AQbD Symposium - Day 1 - ICH Q2(R2)/Q14: Enhanced Approach to Analytical Procedures Development and Validation

Enhancing the Quality of Your Analytical Procedures

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

Embraced by industry, regulators and academia, the application of the AQbD principles aims to improve the quality of analytical procedures by using enhanced approaches to development, validation and performance monitoring.​

Join us on November 28th and 29th to hear from subject matter experts on recent development with ICH quality guidelines, implementation in the industry, and chromatography technologies that mitigate risk in the pharma QC laboratory.​

Each session will feature a panel of 3 forward thinking leaders on the topic who will present their recent work and participate in a round table discussion.

Day 1: ICH Q2(R2)/Q14: Enhanced Approach to Analytical Procedures Development and Validation

Analytical Quality by Design (AQbD) is an enhanced approach to analytical method development that not only reduces risks and produces robust methods across your organization but is also becoming the preferred language of regulators when filing applications for both small and large molecules, synthetic or biological drugs. ​

Using the so-called enhanced approach can significantly reduce the time-to-market, which is crucial in recent times when new drugs are developed on accelerated timelines. ​

Join us on Tuesday, November 28th for an update on the ICH Q14 and Q2(R2) guidelines, and the impact for the industry.​

Followed by a live panel discussion with all the speakers. So have your questions ready!

Overview of ICH Q2(R2)/Q14: ​Development and Validation of Analytical Procedures

Presenter: Nina Cauchon, Ph.D. (Director, Regulatory Affairs, CMC, Amgen)

Nina S. Cauchon, Ph.D. is Director Regulatory Affairs CMC at Amgen Inc in Thousand Oaks, CA, and leads RA-CMC Advocacy and External Engagement. She has experience leading both early phase & commercial programs, including small molecules and biologics. Her areas of interest are regulatory challenges for innovative modalities and emerging technologies, CMC aspects of expedited review pathways, regulatory harmonization, and science and risk-based approaches to regulations.

Nina is active in several external organizations which provide a strong network and knowledge base, including being a speaker/committee member for ISPE, CASSS, PQRI, AAPS, IQ, and DIA. She is a member of the ISPE International Board of Directors, the PhRMA Global Quality and Manufacturing group, and the ICH Q2(R2)/Q14 Expert Working Group, and is currently the ISPE PQLI co-chair. She has a PhD from Purdue University School of Pharmacy and has over 25 years of industry experience.

Quality and Speed – Case Study of Enabling Rapid Drug Development and Method Lifecycle Management

Presenter: Bryan Castle, Ph.D. (Associate Vice President, Synthetic Molecule Design and Development, Eli Lilly)

Bryan Castle, Ph.D. is an Associate Vice President in Eli Lilly & Company's Synthetic Molecule Design and Development organization. He has been part of Team Lilly for over twenty-five years and has held many technical and administrative roles in drug substance and drug product analytical development. He is a technical leader in analytical chemistry and is currently engaged in driving the analytical strategy for the small molecule commercialization portfolio. He is also part of the team that enabled commercialization of the last three oncology drugs, including successful global registrations. Dr. Castle is passionate about people development, efficiency tools, which include excellence in chromatographic separations, automation, and enabling of scientists through better handling of laboratory data. External to Lilly, he is engaged in ICH Q2(R2) and Q14 activities by leading a team at ISPE-PQLI.

AQbD in action: Development of LC method for impurity analysis in new ophtalmic drug product

Presenter: Ivan Sušanj, MPharm (Analytical Development and Stability Senior Scientist, JGL)

After graduation at Faculty of Pharmacy and Biochemistry, University of Zagreb in 2018, Ivan joined JGL R&D team as an Analytical Development and Stability Scientist. Since 2018, he has been working on development (both conventional and QbD approach) and validation of LC methods for product quality testing, in vitro tests and equipment cleaning validation. Current focus of his work are analytical methods for new nasal and eye topical product portfolio, along with broader activites for demonstration of extended pharmaceutical equivalence between JGL test products and RMP products.