U.S.Global
Drug Development 101Country SpecificCountry Specific

Course Curriculum Presented by the
Center for Communication Compliance (CCC)


Course Name
Drug Development 101

Course Focus
What professionals starting out in the pharmaceutical and biotech industry need to know about the drug development process, including overview of a drug's life cycle, from discovery through post-marketing studies. Addresses at a basic level the pre-clinical and clinical phases, and provides easy-to-understand definitions for commonly used terms.

Audience
Any junior to mid-level professional working in the pharmaceutical or biotech industry, or at communication/promotional agencies, who needs a basic-level of understanding of the drug development process.

Course Format and Access

  • One 90-minute module: lecture
  • 24/7 on-demand access from the CCC Web site
  • May be viewed as often as desired

Course Content

  • Overview of life cycle of a drug
  • Drug discovery through post-marketing studies; timeline
  • Differences between preclinical phase and the clinical phases
  • Categories of medical products: synthetic (small molecule), biological, biotechnological
  • A note on devices
  • Outline of drug discovery
  • Researching the target
  • Discovery of lead molecules
  • Accidental versus targeted drug discovery
  • Preclinical Phase
  • Clinical Phases I – IV
  • Duration
  • Purpose/objectives
  • Population
  • Sample size
  • Types of trials/Importance of study design
  • Understanding clinical endpoints
  • Definitions
  • Independent Ethics Committees (IECs) and IRBs
  • CRO
  • Sponsor
  • Regulatory agency
  • Principal Investigator (PI)
  • Therapeutic ratio
  • Patient compliance, adherence, persistence
  • Study protocol
  • Randomized
  • Double-blind placebo-controlled
  • Open label
  • Informed consent
  • Recruitment
  • Inclusion/exclusion criteria
  • Study arm
  • Escape criteria
  • Adverse event
  • Abstract

Course Instructors

Nationally recognized expert on various aspects of healthcare regulation and the drug development process; formerly with the U.S. Food and Drug Administration (FDA).

Wayne Pines

Chair of the CCC Advisory Board. He is a nationally recognized expert on regulatory aspects of healthcare advertising and promotion. Wayne served at the FDA for 10 years as chief of consumer education and information, chief of press relations, and associate commissioner for public affairs.

CCC's Regulatory Compliance Test (RCT)

Certifies competency in the drug development process at the Basic level.