Shaping the Future of Excipients

Learn more about the latest developments
on pharmaceutical excipients and discuss
with experts from across the value chain.

PROGRAMME

Programme

9:00 Opening Remarks
Amina Faham, IFF / Chair, IPEC Europe
MORNING SESSION Moderated by Adrian Bone, IPEC Europe
9:10 Updates from the EDQM and the European Pharmacopoeia
Petra Doerr, EDQM
9:50 Global impact of medicines contaminated with DEG/EG
Rutendo Kuwana, World Health Organization (WHO)
10:30 Coffee Break
11:00 USP standards setting for excipients – present and future
Catherine Sheehan, US Pharmacopeia (USP)
11:40 Regulatory considerations related to quality attributes for excipients used in chemical and biological drug products
Kee Cheung, Lonza
12:20 Q&A – Morning session
12:30 Lunch Break
 AFTERNOON SESSION Moderated by Bastiaan Dickhoff, DFE Pharma
13:30 Future expectations to suppliers on environmental sustainability
Lotte Kok and Morten Storgaard (hybrid Q&A), Novo Nordisk
14:10 Physical Contamination Management – A Challenge for Suppliers & Users
Sandra Millet, Roquette Frères and Bev Stout, GSK
15:10 Coffee Break
15:40 Using big data analysis to better characterize/understand excipients properties and supply chain variability
Pauline van der Wijst-Janssen, DFE Pharma and Mike Tobyn, BMS
16:40 Functional excipients in dry powder formulations for nasal and pulmonary drug delivery
Regina Scherliess, Kiel University, Germany
17:20 Q&A – Closing Remarks
Amina Faham, IFF / Chair, IPEC Europe

Programme subject to change.

SPEAKERS

In order of appearance.

Amina Faham

Vice President, Global Research & Development BIOSCIENCES, IFF and Chair, IPEC Europe

Amina Faham is a highly effective senior leader with several years of experience in leadership, generating business growth thru science & technology expertise and solutions provider creating value in the markets. Amina is a biochemist with a Ph.D. degree in Pharmaceutical Sciences from school of Pharmacy, University de la Mediterranean France. She has over 15 years of Healthcare industry experience and have worked for several pharmaceutical and chemical companies. Amina’s primarily responsibility is developing innovative technology solutions in Pharma, Biotech, and industrial markets, cross-functional collaboration, strengthening competitive position, and talent pipeline development. Since November 2023, Amina is the Vice President of Global Research & Development BIOSCIENCES for IFF.

Adrian Bone

Senior Advisor, IPEC Europe – MODERATOR

Adrian Bone is the Executive Secretary of the IPEC Federation. He graduated in Pharmacy from the University of London in 1979. Thereafter, he pursued a career of 35 years in the pharmaceutical industry working primarily in Quality assurance in several international roles. He also served as Chair of IPEC Europe for two terms and is currently the Senior Advisor for IPEC Europe.

Petra Doerr

Director, European Directorate for the Quality of Medicines & HealthCare (EDQM)

Petra Doerr (pharm. D; PhD) is the Director of the European Directorate for the Quality of Medicines and HealthCare (EDQM), since October 2021. Following the first ten years in the medical products industry, working in international regulatory affairs, she joined Swissmedic, Swiss Agency for Therapeutic Products, in October 2004 as the Head of International Affairs. In 2007, she became a member of the management board and from 2014 to 2019, she served as Head of Communication & Networking and Deputy Executive Director. From July 2019 to October 2020, she provided consultancy services to the WHO, and then joined that WHO as the Head of Unit Regulation and Safety in November 2020.

Rutendo Kuwana

Team Lead, World Health Organization

Rutendo Kuwana is the Team Lead of the Incidents and Substandard/Falsified medical products team at WHO Headquarters in Geneva, Switzerland. Rutendo has 30 years experience in quality assurance and regulation of pharmaceuticals and other medical products. He has been with WHO for past 14 years in various positions.

Catherine Sheehan

Senior Director, Foods and Excipients – Global Science and Standards, US Pharmacopeia

Catherine Sheehan is Senior Director, Foods and Excipients under Global Science and Standards Division at the United States Pharmacopeia (USP), Rockville, MD. She is currently responsible for both Excipients and Foods supporting USP’s mission and priority initiatives for strengthening the global supply of quality medicines and foods. These include developing a definitive source of quality USP-NF and FCC standards and solutions throughout the pharmaceutical and food lifecycles that include traditional standards, physical materials, and other tools and solutions. Dr. Sheehan is active in AAPS and RAPS. She holds a B.Sc. in Science from University College Cork, Ireland, M.S. Regulatory Science degree, and M.S. Molecular Biotechnology degree from The Johns Hopkins University and a doctoral in Regulatory Science, International Center for Regulatory Science, University of Southern California School of Pharmacy.

Kee Cheung

Senior Director for Regulatory Affairs, Lonza

Kee Cheung is the Head of Regulatory Affairs for Biologics Division at Lonza with over twenty years of experience in the biopharmaceutical industry. Kee specialises in Regulatory CMC and is responsible for leading and preparing license and clinical applications to a number of regions globally including the US FDA, EMA and China. Prior to Regulatory Affairs, Kee worked in Quality and Analytical positions. Kee holds a B.Sc. (Hons) in Biochemistry from Kingston University, UK.

IPEC Forum 2020

Bastiaan Dickhoff

Director of Innovation and Technology Services, DFE Pharma – MODERATOR

Bastiaan Dickhoff joined DFE Pharma in 2014. Bastiaan is the current Director of Innovation and Technology Services (ITS) with DFE Pharma.

Bastiaan has been working on application development towards excipients in area of Oral Solid Dose Forms based upon fundamental knowledge of DFE Pharma’s excipients and advances in powder technology. His expertise lies in the understanding powder behaviour in batch and continuous processes coupled with multivariate analysis. In addition, he is from a Technology and Innovation point of view responsible for the outcome of external collaborations. Prior to working at DFE Pharma Bastiaan had roles concerning powder physics and their relationship in processing in food and pharma at RSSL (which is part for Mondelez International (UK)) and prior to that Bastiaan has worked between 2005-2012 for GlaxoSmithKline (UK) in various roles.

Bastiaan holds a PhD from the department Pharmaceutical Technology and Biopharmacy at Groningen University, The Netherlands where he specialized in the relationship between the role of lactose (excipient) and API for inhalation purposes. He has published multiple papers on the relationship of excipients in future manufacturing technologies in Pharma.

Lotte Kok

QA Specialist, Novo Nordisk

Lotte Kok is working as a specialist at Novo Nordisk in the quality assurance department responsible for sourcing raw materials and excipients used worldwide on our sites. In Novo Nordisk, Lotte Kok is Chair for a group evaluating updates of or new external requirements related raw materials, excipients and purchased or manufactured APIs. Lotte is also an active IPEC contributor, being part of the IPEC Europe Board of Directors and the Compendial Committee.

Morten Storgaard

Global Project Lead, Novo Nordisk

Morten Storgaard is the Project lead for Novo Nordisk decarbonisation programme. He has been working for more than 10 years on environmental sustainability, reducing impact from upstream supply chain.

Beverley Stout

Supplier Quality Manager, GSK

Bev Stout is a Global Supplier Quality Manager at GSK based in the North East of England managing a number of key excipient suppliers used in various dose forms including inhaled, oral solid dose, topical and Biopharm products. She has worked at GSK for 37 years in Microbiology, Validation and Supplier Quality. She has a BSc Honours Degree in Biotechnology with Management from Thames Valley University and a Higher National Certificate in Biomedical Science specialising in Medical Microbiology. Bev has represented GSK on the IPEC Europe Quality & Regulatory Affairs Committee since 2010 and has contributed to a number of new and revised IPEC guides including the revised IPEC PQG GMP guide issued in 2022 as well as number of EXCiPACT standard revisions (2017 GMP/GDP revision and PAMS guide 2023) Bev is also a member of the IPEC Europe Event Committee.

Sandra Millet

Pharma Standard Specialist, Roquette Frères

Sandra Millet is Pharma Standard Specialist for Roquette Freres. Graduate as a Food quality engineer, her experience in quality spans through several aspects, including Operational Quality, Quality Management System, Customer Quality dedicated to Pharmaceutical Customers.

In her current position, she is part of the Pharma corporate team and in charge of pharmaceutical Good Practices application.

Pauline van der Wijst-Janssen

Product Application Specialist, DFE Pharma

Pauline Janssen is a Product Application Specialist at DFE Pharma. She has been working on application development of excipients based upon fundamental knowledge of excipients and powder physics. She joined DFE Pharma beginning of 2017 and worked as a product developer and application specialist on multiple OSD and DPI projects. Pauline holds a Master’s Degree (cum laude) in Physical Chemistry from the Radboud University in Nijmegen, with an additional specialization in Science, Management and Innovation. Due to her exceptional research, she is also affiliated with the University of Groningen as a PhD student since April 2022.

Mike Tobyn

Senior Scientific Director, Bristol Myers Squibb (BMS)

Mike Tobyn is a Pharmaceutical Materials Scientist, looking at the properties of API’s and excipients in oral solid dosage forms. Mike Tobyn has been at BMS for 18 years, after previously working for Vectura and in academia. He worked for, and consulted for, excipient companies before his time at BMS.

Regina Scherliess

University Professor, Kiel University

Regina Scherliess is a pharmacist by training and obtained her Doctoral degree at Kiel University with a dissertation on co-precipitated DPI formulations. In her habilitation, Dr. Prof. Scherliess worked on “Formulations for mucosal vaccination” with a focus on the nose. Currently, Regina Scherliess is a Professor for Pharmaceutics and Biopharmaceutics and head of the Department at Kiel University. Her research interests are powder formulations for the respiratory tract and nanoparticles as drug carriers for targeting immune cells.