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The Food and Drug Administration (FDA) announced today that it wants to hire 1,300 biologists, chemists, medical officers and others over the next several months. The agency currently employs more than 10,000 people and wants to add 600 new employees and backfill more than 700 that have been vacant by October. The new hires will triple the number hired from 2005 to 2007. Roughly 30% of all regular FDA staffers and approximately half of FDA managers are already eligible to retire.

An FDA spokesperson said that 400 of the new jobs will be related to drug application review and another 150 will be hired as inspectors to inspect drugs, foods and other related items. The agency will rely on user fees from drug companies to pay for all drug review jobs and about 100 other positions. The rest will come from the funds that were recently appropriated by Congress.

In addition to drug reviewers and inspectors, FDA is seeking consumer safety officers, nurse consultants, statisticians, epidemiologists, pharmacologists, pharmacists and veterinarians. Most of the positions are in the Washington D.C area but some are overseas and in other parts of the US.

This is one of the largest hiring initiatives in FDA’s history. It’s about time that Congress realized that the agency has been seriously under funded and understaffed ever since Bush was elected in 2001. I suspect that the impetus for the additional funding and hiring initiative has a lot to do with the beating that the agency has taken over the past few years. As we all know, FDA has been blasted by consumer advocates and lawmakers for lax oversight and inefficiency.

I can’t recall whether I said this before, but FDA is a great place “to be from”. Many of my colleagues who worked at FDA for three or more years are now highly paid regulatory consultants charging the companies that hire them about $3,000 to $5,000 per day. That said, as a bit of career advice; opportunity is knocking—don’t dither and wait too long before you apply.

Until next time….

Good Luck and Good Job Hunting (at FDA)!!!!!!!!!!

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Brand name pharmaceutical and biotechnology companies have been quietly spending millions to lobby Congress for changes in US patent law. Specifically, these companies want to overhaul the intellectual property rules dealing with the doctrine of “inequitable conduct”. When a company or individual engages in inequitable conduct, it means that the company or individual has misrepresented or concealed information with the intent to deceive the US Patent and Trademark Office (USPTO). In such cases, a federal judge has the legal authority to void the patent and declare that it is unenforceable. Not surprisingly, brand-name drug companies are lobbying Congress to eliminate or curtail inequitable conduct penalties. 

According to the New York Times, in the last 15 years the US Court of Appeals for the Federal Circuit (which handles appellate patent litigation) have ruled in the affirmative on 40 cases of inequitable conduct–14 of which involved pharmaceutical or healthcare companies. Similar rulings have been issued by federal district judges in an indeterminate number of cases that were not appealed (and never reached the Federal Circuit court). The article contends that some drug makers knowingly submitted false statements to the USPTO, inaccurately described experiments in patent applications or concealed information (usually prior art) that contradicted their claims. In one high profile case, the appeals court ruled that the Danish drug maker Novo Nordisk failed to disclose that it had not performed an experiment described in a patent application for human growth hormone. In another notable case, the court contends that Pharmacia (now Pfizer) used an “inaccurate and misleading” affidavit to win a patent for a new glaucoma drug.  Personally, I am aware of several instances in which companies willfully and knowingly failed to disclose prior art in patent applications that were ultimately approved.

Those of us in the biz know that patents are valuable commodities and that the financial stakes surrounding patent estates and intellectual properly are extremely high. A robust patent estate can either make or break a company. Nevertheless, in my opinion, if a company (or individual) cheats by falsifying, concealing or omitting pertinent information in a patent application, they ought to be penalized for it.  As one former USPTO commissioner, who served under George HW Bush puts it: “Patents can be very valuable. There are strong incentives to want to get them. Cheating occurs from time to time. The inequitable conduct doctrine says that if you cheated to get a patent, you should not be able to enforce it.”

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I learned late last evening that Ron Mardigian, founder and manager of Bio-Rad’s Biotechnology Explorer Program, died suddenly and unexpectedly in his sleep last December. Not surprisingly, I learned of his passing in a publication from Bio-Link, an NSF-funded organization committed to biotechnology training at the high school and community college levels.

Ron and I first met (via the telephone) in1996 when he was putting the finishing touches on the first of a series of education kits that would ultimately become Bio-Rad’s Biotechnology Explorer Program. At the time, I was working at Rutgers to create variants of the Green Fluorescent Protein (GFP) that could be used for educational purposes. Like me, Ron immediately realized that GFP could be used as a powerful education tool to showcase the principles of molecular biology and biotechnology. After talking on the phone for hours at a time, Ron and I finally met in 1997 at an International GFP meeting in New Jersey at which he was conducting a series of teacher training workshops. Imagine my surprise when I saw, for the first time, this striking, long-haired, cool-looking dude of indeterminate age who purportedly worked for the Bio-Rad Corporation! I knew that this was the beginning of a long and enduring friendship. 

Ron was one of those special people who have an amazing energy about them. His unrelenting drive, passion and commitment to education (and life for that matter) were always palpable. When Ron was “in the house”, nothing was impossible and no problem was insurmountable. At work, Ron was a consummate professional who was available 24/7. I can’t remember an instance when Ron failed to quickly return a phone call or e-mail query. But, when Ron was on vacation, everybody who knew him understood that it was “his time” and that they shouldn’t bother him. He was an avid windsurfer, cyclist and intrepid explorer who could not resist an adventure. Ron’s annual three week sojourns to Hawaii, Northern California and places unknown are now legendary.

Ron once told me how he convinced the President of Bio-Rad to allow him to start the Biotechnology Explorer Program. As the story goes, Ron, who had worked at Bio-Rad for several years in a technical capacity, was at a crossroad in his career. As he put it, “he needed to clear his head” and the best way for Ron to do that was a road trip. After a three week jaunt to the Baja and Mexico, Ron came up with an idea to leverage his knowledge of molecular biology into a series of self-contained kits to teach biotechnology to high school teachers and students. The fact that he was able to convince a multinational, laboratory reagent and equipment manufacturer to take a risk on education is a testimonial to Ron’s charisma, passion and skills as an inveterate salesperson. Nobody I know was ever able to say no to Ron–including me! 

Unfortunately, the last time I spoke with Ron was about a year ago. He told me that things were going well and that life was full and rich. I regret the fact that I didn’t have an opportunity to speak to him before he passed away.

Bio-Rad’s Biotechnology Explorer Program has been wildly successful during its first 10 years of existence. I’m sure that nobody but Ron expected this. Like any parent, I suspect that he experienced nothing but pleasure and joy watching his baby mature into adolescence. Unfortunately, he will not be here to shepherd his child into adulthood. I hope Bio-Rad will keep Ron’s memory alive by continuing to support and promote the Biotechnology Explorer program.

Farewell “bro”–thank you for allowing me to accompany you on a part of your journey!

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It seems like nothing is going right for Merck these days. On Monday, the US Food and Drug Administration (FDA) issued a “not approvable”–aka a rejection letter–for Merck’s new cholesterol drug called Cordaptive or MK-0524A. The highly-touted drug, which Merck executives hoped would replace Merck’s blockbuster cholesterol drug, Zocor (which lost patent protection a couple of years ago), can both lower LDL (bad) and raise HDL (good) cholesterol. Although experts believe that these properties should benefit people with high cholesterol, the results from recent clinical trials suggest that drugs that raise LDL and lower HDL cholesterol may have safety problems.

Cordaptive consists of an extended-release form of niacin (a B vitamin) and another agent that inhibits a niacin side effect called flushing — redness, burning and tingling of the face. Niacin has been used to control cholesterol for decades. Abbott Laboratories already sells an extended-release form of niacin called Niaspan.

Despite positive results from recent clinical trials and pending approval by the European Union, the agency rejected Merck’s NDA. Regulators also rejected Cordaptive as a brand name. It is likely that FDA is scrutinizing and proceeding cautiously with new cholesterol medications because of the recent flap over Zetia and Vytorin (which are co-marketed and sold by Merck and Schering Plough). As you may recall, both companies have been accused of trying to protect sales of the two drugs by delaying results of a study that showed Vytorin worked no better than Zocor, which is much cheaper.  Merck’s stock price dropped about 5% yesterday after the company announced that it received a not approvable letter from FDA.

Although MK-0524A may ultimately reach the US market, I wouldn’t count on it anytime soon. Merck has seriously tarnished its reputation with FDA because of the Vioxx, Vytorin and Singular controversies. The old adage, “You reap what you sow” is particularly apt in this instance. Look for more “asset reallocation” moves in Rahway.

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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I was reading the paper this morning and I happened upon an article about the uproar over Miley Cyrus aka Hannah Montana posing in a topless photo for Vanity Fair magazine (as it turns out she is not topless, but wrapped in a silk sheet in a very, alluring, adult-like pose). For those of you who care, the photo was taken by Annie Liebowitz, photographer extraordinaire. According to 15 year old Miley, it was a cool, artsy photo that she didn’t have a problem with– although she is now publicly stating that she is “embarrassed” by it!  So, why are parents everywhere in America going ballistic over the photo?

As you may know, Hannah Montana is a Disney creation. And, for some reason, Disney has come to represent “good, clean American family values and fun”.  If this is true, it begs the question: Why would Hannah Montana, who has been canonized as a wholesome, innocent, and drug-free All American teenage girl, pose in a sexually alluring photograph? I think the answer to the question is obvious—money! Miley’s handlers; agents (and parents?) probably understand that she likely has made as many million as she can playing Hannah Montana, the all American girl.  They must have decided that it was time for Miley to grow up, become a sex icon and continue to sell as much merchandise and movie tickets as possible. After all, this tactic has worked for many other young female stars (and has also helped to sell tens of millions of dollars of inappropriate attire to girls aged 8-16), so why should Hannah Montana not be allowed to cash in on the opportunity? Isn’t becoming rich what the American dream is all about?

What I find disingenuous about the whole incident is that Disney is publicly outraged over the photo! I guess they have a right to be; Miley recently signed a new, multimillion, seven year deal with the company.  If, contrary to popular opinion, her image is actually tarnished by the photograph, she may be worth less than less Disney expected and the company may not be able to recover its ROI on the Hannah Montana franchise. What I find even more astonishing is that many Americans truly believe that Disney represents (and is synonymous with) American family values.  I hesitate to tell these folks that Disney is like any other multinational, publicly-traded company —primary goal is to make as much money as possible to provide profits to its stakeholders. Morals and ethics have little to with what actually makes Disney or any other corporation tick! In my opinion, American values ought to be taught to children by their parents, relatives and friends; not publicly traded corporations.

After seeing the photograph, my wife and I had very mixed feelings about the entire Miley Cyrus incident.  So, we asked our nine (9) year old daughter, who is a big fan of Hannah Montana, what she thought about the photo. After viewing the photo, she said that “she thought that it was wrong for Miley Cyrus to have her picture taken that way because she is only 15”. My wife then asked: “How old she thought that someone should be before posing in a picture like that”, my daughter shrugged and said, “I don’t know, 25”?  I must admit, that I was very surprised and pleased with her answer! For the record, my wife and I have never taken our daughter or two sons (ages, 14 and 12) to Disney—so I say “Rock on Hannah Montana”.

Until next time….

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

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I just finished reading a  wonderful article entitled "My Son the Number" that was written by Dulcie Leimbach in  last Sunday's Education section  of the New York Times.  in it, she describes how high school students are now defined by the scores that they receive on standardized tests like the SAT and ACT and by their grade point averages and class rank.  Thankfully, by the end of the article, she posits that numbers are simply numbers and that they are not predicative of how students will perform in college or in life, for that matter.  What is most important, she says, is a student's sense of purpose and his/her ability to get along with others and finish a task at hand. Numbers, she asserts, don't measure creativity and wit and they certainly don't predict the future (something that I have learned along the way too!)

I think that if we want to improve our competitiveness in science than we ought to focus less on the numbers and more on developing a sense of purpose in student who have an interest in science. This means drastically changing the way we teach and promote science at both the primary and secondary school levels. 

I still believe that there is wonder in science and that there is also wonder in being a kid.  So, let's forget about the numbers and allow our kids be kids again! And, we just might be able to regain our edge in science!

Until next time.....

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

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Over the past few days, many drug companies have been reporting their earnings for the first quarter of 2008.  Few, if any, (except for Biogen/IDEC),  met the numbers that Wall Street analysts had expected and most reported that profits were "way down." Unfortunately, this means that more layoffs at drug manufacturers can likely  be expected in the coming months and that drug prices may rise.

Of course, the poor performances of these companies had little bearing on the compensation packages that many of the CEOs of these companies received in 2007.  It never ceases to amaze me that companies can lay off thousands of workers to cut cost s and then turn around and give CEOs who performed horribly (which led to the layoffs) tens of millions or more in compensation.  Just think how many workers could have kept their jobs and been able to feed their familiies if mediocre CEOs, who didn't do their jobs were paid what they are worth!

Ain't capitalism great?

Until next time....

Good Luck and Good Job Hunting!!!!!

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Danish drugmaker Novo Nordisk announced today that it will expand its New Jersey-based North American headquarters. This is welcome news for the state. New Jersey has lost about 10,300 jobs so far this year. And that comes after it added 3,700 jobs last year, its worst performance since 2003. 

I would say things can’t get much worse but …..

Until next time….

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

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Genzyme announced today that it plans to build a research and development center in Beijing as part of its continued global expansion. When completed, the 200,000 square-foot facility (which is expected to cost $90 million to build) will be able to accommodate 350 employees.  The company, which wants to establish a long-term presence in China, expects the facility to open in 2010.

Genzyme said it already has 25 employees working in offices in Beijing and Shanghai and has a pilot program for its cell therapy MACI at Beijing Wujing Hospital. Like other American biotechnology companies, Genzyme see a bright future in China. 

And since I am talking about China, I would be remiss if I didn’t mention that I will be in China in about three weeks to visit my friend who is an executive chef and will be managing food operations at the Beijing Olympics in August, 2008. I plan on visiting Beijing and Shanghai, so if you live in either of these cities and want to get together to chat about biotechnology, blogging or anything else, please feel free to drop me a line.

Until next time….

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

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The Boston Globe reported the other day that regulators at the US Food and Drug Administration (FDA) rejected a request by Framingham, MA-based Genzyme to continue to market and sell its Pompe Disease drug, Myozyme, which is being manufactured at a newly built production facility in Allston, MA. Myozyme is a recombinant version of alglucosidase alfa that is used to treat Pompe Disease, a rare enzyme storage disease. Genzyme is seeking to transfer Myozyme manufacturing operations from its Framingham production site to the larger Allston facility to meet increased market demand for the drug. Pompe Disease affects an estimated 5,000 to 10,000 patients worldwide.

According to Genzyme, FDA rejected the manufacturing transfer request because of slight differences that were detected in the carbohydrate array of Myozyme manufactured at the Allston site as compared with similar material produced in Framingham. Because of these slight but detectable carbohydrate variations, FDA is insisting that Genzyme conduct new clinical studies (safety and efficacy) with Allston-manufactured material before it will allow the company to sell it in the US. Company officials claim that they have data from approximately 900 patients who are currently taking the new version of the drug and will share this information with the agency. Interestingly, over 40 countries have already approved the new version of Myozyme manufactured at the Allston facility.

Personally, I think it is perfectly reasonable for FDA to request additional clinical studies to insure that the Allston version of Myozyme is as safe as the original. For those of you who don’t know, Myozyme was originally approved as an orphan drug. Typically, this means that only a small number of human safety and efficacy trials were conducted to gain initial approval for a product. Therefore, I think that Genzyme should only be required to conduct safety trials (not efficacy studies) before the Allston material is allowed to be sold in the US.  That said, the safety data that Genzyme has already collected from the 900 patients using the Allston-manufactured drug may obviate the need for any safety studies at all!

If FDA forces Genzyme to conduct new efficacy and safety studies, then it wouldn’t be unreasonable for Genzyme to ask the agency to issue a second license for the “new” Myozyme. After all, it appears that FDA is treating the Myozyme manufactured at the two Genzyme –run production facilities as distinct and unrelated drug products. And, according to the provisions of the Orphan Drug Act, newly approved orphan products are entitled to receive seven years of market exclusivity from the their date of approval. Therefore, if FDA issues a new license for the Allston material, Genzyme ought to receive an additional seven years of market exclusivity for Myozyme!

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As I mentioned in a post about a month or so ago, the US Food and Drug Administration (FDA) floated a proposal to ease the rules regarding promotion of off-label use of previously approved drugs. According to the newly proposed rules, FDA would allow drug makers to provide physicians with reprints of journal articles that conspicuously promote off-label uses for previously approved products. At present, drug companies are strictly forbidden to promote off-label use of their products.  A major proviso of the proposed rule changes is that the articles/reprints must be published in peer reviewed medical journals before they can be disseminated to physicians and other healthcare professionals. Apparently, FDA officials believe that peer review can take the place of the rigorous regulations and requirements that are currently in place for US approval of drugs, biologics and medical devices!

For those of you who don’t know, an editorial appeared in last week’sJournal of the American Medical Association (JAMA) that took drug maker Merck to task for using alleged ghostwriters and ghost authors on clinical studies that were published about it painkiller Vioxx. As you all know, Merck voluntarily took Vioxx off the market in 2004 after it was revealed that the drug could lead to increased risk of heart attack and stroke.

The incendiary firestorm that has ensued since the appearance of the  Although I believe that the practices of ghostwriting and ghost authoring are not as widespread as the JAMA authors would like you to believe, I think that it is a good thing that FDA may scuttle its proposed new off-label drug promotion rules.

In my opinion (humble or otherwise), drug makers MUST be required to prove that off-label uses of previously approved products  don’t pose any serious safety or health risks before companies are allowed to promote them for new indications. As we have seen time and again in recent years, safety issues and serious health risks can arise for drugs even though they received FDA approval. With this in mind I ask: “Why would FDA allow drug makers to provide less rigorous proof for an off-label indication than that required for approval of the intended use of the original product?”  It makes little sense to me. However, looking more closely at the proposed rule changes,  it would obviate the need for companies to spend additional monies (possibly hundreds of millions) to garner FDA approval for a new product indication.  Hmmm….maybe I am beginning to see a pattern here!!!!!!!

Until next time….

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

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There’s a ton of stuff online about what kinds of interview questions to expect, and how to answer them to impress the interviewer.  But, you have to remember (and it does wonders for your confidence if you do) that you’re interviewing them, also.  You need to find out if this is a medical sales company that you’re going to be happy working for.  So, what kinds of questions should you ask?  Here’s an article on 10 Questions to Dazzle Would-Be Employers to help you.  Some of my favorites:

“How do you see me benefitting the company?”  Find out what caught their eye about you in the first place, and then you can bring up those qualities for a better sell.

“Why did you choose this company?”  If they haven’t tried to sell you on the company already, this answer gives you some insight.

“When will a decision be made?”  Suprisingly, many people don’t ask that, and end up frustrated if it takes longer than they were expecting. 

Your questions about the company and the job will set you apart from other candidates and show how interested you are in the position.  Not to mention it will give you extra insight into your decision whether or not to work for them.

If you have any  questions for Peggy aka the Medical Sales Recruiter contac her  at: the medical sales recruiter blog!

Until next time.....

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

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Pfizer the world’s largest and least innovative pharmaceutical company  announced yesterday that its profits dropped by 18% last year. The company attributed the loss to reductions in the sale of its blockbuster anti-cholesterol drug Lipitor, which is slated to lose patent protection in the next few years.

Pfizer, which has about $25 billion in cash, has been on something of a buying spree the past couple of years. The company is desperately trying get into biotechnology (too little, too late?) and believes, as it always has, that the best way to enter a new therapeutic area is to buy its way into it! To that end, Pfizer has already purchased two “biotech” companies in 2007 (more purchases are likely on the way) and entered into financially-lucrative, long term research collaborations with several others. Although this strategy has previously worked for Pfizer in the short term, it has proved to be financially disastrous for the company in the long term. Nevertheless, Pfizer said it still expects earnings this year to grow about 11%, due largely to a cost-cutting program that has eliminated 25,000 jobs, or 23% of its work force since 2004.

Until Pfizer executives realize that a robust internal drug discovery and development program is the key to success, Pfizer will continue to be the world’s biggest pharmaceutical company with a constantly flagging stock price.

Until next time….

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

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About five years ago, a friend of mine and I had an idea to form a non-profit dedicated to providing consumers with information regarding the safety of marketed pharmaceutical and biotechnology medicines.  At the time, we observed that consumers were repeatedly being misinformed about the safety and efficacy of many products, most notably follow-on biologics aka biogenerics. Unfortunately, we could not garner enough interest or financial support to get the organization off the ground. I guess that  we had a good idea, but, as usual, were a little ahead of our time. A new organization called The Coalition for a Competitive Pharmaceutical Market has recently set up shop with the same concept in mind.

Members of the coalition include insurance companies (Aetna, Humana, United Health Care and Blue Cross Blue Shield), pharmacies and drug distributors (CVS, Medco, Express Scripts, Rite Aid and Wallgreens), generic manufacturers (Barr Laboratories, Hospira, Teva, Mylan Laboratories and Watson Pharmaceuticals) and a large roster of Fortune 500 companies including General Motors, Ford, Caterpillar, Chrysler, Dow and Eastman Kodak. Think of the lobbying power–how cool is that?

I guess the time has come for rational drug pricing for the US. Big pharma and biotech beware–a nationalized healthcare system may not be far behind!

Until next time….

Good Luck and Good Job Hunting!!!!

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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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People who become scientists spend many years learning how to design, conduct, collect and analyze data from the experiments that they conduct. The ultimate goal of this seemingly endless exercise is to craft peer-reviewed publications that either support or refute the underlying hypotheses used to initiate the experiments in the first place. As part of our training, we are repeatedly reminded that it is our obligation to fastidiously and accurately report the results of our experiments and to assume “full ownership of the manuscripts and publications" that we author. The idea of allowing a person who didn’t participate in the design or execution of the research, to craft a manuscript for peer review is something that is virtually unheard of in the scientific community and, in the minds of some scientists, tantamount to scientific misconduct or fraud.

Physicians, on the other hand, who don’t learn how to conduct research or write scientific papers during their medical training, are frequently poor writers and have a little or no time to spend on writing scientific or medical manuscripts. Because of this, it is not uncommon for physicians who conduct medical research on behalf of pharmaceutical, biotechnology and medical devices companies to hire medical writers to write manuscripts for them. In fact, many physicians who work with pharmaceutical and biotechnology companies prefer and expect this arrangement. So, why the recent commotion over medical “ghostwriting”?

Drug companies typically hire medical communication agencies to develop and craft manuscripts that showcase the results of clinical or research studies that they have conducted. These companies will usually provide an agency with background information about a study, a research summary, clinical study reports, ideas or titles for proposed manuscript and a list of prospective authors (usually physicians who performed the studies on behalf of the company).  Medical writers, who are either employed by the agency or work as freelancers use these materials to craft a detailed outline for the proposed manuscript. After the outline is completed, the agency usually shares the outline with physicians who were named on the list to determine who may be interested in authoring the publication. After an author is identified, the medical writer works closely with the author to develop a first draft of the manuscript. After the draft is reviewed by the author, changes are made to the draft, a revised version is circulated and the process is repeated until all stakeholders are satisfied with the manuscript. Once the publication has been copyedited and undergone legal and regulatory review it is submitted for peer review.

For the record, in my five years as a medical writer, I have never encountered a situation where the primary author doesn’t have final say over what will and won’t appear in a manuscript. When scientific, medical or business disagreements do arise, the author(s), medical writer and company representatives usually negotiate mutually-agreed upon solutions. Rarely, have I seen a company remove an author from a publication because his/her views or interpretations of the data were not consistent with those of the company that sponsored the research. The reason why drug companies and medical communication agencies have recently come under fire for their “ghostwriting” practices is because they have repeatedly failed to disclose that many of their publications were written by medical writers —whose names didn’t appear anywhere on the publications. Although this practice still exists, it is no longer as widespread or commonplace as it once was. These days, the names of medical writers who author manuscripts routinely appear in the acknowledgement sections of many scientific and medical publications. Moreover, in some instances, a medical writer may be able to garner co-author status on a publication —depending upon his/her level of involvement in the project. 

In my opinion, there is little difference between graduate students, postdoctoral fellows and medical writers when it comes to preparing manuscripts for publication. It is not uncommon for the names of PIs, supervisors and others to appear as authors on publications even though their contribution to a project (or preparation of a manuscript) has been limited or nominal at best. Consequently, I fail to see any credible legal or ethical arguments against hiring a medical writer to write manuscript on behalf of an “author” as long as the “author” can demonstrate that he/she actively participated or was intimately associated with study design, conduct or analysis. Finally, to maintain the integrity and transparency of the medical writing process, it is imperative that medical writers who prepare manuscripts on behalf of study authors should be acknowledged or credited with “authorship” somewhere in a publication.

Until next time….

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

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Millennium employees find themselves in an enviable position that most pharmaceutical and biotechnology employee would die for!  Shortly after Takeda announced that it would buy Cambridge MA-based Millennium Pharmaceuticals for $8.8 billion, it offered many Millennium employees retention bonuses to stay at the company for 12 to 24 months until the acquisition is completed. These bonuses will be in addition to cash that many of Millennium’s 1,000 employees will get by exercising their stock options (Takeda is paying a premium to purchase all of Millennium outstanding shares of stock).

While offering retention bonuses to employees of a company that is going to be acquired is unusual it is not unheard of.  Retaining key employees during an acquisition typically makes the transition a lot smoother.  Further, it signals to extant employees that management values their services and that their continued presence at the company is vital to its success.  Finally, it serves to reduce the stress and uncertainty felt by many employees when a company is sold.

In my opinion, offering Millennium employees retention bonuses is a very bold and smart move by Takeda.  Unlike other pharmaceutical companies who have acquired biotechnology companies for their approved drugs or investigational medicines in their pipelines, this is Takeda’s first foray into the biotechnology business. Put simply, Takeda executives lack the expertise and requisite skill sets necessary to successfully compete in the biotechnology arena.  Encouraging and retaining employees who helped to make Millennium a success is a brilliantly crafted strategy that will permit Takeda to quickly learn how to compete in the biotechnology space in a fiscally-responsible manner.

One of the biggest hurdles to overcome after an acquisition is merging the corporate cultures that existed at the two companies prior to acquisition. One possible solution to this problem is to restructure the acquired company and terminate many or all of its employees. Another solution is to determine (over time) which employees are or aren’t vital to operation of the company. Although this approach is not as draconian as the first option, it requires an inordinate amount time and money to implement. Ask any Pfizer executive about this the utility of this approach (I think that they are still trying to recover from the Warner Lambert and Pharmacia acquisitions that took place in the mid to late 1990s).  

I think the Japanese got this one right.   Maybe we Americans can learn a thing or two from them?

Until next time…

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

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Takeda Pharmaceutical Co., Japan’s largest pharmaceutical manufacturer, announced that it has agreed to buy Cambridge MA-based Millennium Pharmaceuticals for $8.8 billion. Millennium, founded in 1993 by high profile MIT researchers and once heralded as one the most innovative American biotechnology companies, never lived up to analyst’s expectations. That said, the company did develop and win regulatory approval for an anti-cancer drug, Velcade, which is expected to garner additional approval for wider use in oncology later this year.

Velcade, which is used to treat relapsed multiple myeloma after other drugs fail generated more than $800 million last year. Millennium anticipates U.S. approval by June to promote Velcade as an initial therapy to treat these disorders. Millennium markets Velcade in the US and shares revenue with Johnson & Johnson which markets Velcade in 85 other countries. Analysts predict that the Takeda acquisition will help to propel Velcade to blockbuster status.

The Takeda-Millennium deal follows Eisai Co.’s (another Japanese company) agreement in December to buy the U.S.'s MGI Pharma Inc. for $3.9 billion as Japanese companies, aided by a weak dollar against the yen, seek growth abroad. Japanese companies have been hampered by government-ordered price cuts, weak pipelines and a lack of new products  As one financial analyst put it ``There's no doubt the weak dollar against the yen is making U.S. biotech very attractive right now to potential Japanese buyers,''

Takeda’s best seller is the diabetes drug Actos which is slated to lose patent protection in the near future. Acquisition of Millennium provides Takeda with an entrée into the oncology and cardiovascular markets both of which are poised for expansive growth in the next five years. Analysts also believe that the Millennium acquisition will boost Takeda’s drug discovery and development flow. Millennium is conducting human trials with experimental drugs for cancer, heart disease, gastrointestinal disorders and rheumatoid arthritis.

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I just returned from my career development sojourn at this year’s FASEB meeting in San Diego, CA. Not surprisingly, all of my sessions were well attended. In fact, attendance at many of the presentations was standing room only. Again, this was not terribly surprising because the job market for graduate students and postdoctoral fellows for the last 5 years has been dismal. However, in contrast with past years, there was a noticeable and palpable difference in the attitudes of many of the students and postdocs who attended the sessions. In previous years, many career development participants seemed resigned to the possibility of a “jobless future”. However, this year there was a small but vocal group of participants who openly expressed their anger and resentment at the possibility of not finding a job after completing their training. I think that many graduate students and postdoctoral fellows have begun to realize that they are being exploited by a fundamentally flawed academic system and that they are “not going to take it anymore.”

Academia has always resembled a medieval, feudal system. Principal Investigators (PIs) are the kings because they hold all the power, money and authority and rule with impunity. Postdoctoral fellows are the lords or vassals who behave somewhat autonomously but have sworn oaths of allegiance and fealty to their kings. Research associates (technicians) are the indentured servants who rely on the king and his vassals for sustenance and protection. Finally, graduate students are the slaves whose lives and well being solely depend upon unquestioned obedience to their Kings. As we all know, feudal systems broke down when kings could no longer maintain control over their slaves and indentured servants. This culminated in rebellions and revolutions, the eventual demise of monarchies and ultimately gave rise to modern republics and democracies.

Although I am not necessarily advocating revolution (okay, so maybe I am), it is time that drastic and systemic changes be made to academia as we know it.  First, there needs to be a limit or moratorium on the number of students that are annually accepted into graduate programs. There are simply not enough academic, industrial or government jobs to justify the number of PhDs and postdoctoral fellows that are trained each year. Second, tenure should be abolished at all research universities and medical schools and be replaced with 5 year renewable contracts. This will force PIs, whose primary job is to do research (not teach), to remain competitive and productive. Further, it will reduce the likelihood that ego-centric PIs will be able to accumulate enough wealth and power to establish the “fiefdoms” that are prevalent in academia today. Third, PIs must increase their reliance on technicians (rather than postdoctoral fellows) to achieve their research objectives and goals. Allowing postdocs to work 5 or more years in the same laboratory because it is cheaper to hire them than technicians is, in my opinion, ethically and morally bankrupt. Finally, and perhaps most importantly, it is vital that PIs actually become mentors and play active roles in advising and shaping the careers of their students and postdoctoral fellows. Given the paucity and competitiveness of academic positions, it is disingenuous for PIs to promote academic careers for every person who passes through or works in their laboratories. As a former medical school tenure track Assistant Professor, I didn’t find it too difficult to identify which students and postdocs were “cut out” for academic careers. Further, it is incumbent upon PIs to take the time to

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I am sitting in Newark Airport waiting for my flight to San Diego which, not surprisingly, has been delayed for about 2 hours.  As you might have guessed from the title of this post, I am on my way to the 2008 FASEB Career Development Symposium which is run every year at the annual FASEB meeting. 

As we have done in the past, my colleagues Eric Celidonio and Joe Tringali, and I  will be presenting seminars and resume writing workshops for graduate students and postdocs.  Our goal, as always is to offer these folks some advice and tips on how to find a job after they complete their training.  Unfortunately, the job market for PhDs has been depressed for the past 8 years or so.  There once was a time, circa 1994-2000, when finding a job for alife sciences or chemistry PhDs was a snap.  In those days, many jobs were left unfilled. Ironically, it  has been scientific advances and technological innovations that have made it more difficult for PhDs to find jobs over the past decade or so.

Anyway, if you are attending FASEB this year, please stop by.  Also, tell all your friends!  We like when it is busy.

Until next time....

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

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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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There is mounting evidence that RNAi, once hailed as a panacea for the pharmaceutical and biotechnology industries, may not be all that it was claimed to be. Yes, there are several new RNAi drug candidates in late stage clinical development but it isn’t clear, at this point, whether any of these products will ever make it to market. Companies like Allergan, Alnylam, Opko Health and Merck, which recently bought the RNAi company Sirna Therapeutics for $1.1 billion, have invested hundreds of millions of dollars and literally “bet the farm” on RNAi therapeutics.

The use of DNA and RNA as therapeutics is not a new or novel idea. Isis Pharmaceuticals, a pioneer and champion of oligonucleotide therapeutics, has only be able to bring a single, oligonucleotide-based product to market in the past 20 years. Ask any Isis executive and they will tell you that turning DNA or RNA into drugs is a challenging process that is fraught with many difficulties. Most notably, there are bioavailability, delivery and target specificity hurdles that most be over come before the utility of these drugs as therapeutic agents can be realized. That said the attractiveness of these molecules as therapeutics (and perhaps their real danger) is the simplicity and elegance of their mechanism(s) of action. Most scientists tend to “fall in love” with elegant and parsimonious solutions to complex processes—why would we not, they are type of discoveries that we all train and live for! And, as many of us know, when people “fall in love”, there is a tendency to overlook or not notice warning signs that things may not be as they seem.

The scientific community fell quickly and deeply in love with RNAi soon after the first papers appeared touting its benefits and possible therapeutic applications. Scientists were so convinced and confident about RNAi that they induced the financial community to invest billions of dollars into the emerging technology. The love and affection for RNAi reached its pinnacle in 2006 when two scientists, who played a crucial role in discovering its mechanism of action, won the Nobel Prize. Since then, the harsh realities of RNAi drug development have begun to be realized by companies that invested in the technology.

I have been around long enough to understand that there are fads in science. In the mid 1990s it was combinatorial chemistry, in the late 1990s it was genomics, proteomics and computational chemistry and in the 2000s it is RNAi. Don’t get me wrong–all of these technologies have helped to advance science and  provide researchers with sophisticated tools that have helped to expedite the drug discovery and development process. That said, none of these technologies, by themselves, yielded the plethora of new medications or therapeutics that their advocates promised. Industry veterans know that there are no easy solutions or panaceas in drug discovery and development. The process is inherently time-intensive, painstaking and tedious. And, despite what we scientists want to believe in our “heart of hearts,” there are no guarantees that simplicity and elegance will translate into safe and effective medications.

Until next time….

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

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There has been some confusion surrounding the reporting of results from the Enhance Trial. As you know, the results from this study showed that the cholesterol-lowering drug Vytorin—a combination of Zetia and Zocor (a statin) —was no better than a generic version of Zocor by itself at controlling atherosclerosis.

In the Enhance clinical trial, 720 patients were treated with Vytorin or a generic version of Zocor and the amount of plaque that accumulated in the arteries of both groups was assessed by blood vessel imaging. Because Vytorin lowers LDL-cholesterol more than Zocor alone, both Schering –Plough and Merck (the companies that sponsored the trial) expected the patients who took Vytorin to have less growth of plaque in their arteries than those who took generic Zocor alone. As we all now know, this was not the case. In fact, there are some data which suggests that Vytorin treatment may actually enhance or promote plaque deposition and growth.

Since arterial plaque is closely associated with heart attack and stroke, the results from the Enhance trial led some to suggest that Vytorin doesn’t work any better than Zocor at preventing heart attack or stroke. While this may prove to be the case, there are currently no data to substantiate or refute this assertion. Those data will be generated in planned outcome trials that will measure the incidence of heart attack and stroke in patients taking Vytorin or Zocor. Merck and Schering-Plough began enrolling patients for these studies in 2006 and don’t expect any results before 2012. This may be too little, too late.

Merck and Schering have come under fire for not releasing the results from the Enhance trial in a timely fashion. A Congressional committee investigating the Vytorin controversy alleges that Merck and Schering Plough executives knew about the results of the Enhance studies at least two years before they released the data. The companies repeatedly delayed releasing the results of the trial, however, saying publicly that many of the images of the arteries were unclear and might need to be re-examined. Both companies have also have been criticized for delaying the initiation of the planned outcomes trials.

Shares of Merck and Schering-Plough plummeted yesterday following Sunday’s announcement at the American College of Cardiology meeting in Chicago.

Until next time….

Good Luck and Good Job Hunting (avoid NJ)!!!!!!!!!

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