Dear IABS members and stakeholders,

Our journal, Biologicals, reached an important milestone in 2023; it’s 50th Anniversary.  If you have not read Volume 85, February 2024, I suggest checking out the first article entitled Fifty Years of Advancing Biologicals and Beyond. The article provides an excellent summary of the evolution of Biologicals and highlights the role the journal played in the transformation of the biologicals arena over the past 5 decades.  Biologicals is a shining star for the Alliance thanks to all of the Editors in Chief and the multitude of individuals involved in the review, editing, and publication process over the years. 

The other recent Alliance activity was the Board meeting which took place just prior to the summer break.  During the meeting, a significant amount of time was dedicated to our conference and workshop schedule.  After beginning the year with a sparsity of conferences, the IABS Scientific Committees have seven workshops or conferences planned for the remainder of the year; setting up 2024 to be another outstanding year for the Alliance.  Several of these conferences build on earlier events (e.g., HPAI, NGS, Statistics) reinforcing the role of IABS in providing events that address ongoing regulatory and scientific issues.  Thanks to the Scientific Committees and Conference Chairs for highlighting the value of IABS as a leader and convener of those interested in advancing contemporary biologics issues. 

Due to the work of our volunteers and staff, IABS remains positioned well for the future.  2024, however, continues to be a year of transformation with additional leadership and organizational changes. The Communications Chair remains vacant and 2024 is an election year for ~1/3 of the Board of Directors members. There will also be four additional Board vacancies with Dr. Becky Sheets, Dr. Takao Hyakawa, Dr. Maria Baca-Estrada, and Dr. John Purves Board of Directors seats opening up.  These four leaders have been a crucial part of IABS history, and we will miss their contributions to the biologicals field and the Alliance (summarized below).  Please join me in thanking them for their service and recognizing their commitments to IABS and global health. 

• Dr. Becky Sheets had a long and distinguished career with the US Government and retired from service in 2013 to serve as a biologicals consultant, educator at a local university, and a distinguished author.  Her IABS activities have been quite varied starting with the Human Vaccine Committee where she served as member, Co-Chair, and Chair.  The first meeting she facilitated was on Human Challenge Trials (now known as CHIM) and she has also organized meetings on cell substrates and adventitious agents, risk assessment and rabies vaccine testing.  While serving on the Board of Directors she has also served on the Communications Committee and as Website Content Manager.  She also served as Biologicals Reviewer and was Board Vice-President. For the past two years she has been IABS’ liaisons to the WHO and has actively represented IABS on many issues.  Becky is an inaugural member of IABS-North America and served as Vice President for the past 6 years. She has leant her expertise across a wide spectrum of IABS activities and her contributions have been invaluable to IABS’ reputation and history.  Becky will be stepping off the Board of Directors when her term ends this December.

• Dr. Takao Hyakawa provided significant contributions to the biological and biotechnology arenas as a regulatory scientist as well as an academic researcher who epitomizes the value of diverse collaboration on issues facing the biological industry.  His participation and leadership in WHO and the foundational phases of the ICH process no doubt influenced the successful path of these global collaborations.  Takao’s contributions and support of IABS conferences throughout the myriad ICH activities helped advance our mission and role in clarifying scientific issues while achieving consensus recommendations in support of the multitude of ICH guidelines he helped develop.  His work continues to impact product development and availability of biologicals globally and his association with IABS helped advance our mission, activities, and reputation.  Takao was instrumental in the establishment of the Cell & Gene Therapy Committee and its creation was critical and timely in addressing the complex emerging issues in this arena.  He has been a long-term Member of the Board of Directors and has helped the Alliance through critical times and issues.  His unique perspective has always added to the conversation and aided the search for positive solutions.  Takao stepped off the Board of Directors late last year and we miss his presence on the Board. 

• Dr. Maria Baca-Estrada received her PhD in immunology from the University of Glasgow, UK and worked at McMaster University (Canada) as a post-doctoral fellow and later as a Research Scientist at the Vaccine and Infectious Disease Organization (Canada). Her research included approaches to develop new vaccine formulations and alternative routes of vaccine administration (e.g. oral, skin). She joined Health Canada in 2002 as a regulatory Scientific Evaluator and was later appointed Manager of the Bacterial and Combination Vaccines Division. Dr. Baca-Estrada worked with the World Health Organization as a Scientist with the Quality, Safety and Standards team and participated in the development of WHO guidelines and recommendations to support regulatory evaluation of vaccines. Dr. Baca-Estrada returned to her position in Health Canada and had a celebrated regulatory science career in Vaccine Quality Review and was actively involved in international collaborations with many organizations in the Biologicals area. Prior to her retirement she led Health Canada’s COVID-dedicated Clinical Review Division helping the world navigate the response to the Pandemic.  Maria served as Chair on the (hugely successful) References Standard meeting in Ottawa and has been an active participant on the Board with many outstanding contributions during her tenure. We will miss her thoughtful and insightful participation on a multitude of Board-related topics.

• Dr. John Purves graduated with a Ph.D. in Pharmacy from Strathclyde University. After a brief stint with R&D in the pharmaceutical industry, he moved to the Medicines Control Agency (MCA; now MHRA), where he managed and coordinated the evaluation of Market Authorisations within the department for the British Government for more than two decades. He subsequently moved to the European Medicines Agency (EMA) from 1996 to 2010, where he had continued involvement in the development of European legislation and guidelines. In his role as the Head of Sector, Quality of Medicines, he managed and coordinated the evaluation and maintenance of Market Authorisations on behalf of the EMA / European Commission in collaboration with the network of Member States and Iceland and Norway. He has extensive experience in the European Regulatory System as an independent advisor to the pharmaceutical industry. More recently, from 2020 onwards, his interests have concentrated on biological sciences in relationship to the quality of medicines in the many innovative aspects of life sciences; which fit well with IABS objectives.  John brought a unique perspective to the IABS Board of Directors, and we will miss his valuable contributions. 

It has been a pleasure to work with these amazing individuals and I especially appreciate their dedication to the mission and skill at providing constructive interventions on a multitude of difficult issues facing the Alliance.  We will miss their contributions to the Board of Directors and their dedication to IABS.  

The next Board meeting will take place in December after fall elections.  Filling vacancies, continuity of operations, and strategic planning will be especially important agenda topics for the meeting.  Specifically, Board meeting will include a strategic session related to preparing for our 75th Anniversary.  Where will the Alliance be in 2030?  What do we hope to achieve by then to best prepares IABS for the future?  As we prepare for the meeting, I am most interested in any comments you have on this topic – feel free to drop me a line with your thoughts.  IABS has evolved and adapted since it was founded in 1955, and the organization will no doubt continue to change.  We are fortunate to have dedicated individuals on the Board and Committees in support of the Mission of IABS and Biologicals.  IABS offers a truly unique perspective on biological standardization and is recognized as a global leader in the biological arena, and I look forward to working with you to maintain this level of excellence. 

Respectfully,

Rick Hill, IABS President