Commentary on the discovery, innovation, and challenges in advancing blood and biotherapies

What is it about?

Advancing innovative research has been a vision of AABB's (Association for the Advancement of Blood and Biotherapies) National Blood Foundation (NBF) since the early 1980s. In 2021, the NBF convened a summit of key scientists and clinicians, many of whom have been funded by NBF, to discuss the incremental advancement throughout the past 40-50 years, current innovations, and challenges faced by the blood and biotherapy communities. Looking at the last half of the 20th century and the beginning of this century, many seminal discoveries have influenced today’s state of the science. The Summit focused on discoveries that have led to dramatic safety advances regarding alloimmunization (erythrocytes and human leukocyte antigens), hemolytic disease of the newborn (Rh immune globulin), infectious disease transmission/prevention, and chimeric antigen receptor (CAR) T- cell therapies. Rightfully so, some of these discoveries have led to Nobel awards and AABB recognition. Not resting on the laurels of the past, the Summit addressed two innovative products – one diagnostic and the other therapeutic – both of which have been incubating for several years. The diagnostic application used functional heads, spacer and lipid epitope constructs to modify erythrocyte membrane with peptides and glycan epitopes through Kode technology. The second was therapeutic, using human platelet lysate for cell therapy and regenerative medicine. In addition, examples from Canadian Blood Services and Vitalant illustrated new concepts to link research and discovery to routine blood operations. Both blood organizations elaborated on the importance of an incubator or “sandbox” environment to bridge from a less regulated environment of the research laboratory to the more stringently regulated environment of formal preclinical development, controlled manufacturing and clinical trials. The importance of a risk-tolerant ecosystem of academic, clinical, corporate and government partners to achieve a high-risk-high-reward transformation was highlighted by the Biological Technologies Office of the Defense Advanced Research Projects Agency (DARPA) of the U.S. Department of Defense. Funding opportunities as well as a new program, Fieldable Solutions for Hemorrhage with bio-artificial Resuscitation Products (FSHARP), highlighted a potential ecosystem for discoveries in the field of blood and biotherapies. One example of government collaboration with academia was DARPA-funded biostasis research for potential human whole blood storage. To this end, Dr. Thomas Boothby and colleagues from the University of Wyoming have applied lessons learned from the study of tardigrades and their ability to survive extreme conditions. Finally, scientific experts addressed challenges facing the blood and biotherapies field and highlighted areas in which innovation is needed. Challenges such as the commercial pipeline of cellular therapeutic products, donor recruitment/retention to support adequate blood supplies for precision transfusion medicine, universal leukoreduction and an adequately medically trained workforce to support the good manufacturing practices (GMPs) in the development of biotherapies, most notably CAR T-cell therapies. The last point reflects the severe manpower shortage of highly trained medical technologists, who deliver most of the direct patient care products and services associated with blood and biotherapies.

Featured Image

Why is it important?

The commentary on the NBF R&D Summit highlights current challenges and the need for an innovative ecosystem supporting collaboration between key government, academic and corporate partners. Within such an ecosystem, pathways need to be established to foster not only foundational discoveries but implement novel discoveries for improved patient outcomes as well as enhancement of process/product improvement. Enhanced blood and biotherapeutic innovative ecosystems are needed for high-risk-high-reward transformation

Perspectives