ICH Q2 and Q14 a small step or a giant leap?

ICH Q2 “Validation of Analytical Procedures” (R2) and ICH Q14 “Analytical Procedure Development” will arrive soon. Beside modernizing the text and addressing topics in the mood of time (Real-Time-Release, multivariate models, …), these two guidelines bring the concepts of Analytical Quality by Design into our regulatory framework.

“Should we prepare for a small step or a giant leap”? The answer is: “it depends on us”. It depends on how the pharmaceutical companies/manufacturers will interpret these texts and what they will propose in the context of their future submissions. It depends on what the regulators will allow and with what conditions. There is a wide array of possibilities that will be determined by the way the pharmaceutical ecosystem will integrate these guidelines and mature their implementation.

Will it be conservative or progressive? In this webinar, each of our experts will share his/her vision on a specific domain of application of ICH Q2/Q14. These presentations aim to kick off the discussions with the audience and among the panellists. The positioning will be knowingly progressive in order to stretch towards the most ambitious vision and to envisage together the long-range benefits that are possible but not promised and, in any case, depend on us.

2 Hour Online Workshop October 17th 2023 at 1:00pm BST / 2:00pm CEST / 8:00am EDT / 5:30pm IST

ICH Q2 Q14 in the Context of Risk-Based Control Strategy and Patient Centric Approaches.

Analytical methods employed for batch release and stability testing are an important instrument to control impact of critical quality attributes on patient safety and product efficacy. The presentation focuses on risks associated with analytical procedure changes and reviews strategies to mitigate these risks e.g. by using an “Analytical Target Profile”.

Gerald Gellermann, Associate Director Scientific Office Analytics, Technical Research and Development at Novartis

Associate Director Scientific Office Analytics, Technical Research and Development Novartis
Gerald currently works as Scientific Officer at Novartis Technical Research and Development (TRD) Biologics. He is member of the Novartis ICHQ12 implementation team and leads the TRD biologics QbD and Control Strategy initiative. Prior to joining Novartis, he gained professional experience in CMC and analytical development during his time at Roche and AbbVie. Gerald holds a Master’s degree in Biology from the University of Constance and a PhD in Molecular Biology from the University of Jena (both Germany). Gerald currently also represents Novartis in the industry consortia workstreams supporting ICH Q2R2 and ICH Q14.

ICH Q2 Q14 and Analytical Method Validation

Giovanni Vitali, Global Subject Matter Expert on Analytical Lifecycle, Global Quality – GSK

Giovanni Vitali holds a Master’s Degree in Pharmaceutical Chemistry from the University of Pisa (IT), in the field of analytical chemistry and quality control. He entered the pharmaceutical world working for CTP, an Italian consultancy company, where he was leading projects for quality control innovation, method validation and transfer for several firms. Seven years ago, he joined GSK where he has occupied positions in Analytical Science and Technology Department in the field of the analytics of biological products; both in the development and the commercial spaces. Currently he is working in GSK Vaccines Global Quality Control team as Global Subject Matter Expert of Analytical Validation and Lifecycle.

ICH Q2 Q14 and Platform Methods

Jean-Francois Dierick, Strategic Analytical Lifecycle Lead, Analytical Research and Development - GSK

Jean-Francois Dierick holds a PhD in Biology from the University of Namur (Be), in the field of proteomics of cellular ageing and a post-doc in proteomics from the University of Brussels (Be). Jean-Francois Dierick entered the pharmaceutical world working for SGS, where he was leading the Biology Department (Biotechnology, Biochemistry, Cell Biology, Molecular Biology, Microbiology, Toxicology) from the site of Bierges (Be). Fifteen years ago, he joined GSK Vaccines where he has occupied several positions in the field of the analytics of biological products, both in the development and the commercial areas. Today he is working in GSK Vaccines R&D / Technical Research and Development as Strategic Analytical Validation and Lifecycle Lead.

ICH Q2 Q14 and the Monitoring of Analytical Method Performance. Highlighting Opportunities for Commercial Method Improvement.

Sarah Thompson, Principal Scientist - Analytical Project Expert and Analytical Method Lifecycle Expert Working Group Co-Lead, Pharmaceutical Technology & Development – AstraZeneca

Sarah Thompson holds a masters in Chemistry, Pharmaceuticals and Life Systems from the University of York (UK) and a Post Graduate Certificate in Quality by Design from De Montfort University Leicester (UK). She has held a number of analytical science positions in her 20 years with AstraZeneca, across small molecule drug substance and drug product development, new commercial product introduction, and in established product technical support. In her current role as ‘Principal Scientist - Analytical Project Expert’ in the Pharmaceutical Technology & Development department, Sarah co-leads the Analytical Method Lifecycle Expert Working Group.

Brooks Ligon, Associate Principal Scientist - Analytical Sciences and Analytical Method Performance Monitoring Business Process Owner, Pharmaceutical Technology & Development – AstraZeneca

Brooks Ligon has worked in the pharmaceutical industry for 11 years and is currently an Associate Principal Scientist at AstraZeneca whose role is focused on 2nd tier analytical and project support for drug products, beginning in late-stage development and spanning throughout the commercial lifespan. Additionally, Brooks leads the Analytical Method Lifecycle Performance Monitoring Network, whose remit is to advocate for the rational adoption of the emerging ICH Q14 Guideline and implement best practices throughout AstraZeneca. Brooks received his M.Sc from Purdue University (US) and has a passion for the intersection of science and pharmaceutical regulation.

Moderator

Frederique Vieville - Chief Regulatory Officer at PHAXIAM

Frederique gained initial experience in a clinical and research environment before moving into the pharma/biotech companies. There, she drew upon her background as a pharmacist and Engineer in Biotechnology to manage production first and then development over ten years (MSD Chibret, then Europhartech). Subsequently, she filled the position of Head of QA/QP Deputy, including the regulatory unit, in CARBOGEN AMCIS. Afterward, she was chosen to design and implement the quality system in 4D Pharma, managing as well IMPD submissions. She founded 5QBD-Biotech, a Quality and Regulatory consultancy company, applying QbD and Lean approaches and guiding small biotechs on regulatory strategies on biological and radiopharmaceutical products. In 2020, she became Quality & Regulatory Affairs Director at Pherecydes Pharma, liaising with cross-functionalteams on the clinical development of bacteriophages, including the in vitro diagnostic test (Phagogram) development. Following the merger with Erytech in June 2023, she handles the global regulatory science (EU and US) at PHAXIAM Therapeutics as Chief Regulatory Officer.