6th IABS Statistics Workshop:
Approaches for Improving Statistical Partnership in CMC Development,
Manufacturing, and Regulation of Biologicals

U.S. Pharrmacopeia
Rockville, Maryland

Due to restrictions associated with the SARS-COVID-2 pandemic,
the 6th IABS Statistics Workshop was held virtually.

An Update on SARS-CoV-2
Friday, October 16,
2020
14:00-16:00 CEST

The first IABS webinar (May 27th) provided insight into what was known at that point in time about SARS-CoV-2:
the epidemiology worldwide; the disease from an immunology viewpoint and the development of vaccines against the virus.


This 3rd International Alliance for Biological Standardization COVID-19 webinar brought together a broad range of
international stakeholders, including academia, regulators, funders and industry, with a considerable delegation
from low- and middle-income countries, to provide an update on
the virology, epidemiology and immunology of, and the vaccine development for SARS-CoV-2,
six months after the previous webinar.

 Although SARS-CoV-2 shows limited evolution, which is beneficial for vaccine development,
recombination of SARS-CoV-2 with another CoV has led to enhanced human-to-human transmissibility of the virus.


Read the Meeting Report

Read the Summary

 

IABS Webinar
SARS-CoV-2
Controlled Human Infection Models (CHIM):
Ethics, Challenge Agent
Production, and Regulatory Issues
June 23rd, 2020 : 14:00-18:00 CEST

 IABS has been asked to organize several webinars in order to share scientific information on SARS-CoV-2.

The first IABS webinar (Wednesday May 27th,14:00-16:00 CEST)  provided an insight to what was known to date about
the epidemiology worldwide, the disease from an immunology viewpoint and progress regarding the development of vaccines against the virus.

The second IABS SARS CoV-2 webinar was devoted to the use of controlled human infection models (CHIM) to accelerate development and market authorization assessment of vaccines against the virus. The webinar consisted of four brief presentations to set the stage, followed by three panel discussions on ethics, challenge agent production
and quality control issues (CMC) and regulatory issues, and provided ample time for discussion between panelists and participants.
The webinar was organized under the Chatham House Rule (https://www.chathamhouse.org): participants are free to use the information received, but neither the identity nor the affiliation of the speaker(s), nor that of any other participant, may be revealed.

The next IABS SARS CoV-2 webinar: Friday, October 16, 2020.

Read the Meeting Report

IABS Webinar
Update on SARS-CoV-2
May 27th,  2020 : 14:00 CEST

IABS has been asked to organize several webinars in order to share scientific information on SARS-CoV-2.

As science is evolving day after day, it is important for many people to have an overview of the actual knowledge at a specific moment in time.

The first IABS webinar that took place Wednesday May 27th from 14:00-16:00 CEST gave you an insight to what is known about SARS-CoV-2, the epidemiology worldwide, the disease from an immunology viewpoint and where we are today with the development of vaccines against the virus.

This webinar is the first in a series of webinars to inform our network on what is known about the virus, the disease, and how to cope with it.

 Read the Meeting Report

The recording of the webinar is available below:

 New paths for sustainable solutions to tackle global and emerging infectious threats

Read the Meeting Report

 IABS celebrated its 65th Anniversary on February 26-28, 2020, in Lyon, France.

3rd Human Challenge Trials in Vaccine Development

Read the Meeting Report

 
 

5th IABS Cell Therapy Conference
Towards international convergence of basic technical requirements
and evaluation of human cell therapy products

Muromachi Mitsui Hall & Conference
Tokyo, Japan
Organized by: International Alliance for Biological Standardization (IABS)

With the support from: Osaka University Graduate School of Medicine

 

Animal Testing for Vaccines
Implementing Replacement, Reduction and Refinement:

Challenges and Priorities

Information about the meeting here

View the Speaker Slides

Read the Meeting Report



2nd Setting Specifications for Biological Products: A Pathway to Harmonization

Information about the meeting here

2nd Conference on Next Generation Sequencing
for Adventitious Virus Detection in
Human and Veterinary Biologics

An IABS-EU Meeting

Read the Meeting Report

 

Quality Requirements for Challenge Agents
An IABS-EU Meeting

Read the Meeting Report 

Towards Rabies Elimination in Asia-Pacific – From Theory to Practice

 

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Meeting objectives
The meeting aims at snowballing efforts and achieving substantial progress in rabies control in the Asia-Pacific region of the world in the near future. As the key focus is placed on canine rabies the meeting will be an important contribution to the initiative of the United Against Rabies collaboration of the World Health Organization (WHO), World Organisation for Animal Health (OIE), Food and Agriculture Organization of the United Nations (FAO), and Global Alliance for Rabies Control (GARC) of ending human dog-mediated rabies by 2030. Recognized international and local experts will give insights into state-of-the art intersectoral One Health approaches, standards, available tools and guidelines developed by international organizations and institutions and best-practice examples from the region on how to prevent human rabies by eliminating rabies at its animal source. As such the meeting provides a platform for health and veterinary services, managers of national and local rabies eliminations programs, researchers and other people interested in advancing knowledge of rabies surveillance, prevention and control, to meet each other, to share their experience and also to discuss challenges to overcome. The meeting is considered to be a starting point for a continuous professional exchange on the way to a rabies free Asia-Pacific.

Scientific Committee :

Dr Charung Muangchana Director, National Veterinary Institute, Thailand
Dr Karoon Chanachai, Department of Livestock Development (DLD), Thailand
Dr Thomas Müller, Chair Friedrich-Loeffler-Institut, Germany
Dr Conrad Freuling, Friedrich-Loeffler-Institut, Germany
Dr Bernadette Abela-Ridder, World Healandh Organization
Dr Ivana Knezevic, World Health Organization
Dr Gregorio Torres, World Organization for Animal Health (OIE)
Dr Katinka de Balogh, Food and Agricultural Organization of the UN (FAO)
Dr Carmen Jungbäck, International Alliance for Biological Standardization (IABS)
Dr Gowri Yale, Mission Rabies
Prof. Louis Nel,Global Alliance for Rabies Control
Dr Ryan Wallace, Centres for Disease Control and Prevention, USA

 

Workshop on
Diagnostics in the Veterinary Field:
The Role in Health Surveillance and Disease Identification

A workshop focusing on advantages / benefits and disadvantages
and gaps of the current methods and methodologies

Read the Meeting Report

 

 

Workshop: Implementing Non-animal Approaches to Human and Veterinary Vaccine Testing:
Achieving Scientific and Regulatory Success for Rabies and Beyond
October 16-17, 2018
National Institutes of Health, Bethesda, Maryland

 Read the Meeting Report

 

The workshop agenda as well as speaker and poster abstracts are included in the e-book. The e-book and speaker slides are posted on the web (e-book* and slides**).

5th Statistical Approaches for CMC Development and
Lifecycle Management of Biotherapeutics and Vaccines

  November 26-28, 2018
Venue: US Pharmacopeia
Rockville, Maryland

Objectives

This meeting is to bring together regulators and scientists to discuss statistical approaches used to help develop and manage processes, which ensure the quality and availability of biotherapeutics and vaccines. Speakers and panel members will engage with meeting participants on challenges and solutions related to CMC development and lifecycle management of biologics.   Areas of attention will include Quality by Design in process and analytical development,  comparability and biosimilarity, stability study design and analysis, validation, and continuous process and analytical verification.  Statistical challenges related to introduction of new technologies and Big Data will be discussed.  Special emphasis will be devoted to collaboration and communication, between scientists and statisticians as well as industry and regulators.  The meeting will bring experts together to discuss the issues and through roundtables attempt to reach conclusions that will add value to global public health.

 

Narcolepsy and Pandemic Influenza Vaccination
What we know and what we need to know before the next Pandemic
March 26-27, 2018
Eurostation II, Place Victor Horta
Brussels, Belgium

In partnership with
Federal Agency for Medicines and Health Products (FAMHP)
Vaccine Center of Excellence

This meeting was held under Chatham House Rule

Read the Meeting Report

Influenza Pandemics occur when an influenza strain circulates that humans have not 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 ? 

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

   Organized by
The International Alliance for Biological Standardization - IABS
with support from and in collaboration with the
California Institute for Regenerative Medicine - CIRM
Los Angeles, Cal
ifornia
June 5-6, 2018

Read the Meeting Report

Objectives and Expected Outcomes

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 highlight 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.

Autogenous Vaccines and Their Role
in Animal Health Strategy

September 25-26, 2017
Venue: Het Pand, University of Ghent
Co-organized by IABS-EU and University of Ghent / PROVAXS

 

 

The purpose of this conference is to start from an overview on the current situation and needs from the perspective of regulators, scientists, manufacturers and the end-user (veterinarians). The main focus will be on food producing animals, including fish. Further, proposals will be presented for a harmonized approach which will lead to a better understanding of the rational for the intended use, better knowledge on the nature of isolates and improved production and quality of the final products. In addition, advanced techniques and methods will be presented and discussed to identify and propagate isolates, to upgrade production and to quickly estimate safety and even efficacy of autogenous vaccines by in vitro methods.

Recommendations will be drafted on how to improve the EU-legislation and communication between the EU-Member States on autogenous vaccines and on ways to increase transparency on quality and safety of the vaccines.

 

Advancing Analytics for Biotechnology Products
An
IABS - FDA international meeting
co-sponsored by NIST
Venue: NIST, Gathersburg, Maryland

Green Auditorium
Gathersburg, Maryland
November 6-8, 2017

 

This meeting is to bring together regulators, and scientists, or those interested in analytics from academia and industry to help resolve existing challenges in ensuring the quality of biotechnology medicinal products and to bring high quality medicines to patients. Guidance on how to use current and novel analytics for a variety of activities required during biotechnology product development such as method development, improvement and replacement, product comparability and process development and execution will be provided by the speakers and panel members. In addition, the complexity of the types of data and the volume being analysed is ever increasing and how best to manage such data will be discussed. The meeting will bring the right experts together to discuss the issues and through roundtables attempt to reach conclusions that will be valuable globally to public health.

NON U.S. CITIZENS PLEASE NOTE: All foreign national visitors must supply additional information. Failure to provide this information prior to arrival will result in significant delays in entering the facility. Authority to gather this information is derived from United States Department of Commerce Department Administrative Order (DAO) number 207-12. Please fax the following NIST 1260 form to Myesha Steadman as soon as registration is complete: fax (301) 975-4629.

 Click here to learn more about the meeting

4th Statistical and Data Management Approaches
for Biotechnology Drug Development
Venue: USP Pharmacopeia, Rockville, Maryland
October 30 - November 1, 2017

 

This meeting is to bring together regulators, and scientists, or those interested in statistics from academia and industry, who have a background in statistics, to help resolve existing challenges in ensuring the quality of biotechnology medicinal products and to bring high quality medicines to patients. Guidance on how to use statistics for a variety of activities required during biotechnology product development such as method development, improvement and replacement, product comparability, biosimilarity exercises and stability program development will be provided by the speakers and panel members. In addition, the complexity of the types of data and the volume being analysed is ever increasing and how best to manage such data will be discussed. The meeting will bring the right experts together to discuss the issues and through roundtables attempt to reach conclusions that will be valuable globally to public health.

Click here to  learn more about the meeting

 

International Alliance for Biological Standardization


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