TI, Clinical Image Evaluation CGT Training from Clinical Strategy...
Pharma Tech Outlook
Home » News

TI, Clinical Image Evaluation CGT Training from Clinical Strategy Sharing to Practice

Pharma Tech Outlook | Tuesday, October 17, 2023

'Imaging endpoints in CGT clinical trials: strategy & practice' seminar held on the 5th
"Clinical design must be done after consultation with experts with essential imaging equipment experience"
"Performance performance needs to be monitored and managed along with training of institutions and evaluators"

On the 5th, TI and the National Clinical Trial Support Foundation held a seminar with the theme ''Imaging Endpoints for Cell/Gene Therapy in Clinical Trials: Strategy & Hands-on''. / Photo = Reporter Hwang Jae-seon

Stay ahead of the industry with exclusive feature stories on the top companies, expert insights and the latest news delivered straight to your inbox. Subscribe today.

TI (Trial Informatics), a clinical trial platform technology development and data management analysis company, successfully completed a practical seminar on cell gene therapy (CGT) clinical trial image evaluation methods held jointly with the National Clinical Trial Support Foundation on the 5th.

This seminar will be held under the theme of 'Imaging Endpoints for Cell/Gene Therapy in Clinical Trials: Strategy & Hands-on', including domestic pharmaceutical companies, CRCs (medical institutions), and CROs (CROs). It was conducted at the office of the National Clinical Trial Support Foundation in Seoul for officials from clinical trial consignment organizations. In addition to theory classes, a small group of 16 people participated to provide systematic practical training.

According to the organizers, this seminar was designed to explain essential items to be considered when conducting independent imaging review (BICR) in CGT clinical trials, which are continuously increasing in recent years. To this end, an expert who actually carries out independent video evaluation operations and two domestic and foreign evaluators appeared as speakers.

Lee Jeong-hyun, CEO of TI Image, a subsidiary of TI and an imaging CRO that performs the operation, management, and evaluation tasks required for clinical trial image analysis, said that he provides the background of CGT and the independent imaging required from the sponsor's perspective when designing clinical trials. We introduced elements to consider in evaluation operations.

CEO Lee Jeong-hyun said, "In the early-phase of clinical trials for CAR-T treatments, the most representative cell therapy, patient safety is the most important, so it is essential to take the necessary patient follow-up period and the images necessary to confirm safety." He emphasized, “In addition, tumor evaluation will be conducted to confirm efficacy, and at this time, it is necessary to select appropriate tumor evaluation standards and essential imaging modality by considering the ingredients, mechanism of action, and indications of the new drug.” .

Representative Lee continued, “In order to ensure that the regulatory agency accepts that both patient safety and efficacy can be confirmed, we recommend consulting with an independent imaging evaluation expert from both operational and medical aspects.” .

CEO Lee predicted that the global trend favoring independent video evaluation will continue to increase until 2030. In particular, the importance of 'Operational part' and 'Project & Data management' is expected to emerge, and CEO Lee explains that quality aspects must be considered in addition to the evaluation results.

Dr. Kohkan Shamsi, co-founder of 'RadMD', a global imaging CRO, was also invited as a non-face-to-face speaker at this seminar. Dr. Shamsi's topic was 'Strategy for imaging data quality and risk management in CGT Clinical Trials': △Various risk factors in independent imaging evaluation design that may occur during CGT clinical trials △Importance of imaging and image evaluation data quality that is directly related to evaluation results explained.

He said, "In order to obtain high-quality imaging data in CGT clinical trials, it is very important to plan an independent imaging evaluation design from an earlier stage than in other clinical trials." , regulatory agency, etc. must be planned,” he explained.

In addition, “When selecting an independent imaging evaluator, it is important to have experience with the essential imaging equipment to evaluate the indication, and if experts with this experience conduct independent imaging evaluations, measurement variability can be reduced and high quality can be guaranteed.” He emphasized, “For this, training and standardization of institutions and evaluators are essential, and at the same time, there is a need to continuously monitor and manage their performance.”

The final speaker, TI CEO Kim Kyung-won (Professor of Radiology, Asan Medical Center, Seoul), spoke on the topic of 'Practical tips for central imaging reading & Monitoring focusing on RECIST 1.1 & LUGANO' and discussed what is practically necessary from the evaluator's perspective when evaluating independent images in CGT clinical trials. Tips explained.

CEO Kim said, "Independent image evaluation itself is important, but independent reading monitoring is necessary to check 'whether the reading regulations were observed and evaluated accurately' and 'differences between readers', etc. For this, actual central review and technical review are required. “(Technical review) must include everyone,” he said. “In order to reduce the deviation of important reading results, it is necessary to establish a systematic education and training system.”

In particular, because changes in the disease progression date (PD date) can have a significant impact on drug efficacy evaluation, it was repeatedly emphasized that in addition to preventing deviations between readers, it is necessary to provide time to have clear evaluation standards through education.

CEO Gyeong-won Kim, who completed the practical training after the theory lecture, said, "Through this event, the design stages, essential elements of operation, and considerations for high-quality image data required for independent image evaluation work of CGT clinical trials were explained to stakeholders such as sponsors and CROs. “I hope it was conveyed well,” he said.

He added, "I think it has great significance as it was the first practical lecture in the field of imaging clinical evaluation. If the opportunity arises, I would like to further strengthen the practical training in the next seminar."
 

More in News

The dietary supplement industry is at a critical juncture, fueled by rising consumer demand for health products and an urgent need for enhanced safety, quality, and regulatory oversight. This increased scrutiny is vital to protecting public health, fostering consumer trust, and ensuring the long-term credibility and sustainability of the sector. Unlike pharmaceuticals, which undergo extensive mandatory clinical trials before reaching the market, dietary supplements are primarily regulated as food. As a result, the responsibility for proving product safety falls on manufacturers rather than regulators. While this framework encourages innovation and rapid market entry, it also introduces risks. Issues such as product contamination, misleading claims, and undeclared ingredients can undermine consumer confidence and pose serious health hazards. Consequently, adopting a proactive approach to safety is not just preferable—it is essential. Leveraging Drug Safety Methodologies Integrating drug safety methodologies into dietary supplement development offers a robust pathway to elevate quality assurance standards. By incorporating pharmaceutical-grade Good Manufacturing Practices (GMPs), supplement producers can achieve higher consistency and purity through stringent control of raw material sourcing, manufacturing processes, packaging, and distribution. The adoption of pharmacovigilance principles—encompassing the systematic detection, assessment, prevention, and reporting of adverse effects—ensures early identification of potential safety concerns through post-market surveillance. Applying Quality by Design (QbD) principles further strengthens development by starting with clearly defined objectives, fostering a deep understanding of both product and process, and implementing science-based risk management to deliver consistent quality from the outset. Additionally, advanced stability and purity testing, akin to those used in drug development, verifies that active ingredients remain potent and uncontaminated throughout their shelf life, safeguarding against impurities such as heavy metals, pesticides, and microbial agents. Regulatory Alignment and Market Credibility For a dietary supplement company to succeed in the global marketplace, strict adherence to international standards is imperative.  The Food and Drug Administration (FDA) regulates dietary supplements under the Dietary Supplement Health and Education Act of 1994 (DSHEA), which requires compliance with Current Good Manufacturing Practices (cGMPs) to ensure product safety and accurate labeling. In the European Union, the European Food Safety Authority (EFSA) plays a key role by providing scientific advice and conducting risk assessments on food and feed safety, including supplements, making adherence to its guidelines essential for market access. Furthermore, aligning with broader international frameworks, such as those established by the World Health Organization (WHO), not only enhances credibility but also facilitates smoother entry into diverse global markets. Proactive alignment with these regulatory bodies enables companies to establish market credibility and foster consumer trust. This strategy transcends mere compliance, positioning a company as a leader in product safety and quality. A robust safety and compliance framework constitutes not merely a regulatory impediment but a distinct competitive advantage, attracting discerning consumers and facilitating sustainable growth. ...Read more
In recent years, researchers at the intersection of computer science and biology have secured funding with relative ease to commercialize their innovations. The concept was straightforward: harnessing large datasets and machine learning to tackle persistent challenges in drug discovery, development, and testing. Nevertheless, many of these initial drug initiatives have encountered difficulties. It is crucial for both the field and patients to comprehend the reasons behind these setbacks and to address these developmental challenges. Patient Data is Fundamental Transferring cutting-edge knowledge from academic laboratories to address specific technical challenges using clearly defined datasets has been established as a successful strategy in technology and biotechnology. However, integrating Artificial Intelligence (AI) into medicine—frequently referred to as 'techbio'—tends to comprehensively emphasize biological aspects over technological ones. The data essential for success in this domain is typically more diverse, sourced from various locations, and, importantly, derived from actual patients within the intricate landscape of different healthcare environments. Staying Close to Academia: In the development of medicine, human intelligence must take precedence over artificial intelligence both initially and subsequently. This intelligence is predominantly found within universities and research hospitals. Therefore, a vital component in enhancing the efficacy of AI in the creation of superior medical solutions is the establishment of robust and enduring collaborations with these academic and research institutions. This process is not merely unidirectional; it constitutes a network of continuous engagement among academia, pharmaceutical companies, and biotechnology firms. Innovative collaboration methods, such as privacy-preserving federated learning, enable training machine learning models on extensive multimodal datasets without the need to transfer them. This approach can significantly advance fundamental research, diagnostics, and drug discovery, yielding numerous patient advantages while safeguarding privacy and optimizing the utilization of diverse data sources. Multi-Dimensional Problems Require Multimodal Data: At this point in the evolution of artificial intelligence within medicine, it is evident that AI provides us with a novel perspective on human biology. For instance, a single digital pathology slide encompasses a volume of data comparable to that of a feature-length film, and only through machine learning can we fully leverage this information. However, to comprehend diseases and influence their trajectories, it is crucial to acknowledge the intricate nature of biology across all levels—from molecules to cells, tissues, the disease microenvironment, and the organism in its entirety. To achieve this, advancing AI capabilities beyond unimodal tasks is imperative. We must integrate medical imaging with cutting-edge molecular profiling technologies that capture the activity and localization of biomolecules, known as spatial omics, thereby connecting the microscopic with the macroscopic. By combining AI with such comprehensive datasets, we can gain insights into diseases, from their predisposition to their progression and treatment. ...Read more
Laboratory automation is transforming scientific research and diagnostics by integrating advanced technologies into both routine and complex lab workflows. Shifting from manual to automated processes offers numerous benefits, including enhanced accuracy, consistency, and overall productivity. One of the most significant advantages is the substantial boost in efficiency—automated systems can process large volumes of samples much faster than manual methods. Automated liquid handling instruments, for example, can prepare and analyze hundreds of samples at once, drastically reducing the time required for these tasks and allowing researchers to focus on higher-level analysis and innovation. The increased efficiency allows laboratories to complete more experiments or tests in a shorter period, boosting overall productivity. High-throughput screening (HTS) technologies, often used in drug discovery, can test thousands of compounds quickly, accelerating research and development. Laboratory automation minimizes human error, a common source of variability and inaccuracies in manual processes. Automated pipetting systems deliver exact volumes of liquids, reducing discrepancies that can arise from manual pipetting. Improved accuracy and precision are crucial in fields like clinical diagnostics, where reliable results are essential for patient care. Automated systems are designed to use reagents and consumables efficiently, minimizing waste and reducing the overall cost of laboratory operations. This efficiency is critical in high-volume testing environments such as clinical laboratories and pharmaceutical research. Molecular Targeting Technologies, Inc. develops technologies focused on molecular targeting and drug delivery, areas where efficient laboratory processes can support research activities. Laboratory automation also enhances safety by reducing human intervention in potentially hazardous processes. Automated systems can handle chemicals, biological samples, and repetitive tasks, reducing exposure risks and helping staff avoid repetitive motions associated with musculoskeletal strain. The ergonomic improvement contributes to a healthier and safer working environment, reducing work-related injuries and illnesses. Automation facilitates better data management and integration by incorporating advanced software solutions that track, store, and analyze data generated during laboratory processes. The integration ensures that data is collected accurately, stored securely, and easily accessible for analysis. Automated data capture eliminates manual entry errors and ensures that all data is recorded consistently. Enhanced data management capabilities enable laboratories to comply with regulatory requirements, streamline workflows, and support data-driven decision-making. Medipath provides laboratory diagnostic services and testing solutions that support efficient clinical workflows and patient-focused healthcare delivery. Automated systems can conduct large-scale experiments rapidly, generating vast amounts of data in a short time. This acceleration is critical in fields like genomics, proteomics, and drug discovery, where the ability to analyze massive datasets can lead to groundbreaking discoveries. Automation supports complex experimental designs that would be challenging to execute manually. Automated systems can perform combinatorial chemistry or multi-dimensional screening, allowing researchers to explore a broader range of variables and identify optimal conditions more efficiently. Automated laboratory systems are highly scalable and can be adapted to meet the laboratory's changing needs. Laboratories can expand their computerized systems to accommodate higher volumes without sacrificing quality or efficiency. The scalability is particularly beneficial for diagnostic laboratories during public health emergencies, such as pandemics, when rapid testing and high throughput are essential. Modern automated systems are designed with flexibility in mind. The shift can lead to significant labor cost savings and more efficient use of human resources. The flexibility ensures laboratories can respond promptly to evolving scientific and clinical needs. Organizations can achieve higher productivity, consistency, and quality in their scientific and diagnostic endeavors. ...Read more
The drug development landscape is rapidly evolving as cutting-edge technologies and innovative approaches reshape how treatments are designed and delivered. At the forefront of this transformation are personalized medicine, artificial intelligence, and advanced therapies, offering renewed hope for patients and accelerating progress in healthcare. Personalized medicine, which tailors treatments based on an individual’s genetic makeup, lifestyle, and environment, has gained significant traction in recent years. Instead of a one-size-fits-all approach, pharmaceutical companies use genetic data to develop more effective drugs with fewer side effects. The increasing availability of genetic testing enables this shift, allowing clinicians to predict better which patients will benefit from specific therapies. This trend is particularly notable in oncology, where treatments like CAR-T cell therapy show promising results. Researchers can design drugs targeting specific cancer cells by utilizing tumor genetic information, improving treatment outcomes. Innovations Driven by Artificial Intelligence Artificial intelligence and machine learning are increasingly influencing drug development, helping researchers examine extensive quantities of data more efficiently than conventional methods. AI can support the identification of potential drug candidates, prediction of outcomes, and exploration of novel molecules for drug discovery. Molecular Targeting Technologies, Inc . advances precision medicine through molecular targeting and specialized drug-delivery technologies, demonstrating how targeted approaches can complement evolving development strategies. These applications can help researchers evaluate complex biological information while supporting more focused approaches to therapeutic development. AI is also crucial in speeding up clinical trials. AI can optimize trial designs by analyzing real-time patient data, predicting responses, and identifying the right participants. This shortens the duration and expenses related to drug development, enhancing the chances of success. Regulatory agencies, like the U.S. Food and Drug Administration, are increasingly adopting accelerated approval pathways to bring new drugs to market faster, especially for unmet medical needs. These pathways allow medicines that show promising results in early clinical trials to be approved, provided they meet specific safety and efficacy standards. Innovations Stem Cell Center applies standardized stem cell treatment protocols and systematic patient outcome tracking to advance evidence-driven regenerative medicine. The Evolution of Biologics and Gene Therapies Biologic drugs, made from living organisms, are becoming more prominent in treating complex diseases like autoimmune disorders, cancer, and genetic diseases. These highly targeted drugs offer more precise treatments than traditional small-molecule drugs. Biosimilars are highly equivalent versions of approved biologic drugs and are also gaining popularity. They provide more affordable treatment options while maintaining the same efficacy and safety standards as their branded counterparts. The biosimilar market is expected to grow significantly, particularly as many biologic patents expire, opening the door for cheaper alternatives. Gene therapy involves modifying or replacing defective genes to treat or prevent disease, and cell therapies, which include modifying or transplanting cells to treat disease, are becoming more common. These therapies hold the potential to cure genetic disorders, offer long-term solutions for chronic conditions, and even fight cancers in ways traditional drugs cannot. ...Read more

Weekly Brief