Pooja Gandhi is Director of Clinical Quality Assurance at GRAIL, where she leads enterprise-wide quality and compliance efforts across global clinical trials. She oversees risk-based audit programs, drives cross-functional remediation strategies, and partners with stakeholders to ensure clinical studies meet regulatory and operational excellence standards. With over 20 years of experience in clinical research, including leadership roles at GRAIL and 23andMe, Pooja brings deep expertise in GCP, FDA regulations, and clinical trial oversight. She is passionate about advancing quality driven processes that enable efficient, compliant, and patient-focused clinical trial execution.
Archives: Speakers
Ted Chun
Ted has decades of experience in the healthcare industry and clinical research. He specializes in clinical operations, project management, data management, and innovative data solutions. He also possesses a diverse executive management background spanning across healthcare, life sciences, telecommunications, and aerospace. He has provided consulting to Neurovascular, Cardiovascular and Orthopedic startup companies, and he was a strategic leader at Stryker Neurovascular managing global clinical operations team, overseeing global pre and post-market clinical studies and a clinical technical field services team, who interfaced closely with our KOLs. He possesses a deep understanding of global device regulations, clinical strategies, and new product development activities, successfully launching many AIS and Hemorrhagic products. Ted has been a speaker or panel member for OCT and CTS events in USA and China over the last 5 years.
Jason Keveryn
Jason Keveryn is Associate Director of Clinical Supply Chain at 4D Molecular Therapeutics. Previously at Cytokinetics he has supported the late-stage development of recently approved Aficamten, a next-generation cardiovascular therapy cardiovascular therapy, and continues to lead clinical supply operations supporting post-market approval studies. With expertise in clinical supply strategy, forecasting, vendor performance optimization, and global distribution, he has driven process innovations that improved forecasting accuracy, strengthened supply continuity, and mitigated patient supply risk.
Roderic Toney
Rutesh Desai
Experienced Senior Supply Chain with a demonstrated history of working in the biotechnology industry. Strong operations professional skilled in Business Process, Biotechnology, Management, SAP ERP, and Business Intelligence
Monica Eris
Monica Eris is a Senior Director and Head of Supply Chain & Logistics at Imugene, where she leads enterprise end-to-end supply chain strategy for a global oncology portfolio. With over 15 years of experience in biopharmaceuticals, she specializes in integrated business planning, external manufacturing strategy, and clinical-to-commercial supply execution. Monica brings deep expertise in global CDMO networks, supply risk management, and enterprise planning transformation, with a strong focus on enabling clinical-to-commercial readiness. She previously held leadership roles at BeiGene, supporting the commercialization of BRUKINSA, and at Genentech/Roche, where she led integrated planning transformation initiatives. She is recognized for building scalable operating models, leading cross-functional teams, and driving commercialization readiness in highly regulated environments.
Marissa Chan
Marissa Chan is a Supervisory Consumer Safety Officer with the FDA’s Division of West Coast Imports, leading import operations across California, Hawaii, and Nevada. She oversees regulatory and inspectional activities involving pharmaceuticals, biologics, medical devices, foods, and other FDA-regulated products entering the United States. With experience in both import and domestic regulatory programs, she brings extensive expertise in compliance, inspections, and global supply chain oversight.
Jessica Lee
LCDR Jessica J. Lee, MPH, CHES®, serves as a Supervisory Consumer Safety Officer with the FDA’s Division of West Coast Imports and leads Northern California import operations. With more than 15 years of experience in import compliance, inspections, and supply chain oversight, she specializes in the importation of pharmaceuticals, biologics, medical devices, and other FDA-regulated products. As a leader within both the FDA and the U.S. Public Health Service Commissioned Corps, she is committed to advancing public health through effective oversight of global medical product supply chains.
Anders Nordell
Anders Nordell is the CEO and Co-Founder of Collective Minds. With a career spanning medical imaging science at Stanford and Karolinska to leadership roles at GE Healthcare, Anders now leads Collective Minds in its mission to break down healthcare silos. His work focuses on leveraging secure, cloud-native platforms to connect hospitals and researchers, accelerating the development of AI-powered diagnostics and therapies through real-world imaging data
Jonathan Wogel
Jonathan Wogel is CEO at NWEH and a senior life sciences leader with more than 35 years’ experience across the pharmaceutical, medical device, and biotech sectors. He has supported the launch and licensing of more than 50 products globally and specialises in business growth, investment strategy, and commercialisation. Jonathan has extensive experience supporting SMEs and is passionate about innovation in life sciences, mentorship, and commercialising cutting-edge technologies.