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CMC Forum Europe 2018: Scientific Program
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To view the final scientific program, click here.




Program Agenda

MONDAY, 14 MAY 2018

EBE Satellite Session
Session Chair: Markus Goese, EBE Biomanufacturing Working Group Chair (F. Hoffmann-La Roche Ltd., Basel, Switzerland)

 Concept Paper Updates
• Drug Device Combination Products / A Biopharmaceutical Industry Perspective on the Control of Visible Particles in Biotechnology-derived Injectable Drug Products
• Quality Aspects of Antibody Drug Conjugates
• EMA Guideline - Reflection Paper on Statistical Methodology for the Comparative Assessment of Quality Attributes in Drug Development

CAR-T Cell Therapy
This session will be comprised of short presentations followed by a panel discussion and will be dedicated to Chimeric Antigen Receptor-T (CAR-T) Cell Therapy. In recent years, we have seen a rapidly emerging immunotherapy approach called Adoptive Cell Transfer (ACT) involving collection and use of patients own immune cells to treat cancer. There are several types of ACT, but CAR-T cell therapy is the one that has advanced the furthest with the first commercial product approval in 2017.

Regulatory Updates from Around the World
Session Chairs: Niklas Ekman, Finnish Medicines Agency (FIMEA) and Kowid Ho, F. Hoffmann-La Roche Ltd.

Including participation from: 
     Medical Evaluations Board (CBG-MEB), Netherlands
     European Medicines Agency (EMA)
     US FDA
     Other European Regulatory Health Authorities
     Other International Regulatory Health Authorities

TUESDAY, 15 MAY 2018

Adding to the Complexity - Combining Drugs and Devices
Session Chairs: Chana Fuchs, CDER, FDA and Ilona Reischl, AGES-Austrian Medicines and Medical Devices Agency

In Europe, different legal frameworks regulate the path to market for medicinal products and medical devices. Challenges exist for development and regulatory control when both regulatory frameworks need to be considered for products that combine medicinal product and medical device aspects. While the term “combination product” is anchored in the US legislation, this is not the case in Europe, where the principal mechanism of action determines the path to the market. Equally, there is a more complex approach for the development of products that need to combine the use of medicinal products and medical devices, for example in the case of companion diagnostics.

Clinical Relevance of Specifications 
Session Chairs: Michael Abernathy, Amgen Inc. and Mark Schenerman, CMC Biotech-MAS Consulting

ICH Q6B has been the primary guidance document outlining the general principles for setting specifications for biological products. While ICH Q6B is a very useful document, it stresses the utilization of data derived from clinical experience when establishing specifications. Recently, with the adoption of ICH Q8, Q9 and Q11, the principles outlined in these guidance’s allow for use of product understanding and risked based approaches (e.g., QbD) to potentially establish limits beyond those establish based solely on clinical exposure. Today, there is a strong industry desire to set commercial product specifications based on clinical and manufacturing experience, as well as prior knowledge. However, establishing a clinical basis for specifications outside the “clinically experience” space is challenging because changes in safety and efficacy may be caused by multiple factors. This session will explore some of the factors that affect clinical relevance and discuss approaches used to address the key questions for therapeutic proteins as well as vaccines. Topics to be covered include pre-clinical studies to assess immunogenicity risk from aggregates and the regulatory view of clinical relevance of specifications in light of industry’s progression towards personalized medicine



Current and Future Approaches to Enhanced Development, QbD and Design Spaces
Session Chairs: Brendan Hughes, Bristol-Myers Squibb Company; Martijn van der Plas, CBG-MEB

Industry and Regulators have gained extensive experience in the application of ICH Q8, Q9, Q10 and Q11 in the development and assessment of biological products. This experience has resulted in the recent publication of additional explanatory documents, e.g. ‘Questions and answers: Improving the understanding of NORs, PARs, DSP and normal variability of process parameters. ’ Notwithstanding this, some principles remain complicated to translate into practice.

This session will examine the current state-of-the-art and experience of regulators and companies in gaining alignment of key principles and applications including CQA assignment, process descriptions, control strategies and specifications. Case studies and experiences will be shared and commentary from regulators and industry experts will be invited.

Prior Knowledge
Session Chairs: Seán Barry, HPRA-Health Products Regulatory Authority and Ronald Imhoff, Janssen Biologics BV

Prior Knowledge has great potential to impact many aspects of CMC development but to date has been relatively under-utilized in regulatory filings. It is well accepted that CMC can represent a bottleneck for the submission and timely approval of products undergoing accelerated development through PRIME in the EU and Breakthrough in the US. In such cases Prior Knowledge can be successfully leveraged to overcome the need for certain product-specific studies, facilitating a tailored approach which can ultimately lead to faster approvals and earlier access for patients. For both accelerated and standard approvals it is important to strike a balance between product-specific data and the application of regulatory flexibility where appropriate.

The areas in which Prior Knowledge can be exploited are wide in scope and include for example CQA and process parameter risk assessments, defining the criticality and proven acceptable ranges for process parameters, and justification of specifications. Moreover, a combination of product-specific data and prior knowledge can be used to underpin the control strategy. One of the key challenges for industry and regulators is how to demonstrate that such knowledge gained during the development of similar products is fully relevant for the product under review. This session will therefore explore a common understanding of Prior Knowledge and discuss the most effective way to present it in regulatory submissions. Discussions will also focus on how uncertainties arising from the use of prior knowledge can be addressed post approval. Finally, this session will share industry and regulators’ experience of Prior Knowledge and build on the recent productive discussions and conclusions of the EMA Prior Knowledge workshop.

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