• Share
  • Email
  • Embed
  • Like
  • Save
  • Private Content
High School Career Day Drug Development 2010
 

High School Career Day Drug Development 2010

on

  • 1,629 views

A presentation to High School students for Career Day.

A presentation to High School students for Career Day.

Statistics

Views

Total Views
1,629
Views on SlideShare
1,626
Embed Views
3

Actions

Likes
0
Downloads
5
Comments
0

1 Embed 3

http://www.linkedin.com 3

Accessibility

Categories

Upload Details

Uploaded via as Microsoft PowerPoint

Usage Rights

© All Rights Reserved

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Processing…
Post Comment
Edit your comment

    High School Career Day Drug Development 2010 High School Career Day Drug Development 2010 Presentation Transcript

    • Northgate High School Career Day 2010
    • Pharmaceuticals, Biologics and Medical Device Development Michael Donatelli President & CEO Insite Quality Assurance, Inc.
    • About Me
      • After High School (1981), attended Cal Poly SLO for a Degree in Biology
      • Changed major to Medical Microbiology (1985)
      • Worked as a laboratory researcher (1986)
      • Learned that FDA was doing many inspections of Clinical Research (1989)
      • Hired to become a quality assurance auditor (1991)
      • Inspired on a business trip (1998)
      • Started my own consulting company (2000)
    • About You
      • How many of you …
        • are searching/lost about what to do in life?
        • enjoy science?
        • are considering a career in medicine?
        • have considered a career in research?
        • curious about how medicines are made?
    • Life Cycle of a Drug/Device Extremely Complex Process
    • Drug Development Timeline Stage Purpose # Compounds Y1 Y2 Y3 Y4 Y5 Y6 Y7 Y8 Y9 Y10 Y11 Y12 Y13 Y14 Research New Information >1,000K + ID Possible NCE Discovery Modeling 100K Modify NCE Characterization Animal Testing Toxicity 10K PK / PD ADME Phase I Initial Safety 100 20 - 100 Patients Months Phase II Efficacy 40 <300 Patients <2 Years Phase III Safety & Efficacy 15 Dosage 300 to >1000 Patients 1 - 4 Years Application Summarize Studies 10 Describe Label New Drug Marketing 6-8  Years of Follow - up
    • Cost of Drug Development 23APR2002 - Tufts University 1976 1982 1987 1994 1997 2001 $ MILLIONS 0 150 300 450 600 750 900 500 250 125 87 54 800 2008 1.2B
    • What Drives Innovation?
      • Technology/New Inventions
        • Engineering
        • Physics
        • Chemistry (Bio, Organic, Inorganic)
        • Genetics
        • Biology
    • Development Stages Discovery Lab Research Animal Research Scale-up & Manufacturing Clinical / Human Research Pharmacokinetics Pharmacodynamics Team Work Product Formulation Marketing Application Labeling & Pricing Negotiations
    • About Insite QA
    • What do you do?
      • What is your “ job ”?
        • A task; an economic role for which a person is paid.
      • What is your “ career ”?
        • One's calling in life; a person's profession; your life’s work.
      • What is your “ business” ?
        • An organization designed to provide goods and/or services (too make money).
      I am paid to do regulatory compliance audits of new drug research. Developing cures for diseases. Build a network of consultants designed to facilitate new drug development.
    • My Company
      • We are a specialized consulting company working with Biotech and Pharmaceutical company’s in new medical therapy research and development.
      • We find and analyze problems and offer solutions.
    • My Impact on Disease
      • Help company’s make products that enable doctors to treat patients
      • Products
        • ICON® Strep-B Diagnostic Test (TM) (Streptococcus b)
        • Mevacor® (Cholesterol lowering agent)
        • Fosamax® (Osteoporosis)
        • Timoptic® (Glaucoma)
        • Proscar® (Benign Prostatic Hyperplasia)
        • Proluekin® (Renal Cell Carcinoma, Melanoma)
        • Betaseron® (Multiple Sclerosis)
        • Tricelluvax® (Diphtheria, Tetanus and Acellular Pertussis)
        • Tobi® (Cystic Fibrosis)
        • Fluad® (Influenza Vaccine)
        • Tamiflu® (Influenza)
        • Viread® (HIV)
        • Qutenza® (Postherpetic Neuralgia)
        • CIMZIA® (Crohn’s Disease and Rheumatoid Arthritis)
    • My Typical Day
    • Office Work
      • Client Calls
        • Describes a need
        • Provide an estimate for work
        • Assign work to an associate
      • Execute the work, make observations
    • On the Road
      • Visit to Clinical Investigator
        • Assess compliance to Food & Drug Law and Declaration of Helsinki
        • Review Patient Charts
          • Look for fraud
          • Assess Protocol Compliance
          • Consent, medical care, study data, drug usage
          • Assess Adverse Events
        • Review Regulatory Documents
        • Identify problems and assess risk
    • Back to the Office
      • Completed Investigation
      • Write a detailed report
        • Who, what, when, where, why, how
        • List observations, discuss risks
      • Present to the client
      • Collect fee
    • An Exciting Day
      • Prostate Cancer Drug
        • Travel around the USA
        • Performing audits for a new drug
        • Discovered problems with documentation
        • Developed a Corrective Action Plan
        • Guided Sponsor
        • Successful FDA inspections
      • Drug approval expected any day now
    • Travel
      • My work is global
        • 5 of 7 continents
        • 26 Country’s
        • 44 of 50 States
        • >930 City’s
      • Upsides; experiencing different cultures, seeing historical sites, frequent flier miles
      • Downsides; away from family, missing events, exhaustion, living out of a suite case
    • My Typical Day is Atypical
      • My work is indoors
        • Behind my desk, at my office
        • At a clients office
        • Doctors office
        • Hospital
        • Clinical Laboratory
        • Manufacturing facility
      • My work day hours
        • Start work between 7am and 11am
        • End work between 3p and 1am
        • Can be anywhere between 2 and 14 hours a day, 5 to 7 days a week, 365 days a year
    • Pros and Cons
    • Biotech Career Pros and Cons
      • Working indoors, desk/paper work
      • Long hours, sometimes weekends and holidays
      • Drug Research Wages
        • Entry level BA/BS $40K to $55k, BA/BS max. $105k
        • Entry level MS/MD/PhD $120k to $180k , Max $260k+
      • Quality Assurance Wages
        • Entry Level BS/MS in Science $40K to $55k, Max. $165k+
      • Contract/consulting Income $100k to $1.5M+
      • Work is more mental than physical
      • Abundant opportunities
      • Significant professional growth opportunities
        • Pharma/Biotech, Contract positions, Business opportunities
      • Great personal satisfaction
        • Bringing new medicines to patients
        • Interact with multiple scientific disciplines
    • Career Opportunities
    • Clinical Research Opportunities
      • Clinical Monitor
      • Documentation Specialist
      • Regulatory Affairs
      • Medical Writer
      • Data Management
      • Biostatistics
      • Compliance Auditor
      • Project Management
      • Database Programmer
    • Major Biotech Centers
      • San Francisco
      • San Diego
      • Los Angeles
      • Seattle
      • Minneapolis
      • Boston
      • New York
      • New Jersey
      • Philadelphia
      • Rochester, MN
      • Baltimore
      • Washington, DC
      • North Carolina
      • Canada
        • Montreal
        • Toronto
        • Mississauga
    • Your Path
      • Must have a college degree
        • Life Sciences, Statistics, Business
      • Work summer internships
      • Go on informational interviews
      • Be willing to live and work away from home
    • Required Skills
      • Scientific & Medical Knowledge
      • Think logically
      • Adept at problem solving
      • Inquisitive nature
      • Clinical experience is helpful (Nursing, Med Tech)
      • Strong personal skills, trouble shooting skills
      • Quick Reader
      • Math, English, Writing, History, Social Studies, Economics
    • Questions?