Accelerating Development of Gene & Cell Therapy

    4 – 6 April 2022, online training


    This unique online training course focuses on methods enabling to leverage patient engagement, novel rare disease trial designs, regulatory incentives and realworld evidence to accelerate the development, approval and patient access of innovative Advanced Therapy Medicinal Products (ATMPs), including autologous and allogeneic gene therapies, tissue engineered products and somatic cell therapies.

    Who should attend?

    Heads of R&D, Global program leads, Regulatory executives, C-level executives, Senior business development strategists, Portfolio executives, Pricing and market access executives, Medical affairs executives, Marketing and Commercial executives, Finance executives, Patient advocates, Epidemiologists, Outcomes researchers, Health economists, Digital health specialists, Big data and RWE researchers

    Learning Objectives

    • Explore the opportunities of digital and big data to accelerate discovery, development, regulatory approval and market access for ATMPs
    • Gain insight into the most recent methodologies for faster, smaller, smarter clinical trials robust enough for marketing application
    • Discuss strategies to limit the number of patients and the placebo exposure of patients in pivotal clinical trials in rare and ultra-rare conditions
    • Discover the newest regulatory approaches for gene and cell therapies
    • Consider the crucial role of patient engagement throughout the lifecycle
    • Analyse the current market access challenges for ATMPs
    • Explore innovative strategies that integrate real-world evidence (RWE)

    Key Topics

    • An Introduction to Advanced Therapy Medicinal Products
    • Accelerated Development Strategy for ATMPs
    • “Fast to Patient” Regulatory Strategy
    • ATMPs Pricing and Market Access
    • Gene Therapy Safety & Risk Evaluation
    • ATMPs Interactive Case Studies


    ORPHA Strategy Consulting, CEO
    David Schwicker has biopharmaceutical consulting expertise spanning more than 25 years. Founder of ORPHA Strategy Consulting, and former Vice President with PAREXEL International in the United States. David is a sought-after expert for accelerating marketing authorization, time to launch, early patient and market access of ATMPs.
    Online Participation
    1 650 Price incl. VAT: 1 650

    Price per delegate including:

    Online participation

    Online workbook & materials


    PC, microphone, camera, stable internet connection and the Zoom application.

    Yes, we will make every effort to ensure best possible interaction. You will see the slides, interact with the trainer and fellow participants. Questions and group exercises will be facilitated through the online meeting platform.

    Yes, you can transfer the registration to a colleague at any time.

    Yes, you may transfer your registration to a different event up to one month before the scheduled dates, provided the training fee has been paid in full.

    Lydia Makori
    +421 222 200 543

    Training Details