Regulaltory Challenges

Notable Labs is a biotech startup revolutionizing cancer treatment through its innovative Precision Predictive Medicine Platform (PMPP), leveraging data and technology to identify the most effective therapies for each patient. Founded by Matthew De Silva after his father's glioblastoma diagnosis, Notable Labs combines De Silva's finance background with the medical expertise of CEO Dr. Thomas Bock. The team includes esteemed professionals like Dr. Joseph Wagner, Dr. Glenn Michelson, and Scott McPherson, who collectively bring decades of experience in biotech, clinical trials, and financial strategy. Notable Labs partners with renowned hospitals and employs cutting-edge drug screening technology to provide personalized, data-driven treatment plans, significantly improving patient outcomes. With a dedicated and diverse team, Notable Labs stands at the forefront of precision oncology, offering hope and new possibilities for cancer patients worldwide.

Notable Labs is a clinical-stage precision oncology company developing new cancer therapies identified by its Predictive Medicine Platform (PMP), today announced progress for the Phase 2 volasertib program following receNotable Labs is a clinical-stage precision oncology company developing new cancer therapies identified by its Predictive Medicine Platform (PMP), today announced progress for the Phase 2 volasertib program following receipt of “Clearance to Proceed” from the FDA and agreement on the dosing plan for its Phase 2 clinical trial. With trial start-up activities launched in the first quarter of this year, Notable intends to initiate enrollment in the Phase 2 study for PMP-enabled development of volasertib for relapsed refractory (R/R) acute myeloid leukemia (AML) in the coming months.ipt of “Clearance to Proceed” from the FDA and agreement on the dosing plan for its Phase 2 clinical trial. With trial start-up activities launched in the first quarter of this year, Notable intends to initiate enrollme

Clinical trials advance medicine, but ensuring ongoing access to successful treatments post-trial is crucial. This blog examines the ethical and practical challenges of post-trial access (PTA), emphasizing its importance for patient rights and welfare. Explore the financial, logistical, and regulatory hurdles, and learn how improved policies and collaboration can help ensure that trial participants continue to benefit from their contributions to research.

Explore how Decentralized Clinical Trials (DCTs) are reshaping medical research by using technology to conduct studies remotely. Learn how DCTs improve accessibility, efficiency, and patient engagement, and discover future trends like AI and blockchain. This blog covers the rapid adoption of DCTs during the pandemic, current advancements, and upcoming challenges in this evolving field.

Explore the vital role of biostatistics in ensuring patient safety during clinical trials. Our blog covers how biostatistical methods aid in study design, data monitoring, and outcome analysis to protect participants and enhance research integrity. Learn about adaptive trial designs, real-world data, and the latest innovations driving safer and more effective clinical trials.

Explore how regulatory science and clinical trials shape the future of healthcare. Our blog delves into how regulatory science ensures the safety and efficacy of medical treatments, the structured phases of clinical trials, and the impact of new technologies. Discover the evolving challenges and innovations in this critical field.

This blog explores how real-world evidence (RWE) is reshaping drug approval by complementing traditional randomized controlled trials (RCTs). It highlights RWE's role in providing broader insights into drug safety and efficacy, its application in regulatory decisions, and its potential to enhance patient care. Discover how integrating RWE into drug development is paving the way for more comprehensive and patient-centered treatments.

Pediatric clinical trials are essential but complex, facing unique challenges such as ethical concerns, regulatory hurdles, and difficulties in recruiting participants. This blog examines these issues, from tailored dosing and formulation to effective study design and communication. It also explores innovative solutions like adaptive trial designs and technological advances, aiming to improve pediatric research and ensure safe, effective treatments for children.

Discover the crucial role of Institutional Review Boards (IRBs) in clinical trials. This blog highlights how IRBs safeguard participant rights, ensure ethical standards, and maintain research integrity. Learn about their review process, challenges, and how they adapt to new trends in medical research.

International clinical trials are crucial for assessing new medical interventions globally, but they face significant hurdles. This blog examines key challenges, including diverse regulatory requirements, cultural and language barriers, logistical complexities, and data management issues. Through insightful analysis and case studies, we highlight strategies for navigating these obstacles and ensuring successful trial outcomes. Discover how to effectively manage the complexities of global clinical research and contribute to advancements in healthcare.