Register: Operationalizing AI in Drug Development: Inside DIA’s Global AI Consortium

Date: Tuesday, March 17, 2026 1–2pm EDT
Event Location: Virtual

Artificial intelligence is rapidly reshaping the life sciences, from automating repetitive tasks to enabling advanced scientific and safety assessments across drugs, biologics, and devices. As adoption grows across regulators, pharmaceutical companies, technology developers, nonprofits, and collaborative consortia, the need for clear, risk-based frameworks for validation, governance and human oversight becomes increasingly critical.

This webinar introduces the DIA Artificial Intelligence Consortium, a neutral, public‑private partnership that convenes regulators, biopharmaceutical companies, academia, and technology providers, including FDA, Health Canada, MHRA, PMDA, IQVIA, Gilead, Otsuka, BeOne Medicines, Beth Israel Deaconess Medical Center–Yale School of Medicine, and others. Consortium partners are building a 7‑step AI use case classification framework, risk‑proportionate validation and monitoring approaches, and aligned regulatory terminology that reflect how global authorities are stratifying AI use, from low‑risk administrative automation to decision‑critical analyses influencing clinical or labeling decisions.

Speakers will walk through use cases across regulatory, clinical, and manufacturing contexts and highlight where human‑in‑the‑loop oversight, documentation expectations, and Good Machine Learning Practice–aligned validation should differ by context of use.

V. “Bala” Balasubramanian, Ph.D., MBA

Strategic Advisor | VB Insights, LLC

V. Balasubramanian (“Bala”) is a globally respected thought leader and transformational executive in Life Sciences IT, with over thirty-five years of international experience spanning the pharmaceutical, financial, and technology sectors. He is a recognized authority in AI Governance, Regulatory Intelligence, Regulatory Information Management (RIM), IDMP, and Enterprise Architecture, with a proven ability to align strategic vision with technology execution. Throughout his career, Bala has led the design and implementation of enterprise-scale solutions that modernize regulatory operations and accelerate business value. His deep expertise in business process harmonization, solution architecture, and user-centered design is matched by a reputation for building high-performing, cross-functional global teams.

Sridevi Nagarajan

Founder & Director | AyusArogya, Ltd

Bringing over two decades of experience, Sridevi Nagarajan is a seasoned strategic portfolio management professional is deeply rooted in data-driven approaches. The expertise lies in successfully steering digital transformations within the Pharmaceutical and Public Health sectors. A collaborative innovator who thrives on cultivating relationships and leveraging data to guide corporations through dynamic business transformations. A motivated and influential leader, equipped with advanced analytical skills and a wealth of knowledge spanning drug development, clinical operations, regulatory affairs, data analytics & AI, digital initiatives, information management, and governance.

Carrie Nielson, Ph.D.

Director, RWE Generation Innovation Unit | Gilead

Carrie Nielson is a Director of Epidemiology at Gilead Sciences, where she focuses on regulatory policy for RWE and on rigorous observational research methods that support reliable evidence generation. She collaborates with industry, academic, and regulatory colleagues, including through the DIA Artificial Intelligence Consortium, helping align on AI use‑case development, risk‑proportionate validation approaches, and defensible oversight and documentation models. Her work centers on translating emerging regulatory expectations into practical, inspection‑ready systems and procedures that enable sound adoption of RWE and AI in drug development contexts.

Jennifer Smith-Parker

Director, Insights