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Johnson & Johnson is arguably one of the world leaders in bringing social media to the pharmaceutical industry. Marc Monseau and his dedicated team oversee a network of blogs, video channels and Twitter feeds while some of J&J’s brand companies even sponsor patient advocacy communities like ADHD Moms and ADHD Allies. However, the company’s recent handling of manufacturing problems and recall of Tylenol and other pediatric medicines seemingly flies in the face of openness and transparency; two of the underlying tenets and guiding principles of social media.

In an article in today’s New York Times, Natasha Singer reports that “a Congressional investigation into a recent recall of children’s Tylenol and other pediatric medicines has been stymied by the manufacturer, Johnson & Johnson, raising the prospect that new measures — like issuing of subpoenas to compel cooperation — could be invoked.”

McNeil Consumer Healthcare, the unit that manufacturers Tylenol and other over-the-counter medications, is no stranger to scrutiny by the US Food and Drug Administration (FDA). It is currently being investigated for a pattern of violations in manufacturing practice and quality control issues that have led to recalls of several medications. Last month, the agency suggested that it was considering criminal penalties or other actions against McNeil executives.

According to the times article, the House committee opened its investigation in early May shortly after McNeil announced a voluntary recall of liquid pediatric Tylenol, Motrin, Benadryl and Zyrtec. FDA investigators uncovered evidence that the products, made at a company plant in Fort Washington, Pa., may have included metal particles, or too much of the active drug ingredient, or inactive ingredients that did not meet testing standards.”

Manufacturing problems are not uncommon in the pharmaceutical industry and it isn’t clear what J&J has to lose by not fully cooperating with FDA officials. In fact, failure to cooperate could lead to harsher penalties and larger fines. However, I suspect that McNeil hasn’t been forthcoming because of allegations of a so-called “phantom recall” that took place last year, where J&J contractors secretly removed alleged defective products from store shelves.” Nevertheless, ongoing media coverage of the recall and the circumstances behind it are beginning to cast a very negative light on McNeil products and the J&J brand.

Pharmaceutical social media advocates contend that one of the reasons why pharma companies ought to use social media tools is information dissemination and so-called damage or crisis control. While I haven’t been assiduously screening all of the J&J social media channels, it seems like now would be an ideal time to begin to leverage them. 

It is unfortunate that an innovative and progressive pharmaceutical company like J&J has come under fire. However, product quality and safety is of paramount importance to consumers. And companies that cannot ensure those product attributes must move quickly and decisively to reinstate them. To that end, J&J ought to fully cooperate with FDA regulators, fix its Tylenol problems and then use its abundant social media channels to reinstate public confidence in McNeil Consumer Healthcare and the J&J brand! After all, isn’t that what social media is all about?

Until next time...

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

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Those of us a certain age have all heard of the so-called new math—which by all accounts wasn’t much different than old math—that was suppose to revolutionize the way math was taught at the primary and secondary education levels. While new math may not have not have much different or better than old math from an academic perspective, pharmaceutical companies will have to reckon with the new math associated with the pricing of brand name prescription drugs if they want to remain competitive in the future.

According to statistics offered in a recent New York Times article on Teva Pharmaceuticals, the world’s largest generic drug manufacturer, generics now account for 75 per cent of the prescriptions filled in the United States. This figure is up 47 percent from a decade ago. Further, a recent study from IMS, the research firm that tracks prescription drug use, generic drugs saved the American healthcare system $734 billion between 1999 and 2008. These numbers, coupled with a paltry 25 per cent market share, suggest that brand name pharmaceutical companies must rethink the low volume, large margin pricing strategy that has guided big pharma for the past 50 years. 

As one Teva executive candidly put it, “If you are used to the fat margins of big pharma, it is hard to compete in the rough and tumble of price-cutting generics.” 

The push for wider adoption and use of generic pharmaceuticals and biologics (as compared with brand name drugs) suggests that there will likely be more belt-tightening at big pharma companies in the not-so-distant future.

Until next time..

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Eli Lilly and Co. announced last Thursday that it plans on cutting 200 sales and marketing support jobs in its U.S. biomedicine group. More than half of those cuts will take place in Indianapolis, the corporate headquarters of the company. The cuts are the latest wave of the drugmaker's previously announced plans to chop 5,500 jobs worldwide by the end of 2011. The layoffs will be the largest since Lilly eliminated 200 jobs from its research laboratories in March.

Big pharmaceutical companies have been laying off marketing and sales reps for the past three years or so in response to lack of newly approved drugs and anticipated revenue losses from blockbuster drugs that are nearing patent expiry. According to a recent survey conducted by SDI Health the number of pharmaceutical sales reps has shrunk to roughly 81,780 in last year’s third quarter from 101,818 in 2005: a nearly 20 per cent. Further a recent post on the Pharmalot blog revealed that “last year, the number of docs willing to see most reps fell nearly 20 percent, the number of prescribers refusing to see most reps increased by half and the number of management-planned sales calls that were nearly impossible to complete topped 8 million” according to ZS Associates, which monitored interactions involving 500,000 physicians nationwide.

Declining revenues from brand name prescription drugs combined with the changing attitudes of physicians to sales reps suggest that marketing and sales jobs in the pharmaceutical industry may become scare in the future. However, as the biotechnology continues to mature, the need for sales reps with backgrounds in molecular biology and protein-based drugs will continue to increase.

While most physicians are very familiar and comfortable with small molecule prescription drugs, their understanding and familiarity with biotechnology drugs is surprisingly deficient. This suggests that PhD-trained life scientists, who are outgoing and don’t have problems “selling”, may want to consider careers in biotechnology sales or marketing.

Until next time…

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

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As reported in the March issue of Pharmaceutical Technology Europe, figures published by the European Medicines Agency (EMA) showed that the approval rate for new drugs (branded, generics, biosimilars and orphan) increased between 2007 and 2009; however most of the approvals were for generic drugs not new ones.

According to the published figures there were 58 new drug approvals in 2007, 66 in 2008 and 117 in 2009. However, the number of approvals for branded products decreased during this period; 35 in 2009 compared with 41 in 2008 and 59 in 2007. On the other hand, the approval rate for generics skyrocketed with more than 50 in 2009 as compared with 4 in 2008 and 5 in 2007.

Interestingly, biosimilar products didn’t fare as well as small molecule generic drugs with the number of applications and approvals decreasing during the period. For example, in 2007 10 new biosimilar applications were filed as compared with 3 in 2008 and 1 in 2009. Likewise, the number of approved biosimilar products decreased with 5 in 2007, 6 in 2008 and 0 in 2009. This trend suggests that biosimilars, mainly therapeutic proteins are not faring well in the European market. However, this is likely to change as patents begin to expire for monoclonal antibody-based drugs which are increasingly becoming the new drugs of choice for many indications including oncology, inflammation and metabolic diseases. Nevertheless, there is a growing emphasis and trend on developing generic medications as compared with new ones. Expect this trend to continue as patent expiry for many small and large molecule continues to draw near.

Until next time…

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The generic drug industry didn’t exist until the passage of the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments). This piece of legislation, better known in the pharmaceutical industry as the Hatch-Waxman Act, was proposed and adopted by the US Congress because of the escalating costs of brand name drugs manufactured by large pharmaceutical companies (sound familiar?). The act provided the US Food and Drug Administration (FDA) with a regulatory pathway to approve and bring to market “generic” versions of branded drugs that lost patent protection. During the debate over the amendment, and for many years thereafter, branded pharmaceutical manufacturers tried to stifle the growth of the generic drug industry by suggesting that generic versions of their branded medications were unreliable and unsafe. This tactic was partly responsible for the stinted growth of the generic pharmaceutical industry until the mid 1990s when the price of branded pharmaceutical drugs began to skyrocket and insurance companies began to realize that something had to be done to manage rising drug reimbursement costs. To that end, insurers and third party payors began requiring patients to use generics (when available) instead of branded products to cap rising prescription drug costs. Because of this, the generic industry has grown by leaps and bound over the past decade and now threatens the stability of the branded pharmaceutical industry! 

Unfortunately, while increased generic drug use may be good for generic drug manufacturers and insurance companies, it isn’t always in the best interests of patients who use prescription medications. For example, there are a growing number of stories and complaints from patients who were forced to switch from a brand name drug to a generic one and had side effects, or found that their symptoms returned or may have been worse than before. In fact, this happened to my mother who was switched from a brand name pain reliever that worked to a generic version that no longer controlled her symptoms and induced some untoward side effects. Scientifically, there ought to be little difference in the efficacy, safety or tolerability profiles of a branded drug and its generic equivalent. This is because both medications contain the same active pharmaceutical ingredient. However, differences in the formulation of the branded and generic versions of the drugs may be responsible for reduced efficacy or safety and tolerability issues.

While clinical studies conducted by the insurance industry suggest there are no safety or tolerability differences between brand name and generic drugs and the American Medical Association’s assertion that, as a whole, generic drugs do work as well as branded drug, there is some evidence to suggest that some generic drugs may not be interchangeable or substitutable for certain branded medications. This appears to be the case for certain drugs that are used to treat neurological conditions and mental health diseases like seizures, depression and bipolar disease. Lesley Alderman, in an article she wrote in today’s New York Time business sections provides excellent examples of this.   

The problems with some generic drugs may arise as a result of the approval process for this class of drugs. According to provisions outlined in the Hatch Waxman Act which stipulate that a generic version must have the same active ingredient, strength and dosage form as the brand name drug or reference product. The generic version must also be demonstrated to be “bioequivalent” to the brand name drug. This means that the generic product must be shown to reach blood levels (drug concentration) that are very similar to the brand name product. This is usually determined by administering the generic and brand name drugs to a relatively small number (24 to 36) of healthy human volunteers. Generally speaking, once bioequivalence is established it paves the way for regulatory approval of the product. Typically, once approved, many generics receive what is known as an AB rating. Generics that are AB-rated can freely be substituted (by a licensed pharmacist) for a brand name product even though the physician may have written the prescription for the branded product.

In the past, patients were usually given a choice between a generic and a brand name drug —a decision that was largely based on the percentage of the cost of drug that would be covered by insurance. These days, patients no longer have a choice and are generally forced to use generic drugs rather than brand name products based on formulary lists compiled by insurance companies. While I am not practically or philosophically opposed to using generic drugs, there is a growing body of evidence which suggests that not all patients respond the same way to branded and for that matter generic drugs. Therefore, I contend that allowances ought to be made for these differences and patients who don’t respond to (or experience side effects) after taking generics shouldn't’t be denied access to the branded product that, in most cases, was originally prescribed by that patient’s physician. It is one thing to cut costs; it is another to increase a patients suffering or anxiety. If you are concerned about switching from a branded medication to a generic, please read this for some helpful tips and guidance.

Until next time...

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

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Daiichi Sankyo will buy a controlling interest (50.1%) of Ranbaxy, India’s third largest generic manufacturer.  Daiichi will pay as much as $4.6 billion for the opportunity.

The deal will put Daiichi Sankyo into ninth place in the $120 billion generic-drug market behind leaders Teva Pharmaceutical Industries Ltd. and Novartis AG's Sandoz unit. According to the report “Daiichi Sankyo is mimicking strategies pursued by Novartis and Johnson & Johnson to weather turbulence in the branded-drug industry by diversifying into other markets. The acquisition also gives the Japanese company more reach in emerging regions including India, China and Eastern Europe. “

I think after this deal, that other pharmaceutical companies may consider buying profitable generics businesses. I am not sure why it has taken innovator companies so long to realize that it is much easier to join (buy??) rather than compete with generic manufacturers. It just seems so obvious to me—and I don’t even have an MBA!  Maybe there is some truth to the age-old aphorism “missing the forest for the trees.”

Until next time…

Good Luck and Good Job Hunting!!!!!

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