$1295 USD – $1595 USD

Drug Development Immersion

December 3-4, 2024 | 9:00am-3:30pm EST

1201 New York Avenue, NW, Suite 1300, Washington, DC 20005-3972

$1295 USD Early Bird BIO Members Until July 1, 2024

$1495 USD Early Bird BIO Non-Members Until July 1, 2024

$1395 USD BIO Members

$1595 USD BIO Non-Members

Kenneth J. Olivier, PhD

Drug Development Immersion

Drug Development Immersion explores the commercial, regulatory, and scientific factors that pave the way for a successful drug launch. It begins by comparing the characteristics of small and large molecule drugs, agonist and antagonist drugs, and their desirable qualities. A high-level overview of the nuanced go/no-go decision-making process, where management carefully assesses each drug candidate, is provided. This course unveils the intricacies of regulatory compliance, expedited programs, and special designations. It details the dynamic process of drug development, including trial design options, endpoint choices, and experimental/control group concepts. This class culminates with real-world evidence initiatives, drug launch best practices, pharmacovigilance expectations, and lifecycle management strategies. Register today and up your drug development acumen!

Takeaways

  1. Become proficient in the terminology and acronyms used in preclinical and clinical development
  2. State the roles of regulatory agencies worldwide and list the tools they use to ensure approved drugs are safe and efficacious
  3. Cite the testing criteria in preclinical development that ensure a candidate drug is safe and supports first-in-human clinical trials
  4. Explore the rationale, study design, and special considerations for both traditional and nontraditional clinical trial phases
  5. Discuss the launch process and post-approval drug safety monitoring to ensure continued safety and efficacy for patients

    Location: 1201 New York Avenue, NW, Suite 1300, Washington, DC 20005-3972

    Dress: Please plan on dressing in layers as we cannot control the temperature in the room.

    What to bring to class: Log into your Biotech Primer dashboard to download or print the electronic workbook as you will need access to this for course activities. You may want to bring a pen and paper to take notes. Please ensure your laptop is fully charged.

    Pricing

     

    Early Bird BIO Members Until July 1, 2024

    • $1295.00 USD

    Early Bird BIO Non-Members Until July 1, 2024

    • $1495.00 USD

    BIO Members

    • $1395.00 USD

    BIO Non-Members

    • $1595.00 USD

     

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