Laura is a Clinical Research Professional. She started in Novo Nordisk in 2013 as CRA and since 2020 she’s exploring and defining Clinical Innovation as Clinical Innovation Manager.
In her current position, she’s leading the Innovation Strategy in her department – Clinical Operations in France, Portugal and Spain and additionally, driving the change and bringing innovation in Region Europe.
Her superpowers: communication, innovation and collaboration.
In my position as Senior Director – Clinical Trial Digital Innovation at Genmab, I lead a team driving AI adoption within clinical operations, decentralized clinical trials and digital innovation in drug development. Previously, I have been working to bring the best disruptive innovation into normal clinical operations at LEO Pharma to help improve and accelerate their clinical trials. Furthermore, I am trying to solve some of the toughest challenges related to scaling digitalization, data, and automation to generate competitive advantages across business units. One aspect is driving the necessary foundational components around a scalable GxP data platform, machine learning opportunities as well as automating digital processes with robotics process automation. Besides leading the necessary change internally, focus is on a design-thinking approach where we put the patient and site at the center. I have an ambition towards “delighting” patients, investigators, and sponsors by solving the real-world challenges they face by leveraging both qualitative interviews and observation, as well as quantitative methods to reveal actionable insights
Roi Amir is an experienced senior executive with a proven track record of success leading teams at the cutting edge of the software industry.
Roi is CEO of Sprout.ai, an award-winning technology solution for the insurance industry, with the vision to enable insurers to deliver a differentiated claims experience to their customers. It uses ground-breaking AI and data-led products to automate every step of the claims journey. Extracting and enhancing relevant claims data, cross-checking this with policies and providing a philosophy-driven adjudication recommendation to conclude a claim in near real-time. Providing claims handlers with time to spend with customers, where human touch and empathy can make a real difference.
Sprout.ai is used by world-leading insurers including Zurich, Generali and AdvanceCare.
I’m the co-founder and Chief Product & Strategy Officer at Elsewhen the Digital Product Consultancy. Among our clients are companies like Spotify, Google, Microsoft and Mastercard.Our mission is to empower leaders to harness a cutting-edge approach to design and technology to deliver positive impact for their organisations. We have three service offerings – Digital Strategy, Digital Transformation and Product Design. I write for publications including Sifted, Venturebeat, City AM and Fintech Futures. I love using my experience in engineering and product to invest in promising early-stage founders.
I have a PH degree in Pharmaceutical sciences by the Barcelona University. I started my career as a researcher in Neurochemical department within the Barcelona Biomedical Research Institute (IIBB), where I developed my PH degree focused on Alzheimer’s disease and Inflammation.
Once I completed my Ph Degree in Neuroscience, I moved to the clinical industry, working most of my career in Data Management, first in a small CRO company and later in the pharma industry.
For along almost 12 years, I was managing phase III clinical trials acting as Global Data Manager Lead, coordinating end-to-end data management activities (including SDTM development) mainly outsourced to global CROs. Apart of the oversight of clinical trials, part of my role as an expert in DM was to lead standardization on E2E data and processes.
On 2018, I completely changed my role and moved to the Quality area. Since then, I’m Director on Clinical Quality Compliance. On this role, I’m providing quality support to Biometrics functions (including DM, Programming and Statistics roles). Among other activities, I’m giving quality related advice and guidance, overseeing quality issues, CAPA implementation and risk management. Coordinating and supporting audit and inspections, as well as preparing teams to be inspection ready at all time.
Since 2020, I’m Regulatory Considerations Expert Group DMEG Chair on the Association for Clinical Data Management. The aim of the Regulatory Considerations Expert Group looks at providing guidance information on several areas surrounding regulations. The expectations and recommendations on implementation and what data management needs to be prepared for in readiness for inspection.
Balint Feher is a senior clinical research manager at Geistlich Pharma AG. He leads eClinical project at Geistlich, supporting the organization to redesign processes and transition to digital arena. He holds PharmD at Semmelweis University, Budapest and double MSc in computer science and biomedical engineering fields. He has 15+ years’ clinical and 5+ years’ IT expertise in pharma and medical devices industries. Balint’s passion lies in the intersection of clinical, regulatory and IT by leading projects where team can solve complex problems needed combined skillset also at project lead’s level.
James Rudge, PhD, is Technical Director at Neoteryx, the microsampling brand of Trajan Scientific and Medical. He is a co-inventor of the Mitra® device and its patented VAMS® technology. Dr. Rudge has co-published 16 papers on VAMS microsampling with co-authors from around the globe, and he authored a book chapter on VAMS in 2021. Among his recent events and speaking engagements, Dr. Rudge was a vision speaker at the 2021 CPSA (Clinical & Pharmaceutical Solutions through Analysis) USA virtual conference and chaired a session at the Outsourcing Clinical Trials conference UK & Ireland focused on decentralized clinical trials. He is involved in several international research collaborations, including a large European research consortium addressing unmet needs in inflammatory disease.
Over 25 years insurance experience holding senior roles at both RSA and Tesco Bank, a decade of which has been building and driving innovation, particularly within the insurance telematics arena, where Paul is a recognised industry expert, launching multiple products across the world. Paul is also a keen runner in his spare time, forever chasing the next PB!
Roi Amir is an experienced senior executive with a proven track record of success leading teams at the cutting edge of the software industry.
Roi is CEO of Sprout.ai, an award-winning technology solution for the insurance industry, with the vision to enable insurers to deliver a differentiated claims experience to their customers. It uses ground-breaking AI and data-led products to automate every step of the claims journey. Extracting and enhancing relevant claims data, cross-checking this with policies and providing a philosophy-driven adjudication recommendation to conclude a claim in near real-time. Providing claims handlers with time to spend with customers, where human touch and empathy can make a real difference.
Sprout.ai is used by world-leading insurers including Zurich, Generali and AdvanceCare.