Still Shaping the Present and Future of Endotoxin Testing 2 nd Global Endotoxin Testing Summit

Transcription

1 Pharma&Biotech Still Shaping the Present and Future of Endotoxin Testing 2 nd Global Endotoxin Testing Summit May 2016 Annapolis, MD and Pickering Beach, DE

2 Join Lonza s 2 nd Global Endotoxin Testing Summit 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 During this summit attendees will interact with peers and regulators to discuss the current status of industry hot topics, like Low Endotoxin Recovery 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 May 2016 Annapolis Marriott Waterfront Hotel 80 Compromise Street Annapolis, MD Phone (International): Toll-free (US): and Pickering Beach Dover, DE 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

3 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, Biologics, 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 Parenteral 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 member for the annual PDA/FDA Joint Regulatory Conference in Washington, DC. Allen served as the Chair for this meeting in Jay Bolden, Eli Lilly and Company, Associate Senior Consultant Biologist Mr. Jay Bolden is an Associate Senior Consultant Biologist in the Eli Lilly and Company Global Quality Laboratories. He is an internal endotoxin subject matter expert and leads a team with global QC oversight for developing, validating, transferring and troubleshooting endotoxin, microbiology, QPCR and ELISA methodologies. Jay holds a B.S. in Biology and an Environmental Studies certificate from Indiana University, and has over 16 years of industry experience in development, process and laboratory microbiology, and microbiology laboratory leadership. 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 He joined Sanofi Pasteur in 1997 as QC Bacteriology manager in Industrial Operation. He joined the Analytical Research and Development Department in 2004 and since that time he worked in the development, validation and the implementation of Microbiology alternative methods based on bacteriology and molecular biology for commercialized products and clinical products. He is currently Microbiology Platform Leader in Analytical R&D and recently part of the USP expert panel in Modern Microbiological Methods (MMM). 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 Research and Development, Quality Control and Regulatory Affairs departments. She holds a Ph.D. from Tulane University and has over 20 years experience working in FDA regulated environments. She currently is responsible for ensuring regulatory compliance at ACC. Glenn Gauvry, Ecological Research & Development Group Inc., Founder and Director Glenn Gauvry is the founder and director of the Ecological 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 growing economy through healthy partnerships between government, industry, environmental groups and communities, therefore works to inspire and assist individuals and organizations to solve problems, change behaviors and promote sound decisions.

4 Tarik Khan, Ph.D., Hoffman-La Roche Ltd., Basel, Switzerland Tarik is currently a group leader in late-stage pharmaceutical and processing development at F. Hoffman-La Roche Ltd. in Basel, Switzerland, where market formulation development is one key component of his role. He holds a Ph.D. in chemical engineering from The University of Texas at Austin. Tarik then became a Whitaker 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 understanding the mechanistic drivers of LER. 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 Nguyen, Spectra Laboratories 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 laboratory. Laurent helped transition use of Tecan and Lonza instrumentation from one LIMS system to another. He worked with Lonza and laboratory programmers to increase automation and reduce reliance on physical printouts. 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 Endotoxin Recovery issues associated with product matrices 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 Medical Technology degree. She also holds an MS in Clinical Chemistry. Johannes Reich, University Regensburg, Germany Ph.D. Student Johannes is a PhD student at University Regensburg, Germany whose research efforts focus on the aggregation and interaction behavior of Lipopolysaccharides, 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 liquidliquid Extraction systems at the Institut de Chimie Séparative de Marcoule in France. Mr. Max Tarkhanov, TEVA Microbiological Lab Section Manager Max is currently the Microbiological Lab Section Manager 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, Israel site in 2002, and became their resident specialist in the Bacterial Endotoxin Test. * The full agenda and further speakers will soon be announced on 4

5 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 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 Your Contact for Questions and Additional Information Lakiya Wimbish Marketing Product Manager, Endotoxin Detection Lonza Pharma&Biotech Bioscience Solutions Phone: [email protected] Contact Information North America Customer Service: (toll free) [email protected] Scientific Support: (toll free) [email protected] Europe Customer Service: [email protected] Scientific Support: [email protected] International Contact your local Lonza distributor Customer Service: Fax: [email protected] International Offices Australia Belgium China Brazil France (toll free) Germany (toll free) India Japan Luxemburg Singapore The Netherlands (toll free) United Kingdom (toll free) Lonza Walkersville, Inc. Walkersville, MD All trademarks belong to Lonza or its affiliates or to their respective third party owners. The information contained herein is believed 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 expressed or implied concerning the use of these products. The buyer assumes all risks of use and/or handling. Any user must make his own determination and satisfy himself that the products supplied 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 infringe any third party s intellectual property rights Lonza. All rights reserved. RT-BR017 05/16 Pharma&Biotech 2 nd Global Endotoxin Testing Summit 2016