ounting evidence points to concerning health trends worldwide. In the US, provisional data reported by the Centers for Disease Control and Prevention (CDC) show that life expectancy, at 76.1 years, is the lowest it has been since 1996. COVID-19 has taken a high toll, but the pre-existing crises of chronic pain, opioid misuse, and obesity and its related conditions like heart disease, kidney failure, and diabetes fuel the loss of not just years but also quality of life.

igital health products (such as digital therapeutics, mobile health, telehealth, and personalized medicine) development has been on the rise in recent years, promising to transform healthcare delivery. However, the challenges faced in developing, commercializing, and marketing successful digital health products are significant, including market access and reimbursement; regulatory challenges due to lengthy and costly regulatory approval processes and the reality that ongoing compliance can be a burden even after approval; data privacy and security concerns; a highly competitive field; and reimbursement and revenue models. To minimize risks and maximize the chances of success, companies need to prioritize five key considerations discussed here: user expectations, digital environment, data, go-to-market strategy, and agility.

evelopment of cell and gene therapy (CGT) products is often challenged by the need to demonstrate product comparability following changes in the manufacturing process. Issues include limited process and product knowledge at different stages of product development compared to more conventional biotherapeutics, the complex mechanism of action, the limited and sometimes variable nature of the starting materials, and analytical methods which are often still in development during a comparability study.

or the more than 1 billion drugs provided or prescribed to patients in the US, what if an adverse event is missed or not reported quickly? That question looms heavily for biotech companies that outsource pharmacovigilance, regardless of whether the company is clinical-stage or commercial-stage.

luePoints Co-Founder and Chief Product & Technology Officer François Torche discusses the challenges of collecting clinical trial data with digital or remote tools (eCOA, ePRO, etc.) without putting the quality of that collected data at risk in the below interview.

n 2022, FDA’s Draft Guidance on Diversity Plans and passage of the Food and Drug Omnibus Reform Act (FDORA) significantly changed the landscape for diversity and inclusion in clinical trials. In the below interview, Curavit President and Co-Founder Dave Hanaman and Clinical Research Business Development Manager Natalia Husby discuss Curavit’s new Inclusivity, Diversity, and Equity in Action (IDEA) service offering with DIA Scientific Programs Associate Director Tamei Elliott.

rtificial intelligence (AI) has massive potential to advance clinical research. A scoping review in 2022 found that use of AI in the design and conduct phases of clinical trials has a positive impact on efficacy, safety and cost containment. From accelerating recruitment and enhancing patient selection, to identifying data quality issues through enhanced statistical analysis, machine learning (ML) and deep learning (DL) approaches are unlocking new possibilities.

linical trials have always required a huge number of interconnecting elements to operate, but the recent proliferation of patient centricity-enabling clinical trial technologies is compounding this complexity. In an open letter to sponsors and contract research organizations (CROs), the Society for Clinical Research Sites said: “As our industry undergoes rapid change and transformation, sites are experiencing unforeseen, unprecedented, and historic increases in costs centered around patient-facing research staff and overhead.”

n oft-quoted benefit of hybrid studies and decentralized clinical trials (DCTs) is that they increase recruitment and retention by making it easier for people to take part. A global survey of more than 11,000 trial participants found travel was a top participation burden. The same survey revealed ways to relieve study participation burden, which can include making study visits virtual, reducing travel times and distances, and allowing at-home visits from medical staff.

It is not the strongest of the species that survives, nor the most intelligent, but the one most responsive to change.”
—Charles Darwin

echnology has helped bring us to the cusp of several crucial conversations in which stakeholders across the entire life sciences and health ecosystems must engage. Diversity, innovation, and AI can create a hugely powerful synergy that drives transformation across the health and life sciences. But clever ideas and inventions are no longer enough;—for these innovations to breathe new life into the real world, we must also work to create an environment ready to receive and adopt them.

n pharmaceutical companies, Medical Information (MI) departments serve a key role in providing balanced scientific and medical information in response to unsolicited requests, through various channels, from healthcare professionals (HCPs).

egulators are advancing information technology and data modernization initiatives to drive more efficiencies and to become more responsive to industry use of digital technologies in drug development. These include digital health technologies to promote decentralized trials, cloud-based platforms to enable more capacity and external collaboration opportunities, and machine learning (ML) technologies including artificial intelligence (AI) to transform review of high-volume data, including real-world evidence programs. A key milestone took place in July of 2023, with the release by the European Medicines Agency (EMA) of a reflection paper sharing their views on the use of AI in the regulation of medicines.

IA has announced enhancements to our DIA Fellows Mentoring Program