Clinical Trials Oncology

Development of personalised cancer therapies - what can we learn from rare cancers?

• Introducing the need for the personalised approach
• Review of the challenges of developing treatments for rare cancers
• Using early clinical data to help predict benefit and enrich your study population
• Co-development of biomarkers & companion diagnostics
• Developing collaborations across industry and academia to foster innovation
• Summarising the future for personalised medicine

Mohamed Raza Dewji, Director, GSK

Overcoming the challenges associated with early drug development to influence decision making earlier on in your cycle

• Uncovering disease hyper-segmentation at the molecular level to pave the way for a fresh new way of thinking
• Highlighting the effects of redundancy, plasticity and reactivity of biological systems to ensure
successful development of your drug
• Overcoming the challenges to cope with resistance to minimise the potential for increased costs
• Outlining the use of biomarkers in the clinical decision making process to speed up delivery of your trial
• Reviewing the potential impact of different classes of biomarkers to aid your decision making process
• Evaluating the level of qualification and validation of biomarkers required to support your clinical decision

Dr. Elisabeth Oelmann, Senior Director, Early Oncology, AstraZeneca

Revealing the criteria needed to select the right biomarker and guarantee the right patient population

• Examining the diversity of patient populations and sub categories within these in order to highlight the advances in personalised medicine
• Understanding the importance of stratification of the patient population to aid the effectiveness of your trial results
• Developing a system that allows you to identify biomarkers to predict the needs and risks of each individual patient so that interventions could become pre-emptive
• Highlighting the molecular signatures for patients who are not likely to respond to standard care to avoid delay furtherdown the trial chain
• Utilising clinical characteristics and molecular profiling techniques in order to match the correct patient to the correct treatment, maximise benefits and reduce cost
• Identifying the methods used to guarantee the correct biomarker is used for your trial; learning from experience to identify what has worked well in the past

Steen Knudsen, CSO and Founder, Medical Prognosis Institute

Highlighting the impact of biomarkers within the trial process to aid effective decision making on your drug

• Understanding the importance of the inclusion of biomarkers in early phase clinical oncology studies in order to build an early hypothesis for patient selection
• Outlining the various types of data that can be generated to minimise risk to the project later down the line
• Highlighting the principles employed to ensure that the inclusion of your biomarker is fit for purpose and will conclude in a valuable contribution to the study
• Assessing the feasibility of including a biomarker in the trial to ensure all preliminary expectations can be met and delivered during the trial
• Devising a biomarker strategy to plan for any unforeseen circumstances that may arise throughout your trial and ensure the contingency plan is underway
• Identifying the need for close collaboration between scientists, physicians and biostatisticians to ensure optimal integration and the highest chance of success

Rob Berg, Director Clinical Research Internal Medicine Early Stage development, Merck Sharp & Dohme

Using non-IMPs (nIMPs) in global trials

• Examining the purposes for which IMPs may be used
• Reviewing the regulatory framework
• Outlining case studies to comprehend the process
• Establishing opportunities for your organisation

Kay-Christian Karstadt, Managing Director, Multipharma

Molecular targeted agents in combination with radiotherapy in solid tumors - A pharmaceutical industry perspective

• What is the pharmaceutical view on radiotherapy combinations where more than 50% of all cancer patients receive radiotherapy for curative intent
• What are the pitfalls and issues on radiotherapy combinations with molecular targeted agents
• What endpoints?
• How should the trial design look like?
• Comparison between chemotherapy and radiotherapy combinations

Ozlem U. Ataman MD PhD, AstraZeneca Radiation Oncology Combinations Clinical Lead (ROCKIT)

Cardiovascular endpoint data in evaluating Risk benefit considerations in Oncology drug development

• Background and trends associated with cardiac safety in Oncology drug development
• Case study review of specific class/compound from a cardiac safety perspective
• Overview of cardiac safety trial design and methodologies

Jeff Helibraun, Director, Strategic Development, CoreLab Partners Inc

Moving from the classical site monitoring techniques to electronic data monitors; best practice to achieve a smooth and fully integrated process

• Establishing current practice and identifying the reasons for why this needs to be changed to save you time in the long-term
• Identifying novel monitoring techniques to aid your clinical process and take up less time
• Encouraging successful integration between clinical monitors, sites, and lab staff to minimise miscommunication and ensure everyone is working to a common goal
• Establishing the need for close contact with the data monitors to be certain that every request is answered in a timely manner
• Anticipating and preparing for the common issues should they arise to achieve a smooth and successful trail process
• Developing and executing a comprehensive monitoring plan to avoid any errors should they arise

Gaspar Amat, Country Study Manager, Roche

Protocol development and site selection, an integrated approach to accelerate study start up and improve recruitment

• Developing and executing a comprehensive study start up plan very early in the planning phase
• Highlighting the importance of feasibility not only for patient recruitment but also for protocol development
• Understanding the advantages of having a patient focus during the trial planning phase, working with oncologists in the field and not only with key opinion leaders
• Building up a motivated trial team with open and honest communication to maximise the value of the trial

Jorg Rennecke, Director Operations, Orion Clinical Services

Overcoming the challenges involved when selecting your site to maximise the potential for your trial

• Investigating the use of a forecasting tool that will pave the way to greater planning and delivery of results
• Identifying the need for local labs in clinical trial sites for oncology patients to determine the necessary mechanisms that should be put in place to minimise unwanted study complications
• Encouraging greater collaboration between the central site and local sites to minimise errors of interpretation of study results
• Ensuring the site of choice is maximising the pre-selected patient population to reduce the drop out rate
• Outlining how best to achieve a means of standardised reference values to ensure clarity of interpretations and results
• Transforming the usual communication techniques employed into transparent and understandable communication to minimise the potential for misunderstanding

Alun Pinnegar, GMO Country Head, Novartis Pharmaceuticals

Translating translational medicine into the clinical trial setting to prevent the disappearance of great ideas

• Building bridges from basic research to analyse the methods of how best to aid the process of drug development
• Understanding the biological reasons for transfer development of your drug to understand how best to utilise your drug in clinical practice
• Explaining the importance of ""cross-talk"" between research experts and lab experts to find a common platform that will encourage the continuous feedback loop of experience and knowledge
• Unravelling the integration of researchers and scientists in practice when following forward with translational medicine, to discover how this could improve your trial process
• Stressing the importance of continual integration between the two groups to ensure the generation of ideas are not forever stuck in the preliminary phase and are pulled into the development process
• Revealing the future for translational medicine: what we can learn from and how best to achieve this given our current knowledge in this field

Timo Schinkoethe, Professor for Tumourbiology, University for Applied Science Bonn-Rhein-Sieg

Outlining the expectations of the study investigator to ensure that expectations are delivered in a timely manner and overestimation of study results does not occur

• Outlining the medical affairs role in clinical trials to ensure that expectations are delivered in a timely manner
• Defining the role and function of medical affairs to help aid confusion over this title
• Exploring the involvement of medical affairs within clinical trials to ensure thorough engagement
• Collaborating between various teams and across functions to ensure tasks are completed in a timely manner
• Liaising with the CRO to produce better communication back and fourth
Inputting academia knowledge to ensure collaboration
• Outlining clinical trials within oncology in the Nordics
• Displaying opportunities and challenges along with future perspectives

Benedikte, Akre, Medical Sciences Manager, Bristol-Myers Squibb

Day Two

Issues and opportunities in early drug development; How can big and small pharma work together?

• Outlining some of the key challenges in early drug development - lessons from the past decade
• Reviewing the molecular re-definition of disease - examples from oncology
• Exploring Hypersegmentation, redundancy and plasticity of biological systems - the challenge for drug development
• Scrutinising how will we develop new treatments that are affordable and re-imbursed?
• Looking at future perspectives - lessons from other worlds

Alan Barge, Chief Medical Officer, ASLAN Pharma

How do we make the most of technology to enhance the clinical trial process in oncology?

• Mapping technology onto a complex trial
• Understanding the impact on roles and the regulatory landscape
• Exploring how we can use technology as a true facilitator to better research and not a barrier
• Technology does not remove risk; how roles change for the better when technology is optimally used
• Looking to the future - what might we see based on increasingly complex protocols

Emma Banks, CEO, Datatrial

Proving fair product value to sustain innovation in an evolving pharmacoeconomic framework in cancer supportive care

• Introducing the challenges of novel therapies entering the market in the face of financial decline
• Outlining the current value-focused pharma paradigm as a key to future success
• Overcoming the barriers to traditional regulatory and payer mindsets to prevent beneficial treatments from reaching the market
• Illustrating true value to achieve a favourable pricing profile and continue delivering innovation
• Evaluating the value to the patient to accurately assess product worth
• Obtaining a fair pricing position to recover development costs and continue investing in innovation

Fiona Cilli, Clinical Project Leader, Actogenix

Imaging in oncology clinical trials: A key leverage on late phase success rates and costs

• Identifying adequate endpoints and criteria to better assess a new molecule
• Reducing data loss and collection burden while improving data quality to decrease trial duration and operational costs
• Reducing the variability of measures for better outcome quality and decision making
• Empowering investigator sites with advanced and standardized image analysis capabilities, therefore reducing the need of independent review and associated related issues

Nicolas Dano, Business Development Manager, Median Technologies

Overcoming the impact of FDA regulation on the future of clinical trials in oncology to aid your drug research and development process

• Uncovering the latest implications and challenges facing oncology drug development today
• Clarifying the increased level of bureaucracy associated with trial development to ensure planning takes place at the outset
• Providing an overview of the efficacy requirements for new targeted cancer therapies on the market in the new era of personalised medicine
• Highlighting the impact of trial duration and costs to allow for better forecasting and planning prevention
• Defining the future of clinical trials in the face of changing regulations

Robert Morgam, Senior Vice President, Regulatory Affairs & Quality/ Pharmaceutical Development, Ziopharm Oncology

Emerging markets: Overcoming the barriers to allow for effective planning and execution of your trial

• Designing a criteria method for selecting regions for specific cancer trials to ensure that you have benefitted your trial process
• Analysing and assessing the qualifications of a site and prioritisation necessary to execute you trial within the given timescale
• Learning from best practice: first hand experience of running oncology trials in Asia to enable a smooth process for when you decide to take the plunge
• Encouraging proactive behaviour with your investigators in emerging regions to allow a continuous flow of communication
• Identifying the logistical challenges when conducting oncology clinical trials in emerging regions and how to overcome these to benefit your future trial
• Outlining how to manage data collection in emerging regions and across multiple locations to avoid chaos and disorganisation in your trial process

Steve Moses, VP Technical Operations, NovaRX