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conference details
Pre & Post Conference Summits
14th and 17th April 2008
 
Pre/Post Conference masterclasses
14th and 17th April 2008
 
Main Conference:
Day 1
15th April: 8am - 5:30pm
Day 2
16th April: 8am - 5:30pm
 
Register online now
or call +65 6322 2710/700

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Stands are limited so BOOK yours today!

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For details contact
Wendy Wong 
+65 6322 2764

Day One 15 April 2008 Tuesday

08.00  Registrations and refreshments

08.30  Organiser’s welcome remarks 

08.45  Guest-of-honour address 
          Lim Hng Kiang
, Minister 
          Ministry of Trade & Industry, Singapore

08.55  Chairman's welcome remarks
          Murali K. Prahalad, Vice President, Molecular Biology Essentials
          Invitrogen Corporation, USA

09.00  Global keynote address and executive interview: The evolving biomedical 
          science and industry

          • Market trends and drivers of the biomedical industry and crystal balling future growth
          • Emerging biomedical innovation from Asia and its impact 
          • The evolution of the global biotech capital market: Where and how does Asia fit into the 
            equation
         Keynote speakers:    
         Gordon Binder, Managing Director, Coastview Capital, USA
         Founder & former CEO, Amgen Inc, USA         
         Philippe Kourilsky, Chair of Immunology, College de France        
         Former Director General, Pasteur Institute, France    
         Ansbert Gadick, Founder & General Partner, MPM Capital, USA       
         Interviewer:
        
Lorraine Hahn, Journalist & TV Presenter, Former TV Talk-show-host & Anchor
         CNN and CNBC, Hong Kong

10.00 Morning refreshments, BioMedical Technology Showcase session & combined 

THE BIOPHARMACEUTICAL MANUFACTURING IN ASIA-PACIFIC

11.00  Chairman’s opening remarks    
          Gerhard Klement, Chief Executive Officer & President of Biopharmaceuticals
          Reliance Life Sciences, India

11.10  International Visionary Panel: Asia’s advantage: Achieving cost-effective 
          biologics production by setting up manufacturing base in Asia

          • Advantages and challenges of setting up manufacturing base in Asia
          • Discussing the major consideration factors in site selection
          • How substantial is the cost benefit?
          • Does the cost advantage outweigh the risk?
          • What does the future hold for Asia’s biomanufacturing industry?
          Moderator:       
          William Downey, President, HighTech Business Decisions, USA
          Panelists: 
          Thibaud Stoll, Head of Global Biopharmaceutical Operations, Novartis, Switzerland
          James Miller, Vice President & General Manager, Singapore Product Operations
          Genentech, Singapore 
          Vincent Hingot, Project & Site Director, GSK Biologicals, Singapore          
          Michael Brown, Vice President of Operations & Site Manager, Lonza, Singapore

11.55  Asian Visionary Panel: Assessing the capability and capacity of Asia’s 
          biopharmaceutical manufacturing industry
       
          • Status and current development of biomanufacturing industry in Asia
          • Analyzing the regional biopharmaceutical market
          • Assessing how well can Asia cope with the booming biomanufacturing industry in terms of 
             the talent pool, manufacturing technology and regulatory infrastructure
          • Addressing key challenges- IP protection and GMP compliance
          • Crystal balling the future of biomanufacturing in Asia 
          Moderator:       
          Jason Gale, Team Leader, Health and Science Asia, Bloomberg L. P., Singapore           
          Panelists:
 
          Ya-Jun Guo, Director, Shanghai Cell Engineering & Antibody Centre, China           
          David Mashaal
, Vice President of Global Business Development, SciGen, Singapore        
          Jun Yamaya, Vice President, CMC R&D Laboratories, Production Division
          Kirin Pharma, Japan 
          Harish Iyer, General Manager of R&D, Biocon, India

12.40 Networking luncheon and showcase session

CELL CULTURE AND UPSTREAM PROCESSING

13.45  Keynote: Cell culture productivity improvements and challenges to downstream 
          processing efficiency
      
          • The evolution of cell culture technologies in biologics manufacturing
          • Reviewing the recent progresses and breakthroughs in cell culture productivity
          • Addressing the impact on plant output and downstream process and how to overcome the 
             bottleneck
          • Predicting how fast downstream processing can catch up given the ongoing improvements  
            in cell culture productivity for the next 10 years
            Joseph Tarnowski, Senior Vice President, Biologics Manufacturing & Process 
            Development, Bristol-Myers Squibb, USA

14.15  Optimisation for glycoprotein production from mammalian cell culture      
          • Key drivers: maximise activity and minimise heterogeneity
          • Design of cell and molecular biology
          • Cell line selection & screening
          • Design of the cell culture process
          • Optimal protein recovery steps
          George Lovrecz, Head of Fermentation, 
          CSIRO Molecular and Health Technologies, Australia

14.45  Case study: Process optimisation and scale up of a perfusion-based process for 
          monoclonal antibody production
     
          • Manufacturing  of  epidermal growth factor receptor antibody,  Nimotuzumab,  utilising  a 
             perfusion process based on spin filter technology
          • Evaluating media and process parameters by simulating perfusion in shake flasks
          • Scaling up of short listed conditions from 2L to 1000L perfusion bioreactors
          • Extensive analysis of product from each scale for downstream purification and 
             characterisation
          Harish Iyer, General Manager of R&D, Biocon, India

15.15  Afternoon refreshments, showcase session & 

16.15  Application of HTP microfluidic culture systems to media and process 
          optimisation
      
          • Current workflow limitations in developing media and bioreactor processes
          • Scale-down models for validation in bioreactors
          • New microfluidic technologies revealing synergies and predicting optimal conditions for 
            bioreactor performance
          • Results of factorial or central composite experiments
          • A cost effective way to validate media formulations and bioreactor parameters for scale-up
          David Zhao, Technical Director for Media Development, Invitrogen, USA

 PAT AND QUALITY BY DESIGN

16.45  PAT architecture for process development and biomanufacturing- building the 
          business case for PAT
 
          • Integrating PAT with the existing infrastructure
          • Designing a PAT infrastructure for process development and for manufacturing, including 
            examples of PAT architecture
          • PAT project development- step-by-step PAT infrastructure implementation and developing 
             the future control and release philosophy
          • PAT as a continuous process understanding improvement tool and the role of Knowledge 
             Management Systems
          Ingrid Maes, Senior Consultant Innovative Technologies, Siemens, Belgium

17.15  Chairman’s closing remarks      
          Gerhard Klement, Chief Executive Officer & President of Biopharmaceuticals
          Reliance Life Sciences, India

17.30  Close of day one

19.00  BioMedical Industry Awards Dinner

 

Day Two 16 April 2008 Wednesday

08.00  Registration and refreshments

08.45  Chairman’s opening remarks          
          James Miller, Vice President & General Manager, Singapore Product Operations
          Genentech, Singapore

DOWNSTREAM PROCESSING

09.00  The presence and future of large scale biochromatography          
          • Initial recovery: Keeping the pace with fermentation
          • Capturing: Is chromatography a lame duck?
          • Polishing: Disposable concepts are en vogue
          • Virus safety: New guidelines provide chances, not threats
          • Process economy: Ways out of the fixed-cost trap
          Uwe Gottschalk, Group Vice President, Purification Technologies
          Sartorius Stedium Biotech, Germany

09.30  A cost-reducing approach by bridging the gap between upstream productivity 
          and downstream processing efficiency
     
          • Tackling the backlog in bioseparation
          • New purification protocols to greatly reduce cost and batch processing time
          • Exploring cost-saving non-Protein A purification processes- comparison of effects with 
            traditional Protein A purification
          • Increasing productivity by integration, reduced cycle times and built-in automation
           Alahari Arunakumari, Senior Director, Medarex, USA

10.00  Case study: Increasing downstream processing capacity for high-titer antibody 
          production
       
          • Innovations in downstream processing to accommodate improvements in antibody 
             expression titers and throughput 
          • Strategies to increase downstream capacity without compromising economics and purity of 
             antibodies
          • Future challenges in downstream processing
          Dan Slone, Senior Director, Manufacturing Purification, Celltrion, Korea

10.30  Morning refreshments and showcase session

PRODUCTIVITY AND ECONOMY IN BIOPROCESSES

11.00  Manufacturing planning in biopharmaceutical operations      
          • Build, retrofit or outsource- committing assets well in advance of sales
          • Lowering COGS by process improvements
          • Patents impacting manufacturing planning
          • Commercial scale planning
          • Single- versus multi-product facility
          Gerhard Klement, Chief Executive Officer & President of Biopharmaceuticals
          Reliance Life Sciences, India

11.30  Integrated process design throughout the product life cycle     
          • Developing platform technologies to support a diverse portfolio of products
          • Integrating and harmonising upstream and downstream processes
          • Implementing appropriate control strategies based on process and product understanding
          • Discussing integrated process designs to generate effective regulatory strategies
          David Glover, Director of Bioprocess R&D, UCB Celltech, UK

12.00  Networking luncheon and showcase session

DISPOSABLE TECHNOLOGY

13.15  Economics of adopting single-use bioprocess containers in Asian manufacturing 
          scenario
       
          • The actual cost of adopting disposable bioprocess containers (BPC)- set up including bags, 
            accessories, connections, mixing devices
          • Costing of high quality fixed volume, multiuse stainless steel tanks fabricated in Asia
          • Overall cost of ownership of steel tanks versus single-use bioprocess containers including 
            capital cost, validations and maintenance
          • Preferred scenarios with advantages of one technology over other 
          • Investigating if the US or European basis of choosing one technology over other is 
             applicable to Asian manufacturers or not
          Swapnil Ballal, Head of Biopharmaceutical Bulk Manufacturing
          Intas Biopharmaceuticals, India

13.45  Discussion panel: Advantages and limitations of using disposables in 
          biopharmaceutical manufacturing
      
          • Pros and cons of using disposable systems in upstream and downstream processing
          • What can be single-use and what cannot
          • Assessing the potential for single-use affinity chromatography columns
          • Disposal challenges of large single-use equipments
          • Addressing regulatory and validation concerns
          Moderator: 
          Swapnil Ballal, Head of Biopharmaceutical Bulk Manufacturing
          Intas Biopharmaceuticals, India 
          Panelists:   
          Dan Slone, Senior Director, Manufacturing Purification, Celltrion, Korea          
          Alahari Arunakumari, Senior Director, Medarex, USA
          Günter Jagschies
, Director Customer Applications R&D,
          GE Healthcare LifeSciences, Sweden   

OPERATIONAL EXCELLENCE- LEAN MANUFACTURING

14.30  Leveraging Manufacturing Automation & Information Solutions to Achieve 
          Operational Excellence
      
          • Review of Industry challenges driving the need to focus on manufacturing for stategic 
            advantage 
          • Operational Excellence and Enterprise Automation & Information Solutions
          • Focus Solutions and case studies
          • Results of executing an operational excellence strategy
          Anthony V. Sollazo, Industry Solutions Manager - Life Sciences Asia Pacific,
          Rockwell Automation, Hong Kong 

15.00  Achieving operational excellence through lean manufacturing      
          • Overview of lean manufacturing- waste reduction in terms of time, labour and materials, 
             paradigm changes in pharmaceutical product lifetimes and applying lean principles in 
             biopharmaceutical manufacturing
          • Lean concepts in process design and manufacturing implementation and quality systems
          • Maximizing manufacturing efficiency by implementing lean concepts right from the start
          • Challenges in lean manufacturing implementation
          • Meeting FDA regulatory requirements in a lean manufacturing environment
          Donald F. Gerson, Chief Operating Officer & President, Celltrion, Korea

15.30  Implementing lean in biopharmaceutical manufacturing – learning from the 
          automotive industry
      
          • Incentives to implement lean in (bio)pharmaceutical manufacturing, taking into account 
             increasing challenges on time, COGS and compliance
          • Examples where lean principles have been applied successfully to large-scale 
             biopharmaceutical manufacturing, leading to improvements in throughput rate, throughput 
             time, productivity, capacity and “waste” reduction
          • Recommendations on additional potential of Lean implementation to gain some significant 
             competitive edge
          Thibaud Stoll, Head of Global Biopharmaceutical Operations, Novartis, Switzerland

16.00  Afternoon Refreshment and showcase session 

16.30  Interactive round table discussion     
          This round table discussion session is an open moderated session where delegates can 
          choose to join a small focus group to discuss a pre-selected topic of their interest. 
          Moderated by key industry experts, the round table discussion will ensure debate and 
          discussion on thought-provoking and controversial issues with industry peers.
          Focus Group 1: Building a world-class GMP-compliant manufacturing facility in 
          Asia
          
          • What are the consideration factors and planning to be done before committing? 
          • How do you manage the risks involved? How to design the most appropriate facility 
            according to your needs?
          Focus Group 2: Future technologies in biologics manufacturing        
          • What are the current limitations in biomanufacturing technologies? 
          • What kind of technological improvements will be needed to meet the growing demand of 
            the biopharmaceutical manufacturing industry for the next 10 years?

17.15  Chairman’s closing remarks 
          James Miller, Vice President & General Manager, Singapore Product Operations
          Genentech, USA

17.25  Close of conference  

 

Contract Manufacturing Summit
Monday 14 April 2008
 

Sponsored by 

 

08.45  Chairman’s opening remarks    
          Bruce Register, Chief Executive Officer & President
          Trusgen, USA

OUTSOURCING BIOPHARMACEUTICAL MANUFACTURING TO ASIA

09.00  Opening address: Beyond Asia: Taking the Asian biopharmaceutical revolution to 
          the world stage

          • Biopharmaceutical innovation across Asia represents an unprecedented explosion of novel 
            approaches to curing and treating debilitating diseases.
          • The most successful Asian companies will need to move beyond the Asian marketplace
          • Cooperation with "Western" manufacturing service providers have the potential to catapult 
             local Asian products and technologies
          • Partnerships will give Asian companies access to world-class expertise and a track record
          Stefan Borgas, Chief Executive Officer
          Lonza, Switzerland

9.30  Keynote: Current trends and developments in the global biopharmaceutical 
        contract manufacturing
      
        • Global presence of CMO emerge to facilitate time-to-clinic approach
        • Maximising capacity utilisation to achieve enhanced productivity in contract manufacturing
        • Strategies in determining product quality and increasing overall yield and process economy
        • Achieving competitive advantage and worldwide regulatory compliance in contract 
          manufacturing
       Rolf Werner, Corporate Senior Vice President, Biopharmaceuticals
       Boehringer Ingelheim, Germany

10.00  Discussion Panel: Should you outsource to Asia?      
          • Discussing the advantages in engaging Asian CMOs, such as pricing and gain of access to 
            Asian markets
          • Challenges- IP protection, GMP compliance, technology transfer and distance
          • What is the future for Asia’s biomanufacturing industry?
          Moderator:  
          Scott M. Wheelwright
, President & Chief Executive Officer
          Strategic Manufacturing Worldwide, USA 
          Panelists:   
          Joseph Tarnowski, Senior Vice President, Biologics Manufacturing & Process Development
          Bristol-Myers Squibb, USA  
          Hajimu Sakamoto, Vice President, Business Development
          Artisan Pharma, USA  
          Joseph Santangelo, Development Director
          SingVax, Singapore   
          Kochung Lin, Chief Executive Officer
          PharmaEssential Corp., Taiwan

10.45  Morning refreshments

11.15  Strategies in ensuring successful technology transfer across continents 
         • Analysing the challenge of changing production environments
          • Overcoming the hurdle of crossing cultural boundaries
          • Sharing tried and tested methods for successful technology transfer
          • Discussing case study examples
          Scott M. Wheelwright, President & CEO
          Strategic Manufacturing Worldwide, USA

PARTNERING WITH ASIA CMO

11.45  Opening the door to Asian CMOs: Taking down the barriers          
          • What are the barriers that keep Asian CMOs from the small to medium biotech market?
          • How can CMO's best communicate their value?
          • How long will the window of opportunity be open to Asian CMOs?
         Bruce Register , CEO & President,
         Trusgen, USA

12.15  Networking luncheon

13.30  Case study: Successful transfer from Bristol-Myers Squibb to Celltrion 
          • Asian contract manufacturing business and operational advantages
          • Technology transfer and scale-up issues
          • Contractual and operational relationships
          • Quality system harmonization
          • Regulatory harmonization and licensure (KFDA and US FDA)
          • Ongoing strategies for supply chain maintenance
          Donald F. Gerson, Chief Operating Officer & President
          Celltrion, Korea

ASIA-PACIFIC CMO PARADE

Home-grown CMOs in Asia are invited to share their views of the region’s contract biologics manufacturing industry and give case-study presentations to exemplify their capacities and technologies in handling contracted biomanufacturing projects.

14.00  Presentation by Inno Biologics 
          Dato' Dr Nazlee Mohd Kamal, Chief Executive Officer
          Inno Biologics, Malaysia

14.15  Presentation by Intas Biopharmaceuticals        
          Swapnil Ballal, Head of Biopharmaceutical Bulk Manufacturing
          Intas Biopharmaceuticals, India

14.30  Presentation by Asahi Glass  
          Hiroko Tsukamoto, Marketing Director
          Asahi Glass, Japan

14.45  Presentation by Reliance Life Sciences     
          Jay Madan, Vice President of Business Development 
          Reliance Life Sciences, India

15.00  Afternoon refreshments

15.45  Interactive Round Table Discussion        
          This round table discussion session is an open moderated session where delegates can 
          choose to join a small focus group to discuss a pre-selected topic of their interest. 
          Moderated by key industry experts, the round table discussion will ensure debate and 
          discussion on thought-provoking and controversial issues with industry peers.
          Focus Group 1:    
          Opportunities for Asia Pacific CMOs in emerging therapeutics- vaccines and stem 
          cells
       
          How can CMOs capitalise on the growing vaccine and stem cells industry in Asia Pacific? 
          What are the unique specifications required? What are the challenges and how to overcome 
          the hurdles?
          Donald F. GersonChief Operating Officer & President
          Celltrion, Korea
          Focus Group 2: 
          Best strategies in streamlining an efficient technology transfer process for 
          outsourced biopharmaceutical manufacturing

          How do you ensure smooth and effective technology transfer to CMO in the shortest possible 
          time especially when clients have not manufactured at full scale? How to achieve strong 
          communication between client and CMO?
          Scott M. Wheelwright, President & Chief Executive Officer
          Strategic Manufacturing Worldwide, USA

16.45  Chairman’s closing remarks   
          Bruce Register, Chief Executive Officer & President
          Trusgen, USA

17.00  Close of pre-conference day

17.30  Site visit to Biopolis 

 

Clinical Partnering Summit
Thursday 17 April 2008
 

Sponsored by 

 

08.45  Chairman’s opening remarks        
          Raymond Chua, Managing Director & Regional Medical Director (Asia Pacific, Oceania & 
          Middle East), Eisai Clinical Research, Singapore

CURRENT TRENDS & DEVELOPMENT OF THE CLINICAL TRIAL INDUSTRY IN ASIA PACIFIC

09.00  Opening Keynote: Country and site selection for global clinical trials: 
          Opportunities and challenges
 
          • R&D drivers for clinical development entry into new theatres of operations
          • Benefits of doing global clinical studies in emerging countries, namely India, China/Asia 
            and Latin America, and the guiding principles
          • Country selection- country assessment criteria, sources of information for assessment, 
            country-by-country analysis
          • Site selection- what do sponsors look for? How do investigators find sponsors? What can 
            investigator sites do to improve their chances for selection for clinical trials? What are 
            some of the investigator site best practices that we have seen?
          • Amgen’s conclusions and recommendations
          Fidela Moreno, Executive Director, Global Development Operations
          Asia and Latin America, Amgen, USA

09.30  Developing clinical trials in new emerging countries in Asia        
          • Rationale for developing clinical trials in emerging Asian countries- Indonesia, Vietnam, 
           Pakistan, Bangladesh and Sri Lanka
          • Diligence prior to commencing activities
          • Common challenges
          • Case studies
          Anand Tharmaratnam, Head of Clinical Development, Asia Pacific & Chief Executive 
          Officer, South East Asia, Quintiles East Asia, Singapore

10.00  Morning refreshments

CONDUCTING CLINCIAL TRIALS IN ASIA PACIFIC

10.30  Joint Discussion: Navigating the regulations in China, India and Australia            
          Clinical experts from the various emerging markets- China, India and Australia- would each 
          give a 15 min presentation on the clinical trial regulatory framework in the respective 
          country, and followed by a 10 min Q&A session that is open to the audience.
          Moderator: 
          Christophe Tournerie
, Executive Director, Clinical Research-AsiaMedical,
          PharmaNet, Singapore    
          Panelists: 
          George Chen, Area Medical Vice President & Chief Medical Officer
          GSK, China/Hong Kong 
          S. K. Gupta, Director General & Dean
          Institute of Clinical Research India, India 
          James Garner, Vice President of Clinical & Medical Affairs
          Progen Pharmaceuticals, Australia

 11.15  Meeting challenges in clinical research in Asia Pacific
           • Understanding regulatory specificities and how to overcome potential issues
           • Saturation of existing sites and scarcity of clinical research professionals in the region
           • Competitive cost vs US and Europe 
           • Fast patient recruitment and compliance with ICH GCPs
           • Adapting start-up strategies to each country specificities  
          Christophe Tournerie, Executive Director, Clinical Research-Asia
          PharmaNet, Singapore

 11.45  Case study: Effectively conducting clinical trials in China           
           • Sharing experience in conducting clinical trials in China
           • Site selection, investigator training and qualification and patient recruitment issues
           • Assessing current clinical trial infrastructure in hospitals in China and how to maximize 
             clinical trial quality and efficiency given the present infrastructure
          George Chen, Area Medical Vice President & Chief Medical Officer
          GSK, China/Hong Kong

12.15  Networking luncheon

13.30  Managing talent in the highly demand driven clinical trial industry in Asia    
          • Discussing recruitment strategies to address the shortage of clinical research talent in Asia
          • Retention, training and development- understanding the needs of your staff
          • Managing clinical staff at the global, regional and country level
          • Planning ahead for your staffing needs
          Ross Horsburgh, Vice President, Global Clinical Development
          Kendle, Singapore

14.00  Panel Discussion: Effective ways to reach out to your desired patient pools in 
          Asia
 
          • Strategies for gaining fast and cost-effective access to targeted patient groups in Asia’s 
            huge patient population
          • Sharing of effective patient recruitment campaigns across Asia
          • Discussing unique issues, such as ethical consideration and obtaining informed consent, 
             faced in patient recruitment and retention in different cultures
          • Recruitment of patients with very unique disease profile or specific treatment window
          Moderator:   
          Fidela Moreno, Executive Director, Global Development Operations, Asia and Latin 
          America, Amgen, USA 
          Panelists:       
          Rose Qiu, Head of Global Clinical Operation, Asia Pacific
          Johnson & Johnson, China 
          James Garner, Vice President of Clinical & Medical Affairs
          Progen Pharmaceuticals, Australia  
          Ross Horsburgh, Vice President, Global Clinical Development,
          Kendle, Singapore    

SUCCESSFUL CLINICAL PARTNERSHIPS IN ASIA-PACIFIC

14.45  Strategies for a successful clinical partnership between sponsors and CROs 
          • Consideration factors in selecting the right CRO for your clinical trials
          • Sharing clinical partnership experience from a sponsor’s perspective
          • Best practices in establishing collaboration with CROs in conducting clinical study to 
             maximise team performance and minimise study time
          • Building a strong long-term working relationship with CRO
          Raymond Chua, Managing Director & Regional Medical Director (Asia Pacific, Oceania & 
          Middle East), Eisai Clinical Research, Singapore

15.15  Afternoon refreshments

15.45  Panel Discussion: Strategies for small pharma/biotech in partnering with a large 
          CRO
   
          • Assessing the needs of small pharma/biotech companies in performing clinical research 
            and how their needs differ from large pharma
          • Discussing the different outsource models that CRO can employ in partnering with small 
             pharma/biotech and how best to cater to them
          • Analysing steps that can be taken by both sides to ensure the most effective execution of 
            clinical project
          Moderator:    
          Paul Anderson, Managing Director
          Orthocell Pty Ltd, Australia   
         
Panelists: 
          Kochung Lin, CEO
          PharmaEssentia Corp., Taiwan 
          Satish Totey, CSO
          Stempeutics, India 
          Narinder Chopra, Director, Clinical Operations
          CombinatoRx, Singapore      
          Anand Tharmaratnam, Head of Clinical Development, Asia Pacific & Chief Executive 
          Officer, South East Asia, Quintiles East Asia, Singapore

16.30  Interactive roundtable discussion  
          This round table discussion session is an open moderated session where delegates can 
          participate in a small focus group to discuss a pre-selected topic in an informal setting. 
          Moderated by key industry expert, the round table discussion will ensure debate and 
          discussion on thought-provoking and controversial issues with industry peers.
          Selecting the right CRO for your clinical research activities in Asia         
          When should you outsource your clinical activities? How can you outsource in the most cost-
          effective and productive manner? What are the consideration factors in choosing a CRO 
          partner?
          James Garner, Vice President of Clinical & Medical Affairs
          Progen Pharmaceutical, Australia         

17.15  Chairman’s closing remarks 
          Raymond Chua, Managing Director & Regional Medical Director (Asia Pacific, Oceania & 
          Middle East), Eisai Clinical Research, Singapore

17.30 Close of post conference day 

 

Post Conference Masterclass
Thursday 17 April 2008
 

* Registration for the Masterclass will commence at 08.30am. The class will commence from 9am 
   to 5pm and refreshments & lunch will be served at appropriate times.

 

Virus and prion clearance of biopharmaceuticals

With the current regulatory requirements ensuring viral safety of biotechnological products, orthogonal strategies for virus clearance must be implemented early-on in the manufacturing process. At least two complementary methods should be utilised in order to meet the specifications set forth by the regulatory organisations.

This will stress the need for implementation of robust and efficient technologies in order to meet the requirements of “risk assessmentbased” virus clearance approaches. Such technologies ideally involve virus removal by nanofiltration, inactivation by UVC and adsorption by membrane chromatography. Additionally, the platform must be characterized by high virus LRVs and product recovery, independent of their position in the downstream process as well as the use of disposable technologies in order to meet the flexibility needed in earlystage process development.

This masterclass will address the following issues:

• Current regulatory expectations on viral safety for biopharmaceuticals early-on in production
• Need for a risk based pragmatic approach to viral safety assurance
• Orthogonal Virus Clearance Technologies – Inactivation, absorption and removal
• Disposables in viral clearance
• Design of virus clearance evaluation (validation) studies in the laboratory
• Case studies

Benefits of attending

• Be informed of the basics required to plan an adequate viral safety program
• Recognise the necessity for incorporating multifaceted and complementary virus control strategies
• Realise how much clearance needs to be incorporated into the manufacturing process in order to 
  ensure viral safety of the product
• Develop an insight into how to evaluate the available viral clearance strategies

Who should attend?

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

Masterclass leader:                                                                                                          Suma Ray, Process Development Scientist
Sartorius-Stedim Biotech, India 

 

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