Clinical Trial Supply Europe - A Virtual Conference

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Session Details: Keynote Address: Un-Fogging The Future Of Clinical Trials: Considering Innovation At Every Stage Across Your Clinical Trial Supply Lifecycle 24-03-2021, 9:00 am View In Agenda

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Session Details: Keynote session: Increasing agility in clinical trial supply to keep up with ever evolving and increasingly complex trial demands 25-03-2021, 9:00 am View In Agenda

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Biography: I am the Senior Director, External Drug Product Supply Strategy, within Pharmaceutical Sciences Small Molecule (PSSM) at Pfizer. I am currently based in La Jolla, CA following 25 years at the Groton, CT site. My current areas of focus include strategic sourcing, vendor relationship management, and integration process improvement within the clinical drug product manufacturing space. I joined Pfizer in 1992 and have held several positions within the Pharmaceutical Sciences organization that covered a broad span of responsibilities. These roles have included leadership of global teams and initiatives, accountability for sourcing and manufacturing oversight of development and commercial stage products for clinical trial use, direct facility support for clinical scale sterile manufacturing, external drug delivery technology evaluation and development, as well as formulation development and analytical characterization responsibilities. I have a BS degree in Chemistry from Central Connecticut State University.

Session Details: Commercialisation Dilemma: Go it Alone or Double Up? 25-03-2021, 11:00 am View In Agenda

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Session Details: Presenting different sourcing models to guarantee you have the correct comparators for your clinical trial 25-03-2021, 9:30 am PANEL DISCUSSION: Discussing the evolving needs for comprehensive clinical comparator sourcing strategies: Globalisation, technological innovation, evolving decentralized models, and the challenges posed by the COVID-19 pandemic 25-03-2021, 12:00 pm PANEL DISCUSSION: Discussing the evolving needs for comprehensive clinical comparator sourcing strategies: Globalisation, technological innovation, evolving decentralized models, and the challenges posed by the COVID-19 pandemic 25-03-2021, 12:00 pm View In Agenda

Biography: Dr. Mishra (Ex-Genentech, Ex-NCI, Ex-NIH) is the Founder and CEO of Agility Pharmaceuticals. He is a serial entrepreneur who founded his first company after graduating high school, and second company during his PhD. Since then, he has accumulated a wealth of experienced by building, investing and advising numerous other companies. He is an investor/ co-founder/ board member of a few US based corporations focused on accelerating drug discovery & development, blockchain & digital health. Dr. Mishra is also founding president & CEO of American Association for Precision Medicine (AAPM) and is leading research efforts focused on preventing & curing chronic diseases; not only treating the sick but also providing knowledge/tools to individuals to live longer, healthier lives. Widely recognized as a thought leader in the field of Technology and Healthcare, Dr. Mishra has keynoted, chaired, curated and organized numerous successful international conferences. Prior to Agility Pharma, Dr. Mishra served as a scientist and Principal Investigator at Genentech, Roche. Moreover, his passion for drug development and precision medicine has led to identification of new drug targets, biomarkers, companion diagnostics and several drugs/ combinations in the clinic. His research work has been recognized globally by over 40 prestigious awards and honors. Due to his unique perspective & selfless service, he is highly respected & sought-after mentor to many. The companies that he has advised have raised multimillion dollars. Notably, he serves as a mentor and advisor to startup accelerators such as IndieBio, Health2.0’s Project Zygote and CLSI FAST program, to help grow California’s life sciences innovation ecosystem.

Session Details: Convergence of Big Data and Artificial Intelligence in Augmenting Drug Discovery, Development and Supply Chain Management 24-03-2021, 2:00 pm View In Agenda

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Session Details: Navigating the Regulatory landscape surrounding Import/Export 25-03-2021, 11:00 am View In Agenda

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Session Details: Patient and Caregivers Perspectives 24-03-2021, 10:00 am View In Agenda

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Session Details: Patient Centricity – A Supply Chain Perspective 24-03-2021, 12:00 pm View In Agenda

Biography: Clinical Research Sourcing Strategist Pfizer Global R&D Based in Berlin, Germany. PhD in Chemistry, has been working for Pfizer Clinical Research for over 20 years as Clinical Monitor (CRA), Study Manager, Group Head, Compliance Oversight Lead and in other roles. Developing sourcing strategies for comparators in clinical trials since 2015.

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Session Details: Optimising communication between sponsors and vendors 24-03-2021, 11:00 am View In Agenda

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Session Details: The global distribution of the COVID-19 vaccine via airfreight 24-03-2021, 1:00 pm View In Agenda

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Biography: Vanessa is the MD of Clinical Services International (CSI) a leading provider of Clinical Trial Supplies. Vanessa started her career as a research associate at Scotland Yard and then subsequently worked 20 years in drug development. She has extensive experience from Preclinical to registration and commercialization strategies and has secured product registration for several orphans and first in class drugs. She is on the Advisory Board of one of the largest NHS hospitals in the UK, undertakes extensive charity work and teaches Pharmaceutical Innovation at Cambridge. She has a PhD in Cardiovascular Genetics from UCL, an MBA from Cambridge and Masters in Market Access from University of Lyon.

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Biography: As Clinical Supply Chain Solutions Consultant, Henk currently assists Suvoda with his deep 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, Henk 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. Henk is well-regarded in the field for his expertise in IRT, temperature excursion management, and direct-to-patient logistics. In addition, he is very experienced in conducting supplier audits, having participated in more than 30 audit visits as a technical expert. He holds a Bachelor of Science degree from Zuyd University of Applied Sciences in Physiotherapy.

Session Details: How to Optimize Your Supply Chain with IRT 24-03-2021, 10:30 am View In Agenda

Biography: Stefan has worked in the IRT for 15+ years and has been with Cenduit since its inception in 2007. He worked in various project management roles including leading the global project management team at Cenduit. Stefan currently is responsible for client delivery of key customer accounts and heads the Cenduit drug supply center of excellence. He is very passionate about finding innovative solutions for clinical supply challenges. Stefan holds a master of science in molecular biology and an international executive MBA of the University of St. Gallen

Session Details: Analysing Different Approaches to Reduce Clinical Supply Wastage 24-03-2021, 11:30 am PANEL DISCUSSION: Looking to the future: Supply chain management post-COVID 24-03-2021, 3:15 pm PANEL DISCUSSION: Looking to the future: Supply chain management post-COVID 24-03-2021, 3:15 pm View In Agenda

Biography: Ph.D. Team/Project Leader with 20 years progressive experience in Global Bio/Pharmaceutical Development from Discovery to Clinical and Commercial Manufacturing. Lead increasing multifunctional groups of scientist, engineers and managers. Thrive in high-pressure environments of biotech start-ups, medium size companies, Big Pharma, CRO/CMO and virtual companies focusing on accomplishments and timely delivery of milestones. Adept in pharmaceutical project management, vendors and contract team management. Certified Project Manager and Supply Chain Manager.

Session Details: 4 Tips When Outlining the Right CMO For You To Avoid Disappointment 25-03-2021, 9:30 am View In Agenda

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Session Details: How Digitalization is Changing the Supply Chain and the Relationship with the Customer 24-03-2021, 12:00 pm View In Agenda

Biography: James L. Sherley, M.D., Ph.D. is the founder and director of Massachusetts stem cell biotechnology company Asymmetrex, LLC.  Asymmetrex develops and markets technologies for advancing stem cell medicine, including the first-in-kind technology for specific counting of adult tissue stem cells.  This technology is also applied to design optimized procedures for more effective manufacturing of therapeutic adult tissue stem cells at greatly reduced cost.  Dr. Sherley is a graduate of Harvard College, with a B.A. degree in biology, and the Johns Hopkins University School of Medicine, earning joint M.D. and Ph.D. degrees.  Prior to founding Asymmetrex, he held academic research appointments at the Fox Chase Cancer Center, Massachusetts Institute of Technology, and Boston Biomedical Research Institute.  Dr. Sherley’s professional awards include Pew Biomedical Research Scholar, Ellison Medical Foundation Senior Scholar in Aging Research, and NIH Director’s Pioneer Award.

Session Details: The evolving supply chain for stem cell therapy clinical trials - What's on the near horizon? 24-03-2021, 2:00 pm View In Agenda

Biography: Amanda is currently Director, Product Management at Medidata, a Dassault Systemes Company and is responsible for developing and implementing the strategic direction for the Rave RTSM Product. She has been in the Life Science Industry for more than 20 years and has held multiple roles in the eClinical space as well as pharmaceutical development and manufacturing. Before joining Medidata two years ago, Amanda focused on patient centricity and reducing patient burden as the Sr. Director of Operations at Altavoz, an eCOA startup that was acquired by IQVIA. Prior to that, Amanda was Sr. Director, RTSM at Bioclinica and oversaw RTSM Operations. Amanda is also active in the Healthcare Businesswomen's Association and is the Monitoring and Evaluation Lead for Women in Healthcare Give Back.

Session Details: The Evolution of Trial Virtualization and its Impact on Clinical Supplies 24-03-2021, 1:30 pm View In Agenda

Biography: Ian has 30 years of pharmaceutical industry experience, predominantly within global organisations such as Pfizer and Eli Lilly.  He built his reputation in the commercialisation of numerous brands in a variety of disease areas, and at every stage of the product lifecycle. During his career, Ian has worked closely with supply chain, ensuring accurate forecasting, and getting medicines to patients through the implementation of novel approaches. Before joining Aposave Ian worked in senior roles at two leading Global Clinical Solutions companies.  He provided many leading pharmaceutical and biotechnology companies with successful Comparator Sourcing Solutions which helped successfully deliver their pivotal late phase clinical trials.

Session Details: Aposave Annual Survey of Clinical Supply Professionals – 2020 25-03-2021, 11:30 am View In Agenda

Biography: Sylvain Berthelot is an IRT Technical Solutions Director at Calyx. Sylvain applies innovative solutions to reduce the technology burden imposed on sites, allowing them to focus on what is the most important: patients. Over his 11 years in the industry, Sylvain has managed product strategy for various eClinical solutions such as IRT, EDC, eCOA, and patient sensors. He is now one of the driving forces behind Calyx’s IRT product innovation.

Session Details: The Use of AI/ML in Clinical Supplies Management 24-03-2021, 9:30 am View In Agenda

Biography: Juan is a transformation and service excellence orientated executive with 18+ years’ experience in delivering technology innovation and leading tech-enabled services teams across healthcare and clinical sectors. During his 15 years at Calyx, he has had several roles across Technology R&D and Professional Services and he is currently leading the global IRT and EDC solutions and services teams. Juan’s background in physics and technology together with his passion for business optimization have driven his interest in exploring the evolution and use of Artificial Intelligence to help bring new medical treatments to market faster.

Session Details: The Use of AI/ML in Clinical Supplies Management 24-03-2021, 9:30 am View In Agenda

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Session Details: A Strategic Approach to CTL Logistics 24-03-2021, 1:30 pm View In Agenda

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Session Details: A Strategic Approach to CTL Logistics 24-03-2021, 1:30 pm View In Agenda

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Session Details: Keynote Address: Un-Fogging The Future Of Clinical Trials: Considering Innovation At Every Stage Across Your Clinical Trial Supply Lifecycle 24-03-2021, 9:00 am View In Agenda

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Session Details: Direct to Patient Challenges and Strategy at Sanofi 24-03-2021, 11:00 am View In Agenda

Biography: Mgr Clinical Supply Chain Project Management, Global Clinical Operations, Global R&D, TEVA Hadar has a B.Sc. in Chemical engineering From BGU (Ben-Gurion University of the Negev) & B.Sc. in Polymer engineering from Shankar College of Engineering. Experienced in leading R&D projects in Biopharmaceutical companies. Worked in Perrigo API performing commercial procurement for the API division, then joined Teva in 2011 as Senior procurement manager in R&D performing global procurement. Since joining Clinical Supply Chain group, within TEVA's R&D global clinical operations in 2018, Hadar been leading clinical supply chain projects within a variety of programs and TAs, each one includes multiple clinical trials in different clinical phases, identifying unique challenges and tailoring the project planning accordingly with ongoing risk management in accordance with international guidelines and regulations. She holds various responsibilities including plan efficient drug product demands, coordinating the manufacturing with CMC in all TEVA's manufacturing plants, sourcing of comparators, plan and design the clinical drug packaging and labeling, Design IRT/RTSM system, set-up and oversee maintenance and overall ensure timely delivery within specifications, quality and standards. Hadar initiated and led new approach for P&L at Teva, following by process change.  

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