Dr. Caroline Sandström received her PhD in Medical Science from Lund University, Sweden in 2008. She has then worked for Novo Nordisk A/S, Denmark for several years as a pharmacologist driving and executing pharmacological plans supporting pre-clinical projects.
Her interest and enthusiasm for project management, continuous improvement, streamlining initiatives and training was then later beneficially used when she moved into the compliance area managing global improvement and training initiatives within R&D Quality Management System (QMS) including Clinical. For example, she was the project manager for implementing the effective use of Root Cause Analysis in Clinical Development activities but also being highly involved in initiatives related to Quality Culture. Ferring Pharmaceuticals A/S in Copenhagen, DK. On a daily basis she was involved in discussing, driving compliance and improvement initiatives within both Non-Clinical, Clinical and Pharmacovigilance related activities. She has taken a very active role in contributing to a collaborative and transparent organization where sharing learnings are a main focus area.
From beginning of May 2022, she moved into the position of being Head of the Global Clinical Quality Department being responsible for the QA support of global key stakeholder areas such as Clinical Development, Regulatory Affairs, Pharmacovigilance and Discovery. Her scientifically driven problem-solving skills are used for implementing global cross-functional initiatives, and for supporting and strengthening the harmonization and quality mindset in the organization.
Thought leader in domestic and global macroeconomic, markets and political analysis. During my career I have been a developer of capital market strategies and managed domestic and global fixed income portfolios, created new products, recast analytic direction, and rejuvenated/rebuilt departments. Written analysis has generated appearances in financial media throughout the world. Contributor to WSJ Economist Survey, CNBC FOMC Survey, Blue Chip Financial Forecast. Current volunteer work — Treasurer of the National Academy of Design, where I created the investment policies for their newly funded endowment, and am Chair of the Investment Policy Committee.
Viktorija Terebaite is professional in the field of Digital Health, boasting four years of direct experience in integrating digital tools into clinical trials and heading Digital Health Technologies team in Lundbeck. Viktorija has a unique perspective on digital health innovation, having been involved not just in the academic and clinical realms, but also in the commercial technology sector where she worked on a development of a software product used by over 60 million people globally.
As Head of Clinical Vendor Management at UCB, Pierre-Gaultier Delheid leads the vendor strategy aiming to design and manage a strong external vendor network. He makes a point of honor to build sustainable and strong alliances to overcome clinical challenges in a flexibility, agile, reliable, green and cost-efficient way. In close collaboration with other UCB business units, he drives a culture of partnership to change the game to a better outcome.
Engineer by background, his experience in bio-pharma industry in CDMO as well as in Sponsor companies and his business DNA gained during an international EMBA (Hult, US/UK) led him to build strong expertise in the field of operation and business optimization as well as building strong partnerships.
Lindsey Marshall is a Director of Clinical Drug Supply & Logistics at Regeneron Pharmaceuticals. She holds a Master in Clinical Research from Drexel University and has been working in the industry for nearly 20 years. Lindsey currently oversees a team responsible for forecasting, planning, and distribution of clinical drug supply for Regeneron’s portfolio.
Blake Wilson is a Partner in Hogan Lovells’ FDA Regulatory group. He holds a juris doctorate from the University of Pennsylvania and a master’s degree in biostatistics from Columbia University. Prior to becoming an attorney he managed Phase I and II pharmaceutical trials at Brown University. His legal practice focuses on FDA’s premarket approval process for drugs/biologics/devices, oversight of clinical trials including BIMO audits, as well as navigating changes in laws or regulations that govern the life sciences industry. He also guides sponsors through the special designation programs available at the premarket stage, like RMAT, accelerated approval, and breakthrough. In this capacity, Blake advises extensively on novel products, study design considerations, and the use of clinical data in FDA-related matters. By stress testing clinical materials through the lens of an FDA reviewer, Blake helps sponsors avoid pitfalls that can delay or derail a project.
