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Complacent or Overly Compliant? Why Has Industry Been Slow to Adopt Single-Use for Bioprocess Control?


A few weeks ago, we hosted a webcast which addressed questions surrounding the relatively slow uptake of single-use technologies for biopharma measurement and control. Speakers Michael Kowolenko (formerly Sr. VP with Wyeth Biotech and Biogen Idec), Kit Erlebach (Merck) and Paul Priebe (Sartorius Stedim) offered a range of perspectives on what has been holding back single-use in biopharma. (A partial transcript is below.

From 'On Pharma'

Wyeth's OpEx Legacy


Did any of you catch that recent WSJ report on the negative impact of mass layoffs? OK, I know that M&A layoffs are different, but today brought the sad news that Pfizer/Wyeth will lay off 6,000 employees and close eight of its manufacturing plants in Ireland, Puerto Rico and the U.S.

From 'On Pharma'

For Pharma and Biotech, It's Easy Being Green


Reading an article online today from the Boston Herald on how AstraZeneca is outfitting its new Waltham, Mass. R&D center with the latest and greatest green bells and whistles . . . it's good to see, but hardly surprising.

From 'On Pharma'

Change: It’s Coming (or “I’ll Get Agile… Mañana”)


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.” 

From 'On Pharma'

Go Out and Gemba


I've always found one of the most evocative terms in the Toyota lexicon to be “gemba” ----the real place, or as it has more poetically been translated, “the place where truth will be found.”  The word already implies that you may have preconceived notions of what the truth is and need a reality check. What better way to define the workplace, whether that's a laboratory or a factory?

From 'On Pharma'

Pfizer Reveals Details of Wyeth-Infused Corporate Structure


Pfizer has announced details of what it will look like following the merger with Wyeth, saying that it aims to keep most key Wyeth execs as heads of a new BioTherapeutics Research Group. The small-molecule group will be labelled, creatively, the PharmaTherapeutics Research Group, and will be run by Martin Mackay, who now oversees PGRD. Here's the official release with more.

 

--PWT

From 'On Pharma'

FDA, Hospital at Fault in Levine Case, Not Wyeth


Yesterday's  big news was the fact that Wyeth Pharmaceuticals lost its appeal in the precedent setting Wyeth vs. Levine safety labeling case.

From 'On Pharma'

Pfizer-Wyeth: The Blockbuster Model's Latest Monster?


The blockbuster model is dying a very slow and painful death and there will be more collateral damage before it's all over. Early morning brought news that Pfizer might buy Wyeth Pharmaceuticals, including its biologics division, for $60 billion. 

Will a short-term financial quick fix steamroll a vibrant company, with all the inevitable layoffs and culture issues that will result?

From 'On Pharma'

Wyeth’s Pearl River Gets the Star Treatment


Wyeth’s Pearl River, NY, facility recently earned an OSHA Voluntary Protection Program (VPP) “star”, designating excellence in workplace health and safety. It was the 2,000th site in the U.S. to earn such status.

 

The VPP program began in 1982 as a proactive effort to encourage safety and health management through collaboration between OSHA, corporate management, and facility workers. It has since become the gold standard for workplace safety.

Pearl River’s initiatives began nearly three years ago when "gap improvement" teams consisting of volunteers across the facility were set up to address safety deficiencies, says Susan Rera, the site's associate director of safety. The teams dealt with each issue one by one until the facility was ready for VPP consideration. Pearl River joins a number of other Wyeth facilities that have star quality. “Any site on the star list has gone well beyond what it is required to do,” says Ted Fitzgerald, an OSHA spokesperson. Other pharma facilities with VPP star designations:

Medicinal Chemicals and Botanical Products

DSM Nutrional Products, Inc., Freeport, TX

Noramco of Delaware, Wilmington, DE

Pfizer Global Kalamzaoo Operations, Kalamazoo, MI

Wyeth Biotech, Sanford, NC

Pharmaceutical Preparations

Baxter McGaw Park, Waukegan, IL

Bristol-Myers Squibb, Evansville, IN

Bristol-Myers Squibb, Mount Vernon, IN

Lilly Technology Center, Indianapolis, IN

Noramco of Athens, Athens, GA

Novartis Pharmaceuticals, East Hanover, NJ

Pfizer Global Manufacturing - Brooklyn Facility, Brooklyn, NY

Pfizer Pharmaceutical, Caguas, PR (Merit)*

Sandoz Pharmaceuticals, Broomfield, CO (Merit)*

Schering Plough - Miami Lakes Ops., Miami Lakes, FL

Schering Plough Healthcare Products, Cleveland, TN

Wyeth Chemical Development, Rouses Point, NY

Wyeth Pharmaceuticals, Rouses Point, NY

Wyeth Pharmaceuticals, Pearl River, NY

Wyeth Pharmaceuticals Plant B, Richmond, VA

Wyeth Research Drug Testing Facility, Chazy, NY

In Vitro and In Vivo Diagnostic Substances

Ortho Raritan Plant, Raritan, NJ

Ortho-Clinical Diagnostics Rochester Plant, Rochester, NY

Biological Products Except Diagnostic Substances

Monsanto Augusta Posilac Plant, Augusta, GA

Pfizer Global Manufacturing, White Hall, IL

Wyeth Biotech Andover-Wilimington, MA, Andover, MA

* “Merit” is one level below “star” designation

From 'On Pharma'

BIO 2008: Quality by Design Needs Champions


Spoke briefly with one, Michael Kowolenko, SVP of biopharmaceutical manufacturing at Wyeth, who talked about the industry’s fear of change, why it exists and offered some suggestions on what to do about it. Below are some (raw) audio snippets of the interview.

An Interview with Michael Kowolenko of Wyeth Biopharma, Part One

An Interview with Michael Kowolenko of Wyeth Biopharma, Part Two

AMS

From 'On Pharma'