International Alliance for Biological Standardization
Meeting - Latest News:
Hybrid Meeting - Autogenous Vaccines - Quality of Production and Movement in a Common Market
September 14-16, 2021
Ludwig-Maxmillians-University Munich
Munich, Germany
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Upcoming events and News
September 14 - 16, 2021 - Autogenous Vaccines Hybrid Meeting
Autogenous Vaccines Hybrid Meeting:
Quality of production and movement in a common market
Ludwig-Maximilians-University Munich
EARLY REGISTRATION ENDS JULY 1, 2021
Registration and Information about the Meeting
Read more ...November 8-11, 2021 - 7th Statistics Workshop
A Virtual Meeting
SAVE THE DATE
Registration Open
Accelerating Drug Development: How QbD, Regulatory Partnerships, and Pandemic Learning
Can Further Expedite Meeting Patient Needs
The pharmaceutical industry, academicians, and global regulators have demonstrated over the past year that drug development can be incredibly accelerated to address urgent, unmet needs. In addition, coupled with that acceleration, the pharmaceutical industry has been on a Quality by Design (QbD) implementation journey for nearly two decades. Acceleration has placed an emphasis on conducting and documenting risk assessments, utilizing modeling to leverage platform knowledge, incorporating digital and technological advances to improve process performance and understanding, and continued refinement and improvement of the information that is submitted to global regulators. What have we learned from these experiences, particularly from the vantage point of CMC statisticians, and what aspects of the near-term dramatic acceleration and longer-term development journey could/should be continued going forward?
This workshop will explore the development journeys over a series of sessions by hearing directly from the industry, professors, and global regulators. By focusing each session on themes that cover QbD, Regulatory, Continuous Manufacturing, and Case Studies, the workshop will be an opportunity to help shape the future of drug development through the role of CMC statisticians. Join us for presentations, panel discussions, and breakout sessions to engage directly with speakers, other experts, and each other.
Meeting rescheduled - New Date - June 8-9, 2022, Ottawa, Canada
Maintaining the quality of vaccines through the use of references standards
Current challenges and future opportunities
Due to the uncertainties concerning the evolution
of the Covid-19 pandemic, the meeting is once again rescheduled
and will now take place on
June 2022
Registration and information about the meeting
Read more ...Meeting rescheduled - New Date Soon
Cross learning experience human and animal vaccine licensure
based on technology platforms
A Joint CEPI / IABS-EU Workshop
Registration and information about the Meeting
MEETING RESCHEDULED
The difficult situation we are facing currently in Europe
and the uncertainties concerning the evolution
of the Covid-19 pandemic has led us to once again postpone
the CEPI / IABS-EU Workshop.
More information will be posted shortly.
In Brief
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IABS Platform Technology Webinar Report Now Available
IABS and the Coalition for Epidemic Preparedness Innovations (CEPI) organized a joint webinar on the use of breakthrough technology in vaccine development. Novel platform technologies such as messenger RNA (mRNA), viral particles, recombinant constructs have greatly contributed to a rapid response to the COVID-19 pandemic. The speed with which COVID-19 vaccines have been developed, manufactured, distributed and last but not least evaluated, assessed, and given a positive conditional approval, constitute a milestone achievement in addressing a global public health emergency. The acceptance of Platform Technology by international regulatory authorities represents a whole new paradigm in regulatory affairs. This achievement led to the acceleration of the regulatory processes regarding the acceptance of the COVID-19 vaccine. This new paradigm was discussed at length during the webinar. Read the Report Here
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Message from the President - April 2021
Biologicals Editor-in-Chief
This spring, there will be a “passing of the baton” to the next Editor-in-Chief for IABS’ Journal Biologicals. After more than six years of leading the way for our Journal, Dr. Robin Thorpe will retire and the role will be assumed by Dr. Norman Baylor. While transitions can be bittersweet, I am pleased to welcome Dr. Baylor to this role and I congratulate and thank Dr. Thorpe for his years of service in this critical role for the Alliance.
Dr. Thorpe assumed the role of Editor-in-Chief of Biologicals on January 1st 2015 after having served as Section Editor for Biotherapeutics for many years (at least 10 years, but probably longer). In addition, he has authored many papers/reviews/meeting reports that have appeared in our Journal. Under Dr. Thorpe’s leadership, thirty-seven issues were published containing four hundred and eighty individual papers. Dr. Thorpe has worked hard to maintain the focus of the journal on regulatory science and as a “niche” Journal for myriad biological products, Dr. Thorpe has endeavoured to maintain the scope of the Journal, as well as its reputation by screening and managing thousands of submissions. Reviewing the accomplishments of the Journal has been an important part the annual IABS Board meetings of which Dr. Thorpe has been an active participant and champion for IABS. Please join me in wishing the best for him as he moves away from daily activities on the Journal to new adventures.
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Accolades for IABS Member
Long-term IABS Board of Directors Member and Alliance Treasurer Dr. Tony Lubiniecki was recently honored for his contributions to Chemistry, Manufacturing, and Controls Regulatory Science by CASSS. CASSS is a California nonprofit corporation which exists to enable a global community of industry, academic and regulatory professionals to work together to resolve scientific challenges in their field.
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3rd Human Challenge Trials in Vaccine Development
February 6-7, 2020
Pembroke College
Oxford, United Kingdom
View the Meeting Report
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Latest news
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Accolades for IABS Member
Long-term IABS Board of Directors Member and Alliance Treasurer Dr. Tony Lubiniecki was recently honored for his contributions to Chemistry, Manufacturing, and Controls Regulatory Science by CASSS. CASSS is a California nonprofit corporation which exists to enable a global community of industry, academic and regulatory professionals to work together to resolve scientific challenges in their field.
“CASSS has honored Tony Lubiniecki, PhD with its prestigious Hancock Award for Outstanding Achievements in CMC Regulatory Science. This annual award recognizes outstanding and sustained contributions in the field of regulatory science. Lubiniecki was announced as the 2020 honoree during CASSS’s 24th Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products, January 28-30, 2020 in Washington DC.” Additional information on the award is located on the CASSS website: https://www.casss.org/news/488524/Tony-Lubiniecki-Announced-as-CASSS-Hancock-Award-Winner-for-2020.htm
CASSS has also recognized several other long-time IABS Members for their contributions to biological/regulatory science. In 2014, Dr. Kathryn Zoon, https://www.casss.org/page/933?&hhsearchterms=%22awards%22 and in 2017, Dr. John Petricciani https://www.casss.org/page/Hancock2017?&hhsearchterms=%22petricciani%22 each received the received William Hancock Award for Outstanding Achievements in CMC Regulatory Science.
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ADVAC 2020
11 to 22 May, 2020
Veyrier du Lac (near Annecy) FranceADVAC 2020 is cancelled.
Due to the increasing travel restrictions and flight cancellations caused by COVID-19 and considering the policies of the organizing institutions, co-sponsor institutions and their government/umbrella institutions, as well as individual discussions and interactions with a number of the ADVAC Scientific Committee and lecturers, the decision has been taken jointly by the Mérieux Foundation and the University of Geneva to cancel this year’s ADVAC
The 21st ADVAC will now take place from 10 to 21 May 2021.
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In May 2019, 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).
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View the speaker slides from the 3Rs meeting, NIH, Bethesda : folder click here
View the meeting webpage Here
Report now available Here
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IABS Presentation to the U.S. Veterinary Biologics Training Program
In May 2018, 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 2600 individuals have attended the program including over 740 international participants from 90 different countries. More than 150 participants attended in 2018. 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 2018-2019 was offered to participants. 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 “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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French speaking visitors can listen to the interviews of Dr. Stanley Plotkin and Dr. Marc Bonneville, during the IABS65 anniversary ceremony in Lyon
The interviews are available here : https://www.lyondemain.fr/iabs-lyon-coronavirus-vaccins-standardisation-merieux-biologie-lyonbiopole-stanley-plotkin-marc-bonneville-maladies-infections-conference/
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Job Opportunity
Associate / Director CMC Statistician
The CMC Statistician is a key member of the Technical Development organization responsible for supporting the integration of statistical strategy throughout CMC. In this role you will contribute directly to advancing Moderna’s portfolio of products from development to commercial manufacturing, and help build technical platforms for a rapidly expanding pipeline. You will collaborate as a key project resource and team member with scientists and engineers working on the forefront of mRNA science. You will design experiments and develop predictive models for technical processes and analytical methods.
At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells.
We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission.
LinkedIn => https://www.linkedin.com/jobs/view/2220730661/?refId=WDm3J%2FTPRoSWNZGCPHAWkA%3D%3D
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IABS joins Animal-Free Safety Assessment Collaboration to promote innovation and global regulatory alignment for human and veterinary biologicals
Geneva (07-Apr- 2021) -- The Animal-Free Safety Assessment Collaboration (AFSA) and the International Alliance for Biological Standardization (IABS) are pleased to announce the beginning of their mutual cooperation, with IABS becoming member of the Collaboration.
Dr Rick HILL, IABS Vice-President and Communication Chair, said: “After careful review of AFSA’s goals and activities, IABS has taken the decision to join the Collaboration, recognizing its efforts to promote worldwide change in the biologicals field through stakeholders’ engagement, and work to make information accessible and widely disseminated.”
Laura Viviani, AFSA biologicals workstream coordinator, said: “We are particularly proud of this cooperation. IABS membership acknowledges the work already done by AFSA in the field of biologicals, and shows a high level of trust and commitment to the Collaboration’s vision of a world where biologicals are developed, tested and produced with innovative approaches and platforms that forego the reliance on obsolete animal methods.”
Through IABS, the stakeholders engaged by AFSA will have access to a network of the foremost world experts of the sector. This will make it possible to multiply the opportunity to inform the scientific debate on biologicals, engage new expertise to the discussion, maintain momentum in a changing environment, and foster a consequential dialogue that can bring about change at a truly global level.
International Alliance for Biological Standardization - IABS
The International Alliance for Biological Standardization (IABS) is a nonprofit neutral organization dedicated solely to addressing key issues in regulatory science that underpin approvals for vaccines and biopharmaceuticals worldwide. For more than 60 years, these contributions have occurred primarily through collaborative scientific meetings and publications in the journal Biologicals. IABS’ unique role and strength reside in its ability to bring together interested parties for scientific discussions of important unresolved or emerging issues, to assist in developing a consensus and an action plan to achieve regulatory progress. IABS.org
Animal Free Safety Assessment Collaboration – AFSA
The Animal-Free Safety Assessment (AFSA) Collaboration brings together corporate and non-profit leaders who share the goal of accelerate global adoption of a modern, human-based approach to safety assessment that will better protect consumers and hasten the replacement of animal testing. AFSAcollaboration.org
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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 non-profit organization.
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Contact Info
CH-1204 Geneva
Switzerland