Archives: Speakers

Passionate about sciences and technologies, Christine studied bioengineering at the Catholic University of Louvain (UCL) in Belgium. After having held several roles in the pharma industry, mainly in Clinical Data Management and Data Surveillance, she took over the role Team Lead Centralized Monitoring at UCB. The team is responsible for Central Monitoring activities, using Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs) and Central Statistical Monitoring tools to detect data anomalies and trends at study, site, and study participant level.

Manan Trivedi, PhD, is a clinical and regulatory project management leader with 15+ years of experience in the pharmaceutical industry, specializing in global clinical trial submissions, regulatory compliance, and process optimization.

As ASSOCIATE DIRECTOR & EU CTR PROJECT LEAD at UCB Biopharma, he spearheads the end-to-end implementation of the EU Clinical Trial Regulation (EU CTR), ensuring streamlined regulatory pathways, cross-functional coordination, and operational efficiencies. His leadership in transitioning trials from CTD to CTR has positioned UCB as an industry front-runner in regulatory compliance.

Cindy Weiss is a speaker on patient-centred packaging systems for remote sample collection and multiomics research.
With a background in industrial design and health innovation, her work focuses on human-centred design, patient engagement, and remote clinical trials.
Through her talks, she shares insights on precision diagnostics, cross-sector collaboration, and the role of design in advancing personalised healthcare.

Valerie Schwartz, Accorto’s Regulatory Affairs Manager, brings strong experience in regulatory operations and scientific research within the nicotine and tobacco harm reduction space. At Juul Labs, she began as an analytical chemistry scientist supporting new product research and development and later transitioned into the Regulatory Operations team, where she led key non-clinical regulatory science projects in support of FDA engagement and product submissions.

At Accorto Regulatory Solutions, Valerie plays a central role in the preparation of FDA submissions for a wide range of nicotine products, including next-generation products. She works cross functionally to manage the development and review of scientific documentation across multiple disciplines, including chemistry, stability, toxicology, and safety assessments. She also monitors and interprets FDA guidance and regulatory trends, integrating strategic updates into scientific testing and submission strategies to ensure each application meets current regulatory expectations.

Amelia Lowe, as the Vice President of Operations at SquareTrade Europe, leads all claims and operational functions across the region. With oversight of Supply Chain, Customer Service, Customer Experience, Solutions & Sustainability, Amelia plays a pivotal role in driving operational excellence and enabling profitable growth. Boasting a ten-year tenure at SquareTrade, Amelia advanced through senior management roles in operations and supply chain before assuming her current position. 

Prior to SquareTrade, Amelia ran her own consulting business, specialising in innovation and strategic guidance for consumer products and services businesses. Her diverse experience spans various industries, showcasing her expertise in operations, consulting, leadership, and strategic planning. 

Ian is a globally experienced industry leader with over 25 years of experience in the pharmaceutical and life sciences sector. He has worked with leading organizations across the globe holding various senior and executive leadership positions including Global CROs, Health Technology, RWD & RWE companies as well as Genomic LABS developing a comprehensive understanding of clinical development and real-world evidence generation.  His career has been largely focused on driving innovation and growth in the life sciences and biotechnology sectors, most recently in the area of genetic diagnostics and evidence generation in rare diseases. 

Jack Funchion is the VP, Global Financial Services at Digital Realty. Jack and his team work with the world’s leading banks, asset managers, hedge funds, financial exchanges, market data providers and insurers. Jack has extensive experience in the financial services industry starting in data centre operations for three major Wall Street brokerages, then transitioning to management consulting focused on data centre issues, and for the last 18 years at Digital Realty. 

Guy Bentley is the director of consumer freedom at Reason Foundation. Bentley’s research focuses on the taxation and regulation of nicotine, gambling, alcohol, and food. Bentley’s work has been featured in The Washington Post, USA Today, The New York Post, and other publications in the U.S. and U.K.

Before joining Reason Foundation, Bentley served as a reporter in London and Washington, D.C.

Lillian Ortega is the Owner and Chief Regulatory Compliance Strategist at WOW Solutions LLC, a consulting firm dedicated to guiding businesses through the complexities of FDA regulatory processes. With over a decade of distinguished service at the Food and Drug Administration, Lillian has extensive experience leading strategic and complex compliance and regulatory projects. Her expertise spans a broad range of sectors, including tobacco products, biologics, and FDA-regulated clinical research.

Before founding WOW Solutions, Lillian served as the Director of Enforcement and Manufacturing at the FDA’s Center for Tobacco Products. In this pivotal role, she led manufacturer compliance and enforcement programs, directed inspection activities, oversaw compliance actions, coordinated tobacco recall operations, and managed import activities.

Lillian’s academic background in Microbiology and Public Health Policy complements her professional experience, enabling her to deliver invaluable insights to her clients. Her unique blend of regulatory oversight and business acumen empowers organizations to successfully navigate the FDA regulatory landscape. Through WOW Solutions, she provides tailored consulting services to position products and operations for success in a highly regulated environment.