Technology Driving Precision Medicine

Co-Located with Molecular Med TRI-CON Asia

May 28-31, 2013
Marina Bay Sands, Singapore

 

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Thursday, May 30

8:00 Morning Coffee


CLINICAL TRIALS MANAGEMENT 

8:40 Chairperson’s Remarks

Allan Bukuya, Clinical Operations Director, TrialDocs Pty Ltd

8:50 Foundations for a Collaborative Clinical Trial Network in Australia

Stewart HayStewart Hay, Ph.D., Chief Executive Officer, Therapeutic Innovation Australia

The Australian Government has recently provided funding to develop local clinical trial capabilities through an investment into its ‘Translating Health Discovery into Clinical Application’ project. The investments made into this area aim to enhance clinical trial infrastructure with a view to increasing Phase 1 capacity and improving recruitment rates for Phase 2 and Phase 3 clinical trials.

Funding has been specifically applied to enable development of a new Phase I clinical trial centre, three molecular pathology centres and improvements to the capabilities of the Australian and New Zealand Clinical Trial Registry. These investments have been made in conjunction with other investments into preclinical testing, drug discovery and biological therapies. Collectively, these developments will progress Australia towards an integrated translational health research infrastructure roadmap that will accelerate translation of research discoveries and also enhance translational efficiency.

These investments are part of a $100M project managed by Therapeutic Innovation Australia (TIA). TIA aims to provide efficient, transparent and accessible linkages to enable fundamental biomedical discoveries to move toward clinical trials.

9:20 Evolving Clinical Trial Scenario in India: Regulatory, Ethical and Social Issues

Y.K. GuptaProfessor Y.K. Gupta, M.D., FAMS, FNASc, FIPS, FIAN, FST, FIACS, Chairman, Department of Pharmacology, National Scientific Coordinator, Pharmacovigilance Program of India; President, Society of Toxicology, India

India is fast becoming a clinical trial hub because of several favorable factors including treatment naive subjects, less cost, strong IT support and proficiency in English. There have been several regulatory changes towards submission and review of INDs, ethics committee approval, mandatory registration of trials, audits, overseeing mechanisms of trials and ethics committees, and compensation guidelines which are positive steps to ensure the confidence of public and parliament and also to ethical and quality conduct of clinical trial in India.

9:50 Coffee Break in the Exhibit Hall with Poster Viewing

10:40 Managing an Orphan Drug Clinical Trial in China

Ying LuoYing Luo, Ph.D., Chairman, President and CEO, Shanghai Genomics, Inc.; Chairman, Beijing Continent Pharmaceuticals, Inc.

From 2002-2010, Shanghai Genomics filed an IND and later conducted clinical trials on pirfenidone for idiopathic pulmonary fibrosis (IPF) in China. A Class 1.1 Drug NDA was approved by SFDA in China in 2011. IPF trial's major challenge was the lack of accurate diagnosis and the requirement for a relatively longer period of treatment for patients. Special review procedure of SFDA had been applied during the NDA review process. In addition, preparation for other anti-fibrosis clinical trials on both pirfenidone and derivative are still ongoing.

11:00 Clinical Trial Management in Asia: A CRO's Perspective

James Cheong, Vice President, Clinical Development, EPS International

11:20 Introduction to Electronic Trial Master Files (eTMF) and TMF Reference Model

Allan Bukuya, Clinical Operations Director, TrialDocs Pty Ltd

Clinical Trial documentation reflects the quality and compliance of project execution. This course relates to improved document management for clinical trial processes. We will introduce you to developments in clinical trial documentation management and global standardisation of the Trial Master File. Historically we have represented trial management through paper trial master files. We will review aspects of paper TMFs to support greater efficiencies and highlight necessary changes in thinking as our organization transitions to an e-TMF. SImplify your documentation processes, make your content more transparent to colleagues and clients and enhance your document quality.

12:10 End of Clinical Data Management and eClinical Trials



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