Archives: Speakers

Dr Domenico Merante completed his degree in medicine in 1988 at the age of 25 and in 1993 became specialist of endocrinology, diabetes and metabolic diseases, both degrees obtained at the University of Pisa/Italy. Dr Merante is currently Clinical Research Lead TA Orphan/ Nephrology at CSL Vifor in Glattbrugg, Switzerland. He previously worked at Sosei Heptares in 2018-2019 as VP of Clinical Development and at Shionogi as VP and Head of Clinical Science in 2017 and 2018. Between 2007 and 2016 he covered the role of Senior Director of Clinical Development at Daiichi Sankyo Development Ltd, UK heading the European Frontiers/Opportunity Department. Dr Merante had previously worked at GSK Italy, Eli Lilly Italy, Novo Nordisk UK and Laboratori Guidotti Italy in several clinical positions. So far Dr Merante has spent 28 years in drug clinical development working in Italy, UK, US and Switzerland in multiple therapeutic areas. These include diabetes and complications (i.e. macular edema and neuropathic pain), fibromyalgia, endocrinology area (i.e. growth hormone deficiencies, Cushing syndrome), severe hypertension, infectious diseases, hematology and nephrology/orphan and rare diseases. Dr Merante has to date 119 publications amongst full papers, abstracts as either main author or co-author and oral presentations made during scientific or industry-based conferences.

Anna has a Master degree in International Business from the University of Parma (Italy) and has 6 years of experience in the field of clinical outsourcing. During this time, she has worked across all study phases in respiratory area mainly in particular in developing strategic relationships with some CROs/Clinical Providers in order to ensure efficiency and processes fluidity in terms of budget and contractual negotiation.

Elena has a Master degree in Pharmaceutical Chemistry and Technology from the University of Padua Italy and has 15+ years of experience in the field of clinical development at pharma and medical device companies. During this time, she has worked across all study phases, including large phase III clinical trials and across different therapeutic areas. As Vendors Alliance Manger, Elena shapes the relationships with the strategic vendors from concept through operationalization to maximise their value and efficiency.

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.