Below for your information is a listing of the 2018 conferences and workshops. Mark your calendar for future IABS conferences, meetings and workshops and watch for future announcements regarding attendance and registration! If you are interested in a conference that was already held, check the IABS website (www.iabs.org) for summary information from the event.

Narcolepsy and Pandemic Influenza Vaccination - an IABS-EU meeting

March 26-27, 2018 - In partnership with Federal Agency for Medicines and Health Products (FAMHP), Belgium

Objectives of the meeting

Influenza Pandemics occur when an influenza strain circulates that humans have been exposed to before. This may lead to widespread circulation and a high case fatality rate.

In 2009 pandemic, several H1N1 vaccines were developed against the new H1N1 virus and were extensively used. In Finland and Sweden an increase in narcolepsy was noted after the mass vaccination with one of these vaccines. Disparate results were seen in other countries with other vaccines. In addition, an increase of narcolepsy has been reported in countries in Asia following wild type influenza infection.

The goal of this meeting is to be prepared for the next pandemic:

  • What are the latest data on the risk of narcolepsy following exposure to 2009 pandemic vaccines?
  • What scientific data are available and what data are lacking to explain the phenomena that was seen in 2009-10?
  • What additional work is needed to prepare for potential use of adjuvanted vaccines for a future pandemic ?

Scientific committee

Steve Black
Co-chair; Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio
Liz Miller
Co-chair; Immunisation Hepatitis and Blood Safety Department, Public Health England, UK z Pieter Neels
IABS, Chair IABS Human Vaccine Committee
Daniel Brasseur
University Libre Bruxelles, Belgium
Christopher Jankosky
FDA Center for Biologics Evaluation and Research (CBER), Silver Spring, Maryland
Kari Johansen
European Centre for Disease Prevention and Control, Solna, Sweden
Brigitte Keller-Stanislavski
Paul-Ehrlich-Institut, Langen, Germany
Emmanuel Mignot
Stanford Center for Sleep Sciences and Medicine, Stanford University, California
Hanna Nohynek
National Institute for Health and Welfare, Helsinki, Finland
Tom Shimabukuro
Immunization Safety Office, Center for Disease Control and Prevention (CDC), Atlanta, Georgia
Lawrence Steinman
Beckman Center for Molecular Medicine, Stanford University, California

4th Cell Therapy Conference: Manufacturing and Testing of Pluripotent Stem Cells

June 5-6, 2018, Los Angeles Airport Marriott Hotel, USA

Objectives of the meeting

The 2018 Cell Therapy conference will identify key unresolved issues that need to be addressed for the manufacture and testing of pluripotent stem cell-based therapies and provide scientific consensus on selected aspects to inform the drafting of future national and international guidance. The meeting will bring together representatives from industry, academia, health services and regulatory bodies.

The overall goal of the conference is to provide the target audience with an appreciation of the importance of a well-controlled manufacturing process for cell therapies that are in development, and to hi-lite specific areas that should be considered during early product development in order to avoid issues in later stages. The target audience includes those individuals and organizations actively pursuing research and development of cell therapies with the intent of achieving pluripotent stem cell therapy products that meets regulatory requirements for approval, thus becoming generally available to treat patients with unmet medical needs.

We will build on previous meetings that generally addressed broader themes of cell therapy studies and manufacturing issues. In addition to reviewing information on the state-of-the-art and recently generated data, this conference ill drill down to key practical issues facing cell therapy developers and regulators to expedite the safe and efficient introduction of new treatments for important diseases where unmet medical needs exist.

More specifically, the conference is expected to provide a basis for new and/or additional guidance on regulatory expectations for developing acceptable pluripotent cell therapy products including testing requirements during manufacture. Concrete conclusions and recommendations will be important outcomes, which are expected to stimulate the field to move forward in a transparent and coordinated manner.

Scientific committee

Abla Creasey
California Institute of Regenerative Medicine (CIRM)
Stephen Lin
California Institute of Regenerative Medicine (CIRM)
Anthony Lubiniecki
International Alliance for Biological Standardization (IABS)
Glyn Stacey
ISCBI
John Petricciani
International Alliance for Biological Standardization (IABS)
Ivana Knezevic
World Health Organization (WHO)
Yoji Sato
National Institute of Health Sciences
Robert Deans
Blue Rock Therapeutics
Kathy Francissen
Genentech
Thorsten Gorba
IQVIA
Elwyn Griffiths
International Alliance for Biological Standardization (IABS)
Karen Hoogendoorn
Leiden University Medical Center
Krish Roy
Bill & Melinda Gates Foundation
Jean-Hugues Trouvin
Université Paris Descartes
Kathy Zoon
NIH

Implementing Nonanimal Approaches to Human and Veterinary Vaccine Testing

October 16-17, 2018 - Natcher Conference Center - NIH - Bethesda, Maryland

Objectives of the meeting

Vaccines improve human and animal health and welfare by preventing the spread of infectious diseases. However, testing to ensure effectiveness and safety of these products often requires the use of large numbers of animals. Technological advances have led to the development of methods that could reduce or eliminate the need for animal testing for vaccines. This workshop will bring together scientific and regulatory leaders from government, academia and industry to develop recommendations to advance alternative methods for human and veterinary rabies vaccine testing. Additional workshop sessions will also spotlight state-of-the-science animal alternatives for other antigens and future possibilities for advancing animal reduction and replacement initiatives.

Scientific committee

CO-CHAIRS
Warren Casey
National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods - NICEATM
Robin Levis
Food & Drug Administration - FDA
Richard Hill
International Alliance for Biological Standardization - IABS
MEMBERS
Juan Arciniega
FDA (retired)
Geetha Srinivas
USDA - CVB
Yvette Diamondidis
Zoetis
Cynthia Allen
Health Canada
Oksana Yarosh
Canadian Food Inspection Agency’s Canadian Centre for Veterinary Biologics - CFIA-CCVB-
Laurent Mallet
Sanofi
Rodney Christmas
Boehringer Ingleheim Animal Health
James Roth
Institute for International - Cooperation in Animal Biologics/ Center for Food Security and Public Health - IICAB/CFSPH
Ray Prasad
Bill & Melinda Gates Foundation
Gautam Sanyal
Bill & Melinda Gates Foundation
Jeffey Brown
People for Ethical Treatment of Animals - International Science Consortium
Laura Viviani
Humane Society International

5th FDA / IABS Sponsored workshop: Statistical Approaches for CMC Development and Lifecycle Management of Biotherapeutics and Vaccines

November 26-28, 2018 - USP - Rockville, Maryland, USA

Objectives of the meeting

Conventional approaches for addressing CMC development and commercial inquiries are hampered by the time and resources necessary to carry out powerful and fully representative studies. These restrictions sometimes result in a failure to appropriately address the study goal, while failing to explore alternative approaches which could lead to better success. In the end, a consequence is a lack in robustness of our manufacturing and control processes, and potential risks to the quality of biotech and vaccines products.

These issues are not unique to CMC, while other pharmaceutical development disciplines have moved forward and embraced alternative approaches for information and decision management. Modeling and simulation as well as Bayesian methods are being employed in bioinformatics and early clinical trials, while “big data” has drawn the attention of the industry. These approaches have been considered and utilized in CMC, but not without cost and effort.

The 5th FDA/IABS sponsored workshop on Statistical Approaches for CMC Development and Lifecycle Management of Biotherapeutics and Vaccines will examine the current and future state of decision making in CMC development and commercial control. Sessions on applications in bioinformatics and early clinical trials as well as training in Bayesian statistics will lay the groundwork for opportunities in CMC. Other sessions will illustrate applications of advanced methods in CMC, including multivariate analysis and advanced DOE. CMC statisticians, process and analytical engineers, and regulators will discuss the hurdles and pathways to adoption of advanced statistical methods to improve CMC development and address commercial challenges.

Scientific committee

Tim Schofield, Chair
GlaxoSmithKline
Stan Altan
J&J
Richard Burdick
Elion Labs
Robert Capen
Merck & Co., Inc.
Katherine Giacoletti
SynoloStats LLC
Kristi Griffeths
Eli Lilly and Company
David LeBlond
CMC Statistics
Ruojia Li
Bristol-Myers Squibb
Tsai-lien Lin
FDA
Chuck Miller
Merck & Co., Inc.
Daniel Obeng
Sanofi
Laura Pack
Seattle Genetics
Jose Ramirez
Amgen
Andrew Rugaiganisa
Pfizer
Meiyu Shen
FDA
Perceval Sondag
Arlenda
Yi Tsong
FDA