We are at the dawn of synthetic medicine, which will forever change how doctors and patients approach healthcare. In fact, simply understanding the basics of synthetic medicine could help many doctors and patients make informed medical decisions.
With this in mind, this article will look at the ways that synthetic medicine could transform healthcare and how those in the biopharmaceutical and healthcare industries can help ensure that it reaches its potential. Read More
Throughout the pandemic, many people abandoned the healthcare field, and yet the need for healthcare workers and clinical study staff continues to increase. According to the U.S. Bureau of Labor Statistics Job Openings and Labor Turnover Summary, the number of quits by healthcare and social assistance workers increased by approximately 69,000 from April to May 2023. At the same time, the number of active clinical trials are growing. CROs are struggling to identify qualified professionals to take on site start-up, clinical operations management, and data management roles. And, it has been exceptionally difficult to fill CRA positions with experienced workers. In fact, CRA positions have seen shortages since at least 2015, according to the Association of Clinical Research Professionals. Furthermore, the Society for Clinical Research Sites reported that the largest group of CRAs leaving the workforce in 2022 were those with 10+ years of experience, a rate 55% higher than in 2021. Read More
Historically, a CRO’s main role has been to provide clinical trial site and data management. However, it also supports other specialized services essential to conduct a successful clinical development program. Beginning in 2017, clinical outsourcing occurred in approximately 50% of trials and has continued to increase.1 The standard list of CRO services now includes site selection and engagement, patient identification and enrollment, trial monitoring and compliance, and data monitoring and analysis.
With a growing demand for CRO services, these companies are developing competitive advantages and methods to increase efficiencies for clinical trials. Although many large CROs are offering end-to-end services, smaller, specialized CROs tend to offer more personalized solutions. At times, companies/institutions may even hire more than one CRO, those of which must collaborate to provide the appropriate services across the clinical trial timeline. Read More
Enrollment, enrollment, enrollment has been the sponsor’s classic mantra for achieving success in a clinical trial. Rather, we should replace this notion with four equally essential building blocks: 1) the selection of the right CRO, 2) the identification of study sites, 3) the engagement of sites, and 4) the enrollment of patients. Clinical development teams must be laser-focused on all four by leveraging advanced technologies (high tech) and personal interactions (high touch). Read More
The notion that a quality clinical trial should be conducted in highly specialized and experienced study centers with tight oversight of patients is becoming obsolete. Decentralization means that clinical trials can now be conducted in routine treatment clinics supervised by medical teams practicing standard of care. Centricity means that data capture can be obtained without significantly interfering with the patient lifestyle. Decentralized centricity follows a simple digital paradigm: anywhere, anytime. Read More
Gene therapies are advancing rapidly as a novel therapeutic modality to provide a functional cure for patients with monogenic diseases. Several gene therapies have already been approved in the past several years. This article provides a roadmap for the biotechnological advances required for monitoring safety and efficacy endpoints, as well as functional biomarkers relevant for gene therapies targeting the liver as a biofactory of defective or missing proteins, with hemophilia A as a representative disease. Read More
★ Clinical applications of gene and cell therapies: case studies for the relevance of precision medicine
Precision medicine, a medical modality focusing on tailoring medical decision-making to individual patients, is changing the way we think about, prevent, treat, and monitor many diseases, including those requiring gene and cell therapies. Read More
Cell therapy requires precise screening and monitoring of patients to ensure that the transfer of either autologous or allogeneic cells to a patient results in a therapeutic effect to targeted organs or tissues.