20 - 22 May, 2019
Sheraton Brussels Airport Hotel, Brussels, Belgium

Main Conference Day 1

8:30 am - 8:55 am Registration and Welcome Coffee

8:55 am - 9:00 am Pharma IQ Welcome

9:00 am - 9:10 am Chairman's Opening Address

Steven Jacobs - Board Chairman, Global Clinical Supplies Group
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Steven Jacobs

Board Chairman
Global Clinical Supplies Group

9:10 am - 9:30 am People Bingo: Interactive Speed Networking

A highlight of Pharma IQ events, now at CTS 2019! Be ready to meet your peers and share best practices. You will have
several 2 minute conversations to enable you to introduce yourself to your peers and add to your contact pool. There is
a prize in it for the winner so get networking!

Please Share:
1. Who you are
2. The scope of your job role
3. What you plan to achieve from attending this event
4. Your #1 challenge

9:30 am - 10:10 am Keynote Address: Blockchain - Buzz Word Or Breakthrough?

Francesco Spoto - Master Site Manager - Clinical and Quality Expert, Novartis
- Analyse the applicability of blockchain within the clinical supply chain – where should you be looking for implementation?
- Examine the path towards implementation - what is the status of adoption? – planning, implementation or testing stages?
- Discuss the proposed benefits of blockchain – traceability, accountability, compliance – and compare with Novartis’ experience in
implementation
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Francesco Spoto

Master Site Manager - Clinical and Quality Expert
Novartis

10:10 am - 10:40 am Just in Time Manufacturing (JTM) – Optimising Flexibility And Adaptability In Clinical Trial Supplies

Natalie Balanovsky - JIT Manufacturing Solutions Manager, Almac
- Understand the application of JTM in optimising your clinical trial supply strategy
- Identify the key considerations for incorporating a JTM strategy for your company
- Examine the benefits of a JTM strategy – including risk mitigation, continuous supply, waste reduction and extending clinical life
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Natalie Balanovsky

JIT Manufacturing Solutions Manager
Almac

10:40 am - 11:10 am Networking Coffee Break

11:10 am - 11:40 am Open Floor Debate: The Brexit Effect – What Has Happened And Where Are We Now?

With your colleagues we will be looking into the industry’s preparation for Brexit and alternative supply routes that could
prevent timeline delays and minimise additional costs.
In addition, we will review what we now know about the impact and cost of Brexit post March 2019

8:00 am - 8:00 am Stream A: Planning and Forecasting Stream

11:40 am - 12:10 pm Optimising Your Clinical Trial Supply Forecasting And Demand Planning Through Innovative IT Solutions

Ahn Louise Larsen - Senior Supply Chain Specialist, CMC Clinical Supplies - Supply Chain Optimisation and Solutions, Novo Nordisk
- Discuss how innovative IT solutions can reduce the pressure on forecasting accuracy and risk mitigation
- Manage the utilisation of your clinical supply and trial data to generate visibility of your supply chain pressure points
- Build your supply strategy and protocols around software implementation to generate an efficient and robust supply model
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Ahn Louise Larsen

Senior Supply Chain Specialist, CMC Clinical Supplies - Supply Chain Optimisation and Solutions
Novo Nordisk

12:15 pm - 12:45 pm Looking Beyond The Basics: Why Forecasting Needs To Be Flexible To Be Accurate

Buz Hillman - Associate Director, Clinical Supply Systems and Strategy, Janssen
- Identify the critical success factors of inventory planning and forecasting models
- Ensure you are incorporating unexpected supply differentials such as resupply and regional market shipment timelines into your forward planning
- Analyse your supply chain visibility and the importance of monitoring supply across the study
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Buz Hillman

Associate Director, Clinical Supply Systems and Strategy
Janssen

8:00 am - 8:00 am Stream B: Commercialisation Stream

11:40 am - 12:10 pm Global Standards For Clinical Trial Kit And Component Identification Across The Supply Chain

Tania Snioch - Director Healthcare, GS1 Global Office
- Analyse the industry move towards standardisation and what it means for the efficient supply of clinical trial products
- Discuss global traceability standards within the clinical trial space and how a move to standardisation could benefit regional market compliance
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Tania Snioch

Director Healthcare
GS1 Global Office

- Defining ‘Optimisation’ in the CTS reality – why it needs to be more than just a mathematical model
- Examine the key pain points you need to consider for end to end supply optimisation
- Discuss the reality of implementation for leading simulation and forecasting models
- Define your supply KPIs as a means of creating internal and external alignment around your program control and supply visibility
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Philippe Verlaine

Head of Global Clinical Supply Optimization, Global Clinical Trials Supply - pending final confirmation
UCB

12:45 pm - 1:45 pm Networking Lunch

1:45 pm - 2:05 pm Live Poll!

Use this opportunity to interact with your peers about the key points being discussed so far and share your opinion with
everyone in the room! Live feeding through our app and polls will give you a 360˚ insight on what the industry’s opinion is!

2:05 pm - 2:35 pm LEAN Transformation in Modern RTSM

Jan Pieter Kappelle - Vice President, Strategy, 4G Clinical
- Reduce waste in effective collaboration between sponsor and vendor
- Apply PDCA (Plan-Do-Check-Act) in RTSM setup and validation
- Understand how Process Maps, Value Stream and SIPOC diagram strengthen partnerships and minimize communication challenges
- Discuss the importance of meaningful KPIs to monitor your RTSM
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Jan Pieter Kappelle

Vice President, Strategy
4G Clinical

2:35 pm - 3:40 pm Interactive Discussion Groups: 2 Rotations

During this part of the forum, delegates will be sorted into small working groups to take part in interactive discussions
around the topics below. Delegates will get the opportunity to select and pre-register for two topics and will rotate
between each 30 minute IDG. Discussion groups are kept small to ensure all delegates get the opportunity to ask their
most pressing questions, ensuring a perfectly tailored experience.

1. Direct To Patient Models For Patient Centric Clinical Supply Models
Dr. Andrea Zobel, Senior Director, PAREXEL Academy

2. Harmonising your CTS Strategy to Effectively Ensure Global Trade Compliance
Bernard Jaucot, Director Process & Systems Optimization (PSO), Global Clinical Supplies, PPD

3. End To End Planning Of Clinical Trial Supply
Kamal Amin (Ph.D), Senior Clinical Supplies Manager, Fujifilm Kyowa Kirin Biologics Co. Ltd

4. Improving Temperature Controlled Logistics In The Clinical Trial Supply Chain
Ayelet Weissbach, Clinical Supply Chain Manager, NeuroDerm

5. Incorporating Flexibility To Future Proof Your Forecasting
Buz Hillman, Associate Director, Clinical Supply Systems and Strategy, Janssen

6. Managing The Challenge Of Efficient Supply To Increasingly Regionalised Clinical Sites
Didier Basseras, Vice President Clinical Supplies - Clinical Supply Chain, Sanofi-Aventis

7. Mapping The Adoption Of Digitalization Through The Clinical Supply Chain
Elisaveta Frenkel, Master Production Planner & CMO Supply Manager, F. Hoffmann-La Roche AG

8. Mapping The Import/Export Process in a Global Study Setting
Leon Dzivinsky, Vice President & Senior Legal Counsel, PRA Health Sciences

3:40 pm - 4:10 pm Evolving from Push to Pull Clinical Supply Chain Management with Early Phase Optimization

Sébastien Coppe - Head of Consulting Group, N-Side
·  Optimize at protocol concept phase to minimise risk of drug shortage during the trial
·  Assess impact on planning and budget by reducing uncertain clinical demand
·  Leverage optimization results for fact-based communication during strategic decision making
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Sébastien Coppe

Head of Consulting Group
N-Side

4:10 pm - 4:40 pm Afternoon Coffee Break

8:00 am - 8:00 am Stream A: Partnership Stream

4:40 pm - 5:10 pm Incorporating The Unexpected Challenge Of Investigator Initiated Trials

Samantha Carmichael - Lead Pharmacist Clinical Trials / R&D, Clinical Research & Development, NHS Greater Glasgow & Clyde
- Understand the parameters of investigator initiated trials – when and how they can occur
- Discuss the realities of implementing investigator trials on the ground
- Identify key factors for trial success from an implementation perspective: what can you do to make our lives easier and get your trial to the front of the line?
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Samantha Carmichael

Lead Pharmacist Clinical Trials / R&D
Clinical Research & Development, NHS Greater Glasgow & Clyde

5:15 pm - 5:45 pm Pluristem's Hip Trial Challenges- How To Solve an Unmet Need Through Efficient Clinical Supply Strategy

Boaz Leshem - VP Operations & Manufacturing, Pluristem Therapeutics
- Examine the benefits and risks to current partnership models used across the clinical supply chain
- Evaluate the critical success factors to enhance transparency and ensure alignment from sponsor and vendor
- Identify ways that you can manage partnership relationships across the trial lifecycle to ensure continued process and delivery alignment
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Boaz Leshem

VP Operations & Manufacturing
Pluristem Therapeutics

8:00 am - 8:00 am Stream B: Data Management Stream

4:40 pm - 5:10 pm Optimising The End To End Utilisation Of Your Clinical Supply Data Framework Whilst Maintaining Regulatory Compliance

Bjoern Rath - Independent Supply Chain Consultant & Sr. Economics Lecturer, GS1
- Understand the role of third party suppliers in data generation and utilisation
- Identify the key tools available to improve your data evaluation
- Utilise your data to safeguard for global regulatory compliance
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Bjoern Rath

Independent Supply Chain Consultant & Sr. Economics Lecturer
GS1

5:15 pm - 5:45 pm Incorporating Clinical Site And Global Patient Feedback Into Your Clinical Supply Program

Esther Sadler-Williams - Managing Director, SimplyESW
Designing our global clinical supply chains continues to be
complex process. Flexibility is often the key to efficiency, but what impact could that have on study recruitment and retention and what could you do to mitigate this?

- Appreciate the global study challenges around patient retention and recruitment.
- Identify what challenges clinical sites face when considering IMP’s
- Discuss what patients are saying about their IMPs on a global scale, and compare and contrast results from 4 regional surveys (US, EU, China and Japan)
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Esther Sadler-Williams

Managing Director
SimplyESW

5:45 pm - 6:00 pm Live Poll!

Use this opportunity to interact with your peers about the key points being discussed so far and share your opinion with
everyone in the room! Live feeding through our app and polls will give you a 360˚ insight on what the industry’s opinion is!

6:00 pm - 6:00 pm Chairman's Summary of Day One

Steven Jacobs - Board Chairman, Global Clinical Supplies Group
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Steven Jacobs

Board Chairman
Global Clinical Supplies Group

6:00 pm - 8:30 pm Networking Drinks Reception