Accelerating Global Deletion of the Abnormal Toxicity Test
Virtual event October 14th, 2021 – 12:30 -16:30 CEST
An EFPIA / AFSA collaboration event, in collaboration with IABS
Building from the results of HSI Symposium (https://lnkd.in/euHjhuer) (Rome, 2019) and on the IABS congress (https://lnkd.in/eGBPcU7X) (Bangkok, 2019), bring together a wider but specific range of key international and local stakeholders— including new ones with a keen interest in vaccine innovation and increased accessibility through diminished reliance on in vivo testing—to strategically agree on the way forward to the elimination of the ATT from the regulatory requirements for vaccines and biologicals.
Read more: (https://lnkd.in/gB-u34W5)
SAVE THE DATE
7th Statistics Workshop
Accelerating Drug Development: How QbD, Regulatory Partnerships, and Pandemic Learning Can Further Expedite Meeting Patient Needs
A Virtual Meeting
November 8-11, 2021
10:00am – 2:00pm EST // 16:00 – 20:00 CET
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.
IABS & BIOASTER Webinar on FMT*
Faecal microbiota transplantation (FMT) is widely reported to be an effective treatment against recurrent Clostridium difficile infections. Recent clinical evidences support the therapeutic use of FMT for several other pathologies including inflammatory bowel disease, cancer and other functional or metabolic disorders.
Initial guidelines are now available to overcome some of the technical and logistical issues in establishing a non-standardised treatment into clinical practice with proper safety and governance.
Recognized experts will give insights into state-of-the art approaches and standards developed by international organizations and institutions.
Panelists include speakers and :
– Dr. Jennifer Wargo, MD Anderson Cancer Center
– Dr. Gary Wu, University of Pennsylvania
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
I hope this message finds you safe and well as we start a New Year – 2021. While 2020 was an unforgettable year from a global public health perspective, it was a very memorable and unexpected year for the International Alliance for Biological Standardization (IABS).
Last January, we were busy putting the final touches on the plans for the 65th Anniversary of the founding our Alliance, as well as finalizing plans for the accompanying scientific conference New Paths for Sustainable Solutions to Tackle Global and Emerging Infectious Threats. As the meeting and a potential pandemic approached, we found ourselves adapting and adjusting as the celebration and meeting date approached. Little did we know that such adaptability would be required in all aspects of our professional and personal lives for the next 12 months.
In the end, the Anniversary celebration was a huge success and our meeting evolved to deal with scientific questions for the control of COVID-19. This foundational meeting also proved to be a preamble and a strong reference to IABS’ subsequent webinars on COVID-19. I was honored to represent the Alliance as the Master of Ceremonies of the event and present remarks on your behalf. For your information, my introductory remarks may be found at President’s Speech, 65th
Following the pandemic declaration, the world stayed at home and quarantined and IABS followed suit and canceled or postponed most of our planned meetings, conferences, and workshops. At the same time, our Scientific Committees quickly adapted to the new world and have since sponsored multiple COVID-19 webinars and held a very successful 4-day virtual meeting, the 6 th IABS Statistics Workshop: Approaches for Improving Statistical Partnership in CMC Development, Manufacturing, and Regulation of Biologicals. My thanks go out to the Human vaccine Committee and Dr. Pieter Neels, the Biotherapeutics Committee and Dr. Tim Schofield, and the Scientific Secretariate for all their hard work and efforts to make these new ventures successful.
While the virtual events have not allowed us to meet, they have allowed us to bring upwards of 500 people together for important global biological issues and topics. Who would have guessed that we would hold meetings in the middle of a pandemic that allowed for more attendees than any other IABS Conference, Meeting, or Workshop! Historically, the most powerful aspect of IABS’ work was to bring people together, face-to-face, at conferences for both interpersonal and professional collaborations.
Until we can meet in-person again we will continue to “see” you via webinars and videoconferencing at virtual events. I remain ever-optimistic that the Board of Directors will be able to meet in Ottawa, Canada in June in conjunction with the conference Maintaining the Quality of Vaccines Through the Use of References Standards: Current Challenges and Future Opportunities. This will be a foundational meeting that builds on the Alliance’s long history of involvement in standards development and standardization; the “S” in IABS. It would be tremendous if this meeting can continue as either a virtual, in-person, or “hybrid” event.
It has been our honor to work all with you this past year, and the Board of Directors and I look forward to our continued association in 2021. I am hopeful that the challenges of 2020 are behind us; and the New Year will bring new connections and opportunities.