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Despite the initial pushback against social media by many pharma and biotech companies it appears that Twitter is emerging as the medium of choice for the life sciences industry. The main reasons for this trend are the 140 character world limit and the real time nature of Twitter. Unlike Facebook pages and blogs, where visitor’s comments (of any length) remain for indefinite periods of time, the information contained in tweets is minimal and their exposure time is second or minutes rather than days or months. These features allow pharma and biotech companies to more easily manage information flow and quickly implement damage control when necessary. 

Because of the growing importance of Twitter in life sciences circles, Mark Senak, the intrepid author of the EyeonFDA blog and a self-proclaimed social media enthusiast, compiled a list of well, useful pharmaceutical Twitter lists. Twitter users can subscribe to lists which are a compilation of tweets from persons who belong to the lists. For those of you who use LinkedIn, Twitter Lists are analogous to LinkedIn Groups.

Mark recommends the following lists to those who want to follow the pharmaceutical/healthcare industry

Healthcare Reporters 

Pharmaceutical Manufacturers 

Device  Manufacturers

Medical Journals

FDA Twitter Feeds.

Government Healthcare

Pharmaceutical and Biotech Jobs

To view these lists you must be a Twitter member!

Hat tip to Mark and to John Mack at the Pharma Marketing Blog for the Twitter image!

Until next time...

Good Luck and Good Tweeting!!!!!!!

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British pharmaceutical giant AstraZeneca today announced that it would invest $200 million into a new manufacturing facility located in China Medical City in Jiangsu province in Eastern China. This is the company’s largest global investment ever in a single manufacturing facility. The new plant which will be completed by 2013 will manufacture intravenous and oral solid drugs. 

AstraZeneca was one of the first Western pharmaceutical companies to establish a presence in China (1993) and has fast become one of the leading biopharmaceutical companies in the country doing about $1.0 billion in business annually. 

Many of Astra Zeneca’s competitors including Novartis, Roche, Merck & Co. and others have also recently made large investments into Chinese R&D and manufacturing facilities. If this doesn’t eliminate anyone’s doubt that pharma is shifting its focus from the West to emerging markets, I am not sure what will!!! While this shift may be bad news for American life scientist seeking employment, it is certainly welcome news for Chinese Nationals who received their life sciences training in the US and other Western nations.

Until next time...

Good Luck and Good Job Hunting (there are openings in China!!!!!!)

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Piscataway, NJ-based Enzon Pharmaceuticals, the once venerable biotechnology that was the first to successfully commercialize protein PEGylation, yesterday announced that it plans to lay off nearly half its employees by the second quarter of next year.

The layoffs will leave Enzon with 47 employees. The company said that the layoffs are intended to align resources with the company's research and development activities. Enzon, once with a market valuation greater than Merck pharmaceuticals, has been steadily losing revenue over the past 10 years and had essentially abandoned R&D in the protein PEGylation field that it had pioneered. Over the same time period, the company had a succession of CEOs, each of whom had a different vision and strategic plan forward.

Enzon was founded in 1982 by Abe Abuchowski, PhD, who validated the commercial possibilities for protein PEGylation while a graduate student at Rutgers University. Abuchowski licensed the rights to protein PEGylation and formed Enzon several years after receiving his PhD degree. He took the company public in 1985 (a feat that was not easy to accomplish back in those days) and went on to use protein PEGylation to develop two products with orphan drug designations (Adagen and Oncospar) and PEG-Intron a second generation biopharmaceutical used to treat Hepatitis C infections.

Abuchowski was CEO and Chairmen of Enzon until 1996. He left the company that he created because its board decided that PEGylated small molecules rather than proteins ought to be the future focus of the company. Enzon abandoned its biopharmaceutical focus in favor of small molecules in the late 1990s. Although in recent years the company tried to resuscitate its protein PEGylation programs, the PEGylation industry had essentially passed the company by and they were no longer competitive.

Abuchowski is currently CEO and Chairman of Prolong Pharmaceuticals, a South Plainfield, NJ-based, company developing products targeting the treatment of anemia resulting from oxygen deficiency. Not surprisingly, many of the products in the company’s pipeline were developed using protein PEGylation technology. While others have contributed to the protein PEGylation field, Abuchowski is generally recognized as the first person to commercialize the technology. He has received numerous awards for his work in protein PEGylation; a technology that generates roughly $30 billion in drug sales annually.

Until next time...

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

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The Pharmalot Blog today reported that a Wall Street Journal article indicated that Pfizer is planning to cut $1.0 billion from its operating budget by 2012. As many of you may recall (especially those who lost their jobs) the world’s largest pharmaceutical company cut 1,100 earlier this year at its research facilities in Groton CT. The new cuts are aimed at reducing Pfizer’s R&D expenses by up to $2.9 billion annually.

The $1.0 billion in cuts is primarily aimed at reducing administrative and management duplications at Pfizer’s headquarters in NYC and worldwide. Other expenses to be trimmed include those related to promotions, travel, entertainment, consultants, print materials and supplies and electronic equipment. While there is no doubt that these cuts will help to control costs, I suspect that substantially more money could be saved if pharma executive salaries and bonuses were also trimmed.

While it is unclear what the additional $1.0 billion in cuts will have on scientists, I suspect it won’t be good. In case you have not noticed by now, Pfizer like many of its competitors are getting out of the R&D business. This means that R&D jobs will continue to dwindle and scientists will continue to struggle to find jobs in a highly competitive job market.

Since Pfizer purchased rival Wyeth Pharmaceuticals in 2009, the company has shed over 20,000 jobs. The reason for the job cuts and massive cost cutting measures at Pfizer is the loss of patent protection in 2012 for its top selling cholesterol medication Lipitor ($10.7 billion in sales) and its ED drug Viagra ($1.9 billion in sales). Last year Pfizer lost patent protection the antidepressant Effexor (peak sales of $3.8 billion) and the Alzheimer’s drug Aricept ($417 million in sales). Also, when mergers take place there is much overlap and duplication of effort that takes several years to sort out.

Don’t be surprised if new Pfizer job cuts are announced late next fall! Now, would be a good time for Pfizer scientists to remove the dust from their CVs; if it is not already too late!

Until next time...

Good Luck and Good Job Hunting!!!!!

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Merck & Co, which yesterday completed its $430 million acquisition of Inspire Pharmaceuticals, announced that it intends to shut down Inspire’s headquarters in Raleigh, NC. According to a Merck spokesperson closure of the former Inspire site will occur before the end of the year and their will be job losses. However, it is not clear at present how many jobs will be lost but both executive and workforce positions are on the chopping block. 

Inspire was founded at the University of North Carolina, Chapel Hill in1995 and went public in 2000. The company employed 240 workers at the beginning of 2011 but it cut 27 percent of its workforce in February after an experimental treatment for cystic fibrosis failed in clinical trials. Merck’s acquisition of Inspire gives the company AzaSite an approved treatment for pink eye and a treatment for dry that is approved in Japan (the drug failed to gain US regulatory approval).

In other industry news, Connecticut-based Alexion announced that it will add 20,000 sq feet of laboratory and office space to its Smithfield, RI location. The company currently employs 125 workers and plans to expand its workforce by 35 percent in the next year or so. Alexion has one approved prescription medication called Soliris, the only approved therapy for persons with paroxysmal nocturnal hemoglboinuria (PNH) an orphan indication.

Until next time...

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

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Takeda Pharmaceutical Company, Japan’s largest pharmaceutical company, yesterday announced its intention to purchase the Swiss drug maker Nycomed for 8 to 10 billion euros ($11.4-14 billion). While the deal is not certain to close, it signals Takeda’s intention to purchase its way into the US and European markets.

Takeda acquired Cambridge, MA-based Millennium Pharmaceuticals in 2008 for $8.8 billion, the largest foreign acquisition ever by a Japanese company. The Millennium acquisition was intended to bolster Takeda’s competencies in genomics and oncology drug discovery. If Takeda is successful in its bid, Nycomed would enhance the company’s standing in treatments for gastric, respiratory and inflammatory disorders. Nycomed has operations in roughly 70 countries, with Europe representing 50 percent of the company’s sale and emerging markets 38 percent.

Takeda’s chief executive officer Yasuchika Hasegawa has pursued an aggressive M&A strategy since assuming control of the company in 2003. Historically, Japanese drugmakers intentionally remained small and were content doing business in local and other Asian markets. However, Hasegawa has changed the “game” and has forced some of Takeda’s rivals to emulate his global strategy. To that end, in recent years Daiichi Sankyo Company has purchased Plexxikon and Ranbaxy and Astellas acquired OSI pharmaceuticals as part of a westward expansion.

While Takeda remains Japan’s largest pharmaceutical company, net profit slumped 17 percent last year and the company is losing patent protection for its largest selling drugs, Prevacid (ulcers) and Actos (diabetes). Like Takeda, Nycomed sales are being hit by the loss of patent protection for its largest selling drug Protonix (antacid). Worldwide sales of the drug plummeted by almost 28 percent. Therefore, it would appear that Takeda’s pursuit of Nycomed is based more on its pipeline rather than currently marketed products.

Stay tuned for late-breaking news on the deal!

Until next time,

Good Luck and Good Job Hunting!!!!!

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The clinical trial phase of the drug development process is labor intensive, costly and usually takes the largest amount of time to complete. In the past, most human clinical trials for new molecular entities discovered by American scientists were conducted in the US. However, growing healthcare costs and shortages of “treatment-naive” trial participants have forced drug makers to take the effort global. To that end, many companies now routinely conduct Phase I (safety) and Phase II (proof of principle) trials in Eastern Europe, Latin America and Asia. Moreover, a growing number of pharmaceutical companies are beginning to conduct pivotal Phase III trials in which a majority of participants come from outside of the US.

Last year, a report from the inspector general of the Department of Health and Human Services revealed that in 2008 a whopping 78 percent of all subjects participating in trials to support drug applications submitted to the US Food and Drug Administration were enrolled in foreign sites. Likewise, in Europe, approximately 61 percent of patients in human trials submitted to the European Medicines Agency (EMA) from 2005-2009 were from developing countries. Additionally, 11 percent of the participants were enrolled in studies conducted in Eastern Europe. Poland and Hungary appear to have benefited the most from this trend; the number of Poles involved in trials rose fivefold over the period while Hungary was up almost fourfold.

According to a recent article from Reuters, ClinicalTrials.gov—a public website managed by the National Institutes of Health that tracks current US clinical trials—lists roughly 106,000 human clinical trials that are underway around the world. Approximately 50 percent of these trials are being conducted in the US. Interestingly, at present, only 43 percent of all pivotal Phase III trials are being conducted in the US.  Not surprisingly, China is the beneficiary of the trend and is experiencing exponential growth in the number of clinical trials conducted within its borders. To date, over 2,700 clinical trials have been performed in China and that number is likely to drastically increase over the next five years as Chinese medical and healthcare infrastructure continue to improve.

While outsourcing human clinical trials may be favorable to drug makers, the trend is beginning to anger many American physicians who previously benefited from managing US-based clinical trials. These physicians blame their misfortune on the life sciences industry’s endless pursuit to lower costs and the increasing regulatory bureaucracy and red tape surrounding clinical trial procedures in the US.

In addition to physician anger, outsourcing human clinical trials poses several other problems. First, there is a question of ethics. For example, is it right to test an expensive new drug in a country where locals may never be able to afford it if approved? And, are foreign patients always adequately informed or educated about the potential risks and side effects associated with experimental medicines? Second, can ethnic differences between patients contribute to differences in drug effectiveness and safety? In other words, will Caucasian patients respond to a new drug in the same ways as Asian patients? Finally, in the absence of rigorous regulatory inspections can Good Clinical Practices be routinely maintained across all global clinical trial sites? To that end, as pointed out in the Reuters article from 2005 to 2009 EMA inspectors only conducted 44 good clinical practice inspections (outside of the US and Europe) from a total of 44,034 clinical sites. Meanwhile, during the same period, the US FDA inspected only 0.7 percent of foreign clinical trial sites as compared with 1.9 percent of domestic sites.

Like it or not, outsourcing of human clinical trials in emerging markets is a trend that is likely here to stay. Hopefully, in the future, regulatory agencies will be able to better oversee foreign human clinical trials to insure that the drugs that they approve continue to be safe and efficacious.

Until next time...

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

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BioJobBlog and BioCrowd co-sponsoring the Business Development Institute and PR Newswire's Healthcare and LIfe Sciences Communications Leadership Forum that will be held on June 9, 2011 in San Diego CA

The forum is comprised of a group of senior marketing and communications executives from prominent biotechnology, pharmaceutical, hospital groups, medical device, and managed care companies. The forum focuses on how healthcare and life sciences brands achieve business objectives with social media and social technologies. The event consists of case study examples from well respected organizations in an intimate setting at AMN Healthcare in San Diego, CA.

• What are the best examples of how to connect with consumers and healthcare professionals through social approaches?
• What are the best case studies of how healthcare brands create and execute content strategies and content based marketing?
• How do you integrate social with your traditional customer service and marketing platforms?
• How are leading brands organizing themselves to best deliver results across the enterprise?
• How have others overcome the compliance and legal challenges with social communications?
• How do you plan, manage, integrate, and leverage data from social, online, and offline programs?
• How are mobile and location-based technologies being applied in healthcare?
• What are the tools, technologies, and best practices for monitoring and measuring social communications?

Speakers:

For additional information, including registration, please click here to visit the event website.

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It seems like hostile takeover bids in the life sciences industry may be de rigueur (how can anyone forget the Sanofi-Aventis/Genzyme hostile takeover saga that dragged on for almost a year). Interestingly, there have been 219 acquisitions of U.S. pharmaceutical companies in the past 12 months, with an average disclosed price of $153.7 million and an average premium of 44 percent!

Late yesterday, Valeant Pharmaceuticals announced plans for a hostile takeover bid for Cephalon, a 24 year old Pennsylvania-based biopharmaceutical company with eight products on the US market and more than 100 products worldwide. The takeover bid became “hostile” after Cephalon’s management team rejected earlier proposals.

Cephalon’s main focus is on nervous system disorders, pain and cancers. It is one of the world’s top 10 and most profitable biopharmaceutical companies. The company had revenues of $2.81 billion last year from sales of its narcolepsy treatment Provigil ($1.2 billion) and its leukemia treatment Treanda ($393 million). Also, according to the Cephalon website, there are several oncology products (lung, melanoma and solid tumors) in its development pipeline. In 2010 Cephalon announced seven acquisitions many of which were intended to bolster its oncology expertise.

Valeant Pharmaceuticals International, long a struggling speciality pharma company, merged with Biovail Corporation late last year and re-emerged as a re-invented company with substantial financial resources at its disposal. Prior to the Biovail merger, Valeant had a long history of acquiring smaller companies to bolster its R&D capability and its flagging drug development pipeline. The new company specializes in neurology and dermatology and has a diverse product portfolio that consists of branded pharmaceuticals, branded generics and over-the-counter medicines. In 2009, its revenues were $1.65 billion and 2010 revenues (to be released) are likely to exceed $2.0 billion. 

According to Bloomberg News, Valeant has offered to buy Cephalon for $5.7 billion in cash. Under terms of the offer, Valeant would pay $73 a share in cash; a 24 percent premium on Cephalon’s Tuesday closing stock price or a 29 percent premium to company’s 30 day trading average. Not surprisingly Cephalon executives summarily rejected the offer as “too low.” Several financial analysts concur with Cephalon and contend that the $73 per share cash offer undervalues the company’s true worth. Valeant and Cephalon are main competitors in the oncology and neurology markets.

Unlike the Sanofi/Genzyme bid, where it was clear at the outset to most observers that Sanofi would ultimately prevail, it isn’t clear whether or not Valeant will be successful in its attempt for Cephalon. While Cephalon has had its share of trouble with FDA over the past few years (for a variety of infractions including off-label marketing of Provigil), the company is in much better shape than Genzyme and the current management team has more resources at its disposable to ward off Valeant’s hostile takeover bid.

The downside of a Valeant-Cephalon merger would be job loss for many current Cephalon employees. This is because Valeant’s bid for Cephalon appears to be a “pipeline grab” rather than an R&D play. Typically, these types of acquisitions result in reorganization and downsizing of personnel because of duplication of effort. Only time will tell if Valeant will prevail.

Stay tuned for more late breaking news!

Until next time...

Good Luck and Good Job Hunting!!!

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The NY Times today reported that a 15-year veteran chemist at the US Food and Drug Administration (FDA) has been charged with using confidential and proprietary information about pending drug applications to buy and sell pharmaceutical and biotechnology company stock.

According to a criminal complaint filed by the US Justice Department, Cheng Yi Liang, 57 and his son Andrew made millions trading stocks on inside information since 2007. The criminal lawsuit alleges that the Liangs traded stocks in five pharmaceutical and biotechnology companies that had drug applications under review at the agency. Cheng Yi Liang’s job gave him access to a password protected-database that tracked the progress of new drug applications. Some of the companies leveraged by the Liangs included Vanda Pharmaceuticals, Clinical Data, Momenta Pharmaceuticals, Middlebrook Pharmaceuticals and Progenics. The Securities and Exchange Commission (SEC) simultaneously filed a civil securities fraud lawsuit against Cheng Yi Liang. 

The elder Liang is accused in the criminal complaint of “of using the FDA database to get an early look at F.D.A. decisions on companies developing drugs and then working with his son to trade on that knowledge, buying stock ahead of good news and selling it before bad news was announced. Both complaints assert that the defendants made just under $2.3 million in direct profits and avoided an additional $1.3 million in losses”. Further, the S.E.C. complaint accused FDA employee Liang of illegally trading ahead of more than two dozen F.D.A. announcements involving drug applications by 19 companies.

The case is noteworthy because, according to the Times article “it is uncommon for insider-trading investigations to involve FDA, despite the significant amount of market-moving information that passes through the agency each year. The agency maintains a rigorous ethics code and imposes significant restrictions on stock ownership and trading by its employees.”  The good news is that insider trading at FDA is rare and that a majority of its employee maintain ethical and moral standards that are consistent with the mission of the agency which is to supply the American public with safe and efficacious medicines. However, while the Liangs got caught, it does not mean that other less-than- scrupulous employees at FDA have also not benefited from less sophisticated insider trading schemes than those employed by the defendants. After all, FDA employees are human like the rest of us and the temptation to “get rich quickly” can be overwhelming especially during hard financial times.

Until next time...

Good Luck and Good Job Hunting (try FDA, there is at least one open position that needs to be filled)

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Last week, the US House of Representatives voted to cut FDA funding by $220 million. The House vote was not surprising given the prevailing attitude among many pharmaceutical and biotechnology company executives that FDA approval of new drugs and devices has become increasingly difficult. While there is no question that the current approval process for new drugs and devices has become more rigorous as compared with the incredibly lax process (and in some cases, the almost non-existent process) used during the Bush Administration, the FDA is simply fulfilling the mandate for the agency when it was created in 1938. That is: to provide the American public with SAFE and efficacious drugs to treat unmet medical need. 

Until recently, the FDA had been chronically under funded. And, because of this, the American public was forced to suffer through the Vioxx scandal, the heparin scare and the appearance on the market of many unapproved medical devices. These and other events that occurred over the past decade beg the question: “Should the American public’s safety be placed in jeopardy again simply because the Republican-controlled House is looking for ways to cut deficit spending?”

Unfortunately, the activity of anti-FDA lobbyists (funded mainly by US pharmaceutical and biotechnology companies) has been ramped up ever since the Democrats lost control of the House. And, since most Republicans believe that any government regulation whatsoever is too much regulation, it is easy to understand the House would vote to cut FDA funding. Nevertheless, insufficient funding will not allow the agency to hire the number of inspectors required to insure that drug manufacturing is conducted according to FDA-mandated regulatory guidelines. These activities are essential to insure the safety of the prescription drugs and medical devices sold on the US market.

According to FDA Current Good Manufacturing Practice (CGMP) guidelines, drug manufacturing plants for all approved drugs and devices are to be inspected every two years. Inspections are required for all manufacturing plants in the US as well as FDA-approved manufacturing facilities overseas. Because of ongoing shortages of FDA inspectors (and the emergence of numerous overseas manufacturing facilities), these inspections are typically conducted every three to five years rather than every two years! Clearly, this is not in the best safety interests of the American public.

A report published by the General Accounting Organization about the heparin scare of three years ago nicely sums up the issues.

“In its response to the heparin crisis, FDA took several actions related to its responsibility to protect the public health by ensuring the safety and security of the nation’s drug and medical device supplies. FDA increased its activities related to oversight of heparin firms by conducting inspections and investigations and monitoring heparin imports, and worked with drug and device manufacturers to recall contaminated products while ensuring that an adequate supply of uncontaminated heparin was available. With the help of external entities, FDA identified the unknown contaminant and developed tests to screen all heparin products. Additionally, the agency reached out to its international regulatory partners during the crisis. However, FDA faced some limitations in its efforts to inspect heparin firms in China and collaborate internationally, and the agency was unable to determine the original source of contamination.”

Interestingly, as today reported by the EyeonFDA blog, the U.S. House of Representatives Energy and Commerce Committee announced today that it was re-opening examination of the heparin contamination issue.  A letter was sent by the Chair of the Committee, Rep. Fred Upton (R-MI) as well as other members to FDA Commissioner Margaret Hamburg requesting that the agency supply all documents in connection with the heparin investigation from January 1, 2008 until present.  In its announcement, the Committee stated:

“It has been almost three years since the FDA linked deaths and serious allergic-type reactions of patients in the United States to supplies of heparin that came from the People’s Republic of China which was adulterated with overly sulfated chondroitin sulfate (OSCS). FDA officials believe this was an instance of economically motivated adulteration,” the members wrote. “However, neither the Chinese government nor the FDA has identified those responsible for the contamination or described how the heparin actually came to be contaminated.”

Mark Senak, author of  EyeonFDA blog aptly noted:

"It is certainly important in that any public health crisis involving the contamination of food or drugs be thoroughly investigated. But the investigating body can’t have it both ways. You can’t criticize an agency for not conducting inspections that are not funded by the same members of the same investigative body."

Is this any way to run a country?

Until next time...

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

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Sam Waksal, the former Founder and CEO of ImClone Systems who was convicted in 2003 of insider stock trading and spent about five years in prison is trying to make a comeback as a biotechnology entrepreneur.

Shortly after his release from prison, Sam started a new, privately-held, biotechnology company called Kadmon (a moniker taken from the Kabbalah). He reportedly was able to raise over $50 million in venture capital (much of it allegedly coming from Carl Icahn a long time investor, business partner and friend.*

Kadmon which has been operating in stealth mode for the past two years today announced that it had acquired Three Rivers Pharmaceuticals, a privately held company in Warrendale, PA that develops and sells drugs to treat hepatitis C infection. Three Rivers was acquired to provide Kadmon with an ongoing source of revenue to help develop other drugs. It sells versions of the drugs alpha interferon and ribavirin, mainstays of hepatitis C treatment.

According to a company spokesperson, Kadmon acquired Three Rivers for over $100 million. Previously, Kadmon quietly acquired PhytoCeutica a company developing a cancer drug derived from traditional Chinese medicine and Flux Therapeutics a company co-found by Thomas E. Shenk, PhD a Princeton University virologist. Coincidentally, Dr. Shenk works in the Carl Icahn Laboratories at Princeton University.

Despite his conviction for insider trading, Sam is a seasoned and successful biotechnology entrepreneur who almost single handedly brought the blockbuster anti-cancer drug Erbitux to market. Sam who has a PhD degree in Immunology from Ohio State University and  has a "leg-up" on many biotechnology entrepreneurs because he understand both science and business.  As you may recall, ImClone System (the company that he founded in the 1980s) was sold two years ago to Eli Lilly for $6.5 billion—a deal brokered by ImClone’s Chairman, Carl Icahn. 

Interestingly, Sam is prohibited by a settlement he made with the Securities and Exchange Commission from serving as a director or executive of a publicly traded company. It will be interesting to see whether or not Kadmon decides to remain private. I suspect that won’t be the case if the IPO window opens up a bit more over the next few years. Once biotechnology companies go public, there is no longer a need for entrepreneurial founders like Sam to stick around!

Until next time...

Good Luck and Good Job Hunting (try Kadmon, they have lots of cash)

 * An NY Times article published on Nov 1, 2010 contends that Carl Icahn had initially considered investing $30 million in Kadmon but ultimately decided to pass.

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Pfizer today announced that it will purchase Bristol, TN-based King Pharmaceuticals for $3.6 billion in cash or $14.25 per share: an approximately 40% premium over King’s closing share price yesterday.

King is a diversified specialty pharmaceutical drug delivery and clinical development company with expertise in delivery of easy to abuse or misuse pain medicines, self injecting delivery devices and animal health

The acquisition will help Pfizer push forward with its new emphasis on biopharmaceuticals and rare disease drugs; both currently require parenteral administration to patients.

The King acquisition is consistent with Pfizer’s M&A strategy to enter new therapeutic areas and markets. In the last 10 years or so Pfizer has acquired Warner Lambert, Pharmacia, Wyeth and several smaller companies including Sugen, Copely Pharmaceuticals, Encysive Pharmaceuticals, Serenex and others.

Whether or not Pfizer can successfully integrate King’s expertise and business units into its existing monolithic corporate structure remains to be see. Pfizer is still trying to right itself after it acquired Wyeth Pharmaceuticals for $65 billion early last year.

Big pharma companies—flush with cash—have been on a buying spree of late. Unfortunately, the availability of this cash is directly related to the massive downsizing and layoffs that have taken place in the industry over the past few years. That said, if I were a King employee, I would be dusting off my resume!

Until next time

Good Luck and Good Job Hunting

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Life sciences employers ranging from academic institution to private sector companies are increasingly turning to telephone interviews as an initial means to screen prospective job candidates. While in many instances these interviews are perfunctory, they are conducted for two main reasons. First, the employer wants to verify that the information presented by the candidate in his/her curriculum vitae is correct and accurate. Second, and perhaps more importantly, to determine whether or not a candidate has sufficient oral communications skills that warrant the cost necessary to bring a candidate in for a face-to-face on site interview. 

The use of telephone interviews has become increasingly popular because of the escalating costs associated with bringing candidates in for onsite interviews and a growing number of foreign born applicants applying for life sciences jobs. Put simply, a prospective employer can easily determine an applicant’s command of the English language and his/her immigration status in a telephone interview. Both immigration status (permanent resident or citizenship) and outstanding command of the English language have become of paramount importance to most life sciences employers over the past five years or so. However, it is important to note, that individual employers place different emphasis on the qualifications and skills of applicants for different job opportunities within an organization.

Like it or not, you may find yourself in the position of having to participate in a telephone interview before a decision is made on whether or not you may be invited to visit for an onsite interview. To that end, Pete Kistler, CEO of Brand-Yourself.com, recently posted a great piece that describes how to best prepare for a phone interview. He offers seven easy-to-follow tips that are likely to increase the probability of a visit for an onsite interview.

1. Use a landline. You don’t want to risk having problems with cell phone service. It is irritating for employers to conduct interviews if the call breaks up frequently or is dropped completely. If you don’t have a land line at home, just make sure you are in an area with as much cell phone service as possible. Do what you can so the process runs as smooth as possible.

2. Keep your materials handy. In fact, lay everything out in front of you. This includes your resume, notes about your career objective (even if it isn’t included in your original cover letter it’s a good idea to have this out depending on the questions he will ask you), a pen and pad of paper for note-taking and anything else you think may be helpful during your interview. Because you won’t have to schlep into an office, you can have anything out in front of you to aid with your success.

3. Steer clear of distractions. Find a quiet place to interview and stay there! There shouldn’t be any noise in the background to distract you or your potential employer. However, it is understandable that this can be tricky if you have young children at home who need your attention. When you set up your interview appointment, try to schedule it for as precise a time or window as possible. That way, you are able to avoid possible distractions (ex.: your phone interview is between 4 and 4:30, so no one can have company over during that time, the kids are fed and occupied or a sitter will watch them, if need be.)

4. Speak slowly and clearly. When you speak to people face-to-face, you are able to understand what they are saying more clearly because you can see their mouth move. So in a way, you are reading their lips! Neither you nor your potential employer will be able to do this over the phone of course, so speak clearly and a little bit more slowly than you would if you were talking to this person in person. If you can’t hear him, drop hints that he isn’t speaking clearly or loud enough by politely asking him to repeat himself. If this makes you uncomfortable at all you can always blame it on your phone: “I’m really sorry, it’s hard to hear you, the volume on my phone just won’t go up!”

5. Remember – you can’t be seen. That means that anything you say cannot be interpreted by your body language. Beware of jokes or sarcastic remarks that would have been harmless had he seen your facial expression. Maintain your professionalism; stay on target with the interview topics and focus on the key information about you that will get you hired.

6. No eating, drinking or chewing gum! This is self-explanatory. But, we humans are creatures of habit and might pop a potato chip in our mouths at just the wrong moment. However, when I say no eating or drinking I mean during the phone interview. You should eat beforehand to get your brain going so you can focus.

7. Prepare questions ahead of time. Just like in a personal interview, prepare a few questions to ask your potential employer at the end of your phone interview. Some examples are:

“What is the start date for the opportunity?”

“What software/equipment would I be using?”

Remember – do not ask about salary or benefits until the employer has brought it up.

Fortunately, it can be less intimidating interviewing over the phone with these telephone interview tips and you may even feel more confident that you’ll do well. Great! As long as you are fully prepared and take the necessary precautions, there is no reason why you shouldn’t have a successful phone interview.

Until next time....

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

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While attending the Advanced Learning Institute conference “Social Media and Pharma” earlier this week I happened to sit down next to Laura Lindsay, a member of Tarrytown, NY-based Regeneron Pharmaceuticals’ corporate communications team. Not surprisingly, we struck up a conversation and I learned that unlike most pharmaceutical and biotechnology companies Regeneron is looking to hire 500 new employee over the next year or so. Yes, you heard it correctly: 500 NEW EMPLOYEES. The company currently employs about 1,200 people.

Regeneron’s hiring spree is largely based on a lucrative research relationship with its partner Sanofi-Aventis and pending positive results from three Phase III clinical trials for several drugs that the company is developing to treat colon cancer, gout and macular degeneration. Industry analysts predict that approval of any or all of the three new drugs may allow Regeneron to Its products could eventually take on Roche Holding AG's $6 billion cancer drug, Avastin, and $3 billion Lucentis eye-disease medicine. The gout drug could attract annual sales of $500 million or more, analysts estimate.

Regeneron is currently not profitable and has one of the largest research budgets (in excess of $700 million) in the biotechnology industry. The 20 year old company sells only one product called Arcalyst; which was approved to treat rare genetic conditions such as Familial Cold Auto-inflammatory Syndrome (FCAS) or Muckle-Wells Syndrome (MWS). Arcalyst annually generates about $20 million in sales. Its current market capitalization is about $2.0 billion. Interestingly, I used to occasionally hang out with one of the company’s founders while I was a postdoc at Columbia Medical School.

While I don’t exactly know what types of jobs are available at Regeneron, you can easily find out for yourselves by visiting the company’s job search center. To learn more about Regeneron please click here.

If anybody out there knows of other life sciences companies that are hiring, please send me the information and I will post it!

Hat tip to Laura for the heads up!

Until next time...

Good Luck and Good Job Hunting (maybe things are really starting to turn around)!!!!!!!!!!!!

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In case you haven’t heard, the Business Development Institute is hosting its Second Annual Social Communications and Healthcare event next Tuesday, May 11, 2010 at the The Graduate Center of The City University of New York in midtown Manhattan, New York City. 

The meeting, which starts at 8:30 AM and continues until 1:00 PM, will consist of a serious of plenary talks followed by moderated round table discussions on a variety of social media and healthcare-related topics. Yours truly will be leading a roundtable discussion on non-promotional uses of social media in the life sciences industry.

Agenda

For more information, including registration, please click here to visit the event website. Or contact Steve Etzler at setzler@bdionline.com or 212-765-8045.

BioJobBlog readers can use promo code BC for a discounted rate of $155.

I hope to see you at next week's meeting!!!!

Until next time …

Good Luck and Good Tweeting!!!!!!

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Merck of Germany announced on Sunday that it had agreed to purchase Millipore, an American supplier of laboratory products and reagents for biotechnology companies for $7.2 billion. The offer comes in the wake of the $6.0 billion offer made last week by Thermo Fisher Scientific one of the largest supplier in the world of laboratory reagents, supplies and equipment. While somewhat of an unconventional move for a healthcare company, Merck executives hailed the acquisition as a strategic move for customers, stakeholders and share holders of both companies.

In other news, Astellas Pharmaceuticals, Japan’s second largest pharmaceutical company said today that it tendered an offer to acquire all outstanding shares of Long Island, NY-based OSI Pharmaceuticals for $52.00 per share or approximately $3.5 billion in cash. OSI, which manufactures and sells Tarceva (erlontinib) a treatment for non-small cell lung and pancreatic cancer (which it co-markets by Genentech in the US and globally with Roche), has a strong oncology pipeline and is also developing treatments for diabetes and obesity. Despite early success with Tarceva, cash-starved OSI has been struggling of late. The acquisition of OSI provides Astellas with a strong pipeline and entrée into the growing US oncology market. OSI would also complement Astellas’ existing strength and franchises in urology and immunology.

While mergers and acquisitions were largely anticipated in the US biopharmaceutical sector over the past few years, the acquisition of American companies like Millipore and OSI Pharmaceuticals by foreign companies suggests that there may be chinks in the armor of once dominant US biotechnology companies. The economic crisis coupled with America’s waning innovation in the life sciences sector suggests that other US-based biopharmaceutical companies may be at risk. Although most foreign governments stumbled when attempting to develop the own internal biotechnology expertise, many cash-rich foreign companies recognize that purchasing US companies with marketed products offers them an opportunity to quickly and strategically gain a foothold in the ever-expanding biotechnology market.

Until next time....

Good Luck and Good Buying!!!!!!!!!

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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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Life sciences employers ranging from academic institution to private sector companies are increasingly turning to telephone interviews as an initial means to screen prospective job candidates. While in many instances these interviews are perfunctory, they are conducted for two main reasons. First, the employer wants to verify that the information presented by the candidate in his/her curriculum vitae is correct and accurate. Second, and perhaps more importantly, to determine whether or not a candidate has sufficient oral communications skills that warrant the cost necessary to bring a candidate in for a face-to-face on site interview. 

The use of telephone interviews has become increasingly popular because of the escalating costs associated with bringing candidates in for onsite interviews and a growing number of foreign born applicants applying for life sciences jobs. Put simply, a prospective employer can easily determine an applicant’s command of the English language and his/her immigration status in a telephone interview. Both immigration status (permanent resident or citizenship) and outstanding command of the English language have become of paramount importance to most life sciences employers over the past five years or so. However, it is important to note, that individual employers place different emphasis on the qualifications and skills of applicants for different job opportunities within an organization.

Like it or not, you may find yourself in the position of having to participate in a telephone interview before a decision is made on whether or not you may be invited to visit for an onsite interview. To that end, Pete Kistler, CEO of Brand-Yourself.com, recently posted a great piece that describes how to best prepare for a phone interview. He offers seven easy-to-follow tips that are likely to increase the probability of a visit for an onsite interview.

1. Use a landline. You don’t want to risk having problems with cell phone service. It is irritating for employers to conduct interviews if the call breaks up frequently or is dropped completely. If you don’t have a land line at home, just make sure you are in an area with as much cell phone service as possible. Do what you can so the process runs as smooth as possible.

2. Keep your materials handy. In fact, lay everything out in front of you. This includes your resume, notes about your career objective (even if it isn’t included in your original cover letter it’s a good idea to have this out depending on the questions he will ask you), a pen and pad of paper for note-taking and anything else you think may be helpful during your interview. Because you won’t have to schlep into an office, you can have anything out in front of you to aid with your success.

3. Steer clear of distractions. Find a quiet place to interview and stay there! There shouldn’t be any noise in the background to distract you or your potential employer. However, it is understandable that this can be tricky if you have young children at home who need your attention. When you set up your interview appointment, try to schedule it for as precise a time or window as possible. That way, you are able to avoid possible distractions (ex.: your phone interview is between 4 and 4:30, so no one can have company over during that time, the kids are fed and occupied or a sitter will watch them, if need be.)

4. Speak slowly and clearly. When you speak to people face-to-face, you are able to understand what they are saying more clearly because you can see their mouth move. So in a way, you are reading their lips! Neither you nor your potential employer will be able to do this over the phone of course, so speak clearly and a little bit more slowly than you would if you were talking to this person in person. If you can’t hear him, drop hints that he isn’t speaking clearly or loud enough by politely asking him to repeat himself. If this makes you uncomfortable at all you can always blame it on your phone: “I’m really sorry, it’s hard to hear you, the volume on my phone just won’t go up!”

5. Remember – you can’t be seen. That means that anything you say cannot be interpreted by your body language. Beware of jokes or sarcastic remarks that would have been harmless had he seen your facial expression. Maintain your professionalism; stay on target with the interview topics and focus on the key information about you that will get you hired.

6. No eating, drinking or chewing gum! This is self-explanatory. But, we humans are creatures of habit and might pop a potato chip in our mouths at just the wrong moment. However, when I say no eating or drinking I mean during the phone interview. You should eat beforehand to get your brain going so you can focus.

7. Prepare questions ahead of time. Just like in a personal interview, prepare a few questions to ask your potential employer at the end of your phone interview. Some examples are:

“What is the start date for the opportunity?”

“What software/equipment would I be using?”

Remember – do not ask about salary or benefits until the employer has brought it up.

Fortunately, it can be less intimidating interviewing over the phone with these telephone interview tips and you may even feel more confident that you’ll do well. Great! As long as you are fully prepared and take the necessary precautions, there is no reason why you shouldn’t have a successful phone interview.

Until next time....

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

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As Jonathan Richman, author of the Dose of Digital blog focused on pharmaceutical marketing aptly put it, its time to “stop talking about social media.” “To recap, in 2009 we demanded the FDA call a hearing to discuss social media…and they did! We wrote and read hundreds, if not thousands, of articles on social media. We transformed (read: hijacked) every digital marketing conference into a social media conference. We launched a ton of social media programs even if they represent a conservative start.”

While I am still an ardent social media enthusiast and supporter, I agree with Jonathan that it may be time to sit back, relax and reflect a little bit until FDA enlightens us with their first round of guidance on social media and the life sciences industry. Having said that, I am certain that the agency’s first iteration will provide us bloggers with sufficient fodder to write about and ignite round 2 of the discussion. In the meantime, @Skypen of Ignite Health graciously created a website called Everything About the FDA, Internet & Social Media that provides updates, commentary and even tweets (#FDASM) about FDA progress or lack thereof.

I think that social media has a role to play in the life sciences industry. However, the role has yet to be defined mostly because of the lack of regulatory guidance in the area.

Until next time...

Good Luck and Good Tweeting!!!!!!!!!

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The holiday season is officially over and its time to face the prospects of a new year! The good news is that the economy is recovering and new job opportunities are beginning to appear at an increasing rate. To that end, it may be a good time to re-evaluate your career options and fine tune every element of your ongoing job search. The most obvious activities include updating your resume (assuming that things have changed since 2009), resuming your networking activities and looking online for new job prospects. However, Phyllis Korkki, a New York Times career columnist, offers some other hints that may help to improve your 2010 job search and hopefully land a new one!

 Until next time...

Good Luck and Good Job Searching!!!!!!!!!!!

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The generic drug industry didn’t exist until the passage of the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments). This piece of legislation, better known in the pharmaceutical industry as the Hatch-Waxman Act, was proposed and adopted by the US Congress because of the escalating costs of brand name drugs manufactured by large pharmaceutical companies (sound familiar?). The act provided the US Food and Drug Administration (FDA) with a regulatory pathway to approve and bring to market “generic” versions of branded drugs that lost patent protection. During the debate over the amendment, and for many years thereafter, branded pharmaceutical manufacturers tried to stifle the growth of the generic drug industry by suggesting that generic versions of their branded medications were unreliable and unsafe. This tactic was partly responsible for the stinted growth of the generic pharmaceutical industry until the mid 1990s when the price of branded pharmaceutical drugs began to skyrocket and insurance companies began to realize that something had to be done to manage rising drug reimbursement costs. To that end, insurers and third party payors began requiring patients to use generics (when available) instead of branded products to cap rising prescription drug costs. Because of this, the generic industry has grown by leaps and bound over the past decade and now threatens the stability of the branded pharmaceutical industry! 

Unfortunately, while increased generic drug use may be good for generic drug manufacturers and insurance companies, it isn’t always in the best interests of patients who use prescription medications. For example, there are a growing number of stories and complaints from patients who were forced to switch from a brand name drug to a generic one and had side effects, or found that their symptoms returned or may have been worse than before. In fact, this happened to my mother who was switched from a brand name pain reliever that worked to a generic version that no longer controlled her symptoms and induced some untoward side effects. Scientifically, there ought to be little difference in the efficacy, safety or tolerability profiles of a branded drug and its generic equivalent. This is because both medications contain the same active pharmaceutical ingredient. However, differences in the formulation of the branded and generic versions of the drugs may be responsible for reduced efficacy or safety and tolerability issues.

While clinical studies conducted by the insurance industry suggest there are no safety or tolerability differences between brand name and generic drugs and the American Medical Association’s assertion that, as a whole, generic drugs do work as well as branded drug, there is some evidence to suggest that some generic drugs may not be interchangeable or substitutable for certain branded medications. This appears to be the case for certain drugs that are used to treat neurological conditions and mental health diseases like seizures, depression and bipolar disease. Lesley Alderman, in an article she wrote in today’s New York Time business sections provides excellent examples of this.   

The problems with some generic drugs may arise as a result of the approval process for this class of drugs. According to provisions outlined in the Hatch Waxman Act which stipulate that a generic version must have the same active ingredient, strength and dosage form as the brand name drug or reference product. The generic version must also be demonstrated to be “bioequivalent” to the brand name drug. This means that the generic product must be shown to reach blood levels (drug concentration) that are very similar to the brand name product. This is usually determined by administering the generic and brand name drugs to a relatively small number (24 to 36) of healthy human volunteers. Generally speaking, once bioequivalence is established it paves the way for regulatory approval of the product. Typically, once approved, many generics receive what is known as an AB rating. Generics that are AB-rated can freely be substituted (by a licensed pharmacist) for a brand name product even though the physician may have written the prescription for the branded product.

In the past, patients were usually given a choice between a generic and a brand name drug —a decision that was largely based on the percentage of the cost of drug that would be covered by insurance. These days, patients no longer have a choice and are generally forced to use generic drugs rather than brand name products based on formulary lists compiled by insurance companies. While I am not practically or philosophically opposed to using generic drugs, there is a growing body of evidence which suggests that not all patients respond the same way to branded and for that matter generic drugs. Therefore, I contend that allowances ought to be made for these differences and patients who don’t respond to (or experience side effects) after taking generics shouldn't’t be denied access to the branded product that, in most cases, was originally prescribed by that patient’s physician. It is one thing to cut costs; it is another to increase a patients suffering or anxiety. If you are concerned about switching from a branded medication to a generic, please read this for some helpful tips and guidance.

Until next time...

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

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The Belgian chemical manufacturer Solvay announced today that it had agreed to sell its pharmaceutical business unit to Abbott Pharmaceuticals for $6.6 billion. By purchasing Solvay, Abbott gains access to emerging markets in Eastern Europe and Asia along with new therapeutic areas, including hormone therapies and vaccines. Solvay's flu vaccine Influvac will give Abbott an entrant in the burgeoning vaccines market, which is currently dominated by European pharmaceutical giants like GlaxoSmithKline and Novartis.

Abbott already holds U.S. marketing rights for Solvay's Trilipix and TriCor, drugs which raise "good" HDL cholesterol while reducing triglycerides and "bad" LDL cholesterol.

Solvay's other top-selling drugs include the Parkinson's disease treatment Duodopa and hormone therapy drugs AndroGel and Duphaston. It is not clear whether or not the Solvay purchase will affect ongoing pharmaceutical operations or staffing decision in the US. However, I suspect that there will be management changes and layoffs in Europe.

In other news, Johnson & Johnson bought an 18 percent stake in Dutch biotechnology company Crucell NV, which is trying to develop a universal flu vaccine, while competitor Merck acquired the rights to sell Australia-based CSL Ltd.'s Afluria flu vaccine in the U.S.

The Solvay deal is the latest in a string of mergers and acquisitions, as cash-rich pharmaceutical companies race to acquire new products amid looming patent expiry on blockbuster drugs. Earlier this year Swiss drugmaker Roche acquired Genentech following similar deals uniting Pfizer Inc. and Wyeth, and Merck & Co. Inc. with Schering-Plough.

Expect more M&A activity in the life sciences sector before year’s end.

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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I suspect that a majority of BioJobBlog readers have at one time or another been prescribed a drug to treat a particular medical condition or ailment. Like most of you, I assumed that my prescription information and history was private and that only healthcare professionals were privy to it. However, after reading an article in this Sunday’s NY Times, I learned how wrong I was! Much to my dismay,  I learned that prescription information including the name and dosage of a drug, the name and address of the physician who prescribed as well as a patient’s address and social security number is a commodity that is regularly bought and sold usually with a patients’ knowledge or permission. And apparently, this practice is perfectly legal as long as patient’s names are removed or encrypted before the information is sold, typically to drug manufacturers.

Unfortunately, privacy experts and information technology specialists contend that it isn’t difficult to match names, addresses, and social security numbers to reconstruct information that had supposedly been rendered anonymous. To make matters worse, until very recently, federal patient privacy and data security rules were loosely enforced and frequently abused by medical marketers, advertisers, drug manufacturers and retail pharmacies. Finally, re-identifying a patient’s prescription drug information and history provides drug makers with a powerful tool to target and market drugs to specific patient populations.

Tracking prescriptions and mining prescription data is not new—it has been big business for many decades. The major players in the drug mining business are companies like IMS Health, Verispan and CVS Caremark. Also, large discount pharmacy retailers like Walgreens and Target engage in this practice and they all sell their prescription information data to interested parties. Prescription drug data-mining companies say that their services are valuable and warranted because gathering and analyzing information from tens of thousands of patients helps drug manufacturers to identify trends and potential safety and tolerability issues with prescription drugs. Nevertheless, despite assertions that prescription drug data are anonymous when it is sold, class action and private lawsuits alleging this not to be the case have been filed against some of the major players including Walgreens, IMS Health and CVS Caremark. While this is troubling, loopholes in the current prescription drug data mining regulations allow pharmacy companies like Walgreens and others to accept money from drug manufacturers to mail advice and reminders to customers to take their medications without first obtaining their permission. The loopholes also allow drug makers to send customers’ promotional information and materials about drugs other than the ones that they are already taking.

Under the Obama Administration’s $19 billion healthcare stimulus package, selling prescription drug data to drug makers will still be allowed (only if patient’s names are removed). Also, subsidized marketing by drug makers will be allowed to continue but companies will no longer be able to promote drugs other than those the customer already buys. While the new legislation allows data mining and the sale of prescription drug information to continue, its primary goal is to tighten and insure patient privacy so that personal prescription drug history and information can no longer be used to exploit the buying habits and behaviors of individual American consumers.

Until next time...

Good Luck and Good Job Hunting!!!!

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Eli Lilly & Co. is offering buyouts to 4,000 U.S. sales representatives to eliminate several hundred jobs and restructure its operations. Sales representatives will be offered four months' pay in addition to the typical Eli Lilly severance package, which ranges from two to 18 months' salary depending on seniority. The company had a total of 40,500 employees at the end of 2008.

Lilly’s best-selling drugs include Zyprexa for schizophrenia and bipolar disorder, Cymbalta for depression, Byetta for type 2 diabetes, and Evista for osteoporosis. The patent supporting Zyprexa, which bought in $4.7 billion in revenue last year, will expire in 2011. The patents on the company's next three top drugs —Cymbalta, Humalog insulin, and cancer drug Gemzar —are set to expire in 2013.

The restructuring is expected to start in mid-November and take effect in January.

Sales reps and R&D scientists have suffered the most during pharma’s recent three year downsizing binge. While many R&D jobs have been shipped overseas, pharma sales reps might consider a new career in biotechnology drug sales. Growth in biotechnology and personalized medicine drugs is expected to increase for the foreseeable future.

Until next time...

Good Luck and Good Job Hunting!!!!!

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The “Social Media and Healthcare” conference that will be held on July 23, 2009 in NYC at the Graduate Center of The City University of NY (365 Fifth Avenue at 34th Street) is shaping up to be a great one. At present, over 350 people have registered for the meeting. There are a few slots left if you are interested in attending.

Several BioJobBlog readers have asked whether or not the sessions will be recorder and available online. Steve Etzler, one of the conference organizers told me that Blogtalkradio.com will broadcast and archive the audio from all of the case studies that will be presented during the morning sessions. Unfortunately, the round table discussions won’t be available.

As I may have mentioned, Cliff Mintz, Co-Founder of BioCrowd will be leading a roundtable discussion entitled “Building Social Networking Sites for Bioprofessionals.”

See you on Thursday!!!

Until next time....

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BioJobBlog and BioCrowd along with the Business Development Institute, the Journal of Communication in Healthcare and others are co-sponsoring a meeting entitled “Social Media and Healthcare” that will be held on July 23, 2009 in NYC at the Graduate Center of The City University of NY (365 Fifth Avenue at 34th Street). Topics that will be covered include:  

1. Managing regulatory and legal issues when planning and implementing social media strategies
2. Is there a role for social media in President Obama’s healthcare reform plans?
3. Why real-time social media tools like Twitter are gaining momentum and when it makes sense to use them
4. How social media has affected crisis communications in the healthcare industry
   
5. Selling social communications projects and proving ROI to senior management
   
6. Creating and participating in communities to achieve communication, educational and branding objectives
7. Planning and executing a social communications plan with little or no budget
8. Building relationships and partnerships with new healthcare media leaders beyond advertising
9. Best practices for using social communications to connect internally with employees and stakeholders
   
10. Tools, technologies, and best practices for monitoring and measuring social communications

The meeting’s agenda features case study presentations and a series of roundtable discussions on social media topics. I will be leading a roundtable discussion called “How to Build a Social Networking Site for Bioscientists.” Approximately 300 senior marketing, communications and media professionals from Fortune 1000, middle market and emerging growth companies are expected to attend from leading pharmaceuticals, medical technology/device companies, managed care providers, hospitals, healthcare media companies, government and nonprofit organizations.  

BioCrowd members can register for the meeting at a discounted rate of $155. Check it out—it will be money well spent!

Hat tip to Steve Etzler at the BDI and Mario R. Nacinovich Jr., Editor-in-Chief, Journal of Communication in Healthcare for organizing this topical and important meeting.

I hope to see you at the meeting next Thursday!!!!

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The drug maker Eli Lilly and Co quietly launched a new website today for a program dubbed Lilly Phenotypic Drug Discovery Initiative or PD². According to the company, “The PD² initiative is a unique opportunity for investigators from external institutions to submit proprietary compounds for potential screening in Lilly's phenotypic assay panel. This highly collaborative process is enabled by a web-based application that facilitates efficient transfer of information between Lilly and the investigator. The PD² screening panel is currently comprised of five modules which are relevant to therapeutic areas of long-term strategic interest, including oncology, neurological disorders, and metabolic diseases. This panel may change over time to reflect additional research interests.”

Company officials believe that program will allow it to evaluate and possibly license treatments from biotech companies and academic institutions "that are never fully evaluated as potential drug candidates." The launch of the PD² website—perhaps the first of its kind—clearly sends a signal that pharmaceutical companies are reducing their reliance on internal discovery programs to identify prospective new molecular entities and are eager to enter into licensing deals to find and acquire them. 

Membership in the PD² requires that a legal representative from the investigator's academic institution or biotech company executes a Material Transfer Agreement (MTA). Once the MTA is reviewed and approved by Lilly officials, the institution can create an account. Until that time, use of the site is limited to browsing only. I have no doubt that technology transfer offices at most major universities will be signing up for membership in short order.

I think the PD² initiative is an innovative and timely one given the massive reductions in R&D jobs that have taken place at many pharma companies over the past two years. Expect other pharma companies to follow Lilly’s lead.

Until next time....

Good Luck and Good Job Hunting!!!!!

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Carl Icahn, former corporate raider, hedge fund owner and activist investor, is still trying to exert his influence at Biogen/IDEC a biotechnology company in which he owns 5.6 percent of its outstanding shares of stock.  As you may recall, last year, Mr. Icahn tried to wrest control of the Biogen/IDEC board to force the company to put itself up for sale. That attempt failed but yesterday Mr. Icahn was managed to get two of his allies appointed to the Biogen/IDEC board of directors at the company's annual shareholder meeting.

Mr Icahn has long contended that Biogen/IDEC's management team is inhibiting growth and squandering shareholder value. Wall Street analysts predict that Carl will push hard to split the company into two separate entities: one focused on neurobiology (Biogen/IDEC is a market leader for drugs designed to treat Multiple Sclerosis) and the other on cancer.  Another scenario suggests that he will leave the company intact and find a buyer for it--similar to the plan that he attempted to implement last year.

The Biogen/IDEC news follows quickly on the heels of a management coup that he orchestrated at Amylin Pharmaceuticals earlier in the week. On Tuesday, Mr Icahn, along with the hedge fund Eastbourne Capital management, were successful in ousting Amylin's Chairman Joseph C. Cook, Jr. and director James N. Wilson. Mr. Icahn exerted his influence at Amylin because he felt that sales of its key diabetes drug Byetta were too low.  Others believe that he is preparing the company for sale to Eli Lilly which co-markets Byetta with Amylin.

Mr Icahn is certainly no stranger when it comes to maximizing shareholder value at biotechnology companies where he holds substantial stock positions.  Last year, he orchestrated the sale of ImClone to Eli Lilly after getting into a protracted bidding war with Bristol Myers Squibb (BMS) over the cancer drug Erbitux.  At that time, BMS had an exclusive marketing agreement with Imclone for US sales of Erbitux.

Whether or not you like Carl, he is very good at what he does. And, in the end, he has a gift for maximixing shareholder value of companies that he and others have invested in!

Until next time...

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

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There has been no shortage of conversation lately about current problems facing the pharmaceutical and biotechnology industries. These industries are faced with the effects of the global recession because of a dangerous combination of falling revenues and spiraling costs. Life sciences company executives are looking for ways to cut production costs and cope with the current decline in drug sales.

“Social networking sites are great to catch-up with old friends, share photographs, music and links but in this climate does the executive community have time for this?” asked Spencer Green CEO of MeettheBoss.com “Credit isn’t the only casualty of the crunch: time is another scarce resource for executives, they need immediate value when online to inform stakeholders and update the public on need developments.

MeettheBoss.com, first launched for the financial services sector in 2008, has just unveiled a new and improved version – redesigned with increased functionality and features, and specifically launched to keep life sciences professionals abreast of late breaking news and trends in the industry. Free Video Roundtables, executive broadcasts and “smartwords” are some of the new functions for the executives to communicate with stakeholders and the public at large. More importantly, it provides instant access to a network of your peers. Also included in the new launch is an upgraded version of MeettheBossTV,an online television channel dedicated to business leaders. The first week of MeettheBoss pharma will feature John Earley, global head of lean and supply at AstraZeneca and Steve Dreamer, VP and head of engineering at Novartis.

While similar to BioCrowd, a social and business networking site for ALL bioprofessionals, MeettheBoss.com is almost exclusively focused on the "goings on" in the pharmaceutical industry.

Please drop me a line and let me know whether or not you like MeettheBoss

Until next time...

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

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Roche announced Tuesday that it will replace Arthur Levinson, PhD, Genentech’s current CEO and American biotechnology pioneer, with Pacal Soriot, DVM, MBA who currently leads Roche’s worldwide commercial operations.  Dr. Levinson will become Chairman of Genentech’s newly configured board of directors but no longer have control over day-to-day operations at the company.  Mr. Soriot will become CEO of Genentech and head all of Roche’s pharmaceutical activities in the US. Some of the other changes that will occur at the company include: Susan Desmond-Hellmann, Genentech’s president of product development, will move into an advisory role after the middle of this year. Genentech CFO David Ebersman is leaving the company and Ian Clark, who heads commercial operations for Genentech, will be chief marketing officer of Roche’s pharma division.

Dr. Levinson and Mr. Soriot will lead the efforts to combine all of Roche’s North American operations which ultimately will be run from Genentech’s South San Francisco location. Many of the activities at Roche’s previous North American headquarters in Nutley, NJ will move west, which means downsizing, more layoffs and possible closure of the Nutley site. 

Dr. Levinson, one of Genentech’s early employees, joined the company as a senior scientist in 1980 and has been its chief executive since 1995. During his tenure, Genentech became the largest, most profitable and perhaps the most innovative biotechnology company in the US. Unlike Dr. Levinson, who is a molecular biologist and has over 30 years of experience in developing successful protein-based drugs, Dr. Soriot, a former Sanofi-Aventis financial and commercial operations executive has little or no experience with biotechnology products.

With this in mind, I suspect that many things will change at Genentech as Roche attempts to transform the once heralded biotechnology company into a subsidiary of its pharmaceutical division. Don’t be surprised if you see a mass exodus from company. Farewell DNA, all good things must end!

Until next time...


Good Luck and Good Job Hunting (try Genentech, there will be openings soon)
 

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As you all know by now, Merck announced on Monday that it will purchase Schering Plough for $41.1billion in a deal constructed as a reverse merger. The reverse merger strategy was concocted to prevent the new company from losing the international sale rights to Remicade, Johnson and Johnson’s lucrative, blockbuster rheumatoid arthritis drug. According to the original deal inked by Johnson and Johnson and Schering Plough, Schering would have to surrender its rights to Remicade— which generated $2.1 billion in sales outside of the US last year —and golimumab (which is pending approval in Europe) if current ownership of Schering changes. Golimumab (CNTO 148) is Johnson and Johnson’s Centocor division next-generation human anti-TNF-alpha monoclonal antibody be developed as monthly subcutaneous treatment for adults with active forms of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.  Since the merger was announced on Monday, Johnson and Johnson hasn’t issued any public statements about the deal—prompting some analysts to speculate that Johnson and Johnson may well make a counteroffer to acquire Schering Plough. Others believe that Johnson and Johnson will challenge the new company’s international rights to Remicade and golimumab despite the great lengths that Merck and Schering Plough management went to structure the acquisition as a reverse merger. Stay tuned for updates.

In other merger news, US-based Gilead announced that it will acquire CV Therapeutics for about $1.4 billion. The deal tops the hostile takeover offer from Astellas Pharma of Japan. Gilead, an HIV drug manufacturer is purchasing CV Therapeutics—which sells the cardiovascular drugs Ranexa (chronic angina) and Lexican (reduces stress during cardiovascular surgical procedures)—to expand its therapeutic repertoire beyond virology. The stock prices of shares of Gilead and CV Therapeutics jumped after the announcement signaling Wall Street’s approval of the deal.   Nevertheless, it may be premature for Gilead and CV Therapeutics to begin celebrating—Astellas may very well tender a counteroffer!

Until next time...

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

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Late Thursday, after 8 months of difficult and often acrimonious negotiations, Genentech’s board finally caved and agreed to allow Roche to purchase the remaining 44% of the outstanding Genentech shares that it doesn’t already own. The price: $95 per share—less than the $112 per share that Genentech’s board and management team wanted —but better than the $86.50 per share that was tendered last fall.

While Roche contends that it will continue to run Genentech as an autonomously operating business unit, many Genentech employees are dubious. I suspect that many DNA (Genentech’s stock symbol) employees will embrace a “wait and see” attitude before any decisions are made about whether or not to stay at the “new company.” Roche’s greatest challenge will be integrating the two companies without ruining Genentech’s innovative culture and immediately sending its best scientists and management team out the door. Pharma and biotech corporate cultures are very different from one another and many biotech employees find it difficult to adapt to big pharma’s slow-moving and anachronistic approach to drug development. As previously reported, US business operations of both companies will be based at Genentech’s headquarters in South San Francisco, CA rather than in Nutley, NJ, where Roche’s American business is currently based. This is not good news for many of Roche’s Nutley employees. Roche has been trying unsuccessfully for years to jettison the Nutley site and it seems likely now. Don’t be surprised if you see a mass exodus at the Nutley site. All of Roche’s US products will be sold under the Genentech brand.

Roche’s purchase of Genentech, America’s oldest biotechnology company (started in 1976) and considered by many to be the crown jewel of the industry, truly signals the end of an era. Let’s hope that another “Genentech” (and others like it) emerge as the US biotechnology industry continues to evolve in the 21^st century.

Until next time...

Good Luck and Good Job Hunting!!!!!

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Merck announced today that it was buying Schering Plough, the Kenilworth-New Jersey based drug maker, for $41.1 billion. The deal comes only six weeks after Pfizer said that it would purchase NJ-based Wyeth Pharmaceuticals. Superficially, the deal may make sense for the two struggling drug makers—they co-market the cholesterol-lowering drug Vytorin and also have collaborations in the respiratory diseases area. Also, Schering Plough has the European rights to the anti-arthritis drug Remicade and its 2007 purchase of the Dutch biopharmaceutical company Organon Biosciences NV provides access to several potential biotechnology drugs. Nevertheless, the impending merger will ultimately result in job losses and higher unemployment in the state of New Jersey.

Merck currently employs 55,200 workers and Schering-Plough—which grew significantly with its purchase of Organon—also has about 55,000 employees. While no immediate job cuts are planned, a company spokesperson acknowledged that the size of the combined workforce will be reduced by approximately 15%-20% over the next year or so. This means that as many as 20,000 pharmaceutical employees may lose their jobs—a time when unemployment in NJ is approaching 10 percent! My sources tell me that Merck employees are already on edge because of surprise layoffs that occurred in early September, 2008. I suspect that employee anxiety will be extremely high at both companies for the foreseeable future—never a good thing from a productivity point of view.

According to press releases, Schering-Plough's shareholders will get $10.50 in cash and 0.5767 Merck shares for each Schering-Plough share they own. That's a 34 percent premium to Schering-Plough's closing stock price on Friday. Merck's top executive, Chairman and CEO Richard Clark, will lead the combined company, which will attempt to remain a dominant player in treatment areas including cholesterol, respiratory, infectious disease and women's drugs, as well as vaccines. Schering-Plough's CEO, Fred Hassan, will participate in planning integration of the two companies until the close of the deal, which is expected in the fourth quarter. The transaction is to be structured as a reverse merger. Schering-Plough will be the surviving corporation but will take the name Merck. The new company will remain at Merck's headquarters in Whitehouse Station, N.J. and a company spokesperson indicated that a "substantial majority" of employees of Schering-Plough will remain with the newly-formed company. The combined revenue of both companies in 2008 was $47 billion.

Mr. Hassan, a talented, “turn-around” pharmaceutical executive, took over Schering-Plough six years ago as chairman and CEO—a time when the company was struggling with a $500 million fine (the largest ever at the time) imposed by the US Food and Drug Administration because of chronic manufacturing problems. While Schering-Plough is now in much better financial shape than when Mr. Hassan first arrived at the company, its stock price is currently almost identical to the price when he took over (it lost 50% of its value in the past 18 months). Let’s see whether or not Richard Clark, Merck’s current Chairman and CEO, has the mettle to run the combined company. While Schering-Plough has long been rumored to be a takeover target, I don’t think that the Merck-Schering Plough deal is a particularly good or strategic one. Both companies have been struggling of late because of near empty drug pipelines and the ongoing brouhaha over Zetia, Vytorin and Merck’s Vioxx. Further, both companies face price reductions and slumping sales in the next year or so because several blockbuster drugs will lose patent protection and face stiff competition from generic drug manufacturers.

Like the Pfizer-Wyeth deal, the Merck-Schering Plough merger may little more than a red herring. I still fail to see how merging two oversized, struggling pharmaceutical companies can possibly result in the creation of a single successful one. The only upside of the deal is that it allows the newly-formed company to restructure operations, eliminate tens of thousands of jobs and cut costs to bolster its stock share price. That said, I don’t think that an artificially-inflated stock share price necessarily translates into the innovation that historically has been required to create new drugs to treat unmet medical needs!

Until next time...

Good Luck and Good Job Hunting (avoid NJ at all costs)!!!!!!!

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For the past decade or so, I have worked as a career counselor at national scientific meetings where I present seminars about resume writing, interviewing techniques and other career related issues. About two years ago, I started to hear about the fierce competition for H-1 and J-1 visas that foreign students must obtain to remain in the US to continue their studies and research. Many of the foreign students that I talked with sounded more like immigration lawyers than graduate students or postdocs—I was amazed at how well informed they were about visa availability and the changes and loopholes in US immigration law that can be exploited to obtain visas.

Since that time, it has become increasingly apparent that the visa problems experienced by most foreign students are beginning to wreak havoc on US science and engineering. Curiously, nobody at the US State Department seems to know why these visa problems exist. According to an article in today’s NY Times, a State Department official claims that visa delays can be attributed to “unfortunate staffing shortages.” Many of the students (and some immigration lawyers) that I talked with believe that it is annual visa limits and quotas not staffing issues that make it so difficult to obtain them.

It is no secret that American middle and high school students are no longer interested in pursuing careers in science and engineering. Because of this, American universities have come to rely on foreign students to fill open slots in graduate and postdoctoral sciences and engineering programs. With this in mind, it should come as no surprise that, over the past decade or more, foreign talent has been largely responsible for much of the technical and scientific innovation in the US.  Finally, and perhaps most importantly, American universities can no longer assume that the US is the first choice or destination for many foreign undergraduate, graduate and postdoctoral students—teaching and research at many foreign universities have vastly improved in recent years and can now compete with the best research institutions in the US.  In the past, it was largely assumed that when given a choice foreign student would choice a US university over all others. Together these findings beg the question: “If foreign students and postdocs are largely responsible for maintaining America’s competitive edge in science and technology, why would the US government make it so difficult to recruit the world’s best and brightest?”

There is no doubt that the US government, in a post-September 11^th world ought to carefully scrutinize foreign students before they are issued visas to study or work in the US. But, why has it become increasingly difficult for foreign students to renew their visas to continue to study or work in the US? Interestingly, visa availability and renewal problems are not only restricted to foreign nationals from likely places like China, India, the Middle East or Russia.  Many students and postdocs from Australia, Europe and elsewhere are also experiencing major delays and difficulty obtaining student or work visas.

While the visa issues facing foreign students may not seem like a big one to most Americans (most of who are not involved in science and engineering), its effects on American science and engineering are beginning to become apparent. For example, conference organizers are reluctant to hold international meetings in the US because they fear that many students and scientists will not be able to attend because of limited visa availability. Further, many talented foreign nationals, who want to remain and work in the US, are frequently forced to return to their home countries (to find employment) because they are unable to renew or extend their US visas. There is no question that America has grown increasingly dependent upon foreign students to conduct research in science and engineering.  I contend, that without these students, America’s competitiveness in science and engineering will continue to wane as it has over the past 20 years.  I believe that America has two choices to prevent this from happening. First, we can somehow convince larger numbers of American high school students to pursue careers in science and engineering. Second, the US government can improve and simply the visa process so that talented foreign students can continue to study and do research in the US. Nevertheless, something must be done soon—the future competitiveness of American science and engineering depends on it!

Until next time...

Good Luck and Good Visa 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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Like it or not, the best way to land a new job whether or not there is a recession is to network. While career counselors and recruiters trumpet the virtues of networking to job seekers, many people really don't understand what it is or how to do it correctly. I found an outstanding article that demystifies networking and offers tips on how to excel at it. 

For many scientists, online networking is ideal because they frequently lack the requisite skills to effectively network in real life situations. Until recently, face-to-face networking at conferences or "professional social events" was the only way to effectively network. However, the advent of web-based social networks allows job seekers to eschew the awkwardness and time requirements for  one-on-one networking in favor of a more convenient and less-threatening online experience. BioCrowd, a new online social network for scientists and other bioprofessionals, was created to help scientists advance their careers and find new jobs. While BioCrowd and similar online networking sites can help scientists make connections, it is still the face-to-face networking experience that will ultimately  help them land new jobs!

Because networking is not taught or emphasized in graduate school, it is not surprising that many graduate students and postdoctoral fellows are notoriously poor “networkers.” That said, for those of you who recognize the importance of networking and want hone your networking skills, Contacts Count a Maryland-based network training company may be worth a visit. I have no doubt that there other organizations and companies out there that specialize in network training. If you find any, let me know and I will gladly post them!

Until next time…

Good Luck and Good Job Hunting

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We in America have grown accustomed to the constant barrage of direct-to-consumer (DTC) advertising of prescription drugs provided to us daily by pharmaceutical and biotechnology companies. That said, some of you may be surprised to learn that DTC advertising of prescription drugs is only permitted in two countries in the world: New Zealand and the US.

According to William Burns, an executive at Roche Pharmaceuticals, “Direct-to-consumer promotion was the single worst decision for the industry." He added, "When industry says we're spending all the money on R&D but actually it's spending it on TV advertising to preserve margins, it doesn't get much credibility." It may not provide much credibility to the industry but is sure does help sales.  reported that a total of $4.2 billion was spent on DTC drug ads in the U.S. in 2005, up 330 percent from 1996.

Apparently Mr. Burns is not alone in his opinion. Angus Russell, chief executive of Britain's Shire Pharmaceuticals also condemned DTC.  As many of you know, I ‘m not a big fan of DTC nor am I flag-waving American but I find it rather curious that after almost 12 years of DTC advertising that European pharma executives are suddenly speaking out against the practice. Could this be little more than a ploy to get the European Commission to re-examine and possibly loosen it restrictions on the way prescription drugs are promoted in the EU? Quite coincidentally, the European Commission is in the process of drawing up legislation that would allow a degree of information to be disseminated about medicines by their makers, although advertising pharmaceuticals would remain banned. The legislation was initially expected to be unveiled by the European Union's executive arm last week but has been delayed.

Drug makers have long campaigned against rules that prevent them from talking directly to consumers in Europe, despite a wealth of often unreliable information being available on the Internet. I think this statement by Mr. Burns sums up the situation "You've got the two extremes on the planet, where we (drug makers) are given access to the public in America, which is too much, and in Europe we're not given access to information" (sounds like sour grapes to me).

Maybe a compromise between the two extremes would be a solution acceptable to both American and European regulators? 

Until next time…

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

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Late yesterday, drug maker and consumer healthcare giant Johnson and Johnson announced that it was buying Mentor, a Santa Barbara, CA maker of skin care products, liposuction equipment and MemoryGel breast implants. According to industry analyst the $1.07 billion that J&J will spend to purchase the company “represents a giant premium for Mentor.” Mentor will become a stand-alone unit of J&J’s Ethicon a leading supplier of sutures, mesh and other surgical products. The cosmetic surgery and anti-aging markets are huge and are expected t to grow as the baby boomer generation continues to age.

J&J is on something of a buying spree and will continue to buy specialty companies to to offset possible losses that may from a weak drug pipeline of its pharmaceutical division. In November, the company purchased Omrix for $438 million, a biopharmaceutical that develops biosurgical and passive immunity products. The deal is expected to close this month.

Unlike most other pharmaceutical companies, J&J has been able to successfully run a diversified conglomerate company that specializes in both pharmaceutical and consumer healthcare products. It is a cash rich company that has a reputation for treating its employees very well! Who said that “beauty is only skin deep?”

Until next time

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

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New Jersey-based Pharmacopeia, the first-ever combinatorial chemistry company, announced that it had agreed to be purchased by Ligand Pharmaceuticals in a stock deal worth about $70 million. Onetime a leader in combinatorial chemistry and high throughput screening, Pharmacopeia has struggled of late after it jettisoned its profitable molecular modeling division several years ago. While the company was able to advance several of its lead compounds into early phase clinical testing, its  longtime business model, predicated on multiple, small discovery deals with large pharmaceutical companies, was unable to provide enough capital to continue to sustain operations.

Pharmacopeia was established in 1993 after its founders licensed from Columbia University several of the first issued combinatorial chemistry patents. The company was a pioneer in combinatorial chemistry (and subsequently high throughput screening) and was the first to publicly tout the virtues of combinatorial chemistry in drug discovery. By the mid-1990s, many pharmaceutical companies had embraced combinatorial chemistry as the “next big thing” and began eliminating traditional natural product and medicinal chemistry jobs. The industry’s love affair with combinatorial chemistry grew so strong that many companies (most notably Merck), completely eliminated their natural products discovery departments in the late 1990s. Unfortunately, the role of combinatorial chemistry in drug discovery never lived up to its promised potential and was largely abandoned in the early 2000s. Although combinatorial chemistry is now part of the modern day drug discovery paradigm, this onetime “shining star” has largely been relegated to a minor supporting role.

I first became acquainted with Pharmacopeia in 1994 after I took a job with Transcell Technologies, a now-defunct biotechnology company that was co-located with Pharmacopeia in a research facility in Monmouth Junction, NJ. While Transcell and Pharmacopeia shared a cafeteria and some common laboratory equipment, Pharmacopeia employees were strictly forbidden to talk with Transcell employees— lest they inadvertently divulge proprietary combinatorial chemistry concepts that might jeopardize the company’s future. Coincidentally, a guy who lived two doors down from my family and me turned out to be Pharmacopeia’s in-house intellectual property attorney. Although, Ron and I became good friends, he was also extremely tight-lipped about the “goings-on” at Pharmacopeia. Privately-held Pharmacopeia went public in 1995 and at one time, its market capitalization was almost $1.0 billion.

By any reckoning, a 15-year run is outstanding for a biopharmaceutical company. However, as the old adage goes, “All good things must come to an end.” At present, it is not clear, whether or not California-based Ligand will relocate the company or cut jobs. Nevertheless, Pharmacopeia’s impending demise sends a clear signal that the golden age of combinatorial chemistry has ended!

Until next time….

Good Luck and Good Job Hunting!!!

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The Pharmalot Blog reported today that Schering Plough will eliminate 1,000sales jobs or 20% of its sales force by October. This latest round of layoffs is part of a reorganization plan that was announced last year to cut 10% of it workforce by 2012 (although must of the downsizing will occur by 2010). The reorganization was announced shortly after Schering purchased Organon Biosciences and the “wheels came off” of its Zetia/Vytorin anti-cholesterol medication franchise.

In other news, BioJobBlog heard through the grapevine that Merck has been quietly laying off workers (since Labor Day) in an attempt to reduce its workforce by 20% over the next few years. Many very talented people who have been with Merck for years are looking for new jobs.

Finally, Montvale, NJ-based Memory Pharmaceuticals announced that it was laying off 55 workers or roughly 50% of its workforce. The company, which went public in a much heralded IPO in 2004, focuses on developing treatments for cognitive disorders. Although the company has never been profitable, the person who ran the company for the past three years (first as president, then CEO and finally CFO) earned $876,807 last year. Not surprisingly, he will be leaving the company as part of the downsizing initiative.

The ongoing pharma slowdown coupled with this week’s Wall Street meltdown (many people who work on Wall Street live in New Jersey) should make New Jersey a very challenging and interesting place to live in the coming months.

Hat tip to Ed at Pharmalot.

Until next time….

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

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I previously posted a piece on BioJobBlog about direct-to-consumer advertising that is used by many pharma and biotech companies to induce people who see the ads to ask their physicians about a “ drug that they heard about on TV.” John Heubusch who runs Writing Frontier.com, read the post and pointed me in the direction of a piece that he wrote on the same topic. His slant on the topic is different than mine but we both reach similar conclusions—DTC advertising needs to be better regulated by FDA.

Until next time… 

Good Luck and Good Job Hunting!!!!

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Despite an increase in profits, BMS announced today that it will continue with its Productivity Transformation Initiative (PTI) that was instituted last fall. According to the PTI, BMS must save $1.0 billion over the next 2 years. Of course, the only way to accomplish this is by laying off employees whose jobs are not directly related to the process of transforming BMS into a “ next generation biopharma company” (Would somebody please write me and explain what that means)???? I suspect that BMS employees will be receiving “pink slips” after Labor Day.

This has been a devastating week for the NJ-based pharmaceutical industry. First, Teva announced last week that it will buy Montvale NJ-based Barr Pharmaceuticals and then earlier this week Roche issued a press release indicating that it will move its corporate headquarters from Nutley NJ to South San Francisco (Genentech’s headquarters) by 2010. The impending layoffs at BMS coupled with job freezes and downsizing at other NJ pharma companies like Schering Plough and Merck may signal the beginning of the end of New Jersey’s status as the “nation’s medicine chest.”

Until next time….

Good Luck and Good Job Hunting (forget New Jersey)!

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At lunch the other day, I was telling a bunch of people about how brilliant Roche’s biotechnology strategy has been for the past 20 years or so. All of this changed for me on Monday, when Roche announced that it wanted to buy the remaining shares of Genentech that it already doesn’t own for $ 43.7 billion —Roche currently owns 56% of Genentech’s stock. More importantly, Roche doesn’t have control of Genentech’s board of directors nor does it influence corporate strategy or product development.

Unlike many other pharma companies who have historically purchased  biotechnology companies and then integrated them into existing corporate structures, Roche previously opted to buy controlling interests in companies and then allowed them to continue to operate independently with little corporate input or guidance. Unlike pharma culture, which is very structured and inherently conservative, the most successful biotechnology companies have been built on cultures that promote creativity and “thinking outside the box”.   If Roche buys Genentech and attempts to integrate it into the existing Roche family of companies, I suspect that all of this will change dramatically.

For the past 30 years or so, Genentech has been one of the brightest stars in the biotechnology universe.  Genentech’s management team worked long and hard to implement and maintain a vision that was formulated way back in the late 1970s when the company was first formed. Even though it is the world’s largest and most financially successful biotechnology company, Genentech has steadfastly resisted the temptation to go “corporate” and has worked diligently to maintain its “biotechnology identity” —symbolized by innovation, creativity and employee-centric policies.

I have no doubt that if the Roche-Genentech deal is approved, there will be a mass exodus of talent from the company. Based on my experience, a publicly-treaded biotechnology employee’s greatest fear is the dreaded corporate takeover! I have yet to meet a biotechnology company employee who is willing to sacrifice freedom and creativity (despite a possible financial upside) for more structure, discipline and an endless plethora of rules! 

In my opinion, the deal makes sense for Roche—competition in the cancer space is intense and they want to hedge their future success on Genentech’s oncology franchise. In the best case scenario, Roche will buy Genentech but allow it to operate as a wholly owned subsidiary with an independent management team that spends as little time in Basel as possible. I think the old adage “If it ain’t broke, don’t fix it” is particularly apt here!

Until next time….

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

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A post today on the Pharmalot blog suggests that Israeli generic manufacturer Teva is in talks to acquire US-based Barr Pharmaceuticals for  $7.0 -7.5$ billion. Barr’s present market cap is approximately $5.0 billion.

The acquisition would make sense for Teva to broaden its reach into the generic and branded generic markets in the US. Also, Barr recently acquired PLIVA which has active research programs on biosimilars and is currently selling its version of EPO in Croatia and other parts of Eastern Europe.

Teva has been trying to get into the biosimilar/follow-on biologics market for the past eight years or so. The company previously bought several early stage biogenerics manufacturers but have yet to advance their plans to formally enter the biosimilar/follow-on biologics market. This may be the opportunity that Teva has been looking for!

Check back for updates.

Until next time…

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

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First, King Pharmaceuticals posted a non-branded high blood pressure video on YouTube in early 2007. Next, Novartis added a 60-second commercial (as part of its Fluflix campaign) asking people to submit videos about what it's like to have the flu. Earlier this year, Insmed upped the ante by posting a video lobbying for new legislation for the approval of follow-on biologics in the US. However, these pharma assaults on YouTube pale in comparison to the launch of Johnson & Johnson’s health channel on YouTube earlier this week.

The channel currently showcases a small selection of health information videos created by NBC News chief medical editor Nancy Snyderman while she worked J&J. Video sites, like YouTube and Vimeo, offer pharma companies a place to feature expensive off media advertising assets (that are currently collecting dust) and to post ads for new drugs and products that are ready for launch.  J &J is the first pharma company to recognize that it can leverage the current social media craze to increase its visibility, sell more drugs and bolster its stock price!

While companies could host videos on their own websites,YouTube’s massive traffic of more than 80 million users offers companies a much larger and diverse audience. And unlike blogs or forums, pharma companies have complete control over the content of the videos that they post on video websites. Moreover, they don't have to worry about negative comments being left after a post (YouTube comments can be turned off), and they can brand and edit video content to target a particular demographic or audience. Finally, videos can be changed or removed by companies as needed.

The bad news is, that like all other forms of media on the Internet, there are currently no regulations for videos posted by pharma companies on video websites sites like YouTube. In other words, pharma companies can do or say whatever they want in the videos that they post—never a good thing! I suspect that at some point FDA will draft a guidance document or two on the topic. But pharma companies need not worry, it will likely be many years before the agency divines regulations guiding the messaging and content of online pharmaceutical videos.

The appearance of pharma videos on YouTube, and the growing number of pharma profiles on social networking sites indicates that pharma is ready to embrace social media as the next best thing since DTC advertising. I was wondering what took them so long?

I hope that J&J doesn’t start following me on Twitter!

Hat tip to Eye on FDA for the story!

Until next time,

Good Luck and Good Job Hunting!!!

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Despite a recent report heralding the ascendancy of the Welsh biotechnology industry, the majority of biotech companies in Britain are in danger of fading away according to a report in London's  Financial Times. According to the Times; “Over the past year the sector has witnessed a string of high-profile drug failures, share prices have plunged and there have been almost no public listings. The sector is shrinking as private biotech companies are bought by cash-rich pharmaceutical companies, most of which are based abroad”.

“The quality of British science has never been in question. Commercial biotech’s perennial problem, say the pundits, is instead a lack of financing, management expertise and commercial savvy. “The UK has always labored under the yoke of not having enough venture capital around and not having the people prepared to take risks” said one analyst.” Nevertheless, the UK is currently  responsible for more than one-third of the European Union’s total drug pipeline.

The British biotechnology industry isn’t alone. Consolidation of the US biotechnology industry has been quietly going on for the past 5-10 years. Many successful American companies have been acquired by major pharmaceutical companies. For example, MedImmune and Millennium Pharmaceuticals were recently purchased by Astra Zeneca and Takeda Pharmaceuticals respectively. That said, I don’t think that what is happening in the UK is unique to the British biotech industry. The bottom line is this; Biotech is a capital-intensive, briskly paced, risky business that is, at most, 35 years old. More companies than not are expected to fail. Pharma, on the other hand, is a conservative and experienced cash-rich industry that is over 100 years old. Therefore, it follows that pharma companies, when possible, will buy successful biotech companies to bolster their thinning pipelines to stabilize their stock prices.

In my opinion, the seminal underpinning and essence of the biotech industry is to harness scientific originality to create innovative l technologies and products. That said, I believe that the biotechnology industry has finally become an integral part of the life sciences ecological food chain (think of biotech as a producer and pharma as a consumer).  I can’t think of many biotechnologies company executives (with the exception of Biogen) that wouldn’t consider acquisition or merger with a major pharmaceutical company as an ideal exit strategy for their stakeholders!

Until next time….

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

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No doubt that many of you already know that DTC advertising is an effective way for pharmaceutical companies to “push” their drugs. However, when I saw the amount of money that was spent on DTC in 2007 I was shocked! In 2007 alone, drug companies spent $5,375,117,382 on advertising. Yes, that's $5.375 billion dollars (think of how many research grants could have been funded or how much money could have been spent on universal healthcare!).  The aggregate ROI for 25 pharma companies examined was impressive–totaling about $32 billion or roughly 7-fold!

A table published by Consumer Reports AdWatch highlights 25 of the biggest spenders along with their sales, giving an indication of how much their ad spending has paid off —or not! The drugs that received the biggest bang for the buck are bolded. Despite the conflict of interest and false advertising DTC flap over Lipitor, it still managed to have the third best return among the 25 products analyzed.

¹Consumer Reports Consumer Drug Reference, 2008.
²Data compiled by Nielsen Media research, March 2008.
³Data provided by Drug Topics and Verispan, March 2008.


No wonder why everybody wants to work for a pharmaceutical company–despite the downsizing there is still substantial money to be made!

Until next time….

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

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It’s summertime during a recession. What better time is there to give employees an extended vacation by announcing job cuts at the start of summer?  

Generic manufacturer Mylan announced that it is cutting jobs at a pharmaceutical manufacturing plant in central Puerto Rico. According to a company spokesperson, 100 jobs will be eliminated in coming weeks. Mylan had announced in February that it would be eliminating jobs at five locations as part of a companywide restructuring. The Pittsburg, PA-based company is the latest pharmaceutical company to announce cuts in Puerto Rico. The industry has eliminated more than 3,000 jobs here since mid-2006.

In other news, Palo Alto, CA-based Jazz Pharmaceuticals Inc. said Wednesday it plans to cut 8 percent of its work force -- or 33 employees -- primarily in research and development and administrative areas, and delay development of two drugs.

Finally, according to Ed Silverman over at Pharmalot, New Jersey-based Schering Plough has begun the massive layoffs it announced last April. As you may recall, CEO Fred Hassan still reeling from the Vytorin and Zetia flap, assured analysts and shareholders that he can right the ship by laying off about 5,500 employees or 10% of Schering’s workforce. He vowed to “consolidate management; use more shared staff support and services; reduce travel; cut sales and marketing; slash R&D; consolidate product lines, particularly in the animal health unit; and close some of the 60 manufacturing plants.” The previously announced job cuts are in addition to the 400 jobs that were eliminated after Schering Plough acquired Organon Biosciences.

Unfortunately, I guess it is going to be a long, hot, summer for the folks who lost their jobs.

Until next time….

Good Luck and Try to Hold On To Your Job (if you have one)

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The Avandia debacle is still ravaging the employee ranks at GlaxoSmithKline especially at its Research Triangle Park, North Carolina and in Philadelphia locations. According to a post at Pharmalot, the UK-based drug manufacturer is cutting as many as 350 jobs (2.0% of its workforce) at both locations. This represents an almost 40% reduction in drug discovery and development activities that take place at both sites.

These cuts come after GSK closed a factory and drastically cut its sales force late last year. To make matters worse (particularly for those folks who lost their jobs) GSK purchased an early-stage drug discovery company called Sirtris Pharmaceuticals for about $720 million earlier this year. Clearly, company executives have more faith in external rather than internal drug discovery at GSK.

The saga continues……

Until next time

Good Luck and Good Job Hunting (forget North Carolina)!!!!!

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Daiichi Sankyo will buy a controlling interest (50.1%) of Ranbaxy, India’s third largest generic manufacturer.  Daiichi will pay as much as $4.6 billion for the opportunity.

The deal will put Daiichi Sankyo into ninth place in the $120 billion generic-drug market behind leaders Teva Pharmaceutical Industries Ltd. and Novartis AG's Sandoz unit. According to the report “Daiichi Sankyo is mimicking strategies pursued by Novartis and Johnson & Johnson to weather turbulence in the branded-drug industry by diversifying into other markets. The acquisition also gives the Japanese company more reach in emerging regions including India, China and Eastern Europe. “

I think after this deal, that other pharmaceutical companies may consider buying profitable generics businesses. I am not sure why it has taken innovator companies so long to realize that it is much easier to join (buy??) rather than compete with generic manufacturers. It just seems so obvious to me—and I don’t even have an MBA!  Maybe there is some truth to the age-old aphorism “missing the forest for the trees.”

Until next time…

Good Luck and Good Job Hunting!!!!!

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Much like Paul Revere back in the day, there have been repeated, urgent warnings about the impending recession that will strike the US economy. Not surprisingly, the Bush administration has done its best to deny the notion that the moribund US economy is actually in recession. 

Today, it was reported that the US unemployment rate hit 5.5% and nearly 49,000 people lost their jobs last month. This is the biggest monthly rise in the unemployment rate since 1986. So far this year, the Unemployed people grew by 861,000 in May rising to 8.5 million. To keep things in perspective, a year ago, the number of unemployed stood at 6.9 million and the jobless rate was 4.5 percent

Last month employers sharply cut jobs in manufacturing, construction, retailing and professional and businesses services. The recent and highly publicized meltdown of the airline industry insures that as many as 10,000 others or more will lose their jobs in the coming weeks. These layoffs, coupled with $4.00 per gallon gasoline, will undoubtedly have a substantial and lasting ripple effect on the American travel and leisure industries. Can anyone still believe that the US economy isn’t in recession (I can think of at least one!).

Until very recently, many of my disgruntled corporate colleagues (who I eat lunch with from time to time) indicated that they were actively seeking new employment. At lunch the other day, a soft spoken but vocal woman who previously said that “she couldn’t take it anymore and was outta here the first chance that she got” quipped; “What’s with all the complaining. We should all consider ourselves lucky that we even have jobs!” I think that says it all….

Until next time….

Good Luck and Good Job Holding!!!!!!

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Novartis announced today that it intends to purchase Malvern, PA-based Protez Pharmaceuticals for $400 million. Protez is developing a novel spectrum carbapenem antibiotic that is active against variety drug-resistant Gram positive (most notably MRSA )and Gram negative bacterial pathogens. Its lead compound, PZ-601, is in Phase II human clinical testing. Protez acquired PZ-601 (formerly SMP-216601) in 2005 from Dainippon Sumitomo Pharmaceuticals.   

Novartis is buying Protez to sure up its antibacterial drug pipeline. Novartis already sells Cubicin, (manufactured by Massachusetts-based Cubist Pharmaceuticals Inc.,) in Europe and is developing other antimicrobials including Aurograb and Tifacogin to treat infections.

Like many of the newly marketed antibiotics, PZ-601 is injected and not orally bioavailable. Nevertheless, it is likely that PZ-601 will provide much needed help against the ever increasing number of drug resistant bacterial isolates. Swiss companies Basilea Pharmaceutica AG and Arpida Ltd. are also working on experimental medicines to treat MRSA.

It is not clear how the acquisition will affect Protez employees.  I suspect that most of the employees will keep their jobs except for Company officers.

Until next time…

Good Luck and Good Job Hunting!!!!!

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As a self-anointed career development professional, I frequently read blogs and online articles dealing with jobs and career development advice. That said,  I happened upon a piece in Yahoo Education entitled “Risky Business: Finding Job Security in Tough Times”. The article featured careers that may provide greater than average job security to employees. Everything was going great until I read the no. 4 career on the list–Medical Scientist– I kid you not. This is what the author had to say about medical/life scientists:

 “With increases in funding for treating cancer, AIDS, mental illness, and other diseases, corporate pharmaceutical, biotech, and university research labs need more people to develop vaccines and treatment drugs. Depending on your medical specialty, you'll typically need a master's degree or PhD. Often M.D.-holders choose research work over medical practice. You can begin traveling this path by earning a bachelor's degree in a biological science, and focusing on chemistry, biology, statistics, and research methods. Salaries in private sector biotech firms are typically higher than those offered at the college research level. There are also jobs with government medical-research agencies. Median salary range: $44,830 to $88,130.”

I ‘m not sure where the author has been or what she has been smoking but it seems to me that she is not in sync with industry trends. Maybe I ought to write to her and ask her to send me a list of companies that are currently hiring. I guess you really can’t believe everything that you read!

Until next time….

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

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

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

Ain't capitalism great?

Until next time....

Good Luck and Good Job Hunting!!!!!

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

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

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

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

Until next time….

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

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

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

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

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

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

Until next time….

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

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

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

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

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

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

Until next time…

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

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

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

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

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

The ongoing acquisition of American biotechnology companies by Japanese pharmaceutical companies reminds me of  the Japanese foray into the US real estate market in the early 1990s. Only time will tell whether the Japanese will be able to hang on to their acquisitions this go around (they weren’t the last time).  Earlier this week, Switzerland's Novartis AG agreed to buy 77 percent of eye-care company Alcon Inc. in a two-step transaction totaling $39 billion. Does anybody else see a troubling trend developing here as a result of the recession that we are in or heading into?

Don’t be surprised to see some “asset reallocation” and downsizing at Millennium. The Japanese are well recognized for increasing efficiency and work output with smaller numbers of employees.

Until next time….

Good Luck and Good Job Hunting (not in Cambridge MA)!!!!!!!!

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I have been following the trials and tribulations of New Jersey-based Enzon Pharmaceuticals for the past decade. My interest in Enzon was kindled because of a friendship with Abe Abuchowski, Enzon’s former Chairman, CEO and Founder.  For those of you who may not know, Abe is sometimes called the “father of protein PEGylation” because he was first to harness the commercial power of the technology (he played a pivotal role in creating the technology as a graduate student in Frank Davis’ lab at Rutgers University).

Abe left Enzon in the early 1990s (after shepherding the US regulatory approval for Adagen®, Oncospar®, and PEG-Intron®) and in 2004, he (along with my help) founded Prolong Pharmaceuticals, a biopharmaceutical company that specializes in PEGylation of biogenerics. Prolong is also using protein PEGylation to create new antimicrobial and blood replacement products.

Over the years, Enzon has had its share of “ups” and “downs.” Although profitable through much of the 1990s, Enzon is now a company riddled with huge debt– mostly because of bad decisions made company executives in the post-Abuchowski era.  Since 2004, Enzon’s Chairman and CEO, Jeffrey Buchalter, has worked diligently to “right” the company. He realigned and focused the company’s strategic objectives and, through some creative financing, reduced some of Enzon/s more onerous debt obligations. To that end, he was able to restore shareholder confidence and stabilize Enzon’s stock price. Unfortunately, Jeff’s efforts may not be enough to save the company from acquisition or merger.

Many industry insiders believe that Buchalter was hired four years ago to prepare the company for sale. Yesterday, Enzon disclosed in a SEC filing, that the self-proclaimed biotech maven, Carl C. Icahn, increased his Enzon stock position from 1,760,001 to 3,072,103 shares. After the purchase, Icahn owns about 6.93% of the company’s outstanding shares and is one of its largest, single shareholders. Not surprisingly, Icahn now wants the company to consider putting itself up for sale. Maybe the insiders were correct in their thinking?

Stay tuned for more details.

Until next time….

Good Luck and Good Job Hunting (forget New Jersey)!!!!!!!

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As the cost of prescription drugs continues to spiral upward, the affordability and accessibility to prescription drugs and healthcare will likely be fiercely debated and may influence the outcome of the presidential election next November. Despite growing public concern over the cost of prescription drugs in the US, Eli Lilly has vowed to fight federal legislation that will allow Americans to import lower-priced prescription drugs from Canada, Japan, Australia and many European nations. Lilly spokespeople and their lobbyists in Washington DC argue that the policy would put consumers at huge risk of consuming dangerous and unsafe counterfeit drugs. Big pharma has been using the drug safety argument for the past decade or so to stifle drug importation legislation. That said, blocking prescription drug importation legislation has very little to do with drug safety and everything to do with profit margins and corporate stock prices.

The stakes of prescription drug importation are high for drug makers. In contrast with the US, most other countries keep drug prices low through government distribution programs and strict price controls. Because the US government does not control prescription drug prices, American typically pay two-thirds more than Canadians, 80% more than Germans and 100 per cent more than French residents for identical prescription drugs. Lilly and other big pharma companies contend that price controls for prescription drugs stifle innovation and competition (tell that to the European and Japanese drug companies). Currently, according to government and industry surveillance data only a tiny fraction of counterfeit drugs (about 5 per cent) actually enter the US market. But Lilly and other pharmaceutical companies argue that there could be enormous increases in the number of counterfeit drugs that enter the US annually if Congress relaxes the federal ban on imported prescription drugs.

Pharma’s counterfeit drug argument is a convenient scare tactic that it has been using to lobby against relaxing current drug importation legislation. What the drug makers don’t tell you is that they routinely import and sell drugs in America that are manufactured in foreign production facilities. Further, many of drugs that are sold in Canada, Europe, Japan and Australia are manufactured in the same production facilities that supply drugs that are sold in the US. This begs the question —if drugs are manufactured in the same foreign production facilities and one lot is sold in the US and the other in Canada, would American consumers really be at a greater risk if they bought a Company’s drug in Canada or the US? The answer to the question is a resounding NO–unless you believe that the Canadian Regulatory Agency is less competent at monitoring and approving drugs than the US FDA The real story is this–.counterfeiters stand to make much more money selling bogus prescription drugs in the US than in other countries because there are no price controls in the US (which means much larger profit margins for the counterfeiters–duh!)

Let me propose a solution to the prescription drug counterfeiting that is plaguing and threatening the safety of American–reduce the price of American prescription drugs to prices that are consistent with prescription drug prices in the rest of the world. This would provide greater access of prescription drugs to all Americans and reduce the need for some Americans to purchase prescription drugs from dubious sources because they can’t afford to buy them at their local pharmacies. Further, price controls would certainly reduce the incidence of counterfeit drugs in American because counterfeiters would no longer be able to command high prices for their products which, in turn, would seriously cut into their profit margins.

Despite the logic and simplicity of my proposal, don’t expect there to be any changes in prescription drug importation policies any time soon! Profits not drug safety or open access to life-saving drugs is what drives big pharma-this is American after all!!!

Until next time….

Good Luck and Good Job Hunting (try Indiana) !!!!!!!!!

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Just what the market needs—another cholesterol control medication. That said you can always count on Genzyme to bring its unique approach to drug development to an already overcrowded marketplace.  

The New York Times reported today that Genzyme inked a deal with Carlsbad CA-based Isis Pharmaceuticals, an early pioneer of anti-sense technology. Genzyme has agreed to pay at least $325 million to win the hotly contested rights to Isis’ potentially powerful cholesterol-lowering drug called mipomersen. Genzyme beat out at least another 10 companies that were interested in the deal. Genzyme, one of the world’s most successful biotechnology companies, primarily creates drugs that are used to treat small numbers of patients with rare genetic diseases like Fabry disease and Type I Gaucher disease.

Mipomersen is in Phase III clinical trials as a treatment for a rare genetic disease that causes people to have astronomical cholesterol levels, raising their risk of premature cardiovascular disease and death. There are only about 10,000 people in the world with the most severe form of the disease, which can cause heart attacks even in young children. According to Isis, the drug lowered levels of cholesterol and other blood lipids more than 40 percent beyond reductions achieved by statins and other existing drugs alone. Isis and Genzyme believe that the drug might also be used for 1.5 million people in the United States and Europe with less severe forms of the genetic disorder and also for millions of people who have high cholesterol that is not controlled sufficiently by statins like Lipitor.

Genzyme appears to be a logical partner for Isis because of its focus on developing medications to treat rare genetic disorders. However, Genzyme’s ability to penetrate the broader cardiovascular market may be hindered by its lack of a large sales force which is typically required to call on general practice physicians who frequently prescribe cholesterol-lowering medications.

Isis and Genzyme hope to submit a new drug application to the US Food and Drug administration in 2009 for approval of mipomersen.

Until next time….

Good Luck and Good Job Hunting (try Genzyme)!!!!!!!!

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Geneva-based Covalence published its third annual ethical reputation ranking, giving the best ranked companies as well as those companies which have made the most progress in 2007.

Best EthicalQuote Score and Best EthicalQuote Progress are given by confronting positive and negative news. Best Reported Performance is calculated by quantifying positive news only – it shows how companies report on their ethical performance without considering criticisms and demands.

Best EthicalQuote Score

1. GlaxoSmithKline
2. Johnson & Johnson
3. Bristol Myers Squibb
4. Abbott
5. Novartis
6. Roche
7. Boehringer Ingelheim
8. Astra Zeneca
9. Pfizer
10. Sanofi Aventis

Best EthicalQuote Progress

1. GlaxoSmithKline
2. Abbott
3. Johnson & Johnson
4. Sanofi Aventis
5. Boehringer Ingelheim
6. Schering Plough
7. Takeda
8. Astra Zeneca
9. Bristol Myers Squibb
10. Amgen

Best Reported Performance

1. GlaxoSmithKline
2. Abbott
3. Novartis
4. Wyeth
5. Merck & Co Inc
6. Pfizer
7. Johnson & Johnson
8. Eli Lilly
9. Sanofi Aventis
10. Astra Zeneca

Finally, some good news for GSK in 2007!!!!

Until next time...

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

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According to Ed Silverman at Pharmalot the newly-formed executive steering committee at Sanofi-Aventis sent a letter to its R &D employees it will take care of implementing “strategic moves,” apportioning resources, overseeing overall management.

A Sanofi spokesman said “is a condensed structure, designed to facilitate quick decision making.” Yeah right–look for some corporate right sizing, allocation of strategic resources and job cuts at the French drug maker.

On another note, West Pharmaceutical Services, a Lionville, PA-based Company announced that it would shed 250 jobs or 13% of its work force as part of a restructuring program. A company spokesperson said it will reduce spending throughout the segment by consolidating two tool production operations into one facility, in Scottsdale, Ariz., and by reductions and consolidations at other production, engineering and administrative operations in North America.

Until next time….

Good Luck and Good Job Hunting!

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The Massachusetts-based biotechnology company, Momenta Pharmaceuticals, announced late yesterday that FDA refused to approve its ANDA filing for M-Enoxaparin, a generic version of Sanofi-Aventis' Lovenox®. The agency cited that Momenta had failed to provide data in its application on the potential immunogenicity of M-Enoxaparin. I find this oversight to be extremely perplexing because Momenta’s management team had to know that regulatory approval of a product –considered to be a follow-on biologic (M-Enoxaparin is a synthetic version of low molecular weight heparin which is a polysaccharide) – would require a rigorous assessment of the product's  potential immunogenicity. If Momenta did not know about the immunogenicity requirements, then Sandoz (its co-development partner) had to be keenly aware of them because Sandoz had to provide immunogenicity data to FDA to garner approval last year of Omnitrope®, a follow-on version of human recombinant growth hormone (rHGH).

Although FDA’s refusal to approve M-Enoxaprin is a setback for the follow-on biologics movement in the US, it is about time, in my opinion, that Momenta’s stock price truly reflects the real market value of the company. Much to my surprise, Momenta’s stock price was over $30 a share about two years ago– presumably founded in the notion that the company’s innovative carbohydrate technology platform could be used to create a generic version of Sanofi’s multi billion dollar a year Lovenox® . I have no doubt that Momenta’s technology platform is one of the more innovative ones in the carbohydrate synthesis biz. However, as a former employee of 2 biotech companies founded on revolutionary carbohydrate synthesis platforms, I think that Momenta’s elevated stock price had more to do with the pedigree of scientists who started the company and the ROI that these scientists previously provided to the VCs who are currently backing Momenta. Further, cutting a deal with Sandoz, a company whose name is now synonymous with follow-on biologics may also have contributed to the elevated stock price.

If I was one of Momenta 100 or so employees I would be dusting off that resume right about now.

Unitl next time....

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

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