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American competitiveness in engineering, technology and science. Unfortunately, while American competitiveness and innovation in these areas continues to wane, little has been done (except talking) about it! Yesterday, Intel and 24 venture capital funds announced that they plan to invest $3.5 billion in American startups and early stage ventures over the next two years. Further, in addition, several of America’s leading technology companies including Google, Cisco Systems, Intel Microsoft and 13 others pledged to add as many as 10,500 jobs into 2010—mainly by hiring Americans graduating from colleges with degrees in computer science and engineering.

The initiative, named the Invest in America Alliance was formed in response to “steadily declining long-term investments in education, technology and human capital” that has been taking place in the US for past 20 years or more. Put simply, the American education system is not training enough qualified individuals to allow the US to compete with other emerging technology and engineering powerhouses that include China, India Finland, Korea and the Netherlands. 

According to Robert Compton, a venture capitalist, entrepreneur and education enthusiast “Fewer than 10 percent of college graduates in the US have engineering degrees, compared with more than one-third in India and China and more foreign-born graduates of US universities are returning to their home countries.” For those of you with degrees in math and science (and you base your calculations on population size), the magnitude of the problem (for Americans anyway) is glaringly obvious. Compton went on to say what many others have been thinking for a while, “Early indicators are that we are not the center of innovation anymore. It is shifting to the East.” And he may be right! Based on surveys conducted by the World Intellectual Property Organization in the last year, patent filings increased 30 percent in China while declining 11 percent in the US.

While the Invest in America Alliance appears to be a great public relations opportunity for the companies and venture firms that are participating in it, its critics doubt whether investing more money in technology startups is going to fix the ongoing problem. Education analysts contend that a better and cheaper solution may be changing US immigration laws so that foreign students who train in the US are allowed to remain in the country after they complete their training. Other naysayers contend that most of the venture money committed by the alliance would have likely gone to American startups anyway (US based venture firms already invest 70 percent of their money in American start ups) and that 10,500 new jobs isn’t enough to make a dent in the US unemployment rolls.

Like the technology industry, a decade of wrong-head immigration policies coupled with a waning American interest in science has begun to jeopardize the US dominance in the life sciences. Further these trends are largely responsible for the massive layoffs and unrelenting outsourcing of pharmaceutical R&D jobs to foreign countries.

Toothless or not, the Invest in America Alliance shows that engineering and technology industry leaders are willing to cooperate with one another and get behind an initiative that raises public awareness about America’s waning competitiveness in these fields. Perhaps,   pharmaceutical, biotechnology and medical devices and diagnostic companies ought to take a page out of the Alliance’s play book to similarly insure the future innovation and competitiveness of the American life sciences industry.

Until next time...

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

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It goes without saying that the competition for jobs in the life sciences industry is extremely fierce. This means that job candidates must use whatever means possible to differentiate themselves from the hundreds, perhaps thousands, of others applying for the same job!

While I have written numerous posts on how job candidates can stand out from their peers, I discovered an insightful article that summarizes my advice in a single post. Like I said, there are no revelations here; just a convenient way to jog your memory as the job search slogs on!

Click here to read the post.

Until next time...

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

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The loss of over 200,000 pharmaceutical jobs over the past three years has been mainly driven by the anticipated loss of revenue from blockbuster drugs that will lose patent protection by 2013. While drug makers frequently cite blockbuster patent expiry as the reason for the need to downsize, they rarely provide the business and economic metrics, numbers and statistics that have influenced their decisions. 

Patricia Van Arnum, Senior Editor of Pharmaceutical Technology wrote a fascinating article in this month’s issue of Pharmaceutical Technology Europe that skillfully outlined the economic forces that are driving branded pharmaceutical companies to downsize and reorganize. According to the article, in October 2009 the pharmaceutical intelligence firm IMS estimated that the global pharmaceutical market is expected to growth 4-6% in 2010 and reach $825 billion. Market growth at an annual rate of 4-7% is expected to continue through 2013 and the size of global pharmaceutical market is projected to exceed $975 billion. The US pharmaceutical market, the largest in the world, is expected to drive much of this growth. However, the growth of the American market is only expected to be 3.5% in 2010. In market contrast, China’s pharmaceutical market is expected to increase by a staggering 20% per year and contribute 21% to the overall growth of the global pharmaceutical market by 2013. 

While prospects for the US market are better than originally anticipated, the loss of nearly $137 billion in revenues in 2013— because of patent expiry of blockbuster products—coupled with fewer new drug approvals are the factors that will limit the growth of the global pharmaceutical market to single digits through 2013 and likely beyond. Some of the drugs slated to lose patent protection by 2013 include Lipitor (atorvastatin) by Pfizer, Plavix (clopidogrel) by Sanofi-Aventis and Bristol-Myers Squibb and Seretide/Advair (salmeterol and fluticasone) by GlaxoSmithKline. Lipitor, Plavix and Seretide were the number one-, two- and foruth best-selling drugs in 2008 with global sales of $13.7 billion, $8.6 billion and $7.7 billion respectively.

The increasing growth of the generic pharmaceutical industry is best reflected in the concomitant growth of merchant active pharmaceutical ingredient (API) manufacturing industry. In the API world, there are two types of manufacturers; the so-called captive API producers or companies that exclusively manufacture APIs for finished, branded products and merchant manufacturers which are third party providers of APIs. Over the past four years or so, the growth of the merchant API market for generic products has substantially outpaced the growth of the API for innovator products. For example, from 2004-2008 the merchant market for generics grew at an average annual rate of 9.1% from $12 billion in 2004 to $17 billion in 2008 according to a recent report by the Chemical Pharmaceutical Association (CPA). In contrast, the CPA determined that the merchant market for innovator/branded APIs only increased at an average annual rate of 4.4% from $16 billion in 2004 to $19 billion in 2008. Looking ahead, the worldwide market for merchant APIs is projected to grow at an average annual growth rate of 6.8% through 2013 to about $50 billion. During this period, growth of innovator APIs is expected to be about 1.8% whereas the growth of generic API is expected to be a robust 11.4%.

The US is currently the largest market for generic APIs and consumed roughly 22.9% of the total global demand for generic APIs in 2008. China, which is the second largest consumer of generic APIs, consumed 19.2%. While the US is expected to remain the largest consumer of both innovator and generic APIs, China is projected to become the largest consumer of generic APIs in 2013 capturing a 26% share of the total generic API market (the US will be number 2 with 20.5% market share).

According to industry analysts, China, India, Latin America and Central and Eastern Europe (most notably Russia), represent attractive growth opportunities for generic APIs. India and China now account for roughly 25% of the global generic market and demand in these countries is expected to remain strong for the foreseeable future as the middle class continues to emerge. To that end, China is projected to have the highest average annual growth rate at 18.4% and India’s market will grow by 14% through 2013. Similar growth is expected for the Eastern European, Russian and Brazilian generic API markets.

While the economic size of emerging generic markets is still small compared with those of the US, Western Europe and Japan, it signals that generic drugs will likely drive the future growth of the pharmaceutical industry. The lack of innovation and rising costs of branded, prescription drugs in developed nations is the main driving force behind the rapid emergence of the generic drug industry. That said, is it any wonder why Pfizer is thinking about entering the generic pharmaceutical business and that Western drug companies are shedding scientists and sales people in the US and Europe and growing the sizes of their R&D and sales force staffs in Asia, Eastern Europe and Latin America? Honestly, if I had any money left to invest, I would seriously be considering traded generic pharmaceutical manufacturers—their future success is almost guaranteed!

Until next time...

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

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Harrison Ford’s new movie “Extraordinary Measures” (also starring Brendan Fraser) is loosely based on John Crowley’s ongoing crusade to find a cure for Pompe Disease a genetically inherited illness that afflicts two of his three children.The film chronicles the 'extraordinary measures' taken by Crowley to find a treatment for the so-called orphan disease that affects the lives of about 40,000 persons worldwide. While I haven’t seen the film, it bears a striking resemble to the 1992 film “Lorenzo’s Oil” which chronicled the struggles of two parents to find a “cure” for their son’s adrenoleukodystrophy an another orphan disease.

Crowley’s story began about 12 years ago when his oldest child was diagnosed with Pompe Disease. For those of you who may not know, Pompe Disease is a progressive, multisystemic, debilitating, and often fatal neuromuscular disorder. The disease is linked to an inherited deficiency of the lysosomal enzyme acid alpha-glucosidase (GAA), which is responsible for the breakdown of glycogen inside the cells. The result is intralysosomal accumulation of glycogen, primarily in muscle cells, that leads to a progressive loss of muscle function and ultimately death. At the time of the diagnosis, Crowley, a Princeton, NJ resident, was working as a marketer for Bristol Myers Squibb. He quickly learned that there was no effective treatment for Pompe Disease and that his daughter may not live beyond early childhood. Further, because the disease afflicted so few individuals, no pharmaceutical or biotechnology companies were working on treatments for Pompe Disease. 

To stave off the likelihood of his daughter’s death, in 2000, Crowley raided his 401k plan and mortgaged his home to start a company called Novazyme that focused exclusively on developing treatments for Pompe Disease. Having no time to waste, Crowley and the Novazyme team worked feverishly to develop an alglucosidase alfa enzyme replacement therapy for Pompe. By 2001, the Novazyme team had identified a likely treatment and Crowley sold his company to Genzyme. As a senior vice president at Genzyme, he oversaw clinical development of the product which is now called Myozyme and is the first FDA-approved treatment for Pompe Disease. Crowley left Genzyme in 2004 and is currently CEO of Amicus Therapeutics a 100 person company focused on developing new treatments for Pompe Disease and other orphan indications.

At present, there are no other treatments besides Myozyme for Pompe Disease. This is because Pompe Disease is designated as an orphan indication and Genzyme received seven years of market exclusivity for Myozyme as stipulated in the Orphan Drug Act. Myozyme received FDA approval in 2006.

While Genzyme has been the only player in the Pompe Disease market for the past four years, manufacturing and scale up problems threaten to jeopardize the Myozyme franchise. Genzyme’s highly publicized problems at its Allston, MA-manufacturing facility have been well documented and Genzyme’s management team is taking bold steps to correct them (including hiring a new senior vice president for global product quality) and entering into an agreement with Hospira Worldwide Inc to provide fill and finish manufacturing services.

But perhaps more troubling, were the problems that the company experienced when attempting to scale up Myozyme production from the 160L to 200L bioreactor scale to meet growing demand for the drug.  FDA informed Genzyme that that Myozyme® (alglucosidase alfa) produced at the 160L bioreactor scale and Myozyme produced at the 2000L scale should be classified as two different products because of differences in the carbohydrate structures of the molecules. And, the company would have to file a new biologics application (BLA) for the 2000L product to garner regulatory approval.

Currently, Genzyme has U.S. approval to sell Myozyme manufactured at the 160L scale, and the company has been seeking clearance from the FDA for Myozyme produced at the 2000L scale (now marketed as Lumizyme). Lumizyme has already been approved in more than 40 countries. However, manufacturing problems and violations at the Allston facility forced FDA to delay a decision on the approvability of Lumizyme this past March. Earlier this week, Genzyme announced that FDA will issue a new decision on Lumizyme in June.

While originally spurned by large drug companies, orphan drug development is becoming much more attractive because of the lack of new blockbuster drugs in most company’s development pipeline. According to a recent report, the number of orphan product designations in the US more than doubled in the last decade rising from 208 in the 2000-02 periods to 425 in 2006-08. More recently, Pfizer, the world’s largest pharmaceutical company announced that it agreed to pay at least $60 million for rights to Protalix Biotherapeutics Inc.'s new treatment (taliglucerase alfa) for Gaucher’s Disease another orphan indication. This suggests that Pfizer has made a decision to directly compete with Genzyme, the world leader in orphan drug development.

Don’t be surprised when other large pharmaceutical and biotechnology companies announce plans to compete in the orphan drug market...there is money to be made!

Until next time...

Good Luck and Good Job Hunting!!!

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I previously posted several articles on interviewing tips. This presupposes that many of my readers have made the first cut and have been invited to participate in a phone or face-to-face onsite job interview. Unfortunately, this isn’t any easy thing to do in today’s current employment market. Nevertheless, there are a variety of things that job seekers can do to help their application standout from the hundreds (thousands) of other applications submitted by others competing for the same position. To that end, I found an article that first appeared on the JobsJournal.com website that offers basic tips on how to design a resume (and accompanying cover letter) to distinguish individual jobseekers from their competition.

While the information contained in the article isn’t “game changing” it does offer fresh insights into how job candidates must position themselves to be noticed in today’s fierce and highly competitive job market.

Until next time...

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

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When Rupert Murdoch, the owner of New Corporation (Fox News), bought MySpace for $580 million in 2005 it was viewed by many as one of his savviest acquisitions ever. At that time, MySpace was arguably the most successful social networking site on the Web and its financial future was extremely bright. Shortly after the acquisition, a young, upstart college social networking site called Facebook began operations without much fanfare. Back in 2005, MySpace had 14 million monthly users and Facebook was still raising capital. Now, MySpace has 126 million users whereas Facebook’s user base has grown to over 200 million. Facebook continues to expand while MySpace’s growth appears to be stagnant. This led to the dismissal last week of one of MySpace’s co-founders and the appointment of a former Facebook executive as CEO.

Since 2005, MySpace has generated about $1.6 billion in revenues and earned 200 million last year alone. However, it is important to note that a major portion of its operating capital comes from $900 million that Google guarantees every year. That agreement comes up for renewal next year and the likelihood of Google agreeing to the original terms is questionable. This is probably why Murdoch is shaking things up at MySpace. While it is likely that Google will attempt to renegotiate the terms of the original agreement, I seriously doubt that it will severe all financial ties with MySpace. That would be a bad business decision and Google doesn’t make many of those!

While many social networking pundits attribute Facebook’s ongoing success to its connectivity rather than its content, I still contend that “content is king” and social networking sites built around user-generated content are great investment opportunities. After all, status updates, pithy wall comments and photo tagging tend to “get old” quickly after a few months.

While the possible loss of Google’s annual cash infusion will hurt MySpace, I don’t think that MySpace is on its “deathbed” yet and rumors of its demise are premature. The social networking universe is vast and niche networks—not large unfocused ones—will ultimately prosper because of targeted advertising and other business opportunities. That said, I believe there will always be a place for MySpace in the social networking world.

Until next time...

Good Luck and Good Networking!!!!!!!!!! 

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The relationship between science, education and industry has always been a tenuous one. To learn more about the complexity of this relationship check out this article that was recently published in a local New Jersey business publication.

Until next time…

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

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