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SPEAKING FACULTY

Jan-Pieter Kappelle, Senior Director, Clinical Trial Supplies, UCB Didier Basseras, VP Global Head Clinical Supply Chain Operations, Sanofi

Henk Dieteren, Clinical Supply Logistics Expert, Associate Director, Grunenthal Niklas Mattsson, Lead Comparator Sourcing and Planning, Merck

Alex Robertson, Senior Director, Supply Chain Management, AstraZeneca

Clive E Badman OBE, VP Pre-Competitive Activities, GSK Henk Mollee, Senior Director CTM Manufacturing, European Technology Division, Astellas

Gary Cunnington, Global Head of Respiratory Clinical Supplies, Boehringer Ingelheim Rolf Baumgartner, Head Clinical Label Management, Roche

Andrea Zobel, Global Head Product Management, Clinical Trial Supplies & Logistics, Parexel Maria Kuthning, Global Head, Clinical Trial Supplies, Boehringer Ingelheim

Dr. David Gilliland, Director, Clinical Supply Operations, Daiichi Sankyo Elnouaman Samadi, SAP Consultant, Hikma Pharmaceuticals

Janet Smith, Associate Director RTSM, Janssen Tania Snioch, Director Healthcare, GS1

Eric Leire, CEO, DanDrit Fan Feng, Clinical Trial Supply Manager, Merck

Anuja Shukla, Clinical Supply Program Manager, UCB Pedro Pala, Clinical Trial Supply Manager, Bial

Tibor Kovacs, Key Account Manager, PharmaRoad Alexandra Tsioni, Clinical Supply Chain Study Lead, Teva

Pieter J. Klaassen, Clinical Trials Operations Manager, NHS Rachal Narrie, Senior IxRS and Medication Manager, Bayer Laurence Ricatte, Clinical Logistic Manager, Sanofi Pasteur

Rebecca Hamilton, Senior Manager, Clinical Supply, Shionogi Julia Kaestel, Senior Clinical Supplies Project Manager, AbbVie

Dr Piyush Gupta, Associate Director, Business Development, GNH Elizabeth Cooper, Supply Chain Operations Manager, Clovis Oncology Angelique van den Berg, Senior Manager Clinical Supply Chain, Amgen

Ramon Lopez Bertrán, Clinical Research - Medical Affairs Manager, Thrombotargets Europe Chris Huang, Director, Life Sciences Product Strategy, Oracle Health Sciences

Dr Ir Peter Slikkerveer, CEO, MpicoSys Solutions B.V.

LEAD SPONSOR

FEATURED SPONSORS

SESSION SPONSORS

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Clinical Trial Supply Europe 2017 Day One | 15th March 2017 Barcelona, Spain

07:45

Registration and refreshments sponsored by:

08:10

Chair’s opening remarks Jan-Pieter Kappelle, Senior Director, Clinical Trial Supplies, UCB

08:15

KEYNOTE PRESENTATION Outlining the current challenges and innovations in clinical trial supply from manufacture to patient

Highlighting persistent operational challenges in the clinical supply process to pinpoint areas for essential improvements

Investigating the differing approach to clinical supplies for companies large and small to overcome challenges associated with each

Discussing the role of your vendor in your clinical supply to build effective relationships and ensure

Assessing the rise in technology innovation to determine what this could mean for you supply chain now and in years to come

Recognising current trends to provide a roadmap for the future of clinical supply Henk Mollee, Senior Director, CTM Manufacturing, Astellas

08:45

Session Reserved for World Courier

09:15

INTERACTIVE DEBATE Which area of you clinical trial supply should receive the priority for funding?

Identifying the options for the aspects of clinical supply which should receive priority funding

Highlighting the benefits to be gained through increasing funding in each area

Considering the impact diminished funding would have on each area to determine where financial backing is crucial

Exploring arguments for priority funding to determine which area has greatest importance Niklas Mattsson, Lead Comparator Sourcing and Planning, Merck Didier Basseras, VP Global Head Clinical Supply Chain Operations, Sanofi Eric Leire, CEO, DanDrit

Lanyard Sponsor:

AGENDA HIGHLIGHT

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09:45

Exploring how clinical supply innovations can contribute to better patient enrolment and efficient drug management at the clinical site

Highlighting the current clinical supply world for patients and clinical sites seen by a leading CRO

Pinpointing clinical supply at a CRO and innovations enabled through technology and logistics departments

Improving processes at the clinical site by IRT, mobile apps and drug packaging solutions and seeing how they contribute to provide an audit trail of the supply chain

Investigating patient centric solutions through the use of home deliveries, innovative drug packages and wearables

Showcasing case studies and first experiences Andrea Zobel, Global Head Product Management, Clinical Trial Supplies & Logistics, Parexel

10:15

Morning refreshments and networking

Clinical Supply Operations Clinical Supply Technology

10:45

Defining waste in clinical supply and developing strategies to optimise supply, drive efficiency and reduce waste

Benchmarking for clinical supply against commercial supply chain for waste measurement and definition

Deciphering why clinical supply chain has comparatively immature approach to waste management

Defining the differences in value drivers for the commercial and clinical supply chains to ensure best approach

Deducing changes in the pharmaceutical industry in launch size and volume to define increased importance of efficiency

Highlighting approaches to reduce waste appropriate in the clinical supply space

Alex Robertson, Senior Director, Supply Chain Management, AstraZeneca

Highlighting automated receipt process of temperature monitored shipments

Discussing lessons learned from shipments without an automated receipt process

Exploring integration of systems to adjust best practice and approach

Discussing vendor involvement and assessing optimum level of collaboration

Defining challenges during set up of the automated process to set the future course

Presenting achievements so far reached to define next steps

Henk Dieteren, Clinical Supply Logistics Expert, Associate Director, Grunenthal

11:15

Sourcing comparators from Rest of World (RoW) markets with confidence

Exploring 5 critical ways RTSM must change to meet our industry’s rapidly evolving business needs

UNIQUE CASE STUDY

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Harnessing bio-similar developments given loss of patents in 2020 to decipher challenges created for comparator sourcing

Tackling your comparator sourcing, the “Achilles heel” for clinical trial industry, which has become even more painful due to increased demand for comparators and limited sourcing options

Looking to rest of world markets as a “source” for comparators while overcoming the concern of the unknown

Seeking answers in little known facts about product registration process in RoW markets, which holds the key to address these concerns and open a whole new source for comparators, reduce costs and speed up development process

Dr Piyush Gupta, Associate Director, Business Development, GNH

Presenting industry case studies and research showing the “road ahead” for randomization and trial supply management from a technology standpoint

Exploring changes required to ensure that RTSM meets the needs of the business and the people charged with managing the systems

Becoming a “proactive” vs a reactive system, with predictive analytics will dramatically increase study design efficiency and reduce cost and risk

Supporting more of the regulatory and supply chain e.g. inspections and drug pedigree

Eliminating point-to-point integrations with other key eClinical systems from planning and initiation to post-marketing – increasing quality, accuracy, and efficiency with data updating automatically across all clinical systems

Chris Huang, Director, Life Sciences Product Strategy, Oracle Health Sciences

11:45

Enhancing packaging and labelling of investigational medicinal products (IMPs) for compliance with both European and US guidelines

Managing the labelling of IMPs in clinical trials when there is limited space to include all the information

Pinpointing requirements for Europe and North America to define differences and manage your operations accordingly

Incorporating JIT labelling to free your clinical supply chain while ensuring compliance with international and local regulations

Delivering examples of JIT labelling to reduce costs and increase efficiencies

Highlight the challenges still encountered in moving to JIT labelling for international trials

Julia Kaestel, Senior Clinical Supplies Project

Safeguarding your patient data while increasing your technology use for clinical trial supply management

Considering the role of clinical trial supply in securing patient data when increasing use of technology for supply management and delivery

Balancing the risks of patient data security with improvements to be gained through increasing your use of IRT and other technologies

Ensuring your direct to patient shipments are fully secured for patient protection

Highlighting challenges in patient security in an ever more connected world

Proposing solutions for protecting patient data during international clinical trials

Gary Cunnington, Global Head of Respiratory Clinical Supplies, Boehringer Ingelheim

AGENDA HIGHLIGHT

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Manager, AbbVie

12:15 Session Reserved for Durbin Session Reserved for Cenduit

12:45 Lunch and Networking

14:00

Defining the patient experience; improving the last mile for the site and the patient

Approaching the final mile of your clinical supply chain from a site perspective to ensure your best efforts are felt right up to patient delivery

Considering your packaging and labelling for the site and patient experience to ensure all components are giving added value

Using ‘real world’ examples to identify useful technologies and those which hinder the patient perspective

Balancing innovations in the supply chain with site capabilities to improve patient experience and delivery of trial drugs

Defining best practices in approaching and managing sites to ensure patient compliance and ease during your clinical trial

Pieter J. Klaassen, Clinical Trials Operations Manager, NHS

Looking at IRT and beyond for techniques to improve your clinical supply chain

Defining IRT as an efficient and dependable randomisation tool to establish the current offering

Moving beyond current standards for IRT to build the system to offer greater efficiencies in your clinical supply chain

Investigating possibility of improvements in direct to patient or on-site labelling through building tools for IRT

Looking at the tools currently available for clinical trial supply to create a cheat sheet for functions and implementation to reach maximum efficiency

Highlighting areas of supply chain which would benefit from greater technology innovation

Rachal Narrie, Senior IxRS and Medication Manager, Bayer

14:30

Communicating ways to help control your controlled substance

Communicating information across all parties involved to avoid last minute surprises

Controlling and managing documentation to ensure adherence to FDA requirements and avoid delays

Highlighting import/export factors that need to be accounted for when shipping controlled substances globally and the impact it has on your timeline

Releasing and managing product and

Discussing how use of ePaper Labels can secure and simplify clinical trials logistics

Exploring eLabels with graphical ePaper displays giving electronically writable – human readable information without the need of powered labels

Integrating Radio Frequency Identification (RFID) technology providing both wireless communication and means to secure the communication and access

Using an IoT (Internet of Things) approach the labels can exchange information via a secure cloud based server

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shipments to avoid delays, missed shipments, site stock out, and minimize patient impact

Pinpointing accountability of product and paperwork to ensure timely closeout of studies and fillings

Rich Nelson, Distribution Services Manager, PCI

Allowing remote updating of all label information in a controlled, verifiable and certifiable way through secure eLabels

Gaining great benefits in multiple points of the clinical trial logistics flow through the use of eLabels

Dr Ir Peter Slikkerveer, CEO, MpicoSys Solutions B.V. Dr Henk Mollee, CTM-Manufacturing, Astellas

15:00 Unravelling challenges with the use of comparators to ensure compliance

Ensuring accurate use of blinding when working with comparators

Managing information unknowns in comparator sourcing where technical specifications are missing

Pinpointing strategies for monitoring temperature accurately for comparators with unwilling suppliers

Preventing counterfeits within your clinical supply chain when dealing with your comparators

Utilising your vendors to source and manage comparators to ensure correct controls

Niklas Mattsson, Lead Comparator Sourcing and Planning, Merck

Using SAP solutions for end-to-end clinical trial supply management

Presenting an overview of SAP to determine how to best utilise the technology for clinical supply

Discussing technology challenges encountered in your clinical supply management with SAP

Aligning your SAP use with your needs in clinical trial management supply solutions and lifecycle

Utilising your SAP solutions for Investigator Initiated Research (IIR) programs to

Moving towards an SAP and temperature maintenance partnership to move towards a more holistic technology use in your clinical supply chain

Elnouaman Samadi, SAP Consultant, Hikma Pharmaceuticals

15:30 Session Reserved for PRA

Session Reserved for Sponsor

16:00 Afternoon refreshments and networking

16:30

Incorporating your clinical supply forecasting and budgets to reach peak efficiency in your clinical supply chain

Identifying critical stages in the clinical plan to ascertain where greater focus is required

Developing the clinical supply plan around the clinical forecast to reduce instances of overages

Developing the initial budget to determine where resources will be allocated

Building flexibility into the supply plan to ensure you stay within budget

INTERACTIVE

WORSHOP

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Handling your budget control through accurate and flexible forecasting Dr. David Gilliland, Director, Clinical Supply Operations, Daiichi Sankyo

17:00

Deciphering how to manage your clinical supply chain from a small company perspective with limited resources

Defining need to haves and nice to haves for your supply chain to create robust protocol for efficiently delivered supplies

Building relationships with sites and vendors to gain higher priority for shipments and trial logistics

Juggling internal resources with tight timelines and global, multi-site trial sites to ensure timely and compliant deliveries

Outlining efficiencies achieved in clinical supply management through small company thinking to be utilised by larger companies

Exploring future innovations in operations and technology to assist in the small company supply chain

Pedro Pala, Clinical Trial Supply Manager, Bial

17:30

Session Reserved for Marken

18:00

Exploring global requirements for temperature monitoring to ensure compliance for international clinical trials

Interpreting how GMP guidelines are upheld internationally for temperature maintenance

Differentiating your temperature maintenance for differing regions to ensure global compliance

Aligning your temperature maintenance strategy globally to reduce operational inconsistencies and fully utilise your internal resources

Pinpointing difficult or emerging regions to spotlight extra care needed to complete timely and cost efficient clinical trials

Looking towards global standards for clinical supplies to highlight inconsistencies and where the regulators could build partnerships

Rebecca Hamilton, Senior Manager, Clinical Supply, Shionogi

18:30

Chair’s summation and close of day one Jan-Pieter Kappelle, Senior Director, Clinical Trial Supplies, UCB

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Clinical Trial Supply Europe 2016 Day Two |16th March 2016 Barcelona, Spain

08:00

Registration and refreshments sponsored by:

08:20

Chair’s opening remarks Jan-Pieter Kappelle, Senior Director, Clinical Trial Supplies, UCB

08:30

KEYNOTE PRESENTATION Digitalising your clinical supply chain to create more patient centric clinical trials

Defining how your current technology systems, such as IRT, are aiding with patient involvement and adherence

Looking beyond IRT to further digitalise your clinical supply chain with the patient at the forefront

Assessing site and patient preferences for digitalisation through exploration of apps and mobile devices for ease of access

Building their own trial; how the patient can use technology for greater autonomy

Incorporating patient lifestyles to clinical development to ease adherence and increase motivation for ongoing partnerships

Didier Basseras, VP Global Head Clinical Supply Chain Operations, Sanofi

09:00 Session Reserved for Faubel

09:30

Fighting daily challenges with labelling in global trials

Explaining the Roche system for supplying medication for over 450 clinical trials per year

Discussing country label requirements and the challenges encountered in supplying for international clinical trials

Improving agility and productivity of the labelling process at Roche to meet the growing demand

Exploring the future for labels and how they look in 10 years with the advent of e-labelling

Rolf Baumgartner, Head Clinical Label Management, Roche

10:00 Session Reserved for Event Sponsor

Lanyard Sponsor:

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10:30 Morning refreshments

Clinical Supply Operations Clinical Supply Technology

11:00

Highlighting unique challenges encountered in an oncology clinical trial to get your supplies from manufacture to the patient

Highlighting challenges in forecasting for oncology clinical trials compared with a standard drug trial

Discussing sourcing of comparators ; challenges and approach for an oncology clinical trial

Reflecting on techniques for site management during an oncology clinical trial when site numbers are high and patient populations low

Pinpointing the challenges and advantages of drug pooling for an oncology clinical trial

Defining the use of technology in oncology clinical trials and how it could be further utilised in the future

Elizabeth Cooper, Supply Chain Operations Manager, Clovis Oncology

Investigating how technology and learning from other industries can impact on your clinical supply chain

Reviewing some technologies including CMAC (Continuous Manufacturing and Crystallisation) and Remedies an Advanced Manufacturing Supply Chain Innovation project

Highlighting the benefits see through these technologies

Reporting on progress of the 3D printing clinical trial

Discussing a move to make to order versus make to supply

Clive E Badman OBE, VP Pre-Competitive Activities, GSK

11:30

Addressing merits and perils of local sourcing; the case study of Hungary

Choosing between sourcing goods and organising site deliveries locally or acquiring supplies and logistics support from centralized depots using the example of Hungary

Establishing central sourcing benefits by its proponents in providing strategic services from limited number of central depots to guarantee highest level of standardized quality across the board as well as increased traceability

Recognising value of local sourcing for

Session Reserved for Sponsor

UNIQUE CASE STUDY

INTERACTIVE WORSHOP

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cost-efficiency which arguably outweighs the increased complexity and potential loss of homogenous quality levels

Weighing up advantages and disadvantages as disputed by pharmaceutical manufacturers and CROs

Using the example of Hungary to demonstrate potential merits and perils of local sourcing where the acquisition of procurement and logistic services for local clinical trials by sponsors and CROs has been gradually increasing in recent years

Tibor Kovacs, Key Account Manager, PharmaRoad

12:00

Building or buying a forecasting model; sharing your experiences, challenges and achievements in your forecasting

Outlining your choice of model and what determined this to assess if it may be time to upgrade

Weighing costs with benefits when buying in forecasting software to ensure you get the right fit for your trials

Discussing your experiences with your model to determine effectiveness in forecasting

Detailing challenges encountered with your system to unlock greater efficiency in forecasting

Looking to the future; how will your forecasting change and how must your model adapt

Anuja Shukla, Clinical Supply Program Manager, UCB

Managing 3rd party technology effectively through your vendor to increase reliability

Highlighting the role and importance of

vendors in your clinical supply chain and their use of technology

Building awareness of the 3rd party technology used for your trials from your vendor companies

Determining your role in vendor management and regulation of their technology

Assessing your trial needs ahead of vendor sourcing and contracting to ensure best technology is utilised for the study

Handling when things don’t go to plan; how to manage your vendor in tricky situations when 3rd party technology has faltered

Janet Smith, Associate Director RTSM, Janssen

12:30

Session Reserved for MENE Research

Session Reserved for Sponsor

13:00 Lunch and networking

AGENDA HIGHLIGHT

INTERACTIVE WORSHOP

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14:00

Considering the role of real world data in improving your forecasting and overage management

Optimising your clinical development through introducing real world component to your clinical trial to assist in clinical supply management

Aligning the increase in real world data and improved hospital access to identify optimum patient population and further refine your inclusion/exclusion criteria

Exploiting your refined patient population to more accurately forecast for your trial

Proposing useful tools for development to increase benefits for your supply chain from real world data

Considering the regulatory perspective; gaining confidence through initial open-mindedness and building further developments

Ramon Lopez Bertrán, Clinical Research - Medical Affairs Manager, Thrombotargets Europe

Using technology for drug tracking and accountability for IMP and non-IMP products

Outlining needs for tracking IMP and non-IMP products for patient safety and accuracy of results

Moving beyond the basics to incorporate greater controls for identifying counterfeits

Discussing current technology offerings on the market and how these can aid your clinical trial

Highlighting specifics of clinical tracking needs with low volume of shipments and often low quantity in shipment to ensure patient availability and safety

Assessing regulatory take on tracking and how this may be progressed to ensure you stay ahead of the curve

Laurence Ricatte, Clinical Logistic Manager, Sanofi Pasteur

14:30

Session Reserved for Sponsor

Session Reserved for Sponsor

15:00

Presenting GS1 standards for compliance in your clinical supply chain

Building accuracy and assurance through tracking and tracing your trial drugs in the clinical supply chain to the point of patient administration

Utilising the GS1 standards database to ensure blinding of active and placebo components

Improving on current distribution controls to improve the focus to prevent counterfeits and minimise patient risk in a clinical trial

Working down to the basics of packaging and drug individuality to identify not only a batch but a single trial

Panel Discussion: Balancing excitement surrounding innovation in clinical supply technology with needs and expectations of your sites and patients; how to get the balance right

Defining technology available and its use and role in managing clinical supplies

Weighing effectiveness of current technology and how this can be improved from a study perspective

Going beyond the pharma perspective to identify site and patient needs

Incorporating site and patient needs into your technology adoption and use

Looking to the future; how to incorporate

AGENDA HIGHLIGHT

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product

Defining the GS1 global standards to minimise deviations in practice

Tania Snioch, Director Healthcare, GS1

innovation with patient centricity and how far do we still have to go?

Panellists: Janet Smith, Associate Director RTSM, Janssen Henk Mollee, Senior Director, CTM Manufacturing, Astellas

15:30 Afternoon refreshments

16:00

Speaker Hosted Roundtables

Each roundtable session lasts for 45 minutes, and delegates may attend 1

roundtable. The roundtable sessions will be allocated on a first come, first served basis.

Each session will focus on their specific region and work towards

having 5 presentable tips, tricks or things to note when supplying to the trials in this area.

Roundtable

1

China Fan Feng, Clinical Trial Supply Manager, Merck

Roundtable 2

Middle East Alexandra Tsioni, Clinical Supply Chain Study Lead, Teva

Roundtable 3

Japan Maria Kuthning, Global Head, Clinical Trial Supplies, Boehringer Ingelheim

Roundtable 4

Russia and Ukraine Angelique van den Berg, Senior Manager Clinical Supply Chain, Amgen

16:45

Presenting your findings: Each host will present the top 5 things for their region Panellists: Fan Feng, Clinical Trial Supply Manager, Merck Alexandra Tsioni, Clinical Supply Chain Study Lead, Teva Maria Kuthning, Global Head, Clinical Trial Supplies, Boehringer Ingelheim Angelique van den Berg, Senior Manager Clinical Supply Chain, Amgen

BRAND NEW FORMAT FOR

2017

NEW FOR 2017

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17:30

Chair’s summation and close of conference Jan-Pieter Kappelle, Senior Director, Clinical Trial Supplies, UCB