Statisticians Role in the Pharmaceutical Industry

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Statisticians Role in the Pharmaceutical Industry

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• Nicole Blackman, PhD
• Manager, Statistics
• Oncology MDC Statistics and Programming
• North Carolina State University
• Department of Statistics
• A Pipeline Issues Workshop - Sept 30, 2006

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OUTLINE

• Introduction
• Drug Development Process
• Statisticians Role
• Statistical Considerations
• Employment Considerations
• QA

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INTRODUCTION
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What is statistics? A collection of techniques
for extracting information from data, and for
ensuring that the data collected contains the
desired information. What does statistics do for
us? Statistics provides an objective basis for
making decisions in the presence of uncertainty.
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THE DRUG DEVELOPMENT PROCESS

• Discovery to Marketing

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Phases of Development
Phase IIIb/IV
Phase III
Phase II
Phase I
Pre-clinical
Research/Discovery
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Phases (continued)

• Discovery
• Genomics
• Combinatorial chemistry
• High-throughput screening
• Medicinal chemistry
• Follow-up screening

Research/Discovery
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Phases (continued)

• Preclinical
• Drug metabolism and pharmacokinetics
• Animal toxicology safety assessment)
• Chemical development
• Analytical, Synthetic chemistry
• Pharmaceutical development
• Final drug formulation pills, liquid, aerosol,
  injectable

Pre-clinical
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Phases (continued)

• Phase I ( 6-12 months )
• First time in humans
• Healthy volunteers
• Safety
• Tolerability
• Pharmacokinetics
• Pharmacodynamics
• Dose Response

Phase I
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Phases (continued)

• Phase II ( 24months)
• Safety
• Tolerability
• Dose response for safety efficacy
• Selection of dose for confirmatory clinical
  trials

Phase II
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Phases (continued)

• Phase III ( 24 - 36 months, or longer)
• General patient population
• Long-term, large studies
• Confirm efficacy for regulatory registration
  (e.g. FDA)
• RiskBenefit assessment
• Product labeling

Phase III
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Phases (continued)

• Phase IIIb/IV
• Post-approval market support
• Publications
• DTC ads
• Detail aids
• Post-approval requested studies
• Regulatory requests
• New indications
• New formulations

Phase IIIb/IV
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STATISTICIANS ROLE
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Statisticians Role

• In Research
• Collaboration
• Design clinical development program
• Design and analyze clinical trials
• Manage the report production process
• Interpret results
• Communicate results

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Statisticians Role (continued)

• In Development and Marketing
• Develop final statistical statements on the
  efficacy and safety for marketing purposes
• Develop publications, package inserts, etc.
• New indications, line extensions, etc.

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STATISTICAL CONSIDERATIONS
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Common Statistical Issues

• Specify the question and the hypothesis
• Select the experimental unit
• Choice of control or comparison group
• Select the design
• Ensure the sample size is sufficient
• Neither too big nor too small

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Common Statistical Issues (continued)

• Randomly allocate experimental units to the
  treatment groups
• Ensure groups are treated as exactly alike as
  possible
• Blinding
• Method of analysis
• Control of false positive (Type I error)

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EMPLOYMENT CONSIDERATIONS
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The Job Search What a Company Looks For

• Education
• Communication skills
• Initiative/Leadership skills
• Team-working skills
• Time/Project Management
• Technical skills (e.g., programming and
  computing)

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Roles by Degree
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Employment Outlook

• Job opportunities should remain favorable (2000 -
  2010, BLS)
• Experienced statisticians very much in demand for
  the pharmaceutical / biotech industry
• www.salary.com for latest on salary information
  and general job description

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Other Research and Development ..

• Anti-infectives
• Augmentin SR
• Zovirax
• Trizivir ...

• Neurosciences
• Paxil
• Wellbutrin SR
• Imitrex ...

• Diabetes
• Avandia ...

• Inflammation, Tissue Repair Oncology
• Relafen/Relifex
• Hycamtin
• Zofran ...

• Respiratory
• Flovent
• Advair ...

• Vaccines
• Havrix
• Engerix-B
• Infanrix
• Twinrix

• Cardiovascular
• Kredex/Coreg
• ...

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www.gsk.comNicole.Blackman-1_at_gsk.com
GlaxoSmithKline Pharmaceuticals
Striving to make peoples lives healthier...
Preventing, diagnosing and curing disease
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Back-up
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Clinical Trial

• A clinical trial is a prospective study comparing
  the effect and value of intervention(s) against a
  control in human subjects.
• Prospective All subjects are followed forward,
  from a well-defined time point.
• Intervention prophylactic, diagnostic or
  therapeutic (drug) agents, devices, regimes,
  procedures.
• Control group Must be sufficiently similar to
  the intervention group at baseline in order that
  differences in outcome may be reasonably
  attributed to the action of the intervention.