Pharma&Biotech
Still
Shaping the Present and
Future of Endotoxin Testing
2
nd
Global Endotoxin Testing Summit
23 – 25 May 2016
Annapolis, MD and Pickering Beach, DE United States of America
Pharma&Biotech –2nd Global Endotoxin Testing Summit 2016
Lonza, a leading expert and provider of high quality endotoxin detection products to the pharmaceutical and medical device industries, is pleased to invite you to attend its second global Endotoxin Testing Summit 2016. During this summit attendees will interact with peers and regulators to discuss the current status of industry hot topics, like Low Endotoxin Re-covery and hold-time studies, as well as recent updates on regulatory guidelines related to endotoxin testing. Included with registration is a trip to a horseshoe crab sanctuary beach (Pickering Beach, DE) to help save horseshoe crabs that have been stranded during spawning
23 – 25 May 2016
Annapolis Marriott Waterfront Hotel
80 Compromise Street – Annapolis, MD 21401 United States of America
Phone (International): +1 410 268 7555 Toll-free (US): +1 888 773 0786 and
Pickering Beach
Dover, DE 19901 United States of America
Join Lonza’s 2
nd
Global
Endotoxin Testing Summit
Preliminary Agenda and
Topics Discussed
Sunday, 22 May 2016
Welcome Reception
Monday, 23 May 2016
The Pharmaceutical/Biomedical Industries Role in Horseshoe Crab Conservation
Low Endotoxin Recovery (LER) & Product Hold-time Studies
– Understanding the Limulus Amebocyte Lysate and Rabbit Pyrogen Tests for Low Endotoxin Recovery Studies
– Variability in Reactivity and Recovery of Endotoxin Sources – Formulation Effects on LPS Structure and Low Endotoxin Recovery – Use of Naturally Occurring Endotoxin (NOE) in Product Hold-time Studies
– Understanding and Overcoming LER – Regulatory Thoughts and Perspective
Ways to Improve Your Current Endotoxin Test Method
– Life Cycle Management of the K-QCL Assay
– The recombinant Factor C Alternative Endotoxin Method: Primed for the Big Time
– Inhibition and Enhancement of the LAL Test
Tuesday, 24 May 2016
Save the Crab
– Crab-flipping activity: trip to “Horseshoe Crab Beach”
(Pickering Beach, DE) to help save horseshoe crabs that have been stranded during spawning
Wednesday, 25 May 2016
Future Testing Considerations
– Laboratory Automation - A Case for More Manageable Endotoxin Testing
– Understanding Data Integrity in the QC Laboratory – USP Update on Depyrogenation and Sterilization Chapter
Ask the Speakers Summit Wrap-Up
Speaker Biographies*
Allen L. Burgenson, Lonza Walkersville, US Manager Regulatory Affairs
Allen has over 30 years of experience in industries regulated by the FDA, including Foods, Drugs, Biolog-ics, Medical Devices, and Cosmetics. He has worked in R&D, QC, QA and Regulatory Affairs.
Allen is involved in several scientific organizations including, the Horseshoe Crab Advisory Panel for the Atlantic States Marine Fisheries Commission (ASMFC) and President of the Capital Area Chapter of the Paren-teral Drug Association (PDA). He is not only involved in PDA activities on the local, national, and international level, but also served as a Program Committee mem-ber for the annual PDA/FDA Joint Regulatory Confer-ence in Washington, DC. Allen served as the Chair for this meeting in 2004.
Glenn Gauvry, Ecological Research & Development Group Inc., Founder and Director
Glenn Gauvry is the founder and director of the Ecolog-ical Research & Development Group Inc., a nonprofit organization established in 1995, whose mission is the conservation of the world’s four horseshoe crab species. Mr. Gauvry is also a founding member of the IUCN Horseshoe Crab Specialist Group. ERDG believes environmental stewardship can thrive within a grow-ing economy through healthy partnerships between government, industry, environmental groups and communities, therefore works to inspire and assist in-dividuals and organizations to solve problems, change behaviors and promote sound decisions.
Thierry Bonnevay, Sanofi Pasteur, Microbiology Platform Leader in Analytical R&D
Thierry obtained his Pharm. D pharmacist with special degree in Industrial Pharmaceutical Microbiology in 1996. He joined Sanofi Pasteur in 1997 as QC Bacte-riology manager in Industrial Operation. He joined the Analytical Research and Development Department in 2004 and since that time he worked in the develop-ment, validation and the implementation of Microbiol-ogy alternative methods based on bacteriolMicrobiol-ogy and molecular biology for commercialized products and clinical products. He is currently Microbiology Plat-form Leader in Analytical R&D and recently part of the USP expert panel in Modern Microbiological Methods (MMM).
Jay Bolden, Eli Lilly and Company, Associate Senior Consultant Biologist
Mr. Jay Bolden is an Associate Senior Consultant Biolo-gist in the Eli Lilly and Company Global Quality Labo-ratories. He is an internal endotoxin subject matter expert and leads a team with global QC oversight for developing, validating, transferring and troubleshoot-ing endotoxin, microbiology, QPCR and ELISA meth-odologies. Jay holds a B.S. in Biology and an Environ-mental Studies certificate from Indiana University, and has over 16 years of industry experience in develop-ment, process and laboratory microbiology, and micro-biology laboratory leadership.
Jennifer Farrington, Ph.D., Associates of Cape Cod, Inc., Quality Control and Regulatory Affairs
Dr. Jennifer Farrington has been with Associates of Cape Cod, Inc. for over 10 years working in the Re-search and Development, Quality Control and Regu-latory Affairs departments. She holds a Ph.D. from Tulane University and has over 20 years experience working in FDA regulated environments. She current-ly is responsible for ensuring regulatory compliance at ACC.
4
Pharma&Biotech –2nd Global Endotoxin Testing Summit 2016
Cheryl Platco, Merck & Co., West Point, PA Principal Scientist, Merck Research Laboratories, Analytical Sciences
Ms. Platco has been involved with endotoxin testing for 29 years and has been employed with Merck & Co. for 30 years. She has experience with all major U.S. LAL vendors. She performs testing for pharmaceutical, vaccine, biological, and monoclonal products as well as a variety of raw materials, active ingredients, and culture media. She has been involved with Low Endo-toxin Recovery issues associated with product matri-ces and participates in the PDA LER Task Force and the BPOG LER task Force as well as the PMF LAL User Group.
Ms. Platco holds a B.S. in Chemistry/Biology and Medi-cal Technology degree. She also holds an MS in CliniMedi-cal Chemistry.
Johannes is a PhD student at University Regensburg, Germany whose research efforts focus on the aggre-gation and interaction behavior of Lipopolysaccha-rides, as well as the related activity in limulus based detection systems.
He previously received his Master of Chemistry at the University of Regensburg. In this role he worked on the Supramolecular Approach of Synergistic liquid-liquid Extraction systems at the Institut de Chimie Séparative de Marcoule in France.
Johannes Reich, University Regensburg, Germany Ph.D. Student
Tarik Khan, Ph.D., Hoffman-La Roche Ltd., Basel, Switzerland
Tarik is currently a group leader in late-stage pharma-ceutical and processing development at F. Hoffman-La Roche Ltd. in Basel, Switzerland, where market formu-lation development is one key component of his role. He holds a Ph.D. in chemical engineering from The Uni-versity of Texas at Austin. Tarik then became a Whita-ker International Postdoctoral Scholar at ETH Zurich. Prior to his current position, he was a postdoctoral fellow working with the University of Basel and Roche, where one of his projects was focused on understand-ing the mechanistic drivers of LER.
* The full agenda and further speakers will soon be announced on www.lonza.com/endosummit.
Mr. Max Tarkhanov, TEVA
Microbiological Lab Section Manager
Max is currently the Microbiological Lab Section Man-ager for Teva Pharmaceuticals Industries in Israel and a graduate of Tel-Aviv University with a degree in Life Sciences (Biology). He joined the Teva - Kfar Saba, Is-rael site in 2002, and became their resident specialist in the Bacterial Endotoxin Test.
Laurent Nguyen, Spectra Laboratories
Robert Lutskus, Lonza Walkersville, US Global Product Delivery Manager
Robert Lutskus is the Global Product Delivery Manager for the Lonza Informatics group which includes the MODA™ EM and WinKQCL™ Software. He has worked in Quality Control microbiology for over 15 years and with Quality Systems for more than 10 years.
Laurent worked at Spectra Laboratories using Tecan Freedom Evo 150 for over 5 years. Spectra uses Lonza Endotoxin and Limulus Amebocyte Lysate to perform over 20,000 tests a month in the West Coast labora-tory.
Laurent helped transition use of Tecan and Lonza in-strumentation from one LIMS system to another. He worked with Lonza and laboratory programmers to increase automation and reduce reliance on physical printouts.
www.lonza.com
www.lonza.com/endosummit
Contact Information
North America
Customer Service: +1 800 638 8174 (toll free) [email protected]
Scientific Support: +1 800 521 0390 (toll free) [email protected] Europe Customer Service: +32 87 321 611 [email protected] Scientific Support: +32 87 321 611 [email protected] International
Contact your local Lonza distributor Customer Service: +1 301 898 7025 Fax: +1 301 845 8291 [email protected] International Offices Australia + 61 3 9550 0883 Belgium + 32 87 321 611 China + 86 21 6340 3488 Brazil + 55 11 2069 8800 France 0800 91 19 81 (toll free) Germany 0800 182 52 87 (toll free) India + 91 22 4342 4000 Japan + 81 3 6264 0660 Luxemburg +32 87 321 611 Singapore + 65 6521 4379
The Netherlands 0800 022 4525 (toll free) United Kingdom 0808 234 97 88 (toll free)
Lonza Walkersville, Inc. – Walkersville, MD 21793
All trademarks belong to Lonza or its affiliates or to their respec-tive third party owners. The information contained herein is belie-ved to be correct and corresponds to the latest state of scientific and technical knowledge. However, no warranty is made, either expressed or implied, regarding its accuracy or the results to be obtained from the use of such information and no warranty is ex-pressed or implied concerning the use of these products. The bu-yer assumes all risks of use and/or handling. Any user must make his own determination and satisfy himself that the products sup-plied by Lonza Group Ltd or its affiliates and the information and recommendations given by Lonza Group Ltd or its affiliates are (i) suitable for intended process or purpose, (ii) in compliance with environmental, health and safety regulations, and (iii) will not in-fringe any third party’s intellectual property rights.
© 2016 Lonza. All rights reserved. RT-BR017 05/16
Summit and Activity Fee
$1300 for registrations received by 31 March 2016 $1500 for registrations received after 31 March 2016 Academic and Government discounts are available.
The group rate is $209 per night for reservations made by 31 March 2016. For reservations made through 31 March 2016, Lonza can book the hotel reservation for you and provide you with the confirmation number. At check-in, you will provide the hotel with your form of payment. You may also contact the hotel directly to make a reservation. After 31 March 2016, room space and rate will be based upon availability.
Registration
The registration fee includes participation in the summit, meals throughout the course of the meeting and associated activity, as well as travel to and from Pickering Beach, DE. Registration fee does not cover costs for travel to the summit venue or attendee hotel accommodations.
Please use our online registration form on www.lonza.com/endosummit.
Your Contact for Questions and
Additional Information
Lakiya Wimbish
Marketing – Product Manager, Endotoxin Detection Lonza Pharma&Biotech – Bioscience Solutions Phone: +1 301 378 1556
