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New Gig for Novartis Alumnus: Rap


Biswant Korrapati, CEO of Move Records which presents rapper Mekka Don (a trained lawyer), apparently used to work at Novartis. 

From 'On Pharma'

Dangerous Documents101: When a Shredder Isn't Enough, There's a Preventive Course


Computer documents have been the downfall of many a company---think Enron.  And things as basic as date and author stamps and wording became very important in Merck's Vioxx case.

From 'On Pharma'

Pfizer to Close Cork Plant


Pfizer has decided to close one of its plants in Cork, Ireland. The company had purchased the plant from Pharmacia in 2005.

From 'On Pharma'

No Place Like U.S. for Manufacturers?


If it hasn’t quite sunk in how much the struggling economy in the U.S. is changing the mindset of industry, heed the words of Dr Heinrich Hiesinger, CEO of Siemens’ Industry Sector. His firm, at least at present, views the U.S. as a “low cost” production country, ripe as a base for exportation. Siemens has always had a strong manufacturing presence in the U.S., and a weak dollar makes exporting attractive. But perhaps Hiesinger’s remark is a sign that corporations may be leaning more towards the U.S. as a desirable manufacturing center, and less towards other countries.

The occasion for Hiesinger’s comments was the eve of the annual Siemens Automation Summit, held this week in Chicago. Siemens is banking on green manufacturing technologies, Hiesinger noted; its windpower drives business is expected to grow by 20% through 2010, compared to, for instance, 9% for product lifecycle management (PLM) software. Hiesinger also called attention to his company’s growing “environmental portfolio”—promoting wind power, enabling low-emission transportation systems, reducing factory energy consumption—which comprised 23% of its entire portfolio in 2007. For Siemens, the U.S. remains the focal point of these manufacturing initiatives.

What’s this have to do with pharma, besides the fact that Siemens has a major presence in the pharmaceutical automation and control market? The company’s bullishness on U.S. manufacturing reminded me of a news item I’d read just a few weeks about a small pharma company, Galexe Pharma Sciences, which chose to build in the U.S. rather than break ground abroad. Galexe, a subsidiary of Virginia-based Excela PharmSci, Inc., is set to open a new drug manufacturing facility in Lenoir, North Carolina. The company will invest $8.6 million over the next three years and create 55 jobs at an average annual salary of $55,455 per year.

“Upon careful consideration of competing locations within the U.S. as well as Hyderabad, India, we chose North Carolina,” says Phanesh Koneru, president and CEO of Galexe. The reasons: low cost of living and doing business, tax incentives, good talent pool, mild year-round weather. Sure, Hyderabad remains a good place for a manufacturing plant. But, weak dollar or no, the U.S. isn’t a bad place either.

Here's more on the Galexe story from the Hickory Record in Caldwell County, North Carolina.

--PWT

From 'On Pharma'

BIO 2008: Manufacturing and Op Ex


Once again, had to miss the best part of this presentation, but did hear Robert Bottone of Genentech discuss the problem that some managers in biopharm and pharma have with Operational Excellence. Many of them still expect “silver bullet’ solutions. This was also a conclusion reached by those who took our recent survey.

Silver bullets simply do not exist, Bottone said. Toyota took nearly 40 years to develop the TPS, so be patient and keep working at it, Bottone suggested. Worthwhile efforts take time.

Decided to ask the panel about error proofing and jidoka and where the industry stands. (For audio of responses, click here). Bottone said that drug manufacturers need to focus on this. William Botha , Director of Operations, Baxter, who will soon publish a book on the subject  of Op Ex(with Wiley) noted the fact that empowering workers is a tough but necessary job. It can’t be done by fiat from a corner office and by patronizing the individual. In addition, he said, operators thrive on challenge. They like it, they need to grow. Fundamental to the whole issue of jidoka and error proofing is respect for the people doing the work. Amen.

BTW, Gwendolyn Galsworth and Martin Hinckley, experts in error proofing and visual systems will be writing regular columns for us on just this topic. This promises to fill a need within pharma and biopharma. Stay tuned.

AMS

From 'On Pharma'

BIO 2008: Doing Well by Doing Good: Can Venture Capital Improve Drug Accessibility?


On Tuesday afternoon, a panel discussed ways in which corporations might be able to stimulate the development of more therapies for serious diseases----the world’s top killers such as malaria. The topic is one that I’m very interested, but, unfortunately, I arrived late and missed much of the discussion.

Genzyme has been doing some pioneering work with orphan drugs and its Gaucher’s disease treatment, Cerezyme, has been profitable.

James Geraghty, SVP of International Development with Genzyme presumably discussed the company’s Humanitarian Assistance for Neglected Diseases Initiative, and efforts such as the one underway with the Oswaldo Cruz Foundation in Brazil.

Una Ryan, President and CEO of Avant Immunotherapeutics, Ltd., also participated in the discussion. Her company has been developing drugs for neglected diseases, including cholera and typhoid, as well as an HIV vaccine, in efforts funded by the Gates Foundation.

Elizabeth Bailey of Commons Capital works with venture capitalists to obtain funding for early stage drug development.  Currently, Commons is working with Gates, Rockefeller and  Lloyd's Foundations.to fund research into therapies for neglected diseases.  At the conference she discussed financing models(some of which were touched on in a 2005 paper, which came out of a workshop on this subject). Financing is most feasible in early stages, she said.

Dr. Ryan  agreed, and emphasized the importance of venture capital in funding these efforts. Big pharma or Big Bio is too locked into production schedules and unlikely to recoup investments, so, despite its worthiness, it’s a hard sell to management. Profitability is critical.

Vaccines are excellent candidates for attracting venture capital for global development, Dr. Ryan said. During the Q&A, someone in the audience spoke of the need to develop an infrastructure that would permit scientists in developing nations to develop innovator products, rather than “copy cat” products. Presumably, they won’t face the 10-year, billion-dollar hurdle that innovators face here.

AMS

From 'On Pharma'

Notes from BIO 2008 - Oh, For a Segway in San Diego


OK, this is not coming at the speed of the Internet. Not even close, as BIO 2008 winds down today. But blame an interesting program spread out on a grand scale. Roller skates or a Segway were a must for anyone attempting to navigate BIO 2008 at the San Diego Convention Center this week.

This was my second BIO show (my first was in Chicago two years ago). While some may criticize the lavishness and spectacle of the conference, there are few events where one can interact so directly with top scientists, officials and professionals within the industry. All you have to do is to ask a question, during Q&As or after their presentations. I saw young professionals ask experts for advice on specific problems they were facing. And they weren’t rebuffed, either.

San Diego is a beautiful town, in that part of California where “beach” means warmth, sand and sun, not rocks, goose bumps and a wet suit. It is also quite cosmopolitan, with a single short stretch of 4th Avenue, in the city’s historic gaslamp quarter, offering Indian, Chinese, Persian, Japanese, French, Italian, Spanish and Arab cuisine.

It may be in an `80’s time warp, with notices of concerts by Billy Idol and others of that era----and a hit musical review, “Boomers.” (It might even have been a bit worse in L.A., where posters of a well-preserved Engelbert Humperdinck were in evidence along the freeway) Coincidentally, Artefill was among the products exhibited at BIO this year. Designed as a companion to Botox, to fill in laugh lines around the cheek, it’s made of polymethylmethacrylate, so the connection to the biotech world seemed somewhat tenuous---alas, no samples

The impact of an aging U.S. population was on the short list of leading topics this year, and the program emphasized the usual subject areas, including intellectual property protection, translational medicine but also some important accents: funding universal access to life-saving medicines and the ascendancy of new drug development powerhouses in Asia, particularly in India.

Thailand: Don’t Patronize Us, Please
On Tuesday morning, one discussion on how corporate biopharma might improve global access to biotech products reportedly brought an angry reaction from a representative of Thailand in the audience, who bristled at any suggestion, however, subtle, that future breakthroughs would necessarily come from the West.

The show dailies and even brochures were more snappily written this year (perhaps reflecting the influence of The Scientist, which wrote the show daily?), although there were a few cliches (shareholder salsa and Indian spice) and curve balls in conference titles “It’s life but not not as we know it, Jim” (on chimeric embryos), for instance, or “what the vector is happening here”…(gene therapy) or my favorite, .the enigmatic “evolving attitudes to obviousness” (about IP). Hmmm. Always easier to edit other people’s work, isn’t it?

The show floor brought the usual lavish booths, competing regional governors (“anything they can do we can do better”), the dueling music from different regional development authorities, there were the usual tschotchkes, freebies (basketballs, for example, from Kansas, whose team won the NCAA championships) and bizarre booth shows, like the puppeteer with the ostrich.

Winning the prize for practicality this year was the foot massage. There were also the spectacular cruises, receptions and parties, including one on the U.S.S. Midway. Oh, yes, and the celebrities, among them Harrison Ford, who, along with E.O. Wilson, took part in an event on Wednesday night publicizing the Invitrogen Foundation’s first grants.

But undoubtedly the main attractions this year (even trumping Colin Powell) were keynote speakers California governor Arnold Schwarzenegger and Craig Venter, whose work has made modern biotech possible.

People began lining up two hours before the luncheon keynote (no preferential treatment for the press this year)

AMS

From 'On Pharma'

Paralyzed by Profits


That's how Control magazine's executive editor Jim Montague described the pharmaceutical industry in a recent and very memorable op-ed (read it here), in which he interviews experts including E-55 insider Gawayne Mahboubian-Jones. Jim brings to the the "so what" detachment of one who has covered PAT and process control as it has advanced in other industries over the years. We may appear to be a bit "gee wiz" on the subjects, if only to encourage the adoption of PAT and the open discussions of best practices, but Jim makes great points.

An accompanying review of pharmaceutical PAT asks whether it's a silver bullet for pharma?  (The bullet was used, in legend, to kill the devil or werewolves...in the case of pharma, it's killing a Frankenstein monster of pharma's own creation, paralyzed on the lab table ---although FDA played a major role in the vignette...which role....Igor? Remember Marty Feldman and Abbie Normal? Sniff. What was once a great Mel Brooks film is now another overblown Broadway musical).   Our own recent survey of pharma op ex practices found an uptick in pharma PAT adoption...although PAT is no longer the top motto (it's now Quality by Design, as enabled by PAT)

Noticed that a number of great blogs are blogging from BIO 2008.  Patent Baristas has entitled its blog "The Road to BIO".  I'm still on that road tonight, quite literally, having made the decision to take the younger children with me on a road trip that started last week...beautiful stretches in New Mexico, particularly....but long stretches. 

Had hoped to be able to cover both Honeywell User's Group in Phoenix and BIO, but their schedules overlap completely....fortunately, our colleagues on Control have promised to help us provide coverage of HUG's extremely interesting pharma and biopharma track.  BTW, Control's   editor-in-chief, Walt Boyes, was very recently elected an ISA Fellow.

From 'On Pharma'

Michele on Chicago News!


Michele on the news

Digital editor Michele Vaccarello was far too modest to post this herself, but she's getting her Master's degree in digital media/ journalism, and she and her classmates recently spent some time with one of Chicago's top nightly news anchor teams.  Way to go, Michele.   You'll be seeing her in more videos on our site, including her video report from Dalian, on Interphex China, next week.

AMS

From 'On Pharma'