Your hosts

Two careers. Two industries. One circle.

One started at a lab bench, the other in a pediatric therapy room. Today they bring more than three decades of combined experience across pharma and medical devices to every conversation.

Pharma & biotech

Vidya Narayanaswamy

MS, MBA, PMP

Lab bench AI drug discovery & regulatory leadership

18+: years across discovery, clinical and regulatory
7: workstreams in the PDLM Center of Excellence she led
AIDD: heads the AI-Enabled Drug Discovery workstream

AI-enabled drug discovery
IND / NDA / BLA / MAA strategy
Clinical trial lifecycle
Portfolio governance
CMC & regulatory integration

Senior Consultant, IPM Integrated Project Management Company

Life sciences portfolio, program, and regulatory leader with more than 18 years of experience spanning AI-enabled drug discovery, preclinical and clinical development, global regulatory submissions, and cross-functional R&D execution. Brings an uncommon combination of bench science, biomarker and bioanalytical operations, clinical program management, regulatory strategy, and PMO design to the question of how complex programs move from hypothesis to approval. Experienced in translating science and regulatory strategy into integrated portfolio plans, stage-gate decisions, governance dashboards, risk frameworks, and executive-ready communications.

She currently serves as Senior Consultant at IPM Integrated Project Management Company, where she led the Product Development Lifecycle Management (PDLM) Center of Excellence, a practice of 7 workstreams. She also heads the AI-Enabled Drug Discovery (AIDD) workstream, where she and her team shaped how AI is applied across the development lifecycle, from tools that accelerate clinical trials and regulatory submissions to the policies that govern their responsible use. She also advises sponsors on regulatory strategy and submissions. Her work helps pharma and biotech sponsors align Research, Clinical, Regulatory, CMC, Safety, Legal, Quality, and external partners around a single, decision-ready plan. Her prior experience spans early discovery through IND-enabling readiness, Phase 3 and pediatric planning, NDA/BLA and MAA strategy, post-approval commitments, global CMC variations, companion and complementary diagnostic strategy, and CRO and vendor governance.

She is also a peer-reviewed author and invited speaker on leadership skills, leading teams through organizational change, clinical trials, concurrent global regulatory submissions, AI-enabled drug discovery, project leadership across the R&D lifecycle, AI and the future of regulatory affairs, career growth for early- to mid-career professionals, and novel antimicrobials against drug-resistant pathogens.

Follow Vidya on LinkedIn

Medical devices

Geethapriya (Priya) Setty

MBA, RAC-Devices, PMP

Therapy room Global device regulation & AI governance

~20: years in healthcare, from clinic to regulation
9: years of focused medical device regulatory practice
EU AI Act: author and speaker on AI governance

Regulatory intelligence
EU AI Act & EU MDR
AI governance
SaMD & AI-enabled devices
Class II & III devices

Manager, Global Regulatory Affairs, Hologic

Regulatory affairs, policy, and digital transformation leader with nearly two decades of healthcare experience, including nine years of focused medical device regulatory practice. Brings an uncommon combination of clinical practice, hospital quality leadership, global device regulation, enterprise information governance, and applied AI expertise to address challenges related to accountability, transparency, and human oversight in adaptive AI systems. Experienced in translating emerging regulatory and ethical requirements into practical governance strategies for product development, quality systems, global market access, and responsible AI oversight.

She currently serves as Manager, Global Regulatory Affairs at Hologic, supporting regulatory intelligence, policy, strategy, and digital transformation initiatives. Her work focuses on helping organizations understand and respond to an increasingly complex regulatory landscape, including the impact of emerging technologies, evolving global requirements, regulatory information management modernization, and the growing role of artificial intelligence in healthcare and medical technology. Her prior experience spans regulatory intelligence and policy, product stewardship, class III structural heart devices, software as a medical device, international submissions, field corrective actions, medical device reporting, regulatory operations, and advertising and promotional review.

She is also a peer-reviewed author and invited speaker on the EU AI Act, EU MDR, ISO/IEC 42001, AI-enabled medical applications, lifecycle governance, AI literacy and the evolving capabilities required of regulatory professionals.

Follow Priya on LinkedIn

Both hosts lead RAPS Southern California networking groups, which gives the show a built-in community of regulatory professionals as guests and viewers.

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