What You Need to Know About Salary Negotiations

Preparing a resume and going through the interview process are a breeze as compared with salary negotiations after an employer has made you a job offer. Negotiating an acceptable salary is never easy. As a job seeker, you want the highest salary that you can negotiate based on your qualifications, years of experience etc. In contrast, your prospective new employer would like to hire you at a salary that is commensurate with your credentials and also consistent with industry standards and what similar employees earn at the company. After successful salary negotiations, both the employer and employee should be satisfied with the negotiated compromise that they reached (For those of you who have not realized it yet, all negotiations are compromises–neither party ever gets everything that they wanted at the outset).

So, when is it appropriate to discuss salary requirements during the job search process? Continue Reading...

Let the Games Begin: Amgen Pink Slips to Appear This Week!

This should not come as a big surprise (especially to the Amgen employees who already know that they will be losing their jobs) but Amgen announced today  that it will be cutting about 450 workers in its West Greenwich, Rhode Island biomanufacturing facility and laying off about 675 workers at its Thousand Oaks, California, headquarters. On Aug. 15, 2007, Amgen, which is the world's largest biotechnology company, announced plans to pare its staff by 12% to 14%, or roughly 2,220 to 2,600 workers, as part of a major restructuring plan.

Although somewhat troubling, this is the first time in 25 years that Amgen is restructuring and has been forced to downsize. Nevertheless, looking on the bright side for Amgen alumni, being formerly employed by the world's largest and most recognized biotechnology company is a not a bad thing when looking for a new job! 

Until next time….

Good Luck and Good Job Hunting……….

The Problem With Some Bloggers

Blogging is a very personal and often times, a subjective exercise. That said, there are many bloggers who blog for personal reasons and then there are some bloggers who blog for commercial, advertising or even sensationalistic purposes. I think that Jacob Goldstein who writes the Wall Street Journal Health Blog fits into the latter category.

First, he floats the idea that Pfizer may acquire Wyeth. Although I believe that anything can happen (like pigs flying) this hypothetical was nothing more than a sensationalistic attempt to bolster the number of folks who visit and read his blog. Today, he blogged about a Seattle-based, so called “biotech superstar”, named Christopher Henney. Apparently, Mr Henney is a superstar because he was co-founder of several successful biotechnology companies that he sold for billions of dollars to the likes of Amgen and Eli Lilly. Interestingly, Mr Henney has started a new company and is seeking to garner sufficient Series A financing to get it off the ground! Is there a better way to get the word out on the street that Mr. Henney is looking for money than by posting it on the Wall Street Journal Health Blog?

The biotech superstardom label ought not to be awarded to individuals solely on the basis of the return on investment that they provided to venture capitalists and stockholders. Continue Reading...

Congress Fails to Pass Legislation for Approval of Follow-on Biologics in the US

The US Congress is poised this week to pass a new healthcare bill that gives the Food and Drug Administration (FDA) more authority to scrutinize drugs after they reach the market, including power to mandate label changes that warn of new risks. This is good news!

The bad news is that follow-on biologics advocates were unable to add legislation to the bill that would allow the FDA to approve follow-on biologics for sale in the US. As many of you may know, there is no legally sanctioned pathway for approval of generic versions of protein-based biotechnology drugs in the US. In stark contrast, the European Medicines Agency (EMEA) crafted legislation in 2006 to allow these products to be approved and sold in Europe. Since that time, several biosimilar drugs (the European name for follow-on biologics) have received marketing authorization by European regulators and are currently marketed in many countries in Europe and elsewhere.

Biotechnology drugs are typically very expensive and out of reach for many people who lack adequate healthcare insurance. Follow-on biologics advocates argue that their products can be sold at lower prices –anywhere from 25%-30% less – than their branded drug counterparts. The lower prices of biosimilar products that are currently sold in the EU tend to support this assertion.


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A Sea Change at FDA?

In an attempt to dispel the notion that it is “dysfunctional” and "lax in policing drugs once they are on the market", the US Food and Drug Administration (FDA) earlier this week launched MedWatch - The FDA Safety Information and Adverse Event Reporting Program. An integral part of the new program is The Drug Safety Newsletter a quarterly publication that provides information on the findings of selected postmarketing drug safety reviews from FDA's Center for Drug Evaluation and Research.

The newsletter also provides information on important emerging drug safety issues and recently approved new molecular entities. FDA hopes the newsletter will raise awareness of reported adverse events, and stimulate additional adverse event reporting by healthcare professionals. The first issue of the newsletter contains reviews of the following products (information in the brackets are the most serious side effects)


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What You Ought to Know to Get a Job in the Pharmaceutical and Biotechnology Industries!

Although industry and academia share a common bond (no pun intended), which is obviously science, the lexicons of these two seemingly similar but parallel worlds are markedly different. For example, do you know what the acronyms IND, NDA, cGMP, cGLP, BLA, CTD, PK or PD stand for? If you cannot decipher any of them, you ought to forget about getting a job in industry and stay in academia. If you know what 95 % or less of them mean, I highly recommend that you get some additional training before applying for your first industrial position. If you are one of the lucky few who recognized and correctly interpreted 100% of the acronyms, you are either working in industry or recently completed some postgraduate training in drug development and regulatory affairs. The point that I am trying to make is that you cannot possibly expect to get a job in industry if can’t speak the language that you need to know in order to succeed! As the old saying goes “You need to learn how to walk before you can run”.

So, take the test and your score will determine whether you are ready to apply for that long sought after job in the pharmaceutical or biotechnology industries.

Footnote: For those of you who are interested, you can decipher all of the acronyms that I listed by visiting and rooting around the FDA website.

Until next time….

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



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Finally-Some Good News for Amgen!

The New York Times reported today that an FDA advisory committee voted on Monday against imposing a new restriction on the use of EPO-like drugs to treat dialysis patients with kidney disease, offering a rare reprieve to Amgen, the manufacturer of the drugs.

The panel voted 14-to-5 against an F.D.A. proposal to set a fairly specific upper range on the drugs’ use. Several studies have linked overuse of the drugs to cardiovascular problems and deaths and, when used to treat cancer patients, to a worsening of tumors.

Nevertheless, although yesterday’s vote made it less likely that there would be drastic restrictions on the use of the drugs in kidney patients, the levels of use are unlikely to return to those common before the safety concerns took hold. Even while rejecting the proposed ceiling, most panel members recommended a treatment target lower than what some dialysis clinics and kidney specialists previously used.

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Manufacturing Problems at Pfizer

Can anything else go wrong at Pfizer? Unfortunately for Pfizer employees, the answer is yes. Pfizer and FDA announced late last week that they found detectable levels of the mutagen/carcinogen ethyl methanesulfonate (EMS) in Viracept, the company’s flagship anti-HIV medication. EMS has long been known to be a potent mutagen and carcinogen. I can attest to the mutagenic potential of EMS, because in my former life as a bench scientist I routinely used it to generate point mutations in the bacteria that I was working with.

Pfizer and FDA agreed not to recall the drug in the US because the quantity of EMS found was “low”. However, Roche, the company that sells Viracept in Europe, did recall the drug (slightly higher levels of EMS were found in the European version of Viracept). Predictably, FDA cautioned that although there are no human data, EMS has been shown to cause mutations, tumors and birth defects in animals and is a "potential human carcinogen. Not surprisingly, Pfizer advises children and pregnant women not to start the drug, although children already taking it may continue (really?).
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The Woes Continue at Wyeth

On Thursday of last week, Wyeth suffered another blow in a long string of regulatory missteps and intellectual property disputes after a judge ruled that Teva (one of the world’s leading generics companies) and its marketing partner Sun Pharmaceuticals could begin marketing a generic version of Wyeth’s popular anti-heartburn medication Protonix. In the decision, a US district court judge refused to uphold Wyeth’s request to extend an injunction against Teva from marketing its version of Protonix. Teva, which is involved in a patent lawsuit with Wyeth and Altana over Protonix, has not yet said whether it will launch the product.
The patent lawsuit between the companies dates back to 2004. In July 2007, Teva agreed not to launch a generic version of Protonix until either a preliminary injunction was denied or it expired (which happened on Friday). Teva could launch the drug, but it would be considered at-risk because of the pending patent dispute. Continue Reading...

Don't Count Merck Out Yet!

I have to tip my hat to Merck. I thought it was silly that company executives decided not to settle all of the litigation surrounding the Vioxx debacle. Instead, the company decided to challenge all of the individual Vioxx lawsuits filed against it. That said, the New York Times reported today that the New Jersey Supreme Court rejected a bid by Vioxx plaintiff lawyers to bring a Vioxx class action suit against Merc which is based in Whitehouse, NJ. The state's highest court reversed two lower court rulings and decided that a nationwide Vioxx class action suit was not appropriate. The suit had been brought by a union health plan on behalf of all insurance plans that paid for Vioxx prescriptions, or about 80 percent of all Vioxx sold.

This was huge victory for Merck because New Jersey consumer fraud law allows for triple damages and the class action suit could have cost the company $15 to $18 billion. Further, the company’s strategy of fighting Vioxx lawsuit individually has also paid off. Of the cases that have reached verdicts, Merck has won 9 and lost 5. A new trial was ordered in one case and two ended in mistrials. To the objective observer, Merck is winning–possibly paving the way for the company to reintroduce Vioxx to the market with new restrictions for use.

After the ruling was made public, shares of Merck rose more than 2 percent to $50.47 on Thursday. For those of you who do not follow the stock market, Merck’s share price plummeted to the mid-twenties after the Vioxx situation developed close to two years ago. I guess that is why Mr. Clark and not I is the CEO of Merck.

Until next time….

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

What are Good Laboratory Practices (GLP) Anyway?

I received a call the other day from a former biotechnology master’s degree student of mine who recently secured a job at a local biotech/medical device company. She called to inquire about training for her laboratory co-workers in Good Laboratory Practices or GLP as it is known in the biz. After a few minutes, I realized that she did not understand what GLP is– like many other people who call me requesting GLP training. With this in mind, I want to try and alleviate the confusion surrounding GLP.

Good Laboratory Practice regulations were established by regulatory authorities (including FDA) in the late 1970s. These regulations were crafted to standardize and improve the methodology and practices for animal safety testing of investigational drugs in pre-clinical development. As many of you may know, all investigational drugs are required to undergo safety testing in animals before regulatory authorities will allow the compound to advance and be tested in human clinical trials.

All of the US GLP regulations are found in 21CFR part 58. After a quick perusal of the regulations,

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What a Difference a Few Years Can Make!!!

The Motley Fool published a synopsis today on the surprising strength of ImClone’s anti-cancer pipeline. According to the article, the company is conducting Phase 2 clinical trials on two new cancer treatments; an anti-insulin-like growth factor-1 receptor monoclonal antibody as a treatment for late stage metastatic prostate cancer and vascular endothelial growth factor receptor (VEGFR) inhibitor as a treatment for metastatic kidney cancer in patients who have failed with other VEGF inhibitors. Both drug candidates are highly touted and stock analysts are anxiously awaiting the results of these trials. Speaking of stocks, ImClone is trading around $35 per share, a stock price that is higher than Pfizer or Schering Plough.

For those of you who don’t remember the ImClone scandal, it resulted in Sam Waksal (ImClone’s CEO and founder) and Martha Stewart (Sam’s friend) going to prison and is partly responsible for the resignation of Bristol Myers Squibb’s previous CEO. Despite all of ImClone’s critics, Erbitux® has turned out to be a pretty good treatment for advanced colon cancer and the company is making money as a result. This has provided ImClone with the largesse to build a new manufacturing facility and add jobs in New Jersey (as I reported in a previous post).

Everyone (Stan Yakatan and I) thought that ImClone was finished a mere five years ago.  What a difference a few years can make in this business!

Until next time…..

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

Sandoz's Generic EPO is Approved in Europe

The New York Times reported today that a generic version of EPO, called epoetin alfa manufactured by Sandoz the generic division of Novartis gained marketing approval by the European Commission.  This is the second biosimilar product manufactured by Sandoz to gain marketing approval in the past two years.  The first, a biosimilar version of human growth hormone, called Omnitrope, was approved in Europe and the US in 2006 after Sandoz sued FDA.

Sandoz's epoetin alfa is the first generic version of EPO to hit the market . The approval of this product should reduce Amgen's strangle hold on the EPO market.  Roche is expected to receive approval of a new EPO-like drug called CERA early next year.  Although FDA is unlikely to approve Sandoz's  epoetin alfa (biosimilars cannot be approved in the US) expect the price of EPO-like drugs to drop over the next few years.

Despite the recent negative press about EPO use, the EU approval of epoetin alfa represents an important first step in legitimizing the follow-on/ biosimilar market.

This is a wake up call for the American pharmaceutical and biotechnology industries-its time to get with the program or lose market share.