Ranbaxy to Shed as Many as 400 Middle and Senior Management Jobs

Posted in BioBusiness

The UK’s Economic Times reported  today that the troubled Indian generic drug manufacturer Ranbaxy may shed as many as 400 jobs from its various divisions. Most of the persons receiving pink slips will be senior and middle management who are likely losing their jobs because of ongoing serious drug manufacturing problems that have plagued the company for over three years.  The drug maker employs about 14, 600 people in 43 countries.

While the job cuts do not represent a significant percentage of Ranbaxy’s workforce, Daiichi Sankyo which owns the company, is likely eliminating members of the management team that have been responsible for the company’s ongoing manufacturing problems. According to the Economic Times article

“On Thursday, some senior executives from the finance department at Ranbaxy were asked to leave. On Friday, some senior executives from the Research & Development wing were given marching orders,” an employee familiar with the job cuts told ET. Another executive said some officials from the API(active pharma ingredient) division have also been handed pink slips.

This past May, Ranbaxy paid the US Department of Justice $500 million to settle criminal and civil charges to resolve the manufacturing problems that prompted the US Food and Drug Administration (FDA) to ban the sale of dozens of drugs manufactured by the company.  More recently, FDA inspectors issued an unsatisfactory inspection report for one of the company’s manufacturing plants in India.

Ranbaxy is one of the world’s leading generic drug manufactures and the company’s ongoing manufacturing problems have certainly hurt Daiichi Sankyo’s image. Also, it has led some analyst to question whether or not Daiichi Sankyo ought to have purchased the troubled generic manufacturer for $4.6 billion in 2008.

Until next time…

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

Why Many Scientists Have A PR Problem!

Posted in BioEducation

I apologize in advance for this rant but I have been participating in an almost six month long thread on LinkedIn discussing whether or not PhD-trained scientists lack the social discipline and knowledge necessary to favorably interact with the lay public. Not surprisingly, a majority of participants contend that most PhD-bearing life scientists lack social graces to the point where they come off as being aloof, condescending and enamored with their own intelligence and projects that they choose to work on.

While I tend to generally agree with this characterization, I contend that the lack of social discipline exhibited by many graduate students and postdocs is not a result of personality defects but can likely be attributed to the attitudes and behaviors learned from their mentors and PIs. Put simply, graduate students and postdocs would likely learn to behave differently in social situations if they were trained differently by their PIs and mentors.

Now: the reason for the rant. In yesterday’s Science Times, there was an article about a Princeton-based writer, Jeffrey Eugenides, who decided to write a novel using a life sciences researcher as its main character. Mr. Eugenides, who previously wrote a well received novel entitled “Middlesex,” does not possess a scientific background nor has he spent any time in a research laboratory. In fact, despite living in Princeton a bastion of life sciences research, he had no friends or even acquaintances who were scientists. His closest connect to science is his wife, an artist who spent a winter in Cold Spring Harbor (but not at the research center). Nevertheless, creating a main character who is a scientist required that he do a lot of internet research to learn about scientific research and what makes “scientists tick.” To that end, he read peer-reviewed yeast genetics papers to better understand the focus of the main character’s research—yeast mating genetics. It took him many years to collect the information necessary to write the novel. And a scientist—whose research laid the foundation for work described in the novel—was astounded that Eugenides got it exactly right!

Because Princeton University is home to one of the world’s leading yeast genetics programs, Eugenides decided to chat with yeast geneticists actively engaged in basic research to get an idea of what actually goes on in a research laboratory. To accomplish this he turned to one of the world’s leading experts on yeast geneticist at Princeton to ask for help. Although the geneticist thought that Eugenides needed an explanation of the research described in the novel, Eugenides simply wanted to spend a day in his laboratory and interact with “real” scientists. After hearing this, the geneticist handed Eugenides off to his laboratory manager and left the lab.

When interviewed for the story in the NY Times, the geneticist quipped “I never heard of the book, and I don’t remember talking to the guy.” Taken at face value his comments are not intentionally pejorative or demeaning. But, they do suggest an air of arrogance, indifference and most importantly disinterest. I suspect that this is because the visit had little to do with the geneticist’s work and, in the end, there was not much in it for him—so why waste his time?

Sadly this is exactly the attitudes and behaviors exhibited by many scientists. Is it any wonder why many lay people think that most scientists are arrogant, self absorbed and indifferent when it comes to social graces? Although the scientist mentioned in the post is world renown in scientific circles, he did not come off well (to me anyway) in the article. That said, he created a PR problem for himself.

While in the past it was convenient for academicians to “live in the ivory tower” the recession, an increasingly lousy job market for PhD-trained scientists and the advent of social media suggests that we have entered into a new age. Like it or not, social skills are absolutely required for gainful employment in today’s world. I think it is time for academics to realize this and change the way in which they train their graduate students and postdocs.

Until next time….

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

 

Why College "Ain't What It Used to Be!

Posted in BioEducation

There was an illuminating review today in the New York Times of a new book entitled “Higher Education? How Colleges are Wasting Our Money and Failing Our Kids-and What We Can Do About it.” Its authors are two longtime faculty members Andrew Hacker (tenured professor) and Claudia Dreifus (a freelance writer and adjunct instructor).

While I haven’t read the book, some of the problems with higher education asserted by the authors (and mentioned in the review) are consistent with my observations and experience. For example the review mentions that:

“Mr. Hacker and Ms. Dreifus list a host of crimes, or at least flaws in the system, some in the control of universities and others built into the external political, cultural or economic environment, or indeed into human nature. These include the narrow self-interestedness of academic departments; the greed of faculty members and administrators alike; the near-universal hypertrophy of “the athletics incubus”; unfunded government mandates; lifetime employment for pampered professors (thanks to the combination of tenure and Congressional abolition of mandatory retirement); and the demands of students and their parents for frivolous extras (driving what the authors call “the amenities arms race”).

The authors raise interesting questions about tenure and its alternatives. Like many critics of tenure, though, they have a keen eye for abuses of power but are remarkably sanguine about the capacity of the First Amendment to shield scholars from pressure exerted by those with the power to fire them.

The authors’ deepest scorn is reserved for the claim that good teaching depends on research, and their most extreme proposal is that universities drastically reduce the amount of research they support, by “spinning off” medical schools and research centers, discontinuing paid sabbaticals and abolishing the current system of promotion and tenure, a system that tends to reward research productivity more than effective teaching.”

While I tend agree that the emphasis on research, the pressure to publish and obtain extramural funding has had a negative impact on teaching, I disagree that teaching isn’t positively impacted by faculty members who are actively involved in scholarly research-what a conundrum!

Nevertheless, this book written by two long-time academicians provides compelling arguments for abolition of tenure and the need to improve teaching at the undergraduate and graduate levels.

Until next time…

Good Luck and Good Job Hunting (try teaching)!!!!!!!!!!

 

Situation Not Improving at Johnson & Johnson's McNeil Consumer Healthcare Unit

Posted in BioBusiness

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!!!!!!!

 

Finally Some Good News for Genzyme

Posted in BioBusiness

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!!!

 

Genzyme v. Icahn: Is Carl's Bark Worst than His Bite?

Posted in BioJobBuzz

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!!!!!!!!

 

Genzyme Expected to Be Fined Almost $200 Million for Manufacturing Problems

Posted in BioBusiness

Genzyme announced yesterday that it expects to be fined roughly $175 million in fines and penalties related to the manufacturing troubles at its Allston Landing, MA manufacturing plant that resulted in severe shortages of two of its best selling products, Cerezyme (Gaucher disease) and Fabrazyme (Fabry disease) 

The fines and penalties are part of a consent decree that the US Food and Drug Administration (FDA) intends to levy against the company for the manufacturing infractions. A substantial portion of the penalties included a disgorgement settlement, a process that allows FDA to collect a certain percentage of the sales of products made at the troubled Genzyme production facility.

According to an article in today’s New York Times business section, Genzyme representatives said that patients using Cerezyme would continue getting half a dose for two or three more months. It previously said full supplies would be restored May.

Patients who use Fabrazyme would continue to be allocated a third of their usual dose at least through the third quarter. The company had previously hoped to resolve the Fabrazyme shortage in the third quarter.

The highly publicized manufacturing problems at Genzyme, has shaken both physician and patient confidence in the company’s ability to safely manufacture and supply sufficient quantities of Cerezyme and Fabrazyme; two orphan drugs designed to treat patients with debilitating genetically-inherited diseases. 

Several physicians and patients who were previously loyal and ardent supporters of Genzyme, have indicated that they may switch to recently approved and new treatments being developed by Genzyme’s competitors that include Shire.

The lack of commitment to quality manufacturing by Genzyme executives has seriously tarnished the image of a once highly respected and reputable orphan drug developer.

Until next time…

Good Luck and Good Job Hunting!!!!!

Until next time…

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

 

The Saga Continues: Will Genzyme Soon Be Up for Sale?

Posted in BioBusiness

While Genzyme has begun to address its manufacturing woes and its CEO and top leadership have managed to keep their jobs, the specter of a possible forced sale of the company has emerged. This is because Carl Icahn, the billionaire, activist investor with a history of forcing the sale of financially-challenged and underperforming public biopharmaceutical companies like ImClone and MedImmune, owns 1 percent of the outstanding shares of Genzyme.

Speculation is rife that Icahn and Ralph Whitworth, a founder of Relational Investors which owns 4 percent of Genzyme’s stock, may force the company to put itself up for sale. While many experts contend that this may not be in the best financial interests of Icahn and Whitworth (or other institutional investors), the threat may allow both men to get themselves or their representatives on Genzyme’s board. This would allow them to control the direction of the company and better position the company (the fifth largest biotechnology company in the world) for future sale. Henri Termeer, Genzyme’s embattle CEO, said he has had no contact with Icahn.

Investors have not been pleased with Genzyme’s current management team’s decision to plow profits from its orphan disease business into R&D activities that have been unsuccessful. According to a recent Citigroup financial report, the company may have squandered over $1.0 billion (throughout its history) by investing into unprofitable, non-core research areas including kidney disease diagnostics and surgical products. Conventional wisdom suggests that if Icahn and Whitworth gain control of the Genzyme board that they could sell off Genzyme’s unprofitable kidney disease and surgical lines which would allow management to focus on orphan diseases drug development and allow the company to fix its recent highly publicized manufacturing problems.  Relational’s Whitworth hinted that this is one scenario that he may be interested in pursuing. To date, Icahn has been uncharacteristically mute on a possible takeover attempt.

Stayed tuned for more details.

Until next time….

Good Luck and Good Job Hunting!!!!!! (try Genzyme, they are probably looking for a few good biomanufacturing executives and managers)  

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Time for a Change: BIO Study–US Students Falling Behind in Bioscience Education

Posted in Career Advice

The Biotechnology Industry Organization (BIO) kicked off its annual meeting in Atlanta, Georgia today and shortly thereafter, issued a press release detailing an education study (that it commissioned) which suggests that American high school students are continuing to fall behind in life sciences education and competitiveness. The timing of the BIO education report is curious, given that over 100,000 life sciences employees have lost their jobs over the past several years and more job cuts at pharmaceutical and biotechnology companies are expected in the next six months or so.

The report concluded that “middle and high school students across the country are generally falling behind in life sciences, and the nation is at risk of producing a dearth of qualified workers for the life sciences industry. Students are showing less interest in taking life sciences and science courses, and high schools are doing a poor job of preparing students for college-level science, The deficiencies will hurt the country’s competitiveness with the rest of the world in the knowledge-based economy.”

Some of the report’s finding include:

  • 52 percent of 12th graders are at or above a basic level of achievement in the sciences as measured by the NAEP science test
  • Average scores on the NAEP for 12th graders in the sciences and life sciences declined from 1996 to 2005
  • Only 28 percent of high school students taking the ACT reached a score indicating college readiness for biology.

The report also found a deficiency in the number of well-qualified biology teachers available in high school, with one-in-eight biology teachers not certified to teach biology. To improve U.S. competitiveness in the biosciences industry, the report recommends that states incorporate biotechnology into their science standards, make sure students are ready to take college biosciences courses and focus more on professional development for teachers.

While BIO ought to be commended for the study, the results and the conclusions of the report are nothing new and have been known for over a decade by industry thought leaders and life sciences industry executives. The crux of the problem is that neither academia nor industry is willing to provide funds or invests in ways to find a solution to this vexing, ongoing issue. Also,while high school science curriculum experts and teachers are typically cited as the cause of the problem, most of the blame more aptly lies with life science educators at the undergraduate and graduate school levels.

Today, many US high schools and community colleges already offer life sciences and biotechnology training to their students. In fact, biotechnology curriculum development and outreach has been ongoing in US for well over a decade. For example, Bio-Link, an NSF-funded consortium of community colleges that began in the late 1990s, has diligently worked to create a network of community colleges and high schools that offer biotechnology education and training ranging from biomanufacturing to bioinformatics to forensic DNA sciences. Further, a quick perusal of many high schools and science academies in biotechnology-rich locales like the Northeast, California, New Jersey, Maryland, North Carolina and others reveals that life sciences education and training are readily available to many students interested in biology and bioscience.

In my opinion, the system doesn’t break down at the high school level but at the undergraduate and graduate school levels. This is because for the past 15 years, many undergraduate life sciences courses have jettisoned their hands on laboratory components in favor of more lecture driven and e-based learning experiences. This is because these laboratories are costly to run and extremely labor intensive. Further, many undergraduate students may choose not pursue science careers because of the mistaken perception that life sciences jobs require a PhD. Ironically, there are many more jobs in the life sciences industry for students with undergraduate or masters’ degrees than for those with PhD. This is because there is a glut of PhDs in today’s market and the number of jobs in academia and the life sciences industry are growing smaller. I believe that academia and industry are responsible for the rapidly declining job market for PhD-life sciences.

First, let’s look at academia. Most academicians who are charged with training PhDs and postdoctoral fellows have little appreciation or understanding of the technical and regulatory skill sets required in the life sciences industry. Second, many academics don’t feel that it is their responsibility to prepare students and postdoctoral fellows for jobs in industry because that is tantamount to job training—a big no-no in academic circles. Finally,and perhaps most important, graduate programs are reluctant to provide career counseling or job-specific training for their students because it might interfere with their productivity, which in turn may reduce the amount of data principal investigators have to write papers and win grants to fund their laboratories. In other words, there is little or no incentive for education and training to change at the graduate level because there is no benefit or upside to principal investigators and tenured faculty members.

While the American life sciences industry has loudly and repeatedly complained about a lack of qualified job candidates to work at its companies, they have done little to support and fund efforts to reform US life science education and training. This is likely because many life sciences executives contend that they are in business not education and the responsibility to prepare students for careers in science should not fall on them. Rather, it rightfully belongs in the purview of secondary and post secondary educational institutions. And, rather than train new employees without previous industrial experience (to inject new talent and ideas into their organizations), companies typically only hire job candidates with previous industrial experience. As many newly minted PhD and postdoctoral students frequently ask: “How are we suppose to get industrial experience if nobody will hire us without previous industrial experience?” Good question! 

The BIO report warns that the US is falling behind in bioscience education and American life science companies may experience workforce shortages in the future. The fact that about 100,000    (many of whom were scientists) pharmaceutical employees have lost their jobs over the past several years, suggests otherwise. Nevertheless, American science education and training needs to be improved and reformed if the US wants to maintain its dominance in the life sciences. The piecemeal approach that has been pursued for past decade or so hasn’t worked. And why should it? Neither academia nor industry, the two main players in the story, don’t really have any “skin in the game.” In other words, they have nothing to lose right now!

I believe that its time for academia, industry and government to come together to craft a cohesive, national life science curriculum that meets the needs of all stakeholders. We have a President in the White House who believes in science, the ingenuity of the American people and change. The time is now!

Until next time…

Good Luck and Good Job Hunting!!!!! 

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