The Pharmaceutical Industry

Posted by on Aug 28, 2013 in Pharmaceutical |

By Dr. Wayne T. Harris

 
The pharmaceutical industry provides tremendous opportunities for career development for college graduates. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), total domestic sales for member companies have increased an average of 11.5% per year from 1970 to 2002. It is this stable growth in sales, which allows for growth in career opportunities. The top areas for college recruitment by this industry are: science, engineering, health professions, finance, marketing and information technology. The member companies of PhRMA include Pfizer, Novartis, Aventis, Eli Lilly, Abbott, Glaxo Smith Kline, Bristol-Meyers, Novo Nordisk and Astra Zeneca.

The previous growth in sales and expectations for the future are fueled by several important trends. First of all, an aging population has an increased need for health care, including prescription medications. It is important to note that development and use of new medicines have contributed significantly to the increased life span that we now enjoy. Secondly, developments in genomics research will result in new approaches to treatment and prevention of disease and a wide variety of new types of pharmaceutical agents. Thirdly, the growing concerns regarding bioterrorism have affected the entire world. Products of the pharmaceutical industry are crucial for adequate response to attacks using biological or chemical weapons.

The development of new drugs requires a substantial investment in research and development. Knowledge of the research and development process allows for a better understanding of the nature of pharmaceutical industry.

The average cost of developing a new drug has increased from $138 million in 1975 to $802 million in 2002, according to the PhRMA. In addition to the financial costs, an average of ten to fifteen years is required to develop a new drug while only 1 of 5000 screened compounds is approved for use as a new medicine. A patent is secured once a new chemical compound is created or identified for a particular biological effect. The United States provides a 20-year patent term and as noted earlier, from ten to fifteen years is required to conduct the required research and development on any new chemical entity.

The research and development process is divided into several stages.

  1. Preclinical/prehuman studies
  2. Phase I clinical trials
  3. Phase II clinical trials
  4. Phase III clinical trials
  5. Phase IV (Post-marketing Surveillance)

Preclinical studies focus on all the scientific disciplines and are involved with appropriate laboratory tests to assure purity, develop analytical procedures, and assure effectiveness in laboratory models of disease and animal models. In addition, marketing analysis and business planning are conducted simultaneously. If this first stage succeeds, the chemical is tested for safety in humans. This step requires submission of an Investigational New Drug (IND) Application to the United States Food and Drug Administration and approval by that agency. Phase I clinical trials focus on demonstrating safety when administered to humans. The manufacturer sets up a research protocol involving healthy volunteers in which doses of the investigational new drug are administered. The purpose of these experiments is to determine whether the drug causes any side effects and the severity of those effects. If the drug survives the safety study, which could take two or three years, the manufacturer will begin Phase II trials in which small-scale experiments in patients with the condition to be treated are used to conduct an effectiveness study. Once those studies are done, the manufacturer undertakes more complicated Phase III clinical trials to determine whether the drug will work in large groups of people with the disease. Successful results through this process will allow for submission of a New Drug Application to the Food and Drug Administration. Approval of the NDA will allow the drug to be used for sale to the general population. As you can see, this is an escalating process and at any point a new chemical entity can be withdrawn from further development if experimental results are not acceptable. The manufacturer could have as little as five years to make a profit on the investment of hundreds of millions of dollars. The final stage in the research and development process is Phase IV (post-marketing surveillance). This is an ongoing process once the FDA has approved a drug. It involves continued clinical trials and reporting of adverse drug reactions.

The member companies of the PhRMA are supporting these long ranges of studies. They invest the hundreds of millions of dollars, and if a drug gets through to the effectiveness trial and doesn’t work, the development stops and continues to the next new chemical entity. After the patent-life of a drug, a generic drug or copy of that drug may be produced and sold by other companies.

It is important to note that the pharmacy practice industry is integrally related to the development and manufacturing industry. The pharmacy practice industry consists of independent health professionals and employees, small and large corporations that focus on treating patients. These companies manage drug distribution, dispensing, counseling patients, and so forth. It too is a huge industry because, as with manufacturing drugs, people have more diseases to treat as they live longer – the number of people who are using drugs is growing, as the baby boomers become retirees and so forth. All the major companies in this sector are looking to expand, because they see the increased need I have described. They are creating new stores in new markets all over the country. The major national companies in this sector are Walgreens, Wal-Mart, Eckerd, Rite Aid, CVS, major food chains and regional chains. These companies are also recruiting college graduates in the same disciplines as the research manufacturers. Opportunities in this pharmacy practice industry are extremely good because the demand for pharmaceuticals is growing. The need for pharmacists is especially acute in most major markets.

The federal government represents another important area for career development and many of the agencies in the federal government are directly involved with the pharmaceutical industry from a regulatory perspective to emergency preparedness. The agencies under the United States Department of Health and Human Services are involved with improving public health (Centers for Disease Control and Prevention and the Health Resources and Services Administration), regulation and approval of prescription drugs (Food and Drug Administration), policy development, and support of basic and clinical research (National Institutes of Health). Opportunities exist for health professionals and majors in science, engineering, business, and information technology. The Health Resources and Services Administration oversees a large variety of programs including those that provide drugs to patients who can’t afford to buy them for themselves. They are usually connected with community health centers, and pharmacists oversee that program.

In discussing career opportunities related to the pharmaceutical industry, I must include education of health professionals for health services throughout the United States as a part of the pharmaceutical industry. The Federal Government through the Department of Health and Human Services (HHS) established a blue print for improving the health of society referred to as “Healthy People 2000.” It was a huge document that set forth a number of objectives for improving the health of society by the year 2000. Those objectives were far-reaching and focused on specific indicators for healthy lives. Lack of physical exercise and smoking are two specific examples. The objectives set specific targets for those major indicators. Analysis of performance in achieving those objectives led to development of “Healthy People 2010,” which set objectives to be achieved by 2010. There are two main goals for “Healthy People 2010.” The first goal is to increase the number of years of healthy life for all citizens of this country, a very lofty goal.

The second main goal for “Healthy People 2010″ is to eliminate health disparities, these meaning differences in prevalence, morbidity and mortality of diseases among people of different racial and ethnic groups. One of the objectives for eliminating health disparities is increasing the number of minority health professionals. “Healthy People 2010″ sets specific targets for 2010. The premise for establishing these targets is that the number of minority health professionals and the number of minority educators who teach in health-profession academic programs should reflect the demographics of society. For example, approximately, five percent of pharmacists in the United States are African Americans while African Americans make up about thirteen percent of the population. That’s a problem and health-professions education must be addressed if continued progress is to be made. The Federal Government has said we cannot achieve the goals of “Healthy People 2010″ without increasing the representation of minority health professionals and educators. The message must be widely disseminated about the need for minority educators in the health- professions programs and minority health professionals.

In conclusion, the opportunities in the pharmaceutical industry are extraordinary. It includes the research and development manufacturers, the practice industry, education of health professionals, and pharmacy academic programs. The interplay between this industry and the Federal Government creates many opportunities in the federal sector as well. Each has many career opportunities. If we are going to deal with health disparities, we must deal with creating health professionals who represent the population. That’s one of the biggest challenge we face.

 

Recruiter’s Advice

Monica Poindexter of Genentech

The single most important advice I would give to collegians to help them succeed in their career within the pharmaceutical industry or with Genentech is to get an industry internship. The landscape for New College is extremely competitive. If you do not have skills or experience to differentiate you from the vast sea of competition, you’re no different from the next student. Seek out internship opportunities and pay attention to the companies that are coming to your campus to host information sessions or meet-the-firm night. Too many times, African-American and other minority students are not informed about the recruitment efforts going on their own campus. It is critical for students to make it their business to research companies who are in their particular field of interest. Don’t wait until the last minute to get an internship; start as early as possible. From a personal standpoint, I had my first internship right out of high school through the INROADS, Inc. program. I kept my same internship for four consecutive summers with my sponsoring company. It is no surprise that I had a job with the very company with which I spent four summers. So my advice: take the time to find an internship!

 

Wayne T. Harris, R.Ph., Ph.D. is Professor and Dean, College of Pharmacy, Xavier University of LA.


 
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