Programme Day One
Monday 29 November 2010
Registration
Medical Director
CancerPartnersUK
Chairman’s welcome address – Essential, cutting edge developments from the forefront of the personalised treatment revolution
Principal Pharmacogenetics Advisor to Oncology
ASTRAZENECA
Case study: Effective use of biomarkers in oncology drug development – lessons from the AstraZeneca experience
- Examining the role of biomarker utilisation in drug development
- Understanding the operational implications involved in the deployment of biomarkers in clinical trials
- Exploring the role of biomarkers as tools to enhance / inform clinical decision making– illustrative case studies of Iressa, Selumetinib, and others
- Assessing the future of biomarker applications in oncology – reviewing lessons learned and forecasting potential prospects
Director Oncology Research
IPSEN
Case Study: The right patient associated with the right preclinical model – Colorectal Cancer study performed with the consortium CREMEC
- Understanding the diversity of patient populations and sub-types in order to advise pre-clinical development
- Evaluating drug candidate selection approaches: one preclinical model vs. one collection of preclinical models
- Stratification of the patient population for your trial
- Single drug vs. drug combinations in personalised medicine – evaluating the “add-on” approach
Chief Executive Officer
INTERLAB
Examining the procedures and logistics involved in collecting biopsies during clinical trials; learning from experience how to efficiently prepare a clinical trial
- Determining and outlining setup activities in order to anticipate and overcome collection errors and shipping delays
- Assessing the implications of biopsy collection on patient wellbeing and developing strategies to ensure proper biopsy material is collected
- Learning from experience to improve preparedness and to overcome common pitfalls
- Effectively involving and training physicians to ensure continued motivation and guideline adherence
- Evaluating the use of a central laboratory to simplify and streamline logistics, analysis and result reporting
10:30 Refreshments and networking
Medical Advisor Oncology
European Medical Lead Crizotinib
PFIZER
Case Study: Examining the strategies, operations, methods and procedures of a successful biomarker driven development – Novel TKI in NSCLC and it’s implications for personalised oncology treatments
- Outlining procedures to validate pre-clinically identified biomarkers in early Phase I to expedite development
- Exploring alternative Phase I designs when including validated biomarkers of engagement
- Understanding the different approaches to continuous monitoring and maximum toxicity in Phase 1 and assessing implications and realities of these approaches
- Uncovering how to successfully conduct adaptive trials – lessons learned from experience
Senior Director Statistics
CYTEL
Developing optimal statistical design strategies to de-risk oncology drug development
- Making the best use of exploratory studies for early development decision-making
- Exploring statistical methods of adaptive dose-finding for targeted therapies
- Examining the use of adaptive designs under international regulatory guidance
- Maximizing the probability of success of your registration trial through novel statistical design
Panel: Assessing the opportunities presented by the redefinition of the oncology field – evaluating the possibility of practical and structural changes in the light of personalised therapies.
- What is a likely to be seen in the next 5 years in terms of practical implementation of technical and R&D advancements in the biomarker field
- The impact of the personalised treatment era on the funding and reimbursement of oncology drugs – outlining key implications for development
- Forecasting the evolving role of adaptive trials in the next generation of oncology drug development
- Essential regulatory considerations influencing progression – how realistic are they and what are their ramifications for development
- How to maximise your chances of adapting and evolving to embrace a developing environment
The morning will conclude with audience Q&A with the panel – an exclusive opportunity to get your questions answered by experts with first-hand experience of successful targeted drug trials.
Pantelli Theocharous
Senior Clinical Project Scientist (Associate Director)
Ortho Biotech Oncology Research & Development
Johnson & Johnson Pharmaceutical R&D
Identifying the possibilities and pitfalls involved in site selection to maximise the potential for patient recruitment in competitive drug development environments
- Identifying the correct strategy for site selection - properly prioritising the "interesting" and the "productive"
- Effectively sourcing sites with maximum prospective population capacity
- Avoiding the most competitive environments to maximise available candidates
- Increasing the accuracy of realistic recruitment forecasts to facilitate more efficient planning
- Encouraging transparent communication with sites to support effective partnerships
13:00 Lunch and networking
Successfully navigating the regulatory challenges and operational complexities of conducting clinical trials in Europe, north America, and emerging markets
Habib Fakhrai
Chief Scientific Officer
Daniel Shawler
Senior Vice President of Operations
NovaRx Corporation
Case studies and first hand experience of running oncology trials in the US and Canada
- Understanding the key distinctions and requirements of the Canadian and US systems
- Overcoming complications in the implementation and running of North American sites
- Examining feedback received from the regulators and exploring how the lessons learned from this can inform your current and future plans
Habib Fakhrai
Chief Scientific Officer
Daniel Shawler
Senior Vice President of Operations
NovaRx Corporation
Update on US healthcare developments and FDA requirements for successful submissions
- Understanding how recent developments in the USA will impact on your FDA submissions
- Forecasting the likely effects of the changing healthcare system on running clinical trials in the USA – understanding how your trials will likely be affected
Director of Scientific Affairs
Nexus Oncology
Clarifying the necessary components of a successful application to regulators to expedite trial plan approval
- Outlining the fundamentals of a successful application
- Defining elements of a thorough development plan to avoid revisions
- Significant considerations for additional evaluations to have on file
- Turning ambiguous regulation into comprehensible objectives
- Defining what is required of an adaptive Phase II-III combination application
- Examining the impact of the most recent EMA review on your application
15:30 Refreshments and Networking
FOCUS AFTERNOON
Through examples drawn from India, Russia and China, learn from direct and personal experiences what the real possibilities and drawbacks are when conducting your oncology trials under non-western regulatory systems and in culturally diverse clinical settings.
Fully understand the true value offered from a variety of international settings through examination and in-depth analysis of cost, patient access, data quality, reliability of information, and common procedural complications, directly from the mouths of unbiased operational experts.
Vice President of Technical Operations
NovaRx
Examining the regulatory complexities of emerging markets when conducting oncology trials
- Understanding the whole picture before investing in site investigation
- Uncovering the most suitable opportunities to meet your specific objectives
- Evaluating the most common points of difference when dealing with emerging market regulators
Case study – trial set up and management in India
- Examining the operational implications of the Indian clinical setting
- Determining the extent of procedural complexities and their timeline and cost implications
- Establishing the true quality of information and data provided
Russia and China; the promise and the reality
- Evaluating the possibilities and drawbacks of conducting oncology clinical trials in China and Russia
- Developing effective strategies of research and investigation to establish the true value of non-western clinical settings
- Lessons learned from clinical exploration in Russia and China – cautionary advice to prevent costly mistakes
Emerging markets; do the benefits really outweigh the costs?
- Maximising your chances of clinical success whilst minimising costs – striking the correct balance through a well informed, thoroughly planned, and intelligent approach to clinical trial strategy
17:45 Close of day one
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