linical trials are critical for advancing healthcare, and technology is playing an increasingly important role in their design and conduct (for example, the use of sensors, telehealth, remote monitoring, AI, etc.). But how does the adoption of these new technologies relate to clinical research ethics and regulation?

he collapse of Silicon Valley Bank (SVB) in March 2023 sent a frisson of concern through the biotechnology and tech industries, given the significant implications the bank’s failure had for some banks and early-stage companies. Because SVB was widely known as the venture capital industry’s leading bank, it immediately raised questions about the role that VCs play in determining the financial fortunes of biotechnology startups. This leads naturally to a related question that I will address in this essay: What is the role of venture capital in drug discovery and development?

he Prescription Medicines Code of Practice Authority (PMCPA) in the UK has stated that patient case studies are likely to be viewed as promotional, and this obviously significantly limits how and when they can be employed. This article focuses on how compliance with the Association of the British Pharmaceutical Industry (ABPI) Code can still be achieved when case studies differ in their content and use. The ABPI code sets standards for pharmaceutical companies with respect to the promotion of medicines as well as the provision of information to patients.

his Mother’s Day, women across the US and in other parts of the world will be celebrated, but this appreciation is not reflected in scientific research, where women continue to face stark inequities. Today’s approach, investment, and mindset fail to deliver complete healthcare to women and limit data capture. Ultimately, this severely curtails the world’s understanding of disease states that impact women the most.

he incredibly fast development and rollout of the COVID-19 vaccines would not have been possible without the critical contributions of real-world data and real-world evidence (RWD/RWE). But the race to use, understand, and accept RWD/RWE throughout the drug development life cycle started a long time ago. While regulators such as the US FDA, EMA, and Taiwan FDA (TFDA) have taken a more pragmatic approach in developing guidelines, regulations, and frameworks, we must ensure that the international collaboration and regulatory standards are harmonized and use similar, if not the same, scientific values. Much needs to be done in terms of predictability, data gathering and interpretation, methodologies used, and acceptance by regulators, HTAs, and payers.

he Conference of the States Parties of the African Medicines Agency (AMA) moved effectively in 2022 to make a key decision: selecting the first country to host the AMA. Their recommendation was endorsed by the Executive Council of the African Union in July, and Rwanda was announced as host of AMA in August.

accination is one of the most efficient public health interventions available and the main tool for primary prevention of communicable diseases. The COVID-19 pandemic has reinforced the health, social, and economic benefits from timely access to vaccines and other essential treatments. The pandemic has also highlighted two critical preconditions to delivering timely access: First, countries must have a responsive and transparent national immunization program; second, countries must establish procurement and financing arrangements that can rapidly execute commercial arrangements to secure supply.

n 26 April, the Commission proposed the largest reform to EU’s pharmaceutical legislation in more than 20 years. The revision includes proposals for a new Directive and a new Regulation, which revise and replace the existing pharmaceutical legislation, including the legislation on medicines for children and for rare diseases.

pidemiological data are important assets, which support government controls and measures to ensure appropriate public health interventions. The Integrated System of Information of Social Protection (SISPRO, its Spanish acronym) provides an online free-access system of databases with information on healthcare quality, assurance, financing, and other aspects of healthcare services in Colombia. This information management system, achieved through digital technologies, has provided multiple benefits for patients and the healthcare system in Colombia.

n January 2023, DIA announced the appointment of Shogo Nakamori as Senior Vice President and Managing Director, DIA Japan and Korea.

Shogo is a pharmacist who has worked in the pharmaceutical and CRO industries for more than 25 years. His career began with drug development work at Ciba- Geigy followed by Novartis, Solvay Pharmaceuticals, AstraZeneca, and Mundipharma. He subsequently managed Acronet and Parexel as president of both CROs. Shogo most recently directed the development of cellular medicine under the Mitsubishi Chemical Holdings umbrella. While at Parexel, Shogo represented the CRO industry on a special advisory committee sponsored by the government to promote clinical trials in Japan. Shogo has also served on the Regional Advisory Council for DIA Japan for four years.