Clinical Research: Phase 1 - Phase 4

Navigating Uncertainty with Confidence: Bringing In Vitro Diagnostics to Market in the EU

In vitro diagnostics (IVDs) have become a cornerstone of modern medicine, and rising demand for these critical medical devices has driven rapid market growth. Since 2021, hospitals and laboratories have demonstrated an increasing preference for point-of-care testing devices to get accurate, real-time data. In addition, government organizations, associations, and agencies are encouraging the use of...

The New Normal for Laboratory Developed Tests: Recent Changes to FDA Regulation

Laboratory developed tests (LDTs) and in vitro diagnostics (IVDs) play a critical role in modern medical care. According to the US Centers for Disease Control and Prevention (CDC), 14 billion laboratory tests are ordered each year and an estimated 70 percent of medical decisions are based on the results of these tests.1 Thus, diagnostic tests—and...

Understanding ISO 14155:2020 to Optimize Outcomes of Clinical Investigations of Medical Devices for Human Subjects

In today’s competitive landscape, device companies are facing increased demand for clinical evidence of product efficacy and safety. In addition to pressure from regulators prior to market approval, device companies must answer to other stakeholders, including: This increased scrutiny has prompted more device companies to perform clinical trials to meet regulatory requirements, differentiate their products,...

FDA’s Diversity Mandate: Transforming Clinical Trials and Drug Development for Better Outcomes for All

On June 26, 2024, the U.S. Food and Drug Administration (FDA) released its much-anticipated draft guidance on clinical trial diversity.1 This 23-page document outlines proposed requirements for racial and ethnic diversity action plans, which will soon become mandatory for studies involving drugs, devices, and other medical products. In this article, we highlight the key provisions...

Navigating Cell Therapy Development: The benefits of working with a Clinical CRO – CDMO Partnership

Cell therapies, despite their transformative potential, face significant barriers that can hinder their development and commercialization. Safety concerns, manufacturing challenges, analytical complexities and scale-up difficulties present substantial risks. Competition from other drug modalities, coupled with the inherent complexity of clinical development, further complicates the pathway to market. Distribution and supply chain challenges add another layer...

Early Cell Therapy Development: Navigating the Journey to First-In-Human Studies

Cell therapy development faces significant challenges on the path from concept to clinical application. From navigating the regulatory landscape to ensuring product consistency and standardization, the initial phases of developing cell therapies require careful planning and close collaboration among cross-functional teams. In this blog, we explore the complexities of early cell therapy development, with a...

Mastering Dose Escalation Studies Part 2: Charting a Clear Path from Planning to Execution

Dose escalation studies are pivotal in the early phases of clinical drug development for evaluating the safety profile of a new therapeutic agent and identifying a recommended dose for further investigation. These studies lay the groundwork for understanding the pharmacokinetic and pharmacodynamic properties of novel therapies and, if designed and executed thoughtfully, can move seamlessly...

Mastering Dose Escalation Studies Part 1: Optimizing Efficiency in Phase I Trial Execution Using Adaptive Design

Adaptive design is a progressive approach that utilizes different statistical modeling to allow for modifications to enrollment in a clinical trial after study initiation without undermining data integrity and validity. This methodology is particularly beneficial and increasingly common in phase 1 clinical trials, which focus primarily on safety, tolerability, pharmacokinetics, and pharmacodynamics. The essence of...

Immune Checkpoint Inhibitor Therapy: Optimize Dose and Patient Selection to Maximize Efficacy and Access

Since the approval of ipilimumab in 2011 for metastatic melanoma, immune checkpoint inhibitors (ICI) have shifted the treatment paradigm in oncology. Now increasingly indicated as first-line treatment of certain metastatic cancers, ICIs can trigger deep, durable responses and offer significant survival benefit. However, the majority of patients do not respond and many epeirence immune-related adverse...

5 Stages of Medical Device Development

Medical device development must address some unique challenges that have grown over the last decade due to increasing medical device complexity, a more complex regulatory framework catching up with the industry, and an established and variable standard clinical practice to compete with: These factors have a major impact on the medical device development cycle, which...