8:35 Designing and Planning Trials in India, China and Southeast Asia: A Western-Asian Business Model

Ulrich Elben, Ph.D., Chief Development Officer, Avaant Pharmaceuticals, Inc.
Avaant Pharmaceuticals is an example of a company founded in India to leverage resources of the Asian hemisphere for drug discovery and development. The presentation will focus on Avaant's experience to combine Western activities with Asian activities for clinical trials. By doing so, Avaant optimizes resources and costs of emerging and existing territories for drug development.

• Incorporate Asia in your early strategy

• Set up multinational studies with the focus on Asia

• Optimize your operations between USA, Europe and Asia

9:05 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

9:35 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 Technology Spotlight (Sponsorship Available)

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 Initiating HIV Clinical Trials in India
Ronald Gugliotti, Director, Clinical Development, Achillion Pharmaceuticals
Emerging countries continue to be limited in their ability to provide access to all HIV drugs currently approved to treat HIV infection. However, these emerging countries are continuing to evolve in their ability conduct clinical trials that meet the regulatory and clinical standards required by agencies such as the US Food and Drug Administration (FDA). Controlled clinical trials result in participating patients having access to new therapies in the context of a scientifically an d ethically controlled clinical trial. The learning experience benefits all parties (investigators, patients, and regulators) across political and economic lines and allows access to potentially new therapies to patients in need. The clinical, regulatory and cultural issues encountered during the initiation of Phase 2 HIV clinical trial will be discussed.

12:00pm Luncheon Workshop (Sponsorship Available) or Lunch on Your Own

1:00 Chairperson's Remarks

1:05 Are You Ready for an FDA Inspection?

Cherif Benattia, M.D., Vice President, Pharmacovigilance & Public Health, Vertex Pharmaceuticals
One of the challenges India (and China) is facing today is the credibility in terms of procedures, SOPs, and compliance (GCP, etc) that ensure the quality of data. A strong "audit" system needs to be developed to be ready to face FDA and other regulators・ inspections. How to prepare for FDA inspections and for audits in Asia and other sites in your global operation is key to making sure your investment in clinical trials in these regions supply the quality of data desired. The only way these regions will succeed is by making sure the quality of data generated there by sponsors and their partners is at least at the same level of that from the West. There is no doubt to the quality of work investigators do there. However, some progress is needed in terms of procedures, documentation, and compliance.

1:35 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
	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.
	Kamala Rai, M.D., Research Director, MSD Pharmaceuticals Pvt Ltd; Medical Director, Merck
	Ronald Gugliotti, Director, Clinical Development, Achillion Pharmaceuticals
	Ulrich Elben, Ph.D., Chief Development Officer, Avaant Pharmaceuticals, Inc.