he implementation of the EU Health Technology Assessment Regulation (HTAR) in January of 2025 marks a new era of joint scientific consultations (JSC) and joint clinical assessments (JCA) for products seeking market access in Europe. Six months in, the transition remains challenging. The broader implications across the healthcare ecosystem are still unclear regarding the impact of the HTAR on time to patient access, innovation, and the adoption of findings or related assessment mechanisms in other jurisdictions and regions.

rtificial intelligence (AI) and more recently generative AI (GenAI) are profoundly transforming the life sciences sector. While offering unprecedented opportunities to enhance drug discovery, accelerate clinical trials, and improve patient outcomes, these technologies also introduce complex ethical, legal, regulatory, and governance challenges. The pace of technological change often outstrips the development of regulatory and governance frameworks, necessitating a proactive approach to align innovation with responsible use of AI.

ffective AI governance is crucial for translating ethical principles and regulatory requirements into actionable organizational practices.

gentic AI represents the next generation of AI in business. This type of AI has the “agency,” or capability, to make decisions, take action, and even interact with outside environments beyond the original data independently, on behalf of a person or system. Gartner projects that in less than three years (by 2028), 33% of enterprise applications will incorporate agentic AI capabilities, which also indicates significant adoption to date.

ife sciences researchers face increasing pressure to deliver results faster and more efficiently. A new generation of purpose-built AI platforms is finally giving them what they need.

arnessing the parallel powers of real-world evidence (RWE) and artificial intelligence (AI) will be particularly beneficial for the development of medicines for underrepresented and underserved populations, such as women of childbearing age (WoCBA) and vulnerable people—especially children and elderly—with rare diseases. More broadly, the use and application of fit-for-purpose RWE and AI will expedite the clinical development process in all disease areas and deliver value to all patients and well-being of society in general. This was the prevailing view at the DIA Europe 2025 Data Science, Real-World Evidence and Artificial Intelligence track.

he stream of complex and cutting-edge therapies sourced from the innovative industry can inundate emerging or less-resourced regulatory agencies that may not have the capacity to properly review them. Regulatory reliance ensures that life-saving therapies that were reviewed stringently by highly developed regulatory authorities can quickly and efficiently reach patients in emerging markets.

hinese innovative biopharma companies are making remarkable strides in global expansion; to evolve from product globalization to true global competitiveness and brand recognition, these companies must prioritize strategic global talent acquisition and precise role placement. This will necessitate the progressive building of an international organizational framework with sustainable operational capacity, ensuring long-term success in the global biopharma arena. However, they face critical challenges in international talent management that pose risks to their overseas growth.

hile medicine has made extraordinary advances over the last several decades, a gaping hole in research for conditions that affect women uniquely, differently, or disproportionately compared to men continues to exist. As a result, women are suffering from delayed diagnoses, ineffective treatments, and poor health outcomes. We lack critical insights into how female physiology impacts disease risk, symptom expression, and treatment response across sex-specific and common conditions. Women are living in worse health despite living longer than men on average globally, and this reality is negatively impacting the global economy. Women’s health is long overdue for a transformation.

A New Era for Clinical Research in Cameroon

Over the past two decades, Cameroon has emerged as a significant player in clinical research, particularly in studies targeting HIV, malaria, and neglected tropical diseases. A review of 2,172 biomedical research protocols approved in Cameroon from 1997 to 2012 showed that 61.3% focused on disease control, with HIV accounting for 25.8% and malaria for 10.3% of all studies. By 2019, the Cameroon Health Research and Evidence Database (CAMHRED) catalogued over 4,384 local health studies, reflecting a sustained and broad increase in research activity across the country. National efforts also prioritized neglected tropical diseases, with research highlighting high-risk rural populations and supporting new intervention programs. Historically, research in Cameroon was guided by international ethical benchmarks such as the Declaration of Helsinki and ICH Good Clinical Practice, before the country established a comprehensive national regulatory framework for clinical research. This gap became more apparent as international collaborations and funding increased, highlighting the urgent need for local oversight to protect clinical trial participants and ensure data integrity.

Cameroon is building a regulatory infrastructure that both fosters clinical research and protects public health. Here we explore the intersection of clinical research and regulatory affairs in Cameroon, illustrating progress with real-world examples, ongoing challenges, and future opportunities.

hen Reena, a 45-year-old from southern India, picked up her new prescription for hypertension, she encountered something that is all too common: an accordion-folded piece of paper buried in the medicine box. Printed in small English text, packed with unfamiliar medical terms, and almost unreadable without glasses, the leaflet seemed more intimidating than helpful. Like many patients, she glanced at it briefly before sliding it back into the box, unread and unused.

iguel Romero is an MD-trained allopathic physician, board certified in family medicine, and currently works in urgent care and community clinics in Tucson, AZ (US). “This means that I deliver care in different facilities with different capacities,” he explains. “Depending on the facility, I have access to a different catalog of therapeutics that I can use based on their profile: how they’re going to help the patient or the limitations they may have.

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