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I have been in the business long enough to remember when Amgen was the largest and most successful biotechnology company in the world. During most of the 90s and early 2000s, Amgen was second to none. But, a lack of innovation, questionable marketing practices and an uncreative executive management team forced the once invincible biotech Giant to recently stumble and relinquish its world class status

For those of you who may not be familiar with Amgen, it was founded in 1980 by a team of scientists led by George B. Rathmann. The company’s original name was Applied Molecular Genetics which was officially changed in 1983 to Amgen. Its first product, Epogen (EPO; epoetin-alfa) an erythropoiesis-stimulating hormone was approved in 1989 when Gordon Binder was CEO. 

EPO quickly became the company’s flagship blockbuster product and was largely responsible for Amgen’s early success.  The company’s second blockbuster product Neupogen (Filgrastim) a recombinant-methionyl human granulocyte colony factor (G-CSF)—also under Binder’s leadership—which stimulates neutrophil (white blood cell) production was approved in 1998. In the early 2000s the company—now under the tutelage of its third CEO, Kevin Shearer—introduced a longer acting, second generation EPO product called Aranesp (darbepoetin-alfa) and Neulasta (pegfilgrastim), a second generation, longer-acting PEGylated version of recombinant G-CSF.

The largesse from the EPO and Filgrastim franchises allowed Amgen to rapidly expand in the 2000s and to heavily invest substantial resources into new drug development (both small molecule and biotechnology). Unfortunately, most of these investments did not pan out; with the possible exception of XGEVA (denosumab) and Prolia (denosumab) a monoclonal antibody (MAb) treatment that recently received approval for the treatment of skeletal-related events including pathological faction in patients with bone metastases from solid tumors and postmenopausal osteoporosis respectively.

In the 2000s, Amgen’s went on something of a “buying spree” during Mr Shearer’s 11 year tenure at the company. During this time Amgen acquired eight companies including three high profiles and well known ones; Immunex (2002) a MAb development company; Tularik (2004) a small molecule discovery company and Abgenix (2006) another MAb development entity. The Immunex acquisition, clearly the most profitable one, gave Amgen access to Enbrel (etanercept) a tumor necrosis factor α MAb indicated for the treatment of various forms of arthritis. Enbrel is currently one of the world’s top selling biotechnology products.

Despite its lack of R&D productivity, Amgen was recognized until recently as the world’s largest and most profitable biotechnology company in the world. However, its lack of R& D productivity coupled with a recent, highly publicized regulatory and criminal inquiry into inappropriate marketing associated with its EPO franchise has seriously tarnished the company’s once impeccable reputation. Interestingly, it appears that Amgen is finally attempting to reinvent itself.

Last week, the company announced that its CEO, Kevin Shearer and Dr. Roger M. Perlmutter, head of R&D will retire early next year. Mr. Shearer will be succeeded by Robert Bradway, a former Wall Street executive who is Amgen’s current chief operating officer. Dr. Perlmutter will be replaced by Sean Harper, MD, the company’s chief medical officer. And, last month, Amgen announced that it plans on buying back up to $5 billion shares of its publicly-held stock in an attempt to return profit to shareholders. Finally, today, the company announced that it entered into a deal with Watson Pharmaceuticals, a leading generics company, to develop biosimilar versions of some of its competitor’s blockbuster cancer-fighting biotechnology drugs. The press release made it clear that the deal did not include developing biosimilar versions of any of Amgen’s currently marketed biotechnology products. Nevertheless, today’s announcement strongly suggests that Amgen is willing to use anything at its disposal (in this case its substantial expertise in biomanufacturing rather than new drug development) to generate additional revenue streams for the company.

The recent organizational changes and strategic decisions made by Amgen’s board of directors and management team tends to validate the need for change at the company so that it can remain profitable and possibly restore its reputation as a global biotechnology leader. That said, like most other things in life, only time can tell!

Until next time...

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

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Bristol-Myers Squibb (BMS) announced today that it had made major changes to its senior management team which is now headed by CEO Lamberto Andreotti.

Giovanni Caforio has been promoted to president, U.S. Pharmaceuticals. Caforio was most recently senior vice president, Oncology and Immunology Global Commercialization. In his new role, Caforio will report to Lamberto Andreotti, chief executive officer, and has been named a member of the Company's Senior Management Team.

In addition, Charles Bancroft and Béatrice Cazala have been appointed Executive Vice Presidents of Bristol-Myers Squibb. Bancroft will add to his role of Chief Financial Officer operational responsibility for the pharmaceutical business in Latin America, Middle East, Africa, Canada, Japan and several other countries in the Pacific Rim. Cazala will add responsibility for global policy to her role leading Global Commercialization, Europe and Emerging Markets. Both will continue to report to Andreotti and serve on the Company's Senior Management Team.

Anthony C. Hooper, senior vice president, Commercial Operations, and president, U.S., Japan and Intercontinental, has decided to leave the company. Hooper, a long time member of BMS's senior management team was obviously not on board with Andreotti's vision for the company's move to become a next generation biopharma company.

Until next time...

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

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Pharmaceutical,biotechnology and other companies that sell prescription drugs and devices are deathly afraid of adverse events (AEs) associated with their products. For those of you who may not know, companies with approved prescription drugs and medical devices are required to track and report any adverse events associated with their products to regulatory agencies like the US Food and Drug Administration (FDA). If FDA receives enough AE complaints about a product, the agency will investigate to determine whether or not there may be efficacy, safety or tolerability issues with it. And, if FDA thinks that the AEs are legitimate, it may ask a company to conduct Phase IV clinical trials with the product in question or require that changes be made to the product’s label. Not surprisingly, these outcomes can be time consuming and perhaps more importantly, costly. Label changes—especially for blockbuster products—frequently lead to changes in physician prescribing habits which can translate into a loss of revenue. Despite the fact that ALL drugs exhibit AEs, many companies falsely cling to the hope that there will be few, if any, AEs reported for their products.

While drug makers are very familiar with the range of possible AEs associated with their drugs—all AEs for a drug are identified and reported during clinical trials—pharmaceutical executives are concerned about social media activities, because they fear that than the number and frequency of AEs reported for their products will increase. This, in turn, would prompt FDA and other regulatory agencies to investigate and more closely scrutinize their marketed products. As Jonathan Richman, author of the Dose of Digital Blog points out in an excellent post entitled the “Myth of Adverse Event Reporting” AEs are a fact of life for prescription drugs. And, that social media may help to improve adverse reporting. Like Jonathan, I contend that social media might allow drug makers to more effectively identify potential safety issues with a product earlier in its lifecycle and thereby minimize possible deleterious effects of the drug on certain patient populations. I think that drug manufacturers ought to begin to consider how they might effectively use social media to improve AE reporting rather than ignore the potential upside of this new medium.

The Myth of Adverse Event Reporting

Adverse Events are nothing more than negative reviews. If you want people to genuinely talk about your brand, they are going to say negative things. But how often do posts include adverse events? Nielsen decided to take a look at this rather than simply assume it was ” a lot,” which of course is a difficult number to manage. Nielsen looked at Yahoo Health boards and took 500 postings. Of these, only 1 contained enough information to qualify as an adverse event that needed to be reported. That’s 0.2%. Why so low? Turns out that someone simply saying that your drug caused them to have a headache isn’t enough to qualify as an adverse event. Nielsen summed up the pieces of information required to report an adverse event and there are four pieces: “(i) an identifiable patient; (ii) an identifiable reporter; (iii) a specific drug or biologic involved in the event; and (iv) an adverse event or fatal outcome.” (Hat tip to Pharma 2.0 for the summary). The study showed that one or two of these pieces were often available, but not all four. In addition, they found that it would be impossible to get all four even with some effort. In fact, the FDA says, “[Without these pieces] a report on the incident should not be submitted to the FDA because reports without such information make interpretation of their significance difficult, at best, and impossible, in most instances.”

This is because people often don’t register or leave their personal information in a post, so there is no way for a company to follow up and fill in the blanks. Naturally, if there is something significant, every effort should be made, but on the often anonymous Internet, this is usually difficult. Suppose for a moment there were several adverse events that need to be reported. How often do they need to be reported? The FDA is pretty clear on this. For new drugs, reports need to be filed quarterly for three years. After that, it’s annually. For “serious and unexpected” events, these have to be reported within 15 days. However, there’s a pretty high threshold for an adverse event to be considered “serious and unexpected.” Every company already has these reporting channels in place, so it is simply a matter of including adverse events received from social media into the workstream. 

Yes, it’s a balance. The fact is adverse events should not be the reason why healthcare shies away from social media. These risks can easily be mitigated and, if done right, can actually be used in a positive way. So, don’t use adverse events as an excuse anymore. You’ve got the data. 1 in 500 posts include a reportable event. You report quarterly at most (which you’re doing anyway). How much ongoing effort do your other marketing programs require? Probably quite a bit more than this. Next time you hear this excuse, you’ve got the data to dispel the myth of adverse event reporting.

Until next time...

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

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Over the past several years, I have publicly called for fundamental changes in graduate education and training for life scientists. To that end, I was delighted to read an OP-ED piece in today’s New York Times entitled “End Universities as We Know It” written by Professor Mark C. Taylor, Chairperson of the religion department at Columbia University. 

In his post, Professor Taylor recommended several fundamental and systemic changes that ought to improve the likelihood that graduate students and postdoctoral fellows find jobs at the end of their graduate education. While some of Dr. Taylor’s ideas are novel and innovative, two in particular; 1) expanding the range of career opportunities for graduate students and postdocs and 2) abolishing tenure and mandatory retirement; are ones that I have suggested many times in the past few years. Rather than paraphrase, I decided to repost what Dr Taylor said about these two very important, seminal issues.

Expand the range of professional options for graduate students

Most graduate students will never hold the kind of job for which they are being trained. It is, therefore, necessary to help them prepare for work in fields other than higher education. The exposure to new approaches and different cultures and the consideration of real-life issues will prepare students for jobs at businesses and nonprofit organizations. Moreover, the knowledge and skills they will cultivate in the new universities will enable them to adapt to a constantly changing world.

Impose mandatory retirement and abolish tenure

Initially intended to protect academic freedom, tenure has resulted in institutions with little turnover and professors impervious to change. After all, once tenure has been granted, there is no leverage to encourage a professor to continue to develop professionally or to require him or her to assume responsibilities like administration and student advising. Tenure should be replaced with seven-year contracts, which, like the programs in which faculty teach, can be terminated or renewed. This policy would enable colleges and universities to reward researchers, scholars and teachers who continue to evolve and remain productive while also making room for young people with new ideas and skills.

For many years now, I have been struggling with the moral and ethical obligations of graduate education. Recently, I came to the conclusion that it is our role as educators to selflessly impart knowledge and training to graduate students and postdoctoral fellows so that they can pursue the careers (and lives) that many have trained for a decade or more. I think Professor Taylor’s view of the role of an educator says it best: “Do not do what I do; rather, take whatever I have to offer and do with it what I could never imagine doing and then come back and tell me about it.” This is the attitude that must be by academicians if America wants to remain competitive in the life sciences.

Until next time....

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

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I just returned from a weekend of teaching regulatory affairs to biotechnology students at Georgetown University where I tried to convince them that the US Food and Drug Administration (FDA) is fundamentally sound despite its near demise during the Bush administration. Even before the Bush-induced wreckage, the agency was chronically understaffed, under funded and had serious leadership and morale problems. This, coupled with two nationwide Salmonella outbreaks in the past year, several highly publicized drug recalls, and steadily declining drug approval rates has prompted its critics to propose that FDA be split into two separate agencies—one that oversees the drug industry and another that would have responsibility for cosmetic and food safety. For those of you who may not know, FDA became responsible for oversight and regulation of the food and drug industries, in addition to the drugs, after passage of the Food, Drug and Cosmetic Act in 1938.

Drug industry advocates and longtime FDA critics contend that the agency as it exists today can no longer effectively oversee and insure the safety of American food and drug supplies. Critics argue that the history of FDA suggests that the agency focuses on medical products and only focuses on food safety when a crisis comes up. And when they occur, FDA is so distracted that it interferes with the drug review/approval process. While this is what FDA critics want you to believe, it is simply not the case. Despite its recent problems, the FDA has historically done an outstanding job when it comes to drug and food safety—when it is funded and staffed to appropriate levels.

Unbeknownst to the American public, food borne illnesses are very common and Americans are only alerted when the outbreaks reach a certain size. While the recent Salmonella outbreaks were larger in scope and breadth than past outbreaks, they were not extraordinary. However, they were extremely media worthy at the time that they were reported on. You may recall that at the time of the outbreaks, the American economy was beginning to fail and there was an inordinate amount of China, Mexico and free trade bashing going on in the US. Unfortunately, the news media decided to exploit the outbreaks to make a case that Americans ought to reduce their reliance on imported foods—a practice that was beginning to cut into the revenues of the US agriculture and food industries. Ironically, the Salmonella outbreaks might have been prevented if the production facilities (owned by American companies) were compliant with FDA mandated quality control and assurance regulations which were designed to insure food safety.

Drug industry advocates who argue that FDA ought to be split into two separate agencies have financial interests rather than safety concerns in mind.  As an investment banker or VC will tell you, slow, new drug approval rates can have serious financial consequences for the companies that are developing them—it can literally cost a company millions of dollars a day for every day the drug is kept off the market.  Interestingly, when FDA increased its drug approval rates in the late 1990s and early 2000s, there weren’t many industry insiders advocating a break up of the agency. Only recently, as FDA has become more risk adverse which in turn, has caused the new drug approval rates to slow again have critics begun to call for massive organizational changes at FDA.

Like I told my biotech students over the weekend, the only mechanism by which FDA can insure food and drug safety is by conducting regular inspections of drug and food manufacturing facilities. Unfortunately, FDA hasn’t been able to keep up with its mandatory inspections schedule because the agency has been under funded and poorly staffed for over a decade. Several FDA inspectors, who I talked with suggested that routine inspections of manufacturing facilities takes place every three to five years rather than every two years as required by FDA regulations. While in theory this shouldn’t affect a company’s ability to remain compliant with FDA regulations, in reality it does. Put simply, pharmaceutical and food companies, like most other for profit industries are incapable of policing themselves in the absence of regulatory oversight.

I ‘m not certain that the agency needs to be split into two separate agencies to continue to insure the safety of the American drug and food supplies. What I know is the agency needs more funding and much larger numbers of trained inspectors to be successful. In my opinion, the safety of the American food and drug supplies can only be guaranteed if the companies regulated by FDA make a commitment to quality manufacturing and play by the rules.

Until next time...

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

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I had many discussions with undergraduate students at the ABRCMS in Orlando last week who were interested in pursuing PhD degrees in the biomedical sciences. I felt that I had an ethical and moral responsibility as a former academic and career development professional to tell them that the job market for PhDs is not good and that it is likely to get worse over the next few years. These discussions prompted me to revisit the role and contributions of tenure to the lack of academic jobs in the US today.

As I stated in a previous post, systemic changes must be made to the current academic paradigm to increase the likelihood that PhDs will be able to find jobs at the end of their training. In that post, I suggested that abolishing tenure and replacing it with renewable, performance-based five year contracts may help to reduce the glut of jobless PhDs by freeing up a small percentage of new faculty positions every five years. While this approach has been tried at several academic institutions, it has been largely been deemed unsuccessful. That said, I came across a provocative article in today’s New York Times about a bold new tenure proposal put forth by Michelle Rhee, the new, 38-year old Chancellor of the Washington, DC school system.

Ms Rhee’s revolutionary proposal offers tenured teachers salaries raises of up to $40,000 per year to give up tenure. It is important to note she has not proposed to completely abolish tenure. Under her proposal, teachers would choose between two compensation options—the green or red plans. Salaries for teachers in the green plan would rise meteorically, nearly doubling by 2010, but they would have to give up tenure for one year, after which they would need a principal’s recommendation to keep their job or face dismissal. Teachers who choose the red plan would also get big pay raises but would lose seniority rights that allow them to bump more junior teachers if their school closes or is overhauled. Red plan teachers who are not hired by other schools would either have to take early retirement, a buyout or face eventual dismissal. I like her plan because poorly- or under performing teachers can opt to take the cash and then either drastically improve to keep their higher paying jobs or do nothing, get paid well for a year or two and then get fired.

While Ms. Rhee’s proposal may work at the primary and secondary school levels, it likely would not be effective at the college and postgraduate levels, where salaries vary widely and are largely grant driven. Instead, I propose that tenure-for-life should remain intact at these institutions but be replaced with a “for cause” tenure review system. This system is tried and true and similar models have been successfully used for over 100 years by employers and labor unions. In this model, management and its unions agree upon the job responsibilities and performance metrics for individual that must be met each year, e.g. an annual performance review.  If a person is under performing or fails to meet his/her performance metrics, an employer can attempt to dismiss the employee “for cause” reasons.  However, before a dismissal for cause can occur, the employer must convince a judge or arbitrator in a hearing that the employee in question has violated the “dismissal for cause” provisions.  Because an employer must prove that an employee has violated the provisions that constitute for cause dismissal, the “for cause” claims against individual employees must be fastidiously documented and vigorously substantiated. This prevents employers from arbitrarily firing employees who are either outspoken troublesome or disruptive. According to my wife, who has been a union-side labor lawyer and union representative for 20 year, this system works well because the players (management and unions) all understand, abide by and play according to the rules of the game.

So what are some of the performance-based “for cause” metrics that I think ought to be considered for yearly evaluations of tenured professors? They are not much different than those currently used to adjudicate tenure decisions. That said, I propose the following five categories: 1) teaching, 2) publication record, 3) grant support, 4) institutional service and 5) commitment to innovation. In my opinion, adoption of the “for cause” tenure review model would help to do two things: improve the overall performance of tenured faculty members and provide newly minted PhDs and postdoctoral fellows with regularly occurring new job opportunities.

Until next time…

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

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After beating Wall Street expectations and disclosing positive results from an osteoporosis (densomab) clinical trial, Amgen was ordered by the US Food and Drug Administration (FDA) yesterday to change the labels for its EPO drugs (Epogen and Aranesp) that will likely further restrict their use in treating patients with cancer.

The label changes ordered by FDA represent the first time that the agency has invoked its power to change prescribing information for drugs that it previously approved. In the past, FDA could only negotiate with drug manufacturers about changes to labels and prescribing information. In my opinion, it’s about time that FDA has been empowered to unilaterally order these types of changes. I have long contended that negotiations between the agency and drug makers about labeling and prescribing information is not in the best interests of Americans who use prescription drugs. To that end, it was negotiations between FDA and Merck about whether the serious cardiovascular risks associated Vioxx should appear on the Vioxx label (they didn’t) that lead to the misuse, safety problems and ultimate recall of the drug.

While the ordered label changes are not good news for Amgen and its partner Johnson and Johnson which sells Procrit (EPO manufactured by Amgen and sold by J&J), they are in the best interests of all Americans who use these drugs to treat anemia caused by cancer chemotherapy and kidney disease.

Until next time….

Good Luck and Good Job Hunting (avoid A Thousand Oaks, CA)!!!!!!!!!!

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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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