CRED Getting the CMC Dossier Right 2024

Bethany Jackson Bethany is an Associate Principal Scientist within Chemical Development at AstraZeneca, a global, science led, patient focused pharmaceutical company. Bethany has 10 years of experience in drug substance development and has been lead author of multiple regulatory submissions. Olivier Dirat Olivier completed his PhD in organic chemistry at Paris University, followed by a post-doctoral position at Stanford University. Olivier has over 20 years of industrial experience in discovery and late-stage API process development at Merck and Pfizer and currently holds the position of Senior Director within Pfizer Global Regulatory Sciences CMC Advisory Office where he provides technical and regulatory guidance and direction to teams on a wide array of topics, including CMC regulatory strategies, the development and articulation of control strategies, impurities management, N-nitrosamines, continuous manufacturing, starting materials, ADCs, mRNA vaccine lipids and other special cases. He chairs one of Pfizer’s Impurities Councils, a multidisciplinary council that provides advice to teams regarding impurities from safety, quality and regulatory perspectives. External to Pfizer, Olivier is involved with ICH as PhRMA deputy topic lead for ICH Q13 IWG, IQ consortium Board of Directors, co-chairs the regulatory advisory committee and also on N-nitrosamines, starting materials, ADCs, and EFPIA on N-nitrosamines, ICH M7, ICH M4Q and ICH Q6. Olivier is based in Sandwich, UK. Bassel Odeh Dr Bassel Odeh has a PhD in Clinical Pharmacy and MSC in Pharmaceutical Sciences from Kingston University and over 20 years of experience in the pharmaceutical industry. Dr Odeh is currently the Head of New Active Substances Team at the Medicines & Healthcare products Regulatory Agency and he is part of the Innovative Medicines and Population Health senior leadership team. He provides operational management support to one of the multidisciplinary teams that evaluate marketing authorisation applications and variation applications for chemical new active substances. Dr Odeh has also worked as a Leading Senior Pharmaceutical Assessor at the Agency where he conducted pharmaceutical assessments, prepared and presented objective assessments and scientific papers to expert advisory committees, and provided regulatory and scientific advice to stakeholders through company meetings and written procedures. Prior to this role, he worked as a Senior Formulation Scientist where he conducted pre-formulation and formulation characterisation studies and supported drug product development, validation, and transferring into GMP manufacturing. Christian Monnerjahn Christian is a biologist by education. After some academia roles, he moved into the pharma industry starting at Salutas Pharma, a Sandoz affiliate. From here he joined the DRA world at the time CTD was introduced. Christian’s role grew from being Germany-focussed to EU to almost global regulatory CMC management for small molecule generics in various dosage forms. In