Biotech companies are under increasing pressure to shorten development timelines, achieve proof-of-concept earlier and maximize the value of their assets. Against this background, integrating Asia-Pacific (APAC) into a global clinical development strategy can provide important advantages across the development lifecycle.
This webinar will examine how Australia, China and Japan can play distinct but complementary roles from first-in-human studies through global registration. Australia can offer an efficient environment for early-phase studies and rapid study start-up, helping sponsors generate initial clinical evidence and make earlier development decisions. China offers access to large patient populations and the potential for rapid enrollment, which can support efficient execution of later-phase studies. Japan provides strong participant retention and low dropout rates, together with opportunities to address ethnic factors and generate evidence suitable for global regulatory submissions.
Rather than approaching these countries as separate development options, the session will explore how they can be connected within a coordinated APAC strategy. Speakers will share practical perspectives on regulatory pathways and local requirements in China and Japan, including factors that may affect study design, start-up, enrollment and registration planning. The discussion will also cover how sponsors can determine the appropriate timing and role of each country within an overall global program.
Attendees will learn how early-phase data, patient access, retention and regulatory planning can be combined to support Phase II and Phase III development, global evidence generation and filing readiness. The session will highlight key decision points, common planning mistakes and practical approaches to reducing unnecessary duplication across markets.
Real-world development frameworks and case examples will illustrate how a coordinated APAC strategy may help sponsors accelerate enrollment, identify risks earlier, improve program efficiency and strengthen the overall value of a development asset.
By the end of the webinar, participants will have a clearer understanding of the opportunities and challenges associated with Australia, China and Japan, as well as practical insights to support development planning, portfolio prioritization and executive-level decision-making.
Register for this webinar to learn how an APAC clinical development strategy can accelerate oncology timelines, reduce unnecessary duplication and support global filing readiness.
- APAC clinical trials ,
- Asia-Pacific drug development ,
- Biotech development strategy ,
- China clinical trials ,
- Clinical Operations ,
- Clinical Research ,
- Clinical trial feasibility ,
- CRO ,
- CRO Partnership ,
- Drug Development ,
- Global Clinical Development ,
- Global Clinical Trials ,
- Japan clinical trials ,
- Oncology ,
- Patient Recruitment ,
- Pharmaceutical Development ,
- Regulatory Strategy ,
- Therapeutic Areas
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
Will Chen, Head of Regulatory Affairs, Emerald Clinical
Will Chen has over 25 years of experience in pharmaceutical product registration. He managed regulatory affairs at multinational corporations and CROs for more than 15 years, leading over 100 drug and medical device registration applications in China and the US, including pre-IND meeting requests, IND, NDA and supplemental applications. Prior to that, he spent 13 years working in drug regulatory authorities, where he was responsible for document review, on-site inspections and drug testing.
Message Presenter
Rokuya Nochi, Executive Officer, EPS Corporation; Head of Global Business Promotion, EPNextS
Rokuya Nochi is an Executive Officer at EPS Corporation and Head of Global Business Promotion at EPNextS, a parent company of EPS Corporation. Since joining the EPS Group in 2009, he has built extensive experience in clinical operations, global clinical trial management and international project leadership.
Throughout his career, he has led multinational clinical development programs, supported Japanese pharmaceutical and biotechnology companies in global drug development and played a key role in strengthening strategic partnerships with international CROs and industry stakeholders.
In addition to his operational expertise, Rokuya has been actively involved in corporate strategy, business development, investment planning and the establishment of global business infrastructures across the EPS Group. He currently oversees global business development initiatives, FSO/FSP operations and international alliance management, with a focus on expanding global clinical development capabilities and accelerating cross-border collaboration for innovative drug development.
Message PresenterWho Should Attend?
This webinar will appeal to:
- Chief Executive Officers (CEOs) of biotech companies evaluating geographic expansion of their oncology pipelines beyond traditional Western markets
- Board of Directors and Non-Executive Directors with life sciences portfolio oversight and R&D capital allocation responsibilities
- Chief Medical Officers (CMOs) responsible for global development strategy and regulatory submission planning
- Chief Operating Officers (COOs) assessing clinical operations scalability and execution risk in new geographies
- VP/SVP Heads of Clinical Development leading programme-level decisions on regional strategy and trial design
- Heads of Regulatory Affairs navigating multi-regional filing strategies, local authority requirements and cross-jurisdictional data acceptability
- Chief Financial Officers (CFOs) evaluating R&D investment efficiency, timeline compression value and pipeline ROI optimisation
- Business Development and Licensing executives assessing APAC partnerships or evaluating regional development value in asset transactions
What You Will Learn
Attendees will gain insight into:
- Why APAC should be part of a global oncology development strategy
- Regulatory pathways and local requirements in China and Japan, including PMDA considerations, CTA processes, ethnic sensitivity, bridging data and GCP requirements
- How site capabilities, investigator experience, infrastructure and local operating models can affect study design and execution
- Common protocol, site selection, enrollment and submission planning mistakes that can create downstream risk and delay program timelines
- How to evaluate when APAC integration makes strategic sense, including realistic expectations for timeline compression and executive-level decision-making
Xtalks Partners
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.
EPS Corporation
EPS Corporation brings together deep local expertise, integrated capabilities, and seamless execution to make drug development in Japan more predictable. For more than 30 years, we have supported pharmaceutical and biotech companies across the development lifecycle, from regulatory strategy and clinical operations to submission and post-marketing. With more than 3,300 professionals and the broader EPS Group network, we help sponsors navigate Japan and Asia, accelerate development, and bring new treatment options to patients.
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