8:35 Effective Strategic & Tactical Integration of Asia in Your Molecule’s Clinical Development Plan

Chet Elias, Senior Manager, Global Regulatory Affairs & Safety, International Expansion, Amgen Inc.
In today’s competitive drug development landscape, it is critical to plan far in advance where to place your clinical studies to maximize enrollment opportunities while at the same time maximizing quality. Since clinical research is generally regulated by the country’s health authorities (i.e., regulatory agencies), it is imperative to engage these regulatory bodies well in advance of the initiation of clinical research. As Asia is becoming a major player in global drug development and clinical research, the health authorities in Asia are getting ever so much more involved. This session will provide highlights of the regional regulatory landscape and provide practical experience on how and when to engage the regulatory agencies to ensure timely initiation and completion of clinical studies.

• How and when to engage with local regulatory agencies

• How to identify potential pitfalls in your drug development program based on potential country selection

• How to leverage regulatory intelligence to minimize approval timelines

• How to minimize intellectual property-related risks in your submissions

9:20 Clinical Trials in India - Phase I

Brijesh Regal, C.E.O., Apothecaries Clinical Research, New Delhi, India (Former WHO Consultant to Drugs Controller General of India, and coordinated the development of Schedule Y)
While Phase I clinical trials are indeed allowed in India – this presentation will go beyond just that. It will provide a practitioner’s perspective of how India as a country and its clinical research stake holders are at phase I of creating infrastructure for global trials. Cutting beyond the hype, the speaker will enlist some key limitations which could turn serious challenges to compliance with GCP requirements in India. Practical India specific nuances, insights and tips will be provided for setting up small, as well as, large trials in the country.

• Potential study sites available in India

• Timelines for setting up trials in India

• Current regulatory nuances and changes in the offing

• How global SOPs may need to be fine-tuned for India

• Import and export regulations for clinical trial material

10:05 Outlook and Global Opinion of Indian Study Data
Kohkan Shamsi, M.D., Ph.D., President & CEO, Acunova Life Sciences Inc. and Director, Symbiotic Pharma Research
Increasing globalization has brought about fundamental changes in the way clinical trials are conducted in India. Adherence of GCP requirements, along with strong international acceptability of research conducted in India (FDA, EMEA & sponsors), has improved the attitude of Indian clinicians towards participation in clinical trials. This presentation will concentrate on the Regulatory aspects to conducting clinical research in India, along with the global opinion of Indian data based on sponsored companies, the FDA and the EMEA.  The following topics will be discussed:

• Why India?
• Regulatory Affairs (DCGI, ICMR, GEAC, DBT, AERB, and other Indian Guidelines)
• Regulatory timelines in India compared to FDA and other countries -Required documents for DCGI (Indian FDA) submission -Opinion of Indian data (Sponsors, FDA, EMEA)

10:20 Coffee Break in the Foyer

11:00 Conducting Phase III and IV Trials in China: Practical Considerations

Mark Engel, Chairman, Excel PharmaStudies
This presentation will offer an overview of lessons learned from conducting multiple phase III and phase IV trials in China. Besides best practices as well as common misconceptions and pitfalls will be discussed under the following topics:

• Regulatory and timing considerations

• Selection and management of sites

• Impact on future sales

11:30 Technology Spotlight
Overview of Drug Development in China
Joanne Jiang, Ph.D., MBA, Vice President, Fountain Medical Development
Why do companies look for China as part of the global development program? Who drives the GCP training and establishes the clinical research expertise in China? How to best position your grand entry into this attractive, but challenging market?
This presentation will focus on these important questions and will provide up-to-date information on clinical study and regulatory landscape in China. This presentation will also provide insights on the commitment of Chinese government on building innovative biomedical research capabilities. As the only CRO supported by Chinese central government, we are leading the effort of China becoming an integral part of the global innovative research and development.

12:00pm Lunch on Your Own

1:00 Chairperson’s Remarks

1:05 Trials and Tribulations of Conducting Clinical Studies in India: Lessons Learned

Navaneetha K. Rao, M.S., Sc.D., Vice President, Clinical Research and Development, Vicus Therapeutics
The key determinants for the successful execution of a GCP compliant study (including the following: well designed protocol, access to good sites and other related personnel, competent project management, regulatory framework and infrastructure) are broadly similar across studies and geographic locations. However, failure to take geographic and related factors into consideration can result in the failure to properly execute even a well designed study. This talk will focus on considerations that are particularly relevant to executing a study (in weight losing patients with end stage lung cancer) in India; suggestions for managing such complex studies will be made and key lessons learned will be discussed.

• Identification and management of CROs and various other vendors

• Subject recruitment

• PI and site management

• Project management (with focus on communication)

• Quality management

Closing Summary and Conclusions: Realistic Opportunities and Main Challenges to Conducting Trials in India, China and Southeast Asia

	Navaneetha K. Rao, M.S., Sc.D., Vice President, Clinical Research and Development, Vicus Therapeutics
	Joanne Jiang, Vice President, Business Development and Project Management, Fountain Medical Development
	Yiyou Chen, Ph.D., Chief Scientific Officer, Crown Bioscience-TigerMed
	Steven J. Potts, Ph.D., MBA, Director, Biopharma, Aperio Technologies