August 31, 2010

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Editor’s corner:
Top 10 Women in Biotech

Today's Top Stories:
1. Ops emphasis lets Pfizer extend product life
2. Ranbaxy may offer payment for FDA reset
3. Report: Target fill/finish to speed vax-making
4. Packaging reminds patients to take drugs
5. Fakes report: Forget handbags, focus on drugs

Spotlight:
Weldon: Long ops fixes under way at J&J

Also Noted:
80 arrests in African counterfeit bust; Clock ticking on UK label rule change; Much more...

News From The Fierce Network:
1. Paper: Roche mulls 'massive' job cuts
2. J&J CEO likely to weather current woes
3. Genzyme rejects Sanofi's $18.5B bid


Editor's Corner

Top 10 Women in Biotech

Comment | Forward | Twitter | Facebook | LinkedIn

It's a well-worn cliché that men dominate the top ranks of the biotech industry. But over the past decade a group of extraordinary women has put that cliché to the test. Perhaps one of the most interesting aspects of our selection of 10 women who have excelled in the industry is that there were so many outstanding women in biotechnology to choose from.

One of this year's group runs a large cancer drug business. One not only founds biotech companies, she also places some savvy venture bets on future stars. Several are CEOs pursuing excellent science and top clinical trial prospects. Some came up through the scientific ranks, others through the business development side of the business.

In an entrepreneurial business like biotech, results are all that matter. So in some respects it's the ideal climate for women who want to reach the top ranks, where the old boy network helps but certainly doesn't rule. And as more women break into these ranks in the years to come, as is certain to happen, this group will become even harder to narrow down to a top 10.

Click here to get started 

Sponsor:Fierce Mobile Apps

Events

> DIA 2011 Call for Proposals Open Until September 13 - September 13
> BioProcess International Conference & Exhibition - September 20 - 24 - Providence, RI
> CPhI Worldwide, BioPh, ICSE, P-MEC Europe - October 5 - 7 - Paris, France

Marketplace

> Download a complimentary biomarker white paper from Thomson Reuters
> From H1N1 and Beyond: Growing The Flu Vaccine Pipeline
> White Paper – Automated Processing of Every Customer Order into ERP
> Innovations and Opportunities in Therapeutic Vaccines

Jobs

> Director Global Health Economics and Outcomes Research - Shire Pharmaceuticals
> Senior Scientist Basic microRNA Mechanisms - Regulus Therapeutics Inc.
> Senior Scientist Metabolic Diseases - Regulus Therapeutics Inc.
> Senior Research Associate/Senior Scientist Immunology - Regulus Therapeutics Inc.
> Senior Director/Vice President Immunology - Regulus Therapeutics Inc.
> Senior Scientist/Associate Director Immunology - Regulus Therapeutics Inc.
> Senior Scientist/Associate Director Fibrosis - Regulus Therapeutics Inc.
> Senior Director/Vice President Fibrosis - Regulus Therapeutics Inc.

Today's Top Stories

1. Ops emphasis lets Pfizer extend product life

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

Product enhancements and reformulations, opportunities in niche markets and better planning for competition as patents expire are tactics Pfizer is adopting at its 2-year-old Established Products business unit. The manufacturing operation in Portage, MI, works to grow sales of products that face competition from generics.

The most recent investment in the plant--the company's largest manufacturing operation--involves a $100-million modular sterile packaging and freeze-drying facility. It took three years to install and ramp up, will provide automated filling and formulation, and promises to keep a cap on operating costs while product yields remain high.

Pfizer had $10 billion in worldwide sales of off-patent products last year, according to a local press report. The company says it expects the global market for such products to grow to $500 billion by 2015, nearly double the 2006 figure.

Among such products produced in Portage are anti-inflammatory medicine Solu-Medrol, antibacterial treatment Zyvox and cancer treatment Camptosar.

-see the article

Related Article:
Pfizer works to lower manufacturing costs

Read more about: Pfizer
back to top



2. Ranbaxy may offer payment for FDA reset

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

Daiichi Sankyo's increasing involvement in the regulatory matters of Ranbaxy, its 2008 acquisition, are kindling hope that the Indian generics maker may soon see an end to the FDA's import ban on 30 of its products. Press reports indicate that Ranbaxy may offer to pay a one-time penalty to settle with the regulator and reset their relationship.

Reports also indicate that an FDA inspection of the company's plants at Dewas and Paonta Sahib, where the troubles began, would follow before matters are resolved. The first inspection would be at the Dewas facility, "because the issue is less complicated there," Moneycontrol reports.

The ban stretches back to 2008 when GMP violations lingered at the two Indian facilities. And in early 2009, the FDA halted review of drug applications from Paonta Sahib, alleging Ranbaxy had falsified data.

- here's a Dow Jones report
- see more here

Related Articles:
Daiichi wants payback for Ranbaxy fixes
Ranbaxy, FDA in warnings dance
Ranbaxy preps for FDA at Indian facility

Read more about: cGMP, Ranbaxy, Daiichi Sankyo
back to top


3. Report: Target fill/finish to speed vax-making

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

Scientists have recommended to President Obama that fill/finish, potency assays and sterility testing are three areas that can be improved to speed the production of pandemic vaccine. The President's Council of Advisors on Science and Technology has submitted a 65-page document, Reengineering the Influenza Vaccine Production Enterprise to Meet the Challenges of Pandemic Influenza, outlining what the government can do to speed up production.

The council advises that pandemic vaccine production time could be halved in three years. One recommendation: government incentives to drive development of the equipment used in fill/finish operations, "a major rate-limiting step" in production. Advisors suggest that a comprehensive six-month review of fill/finish technology is a first step. One focus of the review would be facilities, with an eye toward evaluating the capabilities of existing plants against the promise of new plants.

The advisors also suggest that effort be devoted to improving potency assays, work that should be driven by the FDA and contractors. The council projects that a four- to eight-week time savings may be available in this area.

Similarly, the council suggests that changes to sterility testing could test time in half.

- see this article
- here's the report

Related Articles:
Congress pitched on vaccine business model
Vaccine platform to aid in pandemic preparedness
HHS: U.S. needs $200M biodefense fund

Read more about: Vaccine Production, Pandemic Disease
back to top


4. Packaging reminds patients to take drugs

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

Packaging is paving the way for improved patient compliance with drug regimens. The so-called Pill Timer that is being introduced by the Henry Ford Health System promises to improve treatment outcomes through better medication management by patients.

The solution comes from an alliance between the healthcare provider, prescription-vial maker Rexam and medication management solution provider Med Time. Pharmacists will give patients free programmable timers with Rexam prescription vials; the vials will provide audio and visual alerts at prescribed intervals.

Henry Ford Continued Care will use the enhanced packaging for chronically ill patients. The system meets USP safety requirements, according to an announcement.

- see the Henry Ford release

Related Articles:
Parenteral packaging rises to patient-compliance, brand challenges
Nano-enabled drug packaging market to reach $8B by 2014
Med compliance could save $290B yearly

Read more about: packaging
back to top


5. Fakes report: Forget handbags, focus on drugs

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

A study funded by the European Union finds that, with the notable exception of drugs, counterfeiting is an overblown concern. In fact, it may be good for the brands being copied. However, brand-holders and law enforcement are rejecting the report's conclusions.

The quality of many of the fake goods has "improved greatly," the report says. That's as true for drugs as for any other brand-name product, consumer or otherwise. "We should be focusing on the trade in counterfeit drugs, dodgy aircraft parts and other stuff that really causes public harm," says study co-author David Wall, a University of Durham professor, in a U.K. press report.

The British Journal of Criminology study, co-written by Wall and a U.K. Home Office adviser, calculates that the cost to industry might be a fraction of commonly accepted estimates and says it should be up to the industry--and not police--to halt the trade. That thought appears to have occurred some time ago to Pfizer, the maker of Viagra, which is one of the most copied drugs. The drug giant employs its own counterfeits investigative staff to work with government officials. It has found "a massive black market economy generated by counterfeit medicines," and estimates that as much as 90 percent of medicines bought online are fake or contain too little or none of the active ingredient.

- see the article about the EU report

Related Articles:
Top Counterfeit Drugs Report
Customs officials to fight 600% rise in drug fakes
Counterfeit-fighters face "defining" moment

Read more about: Counterfeit Drugs
back to top


Also Noted

TODAY'S SPOTLIGHT... Weldon: Long ops fixes under way at J&J

J&J chief Bill Weldon says the company has checked quality operations at its 120 factories and realigned its supply chain to ensure the sharing of best practices, in light of its quality meltdown leading to 11 healthcare product recalls in 12 months.  One factory manager has been fired. "We're doing everything we can anyplace in Johnson & Johnson to make sure this never happens again." Article

> A counterfeit bust has netted 20,000 pounds of fake medicine and 80 arrests in six East African nations, says Interpol. Article

> Get ready: the transition period for UK drug labeling changes--requiring the prominent display of API common names--ends in October. Announcement

> Massachusetts-based Xcellerex has signed a memorandum of understanding with SK Chemicals to develop and commercialize the South Korean company's vaccines using the Xcellerex FlexFactory biomanufacturing platform. Xcellerex release

> Drug cargo theft is on the rise on Mexico. Article

> Lufthansa Cargo has unveiled the opticooler shipping container, an electric unit based on compressor technology. Lufthansa Cargo release

Events

> DIA 2011 Call for Proposals Open Until September 13 - September 13

DIA 2011 features new content areas to help you optimize your operations and succeed in the changing global landscape. Click here for track descriptions. Submit proposals for sessions, presentations, workshops, and forums. Proposal Details

> BioProcess International Conference & Exhibition - September 20 - 24 - Providence, RI

Get a glimpse of the caliber of content presented at BPI by accessing two of our 2009 keynote presentations (Free) or by downloading the 2010 conference brochure. BPI is the best place to gain the latest industry updates, make new contacts & initiate collaborations in biopharmaceutical production.

> CPhI Worldwide, BioPh, ICSE, P-MEC Europe - October 5 - 7 - Paris, France

CPhI for ingredients; ICSE for contract services and packaging; P-MEC for equipment, machinery and technology and BioPh for biopharma - will return to Paris -Nord Villepinte for the first time since 2006. Join us for the worlds leading pharmaceutical event. Register Now!

Marketplace

> Download a complimentary biomarker white paper from Thomson Reuters

Biomarkers are forging an important role in drug development. Download Biomarkers: An Indispensable Addition to the Drug Development Toolkit to see how researchers are using biomarkers as evaluative tools to help save time and money at the bench. Includes insight from industry and academia experts.

> From H1N1 and Beyond: Growing The Flu Vaccine Pipeline

The rise in influenza strains like H1N1 — and the demand for new vaccines — signals a new era in vaccines. Learn how flu vaccines have evolved and where they’re headed. Read the white paper from Quintiles’ vaccines experts.

> White Paper – Automated Processing of Every Customer Order into ERP

Learn how top-performing pharma companies manage orders for peak efficiency by reading this white paper from Esker, the document process automation leader. Get your copy of "Customer Retention and Competitive Advantage in the Pharmaceutical Industry: Automating Order Management" today. click here

> Innovations and Opportunities in Therapeutic Vaccines

This report explains what therapeutic vaccines are, how they work, and why drug developers around the world are using this approach to address everything from allergies to cancer. More than 70 new proprietary technologies are named and explained, with details of licensing deals and intellectual property positions. Learn more.

Jobs

> Director Global Health Economics and Outcomes Research - Shire Pharmaceuticals

Primary Role: To provide strategic planning & design input and implementation of health outcomes programs to support the go/no go decision of product candidates, pricing and reimbursement for Shire products across global markets. Learn more.

> Senior Scientist Basic microRNA Mechanisms - Regulus Therapeutics Inc.

We are seeking a Senior Scientist to investigate how microRNA-modulating drugs interact with RNAi machinery. The successful candidate will be experienced in analyzing the biochemistry of RNAi pathways. He/she will also have broad knowledge of microRNAs and expertise in fundamental aspects of the RISC complex. Read more.

> Senior Scientist Metabolic Diseases - Regulus Therapeutics Inc.

The successful candidate will have considerable expertise in metabolism and/or adipose tissue biology and will be expected to spend the majority of his/her time working in the lab. He/she should have experience working with in vivo models of metabolic disease. Read more.

> Senior Research Associate/Senior Scientist Immunology - Regulus Therapeutics Inc.

The successful candidate will have considerable expertise in modern and classical experimental models in immunology and will be expected to spend the majority of his/her time working in the lab. He/she will also have broad knowledge and expertise in fundamental immune mechanisms as well as experience with animal models in immunology. Read more.

> Senior Director/Vice President Immunology - Regulus Therapeutics Inc.

Reporting to the Chief Scientific Officer, the Senior Director/Vice President, Immunology will be an integral member of the Regulus team and will contribute significantly to the advancement of numerous discovery and preclinical compounds into the clinic. Read more.

> Senior Scientist/Associate Director Immunology - Regulus Therapeutics Inc.

The successful candidate will have considerable industrial experience and expertise in modern and classical experimental models in immunology. He/she will also have broad knowledge and expertise in fundamental immune mechanisms as well as experience with animal models in immunology. He/she will be working closely with a small team of scientists involved in cutting-edge research to develop microRNA therapeutics. Read more.

> Senior Scientist/Associate Director Fibrosis - Regulus Therapeutics Inc.

The successful candidate will be an expert in fibrosis/wound healing, with considerable industrial experience in experimental fibrosis research. He/she will also have broad knowledge and published expertise in molecular/cellular biology. He/she will be working closely with a small team of scientists involved in cutting-edge research to develop microRNA therapeutics. Read more.

> Senior Director/Vice President Fibrosis - Regulus Therapeutics Inc.

Reporting to the Chief Scientific Officer, the Senior Director/Vice President, Fibrosis will be an integral member of the Regulus team and will contribute significantly to the advancement of numerous discovery and preclinical compounds into the clinic. Read more


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