The Galien Forum USA 2019



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The marriage of technology and medicine: Bringing out the best in each other

The massive increase in computer power together with the emergence of artificial intelligence (AI) and similarly advanced learning applications promise to put technology at the forefront of medical progress in the next decade. The ability to harness big data, bioengineering and physics to create “virtual” and biological simulations of the human body is one of the most consequential innovations, with potential to improve drug development and delivery and secure better patient outcomes, safely and at lower cost.

Already, the super-computer’s algorithmic, modeling and visualization capabilities enable scientists to construct a virtual, three-dimensional simulation of the actual human body and its numbingly complex biologic structure and systems.  Unlike current static screening tools like the MRI, this virtual display is anatomically precise and graphically interactive when viewed through the accessible architecture of the internet cloud. On the biological front, science is spurring the development of “organoids:” miniature, laboratory-grown versions of human organs.  Each organoid contains several cell types and has a simplified 3D anatomy that resembles the complexity of the in vivo physiology of actual human organs.  Organoids give researchers the ability to study different disease phenotypes, to assess genetic variability and apply tissue engineering and regenerative medicine to advance individual patient treatment – thus reinforcing the premise behind precision medicine.

Moreover, these simulation models will result in reduced risks in testing an early-stage compound or device directly in humans, which should in turn accelerate research while lowering costs by making clinical trials more timely and efficient. Researchers can probe for possible side-effect signals, observe the treatment effects of a drug or device on different organs, and program for hypothetical lifestyle changes and their impact on overall health status.  The models can also help inform delivery of a potential efficacious drug dose to where it will administer the maximum therapeutic effect.

The models are still evolving and will vary as how they are applied to different organs and body systems. At present, the best application for the virtual human model is in the study of heart disease and respiratory disorders that impact the lung. Being able to program for and then visualize various movements of the heart muscle and even see how this vital organ interacts with the lung can provide truly useful lessons for cardiologists in managing the same physiological expression in the real-world clinical setting with patients. One example is the possibility of learning why up to a fifth of pacemakers implanted in humans to regulate heartbeat don’t end up working – a persistent problem that considerably raises the cost of cardiovascular care.

Likewise, the organoid model has two important biomedical applications: to drug discovery and regenerative medicine.  For example, in cancer, the organoids can be used to direct therapy for specific cancer types with a focus on the appropriate selection of standard of care chemotherapeutics.  There is also potential for expanding this screening to include novel anti-cancer compounds.  In regenerative medicine, engineered organoids demonstrate that cells have the ability to reorganize into tissue-specific structures for replacement of parts of severely damaged organs and surrounding tissue.

An important initiative to promote applications of the new technologies is the Innovation Platform in Multiscale Bioimaging partnership between Olympus Inc. and the University of Southern California (USC).  Two internationally recognized scientists, David Angus MD and Scott Fraser Ph.D, and their respective teams are pioneering the development of 3D and 4D imaging of single cells, organoids and tumor ecosystems.  Another pending development, due later this year, is the launch of clinical trials designed to test a personalized, laboratory derived human cell-grown heart valve in patients as an alternative to the standard of care options of a manufactured or animal donor replacement.

To further explore this marriage of technology and medicine, the session panel of experts will discuss the implications of these new models for generating improved safety and efficacy evidence to guide decisions on treatment.  How quickly can these novel multi-disciplinary approaches succeed in transforming clinical research and accelerate the transition to precision medicine? What does the technology mean for the future of clinical development, particularly the choice of end points and the design of an optimized clinical pathway to regulatory approval?  And what does the technology mean for the future of health care in general, particularly as the power of algorithms seconded by AI impact the human element in the delivery of care?

The panel will be chaired by Professor Bengt Samuelsson, 1982 Nobel Prize laureate for physiology or medicine, Former Chairman, Nobel Foundation, Professor Emeritus at the Karolinska Institute and member of the Prix Galien USA Committee.