Bio Job Blog : Bio Jobs : Biotechnology Jobs : Biopharmaceutical Jobs : Bioscience, Biotech Jobs : Bio Job Blog : Biocareer : Bio-Business Training, Biotechnology Training : Jobs in Biology : Internships in Biology : Internships in Biotechnology

Unlike many of my social media colleagues, I’m not attending the FDA public hearing taking place in Washington, D.C today (Friday the 13^th oh my). I wanted to attend and actually testify but I didn’t understand how the process works and blew my opportunity. However, I will be prepared for rounds 2 and 3 and beyond. I can assure you that this will not be the last public meeting organized by the agency to develop guidance for the use of social media in pharmaceutical marketing and advertising. 

The brouhaha over social media and its use in the life sciences industry is purportedly taking place because of the lack of regulatory guidance on the topic. While I agree that FDA needs to craft a reasonable regulatory policy for the use of social media for promotional purposes, the discussion taking place has little to do with the medium and everything to do with the fair balance of ads that are used to promote drug sales. For those of you who may not know, fair balance (in regulatory parlance) means that drug manufacturers are required to fully disclose in print, television, radio and internet ads the benefits as well as the side effects and risks associated with a specific product. Unfortunately, too often, drug makers tend to promote the therapeutic benefits of a drug but downplay its side effects and risks. This isn’t surprising because drug makers, like other for-profit companies, must sell as much product as possible to generate sufficient revenues to remain profitable.  And, as we all know, consumers and physicians are more likely to use or prescribe drugs that have therapeutic benefits without many side effects or risks.

Since the inception of direct-to-consumer advertising, FDA and drug makers have been playing a cat-and mouse-game with the fair balance issue. Most drug makers understand the “balance” that FDA requires for traditional promotional ads, but rather than abide by the rules, many choose to determine how far they can bend the rules before they appear on FDA’s radar. Therefore, it should come as no surprise that drug companies have adopted the same strategy when it comes to Internet advertising and search result ads. To be fair, FDA hasn’t crafted any definitive guidance on Internet advertising or search ad fair balance requirements. However, rather than apply what they have learned over the years about fair balance in print and television advertising, many drug makers chose to ignore fair balance requirements for Internet advertising simply because there are no written regulations or rules. To that end, 14 pharmaceutical and biotechnology companies recently received warning letters about their misuse of promotional drug ads that appeared with Google search results. FDA cited the lack of fair balance in the search ads as reasons for the warning letters. By issuing identical warning letters to 14 different drug companies, the agency was essentially saying “c’mon guys, who are you trying to kid—you ought to know better by now!”

Unfortunately, even when there are regulations, many companies spend hundreds of millions of dollars to look for deficiencies and loopholes that can be exploited to increase and improve drug sales. Therefore, I contend, that regardless of the social media guidance that FDA ultimately issues, drug and device manufacturers will continue to look for work arounds to regulations that they perceive hinder product sales.  

Social media is all about transparency, accessibility and communications between participants. The guidance that FDA issues about the use of social media in the life sciences industry will likely be circumspect and open to interpretation as it usually is. As one FDA legal expert explained to me, “FDA crafts the laws but it is up to the judiciary  to interpret how they ought to be applied.”

I suspect little will change until drug manufacturers realize that full disclosure and transparency, not half-truths and opaqueness, will ultimately lead to improved drug sales in the future.

Until next time...

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

• Email This
• Print
• Comments
• Trackbacks
• Share Link

It’s no secret that major pharmaceutical companies are no longer investing in internal drug discovery initiatives as much as they have in the past. However, I was unaware how drastic the decline in R&D spending was until I read an article entitled “Significant Change Predicted for Bioindustry” by Benjamin J. Conway in the July issue of Genetic Engineering & Biotechnology News. 

Mr. Conway notes that in 1989 more than 50% of the pharmaceutical industry’s budget was spent on preclinical drug discovery and development. During the 1990s, the percentage slowly declined and was approximately 44% by 1999. He asserts that beginning in 2000, “the drop became precipitous” as pharmaceutical companies spent increasing amounts of their R&D budgets on downstream activities including expanded clinical trials. By 2006, big pharma was spending about 25% of its budget on R&D. Strikingly, Mr. Conway contends that “when measured in terms of constant absolute dollars, spending on pre-clinical R&D activities actually declined 0.4% annually over the period, despite annual increases of nearly 7% in total R&D spending.” 

Not surprisingly, the almost decade-long decrease in pharmaceutical R&D spending is best reflected in the lack of new drug approvals over the past five years or so. According to Mr. Conway, throughout the 1990s more than 50% of all new drug approvals originated at big pharma companies. By 2001, these companies were responsible for approximately 60% of new drug approvals. However, since then, pharma’s new drug approvals have plunged to 25% to 30% of annual totals. Some analysts suggest that the figure has been as low as 15%. The decline in new drug approvals almost parallels the decrease in R&D spending at most major pharmaceutical companies. Many industry analysts and thought leaders contend that big pharma companies have gotten too big and unwieldy and can no longer innovate. The unprecedented drops in pharma’s new drug approval rates tend to support that assertion. Mr. Conway points out that the so-called “innovation gap” has been filled by biopharmaceutical companies that “today account for 75% or more of new therapeutics developed each year.”

These changing market dynamics suggests that big pharma must reconfigure the business model that it has clung to for the past 50 years to remain competitive. Not surprisingly, almost all of the major pharmaceutical companies have begun to do just that! For example, over the past three years more than 60,000 R&D scientists have lost their jobs with little likelihood that the vacated jobs will ever be resurrected. Further, big pharmaceutical companies have increasingly begun to outsource many R&D activities to Asia, Eastern Europe and elsewhere. Finally, most big pharma companies have publicly demonstrated—through mergers and acquisitions—that biotechnology products as well as small molecules are in their future.

While big pharma may be retrenching and evolving, don’t expect the pharmaceutical industry on internal drug discovery initiatives —or small molecules for that matter— to disappear any time soon. The industry is going through a transitional period and the companies of the future will look only slightly different than they do today. These companies will still be large and well capitalized, but likely more diversified in their product portfolios (which will surely contain biotechnology drugs). Also, they will continue to excel in new product development, marketing and distribution. However, unlike the past, much less emphasis will be placed on internal R&D programs to discover new molecular entities. This means that pharmaceutical R&D operations will remain lean and companies will increasingly rely on M &A and licensing deals (with smaller specialty pharma and biotechnology companies) to keep their pipelines full.

Until next time...

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

• Email This
• Print
• Comments
• Trackbacks
• Share Link

For those of you who haven’t been able to keep up with the latest pharma layoffs, I came across an article in the Philadelphia Business Journal that does an excellent job of recapping all of the major life sciences layoffs that have taken place in the past year or so. The recent massive pharma layoffs prompted William Ashton, Acting Dean of the University of the Sciences in Philadelphia PA to say “I was in the pharmaceutical industry for 28 years. I’ve never seen such a sea change as is occurring right now. This is really dramatic.” Further, Dr. Ashton predicted that drug companies will increase their use of contract sales forces (CSFs) and contract research organizations (CROs) to contain expenses and that staffing firms will be the winners.

This led to me to wonder what Dean Ashton has been doing for the past 10 years or so because the life sciences industry has already increased its reliance on CROs and CSFs. A quick perusal of the pharma and biotech employees who lost their jobs over the past few years reveals that a majority of them were in sales and R&D. I don’t know whether or not I should break the news to Dean Ashton, but the future is already upon us—another example of how out of touch academia is with industry in the 21^st century.

I think that it is time for industry executives and academicians to begin a serious dialog to determine the type of training that would be appropriate for individuals seeking jobs in the life sciences industry. A failure to do so will likely have a negative adverse effect on the continued growth and future success of the US life science industry.

Until next time…

Good Luck and Good Job Hunting!!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Recently, I have come across posts on blogs and websites reporting on lay offs and cost-cutting measures that are taking place at some biotechnology companies. A good example of this is a post that appeared yesterday on the Fierce Biotech Web Site. The headline read: “New round of layoffs, cost-cutting at biotechs.”  I thought “OMG this can’t be happening—not the biotechnology industry too!”

However, I am happy to report that many  of my concerns were assuaged after I read the post and realized that the reported downsizing was taking place at small companies, most of which were on shaky ground before the recession even began. Some of the companies that were mentioned included: Titan Pharmaceuticals, Pressure BioSciences, Insite Vision, WuXi PharmaTech Cayman and Targeted Genetics—not exactly titans (pardon the wordplay) of the biotechnology industry. 

There is no question that the current economic downturn will hurt some biotechnology companies (mostly because debt financing is so difficult to secure these days). That said, I think that the biotech industry may struggle a bit over the next couple of years but it will survive because it is in much better financial shape than most other American industries. 

It is important to note that the downsizing and cost-cutting taking place at many pharmaceutical companies is based almost exclusively on projected lost revenues that may occur 2-5 years two years from now—when many blockbusters drugs begin to lose patent protection— not on immediate cash concerns (most pharma companies have plenty of cash on hand). Pharma companies began downsizing in earnest about two years ago because they realized that they had gotten too big and their empty pipelines could no longer justify employing large numbers of unproductive employees. In my opinion, the current economic downturn provided pharmaceutical companies with a good excuse to continue to lay off employees, slash costs and maintain their stock prices. 

Many of the companies mentioned in the Fierce Biotech post have been around for 5-10 years and haven’t been profitable since their inception. As a former business partner once said to me “You don’t really have a business unless you have a product to sell and are profitable.” I suspect that many of these so-called biotechnology “companies” will go out of business—not because of the recession—but because they were unable to develop financially-viable products or services.

 Until next time…  

 Good Luck and Good Job Hunting!!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

There was an article in today’s NY Times biz section which suggests that the recent financial crisis is starting to have an effect on the growth of the biotechnology industry, once thought to be a recession-proof sector. The article contends that the lack of available institutional cash and venture money is causing extant biotechnology companies to “tighten their belts.” And, if the trend continues, this lack of capital will stifle innovation, which in turn, will threaten and undermine the stability and future of the entire biotechnology sector. While times are certainly tough, the biotechnology industry, in my opinion, is alive and well and will continue to expand well into the 21^st century.

It is important to note that many biotechnology companies that are struggling today are publicly-traded companies not privately held ones. Unlike publicly-traded companies, privately-held ones don’t have to answer to millions of shareholders or worry about their price per share on a daily basis.  Further, the expectations for privately held companies are much less than those for publicly traded entities. Based on recent discussions with venture capitalist friends and institutional investment bankers (those that still have jobs) there is still substantial funding out there for start-ups and companies that are trying to advance their products from development into clinical testing. Many of the financially-troubled public companies mentioned in the Times article were struggling (and on the verge of failing) before the recent financial meltdown. The recent financial crisis is simply hastening their demise. The reason why many of these companies are on the brink is that they went public in the late 1990s—a time when writing a business plan on the back of a napkin was sufficient for investment bankers to underwrite a company’s IPO. Unfortunately, many of these companies were little more than research or tool box driven companies whose founders failed to understand that products not technology would make their companies successful. Put simply, these companies should have never gone public in the first place!

Not surprisingly, almost all of the companies cited in the Times article fit the ‘product-less biotechnology company’ profile. For example, Maxygen, a company originally founded as a “molecular evolution” company (that went public in 1999) didn’t identify a lead product until a couple of years ago. Unfortunately, after spending millions of dollars on preclinical development, the company no longer has sufficient funds to move the product into human clinical testing. Late last week, Maxygen announced that it would layoff 30% of its workforce and consider selling itself.

Another example cited in the article is Iceland’s DeCode Genetics, once a high flying genomics and bioinformatics company that regularly made headlines for discovering new genes for cancer, cardiovascular and hereditary diseases. While DeCode has a great genomic and bioinformatics platform (and “did outstanding science”—largely because of the genetic purity of the Icelandic population) it was never able to use its technology to identify a lead therapeutic product. DeCode’s stock price has fallen more than 90% in the last year to 29 cents per share and will likely fail given the horrendous state of Iceland’s banking industry and economy.

The impending failure of many financially-strapped biotechnology companies in the current financial environment should come as no surprise to biologists—is very consistent with Darwin’s theory of natural selection which says “only the strongest and the fittest will survive. To survive in the biotechnology industry, companies must be single-mindedly product-driven. Companies that lack a product focus, in this or future economies will be able to survive for a short while but ultimately they are doomed to fail. That said, while there may be fewer companies as the biotechnology industry continues to evolve, the companies that do survive will undoubtedly be extremely robust and fiercely competitive.

Until next time….

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

• Email This
• Print
• Comments
• Trackbacks
• Share Link