• India’s biopharmaceutical development trends, drivers, current developments and future prospects
• Biogenerics vs innovative biopharmaceuticals: Crystal balling the future of the Indian biopharmaceutical industry in the next five years
• Recombinant proteins, proteins, antibodies, cell therapies and gene  therapies R&D landscape in India
• Compare and contrast the biologics development landscape of India vs China

• Clinical trials for biopharmaceuticals: How is it different from small molecules?
• Phase I and II: How can pilot production support clinical trial development?
• Phase III and IV: What could go wrong while moving towards commercial scale?
• Clinical trials for vaccines: Challenges and strategies

• The renaissance of global vaccine business and its impact on human health
• Recent advancement in new generation vaccine development
• New technology breakthroughs and the impact on the industry

• Challenges in developing a dengue vaccine
• Different vaccine candidates and its pros and cons
• Recent development results and future prospects

• What is the developmental stage and results to date
• Different vaccine candidates and its pros and cons
• Moving forward – What are the future prospects and what is to be done next?

• Updates on the development of a novel, highly purified and inactivated JE-virus vaccine that is based on vero cell culture and an attenuated viral strain
• Opportunities and challenges in the development of JE vaccine
• Case study – Intercell and Biological E’s partnership to develop JE vaccine to become a childhood vaccine specially for endemic areas.

• Current trends and usage patterns
• Clinical development
• Access and affordability
• Case study: BIOMAb EGFR - Biocon’s humanized head and neck antibody

• Competitive advantages of regulatory systems and resources in doing stem cell research in India
• From lab to bedside: The gap between the research and industry
• Potential industrial applications of stem cell research: cellbased therapies and screening new drugs and toxins
• Critical concerns in setting up a global partnership in stem cell research in India

• The levels of science and application in stem cells field
• Take advantage of niche areas such as adult stem cells
• Case study: Brainstorm cell therapeutics

• Biomanufacturing trends, key players and forecast of biopharmaceutical industry in India
• Examining cost, capability, capacity advantages
• Overcoming infrastructure challenges in biomanufacturing: facility design and GMP compliance issues
• Lean manufacturing: best operational strategies in engineering, process, automation, technology
• Going global: challenges and opportunities

• The current treatment priorities and trends, East vs West
• The key R&D, manufacturing and marketing driving factors, East vs West
• Resolving the gap, East vs West
• How do we synergise the capability and market drivers?
• Evolving a multi-party (Government, industry and social organizations) approach

• Addressing the issue of increased competition to maintain market share and to stay ahead of the game
• Ensuring speed-to-market to address changing and discriminating market needs on time and on schedule
• Increasing the life span of the product to enhance productivity and profitability
• Addressing the trend from generalised medicine to personalised medicine

• The evolution of biologics regulation – lessons learned
• Assessing Indian cGMP standard against international cGMP standard
• Regulatory pathways to take - Practical strategies to make exporting biopharmaceuticals to US/Europe a mission possible
• Public support for the development of the biopharmaceutical industry in India

• Principles of biosimilarity
• The importance of physico-chemical characterization
• Requirements of non-clinical and clinical evidence for licensing purposes
• Procedures for registration of your biosimilars in the EU    

• Achieving biologic product quality by design
• Determining and understanding the expectations
• Implementing robust traceable processes through development
• Expectations for failure mode analysis – how to get relief?

• Critical issues to consider when making a decision to “build, retrofit or outsource” in biopharmaceutical manufacturing
• Understanding how patent situations across Europe, USA and India affect the planning process
• Strategic commercial scale production planning from Phase III: How to minimize risk and maximize return?
• Assessing critical issues when looking at multi- versus single-product
  facilities

• Examining the challenges of developing better products faster and at a lower cost
• Identifying new and emerging technologies to allow for a risk-based approach to product development
• Adapting to the new regulatory paradigms

Much like speed-dating, through a rotating cocktail table format, you will get the opportunity to meet all your fellow attendees face to face in just 30 minutes. Bring plenty of business cards along for a fast and furious interactive session.

• Enhancing technology transfer to ensure an effective upscaling process
• Understanding critical factors and timelines for a successful technology transfer of a microbial process – multi-scale strategies from medium to large scale
• Meeting technical and regulatory requirements for upscaling to different scales at multipurpose facilities
• Case study: comparison of results of a recombinant product, manufactured at small, medium and large scale
  

• Understanding the process development challenges for a new Mab
• Examining the evolution of manufacturing technology and the current practice
• Exploring different manufacturing method options and the rational behind implementing the plant or cell culture system
• Assessing the impact of disposable technology on facility design, start-up and validation

• Understanding the cell culture process development challenges for a new vaccine
• Learning the evolution of cell culture in vaccine production
• Investigating the impact of disposable technology on facility design, start-up and validation of a cell culture facility
• Crystal balling the future of cell culture based vaccine production in India

• Biomanufacturing trends, key players and forecast of biopharmaceutical industry in India
• Examining cost, capability, capacity advantages
• Overcoming infrastructure challenges in biomanufacturing: facility design and GMP compliance issues
• Lean manufacturing: best operational strategies in engineering, process, automation, technology
• Going global: challenges and opportunities

• The current treatment priorities and trends, East vs West
• The key R&D, manufacturing and marketing driving factors, East vs West
• Resolving the gap, East vs West
• How do we synergise the capability and market drivers?
• Evolving a multi-party (Government, industry and social organizations) approach

• Addressing the issue of increased competition to maintain market share and to stay ahead of the game
• Ensuring speed-to-market to address changing and discriminating market needs on time and on schedule
• Increasing the life span of the product to enhance productivity and profitability
• Addressing the trend from generalised medicine to personalised medicine

• The evolution of biologics regulation – lessons learned
• Assessing Indian cGMP standard against international cGMPv standard
• Regulatory pathways to take - Practical strategies to make exporting biopharmaceuticals to US/Europe a mission possible
• Public support for the development of the biopharmaceutical industry in India

• Principles of biosimilarity
• The importance of physico-chemical characterization
• Requirements of non-clinical and clinical evidence for licensing purposes
• Procedures for registration of your biosimilars in the EU

• Achieving biologic product quality by design
• Determining and understanding the expectations
• Implementing robust traceable processes through development
• Expectations for failure mode analysis – how to get relief?

• Critical issues to consider when making a decision to “build, retrofit or outsource” in biopharmaceutical manufacturing
• Understanding how patent situations across Europe, USA and India affect the planning process
• Strategic commercial scale production planning from Phase III: How to minimize risk and maximize return?
• Assessing critical issues when looking at multi- versus single-product facilities

• Examining the challenges of developing better products faster and at a lower cost
• Identifying new and emerging technologies to allow for a riskbased approach to product development
• Adapting to the new regulatory paradigms

Much like speed-dating, through a rotating cocktail table format, you will get the opportunity to meet all your fellow attendees face to face in just 30 minutes. Bring plenty of business cards along for a fast and furious interactive session.

• Examining CMO market overview
• Identifying outsourcing supply and demand, trends and strategies
• Bio-manufacturing outsourcing to India: How feasible is it?

• Gain critical insights into contract manufacturing capacity and capability in India
• Understand opportunities for process development and testing in India
• Identify the competitive advantages and challenges of contract manufacturing of biologics in India
• Learn the critical evaluation criteria for selecting the best CMO partners and CMO views on setting realistic expectations and goals for a win-win partnership
• Learn how to protect your IP rights and what CMOs in China are doing to help their clients prevent piracy
• How to monitor the manufacturing process to ensure compliance with your corporate product safety and quality
  standards

• Upstream makes the pace: Benchmarks in biomanufacturing
• Biochromatography: the good, the bad and the ugly
• Virus and contaminant safety: GMP is a moving target
• Emerging Technologies: Boring but reliable
• Process economy: Ways out of the fixed-cost trap

• Assessing the impact of integrated process development strategies on the biomanufacturing efficiency and facility through put
• Comparing traditional bioprocesses with advanced technologies and their effect on manufacturing cost of goods
• Discussing integrated process designs to generate effective regulatory strategies for antibody manufacturing

• Examining current practice of viral clearance in downstream processing
• Discussing scale-down model versus large-scale process
• Identifying and addressing challenges of high titer cell culture compared with operations of low titer cell cultures in the past

• Bio-downstream process design – building it for current needs while building it for the future: economics, regulatory and practical issues
• Innovative process solutions that enable future scale up
• Studying your processes – using analytics and statistics to understand your process to ultimately bring it under control

• Examining the impact of cell line and biorector process development advancements
• Addressing the challenges of key downstream unit operation steps in monoclonal antibody processing
• Highlighting some of the process and product improvements to optimally handle the enhanced product throughput requirements

• Understanding effective strategies on how to develop facilities that can accept processes of different nature
• Assessing key drivers of cost of goods in Indian context
• Case studies on adapting processes to facilities to meet market demand as well as cost targets

• Achieving beneficial improvement strategies for process economy
• Resolving facility design issues by implementing disposable technology in production
• Comparing classic fixed installations with disposable set ups
• Discussing single use operations with re-use of raw materials

• Determining and addressing validation and sterilization issues and strategies
• Unraveling best practices in standardisation and optimization
• Weighing economic benefits of single use systems vs. stainless steel system in biopharmaceutical applications
• Review and case studies on existing disposable equipment and future disposable technologies to be introduced

• Enabling operational excellence - Connecting the intelligent life science plant
• Discussing optimized manufacturing process and optimized production process
• Achieving automation and business integration for plant efficiency

The top 3 concerns in biopharmaceutical manufacturing & development from each delegate will be collected. The two most top rated concerns will be assigned and discussed in a small group roundtable setting.

This roundtable discussion session is an open moderated session where delegates are divided into groups of 10 each to discuss a set of topics. This session aims to discuss and address critical issues and problems that delegates want resolved. Moderated by key industry experts, this roundtable discussion will ensure debate and discussion on thought-provoking and controversial issues with industry peers  following multi-disciplinary perspectives.

    The workshop will run from 0900 hrs - 1700 hrs. Refreshments and lunch will be served at the appropriate times

Biosimilar products pose unique challenges from a regulatory perspective. The concept of essential similarity does not apply, requiring a variable combination of evidence to support quality, safety and efficacy, depending on the product.

This workshop will address the following issues:

• The evolution of legislation and guidelines in the EU
• Implications of future regulatory pathways for biosimilars in EU
• Claiming similarity when changing manufacturing sites
• Opportunities and threats for originators and generic companies in the
  market place
• Requirements of clinical evidence for licensing purposes
• The importance of physico-chemical characterization
• Strategies for get approval and registration of your biosimilars in EU

About your workshop Leader:

Louis-Christian Clauss
Global Director of Regulatory Affairs and New Product Development
BioScience, Baxter, France



Dr. Clauss holds a Masters degree in Bio-Pharmacy and a PhD in Pharmacy and in Business Administration (IAE). He was a resident Biologist in public hospitals before moving into the multinational health care industry both in medical devices and pharmaceutical fields (Mérieux, Dow Corning, Boston Scientific, Clintec, B.D® Baxter).
He has over 20 years of experience in international marketing, product development and regulatory affairs.

He leads the development of numerous products, drugs, devices and Biologics such as BioSimilar. He is a member of numerous professional societies like DIA, RAPS (past General secretary, RACS), EUCOMED (past chairman of the FRG), APIMCA (past elected President), among others. He has published more than 40 papers on scientific, regulatory and reimbursement subjects

The workshop will run from 0900 hrs - 1700 hrs. Refreshments and lunch will be served at the appropriate times

 Any biopharmaceutical, regardless of whether it is an existing biogeneric or a product in development, must be demonstrated to be safe from a ‘viral safety’ standpoint if it is human/animal derived or has had exposure to mammalian-sourced components, in order to be introduced into the western and other global markets.

This workshop will address the following issues:

• Need for a pragmatic approach to viral safety assurance
• Safety of source materials, controlled sourcing and its impact on product
  safety
• Risk assessment and risk management in ensuring virological safety
• Current regulatory approach for both marketed products and investigational medicinal products (IMPs)
• Virus Clearance Technologies – Inactivation, absorption and removal
• Design of virus clearance evaluation (validation) studies including data
  evaluation and interpretation
• Case studies

Benefits of Attending

• Be equipped with the basics required to design an adequate viral safety
  program
• Recognize the necessity for incorporating multifaceted and overlapping
  contamination control strategies
• Develop an insight into how to evaluate available viral clearance
  strategies, how to conduct a risk assessment and design risk
  management strategies, and how much clearance to incorporate into
  your process by applying the acquired information

Who should attend?

• Quality assurance and control professionals
• Bioprocess, manufacturing and production professionals
• Research scientists 
• Viral safety
• scientists

About your workshop leader:

Suma Ray
Process Development Scientist
Sartorius-Stedim Biotech, India



Dr. Suma Ray is a Process Development Scientist responsible for Viral Clearance and Cell Line Development technologies at Sartorius-Stedim Biotech. She is an active member of the Global Purification Technology Group at Sartorius, focusing on Viral Clearance technology and applications, and also acts as a cell culture specialist. Prior to joining Sartorius, Dr. Ray was responsible for setting up and conducting Viral Clearance studies at Biocon, in India and has expertise in different mammalian cell culture technologies for production of recombinant therapeutic antibodies.

Dr. Ray holds a PhD degree from All India Institute of Medical Sciences`, followed by post doctorate fellowships from University of Virginia` and `Stanford University School of Medicine. Biosimilar products pose unique challenges from a regulatory perspective. The concept of essential similarity does not apply, requiring a variable combination of evidence to support quality, safety and efficacy, depending
on the product.