AQbD Symposium - Day 1 - Analytical LC Method Strategies in the Q14 Era

AQbD Symposium 2024 (Impact of Q14/Q2 on LC Procedures)

Analytical Quality by Design (AQbD) is a science and risk-based approach to analytical procedure development that “starts with the end in mind”.

The recently adopted quality guidelines Q14 and Q2(R2) leverage AQbD principles. What does that mean for the Pharma LC lab? We are joined by industry thought leaders for an engaging discussion that will encompass strategies and case studies.

Each session will feature a panel of forward thinking leaders on the topic who will present their recent work and participate in a round table discussion. 

Learning Objectives

• Understand opportunities and barriers related to the implementation of Q14
• Learn about analytical development strategies for every phase of clinical development
• Explore case studies applying Q14 to today’s analytical challenges
• Engage with pharma industry thought leaders

Session 1: Analytical LC Method Strategies in the Q14 Era

• Tuesday, December 3, 2024 | Time: 10:00am ET | 3:00pm GMT | 4:00pm CET

With the Q14 and Q2(R2) guidelines now adopted by FDA and EMA, there is an opportunity to rethink strategies around analytical LC procedure development. Platform analytical procedures, phase-appropriate approaches, future proofing procedures for robustness, sustainability and user-friendliness are top-of-mind topics. Our panelists will discuss opportunities and barriers in the implementation of Q14.

Presenter: Timothy Graul, Ph.D. (Director, Global CMC Advisory Office, Pfizer, Inc.)

Timothy W. Graul, Ph.D.,is a Director in the CMC Advisory Office within Pfizer at the Groton, CT site. He received his B.S. Degree in Chemistry at James Madison University and then Ph.D. in Analytical Chemistry at The Florida State University. After completing studies, Tim joined Pfizer Analytical R&D and supported the development of drug product formulations and drug substance synthetic routes. During his time at Pfizer, Tim has been recognized as a leader in Quality by Design for analytical procedures. He has collaborated on publications that have been at the forefront of industry in this area. Tim served as the PhRMA Deputy Topic lead on the ICH Q2/Q14 Expert Working Group and is now an Industry Expert on the Implementation Working Group for the revised Q2 Guideline and new guideline, Q14. He has been a member of industry groups including Land O’ Lakes Pharmaceutical Analysis Conference Planning Committee and AAPS Summer Scientific Forum since 2010, IQ groups such as Analytical Leadership, AQbD, Dissolution, Control Strategy Harmonization Metrics, and Worldwide Specification Harmonization; and is the co-lead of the ISPE PQLI group on Analytical Methods.

Presenter: Gerald Gellermann, Ph.D. (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 in neuroscience research and diagnostic division at Abbott/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 also represents Novartis in the industry consortia workstreams supporting ICH Q2(R2) and ICH Q14.

Presenter: Andrea Gheduzzi (Principal LC Market Dev. Manager, EMEA, Waters Corporation)

Andrea Gheduzzi, is a principal LC market development manager for EMEA at Waters Corporation. Andrea Gheduzzi has spent more than 30 years in the chromatography field. Across his career he had various roles, service engineer, chromatography lab manager position, and technical manager for chromatography columns.

He has mainly been dealing with pharma accounts, also supporting LC method development activities using DoE/QbD approaches. In his previous role as Pharma Business Development Manager at Waters he has further expanded his expertise in AQbD and related applications.

Since 2023 he became principal LC market development manager for EMEA and member of the AQbD working party at the EDQM.

Moderated by: Isabelle Vu Trieu (Pharmaceutical Market Development Manager, Americas, Waters Corporation)

Isabelle is a business development professional dedicated to delivering benefits to analytical scientists in the life sciences industry. With over 20 years of experience in providing chromatography and mass spectrometry solutions, Isabelle is particularly interested in helping pharmaceutical scientists achieve the data quality and integrity needed to drive decisions for drug quality, safety and efficacy. Isabelle joined Waters in 2009 and currently manages the development of the pharmaceutical market in the Americas. She holds Masters’ degrees in Chemistry from Columbia University and the University Claude Bernard in Lyon, France as well as a Chemical Engineering degree from Ecole Supérieure de Chimie Physique Electronique in Lyon, France.