Bio Box Australia

The clinical trial environment was already evolving at a rapid pace before the presence of COVID-19, but now speed and efficiency are paramount. With a focus toward achieving faster time to market, reducing R&D costs, and increasing clinical trial success rates, various digital tools such as AI, machine learning, telemedicine are quickly becoming the next frontier in clinical studies.

Alongside the case study sharing of these digital strategies, multiple illustrative examples will be used to present the practical considerations and execution of designing and running various adaptive design strategies, including logistics and impact on clinical operations, data management, and randomization services with focus on implications for statisticians.

Conducted in the format of a fireside chat, in this session you will be able to gain insights into:

• Understanding the impact of today’s environment on clinical trials and their patients
• Collaboration and new business models
• Clinical study design thinking focus to reduce cost, accelerate speed to market and reduce regulatory burden
• Technology innovation for clinical trials – where do we stand?
• Critical steps of establishing an effective digital strategy
• Case study sharing and Q&A

Moderator:
Dr. Chen Guang, Consultant and Clinical Diagnostics Technologist, Stronghold Diagnostic Lab – A*STAR, Singapore

The Expert Panelists:
Dr. Harish Dave, Co-founder and Chief Medical Officer, AUM Biosciences, Singapore
Dr. Tam C. Nguyen, Deputy Director of Research, St. Vincent’s Hospital Melbourne, Associate Professor, Melbourne Medical School, Adjunct Associate Professor, RMIT University, Australia
Dr. K. Arnold Chan, Director of Clinical Trial Center, National Taiwan University Hospital, Taiwan

The COVID-19 global health emergency has cast a spotlight on the lengthy and complex process of researching, developing and accessing therapies in Australia and around the world. In light of the urgency, stakeholders across the globe have successfully utilised existing fast track mechanisms and developed new ones to allow the rapid approval of clinical trial protocols and evaluation of investigational drugs which had shown therapeutic potential.

This hour-long Bio Box Episode will cover:

• Introduction to the current and evolving regulatory landscape in response to COVID-19
• Compare and contrast the regulatory and government responses in Australia, the US and Europe to allow emergency use for
• In-Vitro Diagnostics (IVD) – how they are being used to respond to the testing needs as the COVID-19 pandemic emerged and spreads.
• Medicines– changes and lessons in light of off-label prescribing
• Vaccines

For each of the above topics, the panel will explore:

• Available regulatory pathways
• Comparative timing in issuing guidance on emergency use
• Accessibility to regulators for guidance

Speakers:

Nicoletta Muner, Managing Director, Canary Regulatory Affairs

Adriana Stefancic, Managing Director & Principal Consultant, Adriaus Consulting

• Addressing the challenges of expensive and time consuming processes with the convergence of AI and cancer therapy
• Going back to the beginning: Re-designing trials for success
• “Dynamic dosing” and dose modification to improve the efficacy and safety of treatments
• The regulatory response and experience

Summary
Traditional clinical trial designs represent established approaches to bring new therapies to patients. Current approaches used to pinpoint suitable doses rely on dosing cohorts which often result in population-based doses, which while suitable for translation, can result in sub-optimal dosing and patient response on a larger scale. To address this challenge, artificial intelligence has been explored to enable patient-specific dosing that uses a patient’s own data to manage only their own care. This scalable approach, which is mechanism-independent and disease indication agnostic has been studied in pilot N-of-1 trials for oncology, infectious diseases, and transplant, and may lead to improved patient response rates and outcomes.

Speaker:

Prof. Dean Ho, Provost’s Chair Professor, Director of The N.1 Institute for Health (N.1), Director of the Institute for Digital Medicine (WisDM), and Head of the Department of Biomedical Engineering at the National University of Singapore

• Emerging digital tools currently used in drug development
• Where the REAL opportunity lies for use of AI and digital medicine
• Tuberculosis case study: From cells to people in a year and a half; cutting treatment time by ½, spending 100x less
• Interpreting fresh data we collect, not using old data
• Combatting COVID-19 – A whole study done in 10 days
• Advantages of this approach for COVID-19

Summary
With the emergence of COVID-19, a global effort to find promising drug candidates has led to broad spectrum of promising agents. However, beyond the identification of suitable therapies, there is a need to develop combination therapy regimens that are efficacious and accessible. To address this challenge, artificial intelligence (AI) has been explored, largely in the drug discovery space. However, it is important to note that drug discovery and drug development are distinct segments of the roadmap that should be seamlessly integrated to ensure that promising drug candidates can be optimally integrated into combination therapy regimens. This talk will discuss recent advances in the use of prospective experimental validation and an AI-based optimisation strategy to actionably pinpoint multi-drug regimens for COVID-19 and other indications.

Speaker:

Prof. Dean Ho, Provost’s Chair Professor, Director of The N.1 Institute for Health (N.1), Director of the Institute for Digital Medicine (WisDM), and Head of the Department of Biomedical Engineering at the National University of Singapore

• Defining virtual trials and understanding the many terms used
• Common technologies used in virtual trials around the world, what are the most effective digital tools used and how does Australia use these compared to other markets?
• The role COVID-19 has played in bringing virtual trials and digital technologies to the fore both here and abroad
• Examples of virtual trials successes here in Australia
• The advantages of virtual clinical trials and using patient facing technologies – particularly in Australia
• Overcoming the obstacles to incorporating virtual components into trials and myth busting
• What needs to be done to realise the potential of virtual trials in Australia?
• How can we retain aspects of virtual trials post-COVID?

Speakers:

Michael Tucker, Senior mHealth Solutions Specialist, Medidata, a Dassault Systèmes company

Dr Tina Soulis, CEO, Neuroscience Trials Australia

Rosa Gonzalez Galindo, Sr Vice President Clinical Development, Immunology and Inflammation, Syneos Health