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I1: Drug discovery and development

The module introduces the different steps along the drug discovery and development process, including its typical implementation in different pharmaceutical companies. It provides insights into the mission and tasks of pharmaceutical companies and the value chain of drug discovery and development.


The module also illustrates how modeling activities are integrated into the project teams and decision making processes. Finally, it gives insight into requirements and perspectives as a pharmacometrician/scientist in modelling&simulation at a pharmaceutical company.

Illustrative schedule

TimeMondayTuesdayWednesdayThursdayFriday
Morning Part IWelcome and introduction to the program and goals; Overview of the company I; Introduction to the R&D value chain with focus on drug discoveryComputational chemistryModeling & Simulation (M&S) in preclinical and clinical development; Final discussion - Q&AIntroduction to drug development; Preclinical developmentPhase III – Efficacy and safety
Coffee break
Morning Part IITarget discovery and validation; High-throughput screeningPresentation of a selected therapeutic areaHR presentation on job opportunities, skill-set requirements and recruitingFormulation and implications; Analytics and qualityRegulatory affairs
Lunch break
Afternoon Part IStructure and organization of project teams, and how they contribute to decision making processes; To visit a facility or departmentTo visit a facility or departmentDeparture from company I and arrival at company IITo visit of a facility or department; Working in a project teamTo visit a facility or department; Modeling & Simulation (M&S) in preclinical and clinical development
Coffee break
Afternoon Part IILead discovery and optimization; Substance repository; Presentation of a selected therapeutic areaPredictive toxicology and early ADME (absorption, distribution, metabolism, excretion); Clinical Pharmacology – Bridging R&DWelcome and introduction to the program; Overview of the company IIPhase I – Tolerance testing in volunteers; Phase II – “Proof-of-Concept” and “Dose Finding”Final discussion – Q&A; HR presentation on job opportunities, skill-set requirements and recruiting
EveningDinner (incl. company I representatives)Dinner (incl. company II representatives)

Optional topics:

  • Production: Chemical and process development
  • Manufacturing
  • Biologicals
  • Phase IV – Interface clinical development and subsidiaries
  • Data management and clinical statistics
  • Pharmacovigilance and epidemiology
  • GLP – GMP – GCP (Good laboratory/medical/clinical practices)
  • Health economics

 

Contributions:

  • Industry representatives and various employees of two of PharMetrX's Industry partners.
 
Frequency: Every other year, typically in October/November.