Clinical Trials Supply Chain Logistics Global Congress 2015 Europe
Clinical Trials Supply Chain Logistics Global Congress 2015 Europe
Paradigm Global Events are proud to present the Clinical Trials Supply Chain Logistics Global Congress 2014 Europe.
The pharmaceutical industry began globalizing clinical trials about 15 years ago and; lured by lower research expenses and rapid patient recruitment half of all clinical trials are conducted offshore and in more developing countries than ever before, profoundly increasing the complexity of supply chain logistics. Some of the forces affecting the industry include access to new markets and patients, regulatory standards for clinical trials supply, supply chain security and other technology for developing and testing medicines.
“The global market for clinical trial supply and logistics services will expand by six percent in 2014, with revenue growth to 2023.??? (Visiongain’s Clinical Trials Supply and Logistics: World Market Outlook 2014 – 2023). Along with this opportunity are challenges and hurdles for the pharmaceutical industry to overcome.
Clinical Trials Supply Chain Logistics Global Congress 2014 – Europe provides a unique platform for an intimate & interactive knowledge sharing and convergence of top tier government, pharmaceuticals, biopharmaceuticals, as well as regional and local manufacturers to discuss the driving macroeconomic factors, policies and issues that will steer the clinical trials supply chain logistics industry.
Gain The Latest Insights on:
- Economic Outlook: Supply Chain Logistics to Steer Clinical Trials
- Globalization of Clinical Trials: Opportunities and Challenges
- Good Distribution Practice (GDP): Increase Demand for Clinical Trials Logistics
- Costs Explained: Maintaining Safety and Efficacy of Drugs
- Security Measures: Holistic Supply Chain Security and Reliability
- Case Study: Challenges in Clinical Trials Supplies for Smaller Companies
- Vendor Management: Develop and Maintain a Successful Vendor Relationship
- Direct – to – Patient (DTP) Distribution: Effectiveness for Multi-Location Trials
- Cool Logistics: Ensure Cold Chain Adherence Downstream and Solid Supply Partnership
- Into the Future: Challenges in the future and staying Ahead of the Game
Who Should Attend:
Presidents, Heads / Chiefs, Directors, VPs and Managers of:
- Clinical Supply Chain
- Clinical Supply Specialist
- Clinical Operations
- Clinical Coordination
- Clinical Supply Planning
- Clinical Materials
- Clinical Logistics / Distribution
- Clinical Purchasing
- Clinical Packaging / Labelling
- Clinical Manufacturing
- Clinical Technical Specialist
- Comparator Specialist / Sourer
- Vendor Management / Contracting
- Lead Processes
Alena Bolazeva, Clinical Supply Operations, Regional Logistics Specialist, Bristol-Myers Squibb
Since joining Bristol-Myers Squibb in 2012 as Regional Logistics Specialist, Alena is supporting management of EMEA / ASIAPAC warehousing infrastructure for Clinical Trials and Expanded Access Programs in compliance with GMP, GSP, GDP and local country regulations.
Alena ‘s responsibilities in optimization of warehousing and distribution activities include distribution planning, vendor selection & qualification processes, monitoring & evaluation of vendor performance, global process improvement, issue resolution and CAPA management. She also contributes to establishing and monitoring of outsourced activities at EU Regional Hub.
Within CSO Regional Logistics, Alena is a Subject Matter Expert in storage and shipping of hazardous materials (Dangerous Goods, Cytotoxics), and in SAP (SD, MM).
Alena holds a Master degree in Supply Chain Management and has 13 years experience in various positions in Customer Service, Demand and Operations within chemical, medical devices and pharmaceutical industries.
Michele Ingravallo is responsible for driving and managing the performance of the Alcura organisation / Brand and businesses related across all the countries and divisional operation, and providing the strategic direction and support to the local operations. Also he is responsible for driving the business innovation process for all the business brands in the pharmaceutical wholesale division of Alliance Boots. He possesses European pharmaceutical experience and he has developed the strategic direction for healthcare and specialised services in the European and Chinese Markets. Michele is a graduate professor in Science, Technology and Maths. He is an MBA Candidate from the University of Bradford – School of Management. Within Alliance Boots, he has held a number of senior positions in the last 9 years where he has developed a series of clinical services for Pharmaceutical Manufacturers, hospitals and CROs. Prior to Alliance Boots, Michele held a number of senior roles in reengineering and consultancy positions in Coca Cola Company, and within the Telecommunication, Bank and the Oil sectors.
Alex trained as a Chemist and has 27 years experience in the Pharmaceutical industry in a wide variety of roles. Alex spent the initial part of his career as a process development chemist working on wide range of projects from early development through to technology transfer and commercial establishment. During this period he also worked in pilot plant chemical manufacturing. He has experience in project management and setting up and managing global commercial stability programmes.
For a significant period Alex worked in a number of quality roles in both commercial and R&D environments. His experience in quality ranges from managing QC laboratories, Quality Management of commercial API manufacture, QA support of investigational medicinal products and Quality Management of API supply to development.
Alex recently managed the Pharmaceutical Development Sourcing group in Astrazeneca which has responsibility for managing all ‘CMC’ activities done externally to support drug development.
Alex is currently Senior Director, Supply Chain Management in AstraZeneca. This group plans and manages the end to end supply chain of materials during the drug development phase from API raw materials to final labelled packs and their distribution to Clinical study centres globally.
Dr. Wolfgang Eglmeier studied biology. He obtained a PhD in neuroscience in 1988. Wolfgang is working in the area of clinical development since 1988. He started as a CRA, monitoring studies in central and Eastern Europe. In the early 90s he was with a software company, which developed data management and remote data entry software. Since 1993 he holds several management positions, mainly on an European level, in the pharmaceutical industry, biotech companies and CROs (e.g. Head Clinical Research Central Europe at Novo Nordisk, Global Head Clinical Development at Paion, Head Clinical Operations Germany at Grünenthal). He has more than 25 years of experience in all aspects of clinical development, like project and study planning, performing and management of trials, data management and reporting.
After 24 years in pharmaceutical industry, biotech and CROs he returned to academia in September 2012. He heads now the ZKS-UW/H (centre for clinical trials University Witten/Herdecke).
Ian Morgan, General Manager, Sharp Clinical Services
Ian has worked in the pharmaceutical industry since 1978.
Before moving into the contracting environment Ian worked for Bayer Schering Pharmaceuticals, with headquarters in Germany. During his time at Bayer Schering he worked within Quality and Manufacturing.
Prior to his recent appointment at Sharp Clinical Services, Ian was responsible for the implementation of the Clinical Trial business for Piramal Healthcare.
Previous roles include Customer Service Director at Fisher Clinical Services, a lead provider in the Packaging, Distribution and IVRS services of Global Clinical Trials.
He has also worked at Quintiles Sciences based in Edinburgh, a clinical contract organisation. At Quintiles Ian was responsible for the Production and Distribution activities associated with Global Clinical Trials
Prior to undertaking the assignment with GS1 Global Office to facilitate the development of process and technical Traceability standards, Janice was a senior Manager with responsibility for eBusiness for Johnson & Johnson’s UK Medical Device and Diagnostic companies. This role continued a common thread throughout her career of roles at various stages of the extended supply chain with the trend of moving downstream closer to the external customer. She has held a number of positions with medical device industry associations: ABHI and Eucomed.
Her MBA dissertation (Hypothesis: Medical Device manufacturer applied or embedded RFID has benefits to Patient Safety over existing Auto-ID technologies, e.g. Bar Codes) received critical acclaim.
- Engineering Degree in Automation Technology at Flensburg University (FH)
- Digital Six Sigma “Green Belt???
- ISMA Leadership program at Georgetown University
- 16 years within Industrial Loss Prevention & Security
- Director Global Supply Chain Security, Business Resilience & Regulatory Programs
- BoD Member of TAPA EMEA since 2003
- TAPA EMEA Chairman 2006 / 2007 / 2008 (partly) / 2009 / 2010 / 2011 / 2012 / 2013 / 2014
- Industry Rep within the European Commission LandSec and ITS initiatives.
- Industry Rep within EUROPOL, INTERPOL & TISPOL Organizations
Internationally-recognised leader in clinical research championing a systemic approach to transforming the infrastructure of conducting clinical research globally; and a “culture of conscience” in human research, focusing on prevention of harm and quality improvement beyond regulatory compliance.
Influential in enhancing research processes domestically and internationally, including processes for accreditation of research sites and human research protections programs, certification of physician investigators, and the formation of the an industry organization for Contract Research Organizations.
- Current Boards of Directors: SAFE-BioPharma and ACRES.
- Senior Scientist at the Institute for Health Policy and Associate Professor of Anesthesia, Massachusetts General Hospital, Harvard Medical School.
- First Director, Office for Human Research Protections (OHRP) at U.S. Department of Health and Human Services; created Program for International Activities within OHRP.
- Consultant to World Health Organization (WHO) to coordinate and strengthen global mechanisms for ethical conduct of human research; and engaged with World Medical Association (WMA) on revisions of the Declaration of Helsinki.
- Government and Multi-lateral Committee service: World Bank, WHO, Hastings Institute, Institute of Medicine (IOM), National Science and Technology Council.
- Editorial Boards for 8 peer-review journals.
- Faculty: Harvard Medical School, Boston University School of Medicine, Vienna (Austria) School for Clinical research; guest lecturer at Rockefeller University, UCSF, Emory, Wayne State, CHoP.
- Keynote speaker at Conferences across Europe, Latin America, and Asia.
RECENT PUBLICATIONS AND PRESENTATIONS related to ACRES
- Interviews: Life Science Leader, CenterWatch, and Clinical Researcher
- Articles: International Clinical Trials, among others
- Peer-reviewed: Annual Reviews of Pharmacology and Toxicology
- Clinical Therapeutics
- Book Chapter: Human Subjects Research Regulation: Perspectives on the Future
- (MIT Press 2014)
- Presentations: Annual Global and domestic conferences including DIA, ACRP, and
- Tufts Center for the Study of Drug Development; as well as international
- regional conferences in Asia, Europe, and Latin America.
- Complete list of Publications and Presentations available upon request.
Johan Leunen, Cargo Marketing Manager – Sales & Marketing, Brussels Airport Company
Johan Leunen initiated his career at the airport in 2000. Over a period of 10 years, Johan built experience and earned his credentials in the cargo handling industry. He first started working in the operations before moving to Customer Support and, later on, holding the function of Sales Manager.
Johan also enriched his career as Business and Market Development Manager in the Forwarding Industry.
On May 1st, 2012, Johan joined Brussels Airport Company as Cargo Marketing Manager. Johan’s main responsibilities include offering operational support to the cargo airlines and assisting in their development at Brussels Airport. Furthermore, he also plays a key role in attracting new carriers to Brussels Airport.
John Murray, Planning & Capability Lead, ASTRAZENECA
John trained as a Chemical Engineer and has worked for 15 years in the pharmaceutical industry in a wide variety of roles. He has international experience of working in a number of countries including UK, USA, Singapore, Puerto Rico and Sweden.
He spent the initial part of his career as an R&D Process Development Engineer. His experiences covered a broad range of Drug Substance related activities from early development in the laboratory to pilot plant and commercial manufacture scale-up. He then moved to a technical support role in Commercial Operations supporting in-line products including day- to- day support, significant process improvements and installation of new manufacturing equipment.
More recently, John gained significant experience as a Project Manager, leading CMC activities (process development, supply, regulatory) for drug development projects. This includes a diverse oncology / infection portfolio ranging from preclinical to late stage development. As a member of Global Project Teams, he helped to shape the overall drug development strategy and ensured the CMC strategy aligned with this.
John is currently Director, Planning and Capability, in R&D Supply Chain. This team manages global planning activities, Supply Chain systems, business processes and metrics for the integrated (internal / external) Supply Chain.
Mike Isles, Executive Director, THE EUROPEAN ALLIANCE FOR ACCESS TO SAFE MEDICINES
Mike is Executive Director of the European Alliance for Access to Safe Medicines (www.eaasm.eu). The EAASM is a panEuropean patient safety organisation, bringing together all concerned with eliminating falsified medicines from the supply chain. With patient safety at its heart, the EAASM is also currently championing positive change in the area of unlicensed/off-label usage of medicines which is severely compromising patients welfare and rights in certain medical conditions and situations. Mike also represents the Secretariat for the Alliance for Safe Online Pharmacy (www.asop.eu). With over 30,000 fake pharmacy websites targeting Europe on any given day, this multisectoral organisation’s mission is to enable patients to buy their medicines online safely – where it is legal to do so. With over 50 participants involving many key internet stakeholders, its aim is to produce concrete voluntary actions that will make a real difference and ultimately benefit the health of patients and the wealth of nations. The estimated cost of counterfeit medicines to the European community is between €1-3bn per year. Mike is also European Medicines Partnership Director for International Health Partners (www.ihpuk.org), a UK charity whose Queen’s Award for Enterprise for continous Innovation in 2011, recognises the tremendous humanitarian work sourcing donated quality medicines from the pharmaceutical industry and coordinating delivery via secure supply chain solutions to disaster-struck areas in close liaison with NGOs. Currently, Mike is working to expand the IHP network so that a European access to medicines platform can be developed to further harness the successful business model across a pan European landscape. Mike is also an Associate of the Ceuta Capability Group (www.ceutacapability.com) a consultancy that provides outsourced management expertise in healthcare. Mike’s professional background is in pharmaceuticals, where he held senior management and director positions covering sales, marketing, commercial and supply chain in a 32 year career.
08:00 – 09:00 – Registration & Coffee
08:45- 09:00 – Chairperson’s Opening Remarks
09:10 – 10-00 – Beyond Silos: How Systems Thinking Will Save the Pharmaceutical Industry
Dr. Greg Koski, PhD, MD, President and CEO, Alliance For Clinical Research Excellence and Safety (ACRES), Senior Scientist, Mongan Institute for Health Policy, HARVARD MEDICAL SCHOOL
10:00 – 10:50 – Direct – Patient (DTP) Distribution: How Effective Is This Approach in Multi – Location Trials?
- What market trends are driving companies to the DTP distribution method?
- What are the advantages and challenges of patient home delivery?
- How has the rise of the orphan drug market increase opportunities for direct – to – patient logistics firms and and how has this steered the logistics industry?
Joaquin Campbell, Head, Global Clinical Trial Support, Alliance Boots
10:50 – 11:30 – Morning Break & Networking
11:30 – 12:20 – Packaging and Distribution Management of High Recruiting Flu Vaccine Clinical Study
- Study Design
- Removal of Expiry dates from IMP
- Interaction with IRT system and Product Release
- Distribution set – up and Management of Cold Chain Process
- Study Close Out and Documentation
Ian Morgan, General Manager, Sharp Clinical Services
12:20 – 13:10 – GS1 Standards: Foundation to Regulatory Compliance and Improving the Efficiency of Your Supply Chain
- Daily interaction is natural and unnoticed
- The latest in GS1 developments
- Enabling regulatory compliance, supply chain security and patient safety
Janice Kite, Traceability Director Healthcare, GS1
13:10 – 14:10 – Networking Lunch
14:10 – 15:00 – Life After the Falsified Medicines Directive – Opportunities and Threats
Mike Isles, Executive Director, The European Alliance for Safe Access to Medicines
15:00 – 15:50 – Security Measures: What Are Some Of The Measures Taken by the Supply Chain to Provide Services in a Safe Manner With High Security and Reliability
- An overview of TAPA as an organisation
- The members and their fight against crime
- What is holistic supply chain security and how can this prevent the three buckets of threats
- Cargo theft and diversion, counterfeiting, and Economically Motivated adulteration
- How collaboration amongst supply chain partners improve security in the supply chain
Laurence Brown, Executive Director, Transported Asset Protection Association EMEA
15:50 – 16:30 – Afternoon Break & Networking
16:30 – 17:10 – Planning Ahead: How Timely and Accurate Forecasting and Supply Planning Affect the Supply Chain and How Can Companies Avoid Supply Delays?
- How can companies integrate strategies and technology to ensure supply reaches the location in a timely and safe manner?
- How to keep supply planning strategies in line with increasingly complex clinical trial designs?
- How to harness effective forecasting to estimate wastage, overage and supply?
John Murray Brown, Planning & Capability Lead, ASTRAZENECA
17:20 – 18:10– Into the Future: What will change in the future for Clinical Trials Logistics and How Should Companies Evolve to Stay Ahead of the Game?
- How the balance of power is shifting along the clinical supply chain and what must companies look out for?
- What technologies and strategies can we expect to see on the horizon?
- Will these technologies and strategies forecast a bright future?
- Joaquin Campbell, Head, Global Clinical Trial Support, Alliance Boots
18:10 – Chairperson’s Closing Remark & End of Day 1
08:00 – 08:45 – Registration & Coffee
08:45 – 09:00 – Chairperson’s Opening Remarks
09:00 – 09:50 – Economic Outlook: How Can Supply Chain Logistics Steer the Clinical Trials Industry and What Must Companies Do to Remain Competitive?
- How can the outsourcing of clinical trial activities to clinical research organisation (CROs) improve the supply chain logistics for clinical trials?
- How economic prosperity in Asia impacts the focus of clinical trials supply chain logistics into the region?
- How can the West compete with Asia or would it make more sense to continue driving clinical trial operations in Asia and how can supply chain logistics facilitate the development of clinical trials in Asia?
Dr. Wolfgang Eglmeier, Head ZKS-UW/H (Centre for Clinical Studies Univeristy Witten / Herdecke), Faculty for Health, University Witten / Herdecke
09:50 – 10:40 – Vendor Management: What Does It Take to Develop and Maintain a Successful and Save Vendor Relationship?
- Importance of negotiating and drafting clear agreements to avoid pitfalls
- What are some of the ways to establish a mutually agreeable approach for both parties?
- How can you retain sufficient control with effective feedback channels and data monitoring?
Alena Bolazeva, Specialist, CSO Regional Logistics – Research & Development, Bristol – Myers Squibb
10:40 – 11:20 – Morning Break & Networking
11:10 – 11:50 – Cool Logistics: What Efforts Should Be Taken to Ensure Cold Chain Adherence Downstream and Solid Supply Chain Partnerships?
- What are some of the ways to mitigate risk throughout the cold chain to ensure products arrive in peak condition?
- How will the strengthening of manufacturer and logistics provider ensure patient safety?
Johan Leunen, Cargo Marketing Manager – Sales Marketing, Brussels Airport Company
11:50 – 12:40 – Global Clinical Trial Landscape: How Does the Globalisation of Clinical Trials Increases the Complexity of Supply Chain Logistics?
- With most clinical trials being conducted in emerging markets, can this address the escalating costs of drug development and market competition?
- How can companies address wide spread differences from country to country in customs knowledge, experience and laws which may affect quality standards in the clinical trials universe?
- With the evolving regulatory requirements in developing countries, how can clinical trials be conducted especially with the increasing protection of research subject?
- Alex Robertson, Senior Director, Supply Chain Management, AstraZeneca
- Dr. Wolfgang Eglmeier, Head ZKS-UW/H (Centre for Clinical Studies University Witten / Herdecke), Faculty for Health University Witten / Herdecke
12:40 – 13:40 – Networking Lunch
Post Conference Workshop:
13:40 – 17:10 – Vendor Management – Outsourcing in Clinical Trials
- Addressing the sponsor – vendor relationship
- Analysis of critical aspects
- Uncovering best practices
- Management of costs
- Dr. Wolfgang Eglmeier, Head ZKS-UW/H (Centre for Clinical Studies University Witten / Herdecke), Faculty for Health University Witten / Herdecke
17:30 – Chairperson’s Closing Remark & End of Conference
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