BIO Asia–Taiwan 2022 亞洲生技大會

BIO Asia–Taiwan 2022 亞洲生技大會

TEACHER

Ken J. Lee

Session 2 (Plenary) – Global Biotech Development

Date:27 July (Wednesday)
Time:  10:40 – 12:10 (GMT+8)

Ken J. Lee

General Manager and Region Head, Asia Pacific
Syneos Health

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Ken is a seasoned professional with almost 20 years of industry experience, including leadership roles in Clinical and Commercial Operations and Medical Affairs for both clinical research organizations and biopharmaceutical companies.

He joined Syneos Health in April this year and is leading the Asia Pacific Clinical Solutions business, providing executive leadership and oversight across thirteen countries, driving growth, customer engagement and quality project delivery.

He has extensive experience in large multinational CRO and pharmaceutical companies including IQVIA, Bayer, UCB and Sanofi. He has covered Asia Pacific, Europe, Canada, Middle East and Africa while being based in 6 different countries.

He graduated from Melbourne University Medical School and has completed executive education at INSEAD, IMD, Centre of Creative Leadership and Asian Leadership Institute.

Speech title & Synopsis

2022 Health Trends: Appropriate Acceleration in Clinical Development

Twelve years. That’s a number we’re all incredibly familiar with – the time to bring a new drug to market. A number all of us are obsessively working to reduce. The global pandemic allowed no such timeline. Even as COVID-19 interrupted important studies globally, clinical teams continued to drive speed in research and development that we’ve never seen before. Along the way, we learned what was possible in a crisis. For every COVID-19 trial working at massive speed and scale, there were many other trials for chronic and acute diseases that realized their own forms of innovation to engage sites and patients in a radically changed world. These experiences changed the expectations of sponsors, sites, advocates, patients and regulators alike. And they will forever change how innovative new therapies are discovered and developed. This session will cover how clinical development will be focused on appropriate acceleration, taking the learnings and advances derived during the pandemic and driven by the four pillars of innovative study design, real world data engines, flexible decentralized engagement and dynamic contracting to make accelerated timelines a reality. Topics include:

The use of platform trials and synthetic arms from real world data, innovative study designs that will drive study efficiency. 

How real world data is transforming our understanding of a new therapy’s use after pivotal trials, opportunities in rare disease and supporting novel approval arrangements.

Faster adoption of decentralization, including the ability to participate from home using remote monitoring and mobile nursing services–enabling clinical trials to be more efficient, reducing burden on patients, healthcare professions and sites, decreasing costs