IITs: a faster route to early evidence?
For companies looking to accelerate development, investigator-initiated trials (IITs) in China can offer a route to early clinical evidence. Speed is the obvious draw. But speed alone isn't a strategy.
Before committing, sponsors need clear answers to a few critical questions:
- Transferability: how far will the data travel? Will regulators in other jurisdictions accept it?
- Oversight: what does effective ethical and clinical oversight look like in practice?
- Global planning: how do you design an IIT so it supports, rather than complicates, a global development plan from day one?
Get these right and an IIT can be a genuine accelerator. Get them wrong and early wins can turn into costly rework later.
Not just a China question
These are no longer questions only for companies already operating in China. As CGT innovation expands across Asia-Pacific, the ripple effects are global:
- Competition: new players and new data are reshaping who leads in key modalities.
- Partnerships: cross-border collaboration is becoming a strategic necessity, not a nice-to-have.
- Investment: capital is following clinical momentum, wherever it happens.
- Manufacturing: where therapies are developed increasingly shapes where, and how, they are made.
Whether you're a biotech planning your first trial, a pharma company scouting partners or an investor building a portfolio, the shift East affects your next move in the West.
Putting it under the spotlight at ATW 2027
At Advanced Therapies Week 2027, two dedicated workshops will tackle these questions head-on, combining practical experience with expert perspectives.
Workshop #1: IITs in China: How to successfully set up, conduct and leverage the data
Sponsored by Dark Horse Consulting Group. What do companies need to consider before pursuing an IIT in China? This workshop covers regulatory pathways, time to results, data acceptability, ethical oversight and the transition to global registration. Expect real-world case studies and plenty of audience Q&A.
Featuring:
- Eugene Jiaxian Wang, Founder & CEO, HELP Therapeutics
- Andrew Lee, Co-Founder & CEO, Spot Biosystems, and Vice President, BAY TRIAL
Workshop #2: Planning and executing overseas IITs across APAC and Australasia
Running IITs across multiple regional regulatory environments brings its own challenges. This session blends hands-on experience with expert discussion on what sponsors should plan for.
Featuring:
- Yoshiaki Maruyama, Director, Office of Cellular and Tissue-based Products, PMDA (Japan)
- Miguel Forte, CEO, Kiji Therapeutics
East meets West in San Diego
From clinical development strategy to cross-border partnerships, the changing CGT landscape raises questions for every part of the industry. The next phase of CGT won't be shaped by one region. It will be shaped by a global community.
Join biotech and pharma leaders, investors, regulators, clinicians and manufacturing experts at Advanced Therapies Week, 18–21 January 2027 in San Diego, to explore the opportunities, challenges and decisions shaping the field worldwide. Find out more about attending Phacilitate Advanced Therapies Week 2027 here.
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