International Alliance for Biological Standardization

Dear IABS Colleagues, Stakeholders, Supporters, and Collaborators,

Welcome to the new year!

I am pleased to report that the International Alliance for Biological Standardization (IABS) Board of Directors and the General Assembly had very successful meetings in December 2024 in Frankfurt, Germany.  Alliance leaders reported on conference and Journal (Biologicals) activities of this past year and outlined plans for 2025.

After beginning the year with a sparsity of conferences, the IABS Scientific Committees finished strong by conducted seven workshops/conferences in 2024.  While the overall revenue for 2024 was slim, from a scientific perspective it was an outstanding year for the Alliance.  Several of our conferences built on earlier events (e.g., HPAI, NGS) and congratulations to the organizers of the Statistics meeting for their 10th meeting; a momentous event!

Feedback from conferences continues to highlight IABS’ 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. Looking ahead, the Alliance is positioned well for a very busy and year in 2025 with nine (9) conferences in the queue.

The Board of Directors also devoted one full day in Frankfurt to strategic planning and discussions focusing on four major areas (Organization and Administration, Marketing and Outreach, Finance, and Biologicals) for the Alliance.  Board and Executive Committee members outlined key activities that will help IABS address what has changed in the world that impacts the way we will fulfill our missions.  Future newsletter updates and other messages are planned to share results with all IABS members as we look ahead to our 75th Anniversary in 2030.

2024 was also a year of transitions related to leadership of the Alliance. Member voting confirmed the appointment or reappointment of 8 Board members who will join current members for the 2024-2026 term.

We are fortunate to have dedicated individuals on the Board and Committees in support of the Missions of IABS and Biologicals.  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 2025 to maintain this level of excellence.

Best wishes for a healthy and prosperous new year.

Respectfully,

Rick Hill, IABS President

IABS’ vision is « health solutions for everyone everywhere”. IABS achieves this through open exchanges between all stakeholders in the field of biologicals (vaccines, biotherapeutics, cell and gene therapy).

The ultimate goal is to increase access to so needed vaccines and innovations  which allow to tackle diseases for which no remedy or prevention existed before. Trough the continuous interactions between all stakeholders, IABS specifically aims at contributing to regulatory process on a science based approach to foster global access.

IABS acts in a totally independent way. It needs support of human and financial resources. When its  board acts on a pro bono principle, its activities are only possible if they can be funded.

To achieve its main goal: global access, it created the funding mechanism ACTORS4HEALTH. ACTORS4HEALTH can receive donations from private persons as well form organisations. The funds go into a common account. The independent scientific committee decides on the allocation of the funding.

Donation to ACTORS4HEALTH in the European Union is compensated by tax reduction for the donor.

ACTORS4HEALTH will allow IABS to diversify and strengthen its actions to increase access to vaccines, biotherapeutics and cell and gene therapies, the latter to fight cancer more efficiently.

Examples of actions with impact on better health care:

• Correlates of Protection for COVID vaccines: bringing vaccines to patients is a lengthy process. Clinical trials take a big part of it.  Vaccines  which are licensed have not only proven safety and efficacy in clinical trials, they also generate important data on immune proflling, like antibodies and cellular  immunity which are in correlation with protection. In almost all cases, one or two vaccines are not enough to cover the needs of everybody everywhere. If we find a way that newcomers can proof that they develop the same or similar amount of antibodies and/or cellular immunity as the already approved vaccine(s), the clinical trials can by shortened tremendously and access to vaccines increased for all with numbers of years. IABS is working on this.

• New platform technologies allow quicker vaccine development. If a vaccine is licensed based on one technology platform, mRNA for example, the same platform can be used to develop a vaccine against other diseases. In that case, these “follower” vaccines can use the common parts of the file without being obliged to redo all the trials. This represents a gain of time and investment to increase access to vaccines for pandemics and diseases for which no vaccine exists today.

• Establishing standards for vaccine testing: the quality of vaccines is tested against validated standards to assure that vaccines reach at least the quality of well-known standards. The production and availability of widely accepted standards is a key factor for global access to quality vaccines. IABS promotes and supports the establishment of such standards to not only assure access to vaccines but also guarantee their quality everywhere.

• Reducing the use of animals for release of vaccines to the market: Since decades, vaccines are released to the market after safety and efficacy testing in animals. These animal tests are costly, lengthy, moderately, and badly reliable and pose a huge burden on animal welfare. In many cases these animal tests can be replaced by in vitro laboratory tests which are much more precise and reliable, short in time and less costly shorting time for access to vaccines and antibodies and increasing global access.

• Quality specifications for biologicals: As in the case for Standards, there is a large array of specifications in vaccine, antibody and cell production that must be complied with to assure the quality of the products. Understanding and complying with the specifications assures robust production processes, high quality and increased access and comparable quality everywhere.

• NGS (New Generation Sequencing) allows to guarantee the quality attributes of biologicals and their purity in a very short time with the highest precision. It allows further reduction of the use of laboratory animals. NGS increase speed of quality assurance and by this way access for all to high quality vaccines, antibodies and cell therapies.

• INNOVATION: innovation and today modern technologies generate vaccines and other biologicals which allow prevention and treatment of diseases which were totally fatal only 10 years ago: without new platform technologies no new vaccines against COVID, RSV (bronchiolitis in children) and many others to come, just like the huge progress in immune and cell therapy in cancer. Innovation is the HIGHEST PRIORITY OF IABS: anticipate the impact of new technologies and assure their way to patients everywhere.

• Cell and gene therapy: IABS is active in supporting cell and gene therapy developments and regulatory processes so that they profit to cancer patients.

• Autogenous vaccines for livestock: animals can be victim of infectious diseases for which no cure nor vaccine exists. In some cases, the solution exists in isolating the germ causing the disease in the farm and make a vaccine out of it for use in the farm. Very often this leads to the solution of the disease problem. IABS promotes the establishment of rules on safety and efficacy specifically adapted to this kind of vaccines.

ACTION MODE OF IABS TO REACH THOSE OBEJCTIVES: bringing together, in each field, the best world specialists recognized for their expertise in science, governance, regulatory, industry, quality assurance in both human and animal health. IABS’ role in these meetings is to push all stakeholders to reach consensus on most relevant solutions. The conclusions are published in free access and serve to adapt regulations resulting in better access for all to quality vaccines, antibodies and other biologicals.

In participating at IABS meetings, each participant behaves independently. As such, IABS meetings generate a better understanding of the problems and challenges faced by each stakeholder.

FUNDING CAPACITY BY ACTORS4HEALTH WILL STRENGTHEN AND EXPAND IABS capacity to go better access to health everywhere.

IABS has been collaborating with Humane World for Animals (HWA) 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).