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Those of you who manufacture products approved by the US Food and Drug Administration (FDA) are well aware of the importance of complying with Current Good Manufacturing Practices (cGMP) during FDA mandated inspections of your manufacturing facilities. Failure to comply with cGMP requirements during an inspections results in the issuance of 483s. And if you fail to adequately address the concerns of the agency outlined in 483s, it may ultimately result in issuance of warning letter to your company.

FDA is more vigilant and aggressive than ever before with its 483 and warning letter enforcement procedures. In the words of Commissioner Margaret Hamburg, FDA is quick, visible and vigilant.  With this in mind, it may be worthwhile to participate in a webinar offered by Expert Briefings.com entitled “Top Compliance Trends for 483 and Warning Letters for 2012—Based on Rare FDA Data.”

The webinar will be held on March 8, 2012 from 2:00-3:30 PM EST and Dennis Moore, Managing Partner, AUK Technical Services and a 28 year veteran FDA investigator will lead it. 

Topics to be covered include:

• Top warning letter trends for 2012, such as more 806 enforcement
• The Top 10 QS 483 Observations for 2010 and 2011
• Most common quality system failures for drugs for 2010
• Top drug and device citations in 483s for 2010
• Top drug and device warning letter citations for 2010
• Total 2010 BIMO inspections for CDER, CBER, CDRH, and CVM
• Details on clinical investigator, sponsor/monitor and IRB audits for 2010
• Most common sponsor deficiencies for 2010
• The rising trend of ‘cease to market’ letters, one of which hit a NY pharma company in 2011
• The total number of 483s issued in 2010 and 2011 – an all time high
• Total CAPA 483 observations in 2010
• How long to receive a warning letter, based upon which offices issues it
• 483 inspection targets for drugs and devices for 2010, 2011, and 2012
• Total warning letters issued by drug and device category in 2010
• Which district offices write the most warning letters
• How long to receive a warning letter, based upon issuing office
• Warning letters issued by QS system for 2010
• 483s broken down by QS subsystem for 2010
• Warning letters by CFR section
• Top device 483 observations for 2010
• Details on process validation observations for 2010
• Design control 483 observations by category for 2010
• Click here to visit Expertbriefings.com.

Click here to visit Expertbriefings.com.

I hope to see (hear ?) you at the webinar!

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The German pharmaceutical company Boehringer Ingelheim (BI) today announced that it plans on investing 70 million Euros to expand its manufacturing facility in the Zhangijiang High-Tech Park in Shanghai China. The expansion will continue through 2013 and the number of employees will increase from 240 to 400 at the new facility

BI was one of the first pharmaceutical companies to enter China in 1994 and the planned expansion was proposed to solidify the company’s position in the emerging Chinese market. The expansion will be modular and based on lean manufacturing practices to provide world class manufacturing capability at the site.   The company already sells certain therapeutic products in China including respiratory, cardiovascular, and CNS. Expansion of the existing manufacturing facility is intended to allow BI to expand into other therapeutic areas that include diabetes, oncology and stroke prevention.

Late last week Merck announced plans to build a new R&D facility in Beijing. Other companies have also announced plans to increase their presence in the Chinese market. I think it may be the time for American student to begin to consider Mandarin as their foreign language in primary and second school education programs.

Until next time...

Good Luck and Good Job Hunting!!!!!

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The Pharmalot blog today reported that pharma and biotech downsizing, restructuring and outsourcing have resulted in 38 manufacturing facilities in 2011. While this may not sound like a lot given the ongoing tough economy, the post reports that 65 facilities were closed in 2010. According to some estimates, these closures have resulted in the loss of roughly 18,000 life sciences manufacturing jobs in the past two years. Sadly, pharmaceutical manufacturing, like almost all other manufacturing jobs in the US are being lost at an unprecedented rate. Further, many of these manufacturing jobs are being outsourced to multinational CMOs or to manufacturing facilities being built by pharma companies in emerging markets like Latin America, Eastern Europe and Asia.

Not surprisingly, most of the 2011 closures were in the Northeast (8) resulting in the loss of roughly 1,400 jobs. And, not surprisingly again, one of the hardest hit states was New Jersey; home to almost all of the major pharmaceutical companies in the world. The next region that was hit hard is the Mid-Atlantic (7) with notable closures in Maryland (Shire Pharmaceuticals) and North Carolina (DSM Pharmaceutical Products).

Interestingly, while plant closures are on the rise, there is new manufacturing facility construction that may help to offset the losses. However, unlike the past, many of the new facilities are being financed by academic institutions and not-for-profits rather than life sciences companies. According to the post, roughly 106 new North American (not only the US) are underway and represent an investment value of $4.3 billion. The new Shire facility being constructed in Lexington, MA and the International Vaccine Center (InterVac) in Saskatoon, Saskatchewan were cited as examples.

Despite the constructions of several new manufacturing facilities in North America, it is obvious that most major life sciences companies are looking South and East for future pharmaceutical and biomanufacturing capabilities. The bottom line is that labor and the cost of goods are cheaper in these markets and in contrast with the past, there are skilled workforces in place to manufacture life sciences products according to American, European and Japanese Current Good Manufacturing Practices. 

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

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Not a day goes by without some report about pharma’s ongoing problems with illegal drug promotions, class action suits against blockbuster medications or civil or criminal settlements with state and federal governments. A quick perusal of articles posted to the Pharmalot Blog in November alone revealed no fewer than eight big pharma companies including Lilly, Merck, GlaxoSmithKline, Bayer, Pfizer, Novartis and Amgen that were involved in some sort of legal action regarding inappropriate marketing claims or failure to disclose potential side effects of blockbuster drugs. To make matters worse, a larger than usual number of pharma companies have experienced manufacturing problems that have resulted in drug recalls or shortages. This list includes companies such as Genzyme, Baxter, Johnson & Johnson, GlaxoSmithKline and most recently Boehringer Ingelheim. While chronic legal and manufacturing problems are extremely troubling (some assert it is just the cost of doing “business”), I believe that the amount of money spent lobbying Congress for legislation favorable to the industry is even more egregious.

According to a recent post on Knowledge Ecology International, the pharma industry has so far spent $115,571,832 on lobbying in 2011 (this number is sure to go higher by the end of this fiscal year). Interestingly, the biggest year for pharmaceutical industry lobbying was in 2009—a year after the Affordable Health Care Bill was passed—with totals in excess of $186,000,000. Just think about how many jobs could have been saved if companies reinvested the money into R&D rather than greasing the palms of lobbyists to induce Congress to pass laws to continue to get favorable tax rates, improve ROI and bolster the stock prices of those companies! To wit, Newt Gingrich, a Republican Presidential candidate and Former Speaker of the House has been accused of lobbying former congressional colleagues to vote for a Medicare drug subsidy while he was a paid consultant to AstraZeneca. Gingrich vehemently denies these allegations; probably because he realizes that most Americans don’t like big pharma and may vote against him if the claims are proven to be true and he wins the Republican presidential nomination.

Not withstanding the legal issues and unnecessary lobbying, what is really hurting the pharmaceutical industry is its lack of communication and transparency with patients and its unfailing practice of putting profits before healthcare. While every big pharma company I know always talks about fulfilling unmet medical needs, meeting those needs always comes at great costs (literally) to patients. Sadly, many patients can no longer afford the costs of potentially lifesaving medicines and treatments. Unless pharma begins to change the way it presents itself to the American public, it will continue to suffer the lost of confidence and trust of the American people. And, if the industry is unable to regain the public’s trust, its inability  will ultimately result in legislation that allows the US government to control drug prices: something that exists in most other countries in the world and big pharma has been desperately trying to prevent for the past 50 years!

Until next time...

Good Luck and Good Job Hunting!!!!!!

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British pharmaceutical giant AstraZeneca today announced that it would invest $200 million into a new manufacturing facility located in China Medical City in Jiangsu province in Eastern China. This is the company’s largest global investment ever in a single manufacturing facility. The new plant which will be completed by 2013 will manufacture intravenous and oral solid drugs. 

AstraZeneca was one of the first Western pharmaceutical companies to establish a presence in China (1993) and has fast become one of the leading biopharmaceutical companies in the country doing about $1.0 billion in business annually. 

Many of Astra Zeneca’s competitors including Novartis, Roche, Merck & Co. and others have also recently made large investments into Chinese R&D and manufacturing facilities. If this doesn’t eliminate anyone’s doubt that pharma is shifting its focus from the West to emerging markets, I am not sure what will!!! While this shift may be bad news for American life scientist seeking employment, it is certainly welcome news for Chinese Nationals who received their life sciences training in the US and other Western nations.

Until next time...

Good Luck and Good Job Hunting (there are openings in China!!!!!!)

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Abbott Laboratories today announced it is eliminating 160 jobs in an attempt to shore up its diagnostics business. Most of the job cuts (150) will take place at the company’s Santa Clara, CA production facility. The remaining jobs will be eliminated at Abbott’s North Chicago corporate headquarters. 

Similarly, Tarrytown, NY-based Progenics announced that it was undergoing a strategic reorganization and it will reduce headcount by 38 or 26% of its staff. The company recently closed it manufacturing facility and discontinued work in virology and infectious diseases, the therapeutic areas that the company was founded on almost 25 years ago. The company is now working in the oncology area and has a prostate cancer diagnostic monoclonal antibody in early clinical development. 

Progenics has one approved product, RELISTOR (methylnaltrexone bromide) a subcutaneous injection treatment for opioid-induced constipation. Regulatory approval is pending for the use of RELISTOR to treat chronic, non-cancer pain. A Phase III clinical trial of an oral formulation of methylnaltrexone is in progress.

Until next time...

Good Luck and Good Job Hunting!!!!!

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During the Bush Administration I, along with many others, was a harsh critic of the US Food and Drug Administration (FDA). The criticisms that I levied against the agency were mainly based on its inability to adequately maintain the safety of the American drug and food supply and Bush’s repeated attempts to politicize the organization and render it useless. That said, it is amazing how much has and will change at the agency during the Obama Administration. To wit, Margaret Hamburg, the current FDA Commissioner yesterday announced plans that would dramatically transform the agency and largely change the way it does business.

In an unusually rare special report entitled “Pathway to Global Product Safety and Quality” Hamburg points out the monitoring problems currently facing the agency and proposes a four-point plan on how to fix them. To understand the importance of this document it is necessary to point out some little know facts about the American food and drug supply.

First, almost two-thirds of all fruits and vegetables and nearly 75 percent of all seafood consumed by Americans is imported. This year the number of these types of food shipments is expected to grow to 24 million through 300 or more ports. A little as a decade ago, the agency was responsible for overseeing and policing six million shipments annually. Second, it is estimated that over 80 percent of the active pharmaceutical ingredients (APIs) found in approved drugs are made in manufacturing plants found mainly in China, India and Latin America. Because of funding and “manpower” shortages, most of these API manufacturing facilities are rarely inspected for regulatory compliance. According to the report, many kinds of antibiotics, oncology drug and other medications are no longer produced in the US or in many cases anywhere in the Western world. Finally, roughly 50 percent of all approved medical devices sold in the US are made in foreign production facilities.

In 2008, government officials determined that the agency would need approximately 13 years to inspect all foreign drug manufacturing plants, 27 years to check every foreign medical device production facility and a whopping 1,900 years to check every foreign food production plant! This is because FDA has only several hundred inspectors who are empowered to perform these inspections. Consequently, only a fraction of the food and APIs imported to the US are inspected. For example, less than one pound in a million of imported seafood gets as much as a “visual inspection” to determine whether or not it is fit for American consumption. This led the report’s authors to contend that “the safety of America’s food and medical products remain under serious threat.”

Yet, despite this ongoing threat, Republican lawmakers last week voted to cut the agency’s budget rather than increase it to perform the necessary number of food and drug inspections. Further, the same lawmakers oppose any corporate or consumer fees, whether voluntary or forced, to help to underwrite the inspections calling them an unacceptable tax. This has forced the agency to enlist the help of regulators in other nations to create a global coalition or network to perform the required inspections to insure the regulatory compliance and safety of foods, drugs and devices imported into the US. While the FDA has limited cooperation agreements with regulators in Europe and other Western countries, it just recently stationed its own inspectors in emerging markets like China, India and Central America. In theory this should work. However, in the past, some of the governments of these countries have refused to fully cooperation with FDA. Further, and perhaps more problematic, is that regulatory agencies in some other countries are largely corrupt or nonexistent. Finally, some outspoken former FDA employees and critics contend that improvements in the communication between FDA in Washington and its field offices in US states may be necessary before the agency can effectively enlist the cooperation of foreign regulators.

There is no doubt that contaminated foods, counterfeit medical devices and tainted drugs are increasingly finding their way into the US. It is FDA’s legislated responsibility to insure that all foods and drugs sold in the US are safe and effective for all Americans. Republican lawmaker’s refusal to increase FDA’s budget to allow the agency to fulfill its mandate is unconscionable and indefensible. The safety and health of all Americans is critically important for the well being of the nation and ought to take precedent over budget shortfalls and a looming US trade deficit.

Until next time...

Good Luck and Good Job Hunting!!!!!!

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The US Food and Drug Administration yesterday announced that a consent decree of permanent injunction has been filed against McNeil-PPC, the consumer products division of Johnson and Johnson, and two of its senior executives, for “failing to comply with current good manufacturing practice requirements as required by federal law. The action prevents McNeil, a subsidiary of Johnson & Johnson, from manufacturing and distributing drugs from its Fort Washington, Pa., facility until the FDA determines that its operations are compliant with the law.”

McNeil Consumer Healthcare Division’s Vice President of Quality Veronica Cruz and the company’s Vice President of Operations for OTC Products Hakan Erdemir were named defendants in the consent decree, filed with the U.S. District Court for the Eastern District of Pennsylvania in Philadelphia on March 10, 2011. The highest ranking company executives in charge of the facilities named in a consent decree are always included (by law) on the civil action.

The decree also requires McNeil to adhere to a strict timetable to bring its facilities in Las Piedras, Puerto Rico, and Lancaster, Pa., into compliance.

Consent decrees are civil actions—not criminal ones— and are meant to be remedial rather than punitive. In other words, there are no fines levied and the agency expects the companies under consent decree to bring their manufacturing facilities back in to compliance with Current Good Manufacturing Practices (CGMP). However, if the company fails or refuses to comply with the FDA, criminal charges can be filed against the companies and the two executives mentioned in the consent decree. The agency had little choice but to seek a consent decree of permanent injunction against McNeil because of manufacturing problems and recalls of several of its signature brands including Tylenol, Motrin, Zyrtec, and Benedryl. Criminal charges may be forthcoming because of possible cover ups of the recall that involved hiring outside contractors to purchase tainted produced in bulk to surreptitiously remove them from store shelves.

FDA had little choice but to seek a consent decree because of the seriousness and continuous nature of the problems at its Fort Washington production facility and the fact that J&J senior executives were either unaware or unconcerned with the problems at its subsidiaries. While working under a consent decree may be embarrassing for J&J, the damage caused by the recalls of some of its most visible consumer and OTC brands may be irreparable.

 Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!

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BioJobBlog readers who understand Current Good Manufacturing Practices (CGMP) for pharmaceuticals and biologics know that the US Food and Drug administration is mandated to review approved drug manufacturing facilities once every two years. While this is the mandated inspection schedule, most industry insiders know that manufacturing plant inspections now take place once every three or more years. This has resulted because of an increased reliance by US drug makers on foreign manufacturing facilities to produce licensed pharmaceuticals and biologics, a lack of regulatory oversight by the agency during the Bush administrations and funding shortfalls that have resulted in a shortage of FDA inspectors.

Congress recently took the agency to task about a lack of oversight for food and drugs manufactured in foreign countries. In September, the Government Accountability offices reported that FDA inspects foreign drug facilities on average once every nine years as compared with every 30 months or more with US plants. To correct this, FDA announced that it aims to increase reliance on third party inspectors in other countries to maintain better oversight of ex-US manufacturing plants. In other words, it is less costly to train and work with inspectors already in foreign countries rather than send US inspectors overseas.

In a post last week on the Pharmalot Blog, Ed Silverman reported that Bloomberg News reviews almost 10,000 inspections at US manufacturing plants from 2000 until September 30, 2010. While the Bloomberg report did not provide details on the frequency and nature of violations uncovered at the inspections, the results of the reports were eye-opening. According to Ed:

“The FDA makes 0.9 visits, on average, to each facility each year, compared with 0.6 visits annually when George W. Bush was in the White House. Looked at another way, the agency NOW visits each of the 2,567 plants registered in the US almost once a year.”

Further he noted:

“Some of the biggest drugmakers do not have a good track record when it comes time for FDA inspectors to visit their plants. Overall, the FDA found violations at 54 percent of plants inspected last year, up 20 percent from a decade low in 2007, according to data obtained from the agency by Bloomberg News. And 80 drugmakers failed more than half of their inspections.”

So, which companies had the poorest inspection track records? Ed noted

“Abbott Labs failed 59 percent of 111 inspections; Pfizer flunked 57 percent of 202 inspections; Merck bombed out on 52 percent of 134 visits and Johnson & Johnson failed 48 percent of 161 inspections. By contrast, [generic drug manufacturer] Mylan passed 79 percent of 56 inspections!”

Republicans are threatening to slash FDA funding for US inspections mainly because the agency is focusing more on overseas manufacturers and suppliers. In response to the funding cut threats, the Obama Administration proposed that drug manufacturers whose production plants fail inspections would be required to pay fines of roughly $49,000. At present, there are no mandatory fines levied against drug makers that fail FDA inspection (the agency can and does impose fines if companies that fail inspections refuse or are reluctant to fix the problems that were uncovered).

I find it interesting that despite the numerous drug recalls and problems with drug safety of approved drugs over the past few years that the Republicans, could in good conscience, threaten to cut FDA funding to increase the frequency of inspections to bring them in line with the mandated once every two years rather than once every 2.5 to 3.0 years that has been the norm for the last decade.

Until next time....

Good Luck and Good Job Hunting!!!!!

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Little is published in the blogosphere about the life sciences industry in Canada. Because of this, many people think that Canadian scientists and other bioprofessionals may have fared better than their US counterparts. However, like the US, thousands of scientists and others have lost jobs throughout Canada during the almost three year global recession.

While the number of layed off employees is no where near the almost 200,000 American pharma employees who have lost their jobs over the past four years, over 3,600 Canadian pharmaceuticals employees lost jobs in the second half of 2010. Most of the jobs were lost in pharmaceutical manufacturing. Like the US, these jobs were mainly lost as a result of outsourcing and corporate downsizing because of escalating financial pressures. Despite this, government officials expect the Canadian life sciences industry to recover by 2015.

Until next time...

Good Luck and Good Job Hunting (Eh)

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After seven months of public bickering over an appropriate sale price, the NY Time reports today that Sanofi Aventis may have hammered out a deal that would enable the French drug maker to acquire the world’s largest orphan drug manufacturer Genzyme for $19 billion. According to the report, Sanofi will acquire Genzyme for a $74 per share which is up from it previous offer of $69 per share.

Most analysts and the Genzyme management team felt that the previous $69 per share offer was too low and that the tipping price would be in the mid 70s. This made sense even to outsiders like me because Eli Lilly purchased ImClone, a company with only one approved product on the market, for $70 per share several years ago. Genzyme has multiple FDA-approved products with a strong late stage drug development pipeline. Not surprisingly, Sanofi tendered a low initial stock price purchase offer to give itself flexibility when it decided to enter into serious negotiations.

Despite the long drawn out and tiresome melodrama, the deal is a good one for Sanofi, a company that desperately needs to bolster its biotechnology pipeline and also for Genzyme which has been rocked by biomanufacturing and quality problems for the past couple of years.

Now that this deal is imminent, does anyone have an idea about which biotechnology company may be the next takeover target?

Until next time..

Good Luck and Good Job Hunting!!!!!!!!

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Layoffs at big pharma companies have become commonplace but downsizing at generic manufacturers? Aren’t generic drugs sales exploding through the roof? And, aren’t all major pharmaceutical companies facing patent cliffs responsible for the massive downsizing that has taken place over the past four years? Teva executives apparently didn’t get that memo and announced today that the company will lay off 200 employees at its Irvine, CA manufacturing facility. Of the 200, 195 will lose their jobs by February 6, 2011.

This is the second round of layoffs at the manufacturing facility that Teva acquired after purchasing biosimilar manufacturer Sicor Inc., in 2003 for $3.4 billion. Last July, 70 jobs were eliminated at the plant which previously manufactured Propofol, the powerful sedative implicated in Michael Jackson’s death. Teva has since discontinued production of the drug because of the drug because it was hard to manufacture and that the company got little or no profit from it.

The company had to halted production and recalled some Propofol in 2009 after 41 patients were sickened with flu-like symptoms. The problem resulted from elevated endotoxin levels found in some vials of the sedative. Several lawsuits also were filed over the drug.

Until next time...

Good Luck and Good Job Hunting!!!!

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Ed Silverman, author of the fabulous Pharmalot Blog, showed his investigative reporting bona fides by revealing today that there may be a direct link between pharma manufacturing facilities, US national security and the brouhaha over WikiLeaks.

Ed uncovered a cable dated Feb. 18, 2009 from the US Secretary of State to all overseas diplomats that stated pharma facilities are vital to US national security and that “losing these facilities could critically impact the public health, economic security, and/or national and homeland security of the United States.”

The cable stressed that these facilities produce insulin, a variety of vaccines that protect against potentially devastating infectious agents and other medications and a vital part of the US National Infrastructure Protection Program. According to Ed’s post, the facilities mentioned in the cable are located all over the world and included companies such as Baxter, GlaxoSmithKline, Novo Nordisk, Sanofi-Aventis, Genzyme, Novartis, IDT Biologika, Vetter Pharma, Roche, CSL Behring and Grifols. Interestingly, only two of the companies mentioned, Baxter and Genzyme, are US-owned companies. Go figure!!!!!!!

Until next time...

Good Luck and Be Alert (you never know who may be watching)

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The New York Times reported today that French drug maker Sanofi Aventis has made a bid to purchase beleaguered orphan drug manufacturer Genzyme. According to the report, Sanofi approached Genzyme about two weeks ago about a possible sale. Sanofi is currently waiting for a response from Genzyme. If Genzyme rebuffs the takeover bid, persons close to the deal said that Sanofi may possibly try to acquire Genzyme via a hostile takeover bid.

Sanofi is facing revenue losses because many of its blockbuster products including the anti-clotting agents Plavix and Lovenox will or have lost patent protection. Plavix's patent expiry will occur in 2001 whereas Lovenox has already lost patent protection ( yesterday the FDA approved a generic version of the drug). Further, Sanofi, unlike most major pharmaceutical companies, is glaringly deficient in biotechnology products and has long been known to be seeking a quick entry into the biotech market. To that end, the Genzyme bid makes complete strategic sense to bolster sales and secure Sanofi's future.

Genzyme is the fifth largest biotechnology company in the world. Sales of it orphan drugs to treat Gaucher’s, Fabry and Pompe disease annually exceed $3.0 billion in sales even though they are used to treat small numbers of patients (<20,000).

Genzyme’s value has plummeted in the past year because of manufacturing problems and is currently operating under a US Food and Drug Administration consent decree after being fined $175 million by the agency. Many shareholders have called for the dismissal of Henri Termeer, Genzyme’s CEO for the past 25 years. To date, Termeer has refused to step down even though Genzyme’s stock continues to under perform. News of a possible takeover caused Genzyme’s stock price to soar; gaining more than 15 per cent on Friday to $62.50.

I believe that Sanofi is approaching Genzyme at the right time. Recently, Genzyme reached an agreement with Carl Icahn, who owns a substantially amount of stock, to prevent a proxy battle to reshape Genzyme’s board and oust Termeer. Also, another major shareholder, Ralph Whitworth, is unhappy with recent events at the company. Sanofi’s acquisition of Genzyme would provide a quick entry into the biotechnology and orphan drug markets and also appease shareholders like Icahn and Whitworth if the deal is rich enough. Also, Sanofi’s manufacturing experience would help Genzyme overcome its problems in that area.

Stay tuned for updates.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

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Johnson & Johnson’s McNeil Consumer Healthcare, already under Congressional investigation for selling allegedly tainted Tylenol, announced late Tuesday that it was recalling other products made in the Puerto Rico manufacturing facility in question.

According to an article in today’s New York Times, “McNeil Consumer Healthcare, the Johnson & Johnson unit, said that it was recalling four lots of certain Benadryl allergy tablets and one lot of Extra Strength Tylenol gel pills. McNeil did not respond to a reporter’s query about how many bottles those lots amounted to.”

Since last November, McNeil has recalled about 11.7 million bottles of various Motrin products and about 6.3 million bottles of Tylenol Arthritis Pain caplets made at the Puerto Rico plant in question. The company began the product recall after receiving numerous consumer complaints about a moldy odor emanating from some of its products.

Company representatives contend that the moldy smell was caused by contamination from a chemical byproduct of a substance used to treat wooden transport pallets. Further, McNeil suggested that the risk of serious medical problems was remote and people should not stop using the products (yeah right).

The current recall just adds to McNeil’s growing manufacturing problems. The company is already under scrutiny by the House Committee on Oversight and Government Reform over a recall last April of an estimated 136 million bottles of liquid pediatric Tylenol, Motrin, Benadryl and Zyrtec.

I suspect that more problems will be uncovered as the FDA and Congressional investigations continue. Serious manufacturing and quality problems can almost always be avoided or minimized when company executives and management makes a bona fide commitment to quality systems. Clearly, the heads of McNeil Consumer Healthcare might benefit from remedial current good manufacturing practices (cGMP) training.

Until next time...

Good Luck and Good Job Hunting!!!!!!!

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After weeks of bad press regarding manufacturing problems and a narrowly-averted proxy contest, Genzyme today announced that its experimental drug for multiple sclerosis, alemtuzumab, received fast track approval status from the US Food and Drug Administration (FDA).

Alemtuzumab (marketed as Campath, MabCampath or Campath-1H) is a monoclonal antibody used in the treatment of chronic lymphocytic leukemia (CLL), cutaneous T-cell lymphoma (CTCL) and T-cell lymphoma. Alemtuzumab targets CD52, a protein present on the surface of mature lymphocytes, but not on the stem cells from which these lymphocytes are derived.

For those of you who may not know, FDA grants fast track status to experimental drug candidates that are designed to treat serious diseases, and may be superior to current treatments. Fast track status includes an expedited review and additional collaboration between Genzyme and the and the agency and allows Genzyme to submit portions of the alemtuzumab BLA as they are completed, rather than waiting to submit the completed application when testing is finished.

Until next time..

Good Luck and Good Job Hunting!!!

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Genzyme announced yesterday that it had reached an agreement with Carl Icahn to settle their very public and bitter proxy battle. As you may recall, Icahn, who controls approximately 4.9% of shares in Genzyme, sought to replace Henri A. Termeer, Genzyme’s embattled long-time CEO and three other company directors.

Under the terms of the agreement, Icahn will withdraw his slate of four nominees for the Genzyme board of directors and vote his shares in favor of two company nominees. Also, the Genzyme board will appoint two Icahn nominees Steven Burakoff, MD and Eric Ende, MD to serve as directors immediately following the company June 16, 2010 annual shareholders meeting. Dr. Burakoff is Professor of Medicine, Hematology and Medical Oncology at the Mount Sinai School of Medicine and Director of the Tisch Cancer Institute at the Mount Sinai Medical Center. Dr. Ende, a participant in the Icahn funds’ proxy solicitation, is a former biotechnology analyst with Merrill Lynch & Co. Inc.

This isn’t the first time that Icahn has threatened a proxy fight to get his nominees elected to the board of directors at companies where he controls a small but significant amount of outstanding shares of stock.  Previously, he attempted to wrest control of the Biogen and ImClone and Enzon Pharmaceuticals board of directors. While his attempt to commandeer the Biogen board failed, he was successful at ImClone, the maker of the anti-colon cancer drug Erbitux that he sold to Eli Lilly in 2008 for ca. $6.1 billion. In Enzon’s case, the CEO resigned about six months after accommodating Icahn’s demands.

It is patently obvious that biotechnology company executives don’t want Icahn to gain control of their companies. This is because once Icahn gains control of the companies he sells them to the highest bidder. While this may make sense to a financial guy like Carl, it doesn’t sit well with company executives who understand that they will likely lose their jobs once a company is sold! 

Although Carl’s public proxy contest strategy usually gets him most of what he wants, I am not sure that it is in the best interests of company stock price and shareholder. Publicly airing a company’s dirty laundry tends to reduce shareholder confidence and may push its stock price lower than necessary. I think that it may be in a company’s best interest to quietly negotiate with Icahn behind the scenes rather than take the fight to the public. In the end, Icahn invariably wins and the management team that is under fire may look less competent or weaker than it actually is. Biogen ultimately won but Enzon and Genzyme lost the public opinion battle.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

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The recent manufacturing woes of orphan drug manufacturer Genzyme have been well documented and widely publicized. These problems resulted in massive shortages of some of its top selling drugs Cerezyme (Gaucher disease) and Fabrazyme (Fabry disease) causing many of the patients who depend on these drugs to maintain their quality of life to go without reduced or no treatments for months. 

Because both drugs were approved by the US Food and Drug Administration (FDA) as orphan drugs they enjoy seven years of market exclusivity from the date of regulatory approval which prohibits other companies from seeking approval and selling similar drugs in the US. Consequently, Genzyme is the only commercially-available source for the drugs. Genzyme’s ongoing biomanufacturing created massive shortages of both drugs last summer. Because of this, FDA allowed two other companies, Shire and Protolix Biotherapeutics (both have treatments for Gaucher (Protalix) and Fabry (Shire) disease in late stage clinical development), to make their drugs available (at no charge) to patients prior to regulatory approval. This was a relatively rare and bold move by the agency. But, to be fair, they had little choice because so many patients were suffering.  

In case you may be wondering there are approximately 1500 Cerezyme users and fewer than 1000 Fabrazyme users in the US. Despite the small numbers of patients, the cost of the treatments are extraordinarily high; costing patients as much as $200,000 per year for treatment.

According to an article in today’s NY Times as many a 15 percent of American Cerezyme users have switched to a different drug. Fewer patients with Fabry disease have switched mostly because Shire’s drug for Fabry disease Replagal was less widely available. The almost year-long shortages of both drugs have seriously tarnished Genzyme’s reputation. And previously loyal patients are questioning their almost decade long allegiance to the company. This, coupled with a 26 per cent decline in Genzyme’s stock price last year suggest that Genzyme’s standing as one of the top five biotechnology companies in the world may be in serious jeopardy. 

Despite calls for his resignation (and an attempt by Carl Icahn to wrest control of the company), CEO Henri A. Termeer, who has led Genzyme for over 20 years has vowed not to resign. While manufacturing problems are not uncommon in the biotechnology industry, the severity and ongoing nature of the manufacturing problems at Genzyme’s Allston Landing, MA production facility are unacceptable; especially for a company that specializes and prides itself in developing treatment for orphan disease indications. The FDA recently announced that it would fine Genzyme and place its manufacturing operations under a consent degree for an indefinite period of time.

Genzyme representatives now contend full supplies of Cerezyme will be available after May 1 and those for Fabrazyme possible in the third quarter of this year.

While so-called “copycat” or “me too” drugs developed by pharmaceutical companies tend to be vilified by consumers and patient advocacy groups, the agency prefers to approve more than one treatment option for a given disease indication in case one medication doesn’t deliver the intended therapeutic benefits or induces untoward adverse events. Unfortunately, the seven years of market exclusivity awarded to orphan drugs manufacturers that garner regulatory approval for their products prohibits this. The biomanufacturing fiasco at Genzyme suggests that it may be time to reexamine the Orphan Drug Act and modify some of the financial and regulatory terms that were included to induce drug companies to develop new treatments for orphan disease indications.

Until next time…

Good Luck and Good Job Hunting!!!!!!!

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Merck & Co. Inc., and Avecia Investments Limited today announced that they have entered into a definitive agreement by which Merck will acquire the biologics business of UK-based Avecia; a contract manufacturing organization with specific expertise in microbial-derived biologics. A Merck executive commented on the deal:

"At Merck we continue to execute on our strategy of expanding our biopharmaceutical expertise and manufacturing capacity, This transaction follows an initial strategic development and supply relationship with Avecia Biologics and will provide us with an operational facility staffed by an experienced workforce that is highly skilled in a broad portfolio of bioprocess systems."

The Avecia acquisition follows Merck’s announcement late last year that the company will enter the global follow-on biologics (aka biosimilar) market. Merck’s decision was likely based on strategic acquisitions several years ago of a small biotech company, Glycofi, which developed a humanized yeast protein production platform, and Insmed, a Richmond, VA-based, follow-on biologics company, which was acquired last summer. Avecia provides Merck with the biomanufacturing capacity and expertise that it will need for clinical development and commercial manufacturing of its follow-on biologics. The company expects to bring its biosimilar products to market by 2017 or earlier.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

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Flu season is upon us and, not surprisingly, there is no dearth of information available to the public about the seasonal and H1N1 flu vaccines. Mostly there are stories about the lack of availability of the vaccines, underreporting of deaths associated from H1N1 infections and perhaps, most importantly concerns about flu vaccine safety. Despite attempts by the CDC and a few dedicated virologists like BioCrowd co-founder Vincent Racaniello, flu vaccine manufacturing is an enigma to the lay public.

While I am a card-carrying microbiologist, my knowledge of the manufacturing of flu vaccine is admittedly lacking. With this in mind, I came across an outstanding tutorial about flu vaccine manufacturing published by the College of Agriculture at the University of Wisconsin-Madison (my alma mater). The UW tutorial is easy to understand and will shed light on and help to demystify flu vaccine production for lay people (and a few scientists like me).

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Astra Zeneca announced today that it would cut 1400 jobs and close several manufacturing facilities worldwide. According to a post on the Pharmalot blog “about 600 full-time jobs will be lost in Sweden as packaging operations are expanded in Wuxi, China. The cuts will come on top of the 7,600 positions the drugmaker plans to eliminate by 2010. The plant closings will occur in Spain, Belgium and Sweden by 2013. Manufacturing jobs will also be trimmed in Sweden and the UK as production is shifted to lower-cost countries in emerging markets.”

On Tuesday Wyeth disclosed that it was eliminating 70 positions at its Pearl River, New York, facility (which employs 3,200 workers, 118 employees at its Rouses Point facility in upstate New York that employs 725 people work, and 124 jobs at its Sanford, North Carolina manufacturing facility. Ironically, as more and more US workers are laid off, many big pharma companies like Merck, Pfizer and GlaxoSmithKline are expanding operations at their research facilities in India. In fact, Merck is doubling its headcount from 800 to 1,600 employees at its research facility in India that was opened a little over a year ago.

Until next time…

Good Luck and Keep on Looking!!!!

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Let me begin with the good news. The Indianapolis Business journal reported today that Schwarz Pharma Manufacturing, Inc is planning a $12 million expansion of its Seymour, Indiana manufacturing plant and distribution center. When completed the expansion is expected to increase the company's employment in the southern Indiana city from 366 to 516 by 2011. The drug maker-a unit of Schwarz Pharma AG of Monheim, Germany-said it plans to begin hiring managers, business associates and production staff later this month.

And now, the bad news. The Pharmalot Blog reported today that the New Jersey-based generic manufacturer Par Pharmaceuticals is eliminating 26 percent of its workforce expected to save from $45 million to $55 million a year. Jobs will be lost in manufacturing, research and development, and other departments. How much more downsizing and job elimination can New Jersey take before it goes bankrupt? Maybe Icelanders can shed some light on that?

Until next time….

Good Luck and Good Job Hunting

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It was only a matter of time after J & J launched its health channel on YouTube two weeks ago, that other pharma companies would begin to post videos on video-sharing sites. As a general rule, nobody in pharma wants to be first but after the first company takes the plunge, nobody wants to be left out or behind. Therefore, it came as no surprise when late last week, GlaxoSmithKline (which has a tendency to be second-to-market with competing products), launched a beta version of it so-called GSKCIC channel on You\Tube.

 According to a post on the Pharmalot blog, so far there are only two videos on the channel. One describes the company ongoing commitment and fight against disease in the developing world (ironically, the video ends prematurely).The second, which is full length, features CEO Andrew Witty telling us about his career at GSK (which began in 1985 as a management trainee) and how GSK is looking for a few good employees who “like a good challenge.” Curiously, the day after the Witty video appeared on YouTube, GSK announced that it was laying off about 90 workers or 10% of its work force at its manufacturing plant in Zebulon, North Carolina. A company spokesperson said that more cuts are expected at the North Carolina facility.

Maybe someone at GSK ought to tell its CEO that the company isn’t hiring at the moment?????????

Hat tip to Ed at Pharmalot!

Until next time….

Good Luck and Good Job Hunting!!!!

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I want to thank my esteemed colleague, Ed Silverman at Pharmalot, for the heads up on this post.  As part of Wyeth’s asset realignment program dubbed “Project Impact”, the company announced today that it would cut another 1,200 jobs at “all facilities in all capacities.”  Meanwhile, late last Friday 141 people at Wyeth’s Pearl River, NY, facility were laid off. Most of the jobs that were cut were in manufacturing and R&D. Of interest, last Friday was also Bob Essner’s last day as Wyeth’s CEO (he will continue as Chairman through December 31, 2008). For those of you who may be interested, Bob’s total compensation package in 2007 was about $20 million (his base salary was a paltry $1.73 million).

The most recent layoffs were made as part of the drug maker’s previously announced plan to cut up to 10 percent of its global workforce of 50,000 by 2011. Wyeth executives contend that Project Impact is warranted because of increased generic drug competition and a weak product pipeline. As you may recall, Wyeth previously laid off 1,240 sales reps late last month due to sagging sales of several of its consumer and pharmaceutical brands.

These new layoffs couldn’t come at a worst time for Wyeth employees. For those of you who still have jobs at the company, I highly recommend that you begin to explore alternative career opportunities. It is going to be a long and difficult ride!

Until next time… 

Good Luck and Good Job Hunting (if there are any left) !!!!!!!

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Eli Lilly & Co. announced today that it will eliminate 500 jobs at its manufacturing facility in Indianapolis, IN. The cuts will affect sites that manufacture active pharmaceutical ingredients for Lilly’s insulin products Humalog® and Humulin® and its osteoporosis medicine Forteo®.

Lilly is offering incentive packages for those employees who voluntarily leave the company. The company has already reduced its global headcount by twelve percent or about 5,500 people since 2004.

Times are tough and getting tougher each day in pharma land. Buckle up–its going to be a rough ride for jobseekers in the pharmaceutical and biotechnology industries.

Until next time….

Good Luck and Good Job Hunting (avoid Indianapolis, who wants to be a Hoosier anyway?)

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Genzyme Corp announced yesterday that it plans to expand it research and manufacturing facilities in Waterford, Ireland. Genzyme originally set up the facility in 2001 and plans to add another 170 employees, expanding its Irish workforce to 600.

This is second time in less than a year that Waterford (internationally known for its crystal manufacturing) has received an investment from a foreign drug manufacturer. Israeli generic drug manufacturer TEVA made a $100 million dollar to expand its Waterford operations and boost its Irish workforce from 650 to 815.

The Irish government said it was offering assistance to subsidize the $200 million Genzyme expansion at the Waterford site. The amount and terms of the subsidiary were confidential and not disclosed. At present, drug companies with operations in Ireland  employ 25, 000 people.

Genzyme, with expertise in developing drugs to treat rare disorders, kidney disease and cancer, employs more than 10,000 people worldwide.

This is more good news for Ireland!

Until next time….

Good Luck and Good Job Hunting (in Ireland)!!!!!!!

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Teva Pharmaceuticals announced  yesterday that it will invest €65 million in its facility in Waterford, Ireland, and that it is creating an additional 165 new jobs over five years. Teva has three pharmaceutical plants and a research and development facility on its Waterford campus which was previously owned by IVAX Corporation. The expansion has been helped by grants from Ireland’s inward investment promotion agency, IDA Ireland. 

The existing facility supplies Teva's European respiratory products and also makes a range of treatments for the US market. The site is also Teva’s main research centre for respiratory products. The investment is expected to double the production capacity of both its inhaler and tablet manufacturing capacity. Pharmaceutical Industries Ltd. acquired the respiratory products business as part of its acquisition of the IVAX Corporation in January 2006. 

This is good news for the Irish pharmaceutical manufacturing industry which has been experiencing something of a slow down over the past year or so.

Until next time….

Good Luck and Good Job Hunting!!!!!!

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Allergan Inc., the maker of Botox, will close a plant in Ireland, eliminating 300 jobs, and transfer production to a factory in Costa Rica.

Ireland has lost about 10 percent of its manufacturing jobs over the last six years, as labor costs climb. As many of you may know, many US pharmaceutical and biotechnology companies set up production facilities in Ireland over the past 10 years or so because of its well trained workforce and lower labor costs.  However, because the Irish economy has grown so quickly and its middle has prospered, labor costs have been rising and manufacturers are now looking elsewhere to control costs. Unfortunately, this is likely to be harbinger of things to come for markets that were once sources of cheap, skilled labor.

Until next time….

Good Luck and Good Job Hunting Lasses and Laddies!!!!!!!!

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 that 660 jobs will be lost at a Pfizer manufacturing facility in Terre Haute, Ind., a result of Pfizer Inc.'s decision to stop production of its inhaled insulin product Exubera.

Nat Ricciardi, president of Pfizer Global Manufacturing, announced Pfizer's decision to cut staff in Terra Haute because the company did not have another use for the specialized Indiana-based production facility.

Facility workers were told of the decision on Monday morning and that told layoffs would begin in March. The production facility employs about 800 workers in total and a majority of the affected employees are those hired within the last five years to produce Exubera. The remaining 140 workers will support the company's sterile manufacturing operation that included antibiotic production.

When the company announced plans in October to discontinue Exubera, it also said about 60 jobs would be lost at its manufacturing plant in Portage, Ind. They are among a total off 200 jobs the company has said will be cut here before the end of this year.

A Pfizer spokesperson said the company is "committed to providing whatever assistance our colleagues need, including internal job postings, job search tools, career and retirement counseling and severance benefits for those who leave the company." It appears that the Midwest is starting to feel pain associated with contraction of the pharmaceutical industry.

Until next time….

Good Luck and Good Job Hunting (forget the Midwest)!!!!!!!!!!

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Reuters reported today that Merck & Co Inc has sold a manufacturing plant in Pennsylvania to PRWT Services Inc, as part of Merck's global restructuring of its manufacturing operations.

PRWT Services has entered into a five-year supply agreement with Merck valued at $100 million to $200 million a year, the companies said in a statement.

The Cherokee manufacturing plant in Riverside, Pennsylvania, employs 400 people, and produces antibiotics for humans and animals. As many of you may know, Merck’s CEO, Richard Clark ran manufacturing operations at Merck for 30 years before being appointed its top executive. Maybe he knows something that we don’t about the future of antibiotics?

Until next time…

Good Luck and Good Job Hunting!!!!!

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