Main Conference Day One, Tuesday, 28 August 2012

Regulatory Updates – Key Implications for Running Early Phase Clinical Trials in Asia

08:30 Registration and Refreshments

09:00 Opening Address and Welcome from the Chairman

09:10 Strategic Planning for Early Phase Clinical Trials in Asia to Optimise Global Clinical Trial Development

  • Understanding the role of early phase trials in Asia
  • How the early phase clinical trials in Asia impacts the later phase trials in the region?
  • Regulatory and market considerations on developing early phase clinical trials in Asia
  • Optimising early phase clinical trials plan to accelerate global clinical development for a multinational company

Hanlim Moon
CEO
CUREnCARE Research

09:50 Examining Strategies to Accelerate Early Phase Clinical Development in Asia

  • Key considerations for country and site selection in Asian markets
  • How to take advantage of the opportunity to conduct early phase trials in Asia?
  • Dos and don’ts in strategic planning of early phase clinical trials involving Asia
  • Crystal balling the future of early phase clinical development in Asia

Melvin Toh
Vice President of Clinical & Regulatory Affairs
CK Life Sciences International

10:30 Morning Tea and Networking

11:00 China - Understanding Regulatory Timelines and Approval Process for Early Phase Trials

  • Understanding SFDA’s requirements of documentation, data and procedures
  • Examining effective strategies to manage timelines and approval in China
  • Key considerations of import and export of clinical products in China
  • Successful case studies of running early phase trials in China

Huichen Liu
Director, Department of Clinical Pharmacology
Aerospace Center Hospital

11:40 India - Key Considerations for Developing Early Phase Clinical Trials: From Registration to Operations

  • Understanding the requirements of documentation, data and procedures for clinical approval
  • How to plan early phase trials in India without FIM
  • (first in human) trials?
  • Examining local facilities and capability for early phase trials – site selection and trial design
  • Analysing the pros and cons of conducting early phase clinical trials in India

Deven Parmar
Vice President - Global Clinical Research
Wockhardt

12:30 Lunch and Networking

Overcoming Scientific Challenges in Conducting Early Phase Clinical Trials to Reduce Trial Failure Rate

13:30 Key Considerations for Conducting an FIH Clinical Trial

  • Review the pharmacological effects observed in toxicology
  • Checking those toxicology findings
  • Learn to be conservative in dosing
  • Advices to non-experienced doctors for conducting an FIH clinical trial

Ling Su
Senior Vice President & Head of Development Greater China
Novartis

14:10 Roundtable Discussion: Pharmacovigilance in Early Phase Clinical Studies - Designing a Streamlined Safety Early Phase Study to Mitigate Risks

This roundtable discussion will allow you more time with your peers to discuss about risk management of investments to EU/US: How it works to mitigate risks. Attendees will be divided into 4 groups. Each group will be led by a facilitator and a speaker from each group will be nominated to share the discussion results.

  • Approaches to safety risk assessment from hazard identification to risk management
  • Prioritising the main risks and taking measures to mitigate them
  • The incorporation of prior preclinical data
  • Ensuring quality assurance of phase one unit
  • Examining how translational and predictive safety modelling is impacting on trial design

Moderated by Chairperson

14:50 Afternoon Tea and Networking

15:20 Strengthen Infrastructure, Enhance Efficiency - How Site Effectively Meet Early Phase Study Objectives

  • Instill accountability among various stakeholders to enhance patient recruitment and patient retention
  • Implementing strategies to achieve operational efficiencies
  • Creating efficiencies by mapping trial objectives to trial management
  • Building a robust clinical trial infrastructure
  • Sustaining standards through investment in people development and facilities upgrading

Joanne Chio
Head of Clinical Trials, Haematology –Oncology Research Group (HORG),
National University HospitalSingapore

16:00 Optimising Trial Design to Reduce Failure Rate and Minimise Costs

  • Approaches to find the dose that is considered to safe and have optimal biologic/immunologic effect (OBD)
  • Assessing the predictability of the early phase trials and the end results – What can be improved?
  • Assessing the reaction of patient and the effect of the dose to make a go or not go decision
  • Optimising biomarker response within safety constraints
  • Managing investments in early stage clinical trials which can make cost savings in the long run
  • Associate Director, Clinical Science

Takeda Pharmaceuticals

16:40 End of Day One and Closing Address by Chairman

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