Cindy Chiu is a Senior Director in Global Regulatory Affairs and Clinical Safety group at Merck & Co. She has over 20 years of experience in the pharmaceutical and energy industries, focusing on post-merger process integration and operations excellence. She has served in various leadership roles overseeing project management, business process improvement and change management initiatives. In her current role at Merck & Co., she is the Lead of the Regulatory Content Authoring and Archiving Management group. Prior to Merck, she worked as a management consultant, where she assisted clients with change management and business process redesign as a result of merger activity or technology integrations.

Bala heads VB Insights, an advisory firm for the Healthcare and Life Sciences sector. Bala brings over 35 years of experience. During his long tenure, he has been responsible for the introduction of Web, document management, global team collaboration, and regulatory information management applications to large pharma. Until recently, Bala was Head of the Healthcare and Life Sciences Industry Solutions Group at Orion Innovation. As an entrepreneur and a thought leader, he has been involved in initiatives to transform regulatory affairs from a document-centric function to a data-driven function. Bala has been associated with DIA for more than 14 years, most recently as the DIA RIM Working Group subteam lead for the RIM Reference Model.

Dr CC Lee is the International Lead for CMC Technical Advocacy and Policy at Merck, managing international policy reviews, coordinating company positions on evolving regulatory guidelines, and developing strategies to influence the global regulatory landscape. Previous roles include working at the UK Medicines and Healthcare products Regulatory Agency and European Medicines Agency as well as serving as an Expert Advisor to the World Health Organization. Dr Lee is known for expertise in global regulatory procedures, collaborative engagement, and advocacy for science-driven policy solutions. She is deeply committed to regulatory harmonization, data-sharing initiatives, and advancing equitable access to medicines worldwide.

Ron Fitzmartin is a Principal Consultant at Decision Analytics. Previously, Ron was Senior Advisor in the Data Standards Branch, Office of Regulatory Operations, Center for Biologics Evaluation and Research, FDA. He provided policy and strategy consultation on electronic regulatory submissions and standardized data. Ron served as Rapporteur for the ICH M11 Expert Working Group and as Co-chair of the Global IDMP Working Group. Prior to FDA, Ron held several leadership positions in industry: VP, Biostatistics and Data Management and VP, Informatics at Daiichi Medical Research and Daiichi Sankyo, respectively. Ron received his PhD in Statistics from the University of Maryland, College Park.

Ciby Abraham is a Senior Director and Group Manager, Project and Product Leadership in CMC Regulatory Affairs at AstraZeneca. Prior to his role with AstraZeneca, Ciby worked at the for several years FDA as a Team Leader. In addition, Ciby worked in the industry as a formulator, analytical method development scientist, and a manufacturing specialist. He was also licensed by the New York State Board of Pharmacy to release compounded products to the market. Ciby holds a Ph.D. in chemistry from Johns Hopkins University, Master’s degree in chemistry from St. John’s University, and a Bachelor’s degree in chemistry from Binghamton University.