8:15 Welcome Address And Chairperson’s Opening Remarks

8:30 Opening Panel Discussion: Building Risk Management Into Your Clinical Trial Logistics

• Developing best practice risk management and joined up solutions-based thinking
• Identifying and then measuring/assessing risks and developing strategies to manage them
• Displaying a tried and tested risk management framework
• Delivering beginning to end clinical logistics management lowering costs and improving compliance and efficiency in all aspects of clinical trial supplies
• Managing import/export requirements, coordination of drug supplies from manufacturers, distribution, drug return and destruction, and inventory management

Panelists:

9:15 Due Diligence In Emerging Markets (EM)

• Examining emerging outsourced clinical trial markets
• Understanding effective contract negotiations with EM partners
• Discovering how to structure and implement quality agreements with partners in EM
• Displaying structure of the partnership for a positive outcome for both parties
• Addressing challenges in communication, time zones, and culture
• Evaluating options for CMO options in EM
• Displaying specific details on a current project in EM

Mark Walls
Director, Clinical Pharmacy
Human Genome Sciences

10:45 How To Avoid Common Mistakes And Pitfalls For Clinical Trial Logistics Challenges In Emerging Countries

• Identifying potential consequences of poor risk mitigation frameworks when considering an overseas project and contingency planning to ameliorate them
• Balancing clinical product integrity, quality and cost
• Understanding the cultural challenges of your new marketplace and how to ensure on time delivery
• Appreciating the High value of quality agreements and why it is essential to collaboratively put them in place with your partner organizations
• Examining techniques to retain and replace talented team members at home and abroad
• Showcasing successful and unsuccessful overseas deployment of Clinical Supplies Logistics

Steve Jacobs
President, Global BioPharm Solutions and former CEO
Bilcare Global Clinical Supplies

11:30 Factors To Consider When Deciding On Internal Vs. External Clinical Manufacturing

• Self Evaluation of Internal capabilities: Capacity, equipment, systems, technical expertise/core competencies and timing
• Project Development Cycle: Phase of project, probability of commercialization and probability of future formulation/process changes
• Optimization of entire clinical supply chain
• KPI’s vs. Critical Success Factors (Long term vs. Short term views)
• Using external Clinical Manufacturing as beginning of commercial Secondary Sourcing Process
• Managing organizational expectations/Involving the whole team
• Legal and Regulatory Implications: Time required for CDA’s/MSA’s, time required for QA Audits, role of QP, quality agreements, filings and import/exports

Michael Colacino
Director, Clinical Manufacturing
Genzyme Drug & Biomedical R&D

2:00 Panel Discussion: Effectively Addressing Challenges Of Storage And Transportation Of Clinical Supplies

• Becoming aware of regulatory requirements both domestically and internationally
• Understanding successful handling of clinical supplies
• Overcoming import/export shipping challenges
• Developing and streamlining packaging, pre-qualification and transportation strategies
• Managing and working successfully with your partnering organizations – Aligning an approach together

Panelists:

3:15 Interactive Global Distribution And Storage Strategies Roundtable Discussions

After a jam-packed day of big picture keynotes, panel discussions, case studies, and presentations, the Clinical Trial Logistics gives you the chance to meet and brainstorm with small groups of your peers during our interactive roundtable discussions. This is a great opportunity to make valuable contacts from your area of interest, and to deep-dive into the tricky details that you may have missed in the course of the day’s sessions.

Round Table Discussions include:

• Setting up a distribution process – focusing on overcoming cold chain challenges - Kevin O’Donnell, Director & Chief Technical Advisor, Tegrant Corp., ThermoSafe Brands & Chair, IATA Time & Temperature Task Force
• Complying efficiently with global regulatory bodies
• Discussing depot selection and management in emerging markets - Steve Jacobs, President, Global BioPharm Solutions and former President, Bilcare Global Clinical Supplies
• Managing supply volumes and overage for individual sites

4:00 Passive Packers Problems: Conditioning Gels And Bricks Prior To Shipment (Case Study)

• Problem Statement: My refrigerated shipment using refrigerated gels and a refrigerated truck never reached anticipated Temperature
• Root Cause Analysis
• Iterative Studies
• Gel conditioning study
• Successful shipment

Alfred L. Mottram III
Associate Director, Drug Supply and Materials Management
Medarex Inc.

4:45 Chairpersons Closing Remarks And Close Of Conference