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  • Extractables & Leachables Europe
  • Extractables and Leachables USA
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Extractables and Leachables USA 2023

May 17, 2023 – May 18, 2023
Arlington, Virginia

@SmithersELEvent Extractables and Leachables Forum
AGENDA ANNOUNCED!

 

Extractables and Leachables USA 2023 Agenda Announced!

7 Sessions Featuring the Latest Innovations & Advancements

Speakers from SGS, Intertek, Solvias, Novo Nordisk, GSK, PPD, SafeBridge, Sartorius, and More!

Since 2006 Smithers’ Extractables & Leachables USA conference has been supporting the advancements in the E&L industry while keeping the industry informed and up to date on new regulations and testing protocols. This event offers the industry a unique opportunity for E&L experts to gather and discuss the latest updates on regulations, best practices, compliance, case studies, biocompatibility, and more. Attendees network, build beneficial relationships, and hear diverse perspectives on issues facing the E&L industry in both the US and globally, delivering high level insight into the market and global landscape. Join The Mailing List to get the latest updates!


                                       

2023 Sessions Include:

  • E&L Industry Present and Future
  • Extractables and Leachables Study Designs
  • Challenges in Identification and Quantification of Extractables
  • Single Use
  • Medical Devices
  • Material Selection Impact on Extractables Profiles
  • Tox Evaluation

Smithers MSE (Materials Science and Engineering) is a leading authority for extractables and leachables studies, with experts who have a proven track record of developing and delivering comprehensive E&L test plans. The partnership between Smithers E&L laboratories and events combines expert technical knowledge, insight into emerging needs, and market intelligence into a collaboration from which the whole industry benefits.
 



 
Extractables and Leachables Photo  Extractables and Leachables Photo  Extractables and Leachables Photo


2023 Agenda

View Full Agenda
DAY ONE: Wednesday, May 17, 2023 DAY TWO: Thursday, May 18, 2023
7:30am
Registration and Continental Breakfast
8:30am
Session I: E&L Industry Present and Future
11:30am
Session II: Extractbles and Leachables Study Designs
2:00pm
Session III: Challenges in Identification and Quantification of Extractables
3:45pm
Session IV: Single Use
5:30pm
Poster Sessions
6:00pm
Networking Reception
7:30am
Registration and Continental Breakfast
8:30am
Session V: Medical Devices
11:00am
Session VI: Material Selection Impact on Extractables Profiles
1:30pm
Session VII: Session Tox Evaluation
5:00pm
End of Event

2023 Speakers

View all 18 speakers
Dennis Jenke - Triad Scientific Solutions

Dennis Jenke

Chief Executive Scientist at Triad Scientific Solutions
Triad Scientific Solutions
Philippe Verlinde PhD - Nelson Labs Europe

Philippe Verlinde PhD

LC/MS-Expert at Nelson Labs Europe
Nelson Labs Europe
Mac Taylor D.V.M., DABT - SafeBridge Regulatory Life Sciences Group

Mac Taylor D.V.M., DABT

Managing Toxicologist at SafeBridge Regulatory Life Sciences Group
SafeBridge Regulatory Life Sciences Group
Dr. Cheryl Stults - C&M Technical Consulting

Dr. Cheryl Stults

Principal at C&M Technical Consulting
Carsten Worsøe - Novo Nordisk

Carsten Worsøe

Principal Scientist Extractables and Leachables at Novo Nordisk
Novo Nordisk
James M. Vergis, Ph.D. - ELSIE Secretariat

James M. Vergis, Ph.D.

Director Science, Research, & Innovation at ELSIE Secretariat
ELSIE Secretariat

Dennis Jenke

Dennis Jenke
Triad Scientific Solutions
Chief Executive Scientist at Triad Scientific Solutions

Dr. Dennis Jenke is a Baxter Distinguished Scientist in the Technology Resources Division of the Baxter Healthcare Corporation. In this role, he works with a team of analytical chemistry professionals whose primary responsibility includes the development, validation and application of diverse analytical strategies and methods for the discovery, identification and quantification of trace constituents in pharmaceutically relevant solutions and samples.

Philippe Verlinde PhD

Philippe Verlinde PhD
Nelson Labs Europe
LC/MS-Expert at Nelson Labs Europe

Philippe Verlinde, Ph.D. Ir. Senior Scientist - Study Director Dr. Verlinde received his Ph.D. from the Faculty of Bioscience Engineering at the University of Leuven (Belgium) in 2009. He worked as a postdoctoral fellow at the University of Leuven (Bioscience Engineering), conducting research in the field of food technology and analytics.

From 2010 to 2013 he joined the Institute for Reference Materials and Measurements (IRMM) of the European Commission’s Joint Research Centre as a scientific support officer and was involved in several research projects in the field of method standardization (CEN, ISO), proficiency testing and regulatory aspects of environmental pollutants and food safety. Due to his background he has gained a strong expertise in analytical chemistry, especially in the field of structural elucidation techniques (NMR, MS), method development and validation, trace analysis by chromatography (GC & LC) hyphenated to mass spectrometry (small molecules). In 2013 he joined Toxikon Europe as an analytical expert and study director at the Pharma Department, focusing on impurity identification projects.

Since 2016 he is acting as a senior scientist in the R&D team at Nelson Labs Europe and is involved in automation projects and the development of state-of-the art analytical services related to extractables and leachables studies for the pharmaceutical and medical device industries.

Mac Taylor D.V.M., DABT

Mac Taylor D.V.M., DABT
SafeBridge Regulatory Life Sciences Group
Managing Toxicologist at SafeBridge Regulatory Life Sciences Group

Mac is a Managing Toxicologist for SafeBridge Regulatory Life Sciences Group and has over 16 years’ experience in pharmacology and toxicology as a researcher, study monitor, and consultant. He has been involved in the toxicological assessment extractable and leachable studies since 2010. Mac is certified by the American Board of Toxicology and holds a D.V.M. from the North Carolina State University, College of Veterinary Medicine

Dr. Cheryl Stults

Dr. Cheryl Stults
Principal at C&M Technical Consulting

Dr. Stults is Principal at C & M Technical Consulting, LLC, working with various local and global companies to advance the development of parenteral and inhalation products. Her primary area of focus is on device and packaging materials analysis and characterization for purposes of selection, qualification and control. She holds a Ph.D. in Analytical Chemistry from Michigan State University and a Masters in Management from Aquinas College. Prior positions include: Senior Fellow at Novartis Pharmaceuticals Corporation, Assistant Research Professor at San Francisco State University and Quality Associate at a Johnson & Johnson owned company. She was co-editor of the Leachables and Extractables Handbook (Wiley 2012) and has been a member of the Board of Directors for two consortia: Extractables and Leachables Safety Information Exchange (ELSIE) and International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS). She has been actively involved in the ELSIE Pilot Protocol Study and database development. She previously led IPAC-RS working groups to develop Materials Baseline Requirements for OINDP, a Leachables and Extractables Development Paradigm and a Chemical Risk Evaluation tool and has continued involvement as an IPAC-RS Science Advisor participating in global outreach and materials related initiatives. Dr. Stults is currently a USP Packaging and Distribution Expert Committee member contributing to development and revision of materials-related chapters.

Carsten Worsøe

Carsten Worsøe
Novo Nordisk
Principal Scientist Extractables and Leachables at Novo Nordisk

Carsten Worsøe is a research scientist in an analytical development department at Novo Nordisk. In over 18 years at Novo Nordisk, his main responsibility has been to develop analytical methods for L&E test procedures of new packaging/container closure systems under development. Within Novo Nordisk Carsten has been one of the main actors to bring relevant people in packaging materials, toxicology, formulation, regulatory and analytical together to perform risk assessments and strategies for L&E testing in development projects.

James M. Vergis, Ph.D.

James M. Vergis, Ph.D.
ELSIE Secretariat
Director Science, Research, & Innovation at ELSIE Secretariat

Jamie is a Director in the law firm of Faegre Drinker Biddle and Reath, LLP providing scientific and strategic consulting services to individual clients and various Pharmaceutical and Biotechnology consortia. He is particularly adept at helping clients streamline the development of new technology and data-sharing processes. As a scientist whose work has touched on various fields of study, Jamie is passionate about helping his clients cultivate new scientific knowledge and drive public policy changes that enhance the drug-development process. Within ELSIE, Jamie is one of the members of the ELSIE Secretariat. He is primarily responsible for the Knowledge Base project and data sharing initiatives currently underway in the consortium. Jamie has a BSc in biochemistry with a minor in computer science from SUNY Geneseo and a PhD in molecular biophysics and biochemistry from Yale University.

2023 Sponsors

View all 13 sponsors
Boston Analytical
EKG Labs / Infinity Laboratories
Instem
Intertek
Namsa
PPD®

Boston Analytical

Boston Analytical
https://bostonanalytical.com/
Boston Analytical is a cGMP compliant, FDA/DEA registered, ISO/IEC-17025:2005 certified analytical laboratory located in Salem, NH. Boston Analytical provides testing services to Pharmaceutical, Biopharmaceutical and Medical Device companies worldwide including Analytical Testing and Method Development, Microbiological Testing and Environmental Monitoring Services, Biologics, Stability Testing & ICH-compliant Storage, Impurities Testing and Extractables & Leachables Studies.

EKG Labs / Infinity Laboratories

EKG Labs / Infinity Laboratories
https://www.ekglabs.com/
EKG Labs is an analytical laboratory that supports medical device and pharmaceutical companies seeking to fast-track their product development. We excel at providing analytical and regulatory services which enable our clients to fulfill complex regulatory requirements and bring their product to market faster. EKG Labs leverages its wealth of medical device and pharmaceutical knowledge to provide a variety of research and development services including:
  • Extractables and Leachables
  • ISO 10993 Chemical Characterization
  • Impurity Identification
  • Elemental Impurities
  • Method Development
  • Method Validation

Instem

Instem
https://www.instem.com/solutions/insilico/predict.php
Instem - Technology Solutions & Outsourced Services for Computational Toxicology

Our leading computational toxicology products and services, originally developed by Leadscope Inc., and now part of the Instem solution portfolio, are helping organizations around the globe to unlock valuable knowledge contained in both public and proprietary sources of research data.

Our computational toxicology solutions support a variety of applications including the ICH M7 pharmaceutical impurities guideline, assessment of extractables and leachables, and classification and labelling.

Leadscope Model Applier: Easy-to-use software to apply prediction models, perform an expert review, and create insightful reports.

Predict™ In Silico Tox Service
A technology-enabled service delivering fast, efficient, comprehensive in silico toxicology predictions

Intertek

Intertek
https://www.intertek.com/pharmaceutical/analysis/whitehouse-nj/
Intertek’s global network of laboratories is designed to exceed our customers' expectations with innovative Assurance-Testing-Inspection-Certification services for their operations and supply chain.  Our Whitehouse NJ laboratory is an FDA and DEA registered cGMP compliant facility with expertise in Method Development/Validation, Stability, Trace Organics, Elemental Impurities, and QC Testing.

Namsa

Namsa
https://namsa.com/
The World’s Leading MedTech CRO Offering Global End-to-End Development Services.
 
Driven by our regulatory expertise and in-depth therapeutic knowledge, NAMSA has assisted thousands of MedTech Sponsors make a positive impact to healthcare since 1967. Today, our team of global Associates delivers market-leading Contract Research Organization (CRO) services to Clients in all major markets of the world. NAMSA provides unparalleled medical device testing capabilities, strategic guidance and tactical support to fast-track market introduction and commercialization. From concept to post-market, we are proud to fully support Clients through the delivery of exceptional outcomes throughout every stage of the MedTech development continuum.

PPD®

PPD®
https://www.ppd.com/our-solutions/ppd-laboratories/

PPD, part of Thermo Fisher Scientific, is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development and optimize value in delivering life-changing therapies to improve health.
 
The dedicated and highly specialized extractables and leachables (E&L) team in the PPD® Laboratories GMP lab has more than 15 years of experience providing full-program support for all aspects of E&L studies, including overall study design/consulting, container/closure selection as well as manufacturing process qualification and validation. Our E&L team and toxicology experts work with clients to make informed decisions on which extractable compounds will be monitored as leachables in long-term stability studies, development of extractable and leachable methods, leachable stability testing, batch extractables testing and USP compendia testing support.

Twitter: @PPDCRO

Advisory Board

View all 9 board members
Dennis Jenke - Triad Scientific Solutions

Dennis Jenke

Chief Executive Scientist at Triad Scientific Solutions
Triad Scientific Solutions
Dr. Cheryl Stults - C&M Technical Consulting

Dr. Cheryl Stults

Principal at C&M Technical Consulting
Carsten Worsøe - Novo Nordisk

Carsten Worsøe

Principal Scientist Extractables and Leachables at Novo Nordisk
Novo Nordisk
Nick Morley - Element Materials Technology

Nick Morley

Principal Scientist at Element Materials Technology
Element Materials Technology
Ron Brown - Risk Science Consortium, LLC & US FDA (Retired)

Ron Brown

Toxicologist at Risk Science Consortium, LLC & US FDA (Retired)
Patricia Parris - Pfizer

Patricia Parris

Global Risk Assessment Services Toxicologist, Drug Safety Research & Development at Pfizer
Pfizer

Dennis Jenke

Dennis Jenke
Triad Scientific Solutions
Chief Executive Scientist at Triad Scientific Solutions

Dr. Dennis Jenke is a Baxter Distinguished Scientist in the Technology Resources Division of the Baxter Healthcare Corporation. In this role, he works with a team of analytical chemistry professionals whose primary responsibility includes the development, validation and application of diverse analytical strategies and methods for the discovery, identification and quantification of trace constituents in pharmaceutically relevant solutions and samples.

Dr. Cheryl Stults

Dr. Cheryl Stults
Principal at C&M Technical Consulting

Dr. Stults is Principal at C & M Technical Consulting, LLC, working with various local and global companies to advance the development of parenteral and inhalation products. Her primary area of focus is on device and packaging materials analysis and characterization for purposes of selection, qualification and control. She holds a Ph.D. in Analytical Chemistry from Michigan State University and a Masters in Management from Aquinas College. Prior positions include: Senior Fellow at Novartis Pharmaceuticals Corporation, Assistant Research Professor at San Francisco State University and Quality Associate at a Johnson & Johnson owned company. She was co-editor of the Leachables and Extractables Handbook (Wiley 2012) and has been a member of the Board of Directors for two consortia: Extractables and Leachables Safety Information Exchange (ELSIE) and International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS). She has been actively involved in the ELSIE Pilot Protocol Study and database development. She previously led IPAC-RS working groups to develop Materials Baseline Requirements for OINDP, a Leachables and Extractables Development Paradigm and a Chemical Risk Evaluation tool and has continued involvement as an IPAC-RS Science Advisor participating in global outreach and materials related initiatives. Dr. Stults is currently a USP Packaging and Distribution Expert Committee member contributing to development and revision of materials-related chapters.

Carsten Worsøe

Carsten Worsøe
Novo Nordisk
Principal Scientist Extractables and Leachables at Novo Nordisk

Carsten Worsøe is a research scientist in an analytical development department at Novo Nordisk. In over 18 years at Novo Nordisk, his main responsibility has been to develop analytical methods for L&E test procedures of new packaging/container closure systems under development. Within Novo Nordisk Carsten has been one of the main actors to bring relevant people in packaging materials, toxicology, formulation, regulatory and analytical together to perform risk assessments and strategies for L&E testing in development projects.

Nick Morley

Nick Morley
Element Materials Technology
Principal Scientist at Element Materials Technology

Nick is a Principal Scientist at Hall Analytical Laboratories responsible for providing technical support to new and existing pharma, med device and ENDs customers in the field of extractables and leachables. Nick’s area of expertise includes E&L study design, defining E&L strategies, performing leachable risk assessments and authoring E&L regulatory sections.

Prior to joining Hall, Nick spent over 10 years at GSK in the field of extractables and leachables. During this time, he worked on a range of therapeutic areas including inhalation, topical and parenteral. Where he had responsibility for the E&L assessment of devices, closure systems and manufacturing processes to ensure patient safety, product quality and regulatory approval.

Ron Brown

Ron Brown
Toxicologist at Risk Science Consortium, LLC & US FDA (Retired)

Ron Brown is a toxicologist with 35 years of experience in regulatory toxicology and risk assessment. He recently retired from the US FDA after 25 years of service and currently directs a small company, Risk Science Consortium, LLC, that provides consultation and training in toxicological risk assessment and computational toxicology. At the FDA, Ron was the senior toxicologist responsible for developing and reviewing toxicological risk assessments of extractable and leachable (E&L) compounds from medical devices. Prior to his position at the US FDA, Ron served as a Senior Associate at the ILSI Risk Science Institute. He is founding member and former President of the Medical Device and Combination Products Specialty Section of the Society of Toxicology and former President of the Dose-Response Specialty Section of the Society for Risk Analysis.

Patricia Parris

Patricia Parris
Pfizer
Global Risk Assessment Services Toxicologist, Drug Safety Research & Development at Pfizer

Trish 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, extractable and leachable, and contamination risk assessments. In recent years, Trish participated in ICH M7 working group to develop Appendix 3 and co-authored 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.

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