2. Life Science Jobs are Found in Many Industries Pharmaceuticals Biotechnology Biomedical Devices Diagnostics Veterinary Health Agriculture Food & Nutrition Cosmetics Health Care Ecology Forensics Etc.
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4. Getting a New Drug to Market The process takes about 14 years on average. Only about 1 in 10,000 compounds investigated will eventually become a drug. The cost of developing a new medicine generally exceeds $1 billion. The are many steps along the way and many different jobs that need to be done.
5. How are Drugs “Discovered?” Serendipity By looking at other situations Rational drug design Library screening
6. Pick a Therapeutic Area The therapeutic area is the particular disease or disorder that is of interest. It may be cancer, pain, diabetes, heart disease, HIV/AIDS, influenza, anxiety, or any other area that you can think of. Market factors have a big influence on a company’s decision regarding what to pursue.
7. Step 1: Identify & Validate a Target Use known science to predict where a drug may have an effect. This may be: an enzyme (a protein in the cell that allows a reaction to occur) a receptor (a lock-and-key binding site for a drug that starts a series of cellular events a gene Validate the target – make sure it has the predicted activity.
8. Step 2: Hit Finding Design, prepare, and test compounds against the target using a variety of techniques such as: Molecular biology Biochemistry Pharmacology Tissue culture Animal studies Identify the best candidate(s)
9. Step 3: Lead Optimization Chemists modify and refine the drug candidates. Do further activity, safety, and side effect studies on the best drug candidates in cells, tissues, and animals. Designate a lead compound.
10. Target Identification, Discovery, Preclinical Development Development Manufacturing Approval, Launch, Post-Launch Pharmacologist Physiologist Biochemist Cell Biologist Geneticist Microbiologist Virologist Toxicologist Biological Technician Chemical Technician Animal Technician Synthetic/Medicinal Chemist Analytical Chemist Organic Chemist Inorganic Chemist Protein Chemist Formulations Scientist Pharmaceutical Chemist Quality Control Analyst Computational Chemist Process Chemist Bioinformatics Specialist Biostatistician Biostatistics Associate Computational Chemist Research Information Tech Clinical Research Assistant Clinical Research Associate Medical Writer Clinical Data Analyst Clinical Data Manager Clinical Data Assistant Clinical Project Managers Documentation Specialist Regulatory Affairs Associate Quality Assurance Specialist Patent Associate Industrial Engineer Environmental Engineer Bioprocess Engineer Biochemical Engineer Biomedical Engineer/Bioengineer Process Engineer Chemical Engineer Materials Engineer Manufacturing Engineer Material Handler Packaging & Handling Technician/Associates Lead Packaging Associate Process Equipment Specialist Aseptic Fill Technician Manufacturing Technician Assay Analyst Aseptic Fill Research Associate Manufacturing Associate Instrumentation/Calibration Associate Validations Technician Manufacturing Trainer Quality Control Engineer Facilities Manager Product Product Support Specialist Marketing Assistant Medical Communications Writer Advertising Associate Medical Information Associate Pharmacovigilence Associate Purchasing Manager Buyer Production Planner Supply Chain Analyst Warehouse Manager/Supervisor Warehouse Specialists
11. Development Many other functions come into play as a drug candidate moves from early to late development and on to launch.
14. Clinical Development – Testing in Humans Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question: Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety. Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use. http://clinicaltrials.gov/info/resources
16. Target Identification, Discovery, Preclinical Development Development Manufacturing Approval, Launch, Post-Launch Pharmacologist Physiologist Biochemist Cell Biologist Geneticist Microbiologist Virologist Toxicologist Biological Technician Chemical Technician Animal Technician Synthetic/Medicinal Chemist Analytical Chemist Protein Chemist Formulations Scientist Biophysical Chemist Pharmaceutical Chemist Quality Control Analyst Computational Chemist Process Chemist Bioinformatics Specialist Biostatistician Biostatistics Associate Computational Chemist Research Information Technician Clinical Research Assistant Clinical Research Associate Medical Writer Clinical Data Analyst Clinical Data Manager Clinical Data Assistant Clinical Project Managers Documentation Specialist Regulatory Affairs Associate Quality Assurance Specialist Patent Associate Industrial Engineer Environmental Engineer Bioprocess Engineer Biochemical Engineer Biomedical Engineer/Bioengineer Process Engineer Chemical Engineer Materials Engineer Manufacturing Engineer Material Handler Packaging & Handling Technician/Associates Lead Packaging Associate Process Equipment Specialist Aseptic Fill Technician Manufacturing Technician Assay Analyst Aseptic Fill Research Associate Manufacturing Associate Instrumentation/Calibration Associate Validations Technician Manufacturing Trainer Quality Control Engineer Facilities Manager Product Product Support Specialist Marketing Assistant Medical Communications Writer Advertising Associate Medical Information Associate Pharmacovigilence Associate Purchasing Manager Buyer Production Planner Supply Chain Analyst Warehouse Manager/Supervisor Warehouse Specialists
17. Approval The Food & Drug Administration (FDA www.fda.gov) regulates what drugs are allowed on the market. The FDA requires extensive testing and the filing of significant documentation detailing what the company has done. A select panel then reviews everything and either approves the drug, requests more tests or information, or turns down the application.
19. Launch The launch of a new drug is a major event for a pharmaceutical company. There is input from marketing, business development, medical communications, and regulatory affairs. Sales and distribution channels are established.
20. Post-Launch Even after launch, the company must continue to monitor it’s product for safety and side effects. Sometimes new uses are discovered for the drug. If the company does not file a New Drug Application with the FDA for these new uses, they are called “off-label” and can’t be advertised. Companies often provide literature, run seminars, and offer courses to help medical professionals understand their products.
21. Target Identification, Discovery, Preclinical Development Development Manufacturing Approval, Launch, Post-Launch Pharmacologist Physiologist Biochemist Cell Biologist Geneticist Microbiologist Virologist Toxicologist Biological Technician Chemical Technician Animal Technician Synthetic/Medicinal Chemist Analytical Chemist Protein Chemist Formulations Scientist Biophysical Chemist Pharmaceutical Chemist Quality Control Analyst Computational Chemist Process Chemist Bioinformatics Specialist Biostatistician Biostatistics Associate Computational Chemist Research Information Technician Clinical Research Assistant Clinical Research Associate Medical Writer Clinical Data Analyst Clinical Data Manager Clinical Data Assistant Clinical Project Managers Documentation Specialist Regulatory Affairs Associate Quality Assurance Specialist Patent Associate Industrial Engineer Environmental Engineer Bioprocess Engineer Biochemical Engineer Biomedical Engineer/Bioengineer Process Engineer Chemical Engineer Materials Engineer Manufacturing Engineer Material Handler Packaging & Handling Technician/Associates Lead Packaging Associate Process Equipment Specialist Aseptic Fill Technician Manufacturing Technician Assay Analyst Aseptic Fill Research Associate Manufacturing Associate Instrumentation/Calibration Associate Validations Technician Manufacturing Trainer Quality Control Engineer Facilities Manager Product Product Support Specialist Marketing Assistant Medical Communications Writer Advertising Associate Medical Information Associate Pharmacovigilence Associate Purchasing Manager Buyer Production Planner Supply Chain Analyst Warehouse Manager/Supervisor Warehouse Specialists
22. Jobs in the Pharmaceutical Industry As you have seen, there are many jobs in the pharmaceutical industry all of which contribute to bringing a new medicine to market. Many of the jobs we discussed today and others, are found in the Life Sciences section of ExploreYourFuture.org.
