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Tuesday, August 9, 2011

Fwd: | 08.09.11 | Merck cuts propel pharma to top of layoffs list



-------- Original Message --------
Subject: | 08.09.11 | Merck cuts propel pharma to top of layoffs list
Date: Tue, 9 Aug 2011 08:57:25 -0400 (EDT)
From: FiercePharmaManufacturing <editors@fiercepharmamanufacturing.com>
Reply-To: editors@fiercepharmamanufacturing.com
To: nbrauchitsch@yahoo.com


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August 9, 2011

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Today's Top Stories:
1. Merck pushes pharma to top jobs-cutter
2. UPS sees new tech, distribution models
3. Roche deals API plants in SC, CO
4. GSK tests wireless water monitoring at plant
5. NSF to provide chemical reference standards

Spotlight:
At the box office, bad boy pharma on top

Also Noted:
Janssen, FDA work on Doxil supply; DSM seeks contracts beyond Big Pharma; Much more...

News From The Fierce Network:
1. Boston Sci invests $37M in Irish facility
2. Knees help Smith & Nephew in Q2
3. Scientists discover possible route to killing pain


Capitalizing on the Outsourcing Option - New Fierce eBook

Risk areas for many biotechs and pharmas in today's changing market include lack of expertise and infrastructure. This eBook addresses recalibration challenges and strategies to capitalize using the contract development and manufacturing (CDMO) option. Download now.


Events

> PDA/FDA Joint Regulatory Conference - Sept. 19-21, 2011 - Washington, DC
> PDA 2011 Combination Products Workshop - Sept. 21-22, 2011 - Washington, DC
> 2011 PDA Visual Inspection Forum & TRI Course - Oct. 3-4, 2011 - Bethesda, MD
> Pharmaceutical Quality System (ICH Q10) Conf. - Oct. 4-6 - Arlington, VA
> PDA Conf. on Pharmaceutical Microbiology - Oct. 17-19 - Bethesda, MD
> BioProcess International Conference & Exhibition - Oct 31 - Nov 4 - Long Beach, CA

Marketplace

> New Fierce eBook: Between an Industry Rock and a Political Hard Place: The FDA's 510(k) Initiative
> Capitalizing on the Outsourcing Option - New Fierce eBook

Jobs

> Regional BD Director

New Fierce eBook: Between an Industry Rock and a Political Hard Place: The FDA's 510(k) Initiative

This FierceMedicalDevices eBook examines the background situation, current position and the future of the CDRH's revision of the 510(k) premarket notification process. Click here to download today.

Today's Top Stories

1. Merck pushes pharma to top jobs-cutter

By George Miller Comment | Forward | < a href="http://links.mkt1985.com/ctt?kn=57&ms=MzU4NTc4OAS2&r=MjM2NzI3MjAzMjcS1&b=0&j=MTEzMTQyOTAwS0&mt=1&rt=0" name="api_addthis_com_oexchange_YTN77QNZ4DGiismfTiwGQ" >Twitter | Facebook | LinkedIn

Merck ($MRK) has almost single-handedly snatched the top spot for monthly job cuts from the U.S. government, ending a 7-month streak by the public-sector behemoth. U.S. job cuts overall jumped a frightening 60% in July. The retail sector joined pharma and the government in the top three.

Merck helped push pharma to the July job-cuts apex of 13,493; the drugmaker accounts for 13,000 of that total, resulting from its previously announced multi-year force reduction. No breakdown of manufacturing versus other types of pharma jobs was available.

By contrast, pharma's cousin, the chemical industry, dropped just one-tenth the number of jobs as pharma, making it the ninth largest jobs-cutter in July. The healthcare/products sector, which includes medical devices, occupies the sixth spot with 5,193 cuts.

"What may be most worrisome is that the heaviest layoffs occurred in industries that have enjoyed relatively low job-cut levels, including pharmaceuticals, computer and retail," says John Challenger, CEO, in the report.

Adding to the pharma darkness is last week's Bureau of Labor Statistics report that the U.S. economy added 117,000 jobs in July and that the unemployment rate fell one-tenth of a percent to 9.1%. The unemployment drop, however, was driven by people leaving the labor force, so it's more representative of economic bad news that coincides with the good news of the added jobs.

Meanwhile, in India, pharma is hiring, according to the Economic Times. In fact, it's been seeing an upswing over the past four years with a growth of 13% to 17%.

- here's the CGC report
- here's the Economic Times article

Related Articles:
PwC reports high pay, attrition at Indian pharmas
Merck hiring may show FDA influence
Genzyme hiring push a hopeful sign for industry

Read more about: jobs, Merck
back to top


2. UPS sees new tech, distribution models

By George Miller Comment | Forward | Twitter | Facebook | LinkedIn

Healthcare changes coupled with increasing and changing regulatory requirements are among factors accelerating the pace of supply chain change among pharma, biotech and medical device companies. Many are turning to new technology to keep up, according to UPS's fourth annual Pain in the Supply Chain report.

Through phone surveys this spring of nearly 250 supply chain execs in the U.S., Europe and Asia (compared with 150 U.S.-only respondents in the 2010 report), UPS is seeing "a complete rethinking of supply chains," says John Menna, director for healthcare strategy, in a phone interview. Supply chain executives are looking for "step changes, not incremental improvements. They have an increasing appetite to do things differently."

Menna's observation of the accelerating pace of change comes not just from respondent answers to survey questions, but also from the types of analyses they undertake and the changes they're making now, he says.

The survey finds 86% of respondents saying they will turn to new technologies as an investment strategy within the next three to 5 years, with 72% saying they have made such investments in the last 18 months. "They're looking at tracking technologies," says Menna, "radio frequency identification tags, for example, and integration of corporate systems with UPS tracking systems."

The respondent company universe is roughly a two to one mix of pharma/biotech companies and medical device companies, respectively.

Also on the tech shopping list: sensing devices, warehouse management software and order-to-cash systems. "They're looking for anything that will make it easier for product ordering, as well as newer functions for supply chain planning," he says.

On the non-tech side, the survey finds changes in distribution channels and models a tactic for achieving greater efficiencies. Some 63% of pharma/biotech respondents say they've used this strategy--including more direct shipments to providers, retailers and patients, as well as increased use of wholesalers and distributors--over the past 18 months. And 81% say they plan to do so in the next three to 5 years.

One distribution model change is a form of logistics handover, in which a drugmaker relinquishes post-manufacturing ops to a logistics provider. One example is the growing collaboration between Merck and UPS. Others involve DHL's Exel unit, which has relationships with Bristol-Myers Squibb and Pfizer.

- here's the release
- see the report (pdf)

Related Articles:
Merck, UPS grow closer in expanded logistics deal
BMS, Pfizer offload logistics to willing shippers
Survey: Raw material link weakens supply chains
Survey: Costs, reform, compliance are chief supply chain concerns

Read more about: Ups Supply Chain
back to top


3. Roche deals API plants in SC, CO

By George Miller Comment | Forward | Twitter | Facebook | LinkedIn

Roche Carolina has returned money given by the state of South Carolina to keep open its 300,000-square-foot facility in Florence. The drugmaker announced late last year that it might close the plant. But it was apparently swayed by a $500,000 state incentive and said in June that it would keep the plant open for "at least a few more years," according to SCnow.com.

But Roche returned the money late last week, and officials hope the funds can be used elsewhere (or by Florence itself in the future). The plant, which employs about 300, manufactures the active ingredients for Tamiflu and Xeloda, a chemotherapy drug. 

The FDA listed Tamiflu for oral suspension in short supply last month and in January.

And in Boulder, CO, last week, International Chemical Investors Group said it plans to acquire Roche Colorado, which includes a pharma production facility. Some 265 development and manufacturing personnel staff the site, which Roche bought in 1994.

ICIG will operate the site as part of its Corden Pharma unit.

Under terms of the transaction, Corden will supply Roche with APIs currently made at the facility. It aims to meet the drugmaker's demand for "commercial scale peptides and other medicinal compounds," according to the Boulder County Business Report. The workforce is expected to remain intact.

- see the SC story
- here's the Boulder story

Related Articles:
Roche/Genentech - The 12 greenest companies in biopharma
Presto! Tamiflu multiplies in supply chain magic

Read more about: Roche, Manufacturing Plant
back to top


4. GSK tests wireless water monitoring at plant

By George Miller Comment | Forward | Twitter | Facebook | LinkedIn

Sustainability-minded GlaxoSmithKline ($GSK) is simultaneously testing two technologies to enhance water use in an API manufacturing operation. The drug giant has combined wireless networking with pressure and flow transmitters at its plant in Cork, Ireland.

The transmitters from Emerson Process Management's Smart Wireless platform are attached to two new storage tanks connected with the facility's water system. The tanks were added when the API operation outgrew its water storage facility. Via the new tanks, the transmitters monitor data throughout the plant and send it to GSK engineers. In addition to studying water usage, the engineers are testing the wireless technology in hopes of being able to create a network that allows for additional process instrumentation, according to an Emerson Process Management case study.

The network currently has 10 Smart Wireless devices: 6 pressure transmitters, two flow transmitters and two level transmitters. Flow data are transmitted every 30 seconds and pressure and level data every 300 seconds to a Smart Wireless Gateway on the roof of the plant's control room building. The wireless system is integrated with GSK's DeltaV utility-control automation system, where it can be accessed by plant operators.  

- here's the case study

Special Report: The 12 greenest companies in biopharma

Related Articles:
GSK furthers pharma's greening
GSK taps Singapore for green manufacturing ops
Pharma finds means to go green

Read more about: API, Glaxosmithkline, Sustainability, Environmental Friendliness
back to top


5. NSF to provide chemical reference standards

By George Miller Comment | Forward | < a href="http://links.mkt1985.com/ctt?kn=68&ms=MzU4NTc4OAS2&r=MjM2NzI3MjAzMjcS1&b=0&j=MTEzMTQyOTAwS0&mt=1&rt=0" name="api_addthis_com_oexchange_kQnEMrQuLIVGorwZr6yQg" >Twitter | Facebook | LinkedIn

Nonprofit NSF International is launching the NSF Reference Standards Program, through which it will provide chemical reference standards as a service to drugmakers. The new program augments the documentary standards service it already provides.

The chemical reference standards, which are used for comparisons that demonstrate the identity, purity, quality and strength of the subject drugs and ingredients, will be traceable to official U.S. and European pharmacopeial standards, according to an announcement. The program will focus on developing reference standards that are in demand by global customers in the pharma and health supplement industries, says Steven Lane, the program's general manager, in an email. One indication of the global scope of the service is the announcement's availability in Chinese as well as English. Lane says that reference standard pricing will be "favorable" relative to other U.S. and European pharmacopeial standards.

Among characteristics of the NSF reference standards: They will be verified to conform to FDA and European Directorate for the Quality of Medicines & HealthCare regulatory requirements; produced and tested in compliance with current good manufacturing practices; and tested independently by a minimum of three collaborating laboratories.

- here's the announcement

Read more about: GMP, NSF International, chemical reference standards
back to top


Also Noted

TODAY'S SPOTLIGHT... At the box office, bad boy pharma on top

In another blow to pharma's tattered image among the public, Rise of the Planet of the Apes makes drug developer Will and Big Pharma the agents of unprecedented disaster. "Will is a brilliant, but cold pharmaceutical scientist who, instead of finding a cure for Alzheimer's disease, starts the cataclysmic extinction of man." Alas, it topped the weekend box office receipts in North America at $54 million, more than double the take of second-place The Smurfs. Review | Box Office Rundown

> Janssen, maker of chemotherapy drug Doxil, says it's "working closely" with the FDA on a plan to get the drug to doctors as soon it becomes available, which it expects to be in late August. Story

> DSM seeks a CMO partner to help it target work in addition to what it receives from Big Pharma. Report

> Vaccine maker MedImmune has opened a second manufacturing plant in Frederick, MD, to expand production capacity. Item

> Abbott Labs will enjoy "significant savings on imports of products from offshore," after its Temecula, CA, plant was admitted to a foreign trade zone. Article

> More demand-driven supply chains can help Big Pharma make the leap from traditional make-to-stock production to more efficient make-to-demand. News

> An unnamed Belgian drugmaker is using RFID and bar code technology to track more than 70,000 bags of products annually as they undergo testing. Story

> Asian distributor Zuellig Pharma has teamed with business-process specialist ADEC Solutions to create a pharma/healthcare knowledge- and business-process outsourcing service provider. ADEC/Zuellig release

> Early results from the first few years of FDA dietary-supplement manufacturing inspections show some common GMP violations. Story

> CMO SynCo Bio Partners has expanded its aseptic filling facility, equipped to fill and lyophilize biopharmaceuticals, including monoclonal antibodies, nucleic acids, proteins, polysaccharides, aluminum-containing vaccines, RNA and live biotherapeutics for clinical and market supply. Item

> AccuDial liquid OTC medications have a two-part label that allows parents to administer milliliter-precision doses based on a child's weight, rather than the more common dosing based on age. Story

Events

> PDA/FDA Joint Regulatory Conference - Sept. 19-21, 2011 - Washington, DC

This Conference offers a unique opportunity to join FDA representatives and industry experts in face-to-face dialogues. FDA speakers provide updates on the current state of efforts impacting global regulatory strategies. Industry professionals will present case studies on how they employ global strategies in their daily processes. Click here.

> PDA 2011 Combination Products Workshop - Sept. 21-22, 2011 - Washington, DC

This workshop focuses on the device design validation requirements of FDA's Quality System Regulation and the international harmonized quality standard ISO 13485:2003 which may be applied during the life-cycle of a combination product. Click here.

> 2011 PDA Visual Inspection Forum & TRI Course - Oct. 3-4, 2011 - Bethesda, MD

This interactive forum will closely examine the latest developments, preparation and use of inspection standards and practical aspects of manual and automated methods along with the regulatory and compendial requirements that govern them. Click here.

> Pharmaceutical Quality System (ICH Q10) Conf. - Oct. 4-6 - Arlington, VA

PDA, ISPE, the FDA and EMA have created a joint conference dedicated to teaching the principles of ICH Q10. This will be a unique opportunity to learn principles from companies that implemented a Pharmaceutical Quality System across the product lifecycle according to the ICH Q10 model. Click here.

> PDA Conf. on Pharmaceutical Microbiology - Oct. 17-19 - Bethesda, MD

This conference will gather industry professionals to network and benefit from a program that demystifies the underlying science of microbiology and seeks to solve the problems that our industry faces. The agenda will include presentations from regulatory and industry representatives globally. Click here.

> BioProcess International Conference & Exhibition - Oct 31 - Nov 4 - Long Beach, CA

BPI is your one stop industry resource for driving down costs, improving quality, achieving rapid, robust and resilient process development and manufacturing. This conference is where challenges are explored, solutions are uncovered and opportunities are developed. Learn more, view the agenda or download the brochure.

Marketplace

> New Fierce eBook: Between an Industry Rock and a Political Hard Place: The FDA's 510(k) Initiative

This FierceMedicalDevices eBook examines the background situation, current position and the future of the CDRH’s revision of the 510(k) premarket notification process. Click here to download today.

> Capitalizing on the Outsourcing Option - New Fierce eBook

Risk areas for many biotechs and pharmas in today's changing market include lack of expertise and infrastructure. This eBook addresses recalibration challenges and strategies to capitalize using the contract development and manufacturing (CDMO) option. Download now.

Jobs

> Regional BD Director

We are considering candidates for a Regional Business Development (BD) Director to join our BD team! The ideal candidate should have specific experience calling on and selling into the R&D and clinical development/operations and study start up side of the industry, including but not limited to Phase I-IIIB as well as Phase IV post marketing surveillance, outcomes research and patient registry programs. Learn more.


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