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 Achieving effective cost modeling of process development through process
simulation
• Identifying key variables and goals early in process development for effective modeling
• Mathematical modeling of bioprocesses to determine the effects of a change, such as cost
effects of implementing disposable technology
• Applications to process optimisation, equipment allocation, manpower and utilities
management and its impact on economics
• Real situation examples
Andrew Sinclair, Co-Founder & Managing Director, BioPharm Services, UK
12.30 Networking luncheon and showcase session
DISPOSABLE TECHNOLOGY
13.45 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
14.15 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
Subhash Kapre, President of R&D, Serum Institute of India, India
Li Xiaoqiang, General Manager, Tasly Jenner Biotech, China
OPERATIONAL EXCELLENCE- LEAN MANUFACTURING
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
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
SUCCESSFUL ASIA CMO PARTNERSHIPS
11.45 Case study: Artisan Pharma's successful CMO partnership with A-Bio
• How to select the right CMO for your biopharmaceutical manufacturing in Asia?
• Discussing issues faced during technology transfer, scale-up and execution of
manufacturing project
• Strategies for a successful contract manufacturing partnership
Vladimir Kostyukovsky, Senior Director, Manufacturing
Artisan Pharma, 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?
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?
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
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:
Werner Katzmann, Regional Medical Director
Schering-Plough, 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 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
11.45 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, Regional Medical Director, Head of Clinical Research Region
Asia Pacific, AstraZeneca, Singapore
12.15 Networking luncheon
13.30 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, Regional Medical Director, Head of Clinical Research Region, Asia Pacific
AstraZeneca, Singapore
Werner Katzmann, Regional Medical Director, Global Clinical Operations
Schering-Plough, Singapore
SUCCESSFUL CLINICAL PARTNERSHIPS IN ASIA-PACIFIC
14.15 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
14.45 Afternoon refreshments
15.15 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
16.00 Interactive roundtable 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:
Implementation of new technologies in clinical trial studies
How useful are the available technological tools (eg. electronic data capture, electronic
patient reported outcomes tools and analytics and reporting tools) in streamlining the
collection and review of data? What are the challenges in implementing these technologies?
Focus Group 2:
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?
Focus Group 3:
Unity is strength- cooperation and collaboration across pharmas and biotechs to
accelerate speed-to-market
How clinical trial knowledge can be exchanged for mutual benefit? How can pharmas and
biotechs work together to minimise cost and time for drug development?
16.50 Chairman's closing remarks
Raymond Chua, Managing Director & Regional Medical Director (Asia Pacific, Oceania &
Middle East), Eisai Clinical Research, Singapore
17.00 Close of post conference day
* 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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