Latest news with #FDA-required
Yahoo
3 days ago
- Business
- Yahoo
Medable Introduces Long-Term Follow-Up Model for Cell & Gene Therapy (CGT) Trials to Reduce Costs and Improve Patient Access
New digital-first solution enables patient engagement and retention while maintaining scientific rigor throughout 15-year CGT trials PALO ALTO, Calif., May 28, 2025--(BUSINESS WIRE)--Medable Inc., a leading technology platform provider for decentralized clinical trials, today unveiled its digital-first Long-Term Follow-Up (LTFU) model for cell and gene therapy (CGT) trials. Medable's platform reduces the burden on patients and sites involved in complex CGT trials and enhances scientific integrity with sustainable data capture across the FDA-required 15-year follow-up period for certain CGTs, including those using genome-editing techniques like CRISPR-Cas9. This extended monitoring period is essential for tracking delayed adverse events, understanding the durability of the therapy, and ensuring the long-term impact on patients – but can add significant hardships. CGTs offer transformative potential yet they also require prolonged safety monitoring, often spanning 15 years post-treatment. Traditional models for LTFU impose logistical and financial challenges on participants, contributing to lower participation and high attrition rates over time. According to a 2024 survey conducted by the Emily Whitehead Foundation and Catalyst Healthcare Consulting, 20% of CAR T-cell therapy patients stop participating in long-term follow-up altogether, with 80% of that group ceasing participation at or after five years post-treatment. Distance to sites, lack of awareness about local follow-up options, and burdensome travel are frequently cited as key barriers. "Long-term follow-up is essential to ensure the durability and safety of advanced therapies, but the current system isn't working for patients or sponsors," said Dr. Pamela Tenaerts, Chief Medical Officer at Medable. "With our new LTFU model, we're reimagining how post-treatment data is captured - putting patients at the center while ensuring scientific and regulatory rigor." Medable's digital-first LTFU offering includes: Remote and Hybrid Patient Interaction: Patients can engage in follow-up through flexible virtual, in-person, or blended formats that meet their individual needs and life circumstances. Seamless Transition from Parent Trials: Integrated workflows and data continuity ensure a frictionless handoff from interventional studies to long-term observational follow-up. Patient-First Data Capture and Adherence Monitoring: Leveraging mobile technology, patient reported questionnaires and local healthcare providers to track key endpoints and ensure consistent participation over time. Personalized Patient Communication: Ongoing engagement through tailored content, reminders, and support tools to build trust and maintain long-term connection. By embracing a digital, patient-centric approach, Medable's model addresses key gaps in traditional LTFU execution – improving retention, increasing diversity, and reducing the long-term cost burden for both sponsors and sites. Learn more about Medable's new digital-based LTFU model at American Society of Clinical Oncology's (ASCO) 2025 Annual Meeting (May 30-June 3) in Chicago at Medable Booth #10105. About Medable Medable is on a mission to get effective therapies to people faster. Its digital clinical trials platform enhances speed, scale, and patient access in clinical research, accelerating medicines for thousands of conditions without treatment or cure. Awarded Best Digital Health Solution by the Galien Foundation, Medable's platform has been deployed in nearly 400 trials in 70 countries and 120 languages, serving more than one million patients globally. Medable is a privately held, venture-backed company headquartered in Palo Alto, California, and was listed for the second year in a row on the Inc. 5000 in 2024. View source version on Contacts Media Contact: Lisa Barbadora, Barbadora INK for Medable+1 (610) 420-3413lbarbadora@ / media@
Business Wire
3 days ago
- Health
- Business Wire
Medable Introduces Long-Term Follow-Up Model for Cell & Gene Therapy (CGT) Trials to Reduce Costs and Improve Patient Access
PALO ALTO, Calif.--(BUSINESS WIRE)--Medable Inc., a leading technology platform provider for decentralized clinical trials, today unveiled its digital-first Long-Term Follow-Up (LTFU) model for cell and gene therapy (CGT) trials. Medable's platform reduces the burden on patients and sites involved in complex CGT trials and enhances scientific integrity with sustainable data capture across the FDA-required 15-year follow-up period for certain CGTs, including those using genome-editing techniques like CRISPR-Cas9. This extended monitoring period is essential for tracking delayed adverse events, understanding the durability of the therapy, and ensuring the long-term impact on patients – but can add significant hardships. By embracing a digital, patient-centric approach, Medable's model addresses key gaps in traditional LTFU execution. Share CGTs offer transformative potential yet they also require prolonged safety monitoring, often spanning 15 years post-treatment. Traditional models for LTFU impose logistical and financial challenges on participants, contributing to lower participation and high attrition rates over time. According to a 2024 survey conducted by the Emily Whitehead Foundation and Catalyst Healthcare Consulting, 20% of CAR T-cell therapy patients stop participating in long-term follow-up altogether, with 80% of that group ceasing participation at or after five years post-treatment. Distance to sites, lack of awareness about local follow-up options, and burdensome travel are frequently cited as key barriers. 'Long-term follow-up is essential to ensure the durability and safety of advanced therapies, but the current system isn't working for patients or sponsors,' said Dr. Pamela Tenaerts, Chief Medical Officer at Medable. 'With our new LTFU model, we're reimagining how post-treatment data is captured - putting patients at the center while ensuring scientific and regulatory rigor.' Medable's digital-first LTFU offering includes: Remote and Hybrid Patient Interaction: Patients can engage in follow-up through flexible virtual, in-person, or blended formats that meet their individual needs and life circumstances. Seamless Transition from Parent Trials: Integrated workflows and data continuity ensure a frictionless handoff from interventional studies to long-term observational follow-up. Patient-First Data Capture and Adherence Monitoring: Leveraging mobile technology, patient reported questionnaires and local healthcare providers to track key endpoints and ensure consistent participation over time. Personalized Patient Communication: Ongoing engagement through tailored content, reminders, and support tools to build trust and maintain long-term connection. By embracing a digital, patient-centric approach, Medable's model addresses key gaps in traditional LTFU execution – improving retention, increasing diversity, and reducing the long-term cost burden for both sponsors and sites. Medable Booth # 10105. About Medable Medable is on a mission to get effective therapies to people faster. Its digital clinical trials platform enhances speed, scale, and patient access in clinical research, accelerating medicines for thousands of conditions without treatment or cure. Awarded Best Digital Health Solution by the Galien Foundation, Medable's platform has been deployed in nearly 400 trials in 70 countries and 120 languages, serving more than one million patients globally. Medable is a privately held, venture-backed company headquartered in Palo Alto, California, and was listed for the second year in a row on the Inc. 5000 in 2024.
Business Wire
4 days ago
- Business
- Business Wire
ReposiTrak Adds 60 New Grocery Suppliers to the Queue for the Rapidly Expanding Food Traceability Network
SALT LAKE CITY--(BUSINESS WIRE)--ReposiTrak (NYSE:TRAK), the world's largest food traceability and regulatory compliance network, leveraging its established inventory management and out-of-stock reduction SaaS platform, is proud to add 60 grocery suppliers to the queue of companies joining the ReposiTrak Traceability Network® (RTN). These companies will efficiently exchange intricate, FDA-required Key Data Elements (KDEs) for each Critical Tracking Event (CTE) in their supply chains, with the goal of meeting traceability requirements before the FDA's 2028 deadline. Among the 60 new grocery suppliers are many with a rich history. One company, founded in 2018, specializes in upcycled dried fruit snacks that retain the peel for added nutrition and sustainability. Another, established in 1929, is a family-owned business renowned for its soda crackers, serving markets across the U.S. and the Caribbean. A third, with over 40 years in operation, is a global supplier of premium tree nut products, including those used in nut butters, offering sustainably sourced ingredients through direct grower partnerships. 'Traceability isn't just for items on the FDA's Food Traceability List anymore,' stated Randy Fields, chairman and CEO of ReposiTrak. 'Retailer requirements are expanding to encompass all food categories, and ReposiTrak ensures that every supplier, whether dealing with traceable items like nut butters or non-listed products, can achieve compliance seamlessly through our hardware free, scalable solution.' The ReposiTrak Traceability Network requires no additional hardware or software and the ReposiTrak team assists in making the connections needed under the new regulation. Suppliers can connect to an unlimited number of trading partners and share data for a low, flat fee. About ReposiTrak ReposiTrak (NYSE: TRAK) provides retailers, suppliers, food manufacturers and wholesalers with a robust solution suite to help reduce risk and remain in compliance with regulatory requirements, enhance operational controls and increase sales with unrivaled brand protection. Consisting of three product families – food traceability, compliance and risk management and supply chain solutions – ReposiTrak's integrated, cloud-based applications are supported by an unparalleled team of experts. For more information, please visit
Yahoo
4 days ago
- Business
- Yahoo
ReposiTrak Adds 60 New Grocery Suppliers to the Queue for the Rapidly Expanding Food Traceability Network
Ahead of regulatory deadlines, 60 grocery suppliers are queued to join ReposiTrak for its innovative, hardware-free traceability solutions SALT LAKE CITY, May 27, 2025--(BUSINESS WIRE)--ReposiTrak (NYSE:TRAK), the world's largest food traceability and regulatory compliance network, leveraging its established inventory management and out-of-stock reduction SaaS platform, is proud to add 60 grocery suppliers to the queue of companies joining the ReposiTrak Traceability Network® (RTN). These companies will efficiently exchange intricate, FDA-required Key Data Elements (KDEs) for each Critical Tracking Event (CTE) in their supply chains, with the goal of meeting traceability requirements before the FDA's 2028 deadline. Among the 60 new grocery suppliers are many with a rich history. One company, founded in 2018, specializes in upcycled dried fruit snacks that retain the peel for added nutrition and sustainability. Another, established in 1929, is a family-owned business renowned for its soda crackers, serving markets across the U.S. and the Caribbean. A third, with over 40 years in operation, is a global supplier of premium tree nut products, including those used in nut butters, offering sustainably sourced ingredients through direct grower partnerships. "Traceability isn't just for items on the FDA's Food Traceability List anymore," stated Randy Fields, chairman and CEO of ReposiTrak. "Retailer requirements are expanding to encompass all food categories, and ReposiTrak ensures that every supplier, whether dealing with traceable items like nut butters or non-listed products, can achieve compliance seamlessly through our hardware free, scalable solution." The ReposiTrak Traceability Network requires no additional hardware or software and the ReposiTrak team assists in making the connections needed under the new regulation. Suppliers can connect to an unlimited number of trading partners and share data for a low, flat fee. About ReposiTrak ReposiTrak (NYSE: TRAK) provides retailers, suppliers, food manufacturers and wholesalers with a robust solution suite to help reduce risk and remain in compliance with regulatory requirements, enhance operational controls and increase sales with unrivaled brand protection. Consisting of three product families – food traceability, compliance and risk management and supply chain solutions – ReposiTrak's integrated, cloud-based applications are supported by an unparalleled team of experts. For more information, please visit View source version on Contacts Investor Relations Contact:John Merrill, CFOInvestor-relations@ OrFNK IRRob Fink646.809.4048rob@ Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Yahoo
4 days ago
- Business
- Yahoo
ReposiTrak Adds 60 New Grocery Suppliers to the Queue for the Rapidly Expanding Food Traceability Network
Ahead of regulatory deadlines, 60 grocery suppliers are queued to join ReposiTrak for its innovative, hardware-free traceability solutions SALT LAKE CITY, May 27, 2025--(BUSINESS WIRE)--ReposiTrak (NYSE:TRAK), the world's largest food traceability and regulatory compliance network, leveraging its established inventory management and out-of-stock reduction SaaS platform, is proud to add 60 grocery suppliers to the queue of companies joining the ReposiTrak Traceability Network® (RTN). These companies will efficiently exchange intricate, FDA-required Key Data Elements (KDEs) for each Critical Tracking Event (CTE) in their supply chains, with the goal of meeting traceability requirements before the FDA's 2028 deadline. Among the 60 new grocery suppliers are many with a rich history. One company, founded in 2018, specializes in upcycled dried fruit snacks that retain the peel for added nutrition and sustainability. Another, established in 1929, is a family-owned business renowned for its soda crackers, serving markets across the U.S. and the Caribbean. A third, with over 40 years in operation, is a global supplier of premium tree nut products, including those used in nut butters, offering sustainably sourced ingredients through direct grower partnerships. "Traceability isn't just for items on the FDA's Food Traceability List anymore," stated Randy Fields, chairman and CEO of ReposiTrak. "Retailer requirements are expanding to encompass all food categories, and ReposiTrak ensures that every supplier, whether dealing with traceable items like nut butters or non-listed products, can achieve compliance seamlessly through our hardware free, scalable solution." The ReposiTrak Traceability Network requires no additional hardware or software and the ReposiTrak team assists in making the connections needed under the new regulation. Suppliers can connect to an unlimited number of trading partners and share data for a low, flat fee. About ReposiTrak ReposiTrak (NYSE: TRAK) provides retailers, suppliers, food manufacturers and wholesalers with a robust solution suite to help reduce risk and remain in compliance with regulatory requirements, enhance operational controls and increase sales with unrivaled brand protection. Consisting of three product families – food traceability, compliance and risk management and supply chain solutions – ReposiTrak's integrated, cloud-based applications are supported by an unparalleled team of experts. For more information, please visit View source version on Contacts Investor Relations Contact:John Merrill, CFOInvestor-relations@ OrFNK IRRob Fink646.809.4048rob@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
