Archives: Speakers

Camille Pataki is an Applied AI Engineer and AI Strategy Coordinator at Eikon Therapeutics, bridging drug discovery, clinical development, and AI. She holds a Ph.D. in Biochemistry from Stanford and has spent nine years in drug discovery and personalized medicine, extracting meaning from biological data and building systems that turn research questions into actionable signals.    

At Eikon, she’s leading the development of agentic systems and doing the unglamorous work of making AI adoption real, in the sense of getting tools into actual workflows and making them stick. A big part of that is helping people develop judgment: knowing when to use AI, and knowing when a problem calls for a Tuesday afternoon fix versus enterprise-scale infrastructure.Today she’s here to talk about what AI enablement actually looks like in practice.  

Tonya Corbin is a Supervisor in the Division of Northeast Import Compliance Branch at the U.S. Food and Drug Administration (FDA), where she oversees import compliance operations and regulatory enforcement activities involving FDA-regulated imported products. With more than 24 years of experience at the FDA, she specializes in import compliance, regulatory enforcement, admissibility review, and interagency collaboration.  

Throughout her career, she has managed complex compliance and enforcement matters involving a broad range of FDA-regulated imported products. She has collaborated with federal, state, and local regulatory and law enforcement partners, including U.S. Customs and Border Protection (CBP) and the FDA Office of Criminal Investigations (OCI), to support enforcement actions, ensure compliance with FDA laws and regulations, and protect public health.  

She began her FDA career in 2002 as a Consumer Safety Officer conducting inspections of domestic food manufacturers. In 2004, she transitioned to import operations as an Entry Reviewer responsible for making admissibility decisions on FDA-regulated imported products. In 2011, she became an Import Compliance Officer before advancing into her current supervisory role in 2020.  

She earned a Bachelor of Arts in Biology from Rutgers University in 2001 and a Master of Public Administration from Delaware State University in 2023.  

A seasoned FDA regulatory professional with 12 years of experience in imports and entry review, Bobbie Whiddon has developed deep expertise in admissibility determinations, compliance assessment, and enforcement actions under the Federal Food, Drug, and Cosmetic Act. Skilled in evaluating foreign shipments across a broad range of FDA-regulated commodities, Bobbie brings a thorough understanding of import regulations, risk-based decision-making, and interagency collaboration. Since August of 2025, Bobbie has led a team of FDA Import Shield reviewers, the agency’s nationalized entry review program for import compliance.  Prior to FDA service, Bobbie worked in industry and brings over 20 years of experience in food safety, medical foods, medical devices, and pharmaceuticals.  

I’m a clinical operations leader who builds AI systems for regulated environments.

14+ years in clinical operations across oncology and several other therapeutic areas have taught me the same lesson from a few directions: too much of trial operations still runs on fragmented systems, manual reconciliation, and weak audit trails.

I started in site-level roles, including Research Site Director, which gave me a ground-up view of what sites actually need from sponsors and CROs. I later moved into CRA work, running site visits across dozens of oncology sites, and today I work in sponsor oversight, where I helped establish the Oversight Office for Therapeutics and Oncology, a centralized function that tracks how active trials are performing in practice and puts oversight attention where the risk is, not where a checklist says to look.

Those gaps, the fragmented systems and the weak audit trails, are why I build. Klyverity is an FDA 21 CFR Part 11 compliant e-signature platform built for regulated industries, because compliance shouldn’t require duct-taping generic enterprise software onto a workflow it was never designed for. I’ve also built and now run a centralized monitoring and RBQM platform, designed so every risk signal traces back to a documented decision an inspector could pull years later. My own operations run on autonomous agents too, and every change they make passes validation gates and a second model’s review before it counts as done.

Callum Kaye is a senior analyst with GlobalData’s Aerospace, Defense, and Security division. Prior to this role, Callum worked at Janes as a Senior Military Intelligence Analyst and holds an MA in International Security from the University of Groningen. At GlobalData, Callum’s research interests cover both military and civilian aviation, including hydrogen and electric propulsion for aircraft and post-pandemic trends in commercial aviation.

Joined Mobil in 1989 and worked in various capacities as Retail Construction Engineer and Environmental Remediation Engineer. In 1997, Tom transitioned to Finished Lubes as a Sales Engineer and then to Lubrication Engineer where he supported industrial and mining segments. In 1999, Tom expanded his support for distributors as the Southwest District’s Distributor Business Consultant until 2010. Since then, Tom has provided technical lubrication support for commercial airlines globally. Tom is based in Southern California.

Andrea Bastek, PhD, is a systems thinker and bridge-builder shaping the future of clinical research. With a PhD in Biomedical Engineering and over 20 years in clinical research, including 15 years in cardiac medical device trials, Andrea has worked side-by-side with PIs, coordinators, site teams, and participants. Her first-hand experience with the challenges sites and patients face fuels her tireless advocacy for process and technology improvements. Today, she leads collaborative initiatives that unite sites, sponsors, and CROs, turning complexity into actionable frameworks and tools. Known for blending empathy with operational precision, Andrea’s work helps make research more inclusive, efficient, and human.