18 - 20 May, 2020
Sheraton Brussels Airport Hotel, Brussels, Belgium

Main Conference Day 2

8:30 am - 9:00 am Registration and Welcome Coffee

9:00 am - 9:15 am Chairman's Summary of Day One

Steven Jacobs, Board Chairman at Global Clinical Supplies Group

Steven Jacobs

Board Chairman
Global Clinical Supplies Group

9:15 am - 9:50 am Managing the co-existence of early access programs with clinical trials through effective data utilisation

- Explore both the internal and external challenges and opportunities associated with the capture of real world data, and how it can be achieved in clinical practice
- Discuss how effective data incorporation and analysis can facilitate patient centric trial design and enable effective trial management
- Examine how early access programme data can be utilised to guide benefit risk management, life-cycle planning and hypothesis testing while still adhering to the basic premise of meeting an unmet medical need
Peter Rutherford, Global Medical Lead Orphan Unit at Vifor Pharma

Peter Rutherford

Global Medical Lead Orphan Unit
Vifor Pharma

9:50 am - 10:25 am Ensure unity across your internal clinical teams: How clinical operations and clinical supply coordination can streamline your clinical development

- Examine your end to end clinical trial environment to identify areas for process consolidation and effective team engagement
- Analyse opportunities for internal coordination across clinical operations and clinical supply teams - how can this enhance your clinical development and minimise downtime
- Discuss ways to deal with internal conflicts proactively to avoid product and process delays
Maria Kuthning, Global Clinical Operations Executive, Former Head of Global Clinical Trial Logistics at Boehringer Ingelheim

Maria Kuthning

Global Clinical Operations Executive, Former Head of Global Clinical Trial Logistics
Boehringer Ingelheim

10:25 am - 11:00 am Session reserved for S-Clinica


Irena Seredina, Executive Director at S-Clinica

Irena Seredina

Executive Director
S-Clinica

11:00 am - 11:15 am 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!

11:15 am - 11:45 am Morning Coffee Break

8:00 am - 8:00 am Stream A: Strategic Stream

11:45 am - 12:20 pm Mapping the patient journey – Towards a digital future for patients with rare disease

- Examine the realities of managing patient engagement, recruitment and retention when coming from a rare disease supply and trial network
- Identify areas where digital investment can enhance the patient journey
- Discuss what the future of rare disease trials could look like, and where future technologies fit into this transformation
- Examine the importance and benefits of team buy in before implementing organisational change
- Analyse common change management strategies and how they can be adapted to the time sensitive and high pressure nature of the clinical trial supply industry

12:25 pm - 1:00 pm Operational challenges and opportunities through the transition to virtual trial networks

- Minimise loss of patient engagement and facilitate the more effective trials through transitioning towards virtual trial networks
- Map out the challenges that occur alongside this transition to avoid common pitfalls
- Examine real life examples of virtual trial management to identify benefits to patient engagement and lean supply management

Rasmus Hogreffe, Head of Virtual Clinical Trials at LEO Innovation

Rasmus Hogreffe

Head of Virtual Clinical Trials
LEO Innovation

1:05 pm - 1:40 pm Interactive Session: Preparing For Virtual Clinical Trials: Strategy, Implementation and Change Management

- Discuss how - and why - Nestle Clinical Development have been preparing for virtual trial implementation
- Identity common roadblocks to compliance and implications of implementation ahead of your rollout!
- Capitalise on real life case studies to identify opportunities for enhancing patient engagement and effectively managing patient populations across your program portfolio

8:00 am - 8:00 am Stream B: Operational Stream

11:45 am - 12:20 pm Reverse logistics 101 – Where your reverse logistics network fits into your outbound strategy

- Discuss the need to integrate both sides of your supply chain during the planning phase to prepare for efficient distribution
- Minimise unforeseen costs by creating a flexible product return and destruction strategy
- Analyse your global trial network to identify market specific reverse logistics challenges and build a compliant returns network
Tatjana Vorobjova, Sr Manager, Global Logistics, Investigational Material Supply Chain at Celgene

Tatjana Vorobjova

Sr Manager, Global Logistics, Investigational Material Supply Chain
Celgene

12:25 pm - 1:00 pm Building a proactive risk assessment strategy to mitigate delays and lost clinical supplies

- Investigate your end to end clinical supply chain to pinpoint areas of weakness
- Map out regions of increased risks such as temperature excursions and delivery interruptions
- Build a proactive risk assessment strategy to mitigate against foreseeable hurdles before it costs you your product
Bjoern Rath, Independent Supply Chain Consultant & Sr. Economics Lecturer at GS1

Bjoern Rath

Independent Supply Chain Consultant & Sr. Economics Lecturer
GS1

1:40 pm - 2:40 pm Networking Lunch


Kamal Amin, Senior Clinical Supplies Manager at Fujifilm Kyowa Kirin Biologics

Kamal Amin

Senior Clinical Supplies Manager
Fujifilm Kyowa Kirin Biologics

2:55 pm - 4:00 pm Scenario round tables

Each roundtable will discuss a different “what if” scenario that mirrors a real clinical trial supply time sensitive challenge or
emergency. Develop strategies to overcome these likely scenarios and share past experiences and ideas. You won’t know
the scenario until you choose your roundtable so get ready for some on-the-spot problem solving and out of the box
thinking with your industry peers!

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

4:30 pm - 5:05 pm From export to administration via the last mile: Utilising risk assessments to achieve lean global clinical supplies

Bringing together two full days of conferences – this keynote presentation will look at your import and export landscape as a basis for
transitioning from a push vs pull trial model to achieve proactive risk assessment and process transformation

5:00 pm - 5:30 pm Panel discussion: True change management: turning change into an opportunity

- Discuss how to minimise the disruption of ‘unknown’ change
- Benchmark solutions to identify unforeseen opportunities to capitalise on the change
- Hear a pan-industry perspective on change management in practice – how does theory stand up in reality?

5:30 pm - 6:00 pm Chairman's Summary and End of Main Conference