|
Biosimilars World Summit Monday 17 Nov 2008
|
9am | Organiser’s welcome remarks
|
9.05am | Chairman’s opening remarks
|
| A GLOBAL PERSPECTIVE ON BIOSIMILARS |
|
9.15am | Opening Keynote: Opportunities and challenges for biosimilars in the global market: Achieving success in the biosimilars business
- Uncovering the potential- why are the emerging markets worth a look?
- Challenges in developing biosimilars for the global market
- Strategies to achieve success in global biosimilars business
|
| | Dr Salah U. Ahmed, Executive Vice President, Global Research and Development and Chief Scientific Officer, Barr Laboratories
|
9.45am | Overcoming the challenges in developing biosimilars in China
- Current status and upcoming trends in biosimilars development in China
- Analysing the differences between biosimilar protein therapeutics and biosimilar antibody therapeutics
- What are the challenges of biosimilar research and development at pre-clinical and clinical stages?
|
| | Dr Jian Ni, Chief Executive Officer & Chief Scientist, Human Antibodomics
|
10.15am | Morning refreshments
|
| DEVELOPING AND MANUFACTURING BIOSIMILARS IN INDIA |
|
11am | Case study: Zenotech’s strategy in commercialising biosimilars: Succeeding in the Indian market and beyond
- Emerging trends in the global biosimilars industry
- Zenotech’s experience in commercialising biosimilars and breaking into the Europe market
- Overcoming the challenges Indian biotechs face in producing biosimilars
|
| |
|
11.30am | Case study: Intas Biopharmaceuticals’ journey from biosimilars to innovation: What does the future hold?
- Intas’ business model in biosimilars and novel biologic products
- Weighing investment in biosimilars versus innovation
- Differences in commercialisation strategies
|
| |
|
12pm | Networking luncheon
|
| NAVIGATING THE REGULATORY LANDSCAPES IN EUROPE AND USA |
|
1.30pm | Best practices in securing EMEA approval for your biosimilars
- Overview of the development of EMEA guidelines on follow-on biologics
- Procedures for the registration of your biosimilars in EU
- Managing the requirements for comparability assessment, non-clinical and clinical data
|
| |
|
2pm | Biosimilars regulatory issues in US: When will the road be clear?
- Current status and development of biosimilars regulation in US
- What does the US FDA really think?
- Technical challenges for the approval of biosimilars
- What is the next step after the approval of Omnitrope?
|
| |
|
| CHRACTERISATION & COMPARABILITY OF BIOSIMILARS
|
|
2.30pm | Immunogenicity assessment of biotechnology derived therapeutic proteins
- Regulatory expectations for assessing immunogenicity
- Common assay techniques used for assessment of immunogenicity
- Challenges in development and validation of these methods
- Immunogenicity studies for follow-on-biologics
|
| |
|
3pm | Afternoon refreshments
|
3.30pm | Tools for the analysis of glycosylation patterns in biosimilars: Are the twins identical or fraternal?
- Why is glycosylation so complex?
- State-of-the-art for glycosylation pattern analysis
- Current challenges and prospects
|
| |
|
| THE BIOSIMILARS BUSINESS |
|
4pm | Panel discussion: Just how lucrative is the biosimilars business as compared to that of innovative biologics?
- Evaluating the cost of producing generic biologics versus innovative biologics
- With the highly extensive characterisation studies required and lengthy approval time, what is the profit margin for biosimilars?
- How much ROI can biomanufacturers achieve from producing and marketing biosimilars?
- What are the strategies that be adopted to enhance economy?
|
| | Moderator: Dr Salah U. Ahmed, Executive Vice President, Global Research and Development and Chief Scientific Officer, Barr Laboratories
|
4.45pm | Chairman’s closing remarks
|
5pm | Close of pre-conference day
|
5.30pm | Welcome cocktail reception
|
|
DAY ONE: 18 November 2008 Tuesday
|
8am | Registration and refreshments
|
8.30am | Organiser’s welcome remarks
|
8.35am | Guest-of-Honour address by Government of India / Government of Andhra Pradesh
|
9.05am | Chairman’s opening remarks
|
| CAPITALISING ON INDIA’S GROWING BIOPHARMACEUTICAL MANUFACTURING INDUSTRY |
|
9.15am | Opening Keynote: Propelling India’s biopharmaceutical production for the future
- Current trends and developments in India’s biopharmaceutical manufacturing industry
- Identifying rising opportunities in US, Europe and Asia
- Crystal-balling the future of India’s biomanufacturing industry
- Maintaining competitiveness in the global biopharmaceutical scene
|
| | Sri B.P. Acharya, Chairman & Managing Director, A.P. Industrial Infrastructure Corporation Ltd.
|
9.45am | Biopharmaceutical manufacturing in India: A different perspective
- Partnerships versus operating your own manufacturing facility in India- pros and cons
- With the rising cost and shortage of expertise, is India still an attractive biologics manufacturing destination for foreign industry players?
- How do the biopharmaceutical business opportunities in India compare to other parts of Asia?
|
| |
|
10.15am | Morning refreshments
|
| PARTNERSHIP AND STRATEGIC ALLIANCES |
|
10.45am | The role of philanthropy and partnerships in global health
- The mission and objectives of the Gates Foundation
- The structure of the organisation
- The areas of focus of the Foundations activities
- The various partnership models for engaging with the Foundation
|
| | Mr Kanwarjit Singh, Senior Programme Officer, Policy & Finance, Bill & Melinda Gates Foundation
|
11.15am | Achieving win-win partnerships with India’s biotech/biopharm companies to accelerate biologics development and strengthen marketing power
- Drivers and values in biopharmaceutical alliances between Western and Asian companies
- Strategic partnership models to tap into India’s growing biopharmaceutical industry
- Framework for structuring and executing strategic alliances with Indian players
|
| |
|
11.45am | Panel discussion: Licensing and risk sharing partnerships as drivers for growth for Indian biopharma/biotech
- Evaluating the need for licensing and partnership to accelerate the development of biologics for the Indian and global market
- Risk sharing as an evolving drug development business model in India
- How can Indian companies seeking licensing partners make their products and technologies more attractive to foreign players?
|
| | Moderator: Mr Gerhard Klement, CEO & President of Biopharmaceuticals, Reliance Life Sciences
|
12.30pm | Networking luncheon
|
| OUTSOURCING BIOMANUFACTURING TO INDIA |
|
1.30pm | Global trends and development in biopharmaceutical contract manufacturing
- Expanding existing manufacturing facilities versus outsourcing- when should you outsource?
- Economic analysis of outsourcing biopharmaceutical manufacturing
- Comparing contract manufacturing landscapes in US, Europe, China and India
- Will India be the global contract manufacturing hub within the next decade?
|
| |
|
2pm | Selection of CMO and strategies in outsourcing to India
- Designing a suitable manufacturing strategy based on your company’s requirements
- Selection of CMO for scale-up and manufacture
- Overcoming the hurdles in outsourcing to India
- Best practices to structure a deal to ensure long-term commitment and mutual satisfaction in an outsourcing relationship
|
| |
|
2.30pm | Case study: Commcercial aspects of outsourcing from Asian CMO
- Global outsourcing model for biologics
- CMO selection criteria and the process
- Business mode and strategies for Asian CMOs to meet the requirements of multinationals
- Opportunities and risks in operating a CMO for biologics
|
| | Dr Umesh Dalvi, Senior Director of Global External Manufacturing, Bristol-Myers Squibb
|
3pm | Afternoon refreshments & speed networking
|
4pm | Best practices in streamlining technology transfer for outsourced biomanufacturing
- Analysing the challenge of changing production environments
- How to ensure efficient technology transfer to CMO when clients have not manufactured at full scale?
- Understanding the manufacturing technology as well as client’s strategy for product development
- Achieving strong communication between client and CMO
- Preparing for regulatory requirements
|
| |
|
| INDIA CMO PARADE |
|
4.30pm | Representatives from India CMOs are welcome to share their views of India’s contract biologics manufacturing industry and give case-study presentations!
Speaking slots are limited and running out fast! To reserve a speaking opportunity to showcase your company’s CMO services, please contact Jill Tan at jill.tan@terrapinn.com or +65 6322 2705 today!
|
5.15pm | Chairman’s closing remarks
|
5.30pm | Close of day one
|
6pm | Seafood extravaganza dinner
|
|
DAY TWO: 19 November 2008 Wednesday
|
9am | Chairman’s opening remarks
|
| EXPRESSION SYSTEM AND PROCESS CHANGES |
|
9.15am | Uncovering the potential economic advantages in high-yielding microbial expression system
- Comparing the classical utilisation of microbial versus mammalian systems and the resulting products
- Engineering a high-producing microbial system to secrete humanised protein
- Assessing the positive impact on the cost of production and therapy
- Analysing the future directions in microbial production
|
| |
|
9.45am | Strategies in minimising risk and impact in process changes
- Challenges associated with making process changes in the development of biological product
- Effect of process changes on product quality and safety profile
- Strategies for minimising the risk/impact and controlling glycosylation
- Discussing analytical methods for comparability studies
|
| | Mr Swapnil Ballal, Head of Biopharmaceutical Bulk Manufacturing, Intas Biopharmaceuticals
|
10.15am | Morning refreshments
|
| DOWNSTREAM PROCESSING |
|
11am | Downstream processing of monoclonal antibodies – An overview of current practices and future directions
- A review of downstream platform processes and methods adopted by various groups to address specific issues/challenges that have led to differences in their platform processes
- A discussion on the impact of the recent advances in cell line development / cell culture on downstream processing, and the further improvements needed to cater to upstream changes
- Challenges associated with the incorporation of parvovirus retaining filters in mAb processes as well as developing UF/DF processes to deliver very high concentration drug substance
|
| |
|
11.30am | Overcoming the limitations in platform technology to increase efficiency and economy in high-titre antibody production
- Analysing the current limitations in platform technology for high-titre antibody purification
- Developing short- and long-term strategies to deal with high-titre production without compromising economy and purity
- Future challenges in downstream processing
|
| |
|
12pm | Networking luncheon
|
| DISPOSABLE TECHNOLOGY |
|
1.30pm | Retrofit of disposables to existing antibody manufacturing process
- Consideration factors in switching to disposable system- economy, validation and limitations
- Impact of changing production equipment from stainless steel to single-use on current manufacturing process
- Case study on the successful implementation of disposable technology to existing antibody production
|
| |
|
2pm | Panel discussion: Single-use technologies in biologics manufacturing: Practical and validation aspects
- Applications of disposable technology from cell culture to filling and formulation- benefits and challenges
- Validation aspects- what needs to be done and the effects on implementation time
- How disposable technology has reduced manufacturing costs
|
| | Moderator: Mr Swapnil Ballal, Head of Biopharmaceutical Bulk Manufacturing, Intas Biopharmaceuticals
|
3pm | Afternoon refreshments
|
| MANUFACTURING STRATEGIES & PLANNING |
|
3.30pm | Effective management of a biologics manufacturing facility and product development
- Identification of a product and setting up of manufacturing system
- Creating better products with new intellectual property
- Maintaining a competitive edge and profitability
|
| |
|
4pm | Global Trends in Biopharmaceutical Plant Design
- Visual factory, Lean factory and Disposable Equipment factory
concepts
- Latest GMP considerations in cell culture factory design
- Equipment trends and offsite fabrication concepts
- Latest Commissioning and Validation concepts
|
| | Marc Pelletier, Director, Strategic BioPharm Solutions Group, CRB Consulting Engineers
|
4.20pm | Designing and construction of a large scale multi-product facility for contract manufacturing
- Start up and the design of quality systems
- Formation of multi-disciplinary project teams
- Staffing and training of personnel
- Manufacturing processes in facility
- Qualification and maintenance strategy
|
| | Dr Donald Gerson, COO & President, Technology & Manufacturing Divisional Group, Celltrion
|
4.50pm | Optimisation of capacity in multi-product facility
- Relation between capacity and production process execution
- Efficiency of product change-overs
- Developing processes with an eye towards facility fit
|
| |
|
5.20pm | Chairman’s closing remarks
|
5.35pm | Close of conference
|
