Digital innovation business leader with vision for turning bold technology innovations into operational realities.

As Emerging Technologies Director I am accountable for the collaboration with cross functional business partners in managing the delivery of promoting solutions between test/start/scale. I am accountable for understanding the demands and implications of solutions and will ensure that the organisation has the capability and capacity to achieve business outcomes with agreement and clarity around roles and responsibility. My role is to forge relationships with internal and external partners to build best practice and establish new ways of working.

My mission is to introduce innovative technologies in AstraZeneca clinical trials, paving the way towards operational excellence.

Biography

Nick De Donder graduated as a biomedical scientist from the University of Ghent, Belgium in 2007 and has been employed since 2008 by Business & Decision Life Sciences at their headquarters in Brussels. He has been moving from being a Data Integration Specialist to Project Manager to Line Manager for the Data Standards team. Since 2020 he is Head of Data Standards. Nick is a member of the SDS team, an authorized CDISC trainer for CDASH, SDTM and Newcomers and a PHUSE committee member since 2017. In 2019 he joined the E3C and is now co-chairing it. Since June 2021 Nick has been product owner of the CORE application.

Debarshi is currently Global Head of Biostatistics and Data Management consisting of approximately 30 Biostatisticians, Statistical Programmers and Data Managers across two global sites in Munich, Germany and Boston, USA for a Bio-Pharmaceutical company engaged in bringing novel drugs in Oncology and Auto-immune disease to patients.

With more than 11 years of experience in drug development in the pharmaceutical industry, Debarshi has extensive and proven track-record of impactful data-driven leadership in all phases of drug development and successful regulatory interactions regarding New Drug Application (NDA) and Biologics License Application (BLA) with USFDA, EMA, and PMDA.

Debarshi was the Lead Statistician of a pivotal oncology study with a real-world component, which resulted in a successful FDA approval in July 2020. In the course of the path to approval, Debarshi provided strategic leadership, led multiple interactions with FDA and provided strong statistical input in regulatory aspects of the submission. Debarshi has designed Phase I-III clinical trials, with complex adaptive features, calculating optimal sample size taking advantage of advanced simulation methods.

In his current role, Debarshi has been instrumental in setting up a fully functional Statistics and Data Management Department from scratch , including a CFR 21 Part 11 validated SAS programming environment for performing in-house programming.

Joined to the project of biotechnologies in 2012, at the beginning of the Advanced Therapies. The labour as Oncologist in Big Pharma from September of 2016 until today has been taking part of international research organizations in which participated actively; Working as a Cross-functional role for Spain and Portugal, clinical development of Lilly portfolio, deep dive of clinical trials and preclinical studies of new drugs, from First Human dose to Phase III/IV. Expert in Regulatory terms and access negotiation, in Pre-launching and Clinical Launching of drugs developing the brand plan and operational plans supporting all implicated areas, from I+D, clinical operations, to marketing and sales.

Other Qualities are management and leadership, strategy and innovation, technology, operations, and value chain management, Emotional intelligence and empathy. The road map to achieve all theses capabilities has been intense working in 10 Hospitals, in basic science, preclinical research in Advanced Therapy Medicinal Product, developing drugs from human origen from Wharthon´s jelly MSCs, fat and dental pulp to recover damaged soft tissue, chronic stroke and chemotherapy damage and been author of books papers, communications in international meetings and participating in many advanced projects nationwide health demonstrating great capacity for teamwork to solve complex situations.

Magali specialises in:

- Risk Based Quality Monitoring
- Centralized Monitoring
- Processes improvement
- Statistical optimizations
- Feasibility
- Vaccines
- Mentoring
- Coaching
- People management

Nilo is a data-fluent digital health leader with a 20+ year track record spanning startups to global pharma. He has experience in building dating platforms in Paris to leading Roche’s Data Fabric across R&D and commercial. He has helped shape how life sciences companies harness data and digital products to create real-world impact.

Suchi is a skilled and motivated Clinical Research Professional with vast experience in Vendor and Clinical Data management. She has been working as operations lead for various therapeutic areas and managing a team. She has independently handled clients and Vendors across the globe and coordinated with horizontal teams using strategic communication skills and increased quality and punctual delivery.

Esther Marfo, is a Project Leader within the Health Equity and Population Sciences department at Genentech. With over 15 years’ experience in the industry, Esther has predominantly worked in clinical trial management and data management roles across Europe, North America and South Africa. Her passion for ensuring that clinical trials are reflective of our society drove her to her most recent work in Health Equity, where she works with a group of committed and passionate individuals to successfully develop and implement scalable and sustainable strategic interventions for the recruitment of underrepresented patient populations.

Charlotte has a PhD in pathobiology and intensive knowledge within data management, clinical development and project management. She has worked in clinical data management for the last 10 years being involved in operational data management tasks, standardisation, process improvement, leadership tasks and strategy development.

Leandro is a seasoned Clinical Research Professional with 17 years of industry experience in Contracts & Legal, Start-up & Regulatory, Clinical Monitoring, and Line Management. Over the past 9 years, he has been dedicated to mentoring and developing Clinical Research Associates, equipping them with the tools, training, and feedback needed to excel in their careers.

He has managed Site Relationships in the Barcelona area, serving as the Key Point of Contact for major pharmaceutical companies. In November 2022, he stepped into the role of Interim Country Head for Portugal, overseeing Country Clinical Operations, Site Identification, Resourcing, and Escalations.

Beyond his professional roles, he has contributed to academia as a Teacher Assistant at the University of Chicago's Clinical Trials Program and currently as a Guest Teacher at ESAME Pharmaceutical Business School. His commitment to educating future professionals underscores his dedication to advancing the clinical research industry and promoting best practices.

Currently, he is the Associate Director of Country Operations at Alexion Pharmaceuticals, leading a team of CRAs and Local Project Managers to bring new treatments to the rare disease field.

Neha has over 14 years of strong experience in project/line management, leading and coordination of international clinical trials (Phases I, II to III) in pharmaceutical and CRO. She has extensive experience in handling varied facets of data management lifecycle, strengthening customer relations and building self driven teams.