Clinical Trials by suchenfz


									Clinical Trials:
Life Beyond Research and

    Kelly Philpot, PhD (2006)
  Clinical Research Associate II
             PPD, Inc.
Kelly Philpot, PhD (MSP, 2006)
Co-Mentor: Michael J. Kuhar, PhD
Co-Mentor: Yoland Smith, PhD
 Dissertation: Characterization of CART-Containing
  Neurons in the Lateral Hypothalamus

 Therapeutic Significance: Drug Addiction and
  Feeding Behavior (Motivational Behaviors)

 Techniques: Immunocytochemistry observed with the
  light microscope and electron microscope, tract-
  tracing techniques, in-situ hybridization, rodent
  feeding behavior
Two revelations. . .

1) Transferable skills

2) BIG Picture
            1. Transferable Skills
        Academics                       Industry
   General writing and         General writing and
    speaking opportunities       speaking opportunities
   Grant writing               FDA applications &
   Managing                     Protocol writing
   Teaching                    Managing
   Research                    Training
                                Research
2. BIG Picture: Drug Development

                                6-10 Years

Non-Human Studies
                       20-100    100-500   1000-5000
                      Healthy   Diseased   Diseased
                      Humans    Humans      Humans
   2. BIG Picture: Drug Development

                     Jack/Jill of All Trades
Expert in One Area
CRO vs. Pharma Company
 CRO = Contract
   Research Organization
     Contracted by
      Companies to run the
      clinical trials in a quick
      and organized fashion
      to. . . SAVE $$$$
                                     =   $$$
 Broader range of opportunities
   in different therapeutics

 More opportunities to get a job
   at a CRO when someone is less
   experienced in clinical trials.
Preparation while in PhD program
 Remember the BIG PICTURE!
      Show tangible activities of interest in business aspects of
       pharmaceuticals and clinical trials

 Take opportunities outside of your research
      Conducted a Phase IV clinical trial in the Himalayas on High
       Altitude Medicine

 Leadership and Business Development Skills
      Co-Chair for the Atlanta Biotech Network when it grew into a
       larger group named the Emerging Leaders Network (ELN)
       associated with the Georgia Biomedical Partnership

 Read books and search internet
      Independent study of Fundamentals of Clinical Trials, FDA
       regulations, and competitive companies and positions
How I got my first job out of Emory!
 Getting the interview:
   Read books on how to interview properly
   Designed my CV to read more like a resume
   Invited numerous business contacts to “coffee”

 I had coffee with the head HR representative (a friend
  through a friend through a friend) at Kendle and my
  CV was put to the top of the pile.

 Getting the job, I had to focus on a lot more than just
  my research experience. . .
Clinical Research Associate (CRA)
 Primary Roles:
     Ensure proper trial conduct
     Train staff at each doctor’s office (site)
     Timely generation and collection of quality
      data (data management)
     Protect subject safety
     Prepare site (doctor’s office) for potential
      FDA audit
     Overall quality control
Clinical Research Associate (CRA)
 Personality:
     Self-starter, independent, self-disciplined
     Good interpersonal skills
     Excellent writing and speaking skills
     Flexible, adaptable to change
     Ability to travel without much added stress
The PhD Candidate vs. The CRA
      PhD candidate                        CRA
   Independent worker         Independent worker
   Developed writing and      Developed writing and
    speaking skills             speaking skills
   Attention to detail        Attention to detail

   Commonly Introverted         Extroverted

   Focuses on one aspect        Works with a variety of
    of one therapeutic area       mechanisms of action in
                                  various therapeutic areas
3 Days in the Life of Kelly. . .
 Average travel: 60-80% (2-4 days/wk)
 Day 1:
   8:00 - 9:00am: Start work from home office 
   Write reports from previous site visits,
    electronic data management, communicate
    with sites via email and phone
   2:00 pm: Leave home to go to airport
   8:00 pm: Get to hotel in another city
   8:00 – 11:00 pm: Finish work and prepare for
    site visit the following day
3 Days in the Life of Kelly. . .
 Day 2:
    6:00 am: Get ready for the day and get a little work
    8:00 am: Arrive at site for the visit
    Depending on visit:
       Interview a site for trial participation: 2 hours

       Train staff on a new trial: 4 hours

       Monitor progress of a trial: 8 hours

       Close-out a trial: 8 hours

    Travel home: 6 hours
 Day 3:
    Write report for previous day’s visit
    Continue cycle
Salaries of CRAs
 CRA I :    work in office, little travel
      ~40-50K
 CRA II:    need at least 1 yr experience as CRA I and will travel
  (also have the potential to work out of home anywhere in US)
      ~55-70k (depends on company, location and
 CRA III:    need at least 2-3 years experience
      ~70-85K
 Sr. CRA:     need at least 5 years experience
      $85K. . .
Beyond The CRA

          VP or
       President of
       VP of Clinical
      Global Manager

    Department Manager

      Project Manager

      CRA – 5 years
Other Career Options in Industry
 Medical Science Liaison: Work for a drug company traveling to
  Dr. offices to discuss and understand the MD’s needs and
  thoughts on current medicines and trials. (not pharm sales!)

 Medical Writer: Designing, writing any documents needed for a
  clinical trial; no travel

 Data Management: very introverted; no travel

 Pharmacovigilance (AKA Safety): no travel

 Ethics Committees (IRBs): Independent safety agencies; no

 FDA: all types of jobs, working for government

 Research Scientist: available in industry and government jobs;
  no travel
Do not be afraid. . .
 Get out there and learn about alternative
  careers in science ON YOUR OWN

 A PhD teaches you much more than just how
  to run a gel or grow cells
     Critical and Independent Thinking
     Research, speaking and writing skills
     Timeliness
          Be Proactive in your career
 Companies of Interest near Atlanta
 Pharmaceutical Companies (variety of jobs)
       Atlanta-based: UCB Pharma, Solvay, AtheroGenics etc!
     Large list of companies in area

 Contract Research Organizations (CRO) (variety of jobs, but little
   research opportunities)
     Quintiles Inc (office in Marietta)
     RTP, N. Carolina: PPD Inc; Kendle International; Covance,

 Biotech Companies (research-based jobs)
       Emtech Bio Briarcliff Campus

 Recruiter specific for Scientific Positions
       KForce
Resources you can Utilize NOW
 Georgia Biomedical Partnership
      Emerging Leaders Network
 Applied Clinical Trials Journal
      Free subscription to monthly journal
 Talk to professors with experience in industry
Books of Interest
If Entering Clinical Trial Realm
 Alternative Careers in Science: Leaving the
  Ivory Tower
     Cynthia Robbins-Roth

 Fundamentals of Clinical Trials
    Friedman, Furberg and DeMets

 The CRA’s Guide to Monitoring Clinical
     Karen E. Woodin, PhD and John C. Schneider
Take Home Questions:
 What type of personality do you have?

 What interests you? One topic or a variety of

 What will get you out of bed in the morning
  (on the right side of the bed)?

 Do you like to work in the lab? Teach?
  Manage? Write? Speak? Travel? All of the
Remember. . .

You may not get your dream job right out of
     graduate school, but at least have
  a 5-10 year plan on reaching that goal.

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