| Day, Month and Year 2009? Day 1 |
| 8:30–17:00 |
Registration
|
9:00–12:00
Workshop |
The Role of Lean Six Sigma in the Complex Bio-pharmaceutical Industry
Speakers:
Victor Awafo, Ph.D.
Manager Process Improvement Sciences, Sanofi Pasteur- Canada
Niranjan M Kumar, Ph.D., EMTM
Sr VP, Biotech Manufacturing
Topics:
The framework needed to understand the future of the bio-pharmaceutical industry from an R&D/manufacturing perspective. Understanding how the role of operations now and in the future. Help drive the implementation of Lean Six Sigma. How Lean Six Sigma can help leaders in the bio-pharmaceutical industry succeed and thrive. Understanding how to tailor Lean Six Sigma for different applications including Cost cutting and Yield improvement and Operational excellence in Biopharmaceutical Manufacturing
|
13:00–17:00
Workshop |
Where are we in terms of Globalization of Clinical Trials? Cost and Regulatory Issues and Global Competition?
Speakers: TBD
Agenda:
Biotech and Pharmaceutical companies conduct clinical trials to study the efficacy and safety before releasing the products to the market. This Session provides a practical and study of regulations that govern conduct of clinical research, the responsibilities of sponsors, ethic boards, CROs, investigators and monitors during the drug development and approval process. It includes knowledge of setting up and monitoring of clinical trials at investigational sites and documentation inherent to the process. This workshop is designed for training individuals who would like to get involved in regulatory, clinical affairs, clinical operations and clinical trial management. This is an interactive workshop encouraging participant's involvement.
|
17:00–18:00
Workshop |
|
| |
| Day 1 |
| 08:30 - 17:00 |
Registration(Continued) |
| 08:30 - 9:00 |
Welcome note by GBPCG Co-Chairs
Dr. Madhavan P N Nair
Professor and Chair of Immunology, College of Medicine & Associate Dean of Bio Medical Research Florida International University
Niranjan M. Kumar, Ph.D., EMTM
Sr VP. USA,
|
| 09:00 - 11:00 |
Inauguration
TBD |
11:00–13:30
|
|
| 13:30 -14:30 |
Keynote-1
Globalization of Biotech Business and Opportunity To create Value proposition:
Innovators Perspective & biosimilars Perspective
Speakers: TBD
|
| 14:30 - 15:00 |
Break
|
15:00 - 16:30
Session – 1 |
|
| 16:30 - 17:00 |
Break |
17:00 - 18:00
|
Corporate Presentations |
| 18:00 - 19:30 |
Networking |
| 19:30 - 21:00 |
Dinner |
| Day 1 |
| 9:00 - 9:30 |
Announcements |
| 9:30 - 12:30 |
Synergistic Developments in India and US/Europe
Topics: Collaboration, Partnering, Contracting, Licensing, Globalizing |
| 12:30 - 13:30 |
Lunch |
| 13:30 - 15:30 |
EU & US Regulatory Environment for Biologic products
Speakers:
From EMEA and US FDA
|
| 15:30 - 16:00 |
Break |
16:00 - 18:00
|
The Recent Progress in Global Clinical Trials and Issues
Speakers:
TBD
|
| 19:00 - 21:00 |
Dinner |
| |
9:00 - 9:15
Session 1
Plenary |
Announcements |
9:15 - 10:15
Session 2
Plenary |
|
10:15 - 11:15
Session 3
Plenary |
" |
| 11: 15 - 11:30 |
Administrative Break
|
11:30 - 12:45
Session 4
Plenary |
|
| 12:45 - 14:00 |
Lunch |
14:00 - 15:00
Session 5
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|
| 15:00 - 15-15 |
Administrative Break |
15:15 - 16:15
Session 6
Track Break-out |
|
| 16:15 - 16:45 |
Refreshment Break |
16:45 - 18:15
Session 7
Plenary |
" |
| 18:15 - 19:00 |
Reception and Dinner - Dining and Networking |
19:00 - 21:00
Session 8
Plenary
Panel Discussion in Dining Room |
|
| 21:00 |
Adjournment |
| |
|
| Day |
9:00 - 10.15
Session 9
Plenary |
Biopharmaceutical Manufacturing, Analytical Development and Quality and Regulatory considerations |
| 10:15 - 10.45 |
Refreshment Break
Partnering Part 1: |
10.45 - 12:15
Session 10
Plenary |
"American, European and Japanese Views on Strategic Alliances with Indian and Chinese Companies: Strategic Considerations"
Recent Trends in strategic A & M, partnerships |
| 12:15 - 13.30 |
Lunch |
13:30 - 14:30
Session 11
Plenary |
Biosimilars: Is it future Threat to Innovators?
Opportunities and challenges in Biosimilars |
14:30 - 16-15
Session 12
Plenary |
|
| 16:15 - 16:30 |
Brief Break |
16:30 - 17:15
Session 13
Plenary |
|
17:15 - 18:30
Session 14
Plenary |
Closing Keynote
"The State of Global Biotechnology Industry: Trends and Strategic Opportunities"
Speaker:
Mr. G. Steven Burrill -TBD
CEO, Burrill & Company
Mr. G. Steven Burrill is founder, Burrill & Company, a life science merchant bank based in San Francisco. In addition to its partnering services and media groups, the firm has nearly US $ 1 Billion under management for venture capital investments globally. Before founding Burrill & Company in 1995, Mr. Burrill served as creator and managing partner of Ernst & Young's technology consulting group, and is widely considered as one of the founders of the biotechnology industry. Over the last 20 years he has written and published the annual report on the industry, His presentation will provide an analysis of the global industry with an emphasis on strategies and opportunities. |
18:30
Closing and Adjournment |
Recognition of Sponsors and Thanking note |
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