Biotech: Drug Development Process to Phase 1

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Bio technology drug approval projects are likely to take several years. Starting from initiation all the way to public use, drugs need to go through different approval processes in different countries pinpointing different targets of interest.

In this template we will cover the drug development process to become a Phase 1 ready only – from initiation to Phase 1 trials.

The Phase 1 project includes several major workstreams:

  1. CMC – Chemistry, Manufacturing, and Control
    • Development and manufacturing of the drug substance
    • Development and manufacturing of the drug product
    • Analytical methods development for substance and product
    • Bio-analytical methods development for rodents and non rodents
  2. Pre-clinical – enabling the later clinical phase and collecting information for the regulatory process
    • PK (pharmacokinetics) – what the body does to the drug
    • Pharmacology – what the drug does to the body and the disposition of a pharmaceutical compound within an organism
    • Safety and Toxicology – the degree to which a substance can damage a living or non-living organisms
  3. Clinical and Regulatory
    • Clinical preparation, protocol and operation
    • Regulatory preparation and submission

Following these workstreams, the project can be controlled with relevant milestones – pre-clinical ready after approximately one year, clinical ready after another year and Phase 1 ready after 2 years or more.

Links and dependencies between activities are presented in high level. Each quarter should be carefully planned to efficiently make progress toward phase 1. Building the CMC process correctly, enables to start the pre-clinical activities earlier and saves time when heading the clinical phase. Once the pre-clinical phase started the focus moves toward the regulatory submission and all activities are targeted to accurately collect and prepare the materials for the  Investigational New Drug (“IND”) application.

Getting IND approval actually moves the process into Phase 1 and beyond this template scope.