With a keen eye for Strategic Vision, Jonathan has been at the forefront of advancing analytical capabilities, particularly in site intelligence, operational metrics, and quality indicators. With a prowess in Digital Transformation has been instrumental in the on-time delivery and precision of a diverse suite of predictive models, leveraging ML/AI and Generative AI technologies.

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.

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.

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.

Magali specialises in:

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

Digital innovation business leader experienced in setting and scaling up digital solutions in the
pharmaceutical space. My mission is to foster innovation in digital health, with the aim to advance healthcare and help patients.

Nina is the co-founder and CEO of Avenna Ltd. Her mission is to make healthcare for chronic inflammatory disease (CIDs) more preventive and personalised. By developing more effective, affordable, and accessible precision medicine solutions we can enable early detection and treatment personalisation for variety of CIDs. Nina has background in finance, business, and healthcare and worked in large multinational companies including Nomura, Bloomberg and Schlumberger, as well as several entrepreneurship ventures.

Nina’s main ability and expertise is to connect the worlds of scientific research and business. She uses this experience to translate the most promising, research-grade technologies into practical solutions for individuals, clinicians, and biopharma. Nina works in collaboration with leading scientists, clinicians, and patients to translate R&D stage technologies into practical clinical solutions. This includes design and execution of clinical studies and trials, development of bioinformatics infrastructure to facilitate the translation of precision health programs for chronic disease prevention into clinical practice.

Francis P. Crawley is a philosopher with a career in bioethics and expertise in research policy, regulation, ethics, integrity & methodology as well as in data/AI/virtual twins ethics and law with particular attention to the life sciences: clinical trials, genomics/omics, new technologies. Expertise in EU, US, international and country-specific ethics, law, and patient and community interests in health-related research. Strong experience working closely with patients, communities, researchers, and policymakers across disciplines. domains, and geographic regions in establishing consortia, developing patient registries, contributing to the development of biobanks, drafting data management and data protection plans, and contributing to building data repositories. A strong background in the methodologies for designing and reviewing health-related research supported by effective communication and leadership skills as well as diplomacy with the ability to influence changes in bioethics and law. Additional strong background in the development of research, guidance, and ethics related to global diseases affecting resource-poor settings and orphan diseases in the context of leading and/or contributing to challenging projects. Wide experience (e.g., UNAIDS, WHO, UNESCO, European Commission, Council of Europe, and others, including local organizations and industry) in developing health-related research projects, collaborative engagements, regulatory and policy outreach, and education and training in Europe, Africa, Asia, the Americas, and Eastern Europe & Central Asia. Leading roles in the development of international and national guidelines, capacity-building, empowerment, and education programmes for health research; including GCP, ethics review systems, genetics and biobanks, and data privacy & management (a GDPR DPO), with expertise in the ELSI aspects of data AI, digital twins, and organoids. Since January 2020 highly active in the research, ethics, data sharing, and policy discussions on COVID-19, particularly in the areas of vaccines, repurposed medicines, and genetic modelling, having organised more than 40 global webinars and coordinating research across HICs and LMICs. Recently engaged in the policy, ethics, and regulation of data and AI in times of crisis. Founded and coordinates the Ukraine Clinical Research Support Initiative (UCRSI) in cooperation with leading Ukrainian, European, and international organizations. He is at the forefront of the European and global movement to reform and advance research assessment in the universities and other research institutions, with a particular emphasis on research ethics and research integrity in developing policy for data and AI in the research assessment process.

Urte Jakimaviciute, MSc, is Senior Director of Market Research and Strategic Intelligence in the healthcare division at GlobalData, London. Her primary responsibility includes managing the market research process for the syndicated portfolio and custom consulting projects, as well as managing strategic research portfolio. Urte has over 15 years of experience in pharmaceutical market research industry. Prior to GlobalData, she held management roles at market research agencies providing consulting and market research services to the healthcare and technology industries.

Urte holds a MS in Economics from the LUISS Guido Carli University, Italy and a BA in Information Management Systems from Vilnius University, Lithuania.

Wafaa Hassan, MSc, is a Senior Pharma Analyst in the Digital team at GlobalData’s London office. Her responsibilities involve writing reports and providing insights on digital strategy across disease areas and channels. Prior to working in the digital team, Wafaa worked in the thematic research team at GlobalData, where she contributed to quantitative and qualitative analysis reports on disruptive themes and technologies, with a focus on Pharma, Healthcare and Medical Devices sectors. Prior to joining GlobalData, Wafaa studied for an MSc in Healthcare Management at City, University of London.