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Claudia |
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Hesselmann, PhD |
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Co-founder & CEO |
ARENSIA |
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Claudia Hesselmann, PhD, a chemist by training, with a PhD in molecular biology. Claudia has twenty years of expertise in the early phases of drug development. Her experience includes co-founding and holding management positions in various CROs. Her extensive background and social acumen, along with her first-hand knowledge of the industry, led Claudia to co-found ARENSIA Exploratory Medicine in Düsseldorf, Germany. Her primary aim is the contribution of innovative approaches to bring about substantial acceleration to the drug development process and enable more agile patient access to novel therapeutics. |
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Narinder |
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Chopra |
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Head of Patient Engagement, Equity and Transparency (PEET) Delivery |
Biogen |
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Lydia |
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Matombo |
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Director Clinical Operations – System & Data Intergration Lead |
MSD |
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Lydia Matombo is a Director, Clinical Operations-Systems & Data Integration Lead for Risk Evaluation & Adaptive Integrated Monitoring (REAIM). In her role she establishes technical and cross functional business needs, aligns with stakeholders, and oversees data integration activities between Merck and Suppliers resulting in the build out, testing,implementation and maintenance of business critical Key Risk Indicators (KRI)s in support of Adaptive Integrated Monitoring (AIM), Global Clinical Trial Operation’s (GCTO) risk based initiative to further the organization’s risk-based quality management (RBQM) approach through advanced analytics. She ensures that supplier systems are ready and maintained throughout the study life cycle to enable execution of central analytics and monitoring activities, including Quality Tolerance Limit analysis, Key Risk Indicator analysis and Central Statistical Analytics. This enables each Clinical Trial Team to support the effective identification of important study issues that require monitoring, management, and adaptation of study plans. Lydia collaborates with other functions, Quality Assurance, Ethics’, and compliance, to ensure that systems and any outlined processes are compliant and Inspection ready.
Lydia has 20 Years of clinical database management expertise, leading end to end clinical trial conduct and execution, strategic implementation of quality-by-design data collection systems, building and leading high-performing teams across many therapeutic areas, and is now in the role of Risk Systems Data Integration Lead. Lydia is committed to creating a diverse and inclusive work environment. She is a member of the GCTO’s Diversity, Equality and Inclusion Ambassadors as well as Merck’s League of Employees of African Descent (LEAD). Lydia holds a BSN (Honors) from Fairleigh Dickinson University in New Jersey, is a Registered Nurse, and is Project Management Professional (PMP®) certified. |
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Domenico |
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Merante |
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VP Clinical Development Nephrology & Orphan Diseases |
CSL Vifor |
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Domenico Merante graduated in Medicine at University of Pisa/Italy in 1988. He specialized at the same University in 1993 and practiced at the main Pisa city hospital of St. Chiara whilst specializing in endocrinology and diabetes. His practice experience is 20+ years, including working as emergency doctor for 12 years in the NHS in Italy. During the compulsory military service, he also worked for three years as Medical Officer and subsequently as Chief Medical Officer of a ship unit named “Ammiraglio Magnaghi” in the Italian Navy. Domenico focus is on diabetic neuropathy, neuropathic pain and diabetic wound treatments.
In addition to his medical practice experience, so far Domenico has developed 26 years’ experience in global clinical development, half of which spent with Japanese organizations (Daiichi Sankyo, Shionogi and Sosei Heptares) within the pharmaceutical and biotechnology environment. The other half of his career was with Lab. Guidotti, Novo Nordisk, Eli Lilly and GSK in Italy and in the UK. In this context, Domenico has worked in global clinical development programs (phase 1,2 and 3) in pain area, infectious diseases, type 1 & 2 diabetes and diabetic complications (including painful diabetic neuropathy), severe hypertension, metabolic and endocrine area. To date Domenico has produced 103 publications as main or co-author among full papers, abstracts and oral presentations. |
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Martin |
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Rodriguez |
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Head of Clinical Strategy & Quality |
Sanofi |
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Martin Rodriguez currently is Head of Clinical Strategy and Quality in Sanofi, Consumer Health Care (CHC)- Clinical Operations. Biochemist by formation and Lean Six-Sigma Green Belt Certified, works in science & clinical research, trial management, quality systems, Operational Excellence and vendors management for more than 25 years. He led and worked in transformation and reengineering programs and optimization of outsourcing models in clinical operations and quality. During the last years, he is part of the implementation of Quality Risk Management and RBM (Risk Based Monitoring) and Innovative /digital capabilities in clinical trials. |
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Tim |
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Rolfe |
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Director, Centralised Statistical Monitoring & Data Analytics |
GSK |
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Tim Rolfe is Director of Central Monitoring & Data Analytics at GlaxoSmithKline & has over 20 years of experience working as a statistician in the pharmaceutical industry.
He has been part of GSKs RBM team since its inception in 2012, providing statistical leadership in the development and implementation of GSK’s RBQM strategy within clinical trials.
Before joining GSK, Tim studied Applied Statistics at Sheffield Hallam University and holds a MSc in Medical Statistics from the University of Leicester in the UK. |
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Jane |
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Twitchen |
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Executive Director, Head, Clinical Trial Accelerator Unit |
Biogen |
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Jane Twitchen graduated with a BSc in Medical Physics from the University of Exeter, UK and commenced her career with Covance, supporting a number of trials investigating radioisotope image optimisation. Having developed a keen interest in processes and systems, she then joined SAS, where she worked in the Alliances team collaborating with partners such as PWC, McKinsey and Accenture to define and implement solutions for pharmaceutical clients. During her tenure with SAS, Jane was also sponsored to complete her MBA. She proceeded to a number of software and service providers prior to joining Biogen in 2013, initially joining the Global Regulatory Affairs Quality and Operations team and moving to Global Clinical Operations in 2015. In her current role, Jane is Executive Director, Head of Biogen’s Clinical Trial Accelerator Unit and is responsible for delivery of Biogen’s goals for accelerated study start-up cycle time, in addition to embedding innovative operational delivery through the use of technology. |
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