Development of Gene and Cell Therapy Training

        Accelerating Development of Gene & Cell Therapy

        New dates TBC, live online training

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        Summary

        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.

        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

        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

        Past participants

        • Global Clinical Leader, Bayer
        • Senior Fellow in Cell & Gene Therapy Development, Ferring
        • Technical Applications Scientist, Fujifilm Irvine Scientific
        • Regulatory Affairs Officer, Genethon
        • ATMPs Regulatory Affairs, Novo Nordisk

        Our online training experience includes

        • Our client zone – a single source for all training materials as well as pre and post-training communication
        • Live interactive format via the Zoom platform
        • Direct interaction with the trainer
        • Q&As, case studies, polls
        • Revisit recorded sessions for 30 days
        • Digital and LinkedIn certificates

        Trainers

        David Schwicker
        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.
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        Online Participation
        1 650 € Price incl. VAT: 1 650 €
        Equivalent of approx. 1 777 USD.
        The price calculation in USD is informative and might slightly differ from your bank exchange rate        .

        Price per delegate including:

        Online participation

        Online workbook & materials

        Certificate

        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.

        pharma learning leader

        Lydia Makori

        l.makori@symmetric.events
        +421 222 200 543

        Training Details
        Request in-house
        What participants said about this course

        "Very well put together content, great presentation and helpful discussions. This training was helpful in providing a very good overview of the clinical development, regulatory and commercial angles to the gene and cell therapy product development."
        Director, Clinical & Regulatory Affairs, Amniotics

        "The questions and answers from participants were very enriching because it comes from real experiences on the area, whether it was from regulators, start-ups or less experienced professionals."
        Responsible Business Development, Genethon

        "Very comprehensive, a huge amount of information."
        Head Of Advanced Therapies, EMA

        "A lot of concrete examples. A lot of passion and energy by David Schwicker."
        Senior Scientist - Gene Therapy, UCB

        "New insights into clinical trial design and using real world evidence. Also hearing experiences from participants was very valuable."
        Clinical Scientist, Bristol Myers Squibb

        "Good and well organized course."
        Senior Manager Technical Development, Helm

        "Very interesting training, a lot of topics discussed in only 3 half days. Interesting case studies and deep dive into Luxturna."
        Project Manager, Treefrog Therapeutics

        "Excellent introduction to cell & gene therapy development covering the clinical development, regulatory environment and Market Access aspects. Good examples to share experience and make it "real life" allowing to implement many new ideas and insights."
        Associate Director Regulatory Affairs, T-Knife