International Alliance for Biological Standardization
“I hold that a man should strive to the uttermost for his life’s set prize”
Robert Browning (7 May 1812 – 12 December 1889), English poet and playwright.
Upcoming events and News
4th Cell Therapy Conference
Register Here for the conference
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 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.
Register HERE for the conference
More information coming soon
Implementing Nonanimal Aapproaches to Human and Veterinary Vaccine Testing
SAVE THE DATE
Implementing nonanimal approaches to human and veterinary vaccine testing:
Achieving scientific and regulatory success for rabies and beyond
Natcher Conference Center
National Institutes of Health
Bethesda, Maryland
October 16-17, 2018
The meeting is co-organized by the National Toxicology Program Interagency Center
for the Evaluation of Alternative Toxicological Methods
NICEATM
and the
International Alliance for Biological Standardization
North America Affiliate, California, USA
IABS-NA
More information soon
5th Statistical Approaches for CMC Development and Lifecycle Management of Biotherapeutics and Vaccines
SAVE THE DATE
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.
More information about this meeting coming soon.
In Brief
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From the President
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Geoffrey Christopher Schild
Dr Geoffrey Schild died in Bergen, Norway, on 3 August 2017, at the age of 81.
Geoffrey was a good friend of IABS who served on the Board of Directors for many years. He had numerous friends and colleagues throughout the world who will miss him, his engaging personality, and his straightforward attitude in dealing with issues.
He graduated from Reading University (UK) in 1958, and went on to pursue his interest in microbiology at Sheffield University where he did a PhD on the common cold. That led him to work on influenza with colleagues at the university until 1967 when he moved to the National Institute for Medical Research (NIMR) at Mill Hill in London. Even in those early years of his career, he had established links with WHO which grew stronger as the years progressed. Geoffrey directed the first of what would become WHO’s network of influenza centres which play a critical role in identifying new viral strains from around the world that are critical for vaccine production.
Geoffrey was recruited to join the National Institute for Biological Standards and Control (NIBSC) in the late 1970s, and he brought with him a strong scientific background that set the stage for a long-term strengthening of the Institute’s role in the regulation of biological products based on sound science and credible data to support safety and efficacy. In addition to his work on influenza, Geoffrey was keen on polio vaccine issues, and he led a group at NIBSC focused on the molecular basis of viral attenuation - the most critical characteristic of live oral polio vaccine. He became the director of NIBSC in 1985, a post he held until his retirement in 2002. During those 17 years, NIBSC continued to thrive under his leadership both in terms of the breadth of the scientific programs and the quality of the staff.
Geoffrey was an enthusiastic activist who enjoyed challenging and being challenged. At the same time, he forged many strong friendships with colleagues throughout the word. He was a unique personality, and he will be remembered with affection by those who knew him well.
Geoffrey is survived by his wife Tora and three children, Oystein, Ingrid, and Peter.
John Petricciani
Past President, IABS -
Thank You Anthony Mire-Sluis
Praise for IABS Biotherapeutics Committee Chair Tony Mire-Sluis
Dear Colleagues,
Please join me in acknowledging and thanking Anthony (Tony) Mire-Sluis for his remarkable management of the IABS Biotherapeutics Committee since 2010. After serving in this role for the past seven years, Tony is rotating out of the Chair position.
While his Committee aided IABS in many ways, one of the most significant accomplishments was the successful collaboration with the US Food and Drug Administration on four FDA/IABS annual workshops on Statistical and Data Management Approaches for Biotechnology Drug Development. These workshops elevated the value of statistics in Chemistry, Manufacturing, and Controls (CMC) development and lifecycle management and brought FDA and industry statisticians and nonstatisticians together to discuss strategies and methods for addressing significant challenges in ensuring the quality of biotechnological and vaccines products. Thank you, Tony, for all of your hard work as Committee Chair
Joris Vandeputte, President IABS
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Welcome Timothy Schofield
Tim Schofield Appointed as New Chair of the IABS Biotherapeutics Committee
Dear Colleagues,
It is a pleasure to announce the appointment of Timothy (Tim) Schofield as Chairman of the IABS Biotherapeutics Committee. On December 9, 2017, the Executive Committee unanimously endorsed Tim to succeed Anthony Mire-Sluis.
Tim is a Senior Advisor in Global Vaccines Technical R&D at GlaxoSmithKline. Prior to joining GSK Tim worked at MedImmune as Senior Fellow in Analytical Biotechnology, Arlenda, Inc. as Managing Director and Head of Nonclinical Statistics, at GSK in US Regulatory Affairs, and at the Merck Research Laboratories heading the Nonclinical Statistics unit, supporting research, development and manufacture of Merck pharmaceuticals, biologics and vaccines. Tim received a Bachelor of Science degree in Mathematics from Lafayette College, and a Master of Arts degree in Statistics and Operations Research in 1976 from the Wharton School of the University of Pennsylvania. Tim is a member of the USP Statistics Expert Committee and has participated in industry initiatives related to Quality by Design, analytical method development and validation, stability and specifications. In addition to serving as the Chairman of the IABS Biotherapeutics Committee, he is a member of the International Consortium for Innovation & Quality (IQ) Biologics Leadership Group. Tim brings a wealth of experience in the biological standardization arena and a tremendous energy as Committee Chair. IABS is lucky to have him join our three other Scientific Committee Chairs in advancing the mission of IABS. Note too that there are vacancies on the Biotherapeutics Committee that Tim will be filling in the near future.
Joris Vandeputte, President IABS
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Latest news
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Join CASSS for the first CASSS Cell & Gene Therapy Products meeting on July 10-12, 2018 at the Bethesda North Marriott Hotel & Conference Center, Rockville, MD.
We are very pleased to be launching the Symposium this July, continuing CASSS’ commitment to driving science forward and pushing through pre-conceived notions.
Learn more at http://www.casss.org/?page=CGTP1801
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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
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IABS is pleased to announce a valuable new book written by Board Member Dr. Rebecca Sheets titled Fundamentals of Biologicals Regulation: Vaccines & Biotechnology Medicines. Dec. 2017, published by Elsevier’s imprint Academic Press.
For more information, please see https://www.elsevier.com/books/fundamentals-of-biologicals-regulation/sheets/978-0-12-809290-3
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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.
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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Contact Info
CH-1204 Geneva
Switzerland