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CMC Forum Europe 2019: Scientific Program
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To view the final scientific program agenda, click HERE




Program Sessions

EBE Satellite Session
Session Chair: Karoline Bechtold-Peters, Novartis Pharma AG and Fionnuala O'Driscoll, Eli Lilly Kinsale Limited 

EBE (European Biopharmaceutical Enterprises) of EFPIA has published a number of position papers and is currently progressing industry consensus activites on other key topics. Updates will be given on the progress of recent position papers relating to certain key topics such as drug device combination products, raw materials and polysorbates. 

A subsequent session comprising of presentations followed by a panel discussion will be dedicated to "Genome Editing by CRISPR / Cas - Potentials for Therapeutic Application and Use in Biotechnology Research and Development". The CRISPR / Cas method (Clustered Regularly Interspaced Short Palindromic Repeats, and CRISPR-associated) is a molecular biology method for the selective cutting and modification of DNA (genome editing). The first scientific documentation on the development and use of the method was published in 2012 by a working group headed by Emmanuelle Charpentier and Jennifer Doudna (Breakthrough of the Year 2015 of the Journal “Science”). Neuroscientist Feng Zhang of the Massachusetts Institute of Technology later succeeded not only in applying the CRISPR method to the bacterium, but also to optimize it for all cells. Although only a short time has elapsed, the CRISPR / Cas method has already found many applications. The Satellite Symposium organized by the EBE BioManufacturing Working Group will present some of these applications.

Regulatory Updates from Around the World
Session Chairs: Ronald Imhoff, Janssen Biologics BV, Ilona Reischl, BASG-Federal Office for Safety in Health Care, Martijn van der Plas, Medical Evaluations Board (MEB)

Including participation from: 
     European Medicines Agency (EMA)
     The Spanish Agency of Medicines and Medical Devices (AEMPS)
     US FDA
     Other European Regulatory Health Authorities
     Other International Regulatory Health Authorities

ICH Q12 and Challenges of Post-approval Changes
Session Chairs: Chana Fuchs, CDER, FDA, Kowid Ho, F. Hoffmann-La Roche Ltd., and Tara Sanderson, UCB 

With legacy products approved 10 or more years ago, LCM can be challenging, especially as control strategies and specifications were established before CQAs and FMEA were well defined and documented in the files. In addition, legacy products typically use older methods and processes where the technology platforms eventually need to be replaced to continue efficient supply. Also post-approval changes in many ROW countries can be very challenging as they often need additional data, have limitations on what changes are allowed compared to EU & US, or constantly changing regulations that need to be managed (e.g., China). In addition, a view on practical implementation of ICHQ12 making the link to the regulatory complexity of life cycle management, how do we envisage incorporation into older files. So we could have some specific presentations on examples of problematic LCM changes eg. extension of shelf life outside of the ‘clinically qualified’ limits, RT storage for bio products, significant process and method changes involving revision of specs, possible implementation of ICH Q12 and then also have at least one presentation on challenges with submissions to ROW.

Status on the ICH Q12 and its implications. How to leverage regulatory relief for post-approval changes; understand the benefits and risks of maintaining KPP or not in ICH Q12; understand the challenges related to concept

CMC Challenges in Accelerated Drug Approval Pathways including PRIME and Breakthrough
Session Chairs: Michael Abernathy, Amgen Inc., Sandra Auguste-Bowler, H. Lundbeck A/S, and Thomas Schreitmüller, F. Hoffmann-La Roche Ltd. 

As industry and health authorities attempt to accelerate access of life-saving therapies to patients, leveraging well designed accelerated drug approval pathways will be key. Examples of products achieving the desired outcomes of these pathways would be beneficial. EMA and FDA experience with PRIME and breakthrough. Solutions to overcome the CMC bottleneck. Review of the joint EMA/FDA workshop on accelerated pathways.

There wias a workshop organized by EMA and Industry on “Support to quality development in early access approaches (i.e. PRIME, Breakthrough Therapies)”, 26 November 2018 at the European Medicines Agency in London. This session is a follow up session in the forum hearing conclusions from regulators and industry on what was discussed during the workshop, enriched with case studies  

ICH Q14 / Q2 - Trends and Concepts for QbD for Analytics and Lifecycle Management of Analytical Methods 
Session Chairs: Emmanuelle Charton, EDQM, Council of Europe, Alistair Kippen, IPSEN Biopharm Limited and Heli Suila, Finnish Medicines Agency 

This session discusses initiation of the harmonized ICH guidances for Analytical Procedure Development (ICH Q14) and Revision of Analytical Validation (Q2 Rev2), to support an updated structured approach to the lifecycle management of analytical methods and their relation to ICH Q8-Q12. The speakers and panel will discuss the application of a QbD approach to the development of analytical methods, understanding of the Analytical Target Profile (ATP) and appropriate method control strategies, and regulatory considerations to the lifecycle management of methods throughout the product lifecycle. The discussion will highlight what issues should Q14/Q2 address, what the guidances should contain, and understanding the Q2/Q14 roadmap, current state of concepts, benefits and challenges. 

Continuous Manufacturing for Biologics
Session Chairs: Brendan Hughes, Bristol-Myers Squibb Company, Robin Levis, CBER, FDA, Bridgett O'Shea, Pfizer, Inc. 

Continuous manufacturing has the potential to improve agility, flexibility, and robustness in manufacture of pharmaceuticals. ICH has recently decided to form an expert working group to generate a technical and scientific guideline on continuous manufacturing for global implementation. This emerging technology, however, has not been reflected in a wide adoption for manufacture of biologics, especially for the downstream manufacturing processes. This CMC Strategy Forum provides for a timely opportunity to discuss the opportunities, gaps/limitations and regulatory landscape across academics, technology innovators, biopharmaceutical companies and the regulators. The outcome of this CMC Strategy Forum will help establish expectations to facilitate implementation and improvement of continuous manufacturing for biologics.

Personalised Medicine and Manufacturing 4.0 for Biopharma - Consequences and Opportunities for CMC: The Journey to Flexible and Modular Facilities and the Use of Rapid Analytics, PAT and RTRT in Continuous Manufacturing
Session Chairs: Seán Barry, HPRA-Health Products Regulatory Authority and Ralf Gleixner, Ares Trading SA, An affiliate of Merck Serono 

Progress towards personlized medicine is rapid. Drug regulations and manufacturing facilities will need to be carefully assessed and re-tooled to address individual product "lots" made specifically for individual pateints. These imminent changes may also pave the way to modern manufacturing including robotisation and autmatisation, and analytical methods for which no current established regulatory paths are available. 
1. Intro to 4.0 (Advanced Manufacturing / Control/Challenges of personalised medicine)   
2. Advanced Processes      
3. Advanced Control and Process Analytics        
4. Data Analytics and Machine Learning

more Calendar

9/14/2020 » 9/17/2020
Mass Spec 2020

9/28/2020 » 10/1/2020
CE Pharm 2020

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