A series of virtual webinars has been organised by the Academy of Pharmaceutical Sciences Biopharmaceutics Focus Group. They will run from January to May, with speakers including Industry, Academia and Regulatory colleagues, with opportunities for questions and discussions. A summary of a previous workshop organised by APS can be found at: https://doi.org/10.3390/pharmaceutics12010019
(Meeting Report: Developing Clinically Relevant Dissolution Specifications for Oral Drug Products—Industrial and Regulatory Perspectives, Pharmaceutics 2020, 12(1), 19, McAllister et al.)
The sessions will include
Introduction to CRDS – the “what” and “why”
Introduction to PBPK/PBBM Modelling – the “what” and “how”
How to develop CRDS including case studies from Industry
Overview of global regulatory trends within CRDS including progress, challenges and emerging opportunities
Future developments with PBBM/PBPK software packages
Emerging opportunities within PBPK/PBBM modelling to support CRDS including new research areas
The webinar series will be of relevance to Industry, Regulators, specialist technology providers Private Sector and Academic colleagues. The aim is to share and discuss progress and challenges through scientific presentations and Q&A sessions. The webinars will cover the current state of scientific affairs in the field, emerging trends and identify areas where Industry and regulators can engage to further harmonise and enable CRDS development moving forwards.
Two Case studies will be presented to demonstrate how PBBM can be used to define acceptable product specifications in terms of critical material attributes or process parameters
Case Study 1: PBPK application to evaluate drug absorption and drug substance PSD safe space size for a BCS 2 compound
The case study will describe the integration of drug product dissolution using two approaches including the outcomes and preferences
Demonstration of how the PBBM model was used to define the edge of the safe space for DS PSD
How the PBBM model together with clinical data was used to set the API PSD specifications
Case Study 2: Establishing clinically relevant specifications in pre-approval and post-approval environment for an orally administered compound formulated in several immediate release drug products
The case study will describe the use of biorelevant dissolution data in PBBM across different drug products
Demonstrate how to build and define an in silico safe space approach for:
Polymorphic purity (Drug Product A)
Particle size and QC dissolution (Drug Product B)
Christophe Tistaert is a Principal Scientist Biopharmaceutics in the Chemical and Pharmaceutical Development & Supply organization of Janssen Research & Development. He joined Janssen in 2012 as a pharmaceutical scientist and has been leading preformulation activities and biopharmaceutical development strategies across the small molecules portfolio. In his current role, he focusses on predictive modeling strategies in pharmaceutical product development, amongst which PBBM and mechanistic understanding of drug substance and drug product performance play a key role.
Xavier Pepin– Principal Scientist Biopharmaceutics, New Modalities and Parenteral Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, UK.
Xavier is a pharmacist (University Paris XI). He has a Ph.D. in granulation technology (powder surface energy and liquid bridges). He has 20-year experience in the pharmaceutical industry with different jobs in preformulation, clinical & commercial development, industrial transfer, regulatory CMC and biopharmaceutics. He was the co-leader of WP4(in silico tools) for the OrBiTo IMI project 2012-2018. He has 40 publications in the field of powder surface energy, granulation technology and biopharmaceutics. His hobbies are building homes, furniture and cooking…
Diansong Zhou- Astra Zeneca
Diansong is a scientist in Clinical Pharmacology & Quantitative Pharmacology Department at AstraZeneca. He has been lead pharmacometrican for early and late stage small molecule and biologic drug development. Diansong has authored/co-authored over 50 peer-reviewed scientific papers in modeling and simulation, clinical pharmacology and drug metabolism. His research interests include strategic application of model informed drug development, pediatric drug development and ethnic impact in drug development.
Buyun Chen -Astra Zeneca
4th Event; 18th May 2021-Overview of global regulatory trends within CRDS including progress, challenges and emerging opportunities
Title: Physiologically Based Biopharmaceutics Models in regulatory applications: The EMA experience
Modelling and Simulation is increasing the importance of its role in drug development in the pharmaceutical industry while more recently it has found its way in regulatory submissions. Physiologically Based Biopharmaceutics Modelling is another opportunity to fulfil the vision of in silico clinical trials in drug approval. The presentation is going to focus on the European Medicines Agency experience, from submissions including PBBM and will cover:
• Background and EMA perspective of PBPK modelling and relevant guidelines
• Experience from PBPK and PBBM submissions
• Selected case studies of regulatory submissions with PBBM to EMA
Aris Dokoumetzidis. Associate Professor of Pharmacometrics in the Department of Pharmacy of the University of Athens (Greece), Member of the Modelling and Simulation Working Party of EMA
Aris Dokoumetzidis is Associate Professor of Pharmacometrics in the Department of Pharmacy of the University of Athens in Greece since 2010 and member of the Modelling and Simulation Working Party of the European Medicines Agency since 2016. Previously he was a Lecturer in the School of Pharmacy at Queen’s University Belfast (UK), and before that from 2003 to 2008 a Research Fellow in the School of Pharmacy of the University of Manchester (UK) while he is a physicist by training. He has contributed to 65 refereed journal papers while his research interests include: Population pharmacokinetics / Pharmacodynamics and Physiologically Based Pharmacokinetic Models with applications in Model Informed Drug Development and Quantitative Clinical Pharmacology.
5th Event; 15th June 2021-• Future developments with PBBM/PBPK software packages
Maxime is now a Senior Scientist at Simulations Plus, the world leader company in innovative modelling and simulation software applied to the pharmaceutical research and development. Before joining Simulations Plus, Dr. Le Merdy received a Pharm.D. from University Paris-Descartes in 2015. In 2014, he received his master’s degree in Pharmacometrics from the same university. He joined the FDA in 2017 as a Post-doctoral fellow in the Division of Quantitative Method and Modeling within the Office of Generic Drugs, where he developed his expertise in PBPK models for locally acting drug products and published multiple paper on ocular delivery models. Prior to this experience, he published on Ethyl-glucuronide, a biomarker of alcohol consumption as well as the physiological modification affecting children’s pharmacokinetics.
David Turner -Simcyp
6th Event; 29th June 2021-Emerging opportunities within PBPK/PBBM modelling to support CRDS including new research areas
“Clinically Relevant Dissolution Specifications – Why, What, and How ?”
Speakers: Dr Paul Dickinson – SEDA Pharmaceutical Development Services and Dr Andreas Abend – MSD
Developing and registering clinically relevant dissolution specifications has been the subject of much discussion and debate for formulation, analytical and regulatory scientists for several years. Recent workshops and literature which have focused on the topic suggest certainly progress and evolution in the area as industry and regulators learn from working “hands on’ with CRDS, however some work remains to reach an agreed scientific framework to routinely establish such specifications for oral immediate-release (IR) drug products and to realise its full potential.
This webinar will set the stage for our seminar series and cover:
The principles and benefits of clinically relevant specifications
Highlight the progress in the area over the last few years including Regulatory and Industry scientific meeting outputs
A cross Industry perspective and recommended roadmap on approaches for establishing CRDS for IR oral drug products.
Dr Paul Dickinson – SEDA Pharmaceutical Development Services
Paul A Dickinson BPharm (Hons) PhD
Director, Seda Pharmaceutical Development Services®
Paul is co-founder of Seda, a company providing pharmaceutical development and clinical pharmacology services and consultancy to the Pharma Industry.
Published in The Times and referenced in FDA draft guidance, Paul has held several senior science leadership roles in Academia and Large Pharma for over 20 years. These roles focused on applying the best science in projects to ensure optimal product performance in the patient, thus bridging pre-clinical, pharmaceutical and clinical disciplines.
Paul has extensive early development, late development and drug registration stage experience including the delivery of several products to approval.
Paul has an international scientific reputation and is past Chair of the AAPS ‘QbD and product performance’ focus group. Paul has been at the forefront of recent technical and regulatory advances in performance criteria that assure drug product performance in the patient (clinically relevant specifications).
Dr Andreas Abend – MSD
Andreas Abend received his PhD degree in Organic Chemistry from the University of Karlsruhe in Germany. Prior to joining MSD as a Senior Project Chemist, Andreas spent 3 years as a Post-Doctoral Fellow at the University of Wisconsin’s Enzyme Institute. He is currently a Director in the Analytical Sciences department leading a group of scientists supporting new drug product development. Throughout his career at MSD, he supported small molecule API and drug product development spanning all clinical phases. Andreas is a member of Merck’s Biopharmaceutical Advisory Team, PQRI’s BTC, and a member of IQ’s Analytical Leadership Group. He presented at many national and international meetings, published several manuscripts on Clinically Relevant Dissolution specifications and he recently served as co-organizer of two workshops at the Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI).
2nd Event; 2nd March 2021-Introduction to PBPK/PBBM. The How and the Why.
March webinar programme – Introduction to PBPK/PBBM. The How and the Why.
Speakers: Andrea Moir- AstraZeneca and Susan Cole – MHRA
PBPK/ PBBM Modelling is increasingly used by Industry to set CRDS and models have been used and accepted in regulatory submissions. There are a number of different approaches to model dissolution within the Industry. As an introduction to examples which will be presented in subsequent webinars, the approach to developing and building a model will be described. Best practices in model building will be considered with regulatory thoughts on assessing predictive performance and qualification of models and with reflection on the relevant guidelines.
This webinar will set the stage for our seminar series and cover:
• Background to PBPK/PBBM
• How to model dissolution (PSD approach, PBDT approach)
• Best practices in PBPK approaches to modelling and model evaluation for CRDS
• Introduction to examples and link to next webinars
Andrea received a degree in chemistry from the University of York followed by a master’s degree in Medicinal chemistry and drug metabolism form Loughborough University. I have worked at AstraZeneca for more than 20 years initially in analytical sciences with a focus on dissolution. For the last 10 years I have worked in biopharmaceutics group. During this time I have used PBBM for a number of projects to build mechanistic understanding of product performance both during development and to support post approval changes.
Susan Cole, Expert pharmacokinetics Assessor, MHRA
Susan Cole is an Expert Pharmacokinetics Assessor and Head of the Pharmacokinetics group at the MHRA, the UK Regulatory Agency. In the past Sue was a member of the Pharmacokinetics Working Party, the Modelling and Simulation Working Group and the Scientific Advice Working Party at the European Medicines Agency.
Prior to joining the MHRA in 2012, Sue worked for 26 years at Pfizer in the UK in the field of Drug Metabolism and Pharmacokinetics. While in Industry Sue fulfilled a number of roles including: Head of the preclinical Pharmacokinetics and Modelling group and as a Clinical Pharmacologist.
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