NEWS

IABS Collaboration with HSI & HealthforAnimals

IABS has been collaborating with Humane Society International (HSI) under the umbrella of the Animal Free Safety Assessment (AFSA) collaboration since 2021 to promote the implementation of non animal based testing within the human and veterinary vaccines’ batch release testing. In the veterinary field, both the organizations started to collaborate with HealthforAnimals in the organization of dedicated events that took place within the 2022 (link to the Biologicals publication; link to the webinars and workshop recordings). The World Organization of Animal Health (WOAH) has been involved since that time to ensure the participation to the events to as many stakeholders as possible worldwide.

The events highlighted the need to set up more coordinated activities within the stakeholders to better disseminate the opportunities to implement non animal testing, or reduce and refine the animal use, and start to promote regulatory acceptance. HSI, IABS and HealthforAnimals created a dedicated project “Implement 3Rs in Veterinary Vaccines Batch Release Testing” that is now under review for funding.

This project was discussed at the WOAH Biological Standards Commission Meeting, that took place on 4-8 September 2023. The Commission expressed their positive opinion on the value of continuing this collaboration, requesting further information on the 3Rs process to define and select alternative methods to ensure quality, validation, and equivalency with existing methods. www.woah.org/app/uploads/2023/10/a-bsc-report-sept-2023-6.pdf (page 23).

President’s Column January 2024

Dear IABS Colleagues, Stakeholders, Supporters, and Collaborators,

The transition to the new year is a good time to reflect on our past as we look ahead to 2024. I am pleased to report that 2023 was an outstanding year for the International Alliance for Biological Standardization (IABS). With seven conferences, meetings, or workshops on three continents in 2023, IABS continues to be recognized for its ability to provide an independent, neutral forum for the discussion of timely regulatory and scientific issues. Our Scientific Committees have been highly successful in reinforcing the value of IABS as a leader and convener of those interested in advancing contemporary biologics issues. 2023 was also a milestone year as the 50th Anniversary of IABS’ Journal Biologicals. Thanks to the vision and leadership of Norman Baylor, Editor-in-Chief, Biologicals is better prepared for future opportunities in the ever-changing publication arena. Look for updates on this milestone on our website, in the newsletter, and in the Journal!

2023 was also a year of transitions related to leadership and organizational change including the planned move of the Resources Mobilization Director to Actors4Health and the unplanned resignation of the Scientific Secretariat and Board and Committee Chairs Members). While we recognize and appreciate the contributions of those leaving leadership positions, we are looking forward to having new leaders join the organization this coming year.

Looking ahead, the Alliance is positioned well for another busy and productive year in 2024. Meetings on Next Generation Sequencing, Vaccination Strategies for High Pathogenicity Avian Influenza, Phage Therapy, Platform Technologies, and advancing Chemistry-Manufacturing-Control issues are just a few examples of planned future topics that will bring us together to help provide health solutions to everyone everywhere.

One of our greatest strengths is the ability to bring stakeholders together to develop innovative solutions for expanded accessibility to biological products and health tools, and I look forward to working with you in 2024 to maintain this level of excellence.

Best wishes for a healthy and prosperous new year.

Respectfully,

Rick Hill, IABS President  

IABS Celebrates the 50ᵗʰ Anniversary of Biologicals

Biologicals is a peer-reviewed journal that provides a modern and multidisciplinary international forum for publishing peer-reviewed original papers, reviews, and letters relevant to regulatory science as it relates to the development, production, quality control, and standardization of biological products for human and veterinary products derived from novel and established biotechnologies.

President’s Column June 2023

Dear IABS Colleagues, Stakeholders, Supporters, and Collaborators,

I am pleased to share highlights from the International Alliance for Biological Standardization’s 201st Board of Directors meeting held this June in Ottawa Canada (and virtually).  Looking ahead, IABS is positioned well to continue  on this path of adapting the organization to the changing world and realizing our mission to increase access to vaccines and other biologicals worldwide. In summary, the Alliance is financially sound, continues to increase its recognition globally and regionally, and is celebrating a milestone with the 50th anniversary of the publication of Biologicals.  IABS continues to lead the way on the shift to hybrid meetings, with most of our meetings now both “in person” and “virtual”.  With six conferences, meetings, or workshops on three continents since the last Board meeting, IABS continues to be recognized for its ability to provide an independent, neutral forum for the discussion of timely regulatory and scientific issues.  Thanks to the Scientific Committees for reinforcing the value of IABS as a leader and convener of parties interested in advancing contemporary biologics issues. 

Administrative announcements included the stepping aside of the Scientific Secretariat, Abbie Charlet, and the resignation of Board Member & former IABS Vice-President and IABS-EU President, Jean-Hugues Trouvin.  Resources Mobilization Director, Philippe Sabot has decided to discontinue activities with IABS and IABS-EU.  The Board recognized contributions and commitments to IABS and IABS-EU by these individuals, and they were thanked for their service and all they have done for the Alliance.  In order to cover all the work of the Alliance, activities were expanded with Madi Cox and her team at MC’Com Agency for IABS.  

Regarding the 50th anniversary milestone for the Alliance’s journal Biologicals, Dr. Norman Baylor, Editor in Chief, provides this update:  This year, 2023, the journal BIOLOGICALS (formerly JOURNAL OF BIOLOGICAL STANDARDIZATION, JBS, until 1989) marks 50 years of advancing the development, manufacturing, quality control, safety, efficacy, and regulatory aspects of biological substances used in medicine. The JBS was established by the International Association of Biological Standardization (IABS) in 1973 to encourage advancement of the standardization of biological substances. The last 50 years have seen significant changes in product portfolios for biological substances used in medicine and in regulatory science. The journal will continue to serve as a forum for the introduction and discussion of topics which directly impact innovation and regulatory strategy in the development and lifecycle management of biological products used to improve human and animal health globally.

The Board received an update regarding the Endowment Fund (currently named Actors4Health), that was established in 2021 for donors who would become eligible for tax reduction within Europe.  Philippe Sabot, Executive Director, Actors4Health endowment fund, provides this summary:  Resources mobilization: Following decrease of revenue from of Biologicals journal royalties and conferences income over past years, the fundraising effort initiated in 2019 is meant to address IABS needs to maintain and grow its capability, aligned with planned scientific projects. Seeking donations is an additional source of revenues, on top of sponsoring contributions from Biologics manufacturers.  An endowment fund eligible for tax reduction within Europe was created in 2021 in France under the control of IABS-EU and provides an additional tool to collect donations. This fund where donations from companies active in the Biologics industry and other contributions are mixed, also allows to manage potential conflict of interest .Together with existing US IABS 501 (c) (3) registered public charities, and IABS Swiss tax-exempt status (still on-going effort), we are looking to set an easy flow of donations revenue from various geographies to support IABS and its affiliates. In 2022 an independent projects committee selection at Endowment fund level was created. First donors are Boehringer-Ingelheim, and Ceva. Sanofi is under negotiation and other companies are targeted. In March 2023 the board decided to give a new name to the IABS endowment fund: Actors4Health.”

In addition to Board, Officer and Affiliate meetings, most participants attended the latest IABS Conference (Maintaining the Quality of Vaccines Through the Use of Standards: Current Challenges and Future Opportunities).  Congratulations to Meeting Co-Chairs, Drs. Maria Baca-Estrada and Carmen Jungbäck for a very successful event!   Presentations and conference conclusions and recommendations will be the IABS website soon. 

IABS has a celebrated history, and there are great things in the future for the Alliance. Thank you for your continued support!

Rick Hill,
IABS President  

President’s Column 2022

Dear IABS Colleagues, Stakeholders, Supporters, and Collaborators, 

It was an honor to assume the presidency of this prestigious organization in 2022.  IABS has a celebrated history, and I am looking forward to more accomplishments to come!  

IABS is positioned well for the future due in large part to our outgoing President,  Dr. Joris Vandeputte.   Joris has an unending passion for the Mission of IABS and in his 6-year term as president he ensured that IABS remained on the cutting edge of biologics innovation as the world changed to meet the challenges of the pandemic.   Thanks to his vision and leadership, our organization is better prepared for future opportunities.  Please join me in congratulating Joris on a few of the accomplishments during his tenure as President:  

  • Updating and modernizing IABS’ Vision for the Future:  Health Solutions for Everyone Everywhere.  
  • Ensuring IABS Conferences adapted to the pandemic by switching to virtual conferences and webinars; many of which were dedicated to better understanding of SARS-CoV-2 and increased availability of vaccines. 
  • Hosting  a highly success celebration of our 65 anniversary along with the corresponding scientific conference in Lyon, France 
  • Highlighting IABS as partner in important global discussion around key topics such as correlates of protection and non-animal testing for batch release of vaccines
  • Facilitating the participation of Low- and Middle-Income Countries in IABS events.
  • Achieving broader recognition of IABS as an independent, high-level, convener among all biological stakeholders
  • Providing support to all  IABS Scientific Committees:  Biotherapeutics, Cell & Gene Therapy, Human Vaccines, and Veterinary Biologics

We are very fortunate that Joris remains as Immediate Past President on the IABS Board of Directors, and continues to play an active role in all of IABS’ activities, including Presidential Representative to the IABS Fonds de dotation.  

Looking ahead, IABS is positioned well to continue  on this path of adapting the organization to the changing world and realizing our mission to increase access to vaccines and other biologicals. One of our greatest strengths is the ability to bring stakeholders together to develop innovative solutions for expanded global accessibility to biological  products and health tools.  Recent meetings on Next Generation Sequencing, Vaccination Strategies for High Pathogenicity Avian Influenza and Advancing Chemistry, Manufacturing and Control, Statistics have spotlighted this ability.  Coming meetings on correlates of protection, non-animal testing, platform technologies, reference standards, globally harmonized specifications, real world data and the application of new generation sequencing are just a few examples of future topics that will bring us together to help provide health solutions to everyone everywhere.  IABS has evolved and diversified considerably since it was founded in 1955; and the organization has continued to improve. There are great things in the future for IABS and I am honored to serve as your President during these exciting times.

Thank you for your continued support and best regards,

Rick Hill,
IABS President  

ADVAC Alumni Webinar

Dear ADVAC Alumni, ADVAC lecturers and other interested participants,

We are pleased to announce the next ADVAC Alumni meeting via Zoom webinar, the details of which are as follows:

Date:  Tuesday, 6 December 2022
Time:  15:00 to 17:00 CET (Geneva time)
Topic:  One Health:  does it work?  The example of monkeypox

 The agenda of the meeting is as follows:

 Co-Chairs

  • Joris Vandeputte, International Alliance for Biological Standardization
  • Kamel Senouci, ADVAC

Welcome and introduction

  • Joris Vandeputte (5 mins.)

Presentations

  • Update on the animal monkeypox (disease, epidemiology/outbreaks, prevention):  Yoshi Nakazawa, US Centers for Disease Control and Prevention (20 mins.)
  • Update on the human monkeypox (disease, epidemiology/outbreaks, prevention):  Brett W. Petersen, US Centers for Disease Control and Prevention (20 mins.)

Panel Discussion (30 mins.)

  • Joris Vandeputte
  • Jean-Marie Okwo-Bele
  • Brett W. Petersen
  • Yoshi Nakazawa
  • Panel Questions:
    • Did we use the adequate strategy to interrupt the human outbreaks?
    • Was the collaboration between veterinarians and medical doctors successful?
    • How to increase performance of early warning systems for early (potential) pathogen detection on animal and human side?
    • What are the challenges for One Health for monkeypox and other human-zoonotic diseases?
    • What are the perspectives for a better collaboration under the One Health umbrella?

General discussion and questions from the audience (45 mins.)

Should you wish to attend this important webinar, you can register directly by clicking on the following link:
https://artcast-medical.zoom.us/meeting/register/tZ0kcu6uqzgtE9L8JP47AdMur4UCd4S9uDAY

We do hope that you will be able to join us.

With best regards,

Philippe

Dr Philippe Duclos
Director, ADVAC

 

Current initiates for vector standards

Current initiates for vector standards

Note: for the purposes of this exercise, we have not considered ‘guidelines’ as standards, because they are intentionally flexible.  This means only physical reference materials are identified, no formal written standards were identified.

AAV

ATCC: Recombinant Adeno-associated virus 8 (VR-1816™)

  • The adenovirus reference standard materials can be used in the calibration of vector standards within individual laboratories and improve preclinical and clinical data comparisons using common dosages.

ATCC: Recombinant Adeno-associated virus 2 (VR-1616™)

Vigene Biosciences: AAV Reference Materials

Adenovirus

ATCC: Human adenovirus 5 (VR-1516™)

ISBioTech: Adenovirus Reference Material Project

4th Statistical and Data Management Approaches for Biotechnology Drug Development

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

Advancing Analytics for Biotechnology Products

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 learn more about the meeting