Biotech China 2014
Second Annual Drug Development India : Planning and Managing Drug Discovery & Development Activities Nov(15-16)
Park Hyatt Philadelphia Hotel
200 South Broad Street
Philadelphia, PA
http://www.healthtech.com/2007/pci/index.ASP
Second Annual Drug Development India : Planning and Managing Drug Discovery&Development Activities
Cambridge Healthtech Institute  
Park Hyatt Philadelphia Hotel
Philadelphia

Event Sponsors

Schedule of Presentations:

Thursday, November 15, 2007
07:30:00 Morning Coffee and Conference Registration (07:30-08:15)
08:15:00 Organizer’s Welcoming Remarks (08:15-08:30) Micah Lieberman
08:30:00 STRATEGIES FOR PARTNERING AND OUTSOURCING (08:30-10:30) Rajiv Gulati, Brijesh Regal, Antal K. Hajos
08:30:00 STRATEGIES FOR PARTNERING AND OUTSOURCING: Critical Components of Successful Entry Strategy (08:30-09:10) Rajiv Gulati
09:10:00 STRATEGIES FOR PARTNERING AND OUTSOURCING: R&D Service Organization to International R&D Network Partner: Survival Strategies for a Captive R&D Center in India (09:10-09:50) Antal K. Hajos
09:50:00 STRATEGIES FOR PARTNERING AND OUTSOURCING: Indian Regulatory Landscape: Terra Incognita (09:50-10:30) Brijesh Regal
10:30:00 STRATEGIES FOR PARTNERING AND OUTSOURCING: Networking Coffee Break (10:30-11:00)
11:00:00 SMALL COMPANY PERSPECTIVES (11:00-12:15) Debra Harris, Dileep Bhagwat, Vijay Ramakrishnan
11:00:00 SMALL COMPANY PERSPECTIVES: Building an Innovation-Driven Biopharmaceutical Startup with a US/India Drug Discovery and Development Model: Issues and Considerations (11:00-11:25) case study Vijay Ramakrishnan
11:25:00 SMALL COMPANY PERSPECTIVES: A Small Molecule Discovery Company’s Experience in Leveraging India for R&D – Clinical, Regulatory, GCP and Operational Considerations (11:25-11:50) Dileep Bhagwat
11:50:00 SMALL COMPANY PERSPECTIVES: SMALL COMPANY PERSPECTIVES: Radiolabeling in India: A Business Deal with the Department of Atomic Energy (11:50-12:15) case study Debra Harris
12:15:00 SMALL COMPANY PERSPECTIVES: Luncheon and Strategic Solutions Presentations (12:15-13:30)
13:30:00 CONTRIBUTION OF ACADEMIC INSTITUTES (13:30-15:00) case study Erich Wohlhieter, Brian K. Ramey, David Johnston, Matthew T. Reding, Raja Ram, Omar Vikin, Gangadhar Sunkara
13:30:00 CONTRIBUTION OF ACADEMIC INSTITUTES: Pharmaceutical Research and Development Environment in India: The Contribution of Aca-demic Institutes (13:30-14:00) case study Gangadhar Sunkara
14:00:00 CONTRIBUTION OF ACADEMIC INSTITUTES: The Battle for Supply Chain Improvement in India: Hurdles, Lessons and a Ongoing Process Improvement Approach (14:00-14:20) case study Omar Vikin
14:20:00 CONTRIBUTION OF ACADEMIC INSTITUTES: INTERACTIVE PANEL Supply Chain Challenges and Solutions to Reduce Cycle Time (14:20-15:00) Erich Wohlhieter, Brian K. Ramey, David Johnston, Matthew T. Reding, Raja Ram, Omar Vikin
15:00:00 CONTRIBUTION OF ACADEMIC INSTITUTES: Networking Refreshment Break (15:00-15:30)
15:30:00 PRECLINICAL DEVELOPMENT AND CHALLENGES: Conducting a Complete Development Program Integrating Preclinical Animal Toxicology and DMPK (15:30-16:00) case study Gopala Krishna
15:30:00 PRECLINICAL DEVELOPMENT AND CHALLENGES (15:30-18:45) case study Nils Heldt, Pankaj Shah, Rajiv Gulati, Antal K. Hajos, Sudhir Borgonha, Gene Williams, Suresh Poosala, Gopala Krishna, Gangadhar Sunkara
16:00:00 PRECLINICAL DEVELOPMENT AND CHALLENGES: CO-PRESENTATION : Overcoming the Regulatory Environment Hurdles in Setting up Vivarium and In Vivo Drug Discovery Resource (16:00-16:30) Gopala Krishna, Suresh Poosala
16:30:00 PRECLINICAL DEVELOPMENT AND CHALLENGES: Conducting Proof of Concept Clinical Programs in India (16:30-17:00) case study Sudhir Borgonha, Gene Williams
17:00:00 PRECLINICAL DEVELOPMENT AND CHALLENGES: INTERACTIVE PANEL :Partnership and Outsourcing Deals in India – Successes and Failures (17:00-17:45) Rajiv Gulati, Nils Heldt, Pankaj Shah, Antal K. Hajos, Gangadhar Sunkara
17:45:00 PRECLINICAL DEVELOPMENT AND CHALLENGES: Networking Cocktail Reception (17:45-18:45)
18:45:00 PRECLINICAL DEVELOPMENT AND CHALLENGES: Close of Day One
Friday, November 16, 2007
07:30:00 Breakfast Workshop or Morning Coffee (07:30-08:15)
08:15:00 PROTECTING AND MANAGING YOUR IP: Chairperson’s Remarks (08:15-08:20)
08:15:00 PROTECTING AND MANAGING YOUR IP (08:15-09:10) Janet M. McNicholas, Mak Jawadekar, Gregory E. Kalbaugh
08:20:00 PROTECTING AND MANAGING YOUR IP: INTERACTIVE CO-PRESENTATION:Global Intellectual Property (IP) Strategy and IP Legislation: Current Trends and Progress in India (08:20-09:10) Janet M. McNicholas, Mak Jawadekar, Gregory E. Kalbaugh
09:10:00 CLINICAL DEVELOPMENT AND OPERATIONS (09:10-14:45) Kohkan Shamsi, Edward J. Brennan, Mamata Gokhale, Dianne C. Kikta, Vinod Mattoo
09:10:00 CLINICAL DEVELOPMENT AND OPERATIONS: Best Practices for Navigating the Clinical Landscape in India (09:10-09:50) Vinod Mattoo
09:50:00 CLINICAL DEVELOPMENT AND OPERATIONS: An Innovative Approach to Establishing a Clinical Research Presence in India: The Wyeth Experience (09:50-10:30) Dianne C. Kikta
10:30:00 CLINICAL DEVELOPMENT AND OPERATIONS: Networking Coffee Break (10:30-11:15)
11:15:00 CLINICAL DEVELOPMENT AND OPERATIONS: Strategic Planning for Clinical Development Operations in India: Short and Long Term Barriers to Overcome (11:15-11:45) Mamata Gokhale
11:45:00 CLINICAL DEVELOPMENT AND OPERATIONS: Challenges and Key Learnings in Placing Early Phase Studies in India (11:45-12:15) case study Edward J. Brennan
12:15:00 CLINICAL DEVELOPMENT AND OPERATIONS: Quality in Clinical Trials from an Indian Perspective (12:15-12:30) case study Kohkan Shamsi
12:30:00 CLINICAL DEVELOPMENT AND OPERATIONS: Luncheon and Strategic Solutions Presentations (12:30-14:00)
14:00:00 CLINICAL DEVELOPMENT AND OPERATIONS: INTERACTIVE PANEL:Outsourcing Globally and Executing International Trials in India (14:00-14:45) Mamata Gokhale, Edward J. Brennan, Dianne C. Kikta, Vinod Mattoo
14:45:00 CLINICAL DEVELOPMENT AND OPERATIONS: Networking Refreshment Break (14:45-15:30)
15:30:00 MANAGING GLOBAL ALLIANCES FOR SUCCESS (15:30-17:00) case study David Johnston, Nils Heldt
15:30:00 MANAGING GLOBAL ALLIANCES FOR SUCCESS: A New Roche Collaboration: Partnering in India and Identifying the Right Candidate to Sup-port Clinical Development Operations (15:30-16:00) case study Nils Heldt
16:00:00 MANAGING GLOBAL ALLIANCES FOR SUCCESS: A New Roche Collaboration: Establishing an R&D Center in India as Part of a Global Strategy to Accelerate the Drug Development Process (16:00-16:30) case study David Johnston
16:30:00 MANAGING GLOBAL ALLIANCES FOR SUCCESS: Chairperson’s Closing Remarks (16:30-17:00)
17:00:00 MANAGING GLOBAL ALLIANCES FOR SUCCESS: Close of Executive Forum close of day two
4th Annual Pharma R&D Asia Congress
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