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Cell & Gene Therapy
There are over 1,500 ongoing clinical trials for cell and gene therapies registered with ClinicalTrials.gov. Of these, 90% are in Phase I and II trials and the median approval rate from Phase II to approval is just 14%, for comparison, small molecules would be around 43%.
It is predicted that the number of trials in 2030 could exceed 5000, highlighting the need to secure true experts in this rapidly evolving landscape.
Today
Cell and gene therapy represent a groundbreaking frontier in medicine, offering immense potential for transforming patient care.
With a growing population facing complex and often incurable diseases, such as cancer, genetic disorders, and autoimmune conditions, there is an urgent need for innovative treatment options.
Cell and gene therapies have shown remarkable promise in providing targeted and personalised treatments, enabling the potential for long-lasting and even curative outcomes. However, the field also faces significant challenges, including limited patient access, high costs, complex manufacturing processes, and stringent regulatory requirements.
Tomorrow
Looking ahead, the future of cell and gene therapy holds great promise.
Advances in gene editing technologies, such as CRISPR-Cas9, have revolutionised the ability to precisely modify genetic material, opening up possibilities for correcting disease-causing mutations. Additionally, the development of novel delivery systems, such as viral vectors and nanoparticles, allows for efficient and targeted delivery of therapeutic genes or cells to the desired sites in the body.
Despite these advancements, manufacturing scalability, quality control, and regulatory considerations remain critical hurdles to overcome in order to ensure widespread adoption and accessibility of these transformative therapies.
Tx Five
Tx Five is uniquely positioned to address the specialised needs of cell and gene therapy. With an extensive network of expert physicians, scientists, and industry professionals, we connect clients with leading minds in the field.
We can partner you with experts able to provide strategic guidance, protocol support, and regulatory expertise, ensuring successful clinical development and implementation.
From designing robust clinical trials and interpreting clinical data to addressing safety and efficacy considerations we are proud to have a network able to deliver cell and gene therapy programs with scientific rigor, keeping complex regulatory pathways in mind.
