Oncology drug development is under increasing pressure as programs face rising costs, extended timelines and persistently low success rates. Traditional oncology trial designs often struggle to keep pace with rapidly evolving science, complex biological targets and the need for earlier, more confident proof-of-concept (PoC) decisions. This webinar explores how adaptive, data-driven and globally integrated approaches can improve development efficiency while maintaining scientific and regulatory rigor.
The session will examine three complementary strategies reshaping oncology trials: Bayesian model-assisted designs, master protocols and the integration of real-world evidence (RWE). With a focus on accelerating PoC and enabling earlier inclusion of China in global development pathways, the webinar will show how these approaches can support faster go/no-go decisions, reduce patient exposure to suboptimal or excessively toxic doses and improve the probability of identifying the optimal biological dose.
Attendees will learn how Bayesian designs can support flexible, information-rich dose finding and extend beyond dose escalation into early expansion cohorts, where safety, pharmacodynamic and preliminary efficacy signals can emerge sooner. The session will also explore how master protocols, including basket, umbrella and platform trials, can reduce redundancy, shorten timelines and improve statistical and operational efficiency across global programs.
RWE will be discussed as a tool for strengthening evidence generation by supporting external or hybrid control arms, contextualizing single-arm PoC results and informing dose, population and endpoint selection. Together, these strategies can help sponsors optimize resource allocation and support earlier, more confident development decisions.
Register for this webinar to learn how oncology trial strategies can accelerate proof-of-concept, improve development efficiency and support global evidence generation.
Speakers
Luke Gill, VP, Global Head of Oncology Scientific and Medical Affairs, Emerald Clinical Trials
Luke Gill, VP, Head Global Oncology, brings more than 25 years of leadership experience spanning global clinical development, operations and strategic partnerships across the biotech and CRO sectors.
He has successfully built and scaled oncology organizations, leading programs from first-in-human and translational studies through PoC to pivotal Phase III trials and regulatory submissions.
Luke holds an MSc in Neuro and Molecular Pharmacology and an MBA, combining deep scientific understanding with strong financial and commercial leadership.
He has held senior executive positions within international CROs, where he was responsible for multi-regional oncology portfolios, operational excellence programs and strategic alliances with leading biotech and pharmaceutical partners across the USA, Europe and Asia-Pacific (including China). His leadership has driven measurable gains in clinical readouts, delivery quality and biotech satisfaction.
Message Presenter
Dr. Yong Wang, Vice President, Head of Biometrics and Strategic Solutions, WuXi AppTec
Dr. Yong Wang is Vice President of WuXi AppTec, Head of WuXi Clinical Strategic Solutions, Data Management, Biostatistics and Statistical Programming. Dr. Wang is a Member of the CDE Tripartite Coordination Committee.
Dr. Wang has extensive experience in clinical trial design and implementation, regulatory submissions, interactions with regulatory authorities, product in-licensing and commercial development across biopharmaceuticals and medical devices. Dr. Wang’s current research interests include the application of innovative statistical methodologies to clinical trial designs. He has been providing extensive consultation to clients on study designs.
Before joining WuXi Clinical, Dr. Wang served as Head of Biostatistics for the Asia-Pacific region at PAREXEL. During his time working in the United States, Dr. Wang held significant management positions at multinational pharmaceutical and medical device companies such as Allergan (now AbbVie) and St. Jude Medical (now part of Abbott). Dr. Wang obtained his PhD in Mathematics in the United States and completed postdoctoral research in the field of Biostatistics and Epidemiology.
Message PresenterWho Should Attend?
This session is designed for Senior Executives and Investors focused on accelerating proof‑of‑concept, improving capital efficiency and optimizing global oncology development strategies:
- Chief Executive Officers (CEOs) of biotech and pharma companies driving enterprise and pipeline value
- Chief Medical Officers (CMOs) responsible for clinical strategy, PoC acceleration and regulatory alignment
- Chief Scientific Officers (CSOs) shaping translational science and early development decision making
- Vice Presidents/Heads of Clinical and Development Operations overseeing global trial execution and efficiency
- Private Equity, Growth Equity and crossover investors evaluating oncology assets, development risk and time‑to‑value
- Senior leaders responsible for global development strategy, including early integration of China and multi‑regional pathways
What You Will Learn
Attendees will gain insights into:
- Traditional oncology trial designs that are no longer fit for purpose, driving the need for faster, more flexible and data‑driven approaches
- How Bayesian dose‑finding designs enable quicker, safer decisions in early development while improving the probability of identifying optimal doses
- Master protocols (basket, umbrella and platform) that accelerate development by testing multiple therapies or biomarkers in parallel, reducing cost and redundancy
- How real‑world evidence strengthens evidence generation, supporting trial design, regulatory decisions and broader applicability beyond controlled studies
Xtalks Partner
Emerald Clinical
Emerald Clinical is where science, speed, and strategy come together to transform healthcare. For over 25 years, we’ve led the way in clinical research, combining global reach with deep Asia-Pacific expertise and unparalleled local insight to deliver smarter trials and stronger outcomes. With teams embedded in communities worldwide, we drive faster recruitment, deeper patient engagement, and meaningful results that move medicine forward.
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