11:10 Utilizing and Integrating Global Clinical Study Data from China to Mutually Support Global and Local Applications in Order to Benefit Unmet Medical Needs

James Cai, M.D., Vice President, R&D and Business Development, AstraZeneca Pharmaceuticals, China
In this session, James Cai will talk about the development strategy and achievements of clinical development for multinational corporations・products in China in the past a few years, focusing on:

• Talent development and capacity building

• Investigator motivation and quality control

• Working together with regulatory authority to extend the horizons of clinical research

• And, most specifically, how to utilize and integrate data to support global and regional applications

11:40 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.

12:10pm 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

12:40 Technology Spotlight (Sponsorship Available)

1:10 Walk & Talk Luncheon in the Exhibit Hall

2:15 Chairperson's Remarks

2:20 Emerging Hub for Global Clinical Trials "India: The Ideal Choice"

Kamala Rai, M.D., Research Director, MSD Pharmaceuticals Pvt Ltd; Medical Director, Merck (India)
A number of global pharmaceutical companies and global CROs are increasing their ground operations to leverage the India potential. Also, with English speaking investigators, a large number of treatment naive patients and ability to enroll a large number of patients in a relatively short span of time have been the topics of interest. This presentation will focus on the critical success factors and opportunities for the next decade.

• Demonstrating key success factors (time, cost and quality) at an Indian site

• Planning for the first milestone "the first patient screened"

• Training of site and monitoring team in protocol approval to last patient -last visit activities