Over the past decade, South Korea has transformed itself from a fast follower into one of the world's leading hubs for oncology clinical research. World-class healthcare infrastructure, a centralized national health insurance system, and highly efficient clinical trial networks have enabled Korea to become a preferred destination for early-phase oncology drug development, delivering rapid patient enrollment and high-quality clinical data.
However, the global oncology landscape is undergoing a profound transformation. China's unprecedented investment in biotechnology, translational research, and innovative drug development has fundamentally reshaped the competitive environment in Asia and beyond. The traditional strengths that established Korea's global reputationㅡspeed, efficiency, and excellence in clinical trial executionㅡare no longer sufficient to maintain leadership.
To remain globally competitive, Korea must redefine its innovation strategy. The next generation of oncology breakthroughs will be driven not only by excellence in clinical trials but also by first-in-class target discovery, biomarker-driven precision medicine, translational research, artificial intelligence, and globally competitive biotechnology. Building an ecosystem that seamlessly integrates hospitals, academia, industry, government, and investment will be essential to accelerating innovation from scientific discovery to patient benefit.
Korea possesses unique advantages, including nationwide genomic data, deep clinical expertise, rapid implementation of next-generation sequencing, and a highly collaborative research environment. These strengths should now be leveraged not only to conduct global clinical trials but also to generate globally transformative therapies.
The future of Korean oncology depends on shifting from participation to leadership, from execution to invention, and from adopting innovation to creating it. By embracing this transformation, Korea can continue to shape the future of global cancer research and deliver the next generation of life-changing therapies for patients worldwide.

The global pharmaceutical and biotechnology industry is undergoing rapid transformation, driven by AI- and big data-enabled drug development, the growth of advanced biopharmaceuticals, and the restructuring of global supply chains. The Korean pharmaceutical and biotechnology industry has established a foundation for growth through expanded R&D investment, the development of innovative drugs and biosimilars, global technology licensing, and strengthened manufacturing capabilities. Nevertheless, it continues to face structural challenges in developing global blockbuster drugs and achieving sustainable industrial growth.
This presentation examines changes in the global pharmaceutical and biotechnology landscape and the innovation ecosystems of major countries, while assessing the current status and competitiveness of the Korean industry. Based on this analysis, it proposes policy measures and strategies to drive an industrial leap centered on innovative drug development. These measures include expanding strategic R&D investment, promoting private-sector investment and global market expansion, accelerating innovation in drug development through AI and digital technologies, and reforming clinical trial systems. Furthermore, the presentation explores policy directions for supporting global market expansion and sustainable industrial growth by establishing a virtuous cycle in which drug development achievements lead to reinvestment and by strengthening collaboration among government, industry, academia, and research institutions.

Bioanalytical methods for biomarkers provide data to support the evaluation of safety and effectiveness of drugs and biological products. Therefore, it is important to ensure the reliability of the data generated by these assays. When biomarker data will be used to support regulatory decision making, such as the pivotal determination of safety and/or effectiveness to support approval or to support dosage instructions in product labeling, the assay should be fully validated as described in the Guidance for Industry: M10 Bioanalytical Method Validation and Study Sample Analysis (November 2022). In summary, bioanalytical methods need to robust and reproducible to ensure the reliability of the data.

Challenges and opportunities in biomarker bioanalysis will be presented in a case example of lipoprotein(a) [Lp(a)]. Lp(a) has been investigated as an independent risk factor as it contributes to the development and progression of major adverse cardiovascular events. Based on literature reports, a causal link between Lp(a) concentrations and cardiovascular outcomes has been established, with therapeutic reduction of Lp(a) expected to contribute to cardiovascular risk mitigation. Currently, many Lp(a)-lowering drugs including various modalities such as monoclonal antibodies, small interfering ribonucleic acids, antisense oligonucleotides, and small molecules are currently under different stages of drug development.

As Lp(a) is considered as a pharmacodynamic biomarker that has a potential to be used in regulatory decision making, understanding the mechanism of action, the complex composition of the molecule, and the principles and expectations of the bioanalytical method for Lp(a) measurement is important.

The landscape of oncology drug development has undergone profound transformation over the past decade. Clinical research has become increasingly global, with a growing proportion of trials conducted outside the traditional centres of drug development. At the same time, advances in molecular characterisation, targeted therapies and immuno-oncology have resulted in smaller, more heterogeneous patient populations and increasingly individualised treatment decisions.
These developments require a broader perspective on the generation and evaluation of clinical evidence. Beyond demonstrating the internal validity of clinical trials, regulators and developers must consider whether evidence can be transported across populations and healthcare settings and whether it is applicable to the decision at hand. Multiregional clinical trials (MRCTs) remain an important strategy for generating evidence that is both globally relevant and locally credible, while recognising that no single development programme can answer every question in every population.
The increasing complexity of oncology also highlights the importance of understanding outcomes that matter to patients. Patient-focused drug development, including the systematic elicitation of patient preferences, provides complementary evidence that can inform the interpretation of benefit–risk assessments when treatment decisions involve meaningful trade-offs. The recently published draft ICH E22 guideline establishes an international framework for the design, conduct and reporting of patient preference studies intended to support drug development and regulatory evaluation.
This presentation will discuss how these scientific and methodological developments are reshaping oncology drug development and evaluation, and consider opportunities for future international collaboration to strengthen global evidence generation while ensuring that patient perspectives are appropriately incorporated into regulatory decision-making.

My presentation may touch such topic: the evolution and background of China's regulatory system and policies; measures to promote innovative drug development; the results after the implementation of these measures; NMPA's requirements for foreign enterprises; the application scope and procedures of China IIT and IND pathway so on(I may make adjustments after discussion by the organizing committee.)

CAR T has reshaped the treatment of certain blood cancers, but its reach remains far too limited. Most patients with cancer will never be offered CAR T, either because they have a solid tumor, where meaningful progress has been difficult, or because access to autologous treatment depends on being in the right place, at the right time, with the right diagnosis, and being treated by the right care team. Allogene is working to change this paradigm by developing off-the-shelf CAR T products designed to overcome many of the logistical and operational barriers associated with individualized therapies, including enabling infusions to patients completely in outpatient setting. ALPHA3, Allogene’s pivotal trial in first-line consolidation for large B-cell lymphoma, is an industry-leading study seeking to bring about a massive shift in lymphoma care, as well as howㅡand whereㅡdoctors use CAR T for patients whose disease is likely to relapse. Allogene is also advancing programs in autoimmune disease and solid tumors, tailoring product design and clinical development strategies to the distinct needs of patients, treatment settings, and disease biology. Across these areas, the ambition is consistent: to expand the reach of CAR T to more patients, across more diseases and more care settings, than is possible today.

Tosposertib (TU2218) is a highly potent dual inhibitor of the transforming growth factor-β type I receptor (TGFβRI/ALK5) and vascular endothelial growth factor receptor 2 (VEGFR2), designed to simultaneously target immunosuppressive tumor microenvironment signaling and angiogenesis. Open-label, multicenter, non-randomized phase IIa trial evaluated the efficacy and safety of tosposertib in combination with pembrolizumab in patients with R/M HNSCC.
Eligible patients included anti-PD-(L)1-naive patients with PD-L1 combined positive score (CPS) ≥1. Tosposertib (97.5 mg twice daily; 2 weeks on/1 week off) was administered orally in combination with pembrolizumab (200 mg intravenously every 3 weeks).
29 patients had been enrolled, with a median follow-up duration of 6.0 months. Primary tumor sites included the oral cavity (n=11, 37.9%), oropharynx (n=6, 20.7%), larynx (n=3, 10.3%), and nasal/paranasal regions (n=3, 10.3%). HPV positivity was observed in 13.8% (4/29) of patients.
Among 26 efficacy-evaluable patients, responses were assessed by treatment line. In the first-line setting, 9 of 12 patients achieved an objective response (ORR, 75.0%), including 1 confirmed complete response (CR) and 8 partial responses (PRs; 6 confirmed, 2 unconfirmed). Among the 14 patients who had received at least one prior systemic therapy, the ORR was 42.9%, with 1 confirmed CR and 5 confirmed PRs. A numerically higher ORR was observed in patients with PD-L1 CPS ≥20 compared with those with CPS 1-10 (66.7% vs 52.9%).
The most frequent any-grade treatment-emergent adverse events (TEAEs), (≥20%) [and ≥ Gr3 TEAEs], were rash (48.3% [20.7%]), mucosal inflammation (34.5% [13.8%]), pruritus (27.6% [3.4%]), weight loss (27.6% [0%]), and elevations in aspartate aminotransferase (AST; 20.7% [3.4%]) or alanine aminotransferase (ALT; 20.7% [3.4%]).
Tosposertib in combination with pembrolizumab demonstrated a manageable safety profile and encouraging antitumor activity in patients with R/M HNSCC, with particularly robust efficacy observed in the first-line setting and a favorable trend in PD-L1-high tumors.

Clinical development often becomes a race of who will be the fastest on the market for a specific compound class. We have seen multiple compounds of the same class being approved and launched in the same markets in the same indication. However, not all indications or even promises these compounds hold are the exact same.
Differentiation is an important part to position a compound in the market. For these positionings it is important to understand the compound class, the individual compounds’ strengths and weaknesses and then decide which patients might benefit the best from that compound compared to others. Once the patient population is understood and subsequently how to position the compound in the market among its competitors, the clinical development has to be tailored to show these claims.
How this differentiation and positioning can be done well and how it affected the clinical development, will be shown with the example of 3 GLP-1 compounds, semaglutide, the most prominent GLP-1 mono, tirzepatide, the first and as of now strongest GLP-1/GIP dual agonist, and survodutide, a GLP-1/Glucagon dual agonist targeting heavily obesity-related comorbidities.

The likelihood of regulatory approval for Phase I development candidates sits below 10%, with drug development attrition highest as it transitions into Phase II. Clinical trial failure is defined as a study that missed its primary or a key endpoint/s, stopped for futility or inferiority, or produced results that are insufficient to support further development, approval or intended practice change. Clinical trial failure is multi-factorial and goes beyond failure to demonstrate efficacy or show unacceptable safety. Unsuccessful trials commonly result from a combination of scientific, clinical, statistical, operational, and organizational factors. While a clinical trial may show a negative or unintended outcome, a well-designed and well-executed trial can still generate valuable evidence about the study population, and why the intervention did not work.

This presentation, through recent real-world cases taken from sponsor disclosures, published US FDA Complete Response Letters (CRL) and other public sources, aims to examine major failure patterns and root causes with focus on results and regulatory decisions from pivotal or registration-enabling trials. It also aims to examine common reasons how some pivotal trial submissions with positive readout still receive a CRL. Lastly, it aims discussed how failures can inform future developmental opportunities.

The FDA Modernization Act 2.0 and subsequent regulatory initiatives, including the FDA Modernization Act 3.0 and the FDA’s roadmap for New Approach Methodologies (NAMs), represent a major shift in nonclinical drug development. The evolving framework moves away from routine animal testing toward science-based, fit-for-purpose approaches supported by mechanism of action (MoA), context of use (CoU), and weight of evidence (WoE).
This presentation reviews the key regulatory developments and recent FDA guidance relevant to monoclonal antibodies, NAMs, and oncology biologics, with particular focus on streamlined nonclinical approaches. It also discusses key principles for NAM validation, including biological relevance, technical reliability, reproducibility, and clearly defined CoU.
These changes present both opportunities and challenges. NAMs may improve R&D efficiency, reduce animal use, and accelerate development, while simultaneously creating new regulatory barriers for organizations lacking appropriate scientific justification, validation capabilities, and reference data.
For Korea, regulatory readiness should therefore extend beyond adopting individual NAM technologies. Establishing MoA-driven nonclinical strategies, robust WoE and background databases, and CoU-based NAM validation capabilities will be essential. Building such comprehensive “NAM coverage” will be critical for ensuring efficient drug development and maintaining global regulatory competitiveness.

The replacement of concurrent control groups (CCGs) with virtual control groups (VCGs) represents one of the most significant methodological shifts in nonclinical toxicology. A VCG is a reference control population reconstructed from standardized historical control data (HCD) using statistical matching and, increasingly, generative AI, allowing background variability to be characterized without the repeated use of live control animals. This aligns directly with the 3Rs principle and the global regulatory transition toward New Approach Methodologies (NAMs), exemplified by the U.S. FDA Modernization Act 2.0.

This presentation reviews the concept of VCGs and their emerging applications in light of the EMA draft Qualification Opinion (2026). Under its agreed Context of Use, VCGs may substitute for CCGs in non-GLP rat dose-range-finding (DRF) studies to inform dose selection for subsequent pivotal GLP repeated-dose studies. Reanalyses of legacy studies showed that VCGs, populated from the SEND-based VICT3R database, reliably support target-organ identification and NOAEL determination without compromising study conclusions establishing a validated, SOP-driven pathway for regulatory acceptance.

Building on this momentum, the Korea Institute of Toxicology (KIT) will launch a national VCG platform program from 2027. Its goals are to (1) build a multi-institutional "safe-share" HCD repository through the Tox-Bridge consortium (10+ pharmaceutical companies and CROs) in partnership with KISTI; (2) develop statistical and generative-AI engines for VCG generation and validation; and (3) achieve GLP field demonstration and international regulatory acceptability (OECD/ICH), progressively expanding coverage from rodents toward primates. Together, these efforts aim to establish VCGs as a practical, globally harmonized standard for replacing control-group animals in nonclinical safety assessment.

Background:
Late-stage safety failures remain a major contributor to drug-development attrition, highlighting the need to identify human-relevant toxicological liabilities before candidate selection and clinical investment. Advances in new approach methodologies (NAMs), high-throughput transcriptomics and artificial intelligence/machine learning (AI/ML) provide an opportunity to integrate mechanistic biology with human exposure to translate preclinical observations into more informed development decisions.

Methods:
Curated compound sets were evaluated across human-relevant 2D and 3D liver, cardiac and kidney in vitro models using automated high-throughput RNA sequencing (ScreenSeq™). Transcriptomic concentration-response data were analysed using differential gene expression, pathway enrichment, benchmark-dose modelling and transcriptomic point-of-departure (TxPoD) approaches. AI/ML models were developed to identify toxicity-associated molecular signatures, and predictions were contextualised against human total plasma exposure (Cmax,tot) to derive clinically relevant safety margins.

Results:
For hepatotoxicity, TxPoD-based classification achieved 84% sensitivity, 90% specificity and 88% overall accuracy, while the AI/ML approach achieved 81% sensitivity, 95% specificity and 88% accuracy. For cardiotoxicity, exposure-based classification at 20× Cmax,tot achieved 86% sensitivity, 85% specificity and 85% accuracy. These complementary approaches enabled quantitative separation of compounds with differing toxicity liabilities while providing mechanistic information concerning the biological pathways underlying predicted risk.

Conclusions:
Integration of human-relevant in vitro models, transcriptomic profiling, human exposure and AI/ML creates a scalable framework for identifying multi-organ safety liabilities earlier in drug discovery. Rather than using AI as a stand-alone prediction tool, this approach connects data-driven classification with mechanistic biology and clinically relevant exposure, supporting more informed candidate selection and earlier risk mitigation. Such strategies could help bridge the traditional divide between preclinical safety assessment and clinical development, enabling safer molecules to progress from discovery toward patients.

The landscape of oncology drug development has evolved significantly with the advent of targeted therapies and immunotherapies, leading to increasing interest in enrolling patients earlier in their treatment journey into early-phase clinical trials. Traditionally, first-in-human and other early-phase oncology studies were largely restricted to patients who had exhausted all available standard treatment options. However, in non-curative settings where long-term survival or cure is unlikely, participation in clinical trials may represent a meaningful therapeutic opportunity for patients. The recently issued Korean guidance, “Considerations for Patient Selection in Early-Phase Oncology Trials in Non-Curative Settings,” was developed to address this changing paradigm and to enhance regulatory predictability while maintaining patient protection.
This presentation will review the scientific and regulatory background that led to the development of the guidance, including evolving perspectives from major regulatory authorities on patient enrollment in early-phase oncology trials conducted in non-curative disease settings. The session will highlight key principles for patient selection, such as the role of available standard therapies, disease prognosis, treatment tolerability, and the level of evidence required to support anticipated clinical benefit.
In addition, practical implementation strategies and real-world examples will be discussed to illustrate how the guidance can be applied during protocol design and regulatory review.

This presentation provides a review of frequently asked questions related to contraception requirements in clinical trials.
Clinical trial sponsors frequently encounter challenges when implementing contraception requirements in study protocols, particularly when global development strategies need to be aligned with Korean labeling information and local regulatory guidelines. While relevant requirements are described in regulations and guidance documents, questions often arise regarding their practical interpretation and application in real-world clinical trial settings.
This presentation will explore common questions and areas of ambiguity related to contraception requirements from a Korean regulatory perspective. Through practical Q&A cases, the session will discuss considerations encountered during protocol development and clinical trial application reviews, including the interpretation of Korean product labeling, the applicability of contraception requirements based on nonclinical and clinical data, acceptable contraceptive methods, and the duration of contraception measures for study participants.
The presentation will also examine situations where global protocol requirements may not fully align with local regulatory expectations and discuss approaches for providing scientific and regulatory justification. By sharing practical examples and regulatory interpretations, the session aims to help participants better understand how Korean regulatory guidelines can be applied consistently and effectively while facilitating efficient interactions with the Ministry of Food and Drug Safety (MFDS).
Participants will gain practical insights into managing contraception-related requirements and addressing common regulatory questions throughout the clinical trial life cycle in Korea.

In multinational clinical trials (MRCTs), sponsors must preserve the scientific consistency of a global protocol while satisfying domestic regulatory requirements. Marketed drugs used in a trial — as investigational products, comparators, rescue medication, challenge agents, endpoint-assessment tools, or background therapy — sit at the center of this tension, particularly when protocol-specified conditions differ from Korean approved labeling.
This presentation first establishes the definitional framework. ICH E6(R3) defines an investigational product by its role in the trial rather than by its authorization status, and Korea's GCP standards under the Regulations on the Safety of Pharmaceuticals mirror that structure. The EU CTAG concept of Auxiliary Medicinal Products (AxMPs) — including authorised, modified authorised, and unauthorised categories — provides a management category for drugs that are relevant to trial design. Korea Regulations already accommodates such products, confirming substantive alignment between global and domestic frameworks.
Building on this, the presentation reviews industry–MFDS consultation on protocol design types. Where globally harmonized criteria are scientifically required, global standards may be accepted when supported by current international approvals and guidelines. Where a protocol permits local practice, the original broad multinational wording may stand, provided Korean labeling information and patient guidance are clearly communicated to sites.
These outcomes are reflected in the Case Book for Approval of Pharmaceutical Clinical Trial Plan Amendments (20 May 2026), whose two new Q&As are interpreted here with practical guidance on evidence packages, site communication, ICF use, and sponsor and investigator obligations.
The conclusion: regulatory harmonization accrues through sustained communication and evidence, where flexibility rests on scientific validity and is sustained by practical accountability — improving predictability of Korean IND approval.

In South Korea, clinical trials can only be conducted at MFDS-designated sites, a structural constraint that has long confined trial access to large tertiary hospitals, leaving community-based clinics, and the patients they serve, outside the system. This talk shares an ongoing effort to work within and around that constraint: designing a Community-Based Research (CBR) model that formally connects a large tertiary hospital with a local private clinic, grounded in the 2024 MFDS guideline. Drawing on lessons learned so far in regulatory engagement and site-level implementation, the session offers a practical look at how regulatory frameworks can be operationalized, not just interpreted, to expand who gets to participate in clinical trials.

Investigational New Drug (IND) submission is not merely the compilation of regulatory documents but the outcome of a well-integrated development strategy established from the earliest stages of drug discovery. Current regulatory guidance emphasizes risk-based and translational development, highlighting the importance of close collaboration between preclinical and clinical teams throughout the development process. Designing preclinical studies with future clinical objectives in mind-including the Target Product Profile (TPP), Clinical Development Plan (CDP), dose selection, PK/PD characterization, biomarker strategy, and target patient population-substantially enhances the translational value of nonclinical data and strengthens regulatory readiness. Such an approach also improves the quality of first-in-human (FIH) study design while reducing development risk.
Another critical principle is fit-for-purpose IND preparation. During early development, generating essential data required for safe clinical initiation is more efficient than conducting unnecessary studies that increase cost and delay timelines. In contrast, late-stage development requires comprehensive, well-organized CMC, nonclinical, and clinical documentation that supports both IND maintenance and future NDA/BLA submissions. Therefore, the scope and depth of IND documentation should be aligned with the project's development strategy and CDP. Integrating preclinical, clinical, CMC, regulatory, and biostatistical functions under a common development strategy improves efficiency, minimizes regulatory risk, and ultimately increases the probability of successful IND approval and subsequent marketing authorization.

Selecting the right dose for first-in-human (FIH) clinical trials is one of the most consequential decisions in drug development. Errors in dose selection can lead to inadequate efficacy, unexpected toxicity, or costly protocol amendments that derail an entire development program. This presentation examines practical, evidence-based frameworks for translating nonclinical pharmacology and toxicology data into rational starting dose and dose escalation strategies for clinical trials.
Drawing on real-world experience from IND submissions to the Korean MFDS and the US FDA across multiple modalities ㅡ including small molecules, therapeutic proteins, monoclonal antibodies, and ATMPs ㅡ this talk will cover: (1) the minimum anticipated biological effect level (MABEL) and maximum recommended starting dose (MRSD) approaches and their regulatory expectations; (2) allometric scaling and interspecies PK/PD extrapolation; (3) model-informed drug development (MIDD) tools including population PK modeling and exposure-response analysis to support dose rationale; and (4) common pitfalls encountered in early-stage biotechs with limited clinical pharmacology resources, and how to address them proactively.
Special emphasis will be placed on the regulatory-strategic interface: how sponsors can use dose selection rationale not merely as a compliance exercise, but as a scientifically compelling narrative that builds regulator confidence and accelerates IND approval. Case examples from AIMS Bioscience’s practice will illustrate how integrated pharmacometric analysis can inform not only the starting dose, but also the therapeutic dose range and biomarker-driven stopping rules.
Attendees will leave with a structured, modality-agnostic framework applicable to their own programs, regardless of development stage.

New Approach Methodologies (NAMs) are rapidly reshaping preclinical drug development by enabling more human-relevant evaluation of therapeutic efficacy and safety. A recent successful FDA IND submission by SillaJen, supported by Qureator, demonstrated that human in vitro efficacy data generated using a vascularized tumor immune microenvironment (vTIME) model—a NAM integrating patient-derived tumor organoids, human vasculature, and immune cells—could support regulatory decision-making without relying on conventional animal efficacy testing. This case represents an important milestone, but broader adoption of NAMs will require more than individual regulatory successes.
The next challenge is how to move from successful individual use cases toward broader and more consistent use of NAM-derived data in drug development. This will require greater confidence in when and how these models can be applied, how their results should be interpreted, and how relevant evidence can be generated and communicated across different stakeholders. Building this foundation is not a challenge for any single organization, but an ecosystem effort requiring collaboration among regulators, research organizations, industry, technology developers, and end users.
Qureator is contributing to this transition through vTIME and related human-relevant microphysiological systems. Following an initial regulatory use case, Qureator is participating in collaborative efforts aimed at advancing validation and standardization of NAM-based approaches for defined drug-development applications.
Looking forward, human-relevant NAM platforms can also generate high-quality, multimodal biological datasets that support the development of predictive AI models. By integrating experimentally generated data with computational approaches, NAMs may evolve from tools that measure drug responses into platforms capable of predicting therapeutic outcomes.
Together, these advances illustrate a broader transition toward more human-relevant, collaborative, and increasingly predictive approaches to preclinical drug development.

The costs of drug development rise disproportionally in later phases (Phase IIb and III). Hence decisions made in the early phases (pre-clinical to Phase IIa) can have disproportionate impact on the overall costs of a development programme. Quantification of parameters informing on; drug distribution to tissues of interest, the relationship between plasma concentration and target occupancy, and pharmacodynamic effects of target engagement can significantly reduce the costs, complexity and failure rate of Phase IIb and Phase II clinical trials. Timely assessment of the appropriate imaging interventions enables efficient planning to insert such studies in the development programme.

This talk provides an overview of imaging methodologies used to generate biologically meaningful outcome measures and discusses different kinds of studies and their role in the drug development pipeline. Both time and resource requirements needed to meaningfully integrate these methods into the development pipeline are explored. This talk will focus on CNS drug development, as the most mature therapeutic area to employ imaging methodologies, but the principles explored are applicable across the therapeutic spectrum

This session will discuss how investors evaluate clinical evidence when reviewing biotech investment and licensing opportunities. From an investor’s perspective, it will cover the key elements that make clinical data credible and decision-relevant, including trial design, patient selection, endpoints, safety, statistical strength, and competitive differentiation.

The session will also highlight what biotech companies should consider when planning clinical development for fundraising or partnering. Topics will include how to generate data that investors can trust, how to present clinical results clearly, and how to align clinical evidence with regulatory, commercial, and deal-making expectations.

By connecting clinical data with investment decision-making, this session aims to help biotech companies better understand what investors look for before committing capital or supporting a transaction.