| |OCTOBER 20248ASKBIO PARTNERS WITH BELIEF BIOMED TO ADVANCE GENE THERAPIESThe World Health Organization (WHO) issued guidance on how to enhance the organization and supervision of clinical trials in nations with diverse income levels. This guidance seeks to enhance country-led research and development ecosystems in order to progress health science and make new, safe, and effective health interventions more accessible and affordable worldwide, quickly.WHO has issued guidelines for national health authorities, regulatory bodies, funders, and others on how to support clinical trials in order to gather evidence on health interventions. It deals with issues like inadequate trial planning, lack of participant diversity, insufficient infrastructure, and bureaucratic inefficiencies, resulting in wasted time, resources, and lives.Serious inequalities in clinical trials are being caused by the global disparities between high-income countries (HICs) and low- and middle-income countries (LMICs). In 2022, 27,133 trials occurred in 86 high-income countries, while 24,791 trials took place in 131 low- to middle-income countries. Sometimes, LMICs are selected for participation in clinical trials because of their high disease rates. However, the data obtained is often used to approve health interventions in HICs rather than in the LMICs themselves."Strengthening country-led research and development and embedding clinical trials in routine clinical and public health services will ensure faster and more equitable access to safe and effective interventions, helping people become healthier," said Dr Jeremy Farrar, WHO's chief scientist. "This new guidance aims to improve the diversity of trial participants to ensure research benefits the broadest range of people possible, decisively moving away from a one-size-fits-all approach." POSklepios BioPharmaceutical (AskBio), has formed a strategic alliance with Belief BioMed in China to further the progress of innovative gene therapies. The goal of the collaboration is to take advantage of the experience of both companies in gene therapy technology, especially for conditions that can be addressed with a focus on the liver.BBM integrates viral vector technology to streamline the development, manufacturing, and medical application of gene therapy products for serious genetic and long-term diseases. The company has developed cutting-edge vector technology and established a platform for producing gene therapy drugs for commercial use in China.AskBio's chief scientific officer Mansuo Shannon explained that the company adopts a collaborative approach in developing new gene therapies, and they search globally for the most promising scientific advancements to achieve their objectives."The potential of BBM's next-generation capsid technology, together with the work we are conducting at AskBio, is promising. We are looking forward to working closely with the team at BBM."In July 2024, China National Medical Products Administration approved Belief BioMed's new drug application for a treatment of haemophilia B. This is the initial gene therapy product application submitted in China for an inherited genetic disorder.BBM has created novel engineered adeno-associated virus vectors. These items have shown promise in lowering immunogenicity and boosting transduction effectiveness in tests involving both humans and animals. Juergen Eckhardt, the head of business development and licensing at Bayer Pharmaceuticals, pointed out that gene therapy holds significant promise in the field of modern medicine, especially in terms of technical advancements. POTOP STORIESWHO ISSUES GUIDANCE TO BOOST CLINICAL TRIALS, SPEED HEALTH INNOVATION
< Page 7 | Page 9 >