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Advanced Therapy and Medicinal Products: How to overcome the hurdles from bench to clinic ?

Post thumbnail Advanced Therapy and Medicinal Products: How to overcome the hurdles from bench to clinic ?

We will review challenges in translation required to develop the ATMPs pharmaceutical product (cell and gene therapy products) from nonclinical to the clinical stage, as well as the challenges related to the determination of proof-of-concept, how to choose clinical dose from nonclinical studies and address the nonclinical questions required to demonstrate ATMP product safety before going into the first-in-human study. Presenters will also discuss how European Regulatory Agencies help the development of ATMP pharmaceutical products.

Key learning points :

Understand in-depth the product in relation to the intended use
Justify the study designs, test model(s) (in vitro, ex vivo, and/or in vivo), and/or absence of specific studies
Use integrated approach covering CMC/NC/Clinical aspects critical for ATMPs pharmaceutical product
Adapt QbD principles such as the development of an adapted Control Strategy based on Risk Assessment: it is possible and encouraged
Engage early dialogue with EMA and National agencies: strongly encouraged for successful such development

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    Featured Speakers

    Cécile Rousseau
    Cécile F. Rousseau, PhD
    Senior Director, Nonclinical
    With 10+ years in nonclinical and translational research and histotechnology, Dr. Cécile F. Rousseau has considerable expertise in medical devices,…
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    Professor Romaldas Maciulaitis thumbnail
    Professor Romaldas Maciulaitis
    Professor Romaldas Maciulaitis has worked at the Institute of Physiology and Pharmacology in the Department Nephrology at the Lithuanian University of Health Studies for more than 28 years. He has also been a CHMP and CAT member at the EMA for 14 years.The Professor completed his MD and PharmD studies more than 20 years ago and after PhD studies in Clinical Pharmacology, was involved into Drug Regulatory and Scientific Appraisals at the national (Lithuania) and international (European) levels. In 2009, he initiated new experimental Pharmacology research direction in his University in Kaunas on Regenerative Pharmacology applying cell preparations with research program focusing on PK/PD of cell therapies in renal and cartilage injuries. He has published more than 20 papers in reputed journals.
    Gopalan Narayanan, M.D. thumbnail
    Gopalan Narayanan, M.D.
    Vice President, Disruptive Biologics