Platform Technology: Is it possible to reduce vaccine development time?

An IABS webinar: Thursday, February 18, 2021 from 14 :00 – 16 :30 CET

Testimonials from J&J, Curevac and BioNtech

Round table discussion with Industry, EMA, FDA, Health Canada, PEI, WHO…

Agenda

Platform Technology: what are the first experiences from different players who were allowed by the authorities to use data from other programs in a platform technology approach in order to shorten the development time.

Webinar Registration link : https://www.iabs.org/platform-technology-webinar.

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ZAPI Stakeholders Final Conference
February 4-5, 2021
A Virtual Meeting


INFORMATION ABOUT AND REGISTRATION FOR THE MEETING HERE


In March 2015, IMI  (Innovative Medicine Initiative - https://www.imi.europa.eu) launched ZAPI (Zoonotic Anticipation and Preparedness Initiative) to set up methodologies and platform technologies that would be ready to put into production for vaccines and neutralizing monoclonal antibodies to efficiently counter emerging or remerging zoonotic viruses.

“The objective is to demonstrate that we can deliver on these platforms, using three different prototype models of diseases that occurred in the recent past and which are zoonotic in nature.” The viruses that [have been] used as models are Middle East respiratory syndrome coronavirus (MERS-CoV); Schmallenberg virus; and Rift Valley Fever virus’. IMI ZAPI Interview

Six years later, the ZAPI project has made great strides in vaccine and antibody design, and new approaches for achieving the “surge manufacturing capacity” objective.

The Final Stakeholders Global Meeting will present an overview of the main findings and key learnings from the ZAPI project partnership’s experience for improving our One Health preparedness status for facing effectively future pandemics.

The ZAPI project benefits from the assistance and financial support of
IMI and the European Commission, and in-kind contributions from EFPIA partners.

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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.

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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 8-9, 2021

 Registration and information about the meeting

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Autogenous Vaccines:
Quality of production and movement in a common market

Ludwig-Maximilians-University Munich

registration and information about the meeting

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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.

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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.


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Read the Summary

 

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

Visit the meeting website

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.

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

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Visit the meeting website

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

Quality Requirements for Challenge Agents
An IABS-EU Meeting

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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**).

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:

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

Information about the meeting here

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

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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.

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

 

3rd Human Challenge Trials in Vaccine Development

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3rd IABS CONFERENCE on CELL THERAPY
MANUFACTURING AND TESTING

This meeting provided an important update on the
Regulation and Standardization of Cell Therapies

November 2-3, 2016
The Wellcome Collection
London, United Kingdom

 

The 2016 Cell Therapy conference will identify the key issues to be addressed for the manufacture of cell therapies and provide scientific consensus on selected aspects to inform the drafting of future guidance. The meeting will bring together representatives from industry, academia, health services and regulatory bodies.

It is intended that the conference output should provide core elements that will be useful in establishing international consensus on the requirements for manufacture of cell based medicines and enable progress towards a potential future WHO endorsed guidance.

  folder Slides are available here

 

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



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.

 

International Alliance for Biological Standardization


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