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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Reuters reported
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
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.
The
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.
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!
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,
New Jersey-based
In an unprecendented move, the
Matt Ferguson the CEO of
Despite Merck's recent decision to abandon its lobbying campaign to promote the use of its HPV vaccine, the
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.

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.