November / December 2023

ATMP-Focused Online Seminars Educate and Inspire

Laura Kuger
Elena VULPE, PhD
ATMP-Focused Online Seminars Educate and Inspire

The field of advanced therapeutic medicinal products (ATMPs) has witnessed remarkable advancements in recent years. The Emerging Leaders (EL) community from the Belgium and Germany/Austria/Switzerland (D/A/CH) affiliates collaborated to develop an inclusive series of online seminars on ATMPs. This article gives highlights of the speakers, topics, and knowledge shared in ATMP online seminars over the past year.

Online seminars provide a dynamic, low-barrier tool for education, collaboration, knowledge transfer, and awareness building. These seminars aimed to connect experts from industry, academia, and service providers worldwide, fostering the exchange of ideas, sharing best practices, and discussing the latest advancements, limitations, and potential solutions in the field.

Highlights of ATMP Seminars

ATMP treatments offer promising solutions, including those that are sometimes last resort therapies for previously untreatable and often rare diseases, and help investigate new avenues for personalized treatments. Promoting innovation and ensuring continuity, the dissemination of knowledge regarding these cutting-edge therapies is crucial for researchers, pharmaceutical industry professionals, the general public, and, particularly, future leaders.

Challenges in ATMPs

In the initial seminar, Jasna Curak from F. Hoffmann-La Roche Ltd presented general challenges faced in the field of ATMPs, and Jerome Toussaint and Viridiana Urena from Catalent introduced cell and gene therapy and T cells manufacturing. This seminar effectively highlighted the industry’s complexities in manufacturing processes, scalability, regulatory frameworks, compliance, and more, while showcasing practical industry examples of overcoming these challenges.

ATMP Manufacturing Processes

The second online seminar focused on the ATMP manufacturing processes and was delivered by Jørgen B. Magnus, PhD, Tania Pereira Chilima, and Hanna Lesch from Bayer AG, Univercells Technologies, and Exothera, respectively. Each speaker brought a unique perspective, offering alternative solutions to the challenges associated with complex ATMP manufacturing processes. They addressed crucial issues such as scalability, manufacturing infrastructure, and supply chain networks, providing valuable insights and potential solutions.

Tissue Engineering

The third edition of our seminar series shifted focus to tissue engineering. This seminar featured Andreas Eberle, PhD, from CO.DON AG, who discussed the industrial production of cartilage cell therapies. Bert Van den Bogerd, PhD, from the University of Antwerp, provided an overview of the current state of academic research in tissue engineering, bringing a fundamental research and development perspective to the table. This combination of industry and academia leaders addressing applications, manufacturing challenges, and prospects in tissue engineering made the exchange of knowledge extremely fruitful, not only for the participants, but for the speakers as well.

ISPE Guide on ATMPs

ISPE offers numerous advantages to its members, including networking opportunities and the availability of a wide range of educational resources. These resources encompass training, guidelines, and articles that cater to the current trends and needs of the pharmaceutical industry. One such valuable resource is the ISPE Guide: Advanced Therapy Medicinal Products (ATMPs) – Autologous Cell Therapy, developed by members of the ISPE ATMP Community of Practice (CoP) and other subject matter experts to assist practitioners in tackling their daily challenges and anticipating future concerns.

During our fourth seminar, Erich H. Bozenhardt from United Therapeutics, Chair of the ATMP CoP, presented the guide and outlined its contents, highlighting use cases, the challenges addressed in the guide, and the value it brings in supporting the industry. The seminar emphasized the significance and practical support provided by the ISPE Guide in the field of autologous cell therapy manufacturing.

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ATMP-Specific Supply Chain Challenges

ATMP-specific supply chain challenges were only briefly touched on in previous seminars, but the fifth one provided a comprehensive exploration of this topic. Alan G. Kelly from Takeda Pharma-ceuticals, Inc., the winning company for the 2022 Supply Chain category for the ISPE Facility of the Year Award (FOYA), delivered a remarkable presentation on the Alofisel Global Program. Takeda demonstrated its capability to deliver an autologous cell therapy within an impressive 72 hours, employing a semi-decentralized approach.

Delving further into the future of supply chain operating models, Martin Lippens and Charlotte Meuldermans from Deloitte Belgium shed light on the significance of end-to-end supply chain orchestration and the pivotal role of data- and technology-driven business decision making. This emphasis on efficient supply chain networks will undoubtedly play a crucial role in the industry’s growth and development.

Gene Editing

Finally, our most recent online seminar was dedicated to gene editing and its applications. Marc Terrones from the Center for Medical Genetics at the University of Antwerp shared exciting insights into his research in the field of oncology and the development of cancer therapeutics. André Cohnen from Bayer Pharmaceuticals provided an interesting overview of the success stories and collaborations between start-ups and pharmaceutical companies, presented applications beyond oncology, and shared some benefits and ethical considerations for gene editing.

Ongoing Learning

These online seminars, organized and hosted by ISPE Emerging Leaders from D/A/CH and Belgium, exemplify the immense value of collaboration across borders and diverse backgrounds. Through our seminars, we successfully transcended barriers and silos—not only geographical ones, but also those stemming from various backgrounds and fields of expertise. This collective effort has fostered a truly inclusive environment, promoting knowledge sharing, innovation, and collaboration in a remarkable manner.

We facilitated low-barrier, direct engagement with leaders and experts through entertaining Q&A sessions and speaker interviews. The seminars therefore also play a crucial role in raising excitement and awareness about certain issues associated with these novel therapies, aiming to inspire and engage young talents to tackle these challenges in their future work.