“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

4th Cell Therapy Conference

SAVE THE DATE

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, California
June 5-6, 2018

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 cell 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 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 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.

 

2nd Human Challenge Trials in Vaccine Development - Slides

2nd Human Challenge Trials in Vaccine Development

Speaker slides now available Here

Autogenous Vaccines and Their Role in Animal Health Strategy-Slides

Autogenous Vaccines and Their Role in Animal Health Strategy

Speaker slides now available HERE

Next Generation Sequencing for Adventitious Virus Detection in Biologics

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

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 conferenceClick here to register and learn more about the meeting

 

Advancing Analytics for Biotechnology Products

REGISTRATIONS CLOSE OCTOBER 30

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 register and learn more about the meeting

In Brief

  • A few words from the President

    The IABS has had a busy and productive year and I am pleased to report to you some of our latest events and activities.
    As President, one of my objectives has been to increase outreach and expand the visibility of IABS among other organizations that have missions similar to, or aligned with IABS.
    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. 

    Learn more here

  • 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

    Learn More

  • 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…

    Learn more

  • 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

  • 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

  • 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

  • IABS “3R” Conferences Highlighted in Presentation at the 10th World Congress on Alternatives and Animal Use in the Life Sciences.

    August 24, 2017, an overview of IABS’ “3R” Conferences, Symposia and Workshops was included in a presentation at the vaccine session at the 10th World Congress on Alternatives and Animal Use in the Life Sciences in Seattle Washington (See Summary Slide below).  The World Congress are periodic scientific meetings with emphasis on the latest technologies for reduction and replacement of animals and innovations in approaches to ethics, animal welfare and public policy.   Interestingly, the World Congress’ first meeting was in 1993, within one year of the IABS’s first Langen Symposium.  The 11th World Congress is scheduled for 2020 in the Netherlands. 

    In general, World Congress participants were aware of IABS’ leadership in the “3R” and Animal “Alternatives” arena and several inquired about the status of future IABS conferences.   The meeting presented an opportunity to discuss IABS overall, but also the organizations strategic priority to host “3R” related meetings by the North American and European Affiliates.

    Respectfully submitted,

    Rick Hill, IABS Communication Committee Chair

     

  • IABS Presentation to the U.S. Veterinary Biologics Training Program

    In May 2017, an overview of IABS’ mission and activities was presented at the U.S. Veterinary Biologics Training Program. The training program is co-sponsored by the USDA APHIS Center for Veterinary Biologics, the USDA APHIS National Veterinary Services Laboratories and the ISU College of Veterinary Medicine’s Institute for International Cooperation in Animal Biologics (IICAB). The IICAB was founded in 1995 by the USDA Animal and Plant Health Inspection Service and Iowa State University. In June 1998, the IICAB received designation as a component of the World Organization for Animal Health (OIE) Collaborating Centre for the Diagnosis of Animal Diseases and Vaccine Evaluation in the Americas. The designation is shared with the USDA APHIS National Veterinary Services Laboratories (NVSL) and Center for Veterinary Biologics (CVB).


    The first Veterinary Biologics Training Program was held in June 1996 at the ISU College of Veterinary Medicine. The training program has been offered each year since then. More than 2500 individuals have attended the program including over 700 international participants from 90 different countries. More than 160 participants attended in 2017. The program is known worldwide as a premier training program in immunology and veterinary vaccines. Many individuals who have participated in the training continue to be actively involved with veterinary biologics issues and activities world-wide.


    Training Program participants were keenly interested in IABS and had many questions. Complimentary IABS Membership for 2017-2018 was offered to participants and more than 40 accepted the offer. IABS is looking forward to some of the new members attending upcoming conferences and workshops and becoming more actively involved with our organization.


    Respectfully submitted,
    Rick Hill, IABS Communication Committee Chair

     

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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.

Learn More

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…

Learn more

 


IABS-EU is officially recognized by French authorities as a nonprofit organization.

You will be hearing more about IABS-EU in the months ahead.

Founding Members :

Read more:

International Alliance for Biological Standardization


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