11:10 Clinical Research Landscape in India

Chandrashekhar Potkar, M.D., Director, Clinical Research, Pfizer Ltd. (India)
The clinical research environment in India is going through a major change. Over the last 3 years, pharmaceutical companies and CROs have scaled up research activity in India. Regulatory changes in 2005 have been a key enabler. Even though there is a substantial interest in India, the current volumes are around 1-2% of global volumes of studies. This presentation, the speaker will review the clinical research landscape, 
                   analyse the reasons for this gap and identify areas of focus going forward.

11:55pm Optimizing Return on Investment (ROI) of Multinational and Domestic Clinical Trials in China

Min Irwin, MD, Ph.D., Medical Director of BSP China, Bayer HealthCare Company Ltd.
According to Chinese regulations, clinical trials in Chinese people have to be conducted
before any new medicine can enter the market. The questions to be addressed are: how to choose the best strategies to ensure early involvement of China in global programs of drug development, how to discover an innovative model to overcome regulatory hurdles, and how to build a high-performing global medical team to achieve desired objectives and results. It is essential to understand the unique environment in China to conduct clinical trials, including the length of time for regulatory submissions and early CTA approvals, site selection and relationships, site training and timelines.  Replicating a global protocol for a Chinese clinical trial may not be the best practice in a rapid growing market and working closely with local experts will ensure the best design to meet the Chinese needs

 1:10 Walk & Talk Luncheon in the Exhibit Hall

2:15 Chairperson’s Remarks
Y.K. Gupta, Head, Dept. of Pharmacology; Coordinator, Zonal Pharmacovigilance Centre, All India Institute of Medical Sciences, New Delhi, India

2:200 Accelerate Oncology Clinical Development in Asia

Michael Shi, Director and Biomarker Project Leader, Exploratory Oncology Development, Novartis Oncology
Some Asian countries offer a highly attractive way to accelerate oncology clinical development programs. These countries have extra large centers by Western standards, rapidly growing clinical trial infrastructure and have been successful in contributing to global Phase II and Phase III clinical trials. An emerging opportunity is also on the horizon to conduct exploratory proof-of-concept studies in some Asian countries/regions.

• Key opportunities and challenges in oncology development in Asia-
  Pacific regions

• Incorporate Asia-Pacific countries into the global development plan

• Define key success factors in oncology development in Asian countries

• Select the optimal clinical sites for exploratory oncology trials

3:050 Roles and Functioning of Institutional and Independent Ethics Committees in India

Y.K. Gupta, Head, Dept. of Pharmacology; Coordinator, Zonal Pharmacovigilance Centre, All India Institute of Medical Sciences, New Delhi, India
The role of ethics committee, both institutional and independent, begins from the inception of the clinical trials and continues through its completion. With India being the destination for clinical trials, the importance of ethics committees is increasing. Schedule Y and guidelines for biomedical research on human participants by Indian Council of Medical Research define the composition and responsibilities of Ethics Committees in India. Attendees will learn:

• Composition, roles & responsibilities of Institutional and Independent Ethics Committees

• Standard operating procedures for Ethics Committees in India

• Status of ethics committees in India

• Teething problems faced by ethics committees and their possible solutions

Utilizing and Integrating Local Clinical Data from Asia to Mutually Support Global and Regional Applications

	Moderator: Michael Shi, Director and Biomarker Project Leader, Exploratory Oncology Development, Novartis Oncology
	Chandrashekhar Potkar, M.D., Director, Clinical Research, Pfizer Ltd. (India)
	Min Irwin, MD, Ph.D., Medical Director of BSP China, Bayer Health Care Company Ltd.
	Mark Engel, Chairman, Excel PharmaStudies
	Ajoy Kumar, M.D., Chief Executive Officer, Neeman Medical International (Asia) Ltd.
	Reiko Nishiguchi, MS, MBA, Asia Clinical Trials Manager, Aperio Technologies, Inc.