International Alliance for Biological Standardization
“Scientific research is one of the most exciting and rewarding of occupations. It is like a voyage of discovery into unknown lands, seeking not for new territory but for new knowledge. It should appeal to those with a good sense of adventure.”
Frederick Sanger (1918 – 2013), Nobel Prize in Chemistry 1958; 1980
Upcoming events and News
Coalition for Epidemic Preparedness Innovations (CEPI)
Coalition for Epidemic Preparedness Innovations (CEPI)
Recent epidemics and pandemics have exposed serious flaws in the world’s capacity to prepare for and respond to infectious disease outbreaks. The Ebola outbreak in West Africa and Zika in the Americas are the most recent instances. But there are many more, including SARS, MERS-CoV, chikungunya and Lassa. In each outbreak, a vaccine could have slowed, halted or even prevented an epidemic. This would have saved many thousands of lives, and prevented profound social and economic disruption in the countries affected. Ebola proved that we can develop vaccines quickly, even in extremely challenging conditions. During the outbreak the global scientific community, including pharmaceutical companies, academics, funders, emergency responders and the WHO, made tremendous efforts to accelerate clinical trials of several promising vaccines.
But we can’t continue to rely on ad-hoc partnerships and the goodwill of a handful of companies. We need a sustainable model for epidemic vaccine development.
CEPI wants to galvanize the development of new vaccines against diseases we know could cause the next devastating epidemic.
CEPI Founding Partners
Government of Norway
Government of India
Wellcome Trust
Bill & Melinda Gates Foundation
World Economic Forum
Partners
Government of Norway
Government of Japan
Federal Government of Germany
Bill and Melinda Gates Foundation
Wellcome Trust
European Commission
The Government of India
For more information: http://cepi.net
Autogenous Vaccines and Their Role in Animal Health Strategy
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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.
You may now register for this conference. Click here to register and learn more about the meeting
2nd Human Challenge Trials Conference
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2nd Human Challenge Trials Conference
Venue: Hilton Hotel, Rockville, Maryland
September 28-30, 2017
Our world needs safer, more effective drugs and vaccines to prevent and treat infectious diseases. Controlled human infections (CHIs) have served as an effective tool to promote this objective. For example, CHIs have led to progress in developing interventions against respiratory pathogens, enteric pathogens, and parasites. The most frequent application is the conduct of human challenge trials (HCTs), which can safely assess the value of novel or improved drugs and vaccines much more rapidly and efficiently than field trials, particularly if efficacy against CHI bridges to the field. Progress against an infectious threat is greatly hampered when the field lacks a supporting human challenge model, such as is the case for human immunodeficiency virus and Mycobacterium tuberculosis.
Based on the premise that optimal use of CHIs is one of the best, most efficient ways to achieve rapid progress against infectious diseases, IABS is hosting a workshop to review the use of HCTs to promote the development of new drugs and vaccines, the benefits and risks of this approach, the regulatory framework within which HCTs are conducted, and novel CHI applications that would open new translational pathways. This workshop follows two and a half years after the first such workshop hosted by IABS in Strasbourg, France, September 2014.
You may now register for this conference. Click here to register and learn more about the meeting
Next Generation Sequencing for Adventitious Virus Detection in Biologics
Early Registration Ends: September 2
Register Now
Next Generation Sequencing for
Adventitious Virus Detection in Biologics
Venue: USP Pharmacopeia, Rockville, Maryland
October 26-27, 2017
The 2017 NGS conference will discuss current perspectives on NGS for adventitious virus detection in biologics with focus on applications for human vaccines and lessons learnt from veterinary vaccines. The meeting will include data presentations and discussions for developing a scientific consensus to draft points for consideration for using NGS for virus detection in selected applications of biologics. The meeting will bring together representatives from industry, academia, service providers, and regulatory bodies.
You may now register for this conference. Click here to register and learn more about the meeting
4th Statistical and Data Management Approaches for Biotechnology Drug Development
Early Registration Ends: September 2
Register Now
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.
You may now register for this conference. Click here to register and learn more about the meeting
Latest Technologies for the Characterization and Control of Biotechnology Products
Early Registration Ends: September 8
Register Now
Latest Technologies for the Characterization
and Control of Biotechnology Products
An IABS, FDA and NIST meeting
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.
You may now register for this conference. Click here to register and learn more about the meeting
In Brief
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A few words from the President
On June 3 2016, the presidency of IABS was passed over to me in agreement with the IABS election process.
Above all, I thank John Petricciani for his exceptional leadership and wise advice.
Read more -
IABS Communication Committee
Recognizing the need for improving the communication process, the IABS Board of Directors established a Communication Committee at the June 2016 Board meeting in Lyon, France.
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Vac2Vac
VAV2VAC is a wide-ranging collaborative research project funded by IMI2 which aims to develop and validate quality testing approaches for both human and veterinary vaccines using non-animal methods. The initiative that started on 1 March 2016 aims to provide the data to support the "Consistency Approach" for quality control of established vaccines, where current quality control approaches are often relying on in vivo methods.
VAC2VAC is a public-private consortium of twenty partners, involving experts from veterinary and human vaccine industry in a partnership with official medicines control laboratories, academia, translational research organisations, and vaccinology alliances. To achieve their goal, the project partners will develop, optimise and evaluate physico-chemical and immunochemical methods, cell-based and other assays for routine batch quality, safety and efficacy testing of vaccines. This will be done in collaboration and consultation with regulatory agencies. The ultimate goal of the project is to develop tests and approaches that will allow acceptance of the "Consistency Approach" for established vaccines by the regulatory agencies and thereby significantly reducing in the future the use of animals for batch testing in routine vaccine production.
Press release -
ZAPI
About ZAPI - The new Zoonoses Anticipation and Preparedness Initiative (ZAPI), part of the Innovative Medicines Initiative (IMI) public-private partnership, aims to enable swift response to major new infectious disease threats in Europe and throughout the world by designing new manufacturing processes (up to large scale) for delivering effective control tools (vaccines, antibodies/antibody-like molecules) against (re-)emerging zoonotic diseases with pandemic potential within a few months after the occurrence of first cases…
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Harmonized Safety Monitoring of Immunization in Pregnancy
The important Harmonized Safety Monitoring of Immunization in Pregnancy International Consensus Conference was recently held at the NIH in Bethesda, Maryland and highlighted progress to date in harmonizing safety monitoring of immunization in pregnancy.
Learn more about the Harmonized Safety Monitoring of Immunization in Pregnancy ICC here
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Scientific Committees
IABS scientific activities are the responsibility of the Scientific Conference Committees, representing special interests within the fields of Human Biologicals and Veterinary Biologicals.
The Scientific Conference Committees are responsible for the organization of scientific conferences.Human Vaccine Committee
Chairpersons:Human Cell & Gene Therapy Committee
Chairperson: Takao Hayakawa (Japan)Human Biotherapeutics Committee
Chairperson: Anthony Mire-Sluis (USA)Veterinary Biologicals Committee
Chairperson: Carmen Jungbäck (Germany)
Please find all the biosketches in the Documents section -
MoU
IABS has signed an MoU with the following organization:
Fondation Mérieux -
Emerging infectious diseases of animals
Slides from Budapest workshop now posted in Past Conferences or folder here
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Call for Communications Committee
At the start of this New Year, we would like to solicite your interest in joining the recently established IABS Communications Committee.
Read more pdf here (414 KB) -
Emerging Diseases in Animals: Recommendations & Conclusions
A comprehensive discussion on all aspects of Emerging Diseases in Animals led to some important observations and conclusions.
Read more pdf here (457 KB)
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Latest news
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Vac2Vac
New website is online
We are pleased to inform you that the VAC2VAC website is online now.
Press release: http://www.bprc.nl/download/BPRC_VAC2VAC.pdf
You can access the site using the following link: www.vac2vac.eu.
Read more at www.vac2vac.eu .
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IABS-NA
IABS Launches its North American Affiliate: IABS-NA
This is another landmark event in the history of lABS, and will open the way for greater participation on scientific activities with partners in Canada, Mexico, and the USA. The objectives of IABS-NA are to support the mission and projects of IABS, to enhance its image, and to develop an outreach within North America. IABS-NA will contribute to the scientific and medical advancement of biologicals by facilitating communication among those who develop, produce and regulate biological products for human and animal health. More specifically, it will focus on issues concerning the regulation and standardization of biological products that are intended for marketing within this region. As a neutral meeting point for the major stakeholders - regulators, academia, and industry- IABS-NA will consider the impact of regulatory requirements on innovation, with the objective of identifying issues that may require further consideration and possible modification.
Discussions are already underway regarding a conference topic that will meet that objective, and that will complement and enhance IABS-EU activities.
IABS-NA is officially recognized by USA authorities as a charitable organization [501(c)(3) designation].
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ZAPI
IABS-EU leads regulatory work package in the IMI Call Zoonosis Anticipation and Preparedness Initiative (ZAPI)
The Zoonoses Anticipation and Preparedness Initiative (ZAPI), part of the Innovative Medicines Initiative (IMI) public-private partnership, aims to enable swift response to major new infectious disease threats in Europe and throughout the world by designing new manufacturing processes (up to large scale) for delivering effective control tools (vaccines, antibodies/antibody-like molecules) against (re-)emerging zoonotic diseases with pandemic potential within a few months after the occurrence of first cases.
This, however, creates an unforeseen regulatory situation: how to proceed in an emergency situation?
In order to respond to this question, IABS-EU has become a facilitator in the elaboration of new regulatory processes. It has created a group of experts composed of regulatory agencies and members of the consortium to address specific issues in emergency situations to ensure that these new tools become quickly available.
ZAPI is a 5 years collaborative partnership between more than 20 European partners, including leading human and veterinary research institutions, non-governmental organizations, regulatory agencies, expert academic groups, and vaccine and biotech manufacturers. With more than 22 million euros in funding, ZAPI is the first true “One Health” project within the scope of IMI and unites experts in animal health and human health.
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Gaia
Harmonized Safety Monitoring of Immunization in Pregnancy
The important Harmonized Safety Monitoring of Immunization in Pregnancy International Consensus Conference was recently held at the NIH in Bethesda, Maryland and highlighted progress to date in harmonizing safety monitoring of immunization in pregnancy.
Learn more about the GAIA conference by visiting:
IABS Past Conferences
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IABS-EU Heads Work Package in new IMI project: VAC2VAC
VAV2VAC is a wide-ranging collaborative research project funded by IMI2 which aims to develop and validate quality testing approaches for both human and veterinary vaccines using non-animal methods. The initiative that started on 1 March 2016 aims to provide the data to support the "Consistency Approach" for quality control of established vaccines, where current quality control approaches are often relying on in vivo methods.
VAC2VAC is a public-private consortium of twenty partners, involving experts from veterinary and human vaccine industry in a partnership with official medicines control laboratories, academia, translational research organisations, and vaccinology alliances. To achieve their goal, the project partners will develop, optimise and evaluate physico-chemical and immunochemical methods, cell-based and other assays for routine batch quality, safety and efficacy testing of vaccines. This will be done in collaboration and consultation with regulatory agencies. The ultimate goal of the project is to develop tests and approaches that will allow acceptance of the "Consistency Approach" for established vaccines by the regulatory agencies and thereby significantly reducing in the future the use of animals for batch testing in routine vaccine production.
ZAPI
About ZAPI - The new Zoonoses Anticipation and Preparedness Initiative (ZAPI), part of the Innovative Medicines Initiative (IMI) public-private partnership, aims to enable swift response to major new infectious disease threats in Europe and throughout the world by designing new manufacturing processes (up to large scale) for delivering effective control tools (vaccines, antibodies/antibody-like molecules) against (re-)emerging zoonotic diseases with pandemic potential within a few months after the occurrence of first cases…
IABS-EU is officially recognized by French authorities as a nonprofit organization.
You will be hearing more about IABS-EU in the months ahead.
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Founding Members :
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Contact Info
CH-1204 Geneva
Switzerland