CONFERENCE DAY TWO – WEDNESDAY 28 MARCH 2012 |
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| 08.30 |
Registration and refreshments |
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| 09:00 |
Opening remarks from the Chair |
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| PATENT SCENARIO
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| 09:10 |
Determining the number of patents due to expire in the next
decade and establishing the optimal time to capitalise on these
opportunities |
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- Investigating the patent scenario in the Indian and international markets and
understanding the opportunities to enter these markets
- Determining the potential of expired patents in the Indian market to maximise
your investment in R&D
- Clarifying the patent complexities in the areas of product, process,
formulation and cell system
- Establishing the implications of infringement and possible solutions around
existing infringement laws
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Rustom Mody,
Chief Scientific Officer
Intas biopharmaceuticals |
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Adda Gogoris,
Partner
Merchant Gould |
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PRODUCT QUALITY |
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| 09:50 |
Evaluating techniques and overcoming complexities to develop
a higher standard quality of biologics |
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- Understanding the latest regulatory protocols on the quality aspects of
biologics
- Demystifying various complexities and clarifying necessary criteria to maintain
quality
- Managing timelines to implement a cost-effective quality system in your
organisation
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Nishodh Saxena,
Technical and Regional Director
Pharma Insight |
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| 10:30 |
Morning refreshments and networking |
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| 11:00 |
PANEL DISCUSSION: |
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Overcoming the complexities in identification, development,
manufacturing and commercialisation of biosimilars to develop
a good quality product |
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- Exploring the strategic priority of biosimilars and biobetters novel molecules
to evaluate their potential in future
- Examining the latest risk-based approaches and mitigation strategies to
develop a technical and commercial perspective of biosimilars for Asia, US
and EU markets
- Assessing the latest advancements in biosimilars regulations to implement in
the early stages of product development
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Moderator: |
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Ms Mahadevan,
Director,
Strategic Marketing, ProcessSolutions Business Unit
Merck Millipore |
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Sandeep Raktate,
Director
Mabpharm |
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Patrick Bennett,
Director, Marketing, Life Sciences Mass Spectrometry
Thermo Fisher Scientific |
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| MANUFACTURING CHALLENGES |
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| 11:40 |
Robust approaches and scale-up strategies in the
biopharmaceutical manufacturing process to meet the
biosimilar demands of the domestic and international markets |
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- Understanding scale-up goals for a typical biosimilars process
- Evaluating scale-up strategies from development to manufacturing and
integrating single-use concepts in the process
- Assessing the process economics from development to manufacturing
- Developing an integrated solution to build a world class manufacturing
facility
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Ms Mahadevan,
Director, Strategic Marketing, ProcessSolutions Business Unit
Merck Millipore |
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| UPSTREAM CHALLENGES |
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| 12:20 |
CASE STUDY
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Overcoming complexities in the upstream process to improve
your biosimilar product quality |
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- Determining the validation process as per the latest regulatory guidelines to
develop a robust upstream process
- Evaluating the requirements to minimise the impact of raw material on
process and product recovery
- Understanding the effects of lot-to-lot variations in raw materials to improve
productivity
- Assessing the usage of antibiotics in the upstream process to eliminate
impurity and improve overall product quality
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Rashbehari Tunga,
General Manager,R&D Biotech
Cadila Pharmaceuticals |
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| 13:00 |
Lunch and Networking |
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| 14:00 |
Identifying the key attributes of cell line characteristics for the
effective development of biosimilars for your organisation’s
requirements |
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- Understanding the differences in the characteristics of bacterial and
mammalian cell culture
- Navigating the various process and technology requirements to fast track the
development of the cell line
- Managing cost implications in cell line development to minimise cost when
the volume of upstream increases
- Developing skill sets required to meet industry standards for developing cell
line characteristics
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Bala Reddy,
Head, Biologics Operations
Hetero Drugs |
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| 14:40 |
Maximising your fermentation and cell line capacity by building
robust scale-up strategies in your upstream process |
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- Establishing a strong vector system to improve the productivity of your current
upstream process
- Addressing complex scaling-up issues to increase your fermentation and cell
line capacity
- Taking preventive actions to minimise any failures occurred in the scale-up
process
- Identifying types of chemicals to be used in the scale-up process to avoid
corrosion of equipment
- Determining precautionary steps to avoid mishaps while moving from the
process R&D to the manufacturing stage
- Tackling fermentation issues with respect to microbial and mammalian cell
culture in the scale-up process
- Applying the latest Quality By Design (QBD) techniques to develop robust
scale-up strategies
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Mk Sahib,
Director Genomics and Biotechnology
Wockhardt |
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DOWNSTREAM CHALLENGES
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| 15:20 |
Overcoming the challenges in the throughput purification
process to achieve a robust and cost-effective downstream
process |
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- Understanding the differences between host cell protein and residual DNA
processes for an effective downstream process
- Devising cost-effective techniques to minimise the losses occurred in the
purification process
- Reducing the bioburn steps in the purification procedures to achieve optimum
downstream process
- Selecting the right resins for the purification process to increase overall yield
in the downstream process
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Sandeep Kale,
Assistant Professor
Centre Of Energy Biosciences UICT |
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| 16:20 |
Close of Conference Day Two |
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