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Day 1,
Thursday, November 16
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Pre-Conference Tutorial:
Evolution of Intellectual Property Management and Trends In India –
An Indian Pharmaceutical Industry perspective
(separate registration
required)
7:30 am Pre-Conference Registration and Morning Coffee
8:00 Facilitator’s Welcome and Opening
Remark
India is one of the fastest growing economies in the world. To augment economic growth, India has evolved to understand the importance of Intellectual Property Management
(IPM) in a global context and has established a legal framework with supporting laws to establish a Product Patent Regime.
The Pre-Conference Tutorial will focus on the evolution of Intellectual Property Management
(IPM) in Indian Pharmaceutical Industry, which can be broadly studied and understood in four phases:
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Early stages (1950-1970),
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Process Patent Era (1970-1994),
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Product Patent, Transition Period, TRIPS Implications (1995-2004)
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Product Patent Regime, Protection & Implementation (Trends post 2005)
The Workshop attendees will gain an understanding of
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Patenting system in India
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Patent protection and execution of Inventors’ rights in India
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IPM experience of an Indian Company, an internal perspective
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IPM viewpoints of an Indian Company as a Collaborator/Outsourcing partner of Global Innovator
Pharma/Biotech, a case study
11:30 Close of Pre-Conference Tutorial
(separate registration
required)
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Main Conference
11:00 am Main Conference Registration
12:15 pm Chairperson’s Opening Remarks
| Keynote |
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12:30 Opportunities and Pitfalls of Establishing an R&D Service Organization in
India
With India becoming a global hub of Pharma R&D, a pure outsourcing model versus establishing an own organization becomes a major strategic decision. This case study reviews the learning’s from a 5-year period of strategic partnering and subsequent establishment of a fully-owned R&D service unit in India by a European MNC. The session will
review:
- The Indian R&D business environment from a Western MNC
perspective
- Successful strategies to get operations started
locally
- Trends and local competition: Infrastructure and
staffing
- Expectation management, interfacing to the global organization and communication needs.
Antal K. Hajos, Ph.D., Managing Director, ALTANA Pharma Pvt.
Ltd.
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| Keynote |
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1:15 Understanding Key Drivers so to Best Leverage Emerging Markets to Develop Novel Drugs: Contract Manufacturing and General Regulatory Considerations
This presentation will cover manufacturing of biologic products in the 21st
century. A brief description of applicable Food and Drug regulations related to contract manufacturing will be given. Also, validation procedures and efforts to meet standards in the manufacturing of biologics using examples from laboratory research will be discussed.
Audience will learn about:
• Basic aspects of R&D and product development
• Concept of contract manufacturing
• Regulatory oversight by sponsors
• Expectations of product specialist at the time of pre-approval inspection
of manufacturing site
• How to control or minimize objectionable conditions at the sponsor’s and
contract manufacturing sites
Subhash Dhawan, Ph.D., Senior Investigator and Chief, Immunopathogenesis Section, Laboratory of Molecular Virology, Division of Emerging and Transfusion Transmitted Diseases, Center for Biologics Evaluation and Research, US Food and Drug Administration
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2:00 Regulatory Landscape, Clinical Trials,
and Drug Registration in India: Opportunities and Challenges
• Regulatory dynamics in India and Asia
• Benefits and challenges in conducting clinical development activities in
India
• Clinical trials requirements
• Drug registration process
Romi Singh, Ph.D., Director, Global Strategic Regulatory Development, Merck & Co., Inc.
3:00 Afternoon Refreshment Break
(Sponsorship Available)
| Interactive
Panel |
3:30 Planning a Global Strategy around IP Protection, Compliance and Leverage
• India’s strength in providing Global Pharma’s needs for outsourcing/charting
the Asia Frontier
• Areas of growth, challenges & opportunities for India
• I.P.-related changes in India & advantages for India’s pharma growth
• India’s rapidly changing pharma landscape
Facilitator:
Mak Jawadekar, Ph.D., Director, WWPM, Pfizer Global R&D
Panelists:
Sri Mosur, Chief Executive Officer, Jubilant Biosys
James Freeman, Ph.D., Vice President Laboratory Sciences, Pfizer Global R&D
Gregory E. Kalbaugh, Associate Director and Counsel Intellectual Property,Trade and Labor, US-India Business Council, US Chamber of Commerce
Dr. Prasad Patala, R&D Business Development, Orchid Chemicals & Pharmaceuticals, Ltd. |
4:30 Strategies for Creating Successful Alliances and Licensing/Outsourcing Partnerships
The presentation will talk about the current status of drug discovery and development in India and relate it to licensing and business development. The strategic role of R&D licensing and partnership in a company’s growth and success, various licensing and alliance opportunities, and how to create winning partnerships that are
productive and good for both partners will be discussed.
• Various licensing and partnership opportunities
• How to identify suitable partners
• Negotiations
• Alliance management
• How to become partner of choice
Shyam Bishen, Ph.D., MBA, Vice President, Global Strategy & Development,
Ranbaxy Laboratories Limited
5:00 Driving Innovation through Capital Markets
Today, the Indian economy is transitioning from traditional farming and handicrafts to modernized industries and services. Healthcare innovation is evolving also as the country leverages its strength in manufacturing and ventures into more ambitious areas such as biopharmaceuticals and
biogenerics. So, how do you create innovation in India? Of course, you need great ideas, scientists and people. Then, you need access to affordable money which can be provided through capital markets. The methods of obtaining capital come with pros and cons.
• What are the benefits and drawbacks of borrowing from banks or venture capitalists?
• What is the good and bad involved with hitting the public markets through
IPOs?
• What are the risks and rewards of entering into a strategic alliance with one of the big pharmaceutical companies?
George W. Bickerstaff, Managing Director, CRT Capital Group LLC and former Chief Financial Officer, Novartis
5:30 Networking Cocktail Reception
(Sponsorship Available)
6:30 Close of Day One
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