Conference Day 2

08:30 AM Coffee & Registration

09:00 AM Chairman’s Recap

09:10 AM How the Internet of things improve the clinical supply chain

Andrea Zobel, Global Senior Director Clinical Project Management, Parexel International
  • Technology solutions to track clinical supplies from manufacturer to patient
  • Mobile apps to make clinical supply handling at clinical sites easier and safer
  • Patient engagement apps for better compliance and data capture

Andrea Zobel

Global Senior Director Clinical Project Management
Parexel International

09:50 AM Regulatory Impact: Technology, Tools, and Insight to Mitigate Risk

Heather Bogle, Supply Chain Solutions Manager, Almac Group
  • Understanding the challenges of staying compliant in the realm of Temperature Management
  • Case study examples to show how processes, technology and tools were implemented
  • Examining global studies to reduce errors, improve efficiencies and improve compliance

Heather Bogle

Supply Chain Solutions Manager
Almac Group

Sponsored by: Almac Group

10:20 AM European Regulatory Discussion

  • What are the practical implications of the new EMA regulations on Clinical Supply Chains?
  • What flexibility will there be with regards to enforcement?
  • What alternative methods would the local authorities recommend that still comply with the regulations?

11:00 AM Coffee & Networking Break

Stream A – Packaging and Labelling

11:40 AM Cast study: Adopting JIT labelling for clinical studies to overcome planning issues for clinical supply

  • Examining how JIT labelling can reduce timelines and minimise risks in standard labelling when incorporated into forecasting
  • Promoting JIT labelling for unlabelled batches used in several different studies for more efficient labelling process
  • What considerations need to be made when choosing vendors to facilitate JIT labelling

  • What financial considerations do SMEs need to make in their supply chain compared with that of Big Pharma?
  • How can SME’s exploit the opportunity of international markets with little experience?
  • What investments need to be made at the outset of a trial to avoid the need for further purchases in infrastructure and resources on the ground?

Ian Walker

Head of Project Leadership
Acacia Pharma

Leon Dzivinsky

Vice President & Senior Legal Counsel
PRA Health Sciences

William Shingler

Senior Development and Clinical Project Manager
Immunocore Limited

Stream A – Packaging and Labelling

12:25 PM Analysing the impact of the expiration of Annex 13 on IMPs

Claudio Lorck, Associate Director Clinical Product Supply EU, QP Lead, Abbvie
  • Understanding the impact of the Clinical Trials Regulation 536/2014 (CTR) on the regulatory landscape for IMPs
  • Analysing what processes will change significantly and lead to expiry of current directives and Annex 13, once the CTR is applicable
  • Exploring the effects of the regulatory changes and constants to be expected and to anticipate how IMP manufacturers can be the be prepared for by manufacturers of IMPs

Claudio Lorck

Associate Director Clinical Product Supply EU, QP Lead

Stream B – SME focused stream

12:25 PM Addressing Logistical Challenges In Clinical Trial For Cell Therapies

Eric Leire, CEO, DanDrit Biotec
  • Offering a commercially viable therapy (patient, physician and hospital-friendly therapy)
  • Dealing with regulatory issues
  • Scaling up production
  • Distributing cell therapies
  • Managing the costs of production

Eric Leire

DanDrit Biotec

1:05 PM Networking Lunch

2:20 PM Case study: Effective methods to overcome challenges with IMPs for Investigator Initiated Studies

Peter Orosz, Head of Clinical Supply Chain Management & Oncology, Boehringer Ingelheim
  • The importance of understanding of regulatory background
  • What has to be considered when initiating a study?
  • What are the supply chain options to facilitate these studies?

Peter Orosz

Head of Clinical Supply Chain Management & Oncology
Boehringer Ingelheim

3:00 PM Case study: How to improve Clinical trials supply chain efficiency by implementing Key Performance Indicators

Philippe Verlaine, Associate Director, Clinical Supply Optimization Lead, UCB
  • Identify the rights KPIs, based on a good understanding of what is important for your organization
  • Implementation of KPIs to benchmark your performance and identify potential improvements
  • Regular reporting through a balanced score card to periodically assess the performances of your organization

Philippe Verlaine

Associate Director, Clinical Supply Optimization Lead

3:40 PM Coffee & Networking Break

  • Table 1: Optimising Waste Through Forecasting - Oli Cunningham, CSC Optimisation Lead, R&D Supply Chain, AstraZeneca
  • Table 2: Returns, Reconciliation And Destruction - Bernard Jaucot, Associate Director Strategic Solutions, Global Clinical Supplies, PPD
  • Table 3: Procurement Strategy In Partnerships - Philippe Verlaine, Senior Clinical Supply Program Manager, Global Clinical Trials Supply, UCB
  • Table 4: The Need For A Clinical Supply Chain To Support Direct To Patient - Asim Khan, Senior Manager, Clinical Research Pharmacy Services, Amgen LTD
  • Table 5: Managing Remote/Global Supply Management Teams - Steve Jacobs, Board Member, Global Clinical Supplies Group

Bernard Jaucot

Associate Director Global Clinical Supplies

Steven Jacobs

Board Chairman
Global Clinical Supplies Group

Asim Khan

Senior Manager, Clinical Research Pharmacy Services

Philippe Verlaine

Associate Director, Clinical Supply Optimization Lead

Oli Cunningham

CSC Optimisation Lead, R&D Supply Chain

5:10 PM Understanding how to facilitate the additional requirements of the supply chain for direct to patient in clinical trials

Asim Khan, Senior Manager, Clinical Research Pharmacy Services, Amgen
  • How can effective tracking and control of delivery to patients be implemented? What technologies exist to help with this?
  • Guaranteeing temperature control at home to ensure that the materials remain safe and secure
  • Considering what additional training is required across the supply chain from patient, courier and sponsor to ensure trial is not compromised

Asim Khan

Senior Manager, Clinical Research Pharmacy Services

5:50 PM Chairman’s Close