ifteen of the top 20, or 75%, of the largest pharmaceutical companies by market cap are actively involved in cell and gene therapy,” explains Timothy Hunt, chief executive officer at the Alliance for Regenerative Medicine (ARM). “These companies are also looking down the road at things like cell therapy in autoimmune disorders, cell therapy in solid tumors, and gene therapies in more prevalent conditions. There is significant potential in these areas, and these investments by the larger biopharmaceutical companies are pretty clear.”

n June 2024, FDA expanded its Risk Evaluation and Mitigation Strategies (REMS) program for CAR T-cell therapies to include all six approved therapies, reducing the burden on healthcare providers by removing the requirement to report serious adverse events related to cytokine release syndrome (CRS) and neurological toxicities. At this same time, FDA modified the Opioid Analgesic REMS program to require manufacturers to provide pre-paid mail-back envelopes for safe disposal of unused opioids and updated the REMS for mifepristone to eliminate the in-person dispensing requirement, which allows certified pharmacies to dispense the medication directly to patients with a prescription.

rtificial intelligence (AI) has emerged as a promising, if not transformative, force in drug development, demonstrating significant technical capabilities across various domains, including target identification, in silico modeling, biomarker discovery, digital pathology, and clinical trial optimization. The synergy between machine learning and high-dimensional biomedical data has fueled growing optimism about AI’s potential to accelerate and enhance the therapeutic development pipeline.

he COVID-19 pandemic forced the clinical research industry to rethink how trials are conducted and revealed that we could adapt quickly under pressure. Today, with significant economic headwinds, escalating complexity, and global and domestic uncertainty reshaping the landscape once again, we face a new imperative: to evolve from reactive to proactive, leveraging technology to forecast with clarity and confidence.

ecruitment and retention in clinical trials pose significant challenges, often due to the burdensome nature of participation. Despite widespread recognition that patient input can alleviate these burdens and improve recruitment and retention rates, the industry has been slow to standardize this approach. This article outlines the transformative journey of a leading global pharmaceutical company towards embedding systematic patient engagement in clinical research.

atient-centricity has become a focal point in the evolution of clinical trials, emphasizing outcomes meaningful to patients. The challenge lies in balancing rigorous scientific evaluation with incorporating patient experiences and preferences.

atin America is at a pivotal moment in the evolution of its regulatory systems. Factors such as the adoption of emerging technologies, the urgent need to accelerate access to medicines, and the region’s increasing economic integration with the rest of the world have brought forth an inescapable question: How can we make health regulation more efficient, transparent, and sustainable?

fter four years of preparation and consultations from key stakeholders, the EU Health Technology Assessment Regulation has been in force since January 2025 and the first two Joint Clinical Assessments (JCA) are in progress, being led by two separate member state HTA bodies/authorities (assessors and co-assessors) including the National Centre for Pharmacoeconomics, Ireland, and the Institute for Quality and Efficiency in Health Care, Germany, on a treatment for pediatric low-grade glioma; and the National Authority for Health, France, and the Agency for Health Technology Assessment and Tariff System, Poland, on an advanced therapy for treatment of melanoma. This regulation aims to simultaneously achieve a high level of protection of health for patients and users and to establish a framework to support Member State cooperation and the measures needed for clinical assessment of health technologies.

adioligand therapy (RLT) is emerging as an important treatment modality in a wide range of cancer types by harnessing the power of radioisotopes to deliver radiation to the target. However, as an innovative technology, RLT presents several regulatory and logistical challenges. In this article, one global pharmaceutical company shares its experience in ensuring accessibility of RLT to patients in Singapore.

arketing prescription medicines, and how this is done, is more often than not a contentious topic. Although marketing prescription medicines is recognized as an important influence on how medicines are used, getting the right balance between the provision of information and education about prescription medicines on the one hand and inappropriate marketing on the other continues to challenge stakeholders.

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