Dr. Steven Cha
Therapeutic Strategy Director
Dr. Cha is Novotech's Therapeutic Strategy Director, bringing more than 20 years of global oncology and hematology drug development experience across small biotech, major pharmaceutical, and clinical leadership environments. His background spans early research, global clinical development, regulatory strategy, and commercialization.
He has held senior roles including Chief Medical Officer, Senior Vice President of Oncology, and Global Clinical Lead, with extensive experience across immuno-oncology, cell therapy, targeted therapies, antibody-drug conjugates (ADCs), and vaccine platforms.
Dr. Tanja Obradovic
Therapeutic Strategy Lead, Oncology
Dr. Obradovic is Novotech's Therapeutic Strategy Lead, Oncology, bringing more than 20 years of oncology drug development experience across pharmaceutical, academic, and advisory environments. Following an academic career as a Research Assistant Professor in immuno-oncology, she held leadership roles in clinical development, medical affairs strategy, and regulatory and commercial functions at leading pharmaceutical companies, including Merck and Takeda.
Tanja has led medical strategy for Keytruda and more than 30 small-molecule, biologic, and cell therapy programs across Phase 1 to Phase 3 development, regulatory filing, and launch. Her regulatory experience includes supporting more than a dozen solid tumor indication submissions and approvals across lines of therapy in more than 40 countries, including the United States, European Union, and Asia.
She is recognized for her advisory expertise in cancer drug development and has served as a treatment guidance committee member, invited speaker, reviewer, author, and expert panelist.
APAC is increasingly central to global oncology development. Sponsors now see APAC not merely as a recruitment geography, but as a strategic launchpad where proof-of-concept and dose exploration in Phase I and Phase II trials can be accelerated. This shift matters because APAC trials are now capable of producing regulatory-grade data suitable for global Phase IIII expansion.
APAC’s Strategic Advantages
- Speed and Patient Access: Early-phase trials in APAC often enrol faster due to high-volume oncology centers and mature biomarker testing capabilities.
- Regulatory-Ready Protocols: Trials designed with global endpoints and regulatory requirements from day one increase the likelihood of seamless expansion to US/EU markets.
- Dose Exploration and Innovation: The patient pool in APAC allows testing multiple doses, including biomarker-driven subgroups, providing richer early efficacy and safety data.
Sponsor Takeaway
Sponsors leveraging APAC strategically can accelerate proof-of-concept and generate globally credible datasets, not just faster enrolment.
Precision Oncology: Opportunity and Risk
While biomarker-driven trials can increase trial precision, they also introduce operational challenges. Mandatory biopsies, narrow eligibility, and assay variability can increase screen failures and extend timelines. Planning biomarker logistics and harmonizing assays across geographic regions early is critical.
Sponsor Takeaway
Early biomarker feasibility planning reduces operational risk and improves recruitment efficiency.
Designing Globally Portable Evidence
Sponsors must design trials in APAC with global portability in mind. This includes endpoints, biomarker assay strategy, regulatory alignment, and operational feasibility. Poor design can lead to downstream delays and missed regulatory expectations.
Sponsor Takeaway
Trials should be designed from the start to produce data that is credible for global regulators and commercially relevant.
A closer look at APAC’s role within clinical oncology drug development
APAC is no longer a secondary region—it is central to strategic global oncology development. Sponsors that understand the operational and regulatory nuances can accelerate timelines, optimize dose selection, expand into relevant tumor types and generate globally applicable data. Novotech’s execution expertise in APAC provides sponsors with the insights and support needed to navigate this complex landscape. Many companies envisioned APAC as an expansion region within PhIII or as Asia-only late-stage step in the past. Now, with the advancement of APAC health systems and research environment, APAC is shaping clinical oncology programs much earlier in their life cycle. The region is not simply contributing patients. It is increasingly contributing to the conditions that determine whether a program can move from first signal to globally credible clinical advancement. These developments are mirroring the outstanding rise of APAC-based innovation, accompanied by an increase in drug candidates in clinical development. McKinsey reported in 2026 that Asia’s share of the global innovative pipeline rose from 28% to 43% over five years, and that the region contributed more than 85% of global growth in innovative pipelines in 2024 [1].
Shift toward APAC importance matters because oncology development has become less forgiving. A clinical trial cannot be considered successful simply because it opens quickly or recruits well. Regulators now expect stronger dose rationale, multiple doses exploration, deeper understanding of drug risk-benefit early, better biomarker discipline, and clearer evidence that early design choices will hold up across regions and support future global development. FDA’s final 2024 guidance on dose optimization in oncology made that expectation explicit. ICH E17 reinforces the same principle from a global-trial perspective: multi-regional studies should be designed so that data are acceptable across regions, not assembled region by region after the fact [2].
The implication for sponsors is straightforward. APAC can accelerate oncology development, but only when it is used as the front end of a global strategy rather than as a regional add-on. In practice, the real risk in APAC is rarely geography itself. It is a weak upstream design: endpoints that do not travel, biomarker workflows that do not hold up in practice, country sequencing that invites amendments, and start-up plans that fail to anticipate the realities of modern oncology.
The strategic question has changed from “Can APAC run the study?” to “Can APAC carry the program?”
The biopharma centre of gravity has been shifting east for years, but the nature of that shift is now different. APAC matters not only because activity is growing, but because more of that activity is becoming scientifically and strategically consequential.
That change is visible in the regional scientific conversation itself. The 2025 ESMO TAT Asia Congress in Hong Kong brought together industry, academia, clinicians, and regulators around innovation, early clinical trials, and regulatory insights — clear evidence that Asia is being treated less as a recruitment region and more as a forum where cancer drug development strategy is actively shaped [3]. This trend is intensifying during this year as the next American Society of Clinical Oncology (ASCO) Breakthrough will be held in Singapore shortly after the USA ASCO conference event [4].
For Biotech sponsors, APAC should no longer be judged only on startup speed or enrolment yield. Its more strategic value lies in helping answer expensive questions earlier: Is the biologic hypothesis strong enough? Is the responder population defined precisely enough? Are the dose and schedule defensible? Is the biomarker assay model reproducible? Can the evidence package withstand global regulatory scrutiny? Answers to these questions shape accelerated clinical development in oncology, support seamless late-stage development and global expansion, and go beyond rapid adoption of advanced biomarker testing practices to reflect the growing relevance of globally synchronized development. NMPA materials published in 2025 state that China’s review and approval framework is intended to support early global synchronized development and international multi-center clinical trials. That reflects China’s increasing importance not only as a source of innovation, but as a serious component of global development planning, getting aligned with the leading regulatory agencies of the US and EU [5].
South Korea matters for concentrated oncology expertise, strong tertiary cancer centers, and a visible role in early-phase and precision-oncology activity. Singapore plays a different role. Its importance lies less in scale than in regulatory connectivity, infrastructure quality, and its function as a coordination hub for disciplined regional execution. HSA’s ACCESS Consortium framework and pipeline meetings are designed to support earlier regulatory dialogue and work-sharing across member agencies [6].
Australia deserves equally explicit attention. It remains one of APAC’s most strategically important early-phase oncology markets because of its first-in-human experience, translational research depth, and start-up environment, which can make it an effective launch point for complex programs. Japan, meanwhile, continues to matter in high-value oncology settings where scientific rigor and evidence quality carry particular weight.
The point is not that one APAC market should replace another. It is that stronger programs assign each market a deliberate role rather than pursuing the region as a generic growth story.
Start-up quality has become part of scientific quality
One of the most underappreciated changes in oncology development is that the start-up strategy is no longer merely administrative. It now has direct scientific consequences.
Novotech’s March 2026 case study on a first-in-human genetically modified organism (GMO) oncology trial illustrates the point well. The study was designed to evaluate safety, tolerability, dose escalation, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity in solid tumors. The challenge was not simply speed. It involved multiple GMO and biosafety oversight pathways, parallel regulatory activity across Australia and the United States, and a limited pool of sites with both early-phase oncology capability and experience handling GMO therapeutics. Novotech responded with a coordinated regulatory strategy, targeted site identification, at-risk start-up work conducted in parallel with review, and centralized cross-regional project management, enabling first patient first dose on 2 December 2025 [7].
The broader lesson extends beyond this modality. In modern oncology, start-up sequencing affects scientific value. Regulatory timing influences activation. Activation influences who can be screened. Screening feasibility affects whether biomarker assumptions hold in practice. Sample logistics affect turnaround times, which can determine whether eligible patients remain eligible long enough to enroll.
In that environment, operational planning is not downstream of science. It is one of the ways science either survives contact with reality or fails. The implications go beyond early-phase trials and affect Phase II and Phase III approaches, where early efficiencies and strategies are applied and expanded, making partner capability crucial, particularly for advanced biomarker testing and in regions where trial density is increasingly concentrated. They also reinforce why APAC should not be discussed as a single undifferentiated region: China contributes scale and increasingly valuable genomic data, South Korea has dense precision-medicine capability, Australia has early-phase agility and translational depth, and Japan has rigor in high-value oncology settings.
But strength does not mean uniform readiness. APACMed’s 2024 white paper on next-generation sequencing in cancer across APAC emphasized that the promise of next-generation sequencing (NGS) capabilities differs among APAC countries. Since 2024, rapid advances have started and are ongoing with great intensity. Increased use of whole genome sequencing implemented within standard oncology practice is notable, especially in China, with the recently announced expansion of NGS capabilities to over 1300 hospitals [8]
For sponsors, that means the biomarker strategy cannot be treated as a side workflow. It is a core development decision. Which countries can support reliable local testing? Where is central confirmation needed? What happens to screening windows if the sample export is slow? How will local and central assay approaches be reconciled if they are not fully aligned?
These are critical elements of success as they shape the interpretability of the trial. In APAC, the strongest biomarker-led programs are not those that simply include biomarker-positive patients. They are the ones whose biomarker workflow can hold up across countries, sites, and later stages of global development. Experience of the CRO partner in this arena is an important driver of innovative early-to-late clinical oncology drug development.
Dose optimization has raised the standard for what an early APAC dataset must accomplish
APAC-led or APAC-first development now requires more discipline because early datasets are being asked to do more than before.
FDA’s 2024 final guidance on oncology dose optimization reflects a broader shift away from the old logic of reaching signal first and refining later. Sponsors are expected to characterize dosage more rigorously during development.
That has direct implications for APAC. If the region is generating the earliest meaningful readout, sponsors must ask whether the trial is capturing the right information for the next question, not only the first one. Does the study support a credible exposure-response narrative? Does the escalation design leave room for a defendable expansion strategy? Will the selected regimen remain convincing if the asset moves into combinations or biomarker-enriched cohorts?
APAC should therefore be seen not as a shortcut, but as an opportunity to improve development quality earlier. A quick signal without a globally defendable dose and evidence narrative is not real acceleration. It is deferred risk.
The strongest proof points now show APAC-linked assets reaching major regulators
The thesis that APAC can shape globally credible oncology development is no longer theoretical. It is visible in programs that have translated into U.S. regulatory outcomes.
In October 2024, Astellas announced U.S. FDA approval of Vyloy (zolbetuximab-clzb) in combination with chemotherapy for first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2-positive, as determined by an FDA-approved test [9]. In July 2025, the FDA granted accelerated approval to sunvozertinib for adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease had progressed on or after platinum-based chemotherapy [10].
These are not simply approval stories. They show that APAC-linked oncology innovation can generate programs that satisfy major regulatory expectations when design is disciplined, biomarker strategy is robust, and the evidence package is built to travel.
The sponsors who benefit most from APAC are the ones who design for portability, not just performance
This is now the real divide in oncology development.
Some sponsors use APAC tactically. They enter the region for recruitment, faster activation, or access to key centers. Those are valid reasons, but they are no longer enough. The stronger sponsors use APAC to build a more portable evidence package from the beginning. They plan a dose strategy early. They settle biomarker logistics early. They decide country roles before activation. They treat start-up architecture as part of scientific design. And they define success not as “study opened,” but as “dataset can travel.”
That is also where Novotech can credibly lead the conversation. The market does not need another generic statement that APAC is growing. What sponsors need is a sharper operating thesis for how to convert APAC’s strengths into globally useful oncology development. The answer is not to move faster in the region at any cost. It is to build programs whose early evidence can survive expansion, scrutiny, and scale.
APAC’s highest value lies in helping sponsors make better decisions earlier
The oncology sponsors most likely to outperform over the next several years are not those that merely add APAC sooner. They are the ones that use APAC to make better decisions sooner: which patients define the biology, which assay model is scalable, which dose is sustainable, which countries create the strongest bridge to the next milestone, and which start-up choices protect rather than erode momentum.
That is the real shift underway. APAC is no longer where oncology programs just move faster. It is increasingly where they are either built for global success—or made harder than they need to be.
In conclusion, advances in innovation, evolving regulatory frameworks, the growth of the differentiated roles of APAC’s leading markets, and the region’s growing contribution to global drug development are enabling faster and more effective clinical development. From early- to late-phase programs, Novotech provides leadership in shaping that future.
References
- McKinsey & Company. The Emerging Epicenter: Asia’s Role in Biopharma’s Future.
https://www.mckinsey.com/industries/life-sciences/our-insights/the-emerging-epicenter-asias-role-in-biopharmas-future - U.S. Food and Drug Administration. Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/optimizing-dosage-human-prescription-drugs-and-biological-products-treatment-oncologic-diseases - European Society for Medical Oncology. ESMO Targeted Anticancer Therapies Asia Congress 2025.
https://www.esmo.org/meeting-calendar/esmo-targeted-anticancer-therapies-asia-congress-2025 - American Society of Clinical Oncology. About ASCO Breakthrough.
https://www.asco.org/breakthrough/program/about - National Medical Products Administration. NMPA Supports Early Global Synchronized Development and International Multi-Center Clinical Trials.
https://english.nmpa.gov.cn/2025-10/14/c_1138493.htm - Health Sciences Authority, Singapore. ACCESS Consortium.
https://www.hsa.gov.sg/therapeutic-products/international-collaboration/access - Novotech. Accelerating First-in-Human Start for a Complex GMO Oncology Clinical Trial.
https://novotech-cro.com/case-studies/accelerating-first-human-start-complex-gmo-oncology-clinical-trial - Gene Solutions. Gene Solutions and Topgen Join Forces to Advance Precision Oncology All Over China.
https://genesolutions.com/news/gene-solutions-and-topgen-join-forces-to-advance-precision-oncology-all-over-china - Astellas Pharma. Astellas VYLOY™ (zolbetuximab-clzb) Approved by U.S. FDA for Treatment of Advanced Gastric and GEJ Cancer.
https://newsroom.astellas.com/2024-10-21-Astellas-VYLOYTM-zolbetuximab-clzb-Approved-by-U-S-FDA-for-Treatment-of-Advanced-Gastric-and-GEJ-Cancer - U.S. Food and Drug Administration. FDA Grants Accelerated Approval to Sunvozertinib for Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations.
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sunvozertinib-metastatic-non-small-cell-lung-cancer-egfr-exon-20