The Programme

Registration and coffee

Opening remarks from the Chair

Identifying practical approaches to carrying out global clinical trials

• Describing the process
• Outlining key organisational issues
• Setting up realistic timelines
• Ensuring efficient co-operation between all stakeholders
• Measuring performance

Outlining patient recruitment strategies worldwide for cancer studies

• Describing difficulties in accessing sufficient patients
• Explaining strategies to meet the need for resources
• Presenting successful recruitment planning within the global infrastructure

Clinical operations excellence strategies in phase IV oncology programmes

• Facts and key objectives
• Key clinical operations trends
• Key initiatives

The ever changing world of data management

• The ever expanding search for patients, including treatment naïve patients
  • The need to seek out remote geographical sites to find these patients
• The increasing complexity of studies
  • Adaptive Trials
  • Evolutionary Trials
  • Increasing role of external data

Ridwaan Jhetam
MD, MBA, Clinical Operations Head: Oncology, Senior Director: J&J Global Clinical Operations
JOHNSON & JOHNSON

Debating organisational and cost issues related to adaptive trials

• Explaining adaptive trials and their benefits
• Assessing logistical and statistical difficulties to be considered
• Is it cost-effective in the long-term?

Phase IV and beyond: post-authorisation safety surveillance studies and non-interventional trials

• Discussing the changing paradigms and regulatory post-approval commitments in oncology
• Anticipating regulatory post-marketing obligations in oncology: risk management plans 
• Complying with the new German and European guidelines for non-interventional trials
• SAE reporting, surveillance for new safety signals in routine use
• Registries for rare diseases - a way forward?

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 trials in oncology

Registration and coffee

Christof von Kalle
MD Director
NATIONAL CENTRE FOR TUMOUR DISEASES
Heidelberg, Head of Department, Translational Oncology GERMAN CANCER RESEARCH CENTRE (DKFZ)

Opening remarks from the Chair

Explaining oncology trial design issues

The assessment of drug-drug interaction in drug development

• Relevance of drug interaction in safety evaluation
• Definitions and types of drug-interaction
• Assessment of risk for drug-interaction
• Critical issues for in vitro and in vivo studies
• Selection of drug interaction studies

Preparing regulatory quality clinical study reports based on data from compassionate use studies

• The challenge of designing studies for an emergency intervention product (glucarpidase, Voraxaze^TM, carboxypeptidase G2) where the patients arise infrequently and need to be treated promptly
• Studies managed by the US National Cancer Institute and Charite – Universitätsmedizin Berlin
• The process of collecting, cleaning and monitoring data
• Reporting data to support an FDA submission
• Outlining the lessons learned

Discussing an oncology first-in-human study

• Preparing the first-in-human study in cancer patients
• Designing the first-in-human study
• Translating first-in-human study to phase II development

Early clinical development in oncology: a biotech approach

• Protocol and design development: make the most of available data
• Going to emerging countries or staying in Western countries
• Partnering with the right CRO

Clinical trials in oncology: an evolving collaborative process

• An overview of clinical trials in oncology from a practical perspective
• Reviewing some recent developments as experienced by ORION Clinical Services
• How these developments may impact on future clinical studies
• Some cautious predictions

Combining therapeutic vaccination with chemotherapy: learning from a randomized phase IIb study in non-small cell lung cancer

• Combining therapeutic vaccination against tumours with polychemotherapy: antinomy or rational motive?
• Case study: randomised phase IIb trial in advanced non-small cell lung cancer
• Discussing clinical and biological results

Development of an immunotherapy approach in oncology targeting the innate immunity

• Gamma delta T lymphocytes functions and rationale for an immunotherapy approach in cancer
• Identifying targets through pre-clinical development
• Challenges in establishing dose and dosing schedule
• Specificities of clinical trials at the early development stage

Providing key study endpoints with imaging

• Outlining key endpoints provided by imaging
• Describing established methods to assess response
• Explaining the independent radiology review process
• Describing novel imaging methodology and where it can benefit exploratory development

Afternoon refreshments

Utility of biomarkers in oncology drug development

• Utility of biomarkers in early stage clinical studies
• Exploring the benefit of biomarkers that predicts response to therapy
• Challenges in developing therapy response biomarkers

Points to consider in the early clinical development of a targeted drug

• Selecting the safe starting dose and escalation scheme
• Subject eligibility: healthy subjects or patients, target-selected or unselected?
• Validating the assay for the target
• Early clinical development of AEZS-108 as a case study

Case study from phase I to phase III: targeted therapy for malignant tumours with the TGF-beta 2 inhibitor AP 12009

• Target selection: therapy with the TGF-beta 2 inhibitor AP 12009
• Risk mitigation in phase I in four tumour indications
• Innovative phase IIb clinical trial in brain tumours
• Successful proof of concept in active controlled and dose finding phase IIb study in recurrent or refractory high-grade glioma
• Phase III study design based on phase II results

Closing remarks from the Chair and end of conference