Editor-in-Chief, DIA Global Forum
was born in the middle of the 20th century. Like all infants, I knew nothing at birth about the discovery, development, and regulation of medicines. As it turns out, there wasn’t very much to know about this, back in 1951. Drug regulation as we know it today was itself an infant.
Fellow of DIA; Global Forum Editor-in-Chief
That state of affairs changed drastically in the ensuing 74 years, generally for the betterment of humankind. But we are now at an inflection point that will likely transform our lives again and far more dramatically—for better or for worse. The nature and impact of this transformation will depend on us all.
I joined DIA in 1984, at the very start of my regulatory affairs career in industry. I knew nothing then, but I would learn much over time.
In those early years, drug development and regulatory affairs were largely local and paper-based. Since then, the field has evolved dramatically. The once-isolated national practices of the 1950s gave way to the globalized frameworks and to the truly global drug development of the 2020s. The principles of quality (1962), safety (1938), and efficacy (1962) became the enduring standards for health products. The randomized clinical trial (RCT) emerged as the world’s gold standard and became a resource-intensive multinational construct, complemented by GMP, GLP, and GCP regulations.
The relationship between the pharmaceutical industry and regulatory agencies became more structured and professional thanks to the US Prescription Drug User Fee Act (PDUFA) and analogous initiatives worldwide. The International Council for Harmonisation (ICH), one of the most successful global collaborations in history, produced over 70 harmonized regulatory guidelines and the broadly accepted Common Technical Document (CTD/eCTD) format for marketing authorization applications.
Other global regulatory milestones included the establishment of the EU Single Market (1992), the European Medicines Agency (EMA) in 1995, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) in 2004, China’s National Medical Products Administration (NMPA) in 2018, and most recently, the African Medicines Agency in 2025. Regulatory reliance is gaining traction globally.
The nature of regulatory work has evolved beyond expectations, thanks to information technology. We have transitioned from voluminous paper-based submissions in the 1960s–1990s to digital, cloud-based dossiers in the 2020s. As of June 30, 2025, the FDA has deployed artificial intelligence (AI) in all scientific reviews, and other agencies are sure to follow, as noted in numerous discussions at the DIA 2025 Global Annual Meeting in the same month.
All of these developments, and many more in science, innovation, and global healthcare, have benefited patients all over the world. For example, global life expectancy has risen from 46 years in the 1950s to 73 years in 2024, and over that time span, the focus of therapeutic interventions has shifted, with considerable public health success, from infectious diseases to highly prevalent noncommunicable diseases like diabetes and cardiovascular disease.
But, as I wrote in July 2024 prior to the seismic geopolitical and national changes we are witnessing this year, globalization as we have known it may be coming to an end. Deglobalization, defunding, and their impact on patients and their access to the treatments they need was and remains a concern. The answer, I think, is to continue to focus relentlessly on patients’ needs in spite of countervailing trends and actions.
Looking to the future, the expected impact of AI on healthcare and drug development was palpable at both the DIA 2025 China Annual Meeting in Shanghai in May and the Global Annual Meeting in Washington, DC, in June. There was energy, excitement, innovation, and a sense that we are entering a fundamentally new era.
Since ChatGPT launched in November 2022, our lives and our thinking have changed, and the possibilities before us have multiplied more rapidly than many had imagined. For our part, Global Forum published 59 AI-related articles between 2023 and 2025, a reflection of the new trends in drug development.
Ray Kurzweil’s 2024 book The Singularity is Nearer: When We Merge With AI—a follow-up to his 2005 book The Singularity is Near—predicts that machines will achieve human-level intelligence by 2029, enabling them to perform any cognitive task that humans can. He argues that this transformation will be driven by exponential advances in computing power, a deeper understanding of biology, and breakthroughs in nanoengineering.
Looking further ahead, Kurzweil forecasts that by 2045, humans will merge with machines, transforming both human consciousness and capability. He posits that we will eventually augment our brains via cloud-based virtual neurons, creating a future in which artificial and human intelligence are indistinguishable. Consider the scale of progress: Kurzweil notes that in 1975, computers performed 130 computations per second; by 2023, Google Cloud could deliver 130 billion.
Kurzweil points to real-world examples of AI’s impact today, noting that machine learning enabled the first COVID-19 vaccine trial just 63 days after the virus’s genetic sequence was released. Looking ahead, he predicts digitized bodies, AI-powered nanobots, vastly improved disease understanding, and much faster discovery and development of treatments.
While some of Kurzweil’s projections remain speculative, his track record and technological trends offer a provocative lens on what AI could mean for the future of healthcare and beyond.
New thinking abounds. One provocative concept shared by Noubar Afeyan in Flagship Pioneering’s 2025 Letter is “Polyintelligence”: a synergistic blend of human, machine, and nature intelligence.
Will clinical trials shrink—or even disappear—in the wake of such advances? Could simulations or highly personalized precision trials actually replace RCTs?
In our April 2025 Global Forum, Janet Woodcock commented that RCTs are often not fit for purpose or practical in rare disease drug development, due to the very small number of patients available to enroll in clinical trials. She observed that convincing evidence of efficacy can arise from alternative study designs, especially when bolstered by robust scientific support.
I will add that the convergence of the vast power of AI to gather and organize information, and the increasing availability of personal data, will make the role of real-world evidence in the pre-market and post-market evaluation of healthcare products more significant as a complement to RCTs, as FDA Commissioner Marty Makary (along with other panelists in various sessions) noted at the DIA Global Annual Meeting.
In the midst of these and more changes, we must increasingly keep the interests of patients at the center of drug development. Innovation can—and should—emerge from anywhere in the world, as long as it meets patient needs and the global standards of quality, safety, and efficacy. Precision medicine, genomic targeting, and real-time data simulation may make future clinical trials faster, smaller, and more personalized.
Work will change as well. A 2025 survey of 500 executives identified key workforce roles for the near future: AI experts, clinical operations leads, clinical research associates, and project managers. But these roles assume the ongoing need for professionals to staff rising numbers of clinical trials large and small. (CROs have seen exponential staff growth, from a few thousand in 1990 to at least 240,000 in 2024, based on the headcount of the largest global CROs.) Will that assumption hold?
Meanwhile, roles such as the compilers of paper-based marketing applications (which contained hundreds of thousands of pages) have faded away, displaced by digital tools and automation. This job-evolution pattern will continue and probably accelerate.
To the young professionals who will shape our field’s future, I offer four suggestions:
First, keep the best interests of patients at the heart of your work, wherever they are in the world.
Second, stay curious. Learn the science, technology, and therapeutic areas that are changing rapidly. Embrace AI to enhance your value and grow your career. Don’t fear job loss—prepare for transformation. Some of today’s jobs will disappear; others, unimaginable today, will be born. If Kurzweil is right, our cognitive capabilities and therefore our learning skills and ability to process more and more information will be vastly expanded in just a few decades from now.
Third, remain adaptable. Hone your data and analytical skills, but also your judgment. Regulators now emphasize the importance of balancing speed with thoughtfulness, especially in the realm of the use of AI. Move fast when necessary but also know when to proceed slowly and deliberately.
Finally, protect your humanity. Cultivate problem-solving skills and people skills; be credible, dependable, and worthy of the trust of others in the age of misinformation. As machines increasingly become part of us, our distinctly human qualities will matter more than ever. Seek out mentors who will help you become your very best exemplar of humanity.
Looking towards 2099, I know this: AI and other transformative innovations will reshape everything. A baby born in 2025 will be 74 years old in 2099. None of us can say what kind of workforce will be needed then, just as we could not have predicted today’s landscape in 1951.
The best we can do is remain open, adaptive, and intentional. We’ve learned to expect the unexpected. We must live accordingly.
Legendary management guru Peter Drucker said, “The best way to predict the future is to create it. The only skill that will be important in the 21st century is the skill of learning new skills. Everything else will become obsolete over time.”