C&R Reporter is here to introduce C&R Research’s latest data-driven innovation.C&R Research is strengthening its capabilities as a specialized Data CROfocused on clinical data.Recently, in collaboration with Mediplexus,C&R Research launched a Hybrid Clinical Solutionconnecting clinical trial data with real-world data(RWD). Here’s what has changed.We introduce the C&R x MPX Hybrid Clinical Solutionand C&R Research’s Data CRO strategy.  Q. What is the C&R x MPX Hybrid Clinical Solution?A. It is a solution that integrates clinical trial data with hospital-based real-world data(RWD). • Mediplexus: Provides hospital EMR-based real-world data(RWD)• C&R Research: Provides data design, standardization, statistical analysis, and reportingBy integrating EMR-based real-world data with standardized research data,the solution generates regulatory-grade real-world evidence(RWE) for decision-making. This enables faster and more precise data-driven decisionsin Risk Management Plan(RMP) and pharmacovigilance research.    Q. How does C&R Research operate data-driven clinical trials?A. C&R Research operates through dedicated data teams. • Data Management: Data collection and management• Biostatistics: Statistical analysis• Medical Operation: RWD-based study planning and reporting• RWO: Clinical operation support From data generation → cleaning → analysis → reporting, C&R Research manages the entire process within one integrated system,ensuring data quality and consistency.Q. What differentiates C&R Research as a Data CRO?A. C&R Research is a specialized Data CRO that transforms data into actionable evidence.• Designs data for regulatory readiness• Implements data strategy across clinical development to post-authorization studies• Applies strategic data utilization in RWD∙RWE environmentsC&R Research is a Data CRO that transforms data from numbers into decision-ready evidence.C&R Research is a Data CRO that manages the full clinical data lifecyclefrom generation to regulatory application.As RWD and RWE expand,C&R Research remains a strategic clinical partner that turns data into value.Learn how C&R Research, a Data CRO,provides end-to-end clinical solutions by visiting our website.Thank you for your continued interest in C&R Research.

 C&R Reporter is here to show how we recharge and thrive at C&R Research. C&R Research is an End-to-End CRO with over 500 clinical experts,supporting the entire clinical process from planning to conduct, data management and reporting. To help our experts work sustainably and confidently, C&R Research offers special employee benefits.  Q. Where do you head first when you arrive at C&R Research?A. The first-floor lounge, featuring coffee, tea, and book lending. It’s where most staff naturally stop in the morning.Even the C&R Reporter starts the day here with a cup of coffee. Coffee and a variety of teas are available to start the day on a positive note. A bookshelf in the back offers book lending for staff leisure, with new titles shared every month.Q. What kinds of books are available?A. The lounge offers a variety of books,from pharmaceutical, biotech, and clinical references to hobby reads for leisure. On the first floor at C&R Research, staff can take a relaxing pause with these books.  Q. What kind of space is on the top terrace at C&R Research?A. The C&R Terrace, a sky garden for staff.It’s a place to enjoy the open sky and nature up close,perfect for a relaxing pause or a light discussion with colleagues.Q. What experiences are available at the C&R Terrace?A. The terrace features workshops, lunch, and relaxation for staff.It also hosts departmental events, and on sunny days, staff can enjoy lunch outdoors.It’s a unique and comfortable spot at C&R Research for recharging during the workday.Q. What unique benefits does C&R Research offer beyond its workspace facilities?A. Family Day and Lunch Day provide staff with flexible work hours and a free lunch.These special benefits give staff time,helping them naturally balance work and personal life.Q. How are Family Day and Lunch Day organized?A. Staff receive two early leaves and two free lunches each month.On Mondays, office staff can enjoy a free lunch,allowing them to focus on work without worrying about meals.On Fridays, staff work only in the morning and leave early,giving them a more relaxed afternoon.Q. What are the benefits of Family Day and Lunch Day?A. They help staff balance work and personal life, and enjoy time with colleagues.Twice a month, staff can manage personal schedules more flexibly and spend relaxed moments over a free lunch.Q. What is the biggest advantage of working at C&R Research?A. As an End-to-End CRO, we support work efficiency while providing clinical experts a stable work environment. C&R Research maintains a healthy balance between work and rest, so everyone can focus with ease.  Learn more about End-to-End CRO solutions at C&R Research on our website.We look forward to sharing more updates from C&R Research with you.

   This is the final part of the 1st C&R Webinar Insights series. * In the previous part, we discussed strategies for successful payload development. In this part, we focus on how ADCs are metabolized and degraded in the body. * | ADC DegradationThe structure of ADC is complex, similar to monoclonal antibody-based therapeutics, and its degradation involves both non-specific and target-specific mechanisms. Non-specific degradation primarily occurs through uptake by macrophages and endothelial cells, followed by protein breakdown in various tissues such as the skin, muscle, and liver. These cells internalize antibodies via non-specific pinocytosis and degrade them through lysosomal proteolysis. For target-specific degradation, ADCs most commonly undergo target-mediated clearance, where the antibody binds to its intended cell-surface antigen, is internalized, and degraded intracellularly according to the ADC’s designed mechanism of action.Please refer to the figure below for an overview of the ADC degradation process.   Figure reference: Metrangolo V, Engelholm LH. Antibody-Drug Conjugates: The Dynamic Evolution from Conventional to Next-Generation Constructs. Cancers (Basel). 2024;16(2):447  * We hope these insights provide valuable perspectives for your ADC research and development. Thank you for your continued interest. * | References 1. Lucas AT, Robinson R, Schorzman AN, Piscitelli JA, Razo JF, Zamboni WC. Pharmacologic Considerations in the Disposition of Antibodies and Antibody-Drug Conjugates in Preclinical Models and in Patients. Antibodies (Basel). 2019;8(1):3. Published 2019 Jan 1. doi:10.3390/antib8010003 2. Gao Y, Xia Y, Chen Y, et al. Key considerations based on pharmacokinetic/pharmacodynamic in the design of antibody-drug conjugates. Front Oncol. 2025;14:1459368. Published 2025 Jan 9. doi:10.3389/fonc.2024.1459368 3. Mahmood I. Clinical Pharmacology of Antibody-Drug Conjugates. Antibodies (Basel). 2021;10(2):20. Published 2021 May 21. doi:10.3390/antib10020020 4. Nguyen TD, Bordeau BM, Balthasar JP. Mechanisms of ADC Toxicity and Strategies to Increase ADC Tolerability. Cancers (Basel). 2023;15(3):713. Published 2023 Jan 24. doi:10.3390/cancers15030713 *

   This is the third part of the 1st C&R Webinar Insights series. * In the previous part, we explored clinical development strategies to expand the market share of an ADC with palliative intent. In this part, we turn our focus to clinical development strategies for successful payload design. * 1. Enhancing SelectivitySelectivity can be improved not only through the identification of cancer-specific targets but also by designing payloads that leverage aberrant signaling pathways or hyperactivated intracellular processes unique to cancer cells. Another promising approach involves developing the ADC in the form of a Probody-Drug Conjugate(PDC), in which the probody is removed upon reaching the tumor microenvironment, triggering the release of the cytotoxic payload.   2. Understanding Payload ResistanceAs the ADC has become more widely used, mechanisms of ADC resistance have been increasingly elucidated. Three primary mechanisms of resistance have been identified: [1] Reduced antigen expression following prolonged ADC exposure [2] Alterations in intracellular trafficking pathways [3] Upregulation of drug efflux pumps leading to payload resistance Ongoing research on novel payloads, dual payload approaches, and BsADCs aims to enhance therapeutic efficacy and minimize resistance.   3. Strengthening Safety through Novel PayloadsIt is known that only a small fraction of administered ADCs reach their intended tumor cells. Novel payloads offer an opportunity to improve safety profiles compared to conventional ADCs, enabling the development of more competitive and clinically viable therapeutics.   4. ADC Sequencing & Synergistic CombinationWhen developing novel payloads, it is important to consider not only the intrinsic properties of the payload itself but also its potential synergy with other ADCs and its ability to overcome resistance from prior ADC treatments. A strategic, integrated approach to payload design is key to developing next-generation, high-performing ADCs. * We hope these insights provide valuable perspectives for your ADC research and development. Thank you for your continued interest. * | References 1. Metrangolo V, Engelholm LH. Antibody-Drug Conjugates: The Dynamic Evolution from Conventional to Next-Generation Constructs. Cancers (Basel). 2024;16(2):447. Published 2024 Jan 20. doi:10.3390/cancers16020447 2. Izzo D, Ascione L, Guidi L, et al. Innovative payloads for ADCs in cancer treatment: moving beyond the selective delivery of chemotherapy. Ther Adv Med Oncol. 2025;17:17588359241309461. Published 2025 Jan 2. doi:10.1177/17588359241309461 3. Grairi M, Le Borgne M. Antibody-drug conjugates: prospects for the next generation. Drug Discov Today. 2024;29(12):104241. doi:10.1016/j.drudis.2024.104241 4. Long R, Zuo H, Tang G, et al. Antibody-drug conjugates in cancer therapy: applications and future advances. Front Immunol. 2025;16:1516419. Published 2025 May 21. doi:10.3389/fimmu.2025.1516419 5. Wang Z, Li H, Gou L, Li W, Wang Y. Antibody-drug conjugates: Recent advances in payloads. Acta Pharm Sin B. 2023;13(10):4025-4059. doi:10.1016/j.apsb.2023.06.015 6. Huppert LA, Mahtani R, Fisch S, et al. Multicenter retrospective cohort study of the sequential use of the antibody-drug conjugates (ADCs) trastuzumab deruxtecan (T-DXd) and sacituzumab govitecan (SG) in patients with HER2-low metastatic breast cancer (MBC). NPJ Breast Cancer. 2025;11(1):34. Published 2025 Apr 15. doi:10.1038/s41523-025-00748-5 *

   Welcome to the second part of the 1st C&R Webinar Insights series. * In the first entry of our series, we explored Next-Generation ADC, focusing on BsADC(Bispecific ADC). This part focuses on clinical development strategies to increase the market share of an ADC with palliative intent. * 1. Discovery and Selection of Ideal Target AntigensIt is crucial to select antigens that are highly expressed in tumors but minimally expressed in normal tissues to minimize adverse effects. Targeting antigens that are commonly present across most patients with a specific cancer type can also broaden the potential patient pool. Selecting non-secretory antigens ensures ADC accuracy and safety, while choosing targets with strong endocytosis capability and appropriate intracellular transport pathways can maximize ADC cytotoxic effects.   2. Biomarker-Based Patient SelectionIdentifying patient populations where the therapeutic effect is likely to be optimal can maximize medical efficiency. The use of CDx(Companion Diagnostics) in a 'Dx-Rx co-development model' can accelerate regulatory approval. Building a biomarker-driven R&D pipeline and incorporating next-generation technologies such as liquid biopsy and AI-based biomarker discovery positions ADC development to lead the market.   3. Combination Therapy StrategiesADC can be combined with other anticancer agents or immunotherapies to achieve synergistic effects. In solid tumors, antigen expression is often heterogeneous, making it difficult to achieve sufficient efficacy with a single target. Strategies such as enhanced payload utilization, BsADC development, and combination therapy approaches are being considered.​​   4. Safety Improvement StrategiesAlthough ADC aim to minimize toxicity by selectively targeting cancer cells, systemic toxicity remains a concern. Optimizing linkers, payloads, conjugation methods, and target antigens can address issues such as linker instability and DAR(Drug–Antibody Ratio) variability. In parallel, balancing dosing and toxicity is critical to improve overall safety profiles.​   5. Significance of Overall Survival(OS) DataThe FDA’s draft guidance (August 2025) emphasizes the significance of Overall Survival(OS) assessment. Collecting robust, long-term OS data from early stages and building Real World Evidence(RWE) capabilities should be incorporated into clinical trial strategies. Focusing pipelines on mechanisms and therapeutic areas where demonstrating OS benefit is feasible, and engaging proactively with regulatory authorities such as the FDA, are essential for strategic clinical planning.   6. Expanding Indications to First-line TherapyFirst-line therapy offers high clinical value, significantly impacting patient survival and prognosis. Expanding ADC indications to first-line treatment provides a 'First-mover advantage', while also offering strategic value through long-term exclusivity secured by patents. * We hope these insights provide valuable perspectives for your ADC research and development. Thank you for your continued interest. * | References 1. Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics. Guidance for Industry. FDA, 2018. 2. Approaches to Assessment of Overall Survival in Oncology Clinical Trials(Draft). Guidance for Industry. FDA, 2025. 3. The Journey of Antibody–Drug Conjugates: Lessons Learned from 40 Years of Development. Cancer Discov. 2024;14:2089–108. 4. Antibody-drug conjugate combinations in cancer treatment: clinical efficacy and clinical study perspectives. Front. Pharmacol. 2025. *