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There was an interesting post today at the Seattle, WA-based  Xconomy.com website about the salaries of people who work in the biotechnology industry. The post mainly focused on the salaries of biotech workers in the Pacific Northwest and based on results of a local survey the median salary is roughly around $60,000 per year. While this pales in comparison to the $81,499 reported earlier this spring from a group sponsored by the Pharmaceutical Research and Manufacturers Association (PhRMA), it is important to note that “real salary” data are difficult to obtain and much of what is released is based on salary figures that don’t include bonuses and other benefits. Further differences survey methodologies may also account for the seemingly disparate results. Nevertheless, salaries in biotech are generally better than those offered in other science-related industries and, not surprisingly, are highly dependent on degree requirements and job duties and responsibilities.

The bottom line: in my opinion, a job in biotech is a good career choice because of the projected upward growth for the industry. More importantly, pharma is continuing to abandon its reliance on small molecules and increasingly embracing biotechnology and its products as the future of the life sciences and healthcare industries. If I was undergraduate life sciences major today, I would be looking to the biotech and medical devices/devices industry, not pharma, for future long term employment!!! And, contrary to popular belief, a PhD degree is no longer a requirement for many biotechnology jobs.

Until next time...

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

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Word on the street suggests that Roche has severed its relationship with the Pharmaceutical Manufacturers of America (PhRMA) the trade group that represents and lobbies on behalf of the pharmaceutical industry. The recent purchase of Genentech must have convinced the venerable 100 year old pharmaceutical company that proteins not small molecule drugs are the key to its future.

According to published reports, the Biotechnology Industry Organization (BIO) has already sent an emissary to Roche's headquarters in Basel to talk to Severin Schwan, its CEO, about the benefits of BIO membership. Will Roche really eschew its membership in RhRMA and join BIO? And,will the loss of Roche's financial contributions substantial reduce PhRMA's influence and lobbying power in Congress? I guess only time will tell!

 Until next time...

 Good Luck and Good Job Hunting!!!!!!

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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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Previously, the US Congress proposed legislation to create a regulatory approval process to allow the Food and Drug Administration (FDA) to approve generic versions of blockbuster biotechnology drugs known as follow-on biologics (FOBs). While a regulatory pathway exists for approval of generic versions of small molecule drugs (as outlined in the Hatch-Waxman Act) there is no legally-approved regulatory pathway to bring FOBs to market in the US. In contrast with the US, the European Union crafted legislation five years ago that allows biosimilars —the name given to FOBs in Europe—to be approved and sold in EU member states. Since 2004, the European Medicines Agency (EMEA), the EU regulatory body, has approved the sale of six biosimilar drugs with many more in the queue awaiting regulatory review.

The debate over FOB legislation started in the US about 10 years ago when patent expiry of many  multi-billion blockbuster biotechnology drugs was fast approaching. From the beginning, many so-called innovator companies (the companies that produced the original branded biotechnology drugs) and the trade associations that represent them on Capital Hill, the Biotechnology Industry Organization (BIO) and the Pharmaceutical Manufacturing Association (PhRMA), aggressively lobbied against any form of FOB legislation. However, late last year, several senators introduced legislation that would permit FDA to approve generic versions of many blockbuster biopharmaceutical products following patent expiry. The proposed legislation stipulated that FOB manufacturers would have to wait 12 years —after patent expiry of previously approved biotechnology drugs—before generic versions of those drugs could be sold in the US. That legislation, which unabashedly favored innovator drug manufacturers, passed the Senate health committee but died without being voted on. The new measure, introduced Thursday, cuts by more than half — to 5 years, from 12 — the time allowed before cheaper versions of biotechnology drugs could compete with the originals. A similar bill was introduced two weeks ago in the House by Representative Henry A. Waxman, Democrat of California and chairman of the Energy and Commerce Committee.

While the proposed reduction in the so-called “FOB waiting period” is commendable, I don’t think that any waiting period is necessary before FOBs can be sold in the US. It is difficult to understand why innovator companies require an additional patent protection—beyond the 20 years already afforded to them under US patent law—to continue to sell their blockbuster products! To that end, Jeff Joseph, a spokesman for the BIO said that the FOB waiting period reduction, “.... Would jeopardize patient safety and undermine our ability to develop future cures and therapies.” I believe that the FOB waiting period being championed by innovators companies is nothing more a thinly veiled attempt by them to continue to maintain monopolistic control over lucrative multibillion dollar biopharmaceutical drug franchises. Biotech executives have vowed to vigorously fight the new legislation, saying it could result in unsafe medicines, fewer cures and fewer jobs in biotechnology centers like Boston, California and elsewhere. Interestingly, similar arguments were put forward by the pharmaceutical industry before the Hatch-Waxman act was passed by Congress in 1984..

Despite the claims that FOBs will stifle innovation and may jeopardize the safety of Americans, the current high costs and lack of access to affordable healthcare will almost certainly leave Congress no choice but to pass legislation that permits the marketing and sale of FOBs in the US. While FOB legislation is a likely fait accompli, US drug manufacturers remain steadfastly opposed to any FOB legislation. I believe that innovator company opposition to FOB legislation is really a “red herring” that serves to detract attention away from the real issue that the drug industry is deathly afraid of federal regulation of drug prices. Interestingly, the US is one of the only countries in the world where drug prices are not regulated or controlled by the government. This permits drug manufacturers to set prices based exclusively on “what price the US market will bear.” In other words, they can charge as much as they want for their drugs, as long as third party payors, insurance companies and Medicare and Medicaid agree to continue to cover the costs of the drugs that they manufacture (it should come as no surprise to anyone that the American pharmaceutical and biotechnology markets are the largest and most financially lucrative in the world).

I have no doubt that innovator companies will continue to fight hard and as long as possible prevent adoption of legislation regulating the approval of FOBs. After all, there are huge sums of money and corporate profits at stake. Like it or not, FOBs will ultimately be sold in the US—the current costs of drug and healthcare are simply too high to sustain. Despite a fierce decade-long struggle, most American drug makers will privately concede that sale of FOBs in the US is inevitable. Nevertheless, innovator companies will likely not publicly endorse FOB legislation until the US government provides them with assurances that it will not seek to regulate American drug prices for the foreseeable future.

Until next time...

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

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It seems that every day a new American industry asks the US government for a bailout because of impending financial exigency. That said, I was somewhat surprised to learn today that the biotechnology industry is planning to ask Congress for a bailout. The plan calls for Congress to temporarily changes tax laws to allow unprofitable biotech companies to get cash now, in exchange for tax credits that they would pledge not to take if they eventually become profitable. The companies that receive the cash would pledge that the money would be used ONLY for research and development activities. The reasoning behind the proposed government bailout is that the infused capital would allow struggling biotech companies to keep their current employees, stay in business and help to stimulate the US economy. It is not clear whether or not all biotechnology companies—publicly traded or privately held—would be eligible for the bailout package.

Currently, there are 327 publicly traded and roughly 1,000 privately held biotechnology companies in the US. A majority of these companies are not profitable and operate almost exclusively on institutional and private venture capital funds. According to the Biotechnology Industry Organization (BIO), 125 of 327 public companies currently have less than 6 months of cash on hand—nearly double the total last year. It is not surprising that the biotechnology industry like most other US industries is struggling and feeling the impact of recent financial meltdown—there simply isn’t enough liquidity in the system to keep all companies afloat. While I am not opposed in principle to government bailouts, there are several reasons why the proposed rescue plan for the biotechnology industry doesn’t sense to me.

First, unlike the automobile industry which employs millions of workers, the biotechnology industry only employs about 200,000 workers, many of whom have advanced degrees and possess specialized technical skills. And, studies show that during recessionary periods workers with specialized skills are more likely to find employment after losing a job than their unskilled counterparts. This suggest that it may be better for the American economy in the long run if the government bails out the auto industry before it even considers a bailout for biotech. Nevertheless, BIO is actively lobbying for a government bailout because it believes that a bailout will not only stimulate the American economy but also help to “preserve American innovation and competitiveness.” Of interest, the pharmaceutical industry which shed over 123,000 jobs in the last year or so is not asking for government assistance. As one Washington lobbyist aptly quipped after hearing about the proposed biotech bailout: saving “research-based companies that employ 30 people won’t necessarily stimulate the economy.”

Second, the biotechnology business is inherently a very risky one. The failure rate among biotech companies is roughly 90%. And, as many of you know, biotechnology companies are always started with venture capital from investors who are willing to invest in risky projects because of possible financially-lucrative returns. Because of this, biotechnology executives are generally beholden to their investors rather than their shareholders, stakeholders or employees. Unfortunately, important business decisions are frequently made at venture-backed biotech companies for financial reasons rather than scientific or medical ones. Further, many financially-challenged, biotechnology companies that would benefit from the bail out started up almost a decade ago when venture capital was abundant and IPOs were daily events. In retrospect, many of these companies shouldn’t have been started in the first place because their technology platforms were either inadequately vetted or their business models were fundamentally flawed. I believe that these financially troubled companies ought to be allowed to fail just like the technology companies that had to close down in the early 2000s after the Internet bubble finally burst.

Third, why should unprofitable companies without products or revenues be bailed out and rewarded for failure? As I posited in a previous post, a company really isn’t a business until it has a product, generates revenues and turns a profit (or at least break even). If a company cannot create a viable business after 5-10 years of capital investments then it wasn’t a good value proposition at the outset. Perhaps a better use of the proposed bailout money would be for the US government to create public funding vehicles for companies that have developed promising new drugs that already have proof of concept in humans and are ready for clinical testing.

Finally, over the past decade, the biotechnology industry has spent hundreds of millions of dollars lobbying against the reimportation of drugs from foreign companies and the development of so-called follow-on biologics (potentially cheaper versions of blockbuster biotechnology drugs that have lost patent protection). This decade-long lobbying effort was undertaken to preserve America’s biotechnology monopoly and to insure that biotech drug prices remain high. Maybe BIO and its member companies should have considered using some of those monies to help struggling biotechnology companies rather than using it to influence politicians for tax breaks and pork barrel legislative initiatives.

Lastly and perhaps most importantly, why should taxpayer dollars be used to bailout an industry that has actively opposed and steadfastly refused to provide ALL Americans with access to reasonably priced, potentially life-saving biotech drugs? Because the biotechnology industry isn’t fundamentally different than any other American industry, I believe that the Darwinian principle of “survival of the fittest ought” to be applied to it. Unless, of course, you work on Wall Street or in Detroit—but don’t get me started!

Until next time…

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

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Just when I thought the absurdities surrounding the American follow-on biologics debate couldn’t get any sillier, the US Federal Trade Commission (FTC) announced today that it would sponsor public workshops and round table discussion to learn more about the impact of follow-on biologics on American competitiveness, regulatory policies and healthcare costs.

I am not certain what role the FTC has in the follow-on biologics debate (as far as I am concerned, it shouldn’t have much of one) but what new information does the FTC think that it is going to get that other more relevant government agencies like FDA or the US Congress don’t already have about follow-on biologics? After all, the debate to formulate an approval pathway for follow-on biologics in the US has gone on for almost 10 years now. How ineffectual and ineffective can the US government and its agencies be (rhetorical question)?

As far as I can ascertain, the main reason why follow-on biologics are not already being sold in the US are the never-ending efforts of power, well-funded lobby organizations like BIO and PhRMA. The data are incontrovertible: 1) the cost of branded drugs is out of reach for many Americans, 2) access to potentially life-saving drugs and treatments is hindered by restrictive drug formularies and onerous insurance co-pays and 3) many local and state governments and large, multi-national corporations can no longer provide adequate healthcare coverage for their employees because of out-of-control medical costs and expenditures.

In my opinion, the irony of the US follow-on biologics brouhaha is that it is putting American companies at a competitive disadvantage in the biosimilar/follow-on biologics space. Selling profitable, cheaper generic versions of blockbuster drugs is no longer a dream but a reality in countries like China and India whose middle class has finally come of age. True, the American pharmaceutical/biotech market is still the largest in the world—but will it still be the largest 10 years from now? Only time (and Asia) will tell.

Until next time….

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

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Last year was a banner year for the pharmaceutical lobby (the largest in Washington DC). It spent over $168 million to inform Congress about issues that its members thought were in the best interest of the pharmaceutical and biotechnology industries. So what were the main issues that occupied a majority of the lobby’s time?

• blocking the importation of inexpensive drugs from other countries
• protecting pharmaceutical patents both within the United States and abroad
• ensuring greater market access for pharmaceutical companies in international free trade agreements

You are probably wondering which company was the top spender—it was Amgen! As you may recall, Amgen’s EPO franchise was under intense medical, regulatory and congressional scrutiny because of safety issue that resulted from over prescription. In my limited understanding of how things work in Washington, I have been told by lobbyist friends of mine that there is no better way to solve nagging problems than by paying influence peddlers to make them go away.  That said, Amgen’s lobbying costs paled in comparison with the $23 million spent by Pharmaceutical Research and Manufacturers of America a pharmaceutical industry trade group.  You Go PhRMA!!!!

A quick perusal of the top lobbying list reveals that all major US pharmaceutical companies invested heavily to influence members of Congress to allow them to preserve their stranglehold on the American healthcare system. Not surprisingly, all of the major foreign pharmaceutical manufacturers were also on list.  Much to my surprise, Teva, the Israeli generic manufacturing giant made the list this year—so it goes!

I guess altruism is out and avarice is still in! Hat tip to Pharmalot.

Until next time….

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