Impurity Analysis Roundtable

Development and manufacture of safe and effective drugs are central to the pharmaceutical industry. Keeping up to date with the latest regulations and new discoveries in this fast-paced environment is essential for all professionals working within this industry.

Presenter: Adrian Clarke, Ph.D. (Global Technical R&D (TRD) & CHAD Analytical Network leader, Novartis Pharma)

Adrian Clarke is a global Technical R&D (TRD) & CHAD Analytical Network leader in Novartis, covering multiple countries, including Switzerland and China. His main responsibilities are to 1) identify the strategic, operational & technological needs of TRD and CHAD analytics; 2) define, develop and implement innovative technologies and global business processes in TRD; 3) improve operational excellence and ensure state of the art analytics, as well as scientific and regulatory standards.

His special interests are liquid phase separations & hyphenated techniques (Fast LC/UHPLC, 2D LC, SFC, MS), column characterisation, method development, and also analytical control & regulatory strategies, including mutagenic impurities.

Adrian obtained his DPhil in Analytical Chemistry (Separation sciences) at the University of York, UK. Following this he joined AstraZeneca (UK) analytical chemistry section of Process R&D in 1998. In 2010 he joined Novartis Pharma AG, Inhalation development (Basel, Switzerland).

Adrian has been a committee member of the Chromatographic Society, UK since 2009 and is involved in International Outreach activities with other societies and groups, organising summer studentships, and he has co-organised around 10 successful scientific meetings. He has a strong publications record and is an invited guest editor to several scientific publications.

Presenter: Julien Patoor (Team Head, Global Analytical Project management, Late phase in Global Drug Development/Technical Research & Development, Novartis Pharma)

Julien Patoor is a team head for Global Analytical Project Management late phase in Analytical Research & Development at Novartis Pharma, and acts as a scientific expert for the review of late phase registration analytical CMC strategy for small molecule drug substances and drug products under development at Novartis and supports the implementation of innovative technologies and global business processes.

Julien joined Novartis Pharma AG (Basel, Switzerland) in 2009. To date he has contributed to the successful late phase development and filing of around 50 NCE compounds.

Julien graduated as a chemical engineer specialized in analytical chemistry from the ECPM Strasbourg and the Ecole Nationale Superieure de Chimie de Mulhouse, France. Before joining Novartis, Julien worked as an analytical chemist for Kodak Ltd (Harrow, UK) and joined GlaxoSmithKline Ltd (Stevenage, UK) as Lead Analyst for drug substance projects in the field of inhalation.

Presenter: Wai-Chi Man (Product Marketing Manager, Thermo Fisher Scientific)

Wai has been with Thermo Fisher Scientific for more than eight years working with a wide range of customers in various industries. She provides ion chromatography (IC) support in method development, troubleshooting, sample preparation, training, seminars, events, and workshops. During this time, she has gained deep knowledge, skill, and understanding in areas such as IC-MS, IC-ICP-MS, carbohydrate analysis, metabolomics, and polar pesticides. Prior to joining the company, she worked for Wellcome Research and GlaxoSmithKline. Wai is passionate about promoting STEM to future scientists by encouraging, nurturing, and supporting them.

Moderator: Jon Bardsley (Vertical Marketing Manager, Pharma-Biopharma, Chromatography and Mass Spectrometry, Thermo Fisher Scientific)

Jon Bardsley has over a decade of experience of small-molecule pharmaceutical DMPK and regulated bioanalytical studies within large Pharmaceutical environments. His passion for development of robust and accurate analytical methods for high-throughput studies has seen him also gain experience in contract research organizations. Jon sits on the Reid BioAnalytical committee of the Chromatography Society and is a subject matter expert in the bioanalysis community. Following a period as Senior Applications Specialist for Chromatography, Jon now holds the position of Vertical Marketing Manager for Pharma & BioPharma within Thermo Fisher Scientific, with a view to bringing relevant technologies together to help solve customer challenges.