Q 1) If you had to explain the drug development process to a 4th grade science class, what would you say?
A drug is developed by a team of scientists trained to understand and evaluate the risks and benefits of a new medicine. To find a drug that promotes health and modifies disease, scientists look for molecules with positive health properties. Usually thousands of molecule combinations are screened in order to find one product that is safe and effective. Once a drug product is identified, its characteristics must be determined by chemical and biochemical analysis. Formulas will be made with the drug and given to animals and humans to assess the safety and effectiveness of the product. The product is then evaluated by the Food and Drug Administration and will be approved if the benefits outweigh the risks and it is safe and effective. This process can take up to 20 years and cost millions of dollars.
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Q 2) What is the overall goal of drug development (i.e., in 10 years, what do we hope to have achieve)?
The goal of drug development is to produce safe and efficacious therapeutic products for the promotion of health, and the prevention, cure and treatment of disease.
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Q 3) What are some of the landmark achievements in drug development to this date?
There have been many great discoveries in drug development that have benefited mankind. Recent developments include unraveling the human genome, which is the genetic blueprint for building a human being. By understanding how the human system works on a molecular level will allow scientists to create better therapies to treat, prevent and cure disease. Other landmark achievements include the discovery of antibiotics, the polio vaccine, biotechnology, modern analysis and computer modeling.
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Q 4) What does the typical day of a drug development scientist look like?
A drug is developed by a team of scientists that have specialized training and expertise in specific disciplines. Some of the scientists are chemists that synthesize and analyze drug products, others are pharmacists that formulate the drugs into dosage forms, others are pharmacologists which examine the metabolism in animals and man, and others are physicians that evaluate the safety and efficacy of the product in diseased population.
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5) What part of your job do you like best? What’s the most challenging?
I enjoy working with a team of professionals committed to producing effective, safe therapies for unmet medical needs. The challenge is that it is hard work and many times during the drug development process, scientists are faced with development disappointments due to unacceptable safety concerns or poor efficacy of the product. Unfortunately, there are more failures than successes with drug development.
The most challenging aspects of product development are anticipating issues that may impact the associated timelines and budgets; maintaining communication across the various disciplines; and keeping the development team focused and excited on the issues at hand. It is a combination of mentor, disciplinarian, participant, confidant and cheerleader. The bottom line is that you are the responsible party for pushing the project through the various regulatory hoops towards approval of the drug product. Failure is not an option.
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Q 6) What achievement at work are you most proud of?
I am proud of the achievements of those I have had the opportunity to mentor. It is a challenge to manage and utilize entry level scientists effectively in the meticulously regulated industrial pharmaceutical setting. Guidance and training are needed for these young scientists to succeed. In addition, you have to provide an atmosphere of professional growth for the scientist, both corporately and intellectually. Now, I am watching many of those scientists becoming mentors to others - it’s a good feeling to see this happen.
There is also a sense of accomplishment when the Food and Drug Administration finally approves a drug product that my colleagues and I have worked so hard for years to develop. It is also exciting to see the product you have worked on in the pharmacy and being dispensed to patients - you know you have made an impact on somebody’s life.
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Q 7) What type of educational background does your field require?
At a minimum, a bachelor’s degree in a relevant scientific fields such as chemistry, pharmacy and biology would be required. Advanced degrees, such as Masters of Science (M.S.), Doctor of Medicine (M.D.), Pharmacy (Pharm.D.) or Philosophy (Ph.D.), are typically needed to advance in the field.
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Q 8) How would you direct someone into your line of work (i.e., what should they study, what internships should they seek, what is the entry level position called, any tips to help get their foot in the door)?
It starts with your education, choosing a science-related major, maintaining you grades, seeking universities to attend that have good reputations in pharmaceutical development, participating, publishing and presenting at scientific meetings. Many professional associations such as AAPS provide opportunities for students to interact with other students (student chapters) and the pharmaceutical industry. Some pharmaceutical companies provide student internships where the student is exposed to the regulated research environment. This allows both the company and student to interact on a temporary basis and establish a working relationship. Entry-level position titles typically are identified by discipline. For example, entry-level chemists can hold the title of Associate Chemist, graduating to Chemist, then Senior Chemist, Principle Chemist, Group Leader, Manager, Director then on up to Vice President.
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Q 9) Is there anything you wish you would have known about your field prior to choosing it as your career?
Unfortunately, many of the academic institutions do not have experience with industrial drug registration processes, so exposure to the FDA regulations prior to entering industry would be extremely beneficial. In addition, the professional and personal rewards associated with drug development are outstanding and I recommended this career to those who enjoy hard work and want to make an impact on people’s health.
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