Target Health is please to announce that Dr. Jules T. Mitchel, President of Target Health was recently quoted in Science Careers (31 October 2008), a publication of Science Magazine. The title of the article “The Other Life-Sciences Industry”, addresses careers in the device and diagnostic industries and is authored by Cliff Mintz. According to Dr. Mitchel, “There is a growing need for molecular biologists, biomaterials scientists, and biomedical and software engineers who understand the science that goes into device design.” Please let Dr. Jules T. Mitchel know if you want a copy of the article. Please visit our website to access our publications (http://www.targethealth.com/articles.aspx).

For more information about Target Health or any of its software tools for clinical research, please contact Dr. Jules T. Mitchel or Ms. Joyce Hays. Target Health’s software tools are designed to partner with both CROs and Sponsors.

Careers/Job Market

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Jules Mitchel, President, Target Health Inc.

From the journal, SCIENCE, Oct-Nov 2008 — “There is a growing need for molecular biologists, biomaterials scientists, and biomedical and software engineers who understand the science that goes into device design.” –Jules Mitchel, Target Health Inc.

Mention medical devices and diagnostics (MD&D) and most life scientists think of surgical instruments, catheters, prosthetic limbs, artificial joints, and imaging machines. Yet, recent advances in genomics and bioinformatics, coupled with nanotechnology and innovations in the biomaterials field, are transforming the MD&D industry. “The medical device and diagnostics business is one of the best kept secrets of the life sciences industry,” says Tom Ippolito, Ph.D., vice president of regulatory affairs and quality assurance at Chembio, a Medford, New York–based medical device and molecular diagnostics manufacturer. “Sequencing the human genome, device miniaturization, and the advent of combination devices have shifted the focus from engineering to the life sciences in the device industry,” adds Jules Mitchel, president of Target Health Inc. in New York City, a company that conducts clinical trials for MD&D companies.

The secret is well-kept among job seekers, too. Focused on the prospect of jobs at biotech and pharma companies, many life scientists overlook MD&D–a field that, though perhaps currently less lucrative than those better known industries, is also easier to enter for early-career life scientists.

Growth

In 2007, the worldwide market capitalization for MD&D companies was roughly $240 billion. That’s less than biotechnology (at $365 billion) and pharmaceuticals (at $1094 billion), but it’s a big industry–according to a report by the consulting firm Frost & Sullivan, it’s projected to grow over the next 3 to 5 years at an annual rate of 9%, a growth rate comparable to big pharma.

The recent growth is driven, experts say, by aging populations and increased life expectancy in the developed world; combination products that couple a medical device with a drug, the device usually acting as a drug-delivery vehicle; miniaturization (via nanotechnology), making medical devices less invasive; and the use of molecular diagnostics to customize therapeutic regimens and to assess individual disease risk. In 2007, the industry received about $4.1 billion in new investment, mostly in neurology, cosmetics and aesthetics, orthopedics, cardiovascular devices, and diagnostics. That’s enough investment to create as many as 2000 new jobs for life scientists.

Medical devices and the FDA

Medical devices range from the simple, such as Band-Aids, to the high-tech, such as imaging machines and the BRCA1 and BRCA2 molecular diagnostic tests for breast cancer (see sidebar).

Examples of medical devices

Coronary stents

Pacemakers

Prosthetic limbs

Medical lasers

Biosensors

CT scanners

Magnetic resonance imaging machines

Catheters

Artificial hips/knees/disks

Surgical instruments

Diagnostic tests (serological and molecular)

Like drugs, medical devices must receive regulatory approval before they can be marketed and sold–but the regulatory hurdles and costs are much lower for devices than they are for drugs. The U.S. Food and Drug Administration (FDA) classifies medical devices and diagnostic tests as Class I, II, or III. In general, Class I and Class II devices don’t require clinical testing. Most Class III devices do require clinical testing, but the clinical trials are typically smaller, much less costly, and shorter in duration than those required for pharmaceuticals.

Career opportunities in MD&D

Until the late 1990s, most MD&D jobs were in engineering, manufacturing, quality control, and marketing and sales. Degree requirements typically ranged from a high school diploma to an undergraduate degree in science or engineering. Since then, the increasing complexity of many devices, coupled with clinical and regulatory requirements, has created opportunities for scientists with graduate degrees. “Because of the increasing design complexity and regulatory requirements for these devices, there is a growing demand for Ph.D.-level employees with … problem-solving skills who can address scientific issues that may arise regarding the design, safety, and efficacy of devices,” says Ippolito.

New disciplines are also coming into play. Ippolito adds that demand is increasing for scientists with expertise in clinical research, regulatory affairs, and quality control and assurance. “There is a growing need for molecular biologists, biomaterials scientists, and biomedical and software engineers who understand the science that goes into device design,” adds Mitchel. Neurology, biochemistry, pharmacology, and physiology are also disciplines of interest. Geographically, many of the larger and more established device manufacturers are located in the Midwest and the Northeast (Table 1), but smaller MD&D start-up companies have begun to appear in most states in the United States.

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The salaries of MD&D scientists tend to be lower than those of their pharmaceutical and biotechnology counterparts. Typically, employee-benefits packages are less comprehensive, annual bonuses are smaller, and there is less opportunity for career advancement in MD&D. But those gaps are likely to close, Ippolito says, as MD&D companies seek top talent to design and manufacture more sophisticated and complex devices.

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Mark Citron

On the plus side, Mark Citron, vice president of clinical and regulatory affairs at TyRx Pharma in Monmouth Junction, New Jersey, a combination cardiac device manufacturer, says it’s much easier for entry-level scientists to find jobs at MD&D companies. “Having a Ph.D. is an advantage, not a requirement for a job, in the device industry,” says Citron. Extended postdoc training and prior industrial experience–absolute musts for pharmaceutical and biotechnology jobs–may not be necessary for entry-level MD&D jobs.

Louise Sigismondi, a neuroscientist, landed a job as a regulatory affairs specialist at ChemBio after a year of postdoctoral training. “After 1 year of postdoctoral training, I realized that I didn’t want to do basic research for the rest of my life. So, I applied for a job at ChemBio, and, much to my surprise, I got it.” Although postdoc training is not essential, it can help job seekers find work at larger and more established MD&D companies, Citron and Ippolito agree. However, these days, much of the cutting-edge science and innovation takes place at start-up and mid-size MD&D companies.

Job requirements, skill sets, and the nature of the work

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Louise Sigismondi

Experts say that research in the MD&D industry–like most industry research–is focused on the market. “The research that we do is rapidly paced, extremely applied, and product-driven,” Ippolito says. “There is virtually no time to pursue basic research problems in this business. I hire self-motivated, team-oriented individuals who are comfortable working in constantly changing research and regulatory environments.” Citron likes to hire “technically competent ‘big picture’ scientists who are comfortable working on multiple projects at the same time. If you don’t like doing applied research, then the device and diagnostics industry may not be for you.” Sigismondi, who has worked at both pharma and device companies, prefers the latter. “My salary is lower, but I enjoy doing applied research because there is a greater likelihood [than in pharma] that the products that I work on will make it to market.”

What does the future hold?

Right now, molecular biologists, immunologists, and quality control and assurance and regulatory scientists are in high demand, especially at diagnostic and biomaterials companies. Most industry experts agree that personalized medicine and theranostics–diagnostic tests bundled with therapeutic agents to treat a specific disease–point to a bright future for the industry. However, as the sophistication and complexity of newer devices increases, so will the costs and regulatory requirements for device approval. This, coupled with rising health care costs and lower reimbursements from insurance companies, may slow the predicted rapid growth of the MD&D industry–and job opportunities–even as the demand for scientists with more advanced training increases.

Another thing to consider before jumping into M&D is the notion that because the industry has a lower status than academia, pharma, or biotech, a ticket to the MD&D industry tends to be one-way. “I think it is much easier for a person with a pharma or biotechnology background to get a job in the device industry than it is for a person with device experience to break into the pharma or biotech business,” says Ippolito, who spent more than 15 years in the biotechnology field before moving into the MD&D field.

Nevertheless, in light of the fierce competition and a slumping market for life sciences jobs in academia, biotechnology, and the pharmaceutical industry, it may be worth considering a career in the MD&D industry. “The salaries may be higher in pharma and biotech,” says Sigismondi, “but my current salary is considerably higher than what I would be making as a postdoc or if I was unemployed.”

Images, top to bottom: PhotoDisc, courtesy of Jules Mitchel, Cliff Mintz, courtesy of Mark Citron, courtesy of Louise Sigismondi

According to a presentation made at the 10 November 2008 annual meeting of the American Society for Reproductive Medicine (ASRM), held in San Francisco, a new technique was reported showing the ability to freeze and transplant ovaries. According to the authors, the technique could help preserve fertility in women facing cancer therapy, as well as to be used by women who want to delay having children. In the presentation, it was reported that an ovary was transplanted from one identical twin to her twin sister, thus allowing the twin with premature ovarian failure to conceive a child. One year after the transplant, the twin with the transplanted ovary had become pregnant. The authors noted that the ability to remove an ovary, freeze it and put it back into the same woman represents the real potential breakthrough. The technique can benefit cancer patients about to undergo radiation, chemotherapy or bone marrow transplant, which would leave them sterile. Currently, women can have their eggs frozen and put back after cancer treatment is complete. But there are disadvantages, in that if all the eggs go through IVF (in vitro fertilization), the chance of pregnancy is no more than 50%. Therefore, if the woman does not become pregnant, there are no other options. With ovary transplantation, however, the woman gets a normally functioning ovary just like she would have if she were younger. The authors reported that they’ve done the procedure nine times.

Dr. Gero Htter, a German hematologist replaced a patient’s bone marrow cells with those from a donor who has a naturally occurring genetic mutation that renders his cells immune to almost all strains of HIV. The patient, a 42-year-old American living in Berlin, is still recovering from his leukemia therapy, but he appears to have won his battle with AIDS. Doctors have not been able to detect the 1) ___ in his blood for more than 600 days, despite his having ceased all conventional AIDS medication. This development suggests a potential new therapeutic approach as the search for a 2) ___ has adopted new urgency. Known as 3) ___, current AIDs medications prevent the virus from replicating. Last year, AIDS killed two million people; 2.7 million more contracted the virus. Back in 1996, when “cocktails” of antiretroviral drugs were proved effective, some researchers proposed that all 4) ___ harboring HIV might eventually die off, leading to eradication of HIV from the body. Those hopes foundered on the discovery that HIV, which integrates itself into a patient’s own 5) ___, hides in so-called “sanctuary cells,” where it lies dormant. But that same year, researchers discovered that some gay men astonishingly remained uninfected despite engaging in risky encounters with multiple partners. These men had inherited a mutation from both their parents that made them virtually 6) ___ to HIV. The mutation prevents a molecule called CCR5 from appearing on the surface of cells. CCR5 acts as a kind of door for the virus. Since most HIV strains must bind to CCR5 to enter cells, the 7) ___ bars the virus from entering. A new AIDS drug, Selzentry, made by Pfizer Inc., doesn’t attack HIV itself but works by 8) ___ CCR5. About 1% of Europeans, and even more in northern Europe, inherit the CCR5 mutation from both parents. People of African, Asian and South American descent almost never carry it. Dr. Htter remembered this research when his American leukemia patient failed first-line 9) ___. He was treating the patient at Berlin’s Charit Medical University, the same institution where German physician Robert Koch performed some of his groundbreaking research on infectious diseases in the 19th century. Finally, he recommended standard second-line treatment: a bone marrow 10) ___ — but from a donor who had inherited the CCR5 mutation from both parents. Bone marrow is where immune-system cells are 11) ___, so transplanting mutant bone-marrow cells could render the patient immune to HIV into perpetuity. There were a total of 80 compatible blood donors living in Germany. Luckily, the mutation appeared from both parents on the 61st sample tested. To prepare for the transplant, Dr. Htter first administered a standard regimen of powerful drugs and radiation to kill the patient’s own bone marrow cells and many immune-system cells. This procedure, lethal to many cells that harbor HIV, may have helped the treatment succeed. The transplant specialists ordered the patient to stop taking his AIDS drugs when they transfused the donor cells, because they feared the powerful drugs might undermine the cells’ ability to survive in their new host. They planned to resume the drugs once HIV re-emerged in the blood. But it never did. Nearly two years later, standard tests haven’t detected virus in his 12) ___.
ANSWERS: 1) virus; 2) cure; 3) antiretrovirals; 4) cells; 5) DNA; 6) immune; 7) mutation; 8) blocking; 9) chemotherapy; 10) transplant; 11) generated; 12) blood