Clinical Trial Supply Europe - A Virtual Conference

Biography: Ingrid brings over 20 years of Supply Chain experience, all at Johnson & Johnson. In these roles, she managed positions of increasing responsibility in Production Planning, Chemical Warehousing, Logistics, Product Ownership, Business Process Management and also Continuous Improvement. Today, she’s leading the Strategy and Continuous Improvement team in Janssen R&D’s large molecule development and supply organization BioTherapeutics Development and Supply (BTDS).  With this team, she supports the organization in different cross-functional processes and projects and the further deployment of Continuous Improvement. Ingrid holds an MBA from the Louvain School of Management in Belgium and a Master of Bioscience Engineering from the Catholic University of Leuven, also in Belgium. She’s also a certified Lean Black Belt, Six Sigma Green Belt and SCOR Professional.

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

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, 1:30 pm 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 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

Biography: Passionate about clinical trial supply chain and clinical trials in general, Bernard started in a Phase I Clinic, developing analytical methods and combining both his Chemistry & Pharmaceutical degrees. After that it was 25 years of anything touching clinical trial supply chain: starting in an IRT department, then moving to a manufacturing environment, followed by outsourcing, heading a global clinical supplies unit of a Big Pharma company, 2 years as QA, and finally started 14 years ago at PPD, now part of Thermo Fisher Scientific. At PPD, part of Thermo Fisher Scientific, Bernard started on the operational side, but is now on the support side, ensuring the department is ready for growth, from an improvement, compliance & resource perspective

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 25-03-2021, 1:00 pm 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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Biography: After graduating in business management, Thierry Gillard has been involved in logistics and supply management for over 20 years. He made his first step in clinical packaging and distribution in 2007 with a major CMO involved worldwide in clinical supplies management. During 10 years with this CMO, he has been contributing to the set-up of a wide array of clinical studies and packaging designs from phase I manually distributed studies, to large Phase III IRT controlled studies, including supply forecasting and Campaigns management. As a Senior Clinical Supplies Manager for Santhera Pharmaceuticals in Switzerland since 2017, a company specializing in neuro-ophthalmological, neuromuscular und pulmonary conditions, widely relying on external vendors, he is in charge of the selection, qualification and oversight of CMO’s providing clinical packaging, distribution and IRT services.

Session Details: Managing the collaboration with vendors: Opportunities and challenges 24-03-2021, 11:00 am View In Agenda

Biography: Francisco (52) is a certified Non-Executive Director, Economic Analyst & MBA with 28 years of experience in International Trade & Air Freight Transportation, specialized on Temperature Controlled Shipments of Pharmaceuticals. Currently, at the International Air Transport Association (IATA) holding the position of Cargo Specialist Manager for the EU, UK, Turkey, Ukraine, Israel, Russia & CIS countries being responsible for delivering IATA’s Cargo Agenda in the Region and supporting the air cargo industry adoption and implementation of IATA´s global certification program for the proper air transportation of pharmaceuticals: being Instructor for the IATA’s Diploma of Air Cargo Transportation of Pharmaceuticals including courses of Temperature Control Risk Management, Temperature Control Air Cargo Operations, Audit and Quality for Temperature Controlled Shipments with more than 350 trained industry professionals globally. Additionally acting also as IATA`s Auditor & Consultant on pharma temperature control projects at Airports in Europe, US, Canada, Latin America and South Africa for Airlines, Airports´ Handling & Ramp Operators, Freight Forwarding Companies and Trucking Companies. Before joining IATA, Francisco owned and managed his own company for 15 years dedicated to Freight Forwarding, Customs Brokerage and Int´l Trade Consulting, and worked for companies like Panalpina and UPS (Supply Chain).

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 to the Biopharmaceutical Industry. Vanessa started her career as a research associate at Scotland Yard. Subsequently she worked for leading CROs  and with some of the largest biopharmaceutical and Biotechscompanies to provide innovative solutions. She has extensive experience in drug development from Preclinical to registration and commercialization strategies and has secured product registration for several orphans and first in class drugs. She has a PhD in Cardiovascular Genetics from UCL, an MBA from Cambridge and Masters in Market Access from University m University of Lyon.

Session Details: The role of clinical trial supplies in pandemic shaped protocols 24-03-2021, 2:30 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: 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.

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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 24-03-2021, 10:00 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, President, and CEO of Massachusetts stem cell biotechnology company Asymmetrex, LLC. Asymmetrex develops and markets technologies for advancing stem cell medicine, including the first method achieving specific and accurate certification of the dosage of therapeutic tissue stem cells, called kinetic stem cell (KSC) counting. Asymmetrex’s kinetic stem cell counting platforms are also used to optimize manufacturing of therapeutic stem cells and for evaluations of drug effects on tissue stem cells. 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 over 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 Abacus Medicine Pharma Services 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 has acquired extensive experience in IRT through various roles within Calyx over his 10+ years in the company. It allows him to grasp where IRT can make a difference based on the protocol design, and accordingly advise clinical trial teams what solution is the most suitable for each trial. Sylvain is a key member of the Calyx IRT product core team, acting as an advocate for end-users, as well as sharing his vision with the team to push the boundaries of IRT.

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

Biography: Joan is a transformation and service excellence oriented executive with 19+ years’ experience in delivering technology innovation and leading tech-enabled services teams across healthcare and clinical sectors. During his 16 years at Calyx, he has had several roles across eClinical Technology R&D and Professional Services. He is currently leading the global IRT and EDC solutions and services teams. Joan’s experience and background have driven his pursuit to find innovative ways to maximize the value Calyx’s products and services delivered 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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Biography: Luca brings over 20 years of experience in Operations and Supply Chain Management in 2 major multinational USA based corporations in the Consumer and Pharma business. In these roles, he managed positions of increasing responsibility in Engineering, Maintenance, Production, Logistics, IT, Operations and General Management. Today, he’s leading the Janssen Clinical Supply Chain organization and is responsible for all activities required to plan, source, make and distribute clinical supplies for all on-going clinical trials at Janssen. Luca holds a Master of Science degree in Mechanical Engineering from the University of Rome Tor Vergata in Italy.  In addition to this, he holds Six Sigma, Lean and APICS certifications.

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: 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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Biography: Natalie joined World Courier in 2018 as Business Development Manager, and is part of the Global KAM program.  With over 18 years of experience within the specialty transport and logistics industry, Natalie has developed an in depth knowledge of regulatory requirements and cool chain through her operational background, and is able to support her clients in designing bespoke logistics solutions to cater for their exacting needs.

Session Details: What is the true cost of quality? Measuring certainty and mitigating risk in the clinical supply chain 24-03-2021, 12:30 pm View In Agenda

Biography: Rita Meirinhos has been working in clinical trial supply chain optimization with N-SIDE for the past 5 years. Rita supported the optimization of multiple trials and programs from different therapeutical areas and pharmaceutical companies. Rita has been providing services that tackle different challenges of the clinical supplies, ranging from clinical trial design, strategic planning and risk management.

Session Details: How to Efficiently Reduce Sourcing Costs and Drug waste? 24-03-2021, 2:30 pm View In Agenda

Biography: Clinical Trial supply Manager CTS systems and innovation, Clinical Trial Supply Global R&D Merck Healthcare KGaA Fan has worked in pharma in the clinical trial supply area for 10 years, focusing on systems and innovation topics, e.g. IRT and simulation for 3 years at Merck in Darmstadt, Germany. She is currently leading a specialist team on IRT standardization and supply strategy optimization and collaborates with service partners to investigate innovative ways to support clinical trial supply strategy and implementation

Session Details: How to Efficiently Reduce Sourcing Costs and Drug waste? 24-03-2021, 2:30 pm View In Agenda

Biography: Vincent is a life-long operations and business management professional with a 24-year career across construction, environmental science, technology and pharmaceuticals. Vincent provides leadership at the nexus of building relationships, innovating technology and driving collaborative efforts to design, build and grow systems of all types and complexity in the real and digital in the service of patients and clinical trials.

Session Details: Temperature Monitoring: Using 2-way Integrations to Reach Beyond just the Shipment Level 24-03-2021, 12:30 pm View In Agenda

Biography: Philip is an experienced international pharmaceutical executive, having worked for large pharmaceutical companies, biotechnology firms and CROs. He has worked in the industry for 30 years in both International roles and country management. Philip has worked in Europe, USA, Australia, Japan and China where he has resided for the last 14 years. Philip’s extensive knowledge of product development, clinical trials and international business will give some unique insights into the strategies that should be utilized for successful comparator sourcing in the Chinese market.

Session Details: Clinical Trials and Comparator Sourcing in China 24-03-2021, 1:30 pm View In Agenda

Biography: Chan Liu, Comparator Strategist Lead, Pfizer, and Master in Pharmaceuticals, First Military Medical University-Nan Fang Hospital, is a leading expert in clinical supplies across the Asia region, incl. China. Chan is managing sourcing projects for both local, regional and global studies and is responsible for the planning and forecasting of comparator needs, coordination of regulatory reviews, confirmation of label requirements, etc. Furthermore, she has the responsibility for the management of all Pfizer vendors in the region

Session Details: Clinical Trials and Comparator Sourcing in China 24-03-2021, 1:30 pm View In Agenda

Biography: Daniela Duffett is the European Solutions Consultant at Suvoda, based out of our Barcelona office. She consults with clients and prospects, delivering presentations and demonstrations, while acting as a Subject Matter Expert on Suvoda’s solutions. She started at Suvoda three years ago on the Project Management side of our Services Delivery organisation, so can impart her hands-on delivery experience & knowledge.  

Session Details: Enabling Patient-focused Trails with Decentralized eClinical Solutions 24-03-2021, 10:30 am View In Agenda

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Session Details: Enabling Patient-focused Trails with Decentralized eClinical Solutions 24-03-2021, 10:30 am View In Agenda

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Session Details: S-Clinica Insights: Site Challenges and the Impact on Clinical Supply Planning Session Reserved for S-Clinica 25-03-2021, 10:00 am View In Agenda

Biography: Thomas has been an instrumental figure in the DHL Life Sciences & Healthcare sector for over 14 years. As a Global Sector Team member, Thomas is now leading the cross-divisional development of clinical trials logistics offering. He recently co-authored the white paper “Pandemic Resilience” and is central to business development efforts in DHL’s Global Task Force to support distribution readiness for global vaccine manufacturers, governments, and NGOs. Thomas is also leading the company’s COVID-19 vaccine distribution strategy. Previously, Thomas was Sales Leader for EMEA, including Emerging Markets in the Middle East and Africa, where he had responsibility for an extensive portfolio of pharmaceutical and medical devices companies. Before joining the DPDHL Group, Thomas spent several years in FMCG and specialty chemicals industries, where he held roles in supply chain and customer services. Thomas holds a Master’s degree in Physics from the WWU Münster, Germany

Session Details: Shifting gears: Accelerating clinical trial logistics in 2021 & beyond 24-03-2021, 11:30 am View In Agenda

Biography: Vanessa is the MD of Clinical Services International (CSI) a leading provider of Clinical Trial Supplies to the Biopharmaceutical Industry. Vanessa started her career as a research associate at Scotland Yard. Subsequently she worked for leading CROs  and with some of the largest biopharmaceutical and Biotechscompanies to provide innovative solutions. She has extensive experience in drug development from Preclinical to registration and commercialization strategies and has secured product registration for several orphans and first in class drugs. She has a PhD in Cardiovascular Genetics from UCL, an MBA from Cambridge and Masters in Market Access from University m University of Lyon.

Session Details: The role of clinical trial supplies in pandemic shaped protocols 24-03-2021, 2:30 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

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Anna Gollmann is part of a team of Global Project Managers and Directors to define, develop and deploy innovative strategic supply chain solutions to increase efficiencies, reduce waste, improve patient access and reduce lead times for clinical supply provision and include programs such as Demand Led Services (DLS) and Direct to Patient (DTP).

She has worked in various clinical supplies roles for 14 years.

Session Details: Title: Harnessing Patient Demand to Gain Clinical Supply Flexibility and Efficiency 25-03-2021, 10:00 am View In Agenda

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Session Details: S-Clinica Insights: Site Challenges and the Impact on Clinical Supply Planning Session Reserved for S-Clinica 25-03-2021, 10:00 am View In Agenda