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, Global Clinical Supplies Group
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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

Peter Rutherford - Global Medical Lead Orphan Unit, Vifor Pharma
- 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
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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

Maria Kuthning - Global Clinical Operations Executive, Former Head of Global Clinical Trial Logistics, Boehringer Ingelheim
- 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
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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, S-Clinica

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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

Nigel Tomkinson - Director - Clinical Operations, ProQR
- 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
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Nigel Tomkinson

Director - Clinical Operations
ProQR

- 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

Rasmus Hogreffe - Head of Virtual Clinical Trials, LEO Innovation
- 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

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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 End to End Optimisation of IMSC Logistics: Where Do Digital Technologies Fit Into The Picture?

Tom Ware - Senior Business Analyst, Celgene
  • Discuss the need to integrate the technology and stakeholders during the planning phase to prepare for efficient distribution
  • Minimise time delays and maximise oversight by utilising new technologies to enhance your network control
  • Analyse your global trial network to identify market specific logistics challenges and build a compliant global network
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Tom Ware

Senior Business Analyst
Celgene

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

Bjoern Rath - Independent Supply Chain Consultant & Sr. Economics Lecturer, GS1
- 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
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Bjoern Rath

Independent Supply Chain Consultant & Sr. Economics Lecturer
GS1

1:40 pm - 2:40 pm Networking Lunch


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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

Bernard Jaucot - Director Strategic Solution, Global Clinical Supplies (GCS, PPD
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
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Bernard Jaucot

Director Strategic Solution, Global Clinical Supplies (GCS
PPD

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