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Given the massive disruption caused by the COVID-19 pandemic, one of the most significant changes recently observed in the clinical trials landscape is the acceleration of the adoption of decentralized trial designs and in particular Direct to Patient shipping models. It’s taken a slow, long-term industry trend and accelerated it rapidly.
Experienced panelists working in the clinical trials world will share their insights and experiences with decentralized trials and the leverage of digital solutions that are allowing to adopt a patient-centric focus when creating and running clinical trials.
Topics that will be covered includes:
- What are decentralized clinical trials?
- What does the decentralized trials global landscape look like?
- What is a Direct to Patient (DtP) trial?
- How has COVID been an inflection point for DtP trials?
- How have trial designs shifted and supply chain strategies changed to accommodate for an increased need for flexibility and decentralization?
- What are some of the barriers clinical trials stakeholders are experiencing to implement these kinds of trials? Any difference between regions?
- Are decentralized trials the future of clinical trials designs going forward?
SPEAKERS
With a wealth of expertise and experience gained across academia, pharmaceutical services and clinical trials logistics, Andrea has served in a number of senior leadership roles in research and development, clinical trial supply chain as well as product and project management. Andrea held various roles and contributed significantly to the development of Parexel clinical trial supply services and the clinical trial supplies and logistics business globally. Currently Andrea leads the Cell and Gene Therapy and Direct-to-Patient service lines at World Courier, with a focus on defining strategy, driving growth and solving operational and process challenges which arise from the complexity of these shipments.
Henk currently assists Suvoda with his knowledge in various areas of clinical trial supply management. Prior to Suvoda, he co-founded the clinical trial supplies department at Grünenthal GmbH and served as its Associate Director for 10 years. While at Grünenthal, he developed operational processes and championed risk management procedures to establish the company as a clear market leader in the area of clinical supply chain. More recently, he served as Senior Investigational Medicinal Product Manager at BioNTech SE, where he streamlined data processing operations in the clinical supply chain for personalized oncology therapies. He is an innovative expert in the field of IRT, temperature excursion management, and direct-to-patient logistics.
A Physician by training specialized in planning, coordinating and managing global clinical trials. Aneta has been working and held various roles in the Pharmaceutical Research and Development division at Bayer over the past 13 years. Currently she is leading the Decentralized Strategy and Implementation within Bayer and is in charge of the internal process adaptations and managing advancing acceptance of Decentralized Clinical Trials across countries.
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