Friday, November 16, 2007

KEYNOTE: Overview of the Clinical Landscape in India 
Vinod Mattoo, M.D., Medical Director, Eli Lilly & Company, India

KEYNOTE: An Innovative Approach to Establishing a Clinical Research Presence
in India: The Wyeth Experience 
Dianne C. Kikta, Ph.D., MBA, Vice President and Chief, Global Clinical Team
Operations, Wyeth Research

This experienced-based presentation will highlight the following:

• Factors to consider in establishing a clinical research presence in India
• Logistical reality of setting up a multinational pharmaceutical company clinical research center in India
• Strategic implementation: Challenges and Opportunities
• Going live: Integration into the global organization

Some key learning points from the presentation will be:

• Business models for establishing a clinical research presence in India
• Questions to ask internally before pursuing India as a company clinical research center
• What you need to do on-shore before you begin off-shoring
• Pointers to help avoid pitfalls and ensure success

CASE STUDY: Opportunities for and Challenges of Lead Optimization and Validation in India

• A model for conducting research in India today...and tomorrow
• Logistical challenges in transferring technology, transferring data, and training staff
• Integrating efforts in India with all other worldwide research activities
• Various business models and approaches to building capabilities in India

CASE STUDY: Conducting a Complete Development Program – Integrating Preclinical Animal Toxicology and DMPK
Gopala Krishna, PhD, DABT, MBA, Senior Director and Head, Preclinical Candidate Evaluation, Supernus Pharmaceuticals, Inc.

• A generalized preclinical candidate selection model
• Key questions to be answered for First In Man trial [global IND, for example]
• Reasons and strategies for conducting a complete development program in India, one that includes preclinical development
• Integrating a preclinical development program
• Key questions to be answered from a “preclinical” perspective for NDA or marketing authorization package

INTERACTIVE CO-PRESENTATION: Overcoming the Regulatory Environment Hurdles in Setting up Vivarium and In Vivo Drug Discovery Resource

• Differences in regulatory environment between USA and India
• Cost implications of setting them up in India
• Compliance, accreditation and research validation hurdles

Dr. Suresh Poosala, DVM, M.S., Ph.D., Chief of Comparative Medicine and 
Animal Program Director, GRC/NIA/NIH
Gopala Krishna, PhD, DABT, MBA, Senior Director and Head, Preclinical Candidate Evaluation, Supernus Pharmaceuticals, Inc.

Strategic Planning for Clinical Development Operations in India: Short and Long Term Barriers to Overcome
Mamata Gokhale, Ph.D., Director, Asia Latin America Development Operations, Global Development Operations, Amgen Inc.
Firm commitment and local knowledge are key factors for successful clinical development in India. The Clinical Development Operations should be built around following considerations: 

• Major drivers behind the clinical development in India
• Differences in conducting clinical trials in US vs. in India 
• Advantages, Challenges and Risks in India

CASE STUDY: Challenges and Key Learnings in Placing Early Phase I and II Studies in India
Edward J. Brennan, Jr., MD, FACS, President and CEO, IndiPharm LLC

• Capabilities of Phase I CROs and the structure of these partnerships to date
• Review of patient sites for the early phase (Phase 2A) studies with a focus on oncology studies
• Challenges to the implementation of the Clinical Pharmacology Studies

CASE STUDY: Translational Medicine in India: Update from a Cohort Study in a Major Chronic Disease
Gene Williams, Chief Executive Officer, Cambridge Healthtech Associates
Sudhir Borgonha, M.D., Chief Executive Officer, Translational Medicine India

• Cohort study design and objectives
• Status of bio-analytics capabilities in India
• Patient enrollment and study retention
• Business model and study design to address ethics and privacy issues
• Government policy considerations
• Future prospects for “translational medicine” in India

• Strategies and tactics to establish a clinical development unit in India
• Establishing and utilizing global clinical performance metrics
• Defining and leveraging regional advantages for superior operational delivery
• Understanding the architecture and processes of a successful outsourced global clinical supply chain
• Achieving GCP compliance
• Reviewing potential liability concerns
• Avoiding common outsourcing pitfalls
• Managing partner relationships

Vinod Mattoo, M.D., Medical Director, Eli Lilly & Company, India
Edward J. Brennan, Jr., MD, FACS, President and CEO, IndiPharm LLC
Mamata Gokhale, Ph.D., Director, Asia Latin America Development Operations, Global Development Operations, Amgen Inc.
Sudhir Borgonha, M.D., Chief Executive Officer, Translational Medicine India

CLOSING KEYNOTE: Managing Alliances through Different Phases
Charles Dhanaraj, Ph.D., Associate Professor of Management, Kelley School of Business, Indiana University

Close of Executive Forum

View Day 1