Clinical Trial Supply Europe 2020

Biography: Three University degrees at the University of Augsburg 5 years of Supply Chain Management responsibilities in automotive electronics industry 12 years of Management responsibilities in multiple roles (SCM, IT, Sales) in the pharma industry Since 2014 Head of Clinical Trial Supply (Sales) of Teva Europe. Offering Teva widest pipeline of pharmaceuticals, placebos and manufacturing for clinical trial purposes. Since 2017 Head of Global Health Tendering of Teva Global. Offering Teva widest pipeline to NGOs, GOs and UN related organizations. Married and father of three beautiful kids

Session Details: Sustaining an operationally streamlined clinical supply chain in light of more complex demands 11-03-2020, 9:15 am View In Agenda

Biography:

Session Details: Panel discussion: Exploring various comparator sourcing models to establish which is most cost effective and ensures the least disruption to your supply chain 12-03-2020, 3:30 pm View In Agenda

Biography:

Session Details: Panel Discussion: The Role of Innovation in Clinical Trial Supply: How Far Are We Ready to Venture? 12-03-2020, 10:00 am View In Agenda

Biography: Susan Carino, MBA, MS, PMP, RAC is a Principal Consultant with Integrated Project Management Company, Inc., (IPM) headquartered in Chicago, IL with offices in Boston, Los Angeles, Minneapolis, New Jersey, Saint Louis, and San Francisco. She has 25 years of industry experience in R&D across multiple therapeutic areas and specializes in project/program/portfolio management and regulatory submissions. She is a founding member of IPM’s Center of Excellence for Quality and Regulatory Affairs. Her career includes roles leading diverse cross-functional program teams engaged in complex product development, clinical trial conduct, regulatory submissions, product launches, and post-approval regulatory commitments to ensure quality and regulatory compliance. Projects she has led include the development and launch of new pharmaceuticals, biologics, medical devices, and in vitro diagnostic tests. Susan is a certified Project Management Professional (PMP) with the Project Management Institute (PMI) and is also certified in Regulatory Affairs (RAC) currently serving as the San Francisco Bay Area Chair for the Regulatory Affairs Professionals Society (RAPS). Susan is a UC Berkeley Extension Advisory Board Member for the Clinical Research Conduct and Management Certificate Program. She is also a course developer and instructor. Susan holds a Bachelor of Arts (BA) in Chemistry from Oberlin College, a Master of Science (MS) from the University of Wisconsin at Madison,

Session Details: View In Agenda

Biography: Anja Haumann is a Business Consultancy Expert at Boehringer Ingelheim. With a Pharmacy degree from University of Munich she now has over 12 years of experience in Clinical Trial Supplies arena.  Anja is a champion for change within a global organization, leading many key innovation projects and delivering fresh new ways to overcome the challenges of the industry. New integrated planning and forecasting  tools, changes in the Quality standard applied to Japanese patient supplies and re-defining (real) Direct to Patient opportunities are just some of the projects successfully delivered by Anja and her team.

Session Details: Clinical Trial Supply Chain – A new opportunity to deliver Investigation Medicinal Products to patients? 12-03-2020, 9:00 am View In Agenda

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.

Session Details: Safeguarding the Progress of Medicine through optimal Comparator Sourcing 12-03-2020, 9:30 am Panel discussion: Exploring various comparator sourcing models to establish which is most cost effective and ensures the least disruption to your supply chain 12-03-2020, 3:30 pm View In Agenda

Biography:

Session Details: View In Agenda

Biography:

Session Details: View In Agenda

Biography: Chris Wallace is Senior Director Global Logistics Operations for Celgene, based in Boudry, Switzerland. At Celgene Chris is responsible for all of Celgene’s logistics and distribution operations worldwide, from the movement of API through to the supply of finished goods, order management, external clinical supply, transportation and import/export activities and inventory deployment. Chris’ team interacts with internal & external manufacturing, distributors, logistics service providers (LSP’s) as well as end customers. Prior to this appointment he worked at Sanofi Genzyme for 10 years in a variety of Supply Chain roles covering distribution operations, supply chain developments including the set-up of new operations and routes to market, new product introductions (NPI), external clinical supply, as well as acting as the supply chain business partner for the Emerging Markets. He has over 30 years supply chain experience in a variety of market sectors quite apart from biologics or pharmaceuticals, e.g. medical device, nuclear fuels, retail, spare parts and automotive. He has a degree from University of Manchester, a postgraduate diploma from University of London and MBA from Aston University in Birmingham. Chris represents Celgene at the EFPIA Supply Chain Group and is an examiner for the UK Chartered Institute of Logistics & Transport

Session Details: View In Agenda

Biography:

Session Details: Navigating the Regulatory landscape surrounding Import/Export 12-03-2020, 10:00 am 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.

Session Details: Panel discussion: Discussing common miscommunications between sponsors and vendors to strengthen collaboration and achieve goals throughout the Clinical Supply Chain 11-03-2020, 3:00 pm View In Agenda

Biography:

Session Details: Panel discussion: Discussing common miscommunications between sponsors and vendors to strengthen collaboration and achieve goals throughout the Clinical Supply Chain 11-03-2020, 3:00 pm View In Agenda

Biography:

Session Details: View In Agenda

Biography:

Session Details: View In Agenda

Biography: Mike has over 35 years of experience in Logistics, with the last 20 years focused on the distribution of pharmaceuticals, biologics and medical devices as a wholesaler and 3PL. For the last 12 years, Mike has been responsible for Quality & Regulatory Compliance within the DHL Life Sciences sector and a member of the GS1 Healthcare Leadership Team. During this period he has been involved in setting up DHL Global Clinical Trials depots for major Global biological and pharmaceutical manufacturers including chilled, frozen and cryogenic studies. Mike is a member and part of the leadership team of GS1 Healthcare and has contributed to the development of new GS1 standards for Clinical Trials. Mike has written a number of articles on regulatory compliance, patient safety and on reducing risks in the GCCMP. He has also presented at a number of healthcare events around the world including the HPCLC, LogiPharma, INTERPHEX Japan, Eyeforpharma Mexico, CLFP China etc. Twitter @MikeMeakinDHL https://www.linkedin.com/in/mike-meakin-8677112

Session Details: Providing agile and compliant solutions in a changing environment 11-03-2020, 11:15 am View In Agenda

Biography: Miki Goetsch is a Director at Inceptua Group, responsible for rapidly growing regions, such as Asia’s developing clinical trial market. Miki is also a board member for Inceptua’s Japan office in Kobe, Shanghai Office in China, and Hong Kong. Miki has extensive experience working with Japanese, American, and European companies, particularly with consulting on how to benefit most efficiently from the opportunities of collaboration between East and West. During her time at Inceptua, Miki has been responsible for ensuring the success and setup of the Japan, China, and UK offices, as well as leading the Operations team in the Clinical Trial Services department. Her main focus is to strategically implement what is best for clients in terms of their needs from EU/US to Asia. Miki is fluent in Japanese and English.

Session Details: Comparator Sourcing: What trials? What Products? What countries? 11-03-2020, 12:15 pm View In Agenda

Biography: Nathan has been with Almac since 2005 and has over 15 years’ experience in Clinical Trial Supply Chain Operations including Cold Chain, Distribution and Project Management and Supply Chain Management. This wealth of experience has given him a passion in delivering excellence in customer service to help reduce timelines and clinical trial complexity for sponsors. In his current position as Label Solutions Manager, he is responsible for providing innovative solutions to product labelling needs for sponsors. Nathan graduated with a Degree in Mathematics from Edinburgh University and has a Diploma in Management and Leadership.

Session Details: Improving Clinical Labelling Through digital transformation 11-03-2020, 2:30 pm View In Agenda

Biography:

Session Details: How to Upgrade Your Clinical Trial Logistics Through a Value-Added Strategic Partnership 11-03-2020, 3:30 pm View In Agenda

Biography: Amaury Jeandrain has a Master’s Degree in Business Engineering with a specialization in supply chain management. After working for a CRO, he joined N-SIDE where he supported the optimization of hundreds of trials from different indications and pharmaceutical companies, providing services ranging from risk-based optimization to clinical trial design and solving drug supply shortage problems. Amaury now leads a group of consultants, focusing on the extension of N-SIDE’s solutions.

Session Details: How to accelerate time to market thanks to end-to-end supply optimization - Case study 11-03-2020, 2:30 pm View In Agenda

Biography: Hasse is currently holding the position of Director of External Clinical Project Management at LEO Pharma, a Danish mid-size pharma company focusing on dermatology. He has almost 20 years of experience in the pharmaceutical industry and has for the past 12 years worked in different position focusing on externalization and outsourcing in both research and development. In his current position, Hasse is working to establish an alternative operating model for outsourcing clinical trials at LEO Pharma and is furthermore responsible for the Clinical Trial Supply and Partnership Management groups within Global Clinical Operations.

Session Details: Panel discussion: Discussing common miscommunications between sponsors and vendors to strengthen collaboration and achieve goals throughout the Clinical Supply Chain 11-03-2020, 3:00 pm View In Agenda

Biography: Ladislav Works as a Senior Team Head, External Operations Management for Global Clinical Supply at Novartis Pharma AG in Basel. Born in Prague, Czechia, he moved to the UK in his early twenties to study International Business and pursue rugby career. After 2.5 years in pharma commercial segment as a Service Delivery Manager at Alliance Sante UK, he moved to clinical supply business and arrived via Fisher Clinical Services sites in the UK and Switzerland at Novartis Pharma AG in Basel in 2012. Before taking up his current role, he was responsible for the overall Novartis internal and external clinical trial distribution. He enjoys looking into new options and technologies that can enable the improvement of patients’ experiences with clinical trials.

Session Details: Fireside chat: Distribution strategies for (sub-Saharan) Africa 11-03-2020, 11:45 am View In Agenda

Biography:

Session Details: Achieving clinical trial supply readiness for small-medium size pharma 12-03-2020, 11:30 am View In Agenda

Biography:

Session Details: Comparing the virtual clinical trial supply model against that of the traditional model: which model best fits your supply chain? 12-03-2020, 9:00 am Panel Discussion: The Role of Innovation in Clinical Trial Supply: How Far Are We Ready to Venture? 12-03-2020, 10:00 am View In Agenda

Biography:

Session Details: Morning refreshments and networking 11-03-2020, 10:15 am A Day in the Life of a Clinical Supply Planner - from Early Feasibility to Detailed Forecasting 11-03-2020, 11:15 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.  

Session Details: View In Agenda

Biography:

Session Details: How digitalization is changing the supply chain and the relationship with the customer 11-03-2020, 3:00 pm View In Agenda

Biography:

Session Details: Strategies to protect the blind in an on-going trial 12-03-2020, 12:30 pm View In Agenda

Biography:

Session Details: Unpacking Various Categories of Innovation within the Clinical Supply Chain: The Janssen Perspective 11-03-2020, 10:45 am View In Agenda

Biography:

Session Details: Morning refreshments and networking 11-03-2020, 10:15 am An overview of the Time Critical global Air Cargo Supply Chain 11-03-2020, 2:00 pm Think Tank 2: Key takeaways from the Time Critical global Air Cargo Supply Chain 11-03-2020, 4:30 pm View In Agenda

Biography:

Session Details: Digital Transformation in the Clinical Trial Supply Chain 11-03-2020, 9:45 am 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: The benefits of partnering with an IRT vendor to develop clinical supply standards: An industry collaboration case study 11-03-2020, 3:30 pm View In Agenda

Biography:

Session Details: The benefits of partnering with an IRT vendor to develop clinical supply standards: An industry collaboration case study 11-03-2020, 3:30 pm View In Agenda

Biography:

Session Details: Employing Technology to Better Manage Your Supply Chain 12-03-2020, 12:00 pm View In Agenda

Biography:

Session Details: How Thoughtful Protocol Design Can Reduce Comparator Sourcing Cost, Timelines, Complexity & Risk 12-03-2020, 10:30 am View In Agenda

Biography:

Session Details: Beyond Brexit: What Now for Clinical Supply Services across Europe? 12-03-2020, 9:30 am View In Agenda