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Eyf webinar sepa career fair 2010
Eyf webinar sepa career fair 2010
Eyf webinar sepa career fair 2010
Eyf webinar sepa career fair 2010
Eyf webinar sepa career fair 2010
Eyf webinar sepa career fair 2010
Eyf webinar sepa career fair 2010
Eyf webinar sepa career fair 2010
Eyf webinar sepa career fair 2010
Eyf webinar sepa career fair 2010
Eyf webinar sepa career fair 2010
Eyf webinar sepa career fair 2010
Eyf webinar sepa career fair 2010
Eyf webinar sepa career fair 2010
Eyf webinar sepa career fair 2010
Eyf webinar sepa career fair 2010
Eyf webinar sepa career fair 2010
Eyf webinar sepa career fair 2010
Eyf webinar sepa career fair 2010
Eyf webinar sepa career fair 2010
Eyf webinar sepa career fair 2010
Eyf webinar sepa career fair 2010
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Eyf webinar sepa career fair 2010

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Transcript

  • 1. STEM Career Exploration with
    An Overview of Jobs in the Biopharmaceutical Industry
  • 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.
  • 3.
  • 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.
  • 12. Preclinical Studies
    Absorption
    Distribution
    Metabolism
    Excretion
    Toxicology
  • 13. Product Development
    Formulations Development
    Stability Testing
    QA/QC
    Small Batch Synthesis
  • 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
  • 15. Other Development Functions
    Regulatory Affairs
    Medical Writing
    Business Development
    Sales & Marketing
  • 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.
  • 18. Manufacturing
    Chemical Process Development
    Manufacturing
    Packaging
  • 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.

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