SPARK Educational Forum: Advanced Therapy Medicinal Products

Advanced Therapy Medicinal Products (ATMPs) are a particularly challenging medicinal product class with specific regulations. One particular challenge lies in the design of production. Moreover, the starting materials vary and regulations are tight, in terms of the quality assessment and release criteria necessary for ATMPs. New scientific insights and increased understanding of immunological and biological functions encourage development of novel ATMPs, and increase the need for understanding the regulatory requirements and the path forward from bench to bedside.

Dr. Xenia Boergen is an attorney, biochemist and biotechnologist with extensive experience in ATMP regulations. She has been engaged in approvals for several different ATMPs at various stages, and is well connected with industry, as well as academia. Xenia will give us a broad perspective on what makes the ATMP field so challenging, and will highlight the importance of common strategies to advance this field for the sake of improved patient care.

Dr. Vilma Methner is a seasoned entrepreneur and previous board member of a stock corporation. She has developed an ATMP all the way from bench to approval and market entry, and will give us her insights and expe­riences from the ATMP field. Vilma will share her high-level view on the challenges associated with such an endeavor, in particular with the ATMP setting, and will touch upon similarities and profound differences between development of ATMPs and other medicines.