Clinical Trial Supply

Venue l Registration

Programme

Day One | Day Two

Agenda
DAY ONE: TUESDAY OCTOBER 18 TH 2005
08.30	Registration and coffee
09.00	Opening remarks from the Chair
09:10	Delayn S. Haynes Senior Director Global Supply Chain PFIZER GLOBAL R&D	Case study: aligning global clinical trial supplies processes Define the need for aligning the supply of Clinical Trial Supplies with the Clinical Development organization Identifying and utilizing a project management system to align processes Aligning project management and change management across the organization
09:55	David Russell Project Manager, Investigational Products ASTRAZENECA	Case study: implementing a global clinical supply chain system A background on the project: organization, scope, and desired benefits Determining global user system requirements Vendor selection options and process Process development, implementation and lessons learned Expectation management Cultural impacts, global working and consensus building
10:40	Morning refreshments
11:00	Dr. Gabriele Roth Global Head Roche Internal Systems, GCP Auditing (PDQA) ROCHE IVRS	Case study: global systems QA strategy of IMP distribution Assurance of proper management of Investigational Medicinal Product (IMP) distribution Impact of recent regulations governing medicinal products (including EU Regulations) Cross-functional GxP QA strategy: from good manufacturing via good distribution to good clinical practice Audit and non-audit tools
11:45	Todd Kole Director of Operations CLINPHONE	Case study: using IVR (Interactive Voice Response) technology to reduce clinical supply waste in titration clinical trials Dose titration clinical trials: where clinicians are allowed to individualize a patient's dosage or medication regimen based on efficacy or side effects at the time of the patient visit Understanding the difficulties of managing dose titration clinical trials from a supply chain perspective Managing the unpredictability of actual CTM requirements under ‘normal’ circumstances and when there are limited supplies Two case studies describing the real-world use of IVRS to manage limited CTM
12:30	Lunch
2:00	Lisa Ortega Manager, Investigational Supply, Planning & Logistics ALLERGAN	Case study: our e-Clinical status – implementing SAP, CTMS & IVRS Identifying the critical success factors and key benefits to drive our e-Clinical initiatives Utilizing SAP for clinical inventory management, demand planning and shipment orders Implementing clinical trial management systems for regulatory document management, patient recruitment and drug management Assessing the impact of using Interactive Voice Response Systems (IVRS) from the perspective of clinical supplies
2:45	Eric Bergmann Director of Logistics, Clinical Supply Services CARDINAL HEALTH	Cold chain distribution of clinical trial supplies Ensuring validation throughout the chain Managing GMP within the cold chain Innovative packaging solutions Measuring the performance of your cold chain
3:30	Afternoon refreshments
3:45	Charles Blenner R.Ph, Senior Project Manager COVANCE	The mutual impact of clinical protocol design and drug inventory management
4:30	Delayn Haynes Senior Director Global Supply Chain PFIZER GLOBAL R&D	Day 1 Panel Discussion Speakers from the day will review the major topics, questions and debates raised throughout the presentations, share experiences and take further questions from the delegate audience.
5:00	Closing Remarks from the Chair
5:05	End of Day One & Drinks Reception Delegates are invited to join the speakers, sponsors and exhibitors at an informal drinks reception.

DAY TWO: WEDNESDAY OCTOBER 13 TH 2005
08.30	Registration and coffee
09.00	Opening remarks from the Chair
09:10	Tor Ramsland Associate Director, Strategic Procurement and Operations CHIRON	Case study: initiating and executing a clinical supply chain management improvement program Identifying our current challenges to ensure the accurate and timely supply of materials for clinical trials at Chiron Lessons learnt from process mapping our previous systems Examining the decision-making involved, steps taken and elements that were focused on when developing the improvement Program Outlining the challenges ahead and the expected benefits of the program
09:50	Leon Wyszkowski Director of Operations CLINTRAK PHARMACEUTICAL SERVICES	Identifying the efficiencies to be gained in ID and Release testing of CTM through the use of electronic systems
10:30	Morning refreshments
10:50	Eileen Sullivan Associate Director, Clinical Supplies JANSSEN PHARMACEUTICALS	Developing cross-functional teams to improve supply operations Enhancing communication between clinical and packaging Developing a refined path from early protocol development to final packaging The "Early On" approach, what is best to know early on, how early is too early Team involvement: How do you obtain team support, how to implement support Marketing expertise, how to help and not hinder current processes The ever-changing world of clinical supplies, how to keep up with communication in an ever-changing environment, best practices
11:40	Kunal Jaiswal Associate Director, Clinical Supplies SCHERING PLOUGH	Managing expectations for drug supply delivery A description of the challenges faced in delivering domestic / international supplies, e.g. EU CT Directive, Label Approvals and Protocol Changes Benefits of a "gated" Clinical Supply Agreement with Clinical / Medical colleagues to manage expectations - in an environment where demand is near (or exceeds) capacity of the clinical supply group Description and utility of a Clinical Supply Agreement Translating demand to forecasts for Operations Group Materials Management, Manufacturing, Packaging, Analytical, QA and Distribution
12:20	Lunch
2:00	Jim Krupa Associate Director, Clinical Pharmacy WYETH-AYERST RESEARCH	Solutions, challenges and regulatory considerations for blinding and testing comparator clinical supplies What are the most successful ways to blind clinical supplies for solid dosage as well as liquid or powders? Competitively sourcing comparator products within short timeframes Release and stability testing Evaluating the cost-efficiency of using CROs for testing of comparator products
2:40	Jim Benkendorf Executive Vice President XERIMIS	Managing the clinical labeling process for international trials Guidance for the efficient management of the label text design, approval and production process of multi-lingual labels for international trials Sourcing of translations, regulatory review and approval of text and the management of timelines Analyzing the benefits and drawbacks of the use of booklet labels including their impact on bulk drug supply and depot inventory levels
3:20	Jim Krupa Associate Director, Clinical Pharmacy WYETH-AYERST RESEARCH	Day 2 Panel Discussion Speakers from the day will review the major topics, questions and debates raised throughout the presentations, share experiences and take further questions from the delegate audience. This session will be chaired by:
4:00	Closing remarks from the chair
4:10	Afternoon refreshments & champagne draw
4:30	End of conference

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