they were not probed in depth, by themselves, in this survey.

Among other subjects that came up at this discussion was IBM’s patient-centered healthcare project,

Also talked about was the MidEast Consortium on Infectious Diseases, a program underway in the
Middle East that is using supercomputers to predict future pandemics and the potential impact of changes within patient population.

Look for more detailed reporting on the research and trends in future issues of our magazine and online.

And now for something completely different (for any opera fans or Italophiles out there).

AMS

We all know that physicians must distance themselves from patients to keep from becoming too emotionally involved in each case.  Perhaps this applies to drug development and manufacturing as well, and industry profesionals may risk viewing adverse patient reactions as a mere statistic.

Emotional connection to the patient is essential to preventing future quality control disasters like the adulterated Heparin case now playing out on a global stage.

This week, those who lost family members injected with contaminated Heparin, testified before the House. One man lost both his wife and his son.  Since a picture says a thousand words (and a video clip, several thousand), here's a quick montage of multimedia sound bites.

A California network offered very concise coverage in this clip.  Hear more from this widow in this sound bite , which includes a statement from Baxter's top executive (notice Janet Woodcock in the background). 

This very brief Associated Press clip, from last week,  shows FDA Commissioner Van Eschenbach on the hot seat before Rep. Dingell, who repeatedly drums on the table.  It is something of a classic, illustrating the relationship that FDA leadership have with U.S. legislators.  ( The clip was cut off before Von Eschenbach could  elaborate on the tremendous costs that would be required to inspect the growing number of overseas plants.)

We'll run more in depth coverage of the testimony in our next issue.

By the way, FDA's public relations team appears to be embracing Web 2.0 and digital media in a big way.  Has anyone missed reading  (or listening to) "Andy's Take," FDA Commisioner Von Eschenbach's blog? 

AMS

We're updating and reviving our video RSS feed, and Bloomberg posted several interesting interviews this week.  To watch clips, click here.

Friday will bring a new White Paper,  "The Continuing Evolution of the Pharmaceutical Industry: Career Challenges and Opportunities" by Michael Steiner et al, of RegentAtlantic Capital LLC.  that tackles a critical topic: job security for the senior-level professional in an industry that's undergoing major transition.

Instead of rehashing all the "transformations" going on within the industry, it correlates them to the individual pharma professional's job development to answer the questions: 

• What do I need to do to remain employable in this industry? 
• What are the key driving forces shaping the pharma industry job market?
• How can I manage my career to ride all these waves? 
• How can I manage my personal finances to weather the storm following a layoff?

Not too many of you will or could follow Peter Rost's path into creative writing, the ultimate question is:  will you be a specialist or an "athlete" with a broad set of capabilities and the range of experience that will allow you to manage complexity easily)? 

Warning:  Going too far in either direction probably won't pay off. 

We're posting excerpts from the study on PharmaManufacturing.com and KnowPharma.com, and will post the entire white paper (which will also accessible via www.regentatlantic.com) on Friday. 

These graphics are from the draft version of the report, which may differ somewhat from the final version coming out later this week (please credit the RegentAtlantic report fully if you use these!).

AMS