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Oncology Drug Development Course - A Comprehensive Overview


Course Director

Course Fee

$2150.00 Regular Registration

$1950.00 Early Bird Pricing (Register 30 Days in Advance)

Course Description

The objective of this Oncology Drug Development course is to provide an overview on the developments of drugs in oncology, from early clinical strategy (how to translate a scientific concept in a clinical study) to the execution of this strategy (how to run a clinical trial from start-up to close-out). 


The 15 hour course will cover the current oncology treatment landscape of top human cancer, the principle of oncology drug development, the regulatory process, and approaches to accelerate drug development. Included will be the phases of cancer drug development and the process of cancer drug discovery. 

Who Should Attend

The Oncology Drug Development course is targeted at professionals from the academia, pharmaceutical industry, biotechnology sector (Biologists, pharmacists, veterinarians, nurses, biochemists, Clinical research associate, data manager, regulatory experts) who wish to gain in-depth understanding of the clinical development in oncology.

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  • Learning Objectives

    • Understand the biology of cancer at the cellular and molecular level
    • Explain the oncology clinical process from phase I to phase III 
    • Learn the fundamentals for running a clinical trial from study set-up to study close-out

  • Agenda


    Hallmark of Cancer 


    Biology of cancer

    • The molecular biology of cancer cells 
    • The tumor micro-environment 
    • The role of the immune system in cancer 

    Leading cancer types (Breast, lung, colorectal, prostate) 

    • Nature 
    • Epidemiology

    Cancer treatment modalities

    • Historical perspective 
    • Current oncology treatment landscape (from chemotherapy to cell and gene therapy)

    Principle of Clinical Development 


    Clinical development stages: 

    • lead optimization
    • candidate selection
    • preclinical studies
    • phase I, II, III, IV

    Clinical Development strategies:

    • linking the cross-functional activities (translational medicine; biostatistics; clinical pharmacology; regulatory; CMC) 
    • Target Product Profile 
    • Clinical Development Plan 

    Methodology of clinical trial 

    • Study design and endpoint selection 
    • Evaluation of response to treatment 
    • Toxicity assessment 
    • Statistical considerations 

    Phase I

    • Selection of starting dose 
    • Dose escalation models (3+3, CRM, etc.) 
    • Safety evaluation 
    • Recommended Phase II dose 
    • FDA guideline for dose selection (Optimus project) 

    Case study: Lessons from TGN1412 


    Case study: BIA-2474 trial 


    Case study: The Her-2 journey; story of breast cancer breakthrough, 30 years in the making


    Conduct of Clinical Trial: Clinical Trial Set-up

    • Budget development and resource planning 
    • Clinical Trial Documents (clinical study protocol, Informed Consent, Committee charter, Investigator Brochure)
    • Legislative requirement and Good Clinical Practice (GCP) 
    • Investigator and site recruitment

    Clinical Trial Conduct

    • Recruitment and retention of study subject 
    • Data collection and data management 
    • Monitoring of clinical studies

    Clinical Trial Close-out

    • Clinical trial close-out activities 
    • Data cleaning 
    • Data base-lock 
    • Clinical Study Report Bioavailability and Bioequivalence Evaluations

    Regulatory Process Investigator New Drug Application

    • Expedited programs 
    • Interactions with regulatory agencies (why, when, how)

    Accelerating Drug Development New Clinical Trial Design

    • Decentralized Clinical Trial 
    • Real Word Data 
    • Digital endpoint

Registrant Information:

Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.

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