The Next Big Thing in Biotech: Medical Devices And Diagnostic Products

In the not so distant past, biotechnology and pharmaceutical scientists looked down their noses at other scientists who worked in the medical devices and diagnostics industry. Boy, have times changed! Medical devices and diagnostic products are two of the fastest growing segments of the healthcare markets (anybody ever hear of drug-coated stents or artificial bone?). In contrast, pharma drug pipelines are essentially empty and biotech is becoming too risk adverse to invest much needed funds into innovative drug discovery and development to meet unmet medical needs..

The recent emphasis on medical devices and diagnostic products can be directly traced to two seminal events in recent American history: 1) the sequencing of the human genome and 2) the World Trade Center attacks of September 11, 2001. The sequencing of the human genome gave us a roadmap and the tools that are necessary to develop new diagnostic products and medical devices whereas the September 11 attacks made it abundantly clear that new bioterror detection and diagnostic products will be necessary for survival the 21st century.
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Genentech to Build a New Biomanufacturing Plant in Singapore

Reuters reported that Genentech Inc., the world's second-biggest biotechnology company, said on Wednesday it would spend US$140 million on a new manufacturing plant in Singapore.

The new plant will employ about 100 people and produce E. coli-derived products including Lucentis, which is used to treat a form of blindness . Genentech also has plans to buy an existing cancer drug manufacturing facility in Singapore from the Swiss speciality contract manufacturing firm Lonza. Construction of the new plant will begin in late 2007 and is expected to be completed by 2010.

Singapore, a county of  little over 2.0 million people, has made a huge commitment and investment in biotechnology over the past eight  years.  Some of the world's largest pharmaceutical companies including Glaxo SmithKline, and Pfizer have already have research facilities in Singapore.

For those of you foreign nationals looking for jobs, you may want to consider Singapore.

Until next time....

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

Follow-On Biologics: Here We Go Again.....

The official debate over the future of follow-on biologics in the U.S. began in earnest today in Washington D.C. during hearings held by the House Oversight Committee. One of the first people to tesify before the Committee was Dr. Janet Woodcock, Deputy Director of FDA.  She told committee members and representatives from the biotechnology and pharmaceutical industries that “while FDA can currently establish the safety between versions of simple protein-based drugs, it will likely "be a stepwise progression over a decade or so," before the agency can scientifically verify that a knockoff version of a complex biotech drug is similar to the original “.  Nothing new here...Janet has been saying the same thing about follow-on biologics ever since the debate began back in 1999.  But, her statements today led me to wonder where Dr. Woodcock has been over the past few years? Because, in 2006, EMEA  (the European regulatory agency) crafted an approval pathway for follow-on biologics or biosimilars as they are called in Europe.

It took EMEA over five years to develop the regulatory process but at least the EU, (unlike the US) has one for these new products!  Several biosimilars including Omnitrope and Valtropin are already being sold with much success in EU countries. And, much to the surprise (I am sure) of BIO, PhARMA, and other lobbying groups who have mounted expensive and aggressive lobbing campaigns against approval of follow-on biologics, Europeans are not dying in droves after using biosimilar products. All kidding aside, the bottom line is that any regulatory approval process for follow-on products in the US will require  human clinical trials. That said, the number and type(s) of human clinical trials that will be required for regulatory approval will be determined on a case by case basis. This, in turn, will determine whether follow-on products can really be sold at  lower prices. Based on current scientific and technological capabilities, I believe that even the most complex follow-on biologics can be brought to market with good safety profiles  coupled with a 15%-20% price discount over existing branded products

I think it is time for FDA to get back to the business of approving safe, efficacious and cost- effective medicines rather than supporting lobbying efforts and engaging in politics to allow the American biotechnology industry to maintain its global dominance in biopharmaceuticals.

Until next time.....

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

Why Are Biotechnology Drugs So Expensive?

I just finished teaching in the SUNY-Stonybrook Fundamentals of Biotechnology Certificate Program and the Georgetown Masters of Biotechnology Program for the year. Each year, I ask my students how much they think it costs to develop biotechnology drugs and they invariably give me the $800-$1.2 million figure that is bandied about by the Tufts Center for Drug Development. I contend that this number is grossly over-inflated when one realizes that the lion's share of development costs is used for advertising, promotion and sales. Because the pharmaceutical and biotechnology industries complain about the extremely high costs of drug development, they feel that it is their "god-given' right to charge exorbitant prices for their products.  A recent article listed the price per patient costs for some commonly-used biotechnology-based cancers drugs. The important thing to understand about mthese drugs is that most of them do not "cure" cancer but simply extend patent's lives (by months not years).  Some examples are listed below.

Avastin
Genentech
(NYSE:DNA)
colorectal: $46,000
lung: $56,000

Vectibix
Amgen (NasdaqGS: AMGN)
colorectal: $36,000

Revlimid
Celgene
(NasdaqGS: CELG)
multiple Myeloma: $67,000

Sutent
Pfizer
(NYSE: PFE - News)
kidney: $46,500

The product price that I find most curious is Revlimid which was developed by NJ-based Celgene. For those of you who don't know , Revlimid is a modified version of thalidomide, which is an off patent small molecule drug (not a biotech product) that was used incorrectly in the 1950s to treat morning sickness in pregnant women.  I guess Celegene charges biotechnology-like prices for its small molecule product simply because there is a vibrant market for the product.

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Let The Games Begin......

The New York Times reported today that a Congressional committee has begun an inquiry into the marketing and regulation of widely used anemia drugs that have recently raised safety concerns. The House Committee on Energy and Commerce has sent letters to Amgen and Johnson & Johnson, the drugs’ marketers, requesting information about when they knew of possible risks and about how they have promoted the products.

The letters also asked them to suspend any consumer advertising of the drugs and any incentive programs for doctors who prescribe them until after the Food and Drug Administration has time to determine whether further safety precautions are necessary.

The products — Epogen and Aranesp from Amgen and Procrit from Johnson & Johnson — are all forms of erythropoietin, or Epo, a protein made by the human kidney to spur production of red blood cells. The drugs are mainly used to treat the anemia caused by kidney failure or cancer chemotherapy and have combined worldwide sales of roughly $10 billion a year.

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Something is NOT Rotten in the State of Denmark!

It is not surprising to learn that American economists believe that corporate downsizing and layoffs are necessary to keep the US economy vibrant. In marked contrast, European and Japanese economists feel that layoffs are barbaric and employee job security is vital for robust economic health. As is always the case, the reality is somewhere in between these two extremes.

In a recent article, Louis Uchitelle described a novel approach to job security that was conceived in Denmark. In the Danish model, employers are relatively free to “layoff” workers. When this occurs the Danish government steps in and provides benefits to laid-off employees that replaces 70 per cent of lost income for four years. The government also finances retraining and education, pressures unemployed workers to participate in the programs and then insists that the unemployed accept reasonable job offers or risk cuts in their benefits. At present, the Danish government devotes 3 percent of the nations GDP to training as compared with less than 1 percent in the US. The Danish approach appears to be working-unemployment is low and the economy is stable.
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Negotiating A Job Offer

I used to tell all my job candidates that getting a job offer was always the preferred result of a job interview (whether you wanted  the job or not). However, after an offer is extended, negotiating terms that are acceptable you may be more difficult than the job interview itself. The rule of thumb is that you should NEVER accept the first offer that is put on the table (unless of course, it is an offer that you cannot refuse). The first offer typically represents a Company’s initial attempt to get you onboard as “cheaply as possible”. That is not to say that a first offer will always be a bad offer. The company is simply testing the waters to determine what it is going to take to induce you to join the organization. Most corporate HR professionals expect that negotiations will be required to get a prospective new hire to sign on the dotted line. So, do not feel like you are being ungrateful if you choose to negotiate your job offer…it is expected!

In my experience, everyone wants a higher salary than the company is will to pay. That said, there is usually only about 5%-7% upward flexibility on starting salaries. However, it is important to emphasis that getting a nominal increase in starting salary may require a substantial amount of back and forth. Frequently, this back and forth can get a little uncomfortable and tense for both parties. That is why it is always a good idea to let a recruiter (if a recruiter brought the job opportunity to you) to do the negotiating for you! Companies want to keep starting salaries low because annual raises and bonuses are calculated based on an employee’s base salary. Sometimes, in lieu of an increase in starting salary increase, companies are willing to offer job candidates a signing bonus. The purpose of the signing bonus is to show the job candidate that the company is negotiating in good faith and that it more than willing to try to accommodate the financial needs of potential new hires. However, realize that a signing bonus is a “one time deal” and it will not factor into any subsequent raises or bonuses that you are awarded.
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Internships Available at FDA for Summer, 2007

Frequently, students who I teach in the NY Biotechnology Center's "Fundamentals for Biotechnology Certificate Program" and the "Georgetown Biotechnology Masters Program" ask me about internship opportunities.  My lack of knowledge regarding student internships led me to check out what type of internship opportunities exist at various government agencies.  Lo and behold, FDA has a little known summer student internship program that is currently acccept.ing applications this summer. This is what I found at the agency webstie:

Office of Policy Internships

The Office of Policy offers non-paid internships for interested undergraduate, graduate, and doctoral students. Past interns have had diverse educational interests, such as pharmacy, law, government, economics, and management. Our interns have worked on congressional hearings, drug importation investigations, novel disease outbreak issues, and briefings for senior agency officials. As an Office of Policy intern, you can expect to work on substantive projects, develop professional skills, and benefit from the personal attention of a mentor.

Purpose of Internship Program
The primary purpose of the Office of Policy internship program is to give students an opportunity to learn about federal programs, policies, and practices first-hand. By the end of the internship, each student will have the skills and knowledge necessary to allow him or her to make a significant contribution to public health.

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Job Cuts at Schering Plough?

New Jersey-based Schering Plough announced on Monday, March 12, 2007 that is plans on buying Organon Biosciences, a division of Akzo Nobel NV for $14.4 billion.  The deal makes sense for Schering whose pipeline was thin and relied too heavily on its cholesterol-lowering franchise for revenue.  That said, Schering Plough CEO, Fred Hassan, suggested that there may be some job cuts as a result of the deal. Schering Plough employs 35,000 people whereas Organon employs 19,000.  Although a majority of any cuts would likely come from the Organon side of the deal, you just never know. It looks like the NJ job market may take another hit.

Stay tuned for more details!

Until next time....

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

Role Reversal: University of Michigan to Hire Pfizer Ex-Employees

In an unprecendented move, the University of Michigan announced on March 9, 2007 that it has set aside $3.0 million to attract and hire workers from the Pfizer research facility (formerly Parke Davis Pharmaceuticals) that is closing in Ann Arbor. University officials indicated that the fund will be spent over three years to help to hire Pfizer employees for research- track positions in the various departments at the university. This move is part of an effort to help to keep talented researchers in .Ann Arbor as part of the University's efforts to sustain a fledgling, local biotechnology industry.

Pfizer announced on Jan 22, 2007 that it planned to shut down facilities in Ann Arbor, Kalamazoo and surburban Detroit as part of a restructuring plan, affecting about 2,410 Michigan jobs by the end of 2008.  All but about 310 of those jobs is in the Ann Arbor area. Pfizer plans to transfer up to 70 percent of the Ann Arbor employees to other company positions- although about 25 percent expressed an interest in remaining in the area.

Now is not a good time to be lookng for employment at Pfizer!!!!!!!

Unitl next time.....

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

Major New Job Trends for 2007

Matt Ferguson the CEO of Careerbuilder.com commisioned a survey to identify new trends in the job market for 2007.  The results fo the survey indicated that there may be as many as 7 new major trends in the job market for 2007. They are:

  1. Bigger Paychecks
  2. Increased Diversity Recruitment
  3. More Flexible Work Arrangements
  4. Rehiring Retirees
  5. More Promotions
  6. Better Training
  7. Hiring Overseas

As much as I respect the gurus over at Careerbuilder.com, these so-called trends do not seem like new ones to me. Call me crazy, but Ithe need for bigger paychecks, increases in diversity recruitment, more training and more flexible work arrangements has been long overdue for the American workforce.  Who knows, maybe something will change in 2007?

Until next time....

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

Cervical Cancer Vaccine Redux

Despite Merck's recent decision to abandon its lobbying campaign to promote the use of its HPV vaccine, the Colorado state legislature is still considering making cervical cancer vaccination mandatory for all girls who are in the sixth grade.  Girls would have to show proof of vaccination before they could attend Colorado middles schools (although provisions in the legislation would make proof of vaccination confidential ).  In another twist, Colorado state legislators also put forth a bill that would require all Colorado health insurers to pay for the vaccinations.  

The efforts by the Colorado state legislature and other state governments to help to reduce the incidence of cervical cancer among American women are laudable. However, the morbidity and mortality associated with cervical cancer in the US are extremely low . This is due to an excellent  cervical cancer survelliance and screenining system that was put into place in the US in the1960s.  In marked contrast with the US., the incidence of cervical cancer is reaching epidemic proportions in countries like China and India.  If Merck is truly intent on  reducing the global incidence of cervical

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Contract Employment: A New Paradigm for Pharma and Biotech

The practice of hiring temporary employees for short term, contract-based work is not a novel or new one. IT companies championed this practice in the mid 1990s and have been successfully hiring “contractors” over the past decade. These companies quickly realized that the contract employee paradigm made fiscal and operational sense. For those of you who may be unfamiliar with contract employees, they are typically hired on three (3) to six (6) month-long contracts and are paid an hourly rate. Unlike salaried employees, contractors are not entitled to receive any company benefits like health insurance or 401K plans. Large companies can save hundreds of millions of dollars by not offering benefits to temporary employees. Another financial benefit is that contract employees are only paid when they show up for work! This is in marked contrast with salaried employees who rarely have to account for time spent in or out of the office. Not surprisingly, contractors are carefully scrutinized for the hours they work and must submit weekly timecards (that summarize total hours worked) before they are paid. From an operational perspective, contract employment permits employers to determine whether a particular contractor is the”right fit’ for a company. If a contractor is deemed to be a good employee worth retaining, a company has the option of either offering a contractor a second contract or hiring them on as a full-time employee. On the other hand, if a contractor is not working out, the company can “let them go” without any hesitation because temporary employees have no employment protections. Continue Reading...

Bayer to Cut 6,100 Jobs

 

German drugmaker Bayer AG said Friday it would cut 6,100 jobs worldwide as it integrates Schering AG into its healthcare subsidiary. The cuts include 3,150 jobs in Europe -- 1,500 of them in Germany -- 1,000 in the United States, 1,200 in Canada and Latin America, and 750 in Asia and the Pacific Rim, the company said.

Bayer and Schering's pharmaceutical operations employ some 60,000 people worldwide.

Bayer Healthcare AG Chairman Arthur Higgins called the cuts "unfortunate but unavoidable" as the company seeks to achieve competitive cost structures.

The integration into the new Bayer Schering Pharma AG will cost $1.3 billion through 2008 and is projected to save about $925 million a year starting in 2009, Bayer said.

Construction of Genentech's New Biomanufcturing Facility Will Be Completed in the Summer of 2007

The construction of Genentech's $1.0 billion biomanufacturing facility is slated to be completed by the summer of 2007.  The plant will be located in Vacaville, California.  Construction of the plant begain in Fall, 2004.  Stay tuned for new job opportunities...after all, they will need workers to staff this new state of the industry biologics manufacturing facility.

Until next time....

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

Now Its Amgen's Turn....

Amgen is the world’s largest biotechnology company and employs almost 17,000 people. The  company’s best selling products are Epogen® (EPO) and Aranesp® (ARA) which are recombinant proteins that stimulate red blood cell production. EPO and ARA account for over half of Amgen’s yearly income. In 2006, the combined sales for the two products was approximately $6.6 billion (ARA, $4.5 billion; EPO, 2.1 billion). Both EPO and ARA have been approved to treat kidney dialysis patients who are anemic whereas similar products, e.g. Procrit®, Eprex®, are used to treat chemotherapy-induce anemia in cancer patients. Over the past 6 months, there has been a growing body of evidence that EPO, ARA and Procrit are being used to over-stimulate red blood cell production to levels that may cause heart attack or stroke in dialysis and cancer patients. More recently, results from clinical trials to determine whether EPO and ARA can be used to treat non-chemotherapy induced anemia in cancer patients indicated that cancer patients treated with EPO or ARA are at greater risk for death as compared to placebo-treated patients. Together, these data may prevent Amgen from gaining regulatory approval for use of EPO or ARA in new oncology indications.

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