09:00 Opening Address and Welcome from the Chairman

09:10 Analysing the Challenges and Development Trend of Translational Strategy in Early Phase Clinical Trials

• What must change in the industry to efficiently achieve human target validation
• The challenge: Understanding the science vs rapidly progressing the drug in development
• The role of animal models in guiding clinical development

Danny Soon
Managing Director & Principal Investigator, Lilly-NUS Centre for Clinical Pharmacology
Singapore

09:50 Translational Strategy: Aligning Preclinical Models with Clinical Strategy

• Analysing the role of translational research and the impact on clinical strategy
• Effectively measuring preclinical models to better serve early phase clinical practice
• Examining preclinical data required for FIM to
• PoC: PK/PD, safety and efficacy
• Key considerations for first in human study and patients behaviour outcome measures
• Developing translational development strategies and commercial viability

Dr. Joalin Lim
Director of Regulatory Affairs
Anidan Group

11:00 Understanding Target Engagement in Planning an Early Phase Study to Reduce Trial Failure Rate

• Analysing Methods of detecting target engagement in clinical trials
• Approaches of candidate pharmacodynamic measures of target engagement and disease modulation
• Assessing target engagement and biologic effect
• Linking target engagement to a meaningful change in a clinical endpoint

Akhilesh Sharma
VP & Global Head of Clinical Management & Global Pharmacovigilance
Dr Reddy's Laboratories

11:40 Examining the Value of Different Primary Endpoints in Early Phase Trials to Control Cost and Speed Up Time to Market

• Choosing the most suitable primary endpoint to ensure positive implications for cost control, funding, licensing and reimbursement
• Determining the viability of overall survival as an achievable endpoint
• Analysing potential pitfalls of ending points selection
• Outlining experiences on how to select a good primary endpoint

Christine Dela Cruz
Director, Global Clinical Research – Oncology
Bristol-Myers Squibb

13:30 Assessing the Implementation of Biomarkers in Early Phase Clinical Trials

• Understanding the types of biomarkers
  • Diagnostic Biomarkers: Early detection biomarkers, Disease classification
  • Predictive Biomarkers: Predict patients likely to respond to a specific agent, Predict patients likely to have an adverse event to a specific agent
  • Metabolism Biomarkers: Dose defining
  • Outcome Biomarkers: Forecast response, Forecast
• Examples of when they have worked well and not so well
• Comparing biomarkers with existing approaches in terms of safety, timelines and cost
• Considerations in biomarker development in FIM trials

Zaiqi Wang
Director of Clinical Research
Singapore MSD Translational Research Centre

Outsourcing and Operation Strategies of Early Phase Clinical Trials in Asia

14:10 Panel Discussion: Outsourcing and Partnership Strategies with CROs

• Examining main trends for outsourcing models for early phase trials
• Analysing the pros and cons of outsourcing and inhouse research for early phase trials
• Key considerations of selecting a local CRO partner considering varies cultures, languages, facilities and resources in different Asian markets
• Assessing advantages and disadvantages when working with the same CRO on both Phase I and II studies
• How do pharma companies maintain appropriate control when studies have been outsourced?

Panellists:

15:20 Reducing Clinical Trial Costs and Timelines through Patient Engagement

• How will your engagement with patients affect your clinical trial costs, success and timeline?
• How to decide your balance of healthy volunteer versus patient studies?
• What can Phase I learn from Phase II patient recruitment?
• Using recruitment projection and triggers in Phase I planning

Rupesh Patki
Regional Area Manager, Asia Global Monitoring Operations
Allergan Singapore Pte. Ltd

16:00 Effectively Designing and Conducting Tumor Marker Study

• Understanding the main challenges of tumor marker study nowadays
• What tumor markers are currently being used, and for which cancer types?
• Analysing the materials and methods of tumor marker study
• Implications for future research and clinical value

Aung Myo
Head of Clinical Development, Cancer Immunotherapeutics, Asia-Pacific(APJEM)
GlaxoSmithKline Biologicals

16:30 End of Day Two and Closing Address by Chairman