Programme

Evaluating the performance of the CTS processes using KPIs

• Establishing accurate KPIs
• Calculating the success of the supply chain as a whole
• Ensuring successful supply chain management

Andrea Zobel
Director, Clinical Logistics, Europe, Clinical Research Services
PAREXEL Inc.

and
Graham Nicholls
Product Manager
Perceptive Informatics

Efficient supply chain management through integrated e-clinical solutions

• The challenges in effective supply chain management: a depot perspective
• Using central IP management software across the supply depot network
• Providing a fully integrated approach to supply chain management and drug accountability by integration with IVR/IWR and drug accountability solutions

Simulating optimal clinical drug supply

• Assessing the tools and techniques
• Practical examples: successes and challenges
• Ensuring an accurate drug supply throughout the clinical trial

and
Paul Skerker
Director, Investigational Supply Operations
Millennium Pharmaceuticals

Case study: global drug pooling

• The pooling value proposition
• Regulatory challenges and responses
• Forecasting, IVRS and labelling
• Metrics comparison against non-pooled studies

Exploring CTS: an end user’s perspective

• Taking the needs of the end user into account when setting up the supply chain
• Pitfalls at the end of the supply chain
• Maximising IVRS efficiency and compliance at the user’s level

Chedia Abdelkafi
Director, Clinical Supplies Solutions
N-Side

Balancing costs and risk to optimise the clinical supply chain: a step beyond simulation

• Combining simulation and optimisation techniques to make informed decisions
• A novel approach to supply strategy re-evaluation: applying a Bayesian algorithm to fully leverage IVRS actual data
• Obtaining a production plan and IVRS inventory management parameters as an output: replacing a “testing” approach by an actual optimisation
• Operational considerations: how to effectively assess, implement and utilise a forecasting tool

EU investigator initiated trials: material supply challenges, a perspective

• Different approaches to material supply for EU IITs
• Forecasting and planning: is it possible to get accurate information?
• Distribution: single or multiple shipments?

Practicalities of global depot management

• Ever expanding clinical horizons
• Considerations prior to study commencement
• Best supply chain management practices
• Focusing on controlled substance and cold chain IMP's

Reviewing CTS in emerging countries

• Exploring the challenges and trends
• Difficulties in handling investigational drugs
• What the sponsors and CROs are looking for
• Detailing the benefits of in-country solutions
• Case study: Overcoming regulatory hurdles in China

Sourcing comparators for clinical trials in India

• Exploring the Indian pharma market
• Challenges of procuring comparator drugs
• Reviewing the necessary documentation needed
• Managing the logistics and security of supplying lines

Developing and maintaining a successful sponsor/service provider relationship

• Vendor selection and management
• Clear agreements to avoid pitfalls
• Establishing a personal relationship

Case study: deciding to outsource or work in-house

• Examining internal core competencies
• Objectifying the reasons to outsource
• Taking a long term strategic view
• Communicating with the key players
• Making the decision

Challenges to controlled drug distribution

• Exploring facility licenses to store and distribute narcotic clinical trial materials
• Moving clinical trial materials between countries
• Analysing different country requirements for different schedules of controlled drugs

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.

Patient adherence in the clinic: myth or truth?

• Focusing on the consequences and costs of sub-optimal adherence
• Packaging driven strategies to measure and optimise outcomes
• Best practice techniques to ensure patient adherence

Supplying multilingual labels for increasingly global clinical trials

• Constructing a multilingual label
• Establishing efficient processes to achieve the best results
• Meeting a wide range of regulations in one design

Tackling packaging challenges for clinical trials

• The need for compliant packaging with maximum flexibility for modification
• Assessing outsourcing to contract manufacturers
• Producing cost effective clinical trial kits

Jagath Wanninayake
Vice President,
Clarix Products Group
Phase Forward

Leveraging interactive response systems to manage cost and risk around drug reconciliation

• Streamlining the drug reconciliation process by eliminating multiple data entry and data discrepancies
• Eliminating lag of data visibility with access to real time information: speeding up database finalisation
• Mitigating risks and improving compliance through electronic signatures and edit/logic checks

Modifying the clinical supply chain to accommodate adaptive trials

• Understanding how adaptive trials will impact on CTS
• Adjusting current procedures to facilitate adaptive trials
• Ensuring flexibility in the supply chain to support adaptive trial design

Adaptive trial design: optimising the clinical supply process

• Analysing adaptive trial impact on trial management
• Reviewing drug production and inventory strategies and drug supply implications
• Resource needs for adaptive trial designs
• Cost of adaptive design trial drug supplies (vs standard design trials)