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: Putting the patient at the centre of your trial

Cathy Molohan - Parkinson’s Advocate, .
 - Practical patient centricity within the clinical trial paradigm and how it can promote efficient and accurate supply management
 - Benchmark your companies clinical supply processes against the patient experience and ensure that you maximise patient engagement and retention by incorporating real life best practices
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Cathy Molohan

Parkinson’s Advocate
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10:10 am - 10:50 am Keynote Address: Un-fogging the future of clinical trials: Considering innovation at every stage across your clinical trial supply lifecycle

Luca Russo - VP Global Head Clinical Supply Chain, Janssen
- Re-assess your thinking: How clinical trials can be a source of innovation and development, not just a cost and timeline impediment
- Identify opportunities to innovate across your clinical trial supply lifecycle
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Luca Russo

VP Global Head Clinical Supply Chain
Janssen

10:50 am - 11:20 am Ensuring supply chain flexibility and viability for biologics

Natalie Balanovsky - JIT Manufacturing Solutions Manager, Almac
Understand the key milestones that directly impact clinical trial supply, and explore current and projected shifts in the clinical trial
landscape, which will require sponsors to be more responsive to change. Topics that will be covered include:
- The rise of biologics and market pressures
- The complexity of biologics supply chain management
- Flexible clinical trial supply solutions including Just in Time Manufacturing
- Critical considerations for cold chain management
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Natalie Balanovsky

JIT Manufacturing Solutions Manager
Almac

11:20 am - 11:50 am Networking Coffee Break

11:50 am - 12:30 pm Interactive Discussion Session: Communication and coordination for effective end-to-end clinical trial management

- Consider the intersection of clinical trial supply, clinical operations and clinical quality assurance to assess where internal harmonisation and alignment can be achieved
- Identify strategies to enhance your communication, coordination and trial management across your clinical development lifecycle
- Examine common areas of miscommunication and misalignment to avoid unexpected hurdles!

8:00 am - 8:00 am Stream A: Future trial focus

1:05 pm - 1:35 pm Janssens J.I.T Labelling Program – Where are we now?

Buz Hillman - Associate Director, Clinical Supply Systems and Strategy, Janssen
- Consider how just in time labelling programs can respond to evolving trial requirements and pressure to streamline production
- Discuss process transformation as a driver to react effectively to demand whilst ensuring end-to-end compliance
- Examine the cost vs benefits of adopting just in time labelling technologies
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Buz Hillman

Associate Director, Clinical Supply Systems and Strategy
Janssen

8:00 am - 8:00 am Stream B: Planning and forecasting

12:30 pm - 1:00 pm Direct to patient trial management: Beyond theory and into practice

Robin Marcus - Chief Strategy Officer, Global Care
- Analyse the impact of bringing the patient into your clinical supply management strategy from planning onwards
- Map out the realities of running direct to patient models in real life
- Examine the benefits of patient centric supply on your clinical development, trial supply and real world evidence
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Robin Marcus

Chief Strategy Officer
Global Care

- Discuss the formation of flexible and forward thinking business processes for the global movement of clinical product
- Map out the role of each logistical channel and shipping lane to begin the process of consolidation
- Analyse how to bring all internal stakeholders on board to ensure you can meet your global shipping deadlines while overcoming import/export challenges
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Monica Paccione

Executive Director, Clinical Research and Development
Teva Pharmaceuticals

1:40 pm - 2:40 pm Networking Lunch

2:40 pm - 3:00 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!

3:00 pm - 3:30 pm LEAN Transformation in Modern RTSM

Jan Pieter Kappelle - Vice President, Strategy, 4G Clinical

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Jan Pieter Kappelle

Vice President, Strategy
4G Clinical

3:30 pm - 4:35 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. Clinical Supply Management in large phase 3 multi-country studies
Sarah Brown, Lead, Clinical Supplies Manager, Vectura

2. Mapping import / export regulatory requirements for global clinical supply networks

3. eTMF and clinical supplies – What are the roles and responsibilities?

4. Ensuring temperature control across your clinical supply network to achieve compliance
Damian Flynn, Clinical Trial Supply Manager, ObsEva

5. Bringing out the best in your teams: Strategies to manage more effectively
Lindsey Marshall, M.S., Senior Manager, Clinical Logistics - Global Clinical Operations, Regeneron

6. Shifting from reactive quality management to proactive quality assurance across your global trial network
Marianne Oth, PR&D QA- Global Projects Leader – Elects European Development Quality, Eli Lilly

7. Digital trial environments in clinical trial supply and the impact on supply management
John Murray, Senior Director, Clinical Supply Chain Transformation, AstraZeneca

8. Building a cryo supply chain for successful atmp trial management

4:30 pm - 5:00 pm Afternoon Coffee Break

5:00 pm - 5:30 pm Optimising your drug supplies at program level

Sébastien Coppe - Head of Consulting Group, N-Side
- Optimise all your decisions from API manufacturing to IMP packaging and labelling activities based on patient supply risk assessment
- Drug pooling at program level thanks to smart uncertainty management of each single trial
- Leverage your stability plan in the end-to-end optimisation and optimise upcoming milestones
- Risk-based optimisation of your Drug Products allocation to different trials.
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Sébastien Coppe

Head of Consulting Group
N-Side

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

4:40 pm - 5:10 pm Goal setting and RACI at the outset: How to proactively build vendor relationships

Steven Jacobs - Board Chairman, Global Clinical Supplies Group
- Maximise your ROI though proactively engaging with trial
supply vendors and suppliers before the problem occurs!
- Align on accountability across your vendor network to
minimise unforeseen disruptions
- Discuss how to proactively align critical success factors and
communication requirements
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Steven Jacobs

Board Chairman
Global Clinical Supplies Group

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

4:40 pm - 5:10 pm Managing your global trial network Streamlining clinical trial supply processes using global standards

Tania Snioch - Director Healthcare, GS1 Global Office
- Understand the value to the sector from sharing global data
via standardised electronic formats
- Learn about existing implementations and current industry
status across multiple regions
- Hear of future plans to continue standardisation efforts and
how to get involved!
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Tania Snioch

Director Healthcare
GS1 Global Office

6:05 pm - 6:35 pm Digitalisation, automation and patient centricity – Where does it all fit?

John Murray - Senior Director, Clinical Supply Chain Transformation, AstraZeneca
- Examine the AstraZeneca digital transformation journey so far – what are the priorities and where are we currently?
- Discuss how to identify opportunities for the successfully incorporation of data management, advanced analytics and supply chain
design tools
- Analyse how future technologies can be used to build a digital patient supply chain and how this contributes to process
transformation
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John Murray

Senior Director, Clinical Supply Chain Transformation
AstraZeneca

6:35 pm - 6:35 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

6:45 pm - 9:15 pm Networking Drinks Reception