became a DIA member in 1984 when I was an entry-level Regulatory Associate in a large pharmaceutical company. I knew very little, but I knew that I needed to learn a great deal more.

In between, I grew up as a professional and I learned many things, in good measure thanks to DIA.

But now, there is so much more to be learned to build our future. And DIA, in this 60th anniversary year and beyond, is a really cool place to find it, to learn together, and to build our future together.

linical investigative sites face unprecedented operating challenges, from increasing protocol complexity to resource constraints, protracted budget negotiations, and workforce turnover, to contending with myriad new technologies. At the same time, sponsors and CROs (Clinical Research Organizations) attempt to determine how best to collaborate with the sites and aim to become a top “sponsor/CRO-of-choice” in their quest to improve site performance. Inspired by the findings of a survey the Tufts Center for the Study of Drug Development (CSDD) conducted in 2022, as well as their own mission to improve site partnering, a global CRO was interested in further exploring opportunities to obtain a deeper understanding of root causes related to the complexities of sponsor/CRO/site relationships and address site operating challenges.

he widespread availability of data in electronic health records (EHRs), patient registries, and administrative claims databases has ignited an evolutionary shift in life sciences, propelling the field towards a data-centric paradigm across the drug development and post-approval lifecycles. This shift, while touting new possibilities for medical innovation, introduces a complex set of challenges around data integrity, fitness-for-purpose, statistical and epidemiologic methods, patient privacy, data security, and institutional confidentiality.

he continuing growth of real-world data (RWD) sources and better-quality real-world evidence (RWE) is changing pharmaceutical development and regulatory decision making for sponsors. For example, in 2023, FDA issued new guidance to industry on the use of RWE to support regulatory decision making, a strong signal of their shift toward more acceptance of these less traditional data sources. As a complement to randomized clinical trials, real-world evidence holds tremendous promise for the future of pharmaceuticals, patient care, equitable access, and how we develop and bring drugs to market.

his article is first in a series that explores the potential of AI in the healthcare sector and paves the way to uniting the global community of patients, data scientists, medical professionals, and clinical representatives. Subsequent articles in future issues of Global Forum will examine specific use cases within healthcare, the regulatory landscape surrounding AI implementation, the integration of human-centric AI, change management strategies, and optimizing synergy between artificial and human intelligences.

dentification of Medicinal Products (IDMP), a suite of five standards developed by the International Organization for Standardization, provides an international framework to uniquely identify and describe medicinal products with consistent documentation and terminologies, and facilitates the exchange of product information between global regulators, manufacturers, suppliers, and distributors. When fully implemented globally, the standards will facilitate the unique identification of medicinal products in the context of pharmacovigilance, drug shortages, and the safety of medications (and patients who take them) throughout the world. The following fictional use case illustrates a potential benefit of the Global Pharmaceutical Product Identification (PhPID) of IDMP.

he International Organization for Standardization (ISO) developed a suite of five standards for the Identification of Medicinal Products (IDMP) to internationally harmonize specifications for the identification, description, and exchange of medicinal products between regulatory agencies and biopharmaceutical companies. These standards support the global regulatory activities related to the lifecycle management of medicinal products. When fully implemented globally, the standards, and specifically Pharmaceutical Product Identification (PhPID), will facilitate the unique identification of medicinal products in the context of pharmacovigilance, drug shortages, and the safety of medications (and patients who take them) throughout the world.

ne of the overarching themes of DIA Europe 2024 was the imperative of alignment and harmonization across regulatory bodies and stakeholders. Representatives from the European Medicines Agency (EMA), World Health Organization (WHO), US Food & Drug Administration (FDA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) echoed the importance of increasing regulatory convergence, particularly in real-world evidence (RWE) guidance for drug safety assessments. Collaborative efforts at the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the International Coalition of Medicines Regulatory Authorities (ICMRA) have proven instrumental in driving this agenda forward and have paved the way for more streamlined processes and enhanced regulatory coherence.

n a recent Global Forum interview, FDA India Office Director Sarah McMullen reflected on her vision and in-country experience in India. As Director McMullen explained, India is one of the world’s largest producers of generic drugs, with 40% of generics in the US coming from India, and many of the bioavailability and bioequivalence (BA/BE) studies done to support those applications are conducted in India. Approximately 30% of FDA’s foreign trial inspections are done in India, per this interview, with the majority of those relating to BA/BE trials. She mentioned that although this has led to India being a key player in the global pharmaceutical industry and a major supplier of affordable medications worldwide, it is disheartening to continue to see clinical trial conduct issues in India.

rug expenditure as a percentage of healthcare costs in Japan has been stable at approximately 22% in the past quarter-century. As Japan’s society ages, overall healthcare costs have increased and drug costs have increased in parallel, a trend observed worldwide. However, according to one industry report, Japan’s share of the global pharmaceutical market showed continuous decline in the past 20 years, from 12.0% in 2003 to 5.1% in 2022. Market share often reflects the market’s attractiveness to industry investment as well as the foundation to directly support pharmaceutical innovation. Japan is now struggling to sustain universal healthcare coverage and encourage innovation in the industry at the same time.

Ling Su: I’m Ling Su. I’m currently a venture partner in LAV (Lily Asia Ventures), where I support evaluation and post-investment management of our biotech portfolio companies. I’m also the Chief Development Officer in Skyline Therapeutics, a clinical-stage gene therapy biotech company.

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