The Programme

Day One
Monday 19 October 2009

Registration

Opening remarks from the Chair

Dr. Brenda Uratani, Ph.D.
Assistant Director
China Office
US Food and Drug Administration
HHS/FDA

Keynote: FDA regulatory update – understanding the key requirements to ensure compliance

• Outlining the cGMP requirement for Phase 1 and beyond to achieve legislative compliance
• Highlighting specific issues relating to GMP to ensure compliant clinical manufacturing
• Ensuring effective quality management when producing investigational products at a global level

Boosting clinical trial efficiency by outsourcing clinical logistics to global partners

• Outlining the decision factors when choosing to outsource clinical logistics
• Developing steps for building a global alliance with preferred partners
• Defining SOPs and KPIs
• Implementing effective service and quality agreements
• Extending global reach and finding additional cost-cutting opportunities and services by moving from 3PL partnerships to 4PL
• Advanced temperature control packaging choices for our clinical supplies
• Establishing 'chain of custody' of our clinical supplies internally and with our global partners
• Implementing innovative methods to track temperature and location, providing data points for overall supply chain databases

Maximizing the potential of IVRS to ensure the efficient management of clinical supplies

• Utilizing IVRS as an inventory management tool, a real-time project information tool and a subject recruitment tool to maximize clinical trial supply efficiency
• Gaining full business benefits using efficient change management strategies to maximize your clinical trial supply strategies in today’s economic environment
• Implementing randomization strategies to minimize drug wastage
• Leveraging your IVR to maximize efficiencies in the clinical supply chain by ensuring supplies are delivered to active sites
• Using predictive supply strategies to provide for more efficient deliver

Morning refreshments

Proactively preparing for strategic comparator sourcing

• Determining the sourcing complexity during the design process of the trial
• Compiling a sourcing strategy – identifying the selection criteria of a comparator sourcing specialist
• Understanding the unique sourcing criteria of comparators – considerations and how to overcome them
• Discussing comparator sourcing obstacles and hurdles

Maximizing clinical supply management by efficient methodologies

• Source area alignment through tools that promote predictability
• Governance and structure to facilitate conflict resolution
• Use of the clinical supply contract to map out expectations
• Shared accountability and transparency in the process

Improving the translatability and efficiency of labeling processes when distributing to multiple international sites

• Understanding the common challenges in the label text development process
• How efficient systems can help with translation cycle times
• Case study using proven systems and processes
• Techniques for implementing these solutions to maximize labeling process efficiency

Lunch

Techniques for improving clinical material planning accuracy through forecasting, effective communication and process management

• Identifying accurate forecasting strategies
• Outlining available forecasting and simulation tools – balancing pros and cons in order to evaluate the most appropriate tool for your needs
• Developing teamwork and improving communication channels to ensure success
• Improving clinical demand planning and operations management coordination

Acceptance and diffusion of clinical supply chain simulation tools: From concepts to demonstrated value

• Perceived usefulness and Ease-of-Use
• Usefulness: Addressing practical issues, reducing costs and controlling risk
• Ease-of-Use: Training, user interface and process
• Increasing usefulness and Ease-of-Use through integration

Harp Dhaliwal
Director, Planning and Development Operations
BIOGEN IDEC
and
Ram Narayanan
Associate Director, Clinical Planning and Development Operations
BIOGEN IDEC

Managing the clinical trial supply planning function

• Increasing scalability - handling more studies with limited resources
• Supply management on a project lifecycle concept - creating structures for better resource utilization
• Effective project management and partnerships
• Minimizing waste while maximizing flexibility

Gaining surprisingly positive side-effects when using CTS simulation

• Outlining kit randomization and packing plans to maximize simulation accuracy
• Achieving common understanding, QA involvement and efficient training methodologies
• Setting automatic IVRS specifications to achieve accurate simulation results
• Understanding enterprise demand all the way up the chain to establish requirements
• Optimising program designs and outlining lessons learned

End to end Clinical Trial Supply Management (CTSM) with SAP

• Overall framework of clinical trial processes - CTSM versus Clinical Trial Management System (CTMS)
• Identifying business drivers and benefits of CTSM transformation
• Outlining challenges in CTSM and strategies to overcome them
• Leveraging SAP to support CTSM processes - planning, packaging & distribution, study design, randomization, order management and IVRS
• Case study – implementation of CTSM in SAP
  • Project scope
  • Implementation approach
  • Lessons learned

Case study: To do or not to do over labeling at the site

• Celgene’s take on over labeling at sites to manage suppliers efficiently
• Discussing the pros and cons of over labeling at sites
• Pro = prolong inventory when shortage of supplies occurs
• Con = lack of control when utilizing this quick fix method
• What the steps are if you take the approach and how to maximize the outcome
• Issues that may arise when over labeling at sites and how to overcome them
• Ways to prevent over labeling at site by efficient IVR strategies and stability programs

Closing remarks from the Chair

Close of Day One

ALMAC drinks reception
At the end of the day one you are invited to attend a drinks reception hosted by our lead sponsor, Almac. Unwind, discuss the day’s presentations and network with your peers.

Registration

Opening remarks from the Chair

Delegates will be able to attend three one-hour roundtable discussion groups from a selection of key topics. Each session will be chaired by an industry expert who will facilitate an exchange of opinions, essential experiences and learning related to a current aspect of clinical trial supply.

Lunch

Keynote: Building a supply chain project management core competency

Mariam Abdallah
Supply Chain Trial Manager, Clinical Supply Chain
SANOFI-AVENTIS

Case study: Defining import and export regulations, procedures and strategies to run successful global studies

Meeting USDA APHIS requirements for importing Clinical Trial Material (CTM)

Meeting Phase I clinical supply challenges

Understanding importing and exporting requirements when shipping clinical materials to run successful global studies

• Agencies and regulations pertaining to investigational materials
• Departments involved in processing supplies
• Identifying potential and final country list to ensure smooth logistic and distribution processes
• Meeting FDA requirements utilizing 21 CFR 312.120 for exporting non-IND studies
• How to avoid detention of investigational material when importing to the USA
• Current FDA communications on importing to US to prevent the oversight of key necessities

Closing remarks from the Chair

Champagne prize draw