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4th Extractables & Leachables Summit

  • 10th – 11th May 2023
  • Austria flag Austria Vienna

The characterisation of extractables and leachables (E&L) for drugs, biologics, medical devices and drug-device combination products to ensure product safety has matured in the last periods, and today we all are waiting in anticipation for the publication of the ICH Q3E guideline on E&L.

Since more new and complex pharmaceutical manufacturing and delivery systems are progressing towards development, a variety of ongoing practical considerations and insights around E&L are accumulated, the current E&L regulations are evolving, and new regulatory requirements are coming.

The analytical, toxicological, and regulatory experts in the E&L area will elaborate on ensuring the safety, quality, compatibility, and regulatory compliance for drugs, biologics, medical devices, and combination products.

Explore technical presentations and practical case studies, participate in Q&As and interactive panel discussions, and leverage win-win strategies, perspectives, and partnership opportunities at the 4th Extractables & Leachables (E&L) Summit on May 10-11, 2023.

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About the 4th Extractables and Leachables (E&L) - #VLEnL by Vonlanthen

The characterisation of extractables and leachables (E&L) for drugs, biologics, medical devices, and drug-device combination products to ensure product safety has matured in the last periods, and today we all are waiting in anticipation for the publication of the ICH Q3E guideline on E&L.

The ICH Q3E: Guideline for Extractables and Leachables (E&L) is due for finalisation in 2025. The public consultation on the proposals is expected to start in 2023, opening opportunity for reviews and commenting of the document.

Well-designed E&L studies, robust analytical testing, and consistent chemical and toxicological assessment are vital to perform comprehensive E&L assessment.

E&L risk assessment continues to be critical to the biopharmaceutical drug development and manufacturing processes.

Since more new and complex pharmaceutical manufacturing and delivery systems are progressing towards development, a variety of ongoing practical considerations and insights around E&L are accumulated, the current E&L regulations are evolving, and new regulatory requirements are coming.

Addressing trending and future challenges of E&L analysis is highly important, including the understanding of:

  • Advancing E&L regulations
  • The increasing number and complexity of medical devices, new materials, and sensitivity of testing equipment
  • The gap in the availability of the specific guidelines for E&L studies in area of emerging cell and gene therapy (CGT) products and other novel therapeutics
  • How to eliminate the gaps between end user expectations and supplier capabilities
  • …and many others

The analytical, toxicological, and regulatory experts in the E&L area will elaborate on ensuring the safety, quality, compatibility, and regulatory compliance for drugs, biologics, medical devices, and combination products.

Following the recent revisions to USP chapters and FDA guidance, attendees of the #VLEnL May 2023 conference and expo will get a toolbox and best practices in materials and chemistry characterisation to speed up and strengthen their process qualifications, ensuring high product quality and patient safety.

At the #VLEnL May 2023 Summit, key experts, advisers, and practitioners will focus on:

  • Strengthening E&L risk assessment for drugs, biologics, and medical devices
  • Overcoming common analytical constraints related to E&L study design
  • Leveraging current toxicological requirements for E&L
  • Implementing new technologies, advanced analytics and applied informatics, digitalisation, and automation to advance the E&L field
  • Meeting regulatory expectations for E&L in drug products, delivery systems, medical devices, and packaging
  • Overviewing the guidelines and recommendations for a successful selection, fast qualification, and safe use of container closure systems (CCS) and polymeric single-use systems (SUS)
  • Understanding future trends as well as uncertainties in E&L analysis
  • Gaining insights on E&L related to novel therapeutics, including messenger RNA (mRNA), cell and gene therapies, and combination products

Explore technical presentations and practical case studies, participate in Q&As and interactive panel discussions, and leverage win-win strategies, perspectives, and partnership opportunities at the 4th Extractables & Leachables (E&L) Summit on May 10-11, 2023.

Chief Executives, Vice Presidents, Directors, Heads, Leaders, and Managers specialising in:

  • Active Pharmaceutical Ingredient (API)
  • Analytical Science
  • Assay Development
  • Bioprocessing
  • Carcinogens
  • Chemistry (Analytical, Organic, Medicinal, Protein)
  • Chemistry, Manufacturing and Controls (CMC)
  • Container Development
  • Device Engineering
  • Drug Development
  • Drug Safety
  • Elemental Impurities
  • Extractables & Leachables (E&L)
  • Formulation
  • Genetic Toxicology
  • Genotoxic Impurities (GTIs)
  • Genotoxicity
  • Good Laboratory Practice (GLP)
  • Good Manufacturing Practices (GMP)
  • Impurities
  • In Silico
  • Manufacturing Science and Technology
  • Materials Science
  • Medical Devices
  • Microscopy
  • Mutagenic Impurities
  • Mutagenicity
  • N-Nitrosamine
  • Organic Synthesis
  • Packaging and Labelling
  • Parenterals
  • Permitted Daily Exposure (PDEs)
  • Pharmaceutical Analysis
  • Product and Process Development
  • Purification
  • Quality Assurance (QA)
  • Quality by Design (QbD)
  • Quality Control (QC)
  • Quantitative Structure-Activity Relationship (QSAR)
  • Regulatory
  • Regulatory Affairs
  • Safety Assessments
  • Standardisation
  • Testing
  • Toxicology
  • Validation

Buy your package now, the discount is valid until March

 

The Early Bird Offer expires in 21 days!

REQUEST A BROCHURE

To request an agenda for this Summit, please complete the details below. We will send you the agenda via email.

Key Practical Learning Points

  • Strengthening E&L risk assessment for drugs, biologics, and medical devices
  • Overcoming common analytical constraints related to E&L study design
  • Leveraging current toxicological requirements for E&L
  • Implementing new technologies, advanced analytics, and applied informatics, digitalisation, and automation to advance the E&L field
  • Meeting regulatory expectations for E&L in drug products, delivery systems, medical devices, and packaging
  • Overviewing the guidelines and recommendations for a successful selection, fast qualification, and safe use of container closure systems (CCS) and polymeric single-use systems (SUS)
  • Understanding future trends as well as uncertainties in E&L analysis
  • Gaining insights on E&L related to novel therapeutics, including messenger RNA (mRNA), cell and gene therapies, and combination products

Buy your package now, the discount is valid until March

 

The Early Bird Offer expires in 21 days!

Dr. Elizabeth Martin, UK

Senior Director, Toxicologist

AstraZeneca

Dr. Elizabeth Martin is currently based in Cambridge, UK and is a Senior Director at AstraZeneca with the joint role of Project Toxicologist and Strategic Impurities Toxicology Lead. She is a European Registered Toxicologist. Dr. Martin gained her PhD at the University of Wales, before joining the Medical Research Council Toxicology Unit where she led a research group focused on assessing the consequences of DNA damage and their use in predicting carcinogenic risk. Dr. Martin joined AstraZeneca in 2001 and in her current role supports the portfolio with the safety assessment of impurities, including the risk assessment of Extractables & Leachables.

Patricia Parris, UK

Global Risk Assessment Services Toxicologist / Drug Safety Research & Development

Pfizer

Trish Parris joined Pfizer in February 2020 as a global risk assessment services toxicologist in drug safety R&D. Trish has a background in genetic toxicology and, over the last 12 years, has built expertise in mutagenic impurity, E&L, and contamination risk assessments. In recent years, Trish participated in the ICH M7 working group to develop appendix 3 and co-authored the hydrogen peroxide monograph. In addition, she authored the vinyl acetate monograph in the subsequent publication Bercu et al., (2018). Trish is also the co-chair of the Extractables and Leachables Safety Information Exchange (ELSIE) PDE and Sensitisation sub-teams and is an active member of the EFPIA working group to support ICHQ3E.

Dr. James Vergis, US

Director - Science Research & Innovation

ELSIE Secretariat

James Vergis, PhD, is a director of science, research, and innovation at the law firm of Faegre Drinker Biddle and Reath, LLP, and is a member of the firm’s life sciences consortium management team and government and regulatory affairs practice group. As one of the consulting professionals within the law firm, Jamie provides scientific and strategic consulting services to individual clients and various pharmaceutical and biotechnology consortia such as Allotrope Foundation, Enabling Technologies Consortium (ETC), the Extractables and Leachables Safety Information Exchange (ELSIE), and the International Pharmaceutical Consortium on Innovation and Quality (IQ). As a scientist whose work has touched on various fields of study, Jamie is passionate about helping clients cultivate new scientific knowledge and drive public policy changes that enhance the drug-development process. He is particularly adept at helping clients streamline the development of new technology and data-sharing processes.

Jamie has a BS in biochemistry with a minor in computer science from SUNY Geneseo and a PhD in molecular biophysics and biochemistry from Yale University.

Jéssica Marques, UK

Trace Analysis, Extractables and Leachables Scientist

GSK

Jessica Marques obtained a master's degree in biochemistry from the University of Aveiro, Portugal. She has been working at GSK Stevenage, United Kingdom, as part of the trace analysis, E&L team for over two years. Her work focusses on E&L risk assessments within biopharma and cell and gene therapy and trace level analysis to support control and assessment of mutagenic impurities.

Dr. Ana Kuschel, DE

Principal Scientific Affairs, Europe

West Pharmaceutical Services Deutschland GmbH & Co. KG

Dr. Roberto Menzel, DE

Head of Extractables Laboratory

Sartorius Stedim Biotech

Dr. Carla Landolfi, IT

Founder & Toxicology Risk Assessor

ToxHub

Dr. Carla Landolfi has about 25 years of experience in toxicology field gained in the pharmaceutical industry, eight of them as manager to a toxicology group. She has solid knowledge in the development of safety programs for pharmaceuticals, cosmetics, food supplements, medical devices, biocides, and other consumer products.

Carla has broad experience with regulatory national and international guidelines and rules (ICH/EMA/FDA/GLP/ISO) and she has been the main or co-author of several papers and posters, published in peer-reviewed journals. She's also a professor at university masters as well as a founding editor of Archives of Clinical Toxicology.

Dr. Dujuan Lu, US

Manager/Global Leader-E&L

SGS

Dr. Dujuan Lu serves as the manager for the E&L team at the SGS Health Science Fairfield, New Jersey, facility as well as the global leader amongst the global E&L centres of excellence. Dujuan obtained her PhD in analytical chemistry from the University of Pittsburgh and has extensive CRO and pharmaceutical/medical device industry experience with more than 500 E&L projects. She was named one of the top 60 most influential people working in the pharmaceutical industry in the Medicine Maker’s 2020 power list.

Markus Obkircher, DE

Director, Research & Development

Merck Life Science

Markus Obkircher is director of R&D, heading Merck’s reference materials and proficiency testing division with teams in the US and Switzerland. He is responsible for the in-house development of new analytical standards and certified reference materials under ISO/IEC 17025 and ISO 17034 double accreditation. Prior to this position he was R&D manager in Buchs, Switzerland, with a strong focus on synthesis, characterisation, and certification of reference materials. He joined Merck/Sigma-Aldrich eight years ago after heading the development unit for a custom API manufacturer. He completed his post-doctoral studies at Harvard in Boston and his PhD thesis in Basel, and further holds an executive MBA degree from the University of Zurich.

Dr. Atish Sen, US

Senior Scientist

AstraZeneca

Jason Creasey, UK

Managing Director

Maven E&L Ltd

Jason Creasey is a graduate Analytical Chemist. He set up in 2019 as an independent consultant providing advice on the topic of extractables and leachables (E&L), after working for GSK in the area of extractables and leachables since the mid-1990s. 

Over that time, he has seen demand in this area grow exponentially, and Jason has held roles of increasing seniority in relation to providing support to extractables and leachables. Before setting up Maven E&L Ltd - a specialist consultancy for all things E&L related, he was the director of a team of analytical chemists who are responsible for GSK’s global R&D support for E&L activities across a wide range of product types and modalities. He has had the pleasure of commenting on OINDP PQRI guidelines on E&L for GSK and co-authoring a chapter within a book entitled “Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products”.   

Since setting up Maven E&L; he continues to present, discuss, and write about E&L. He is a scientific advisor to Extractable and Leachable Safety Information Exchange, otherwise known as ELSIE. He is now publishing a regular E&L blog through LinkedIn and his Website (www.MavenEandL.com), recently adding an E&L Forum for the exchange of ideas. As well as supporting client projects - among recent E&L activity, he is working and commenting on risk-based approaches to E&L requirements that he hopes will form part of an ICH guidance in the not too distant future.

Mike Ludlow, UK

Science Lead, Analytical and Materials Science

Drug Development Solutions

Mike Ludlow is science lead for the analytical and materials science division within Drug Development Solutions (formerly LGC). He is an analytical chemist with over 25 years’ experience in chromatographic and spectroscopic techniques, specialising in the area of extractable and leachable testing and impurity characterisation.

In his current position, Mike provides technical support to operational and commercial colleagues and to an extensive client base, primarily focussed on the pharmaceutical and consumer healthcare sectors. He has presented at numerous international events on topics including extractables and leachables, genotoxic impurity analysis, and experimental design.

Mike is currently on the Register of Specialists for the UK Government Office of Product Safety and Standards (OPSS). He previously worked for ICI Chemicals and Polymers division where he was responsible for the NMR area providing support to the research function at Runcorn in the UK.

Mike holds a BSc Hons in applied chemistry, an MSc in analytical chemistry, and an MBA from Warwick Business School.

Sandi Schaible, US

Sr. Director of Analytical Chemistry and Regulatory Toxicology

WuXi AppTec

With over 30 years’ experience, Sandi Schaible is responsible for oversight and direction of WuXi AppTec’s analytical chemistry and regulatory toxicology departments in St Paul, Minnesota, USA. The analytical staff she manages is responsible for providing custom chemistry testing services including extractables/leachables, materials characterisation and target analysis testing, method development, and method validation, as well as completing risk assessments and biological evaluations.

Sandi received her bachelor's in chemistry from Winona State University, and has experience working in the pharmaceutical, medical device, environmental, and R&D industries, including over 15 years of analytical experience in GLP, GMP, FDA, and ISO regulated laboratories. She provides technical guidance and testing program design, and is an international and US delegate for TC 194, the technical committee for ISO 10993.

Dr. Jianwei Li, US

Chemical Characterisation Consultant & Technical Writer

Chemical Characterization Solutions LLC

Dr. Jianwei Li is currently the principal E&L consultant and chemistry writer at Chemical Characterization Solutions LLC in the areas of E&L evaluation, chemical characterisation, biocompatibility, and compatibility of drug-device combination products. He worked at Medtronic for nearly 16 years as a chemistry subject matter expert and technical fellow. In this role at Medtronic, he worked with a team of analytical chemistry, toxicology, and biology professionals whose primary responsibility includes the application of diverse analytical strategies and methods for the discovery, identification, and quantification of trace constituents in drug-device combination products and medical devices. Foremost among these activities was the initiation and establishment of one of the best analytical laboratories to perform the drug product E&L analysis and medical device chemical characterisation. He also worked for 3M for eight years in its pharmaceutical business. Over the course of his nearly 23-year industry career, he has published extensively in the areas of analytical chemistry with nearly 45 publications and served as frequent scientific reviewers for over 10 international journals.

He received his PhD in analytical chemistry from Purdue University, USA, and did his postdoctoral research at the University of Minnesota, USA.

Dr. Elizabeth Martin, UK

Senior Director, Toxicologist

AstraZeneca

Patricia Parris, UK

Global Risk Assessment Services Toxicologist / Drug Safety Research & Development

Pfizer

Dr. James Vergis, US

Director - Science Research & Innovation

ELSIE Secretariat

Jéssica Marques, UK

Trace Analysis, Extractables and Leachables Scientist

GSK

Dr. Ana Kuschel, DE

Principal Scientific Affairs, Europe

West Pharmaceutical Services Deutschland GmbH & Co. KG

Dr. Roberto Menzel, DE

Head of Extractables Laboratory

Sartorius Stedim Biotech

Dr. Carla Landolfi, IT

Founder & Toxicology Risk Assessor

ToxHub

Dr. Dujuan Lu, US

Manager/Global Leader-E&L

SGS

Markus Obkircher, DE

Director, Research & Development

Merck Life Science

Dr. Atish Sen, US

Senior Scientist

AstraZeneca

Jason Creasey, UK

Managing Director

Maven E&L Ltd

Mike Ludlow, UK

Science Lead, Analytical and Materials Science

Drug Development Solutions

Sandi Schaible, US

Sr. Director of Analytical Chemistry and Regulatory Toxicology

WuXi AppTec

Dr. Jianwei Li, US

Chemical Characterisation Consultant & Technical Writer

Chemical Characterization Solutions LLC

BROCHURE

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What our
participants
are saying

The speaker lineup was great in covering so many diverse issues in E&L. They brought an extraordinary knowledge and experience in the presentation.

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Attendee

I am very keen to continue discussion around the expected ICH Q3E: Guideline for Extractables and Leachables (E&L) with the practitioners and consultants at the #VLEnL May 2023.

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Attendee

Exploring current E&L best practices, the panelists were discussing as well the regulatory trends for drugs and medical devices they see for E&L studies in the future.

The success of the #VLEnL conference is in great organization and accurately defined presentations from the recognized experts in the area of extractables and leachables, providing a clear overlook for the future.

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Attendee