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It’s no secret that pharmaceutical and biotechnology companies are “not in love” with social media. However, whether life sciences company like it or not, social media is beginning to affect human clinical testing with an increasing number of patients demanding access to unapproved experimental drugs to treat life-threatening illnesses. 

In a recent article that appeared in the January 15, 2010 issue of Genetic Engineering and Biotechnology News entitled “Expanded Access to Investigational New Drugs”, Natalie Douglas, CEO of UK-based Idis Pharma wrote:

"...the trend toward greater transparency of drug development pipelines and the accessibility of powerful social media tools, have led us to a more informed empowered and vocal population of patients. This, in turn, has led to increased demands for access to unapproved drugs that are in various stages of human clinical testing. “Patients can easily access information about investigational drugs via the Internet and are leveraging social media tools such as YouTube, Twitter and blog to influence companies to garner access to them” Douglas added.

This can place enormous pressure on the companies that are testing investigational new drugs because the safety and efficacy of the drug candidates has yet to be determined. Understandably, companies are loath to provide patients who don’t meet clinical trial inclusion requirements access to experimental drugs with unknown safety and efficacy characteristics. Nonetheless, if requests for access to investigational drugs are denied, social media tools can easily be used to quickly and widely publicize the denial. According to Douglas, aggressive use of social media tools by patients seeking access to investigational drugs has helped their stories make national news. This can create gargantuan regulatory and public relations problems for companies with drugs in clinical development and put them at the center of an ethical and moral firestorm—despite their best intentions to develop new drugs that eventually may help millions of patients suffering from various diseases and conditions.

Many patient advocacy groups, consumers and shareholders understand the almost limitless reach of social media and its ability to influence public opinion, discussions and trends. Whether or not drug makers are willing to use social media, many have yet to understand that they are already part of the social media conversation that is taking place daily. And, as all social media enthusiasts have realized, if you are not part of the conversation then you don’t know what is being said about you on the Internet. More importantly perhaps, is that by choosing not to participate in the conversation, companies have lost all ability to influence and manage what is being said. In other words, life sciences companies that steadfastly choose not to use social media may, paradoxically, be setting themselves up for public relations and regulatory headaches that could have easily been avoided.

While the social media frenzy may be beginning to wane, there is no question that it has changed the way people interact and influenced the way business is transacted online and in real life. Companies that insist on clinging to past business practices that are exclusive, non-interactive and designed to promote opacity are likely to lose customers and market share as 21^st century technology continues to unfold.

Hat tip to Natalie!

Until next time...

Good Luck and Good Tweeting!

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While I never was involved in a corporate acquisition or merger, I have many friends who have lived through them and based on their experiences it is a never a “pretty sight.” Merger aftermaths usually feature massive layoffs, executive management disputes and turf wars and corporate culture clashes tha occur when two workforces are forced to merge as one. However, sometimes mergers may be a good thing for struggling companies. To that end, Pfizer may actually benefit from it $68 billion acquisition of Wyeth late last year.

The acquisition will cost at least 20,000 employees their jobs—not a good thing in a national economy where unemployment is well over 10 percent (despite claims to the contrary). However, this merger is strikingly different than Pfizer’s questionable past mergers and acquisitions which were primarily engineered to procure one or two drugs that had blockbuster potential e.g. Lipitor and Celebrex. This time around, Pfizer’s management team is actually re-evaluating its entire drug development portfolio and attempting to expand the company’s pipeline to include vaccines, therapeutic proteins and other biologics. As I previously noted, most major pharmaceutical companies believe that biologics will be the major driver of pharmaceutical markets in the not so distant future.

According to a post on PharmaLive, Pfizer announced that it will discontinue research and development on roughly 100 experimental new drug candidates. Pfizer officials revealed that the company will continue with 500 research projects in six areas of: 1) Alzheimer’s disease, 2) diabetes, 3) pain, 4) cancer and 5) mental illness (including schizophrenia).

Of the 500 projects, 30 drugs are being tested for cancer indications, 10 for Alzheimer’s disease, eight for pain and 11 for inflammation. Further,133 are in various stages of human clinical testing, including several that are awaiting regulatory approval in the US and elsewhere. 

On the biologics front, Pfizer has six vaccines and 27 biopharmaceutical drugs in development. Prior to the Wyeth acquisition, the company only had one vaccine and 16 new biologics that it was testing. Like most other pharmaceutical companies, Pfizer wants to be a major player in the biopharmaceutical and biologics markets by 2015.

Only time will tell!

Until next time,

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

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Mark Senak who writes the EyeonFDA blog has compiled a list of the life sciences companies that presently have a Twitter account and use it. While there are only 12 companies on the list, he provides a nice commentary on their use and makes some recommendations for improvement.

Although I am a staunch supporter of the use of social media in the life sciences, it appears to me that the discussion about its use has been somewhat muted since the FDA convened a public hearing on the topic last month. I suspect that many of the companies and stakeholders who participated in the discussion prior to the FDA meeting are presently in “wait and see” mode. However, don’t be surprised if the social media guidance issued by FDA is lacking and excruciatingly wanting!!!! For those of you who may not be familiar with the ways in which the agency operates, its regulators tend to craft guidance and regulation that are broad, loosely defined and open to interpretation. The agency intentionally crafts its guidance and regulations this way because it doesn’t want its rules and regulations to be “literally interpreted” by companies and other stakeholders. Generally speaking, its regulations represent the “minimum” requirements that must be met in order to insure regulatory compliance. In other words, there is no upper limit on what companies can do to insure compliance but there certainly is a minimum requirement that must be met to avoid regulatory sanctions and penalties. As one lawyer who used to work for the agency shared with me recently, “FDA crafts the regulations but it is left to the companies and courts to interpret them.”

Most of the current discussions about social media and the life sciences industry primarily focus on its use as marketing and promotional vehicle. And, as many of you may already know, FDA isn’t exactly keen or pleased with the current marketing and advertising strategies and practices utilized by a sizeable number of life sciences companies. Perhaps a shift away from marketing and advertising discussions to more regulatory-friendly and practical applications like clinical trials recruitment and public outreach may lead to a more rapid uptake of social media by FDA and life sciences companies? Just sayin’

Until next time...

Good Luck and Good Tweeting!!!!

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I suspect that many of you (after reading the title of this post) might be expecting another rant about the need for new antibiotics to treat infections caused by multiple drug resistant strains of bacteria. Sorry to disappoint you because that isn’t what this post is about. After reading and listening to several seemingly disparate radio and newspaper stories this morning, I decided to combine three different stories into a single post that touches on several common themes.

First, I heard a story on NPR this morning (while driving my daughter to middle school) about FDA’s initiative to require that oysters harvested from the Gulf of Mexico be pretreated before they can be served in restaurants and eaten raw. The reason for this initiative is that a majority of live oysters harvested from the Gulf of Mexico are usually contaminated with the opportunistic bacterial pathogen Vibrio vulnificus and other Vibrio species. Approximately, 15 or more immunocompromised patents die each year and many more get ill after ingesting raw Louisiana oysters infected with V. vulnificus. FDA, (which for those of you who don’t know also regulates the food and cosmetic industries in addition to the drug and devices industries), spent the past few years crafting regulatory guidelines that called for mandatory  treatment (irradiation or pasteurization) of oysters from the Gulf of Mexico before they are served “raw” at restaurants and other commercial food operations. The regulations were to be implemented sometime in 2011. While many of the larger commercial Louisiana-based raw oyster producers already pre-treat their oysters before they are sold to restaurants, the pretreatment requirement would be economically onerous and challenging to “mom and pop” oyster business throughout Louisiana. Not surprisingly, given the economic devastation caused by hurricane Katrina several years ago, FDA was assaulted by oyster manufacturing trade groups and Louisiana politicians and lobbyists asking the agency to delay implementation of the new rules. Unfortunately, FDA officials caved and yielded to the onslaught and agreed to conduct a pilot study designed to assess the effectiveness of the program before forcing the new rules on the Gulf Coast oyster industry.  For the record, I love eating raw oysters and the thought of eating a so-called “raw oysters” that have previously been pasteurized or irradiated seems unseemly and unappealing to me. However, FDA’s mission is to provide Americans with a safe food supply and to minimize the incidence of any public health risks associated with or caused by it. The fact that FDA was cajoled and yielded to calls that that the agency placed economic concerns ahead of known public health risks is lamentable and truly regrettable. Rather than spending excessive amounts of money on lobbying efforts to delay appropriate public health initiatives, the Gulf Coast oyster industry and its trade groups and lobbyist ought to consider investing in efforts to combat global warming and Gulf of Mexico water pollution, which in turn, would reduce the bacterial load of live oysters harvested from the Gulf of Mexico and serve to raw oyster enthusiasts. 

On a more upbeat note about infectious diseases (sort of), there was an article in today’s Science Times which reported the results of a study that linked exposure to five so-called common pathogens, Chalmydia pneumoniae, Helicobacter pylori, cytomegalovirus and Herpes simplex types 1 and 2 to increased risk of stroke. According to the article, each of these pathogens may persist after acute infections and contribute to an ongoing chronic low level infection. These low level infections coupled with chronic inflammation of blood vessels induced by the infections may contribute to the increased likelihood of stroke. While intriguing, authors of the study warn that their results don’t establish a cause-and-effect relationship between these infections and stroke. More research will be required to determine whether or not there is a definitive link between these infections and the incidence of stroke..

Speaking of stroke and heart attacks, I want to turn my attention to the clinical trial results reported yesterday by Merck & Co about its cholesterol-lowering drugs Zetia and Vytorin. As you may recall, a brouhaha erupted about a year ago about whether or not the cholesterol-lowering effects of  Merck’s  blockbuster drugs Zetia and Vytorin (which is a combination of Zetia and the statin Zocor) actually protected patients from increased risk of heart attack and stroke. The results of the long awaited study which were presented at an American Heart Association meeting on Monday support previous findings of two earlier clinical studies which showed that despite lowering LDL cholesterol levels, Zetia and Vytorin don’t reduce the risk of heart attack or stroke in at-risk patients. 

In the study patients who were at risk for cardiovascular disease were treated with statins in combination with either Zetia or Niaspan (a prescription, controlled-release formulation of over-the-counter niacin supplements that exhibits cholesterol-lowering properties). Patients who received statins plus Niaspan had decreased thickening of the walls (caused by atherosclerosis) of the carotid artery whereas those treated with Zetia failed to inhibit arterial plaque buildup. In other words, Zetia (and Vytorin) which are expensive prescription drugs don’t provide any health benefits beyond those offered by statins, many of which (including Merck’s Zocor) are available as low-cost generics.

Despite the lack of any clear medical or health benefits, sales of Zetia and Vytorin generated about $4.8 billion in sales last year. You would think that Merck and its stakeholders would be devastated by the results of the new study. However, they were actually happy about the news—they were fearful (based on data from the earlier studies) that Zetia may actually increase the risk of heart attack and stroke! What is particularly revealing (and disturbing) about the whole Zetia/Vytorin story is that Merck is relieved that an expensive drug that it heavily promoted as being beneficial and safe is in reality not beneficial. When did it become acceptable that the only requirement for FDA approval of prescription drugs is safety? Doesn’t a drug have to also show a positive therapeutic and clinical effect (over previously approved drugs for the same indication) before it wins regulatory approval? The fact that physicians continue to prescribe ineffective, multi-billion dollar drugs like Zetia instead of cheaper and effective generic versions of cholesterol-lowering drugs another troubling sign of  our current economic situation and the need for healthcare reform in the US.

Finally, for you patent aficionados, there was an illuminating and incisive op-ed piece in today’s NY Times that shed light on the problems with the current US patent approval process. While I have substantial experience in this area, I learned more from reading this article than I did from the many years that I worked closely with patent and intellectual property attorneys. This article is a must read for those persons considering careers in intellectual property and patent law and entrepreneurial individuals who are interested in starting up life sciences companies.

Until next time...

Good Luck and Live and Learn!!!!

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It is amazing the things you learn if you pay attention from time to time.  While attending a meeting on e-healthcare last week in Philadelphia I learned that according to the American public the pharmaceutical industry is less popular than the banking industry. This was startling to me given that the recent financial collapse was caused almost entirely by the banking industry.  That the pharmaceutical industry is more reviled than the banking industry suggests that life sciences company have a bit of PR work to do.  But, not to worry, people still hate the oil industry more than the pharmaceutical industry.

On another note, the US FDA decided to raise the cost of regulatory filings for fiscal year 2010.  The cost of filing an application with clinical data is $1.4 million (up from $ 1.2 million in FY 2009); $702, 750 for an application not requiring clinical data or a supplement requiring clinical data (up from $623,600 in 2009) and 457,200 as compared with $425,000 in FY 2009 for an establishment fee (for facilities where drugs are made).* 

I guess the agency figures that pharma can handle the increases despite poor public image and an ongoing recession.

* AAPS News Magazine, Oct-Nov '09

Until next time...

Good Luck and Good Job Hunting

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I don’t want to brag but I have been touting career options in health informatics and health information technology (HIT) for the past year or so. Today, I came across a post by CareerBuilders declaring health informatics and HIT are the hottest new career trends to hit the market in recent years. As the drive towards digitizing medical and healthcare records continue, there will be literally thousands of job opportunities for people with the right skill set. This is what the post had to say about health informatics and HIT careers and job opportunities. 

Health Informatics
Health informatics will put technology in place that provides hospitals and other health-care providers with access to an electronic network of vital patient information such as like medical histories and prescriptions. The information age finally meets healthcare administration.

The facts
The health informatics initiative won’t succeed unless employees — that’s you! — bring the specialized skills needed to build and expand the network. All other pieces are in place:

• The American Recovery and Reinvestment Act of 2009 includes $20.6 billion to help providers drive adoption and development of the IT infrastructure needed
• The U.S. Bureau of Labor Statistics (BLS) projects health information management employment to grow nearly 18 percent by 2016
• The BLS projects a need for more than 6,000 new professionals each year through 2014 — but only 2,600 graduates have entered the field this past year 

Your opportunity
To succeed, health informatics (HIM) will demand a wide variety of specialized positions across IT and health care. It will engage conventional experience from both areas — such as registered nurses and LPNs/LVNs, or IT implementation specialists and IT project managers — if you’re looking for a new twist on your current career.

But new positions will also thrive in this hybrid field. Look for new HIM job titles in your next job search, like health IT professionals, HIM coders, HIM medical records professionals and various health informatics specialists, including trainers, researchers and analysts.

Get online to check out the job titles mentioned above and listed below for related descriptions, and see if you might need any additional training to meet requirements: 

Nursing
- Telemedicine clinical professionals

- Chief nursing information officers

- Clinical IT liaisons 

Health-care administration
- Medical and health services managers

- Document scanners

- Data entry clerks

- File clerks

IT specialists
- Senior programmers

- Senior clinical analysts

- Database analysts

- Developers

- Business analysts

- Software engineers

- Data integration specialists

Not too shabby of a list! In a previous blog post I identified a variety of training options for people interested in pursuing careers in health informatics and HIT. Check it out!

Until next time....

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

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The New York Times that W. Scott Harkonen, MD the former chief executive of InterMune, a Brisbane, CA biopharmaceutical company, was convicted yesterday for issuing what federal prosecutors called a misleading press release that contributed to off-label sales of the company’s drug Actimmune.

Actimmune is bioengineered form of interferon gamma approved in 2000 to treat children and adults with chronic granulomatous disease (CGD) and severe, malignant osteopetrosis—two relatively rare genetic diseases. But the main sales of the drug, which peaked at $141million in 2003, came from an unapproved use: treating idiopathic pulmonary fibrosis, a scarring of the lungs that can be fatal. While licensed physicians in the US can prescribe approved drugs for off label, it is illegal for drug makers to promote the use of prescription drugs to treat indications for which the drug didn’t receive approval.

According to the Times article, InterMune conducted a large clinical trial testing Actimmune as a treatment for the lung disease. The drug did not achieve the clinical endpoints of the trial, which was to improve lung function of patients receiving Actimmune as compared with patients receiving a placebo. However, a review of the statistical analyses of the trial revealed that if only the patients in the trial with mild or moderate disease were considered, those who got the drug lived longer than those who received the placebo .The company highlighted the “survival benefit” of patients treated with Actimmune in a news release, issued in August 2002.  Following the press release, sales of Actimmune (which costs about $50,000 per year) peak at $141 million in 2003—the drug was mainly being used to treat idiopathic pulmonary fibrosis an indication for which the drug hadn’t received regulatory approval. Because of this, federal prosecutors contended that the news release was part of a scheme to induce off-label sales of Actimmune. Interestingly, in 2007, a second large clinical trial of Actimmune found that the drug didn’t prolong the lives of patients with pulmonary fibrosis.

The InterMune case isn’t unique in the life sciences industry. Time and time again companies are charged with off-label promotional activities and typically these cases are settled before they go to trial. To that end, the InterMune case is an exception but Harkonen’s conviction sends a warn drug company executives that the US government takes off label promotion seriously and it will no longer be tolerated.

While it can be argued that off label drug use can benefit patients and ought to be allowed, off label promotion of previously approved drugs allows drug companies to benefit financially without investing in expensive clinical trials to win regulatory approval for the off label indication. In other words, off label promotion of prescription drugs can be a financial windfall for companies and induce them to place profits ahead of patient safety and drug efficacy. This is why promotion of off label use of prescription drugs is illegal and a prosecutable crime. 

It is important to remember that prescription drugs are required to undergo a rigorous regulatory review to insure that they are safe and efficacious. While the use of approved drugs to treat off label indications may benefit some patients, the drugs in question must be rigorously tested for safety and efficacy to treat the indication before they are used to in large numbers of patients. And, as we have seen in recent years, even drugs that have gone through clinical testing and garnered regulatory approval may not be as effective or safe when used to treat billions of patients!

Until next time...

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

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The increasing costs of conducting human clinical trials and the requirement for more stringent safety data for new molecular entities is forcing a growing number of pharmaceutical and biotechnology companies to outsource clinical development of new drugs to Central and Eastern Europe and Asia, most notably India. If your company is considering this option, you may be interested in attending an upcoming conference and workshop sponsored by Next Level Pharma. 

 “Clinical Outsourcing Alliances in Central & Eastern Europe” is a one day conference that will be held on October 8, 2009 in Boston, MA. Company representatives from American and European life science companies and clinical research organization will present talks on the “nuts and bolts” of setting up and conducting human clinical trials in Europe.

A half-day workshop entitled “Clinical Outsource Alliances in India” is being offered on day 2 of the conference. The workshop is intended to introduce American clinical trial sponsors interested in conducting human clinical trials in India to prospective Indian CROs. Presentations from American pharmaceutical executives and Indian CRO representatives will describe the realities of running clinical trials in India and allow attendees to identify potential clinical development partners.

Don’t miss this opportunity to learn the “ins” and “outs of outsourcing foreign clinical drug development.

Until next time...

Good Luck and Good Job Hunting!!!!!

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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!!!!!!!!!!

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The debate, if you can call it that, over whether or not interactive social media platforms like Facebook and Twitter can be used in the life science industry is moving forward at glacial speed. I decided that it was time to propose some ideas rather than continue to admonish the US Food and Drug Administration (FDA) for a lack of guidance.

There are several reasons which may explain the inertia surrounding the adoption of social media by pharmaceutical, biotechnology and medical devices and diagnostics companies. First, and perhaps foremost, FDA has been consistently reluctant to craft any useful guidance on the use of Web 2.0 technologies for research, clinical or promotional purposes. The FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) is still trying to figure out how to regulate website content. Is it any wonder that FDA is reluctant to tackle the regulatory implications and issues associated with social media platforms like Facebook and Twitter? Second, a majority of social media advocates— who are leading the charge at many life sciences companies—are marketing and advertising executives who tend to look at social media strictly as a promotional tool. Finally, much of what takes place at life sciences companies is proprietary and confidential—information flow between the company and its employees and the public is fastidiously monitored and tightly regulated. Because of this, the life sciences industry’s “process” is intentionally opaque—which is contrary to the goals of social media which is to promote transparency (or the illusion of it).

There is no doubt that the life sciences industry is the most highly regulated industry on the planet. While this represents a formidable challenge for adoption of social media, it is by no means insurmountable—especially if social media is used for purposes other than branding, marketing and advertising. For example, the most straight forward application of social media at life sciences companies would be in the areas of corporate recruitment and employee retention. Many Fortune 500 companies outside of the life sciences industry have been using Facebook, MySpace and LinkedIn for years for recruiting purposes. While not commonly acknowledged, life sciences companies have quietly begun to use Facebook, LinkedIn and MySpace to recruit prospective employees. Interestingly, the new kid on the block—Twitter—looks to potentially be a more powerful recruiting tool than any of its predecessors. Unfortunately, employee retention is no longer a priority at many companies. However, before the economic meltdown a number of companies, most notably Best Buy, were experimenting with social media to retain talented employees.

Another potential use of social media is for pharmacovigilance and adverse events reporting. Companies with approved products on the market are required by FDA (and other regulatory agencies that approved their products) to set up post marketing surveillance programs for adverse events reporting. By law, companies that receive adverse events reports from consumers, physicians or other entities must report them to the regulatory agencies that approved the product. Regulatory agencies maintain adverse events databases for all approved drugs and devices to monitor drug safety.  If designed and implemented correctly, interactive social media platforms like Facebook and Twitter (which operates in real-time) would make excellent pharmacovigilance and adverse reporting tools. Quite coincidentally, John Mack, who runs the Pharma Marketing Blog, reported a partnership between UCB and PatientsLikeMe.com to create a pharmacovigilance reporting platform for UCB products.

Recruiting patients for participation in clinical trials (to assess efficacy and safety of prospective new drugs) has become extremely challenging over the past few years.Traditional patient recruitment strategies include print, television and radio ads and in some instances, websites. All of these recruitment methods are costly, labor intensive and limited in their effectiveness because they only reach small number of prospective clinical trial participants. I contend that Facebook with over 200 million users, LinkedIn with members in over 140 different countries and Twitter which is growing rapidly would be ideal for clinical trial recruitment and retention purposes. Others have also proposed this idea.

Finally, while the use of social media to promote approved drugs and devices may be difficult because of regulatory constraints, it can be utilized to keep the public informed about prospective new medicines and promote a company’s image or brand. There is no question that the public perception of the pharmaceutical industry has been severely tarnished over the last few years.  The industry’s continued lack of transparency and failure to adequately disclose potential safety risks about some approved products continues perpetuate a negative image. One way to restore public trust and confidence is to use social media to actively engage the public in conversation on wellness, addressing unmet medical needs and prospective new medicines and treatments that are being developed. Also, social media platforms could be employed to showcase community outreach programs and discuss educational initiatives to improve science education and training.

Social media is no longer a new phenomenon or technology. It is a legitimate form of communication which has become an integral part of the Web 2.0 experience. I suspect that the life sciences industry will have to make a decision about social media in the not so distant future—or possibly miss a potentially game-changing business opportunity. And, as Ken Kesey aptly said in Tom Wolfe’s ‘The Electric Kool-Aid Acid Test’—“You’re either on the bus…or off the bus.”

 Until next time...

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

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By now, I think that most BioJobBlog readers understand that the job market for life scientists is lousy and that it isn’t likely to improve anytime soon. I know that many of you have spent close to 10 years training for a shot at an R&D job but the reality is that everybody needs to work to put food on the table—whether or not you find a job in your chosen profession. To that end, now may be a good time for those of you who are finding it difficult to land a job to consider one more year of training to get a certificate in a field that keeps you in science but not in R&D.

I came across interesting post today at the Resume Bear blog that discussed 10 certificate programs that can help people transition to new careers to find jobs. Interestingly, four of the programs are good fits for life scientists who are willing modify their careers to be gainfully employed. They are:

Clinical Trials Design and Management

“Pharmaceutical drug and medical device development is one of the premier industries of the 21st century, and the success of this vital industry depends upon the complex process of studying new products to verify their effectiveness and safety.”

Regulatory Affairs

“Professionals are needed to guide drug development and medical device companies through FDA imposed regulation issues pertinent to the pharmaceutical and biological industry.”

Project Management

“As project cycles get shorter – and budgets get leaner – project managers are vital to the success of organizations today.”

Copyediting

“Bridging the gap between writers and publishers – especially technical and nonfiction copyediting – is one of today’s most marketable skills for both full-time and freelance work.”

Another one that was not on the list biotechnology certificate programs in which students learn about product development, regulatory affairs and best business practices in the life sciences industry.

Not surprisingly, many certificate programs are offered at local community colleges and frequently online. For regulatory affairs training you might try the Drug Information Association and Regulatory Affairs Professionals Society. The Project Management Institute offers training in project management and the Editorial Freelancers Association offers its members courses in copyediting. Mercer County College in West Windsor NJ in association with a local clinical research organization developed a “hands-on” certificate program in clinical trials design and management. 

In my opinion, certificate programs are worth checking out. They are designed for working professionals (courses are typically given in the evenings and weekends); usually only take 12 months to complete (what is one more year in the scheme of things) and improves the likelihood of finding a job because you now have a marketable skill set! It certainly beats collecting unemployment or sleeping in your old bed at your parent’s home—or not?

Hat tip to Resume Bear

Until next time...

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The New York Times reported today that Genentech’s blockbuster cancer treatment, Avastin, failed to show a significant effect on preventing the recurrence of colon cancer, limiting its utility as an adjunct treatment to treat primary colorectal cancer. While Avastin is already a best-selling cancer treatment, success in this closely watched and highly visible clinical trial could have paved the way to a new uses of the drug, potentially increasing sales by billions of dollars a year.

Avastin had sales of $2.7 billion in the United States alone last year. But it is currently approved only for late-stage colon, breast and lung cancers. For those indications, patient’s lives have been prolonged for up to a few months. The new trial was designed to determine whether or not Avastin could be used earlier in the course of the disease, right after surgery to remove the tumor. The hope of such so-called adjuvant therapy is to prevent the cancer from coming back at all, effectively curing the patient.

While the Avastin failure will have little or no effect on Genentech’s financial outlook, it does call into question whether or not Roche paid too much last month to buy the 44 percent of Genentech it did not already own. Roche has long insisted that its desire to own all of Genentech did not hinge on the results of this trial. And yet, the trial appeared to play a major role in Roche’s months-long negotiations with Genentech.  It appeared that Roche, which had started those discussions last summer, wanted to complete the deal before results of the Avastin trial were announced — on the assumption that a successful trial would have sent Genentech’s stock soaring, possibly putting the takeover price it offered out of reach.  A failed trial, on the other hand, could have pushed down the value of Genentech’s stock. So it now looks as if Roche could have paid less had the results of the Avastin trial come out before it completed the deal.

Art Levinson, Genentech’s former CEO who played hardball with Roche over the course of negotiations, needs to be recognized for his outstanding business acumen. He and other Genentech executives convinced Roche that Avastin sales could quadruple, to $10 billion, by 2015 if the drug could be used for early-stage colon, lung and breast cancers. This possibility induced Roche to raise its bid for Genentech’s outstanding shares from $86.50 to $95 per share. Although Dr. Levinson wasn’t able to fend off Roche’s takeover and is no longer Genetech's CEO, he is likely “laughing all the way to the bank” as the expression goes. And, who said that PhDs aren’t any good at business?

Roche shares were down more than 10 percent on Wednesday, closing at $29.54.

Until next time...

Good Luck and Good Job Hunting!!!!!

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Did you know that the top ten pharmaceutical companies in the world spent close to $50 billion dollars last year on R&D? That sum could be used to purchase the entire US biotechnology industry except for the five largest companies—Genentech, Amgen, Gilead Genzyme and Celgene. Further, pharma’s R&D budget is about 4 times the R&D budget of all of the US biotechnology companies combined. According to a blurb in breakingviews.com, Pfizer alone spent $8 billion last year which was greater than the sum spent by biotech’s top five companies. What this tells us is that pharmaceutical companies are grossly unproductive when it comes to drug discovery and development. This would explain why nearly three-quarters of all new medicines approved for sale in the US last year originated at biotechnology companies.

It is becoming increasingly apparent that biotechnology companies are much more efficient at R&D than pharmaceutical companies. More importantly this suggests that something must change so that pharma can continue receive adequate ROI on internal discovery programs. Perhaps big pharma ought to spend a greater portion of its R&D budget on biotech mergers and acquisitions rather than continuing to invest in inefficient and failing internal R&D programs. While biotechnologynology companies are exceptional in drug discovery, they are severely lacking when it comes to clinical development of new drugs. This is largely due the high costs of conducting human clinical trials (which are required for regulatory approval of all new medicines). Most biotechnology companies are strapped for cash and don’t have sufficient funds to conduct clinical trials on their own.

Not surprisingly, given the recent financial downturn, there has been a recent spate of deals in which pharma has been willing to pay large sums of money for clinical development rights to promising new biotechnology drugs. Moreover, a majority of the almost 160,000 employees layed off by pharma companies in the past few years have been R&D scientists. This suggests that pharma is beginning to realize that its money may be better spent doing deals or buying biotech companies rather than continuing to invest large sums of money into it’s own unproductive R&D programs. Unfortunately, this paradigm shift doesn’t bode well for doctoral students and post-doctoral fellows who are training in the life sciences. This is because many entry-level biotech positions, traditionally filled by newly-minted PhDs and postdoctoral fellows will likely be filled by experienced, pharmaceutical employees who lost their jobs in the recent rounds of layoffs. As much as I hate to say this, if I were a life sciences graduate student or postdoctoral fellow considering an R&D career in industry, I would begin to explore alternative career options.

Until next time….

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

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Optimer, a San-Diego, CA-based biopharmaceutical company, reported positive Phase III clinical trial results for OPT-80, its lead treatment for Clostridium difficile gastroenteritis. C. difficile gastroenteritis is caused by exotoxins secreted by clostridia that have colonized the colon following prolonged antibiotic treatment for other bacterial infections. If left untreated, patients can die from a pseudo-membrane that forms in the colons of C. difficile-infected people. The incidence of C. difficile gastroenteritis has drastically increased over the past decade because of prolonged treatments with multiple antibiotics that are often necessary to eradicate infections caused by multiple drug resistant bacteria.

Historically, CHO-based drugs (with a few notably exceptions like heparin) have not fared well as therapeutic agents. To my knowledge, OPT-80 is the first synthetic carbohydrate (CHO)-based antibiotic to demonstrate anti-bacterial efficacy in a Phase III clinical trial. Having worked for Transcell Technologies (now defunct) and Alchemia,Pty—both of which attempted to develop CHO-based antibiotics—Optimer’s clinical success with OPT-80 is certainly noteworthy. I wish the company continued success in the future—mostly because I have always thought that carbohydrates would make good antibiotics!

Until next time…

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

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Indianapolis-based Eli Lilly & Co announced today that it will transfer its clinical trial monitoring and data management operations to Quintiles and i3.  About half of the affected 265 Eli Lilly employees will lose their jobs.

Like other pharma companies, Lilly is looking at ways to cut costs. And as everyone knows, the best way to save money is to outsource operations and lay-off full time employees who are expensive because of high salaries and benefits.

Until next time….

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

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The old adage “When it rains, it pours” is particular apt for the bad news that has plagued the once venerable Merck & Co for the past five years. First, there was the Vioxx scandal, followed in short order by the Vytorin and Singulair messes and now it appears that the company’s new anti-cervical cancer vaccine, Gardasil, may have —pardon the expression — a few “warts” on it. 

Last night on my local nightly news, there was a brief report about emerging safety issues with Gardasil. According to the report, adverse events ranging from “massive wart outbreaks to seizures and paralysis” have been reported for the anti-HPV vaccine. Since its approval in 2006, over 8,000 adverse event reports (the total number of people vaccinated was not disclosed) and 18 alleged deaths have been reported for Gardasil (although none of the deaths has been directly linked to Gardasil vaccination). This news comes on the heels of a recent Wall Street analyst’s report indicating that sales of Gardasil are much lower than expected. It appears that the vaccine, once considered by Merck insiders as the new blockbuster that could save the flagging drug maker, may, after all, be relegated to specialty drug status.

As many of you may know, GlaxoSmithKline (GSK) is seeking US approval for its anti-cervical cancer vaccine called Cervarix. Although Merck beat GSK to market, Cervarix has undergone more clinical testing and allegedly may have a better safety and tolerability profile than Gardasil (only the regulatory agencies know for sure). Nevertheless, it is not clear whether GSK will benefit or be injured by the negative publicity that Gardasil is receiving. As I mentioned in a previous post, the US Food and Drug Administration (FDA) recently delayed Cervarix’s approval pending submission of additional data that the agency requested from GSK.

Before anybody puts a nail in Gardasil’s coffin, it is important to point out who started the recent firestorm about the vaccine. It was none other than the conservative-funded public interest group Judicial Watch. It is no secret that this group advocates abstinence over condom usage and other methods to prevent sexually transmitted diseases. Further,  I suspect that a majority of Judicial Watch’s members don’t believe sex education or pre-marital sex for that matter. Finally, I have no doubt that Judicial Watch received some support (financial, spiritual or otherwise) from the anti-vaccination lobby that is unfortunately gaining strength in the US and elsewhere.

From a scientific standpoint, it is difficult to get a real measure of the safety of a vaccine until it has been widely used by large numbers of people. Although pivotal Phase III trials are required for all vaccine approvals, the number of people studied in these trials (sometimes in the tens of thousands) is not sufficient to predict all possible safety problems that may emerge when the vaccine gains widespread use. For this reason, regulatory agencies typically require vaccine manufacturers to conduct mandatory post marketing Phase IV clinical trials that are designed to address the seriousness of any possible safety concerns that may have emerged after a vaccine has been on the market for several years. Because all vaccine makers know this, it is still not clear to me why Merck, a company which has been in the vaccine business for a very long time, embarked on its failed lobbying campaign to get Gardasil on the mandatory US vaccination schedule shortly after it was approved. 

As I have said in the past, ALL pharmaceutical and biotechnology drugs have side effects and their occurrence and severity varies from person to person. Generally speaking, most drugs are approved by regulatory agencies because their potential benefits outweigh real or presumed safety risks. That said, the question facing all parents who have daughters is: Does protection against cervical cancer outweigh any adverse events or potential safety risks associated with Gardasil or Cervarix vaccination? It is a tough question but one that my wife and I and others will have to answer for our daughters!

Until next time…

Good Luck and Good Job Hunting (avoid Whitehouse Station, NJ)!!!!!!!!!

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Somebody once said “Jews know two things—suffering and where to find good Chinese food”. Since I am Jewish, it is not surprising that I have experienced a fair amount of suffering throughout my life and, wherever I go, I seem to know where to find “good” Chinese food.  That said, my interest was piqued when I found a post in Yahoo Science News entitled “Study finds Chinese food good for your heart”. Given my lifelong fondness and penchant for Chinese cuisine, I thought that all of that eating that I had done had finally paid off. Unfortunately, after reading the subtitle of the article; “Chinese red yeast rice reduces repeat heart attacks/mortality rates” I realized that my joy and optimism were somewhat premature.

According to the report, researchers at Jefferson Medical College found that a partially purified extract of Chinese red yeast rice, Xuezhikang (XZK), reduced the risk of repeat heart attacks by 45%, revascularization (bypass surgery/angioplasty), cardiovascular mortality and total mortality by one-third and cancer mortality by two-thirds. The multicenter, randomized, double-blind clinical study was conducted on about 5,000 heart attack patients, ranging in age from 18-70 during a five-year period at over 60 hospitals in the People's Republic of China. Study participants were given 300-milligram XZK capsules or a placebo and tracked over a five-year period. The XZK extract used in the study contained a combination of lovastatin, lovastatin hydroxyl acid, ergosterol and several uncharacterized components.

Based on study results, the study’s authors believe that XZK may offer therapeutic benefits to people at risk of heart attack and cardiovascular disease. However, they cautioned that the active pharmacologic ingredient (API) of the red yeast rice is unknown and it isn’t clear how XZK works to fight cardiovascular disease.

Chinese medicine practitioners have long touted the benefits of red yeast rice for heart patients. Nevertheless, this is the first controlled clinical study of red yeast rice that tends to substantiate these claims. According to the study authors it is important to note that “the commercially available over-the-counter supplement found in your average health food store is not what was studied here. Those over-the-counter supplements are not regulated (by the US Food and Drug Administration), so exact amounts of active ingredient are unknown and their efficacy has not been studied yet.”

It is unfortunate that I didn’t know about the benefits of red yeast rice during my recent trip to China. I certainly would have gone out of my way to try some. That said, given the plethora of exotic foods that I tasted in China, maybe I ate some XZK without knowing it!

Until next time

Good Luck and Good Eating (Chinese of course)……

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