With the high levels of uncertainty when working on live animals and human models, it is unsurprising that approximately 30 percent of promising medications fail in human clinical trials because of their pharmacovigilance properties. Thus, eliminating adverse effects at the earlier stage of drug development process will save costs and time for sponsor companies investing in the research, enabling researchers to better to focus more of their time in working on safer, more promising drugs.
Joining us at BioPharma Asia in Singapore on 21-23 March, is Dr Dan Tagle, Associate Director for special initiatives at NCATS. Also recently appointed to serve as the acting director of the NCATS Office of Grants Management and Scientific Review, he is also the executive secretary to the NCATS Advisory Council and Cures Acceleration Network Review Board. Prior to his presentation at Biopharma Asia, we asked him a few questions to provide our readers a better understanding on what they can expect from his presentation on how tissue chips can help in better disease modelling.
Q: Please tell us more about the limitations of current disease modelling methods
Tagle: While current in vitro and in vivo disease models have led to some key discoveries and therapies in the past, there are still inefficiencies in the drug development process using these current tools which have contributed to the high cost and lengthy time line in getting drugs to patients. Despite the promising results from pre-clinical studies, about 30% of drugs have failed human clinical trials due to adverse events, and another 60% fail due to lack of efficacy.
Q: How do tissue chips help to mimic life systems and improve drug development success rates?
Tagle: Tissue chips are bioengineered microphysiological systems that utilizes chip technology and microfluidics to mimic tissue cytoarchitecture and functional units of human organs. Since tissue chips capture the complex cellular composition, microenvironment and biomechanical properties of the various human organ systems, it is anticipated that more physiological response to drugs, toxins and other agents can be obtained using these tools.
Q: What are the alternative ways other than tissue chips, which can be considered for a more success drug development process?
Tagle: There is a shift towards more 3-D methods, such as 3-D bioprinting or organoids in culture, in an attempt to capture more physiological human response to candidate drugs, however these systems do not have the biomechanical features that would be found in tissue chip technology. Other approaches would involve “humanized” animal models.
Q: How do these techniques help in moving forward towards the goal of personalised medicine?
Tagle: Tissue chips uses predominantly iPSC-derived cells from patients and controls to mimic the tissue architecture of human organ function under normal or diseased conditions. It is conceivable to have many tissue chips seeded with iPSC from diverse sources representing the demographics of a country or world. Likewise individual genotypes can also be represented on tissue chips to capture a single person’s response to a particular therapeutic. It would be an ideal tool to find the right medicine for the right person at the right time.
Q: What’s the role of NIH in leading research towards personalised medicine, and how does it impact the populations in Asia?
Tagle: The NIH is a leader in biomedical research funding, including the area of personalized or precision medicine. Through the “All of Us” research program , the NIH is leading efforts to build a national, large-scale research infrastructure to engage at least a million individuals in a study in order to gain a better understanding of how individual variability in environmental exposure, lifestyle and genotype can be used to develop more effective ways to maintain health and treat disease for each individual, and the population as a whole. Science is very a global enterprise , and any NIH-led effort to improve health will no doubt have an impact worldwide, including populations in Asia.