The complement system is a crucial component of the immune system and is involved in nearly every cellular process. It plays a role in various diseases, including autoimmune disorders and inflammatory conditions. In 2023, the FDA approved four new complement inhibitors for different diseases. Three of these inhibitors target Complement C5 central protein, and one targets Factor B. The development of complement-targeting therapies holds immense potential in addressing these challenging conditions.
In 2024, the Life Science industry can expect significant progress in the development of complement-targeting therapies, with a focus on new target molecules, including the first inhibitors of Factor D. We anticipate that the advent of innovative pharmaceutical tools such as Complement-dependent cytotoxic assays, functional assays, and cell-based assays will pave the way for the development of novel modulators to enhance the development of these therapeutics.
The development of curative therapies, such as gene therapy and immunotherapy, has revolutionized the treatment landscape for a range of diseases. However, as we progress in the field, the need to ensure safety is becoming crucial. The assessment of the complement activation in response to viral vectors has gained relevance since more evidence of the complement system's role in viral vectors and gene therapy has emerged in 2023.
In 2024, we expect more advancements in using novel bioassay technologies, such as the AAV Nabs assay, to determine immune barriers that could affect the efficacy of gene therapy.
In 2023, the use of monoclonal antibodies and bispecific antibodies to treat different types of cancer reached new heights. The FDA approved four bispecific antibodies, two of them being CD20xCD3 bispecific antibodies. Two PD1-targeted monoclonal antibodies also receive FDA approval, one for metastatic or recurrent locally advanced Merkel cell carcinoma and the other for nasopharyngeal carcinoma. These antibodies are a class of immune checkpoint inhibitors that activate T-cell responses in cancers.
Robust CDC, ADCP, and ADCC assays will enable more precise and reliable assessment of monoclonal antibodies and bispecific used in immunology. We are confident that these assessments will accelerate the development and approval of transformative treatments, bringing hope to patients in need.
The rapid advancement of digital health technologies has paved the way for a patient-centric revolution in healthcare. This is particularly evident in the rise of gastrointestinal diseases like IBD, which significantly impact patients' quality of life. With reliable eHealth solutions, IBD patients can remotely monitor their condition, which empowers them to take proactive and efficient care of their health since it helps reduce the number of acute visits and admissions.
Additionally, eHealth technology enables the monitoring of disease activity in real-time, allowing for personalized treatment and improved patient outcomes. In 2023, reimbursing eHealth solutions for IBD care was adopted by the Chezch Republic, and we hope that other countries will follow suit. Furthermore, we can expect further integration of eHealth solutions in clinics by 2024.
In the quest for precision medicine, patient-centric approaches are gaining prominence. Therapeutic Drug Monitoring (TDM) is one such approach that involves monitoring drug levels in patients. By monitoring drug levels in patients, healthcare providers can customize treatment plans to fit their unique needs, optimizing dosing and minimizing side effects. Healthcare providers can feel confident in TDM's ability to provide personalized care.
In 2024, we hope to see an increase in patient-centricity, with TDM becoming an integral part of therapeutic strategies.