|DAY 1||TUESDAY 25 APRIL|
|7.30 – 8.30||Registration and breakfast|
|8.30 – 8.40||Welcome and introduction
Barbara A. Paldus, Ph.D.,
|8.40 – 9.15||Life sciences market overview
Investors perspective on the current state
Generics and biosimilars segment
Navigating market dynamics
Deep analysis of the myths, misconceptions
Perspectives on the future of life science investmentElizabeth Mily,
Barclays Investment Bank
|9.15 – 9.50||Evolutionary and revolutionary process intensification
Fed batch intensification using “HIPDOG” glucose feeds,
Revolutionary perfusion in the production bioreactor
Director of Bioprocess Engineering,
|9.50 – 10.15||Coffee break / refreshments|
|10.15 – 10.50||Process intensification enabling technologies
Background of the new vaccine production plant
Upstream process trends will be reviewed and case studies presented to highlight impact on cost of supply, facility capacity and risk mitigation towards uncertainty.
Downstream process bottlenecks and their impact of facility utilization and productivity will be addressed and emerging technology solutions presented.
Capability needs, technology gaps and implementation challenges will also be summarised.Jonathan Souquet Ph.D.,
Head of Biotech Process
Science Technology and Innovation,
|10.50 – 11.25||Customized single-use bioreactors
for a new vaccine production plant
Background of the new vaccine production plant
High-level overview of vaccine production process
Challenges and solutions for single-use bioreactor design
Product Development Engineer,
|11.25 – 12.00||Overcoming challenges for engineered
autologous T cell therapy
CAR-T therapies have created considerable excitement within the medical / scientific community due to spectacular early clinical success in difficult-to-treat haematological cancers
CAR-T products are complex, personalised advanced therapy medicines (ATMPs) and consequently require a correspondingly complex manufacturing process
We will focus on how to develop and commercialise CAR-T cell products, and more specifically on the following points:
Executive Vice President R&D,
|12.00 – 13.00||Lunch|
|13.00 – 13.35||Engineering human T cell circuitry
CRISPR / Cas9 has facilitated genome engineering in
To highlight a CRISPR / Cas9-based platform that enables both knock-out and knock-in genome editing in primary human T cells by electroporation of Cas9:single-guide RNA ribonucleoproteins (Cas9 RNPs)
Cas9 RNPs paired with homology-directed repair (HDR) template oligonucleotides can generate a high frequency of knock-in targeted genome modifications in primary T cells
The technology enables unprecedented explorations
To understand how sequence variation throughout the human genome affects T cell circuits in health and diseaseAlexander Marson,
Assistant Professor, Microbiology and Immunology,
UCSF School of Medicine
|13.35 – 14.10||Out of the box strategies and innovative solutions
to bring cell therapies to market
Overview of the cell therapy industry 2017 update
Challenges in cell therapy commercialisation
Innovative solutions for cell culturing
Automation and scale outOhad Karnieli (PhD, MBA),
|14.10 – 14.45||Future vision of building a biologics (DS/DP)
manufacturing facility in 6 months
Business requirements driving this need
How technology is enabling this reality
Case study: A journey from ideation to reality
What a responsive and efficient supply chain looks like
How to promote a culture of innovation within engineeringCarrier Li,
Director for Global Asset Planning
|14.45 – 15.20||Process automation for autologous manufacturing – a
mid-term view on commercial sustainability
Autologous manufacturing scope
Unit operations and cost drivers
Cocoon technology – capabilities and must-haves
Initial data reviewNina Bauer,
|15.20 – 15.45||Coffee break / refreshments|
|15.45 – 16.30||Panel discussion: The road to personalized medicine
Personalized or ‘precision’ medicine is on the rise, due to advancements in, and the emerging integration of, biology, biotechnology, DNA sequencing, IT, and IoT.
How do we address ever-increasing the costs of care?
What are regulatory challenges?
What happens to health insurance?
This panel discussion will address these crucial questions in achieving personalized medicine with experts from the state and businesses.
Keynote: Colloidal nonlinear optics for
Nonlinear optics using optical forces for protein characterization
Determination of size, conformation, and dielectric signatures
Potential for determining parameters in seconds
Implementable with pico-liter volumes of lysatesNabil M. Lawandy,
Chairman, President & CEO,
Spectra Systems Corporation
|DAY 2||WEDNESDAY 26 APRIL|
|7.30 – 8.30||Breakfast|
|8.30 – 8.40||Welcome, day one summary,
and day two introduction
Barbara A. Paldus, Ph.D.,
Vice President & General Manager,
Finesse, part of Thermo Fisher Scientific
|8.40 – 9.15||The presidential and congressional
elections impact on FDA
What are the major implications for FDA?
What are the issues that may impact
What are the factors that will impact
What are the issues that may impact FDA’s
Will the election result in fundamental
Compliance and Regulatory Affairs,
Greenleaf Health Inc.
|9.15 – 9.50||Opportunities and limits of continuous processing
The drivers for continuous processing
Pros and cons of the most common perfusion approaches
How to implement perfusion fermentation into downstream operations to create fully integrated continuous processing
How is a batch defined in a continuous process?
What are the major risks and gaps?
Upgrading versus building new facilities to accomodate continuous processingBerthold Boedeker,
Bayer Pharma AG
|9.50 – 10.25||Single-use bioreactor scale up:
Introduction of a 2000L SUB in 12 months
Background on the design of the 2000L SUB suite
Engineering run and scale up data
Comparison between stainless steel manufacturing
Manufacturing Process Specialist,
|10.25 – 11.00||SmartFactory in action: A year later, Alvotech’s
state-of-the-art manufacturing and lab facility
Alvotech, company introduction
The challenge of rapid expansion of production
Leveraging cutting-edge automation, enabling higher yields, reducing labour and capital expenses whilst maintaining flexibility in operations management systems
Introducing a SmartFactory platform, which features an open architecture enabling flexibility to develop and manufacture an impressive line-up of biosimilar products
Using Smart technology in process control, batch automation and data management
Integrating upstream and downstream automation for quick transfer without compromising on costs and cycle timesFjalar Kristjansson,
Chief Operating Officer,
|11.00 – 11.15||Coffee break / refreshments|
|11.15 – 11.50||Biosimilars: Trends, benefits and challenges
Current global trends and market position
Exploring opportunities for biosimilar development
With drug pricing pressure, how can bio manufacturers increase production, yields, characterization, economics, and quality?
Quality considerations for biosimilar development
New global developments in regulatory framework
The future of biosimilarsEmmanuelle Lepine,
|11.50 – 12.25||Disposable technology in manufacturing of
biosimilar monoclonal antibodies
Disposable or stainless steel – project start decision
Which supplier for process to choose – decision drivers
How to keep quality and similarity of product using disposable technology
Management view on process costs in production scale
Laboratory scale and production scale – how to alignAdriana Kiędzierska-Mencfeld,
|12.25 – 13.00||Case study: Tech transfer of mammalian cell culture
process from lab scale to production scale using
Process development in lab scale – AMBR system,
Tech transfer GAP analysis – risk evaluation
Process scale up to 50L single-use bioreactor
Process scale up from 50L to 250L single-use bioreactor
Final scale 1000L in single-use bioreactor
Process expansion – second 1000L bioreactorDawid Suwala,
Mammalian Cells Bioprocess Coordinator,
|13.00 – 14.00||Lunch|
|14.00 – 14.35||Data integrity on the shop floor – how proper production control and MES enable "right first time"
Define a proper production control strategy
Show how the production control strategy drives
Identify the organization and technical elements that are critical to driving the production control strategy and improving data integrity
Demonstrate where electronic systems like MES become
Vice President Operations,
|14.35 – 15:10||“Disposables are not something to throw away.
Why single-use is here to stay!”
How bioprocessing steps have been transformed by
What has worked well, not so well, and how the assumed benefits of single-use have transpired in practice.
What are the transient elements of a single-use plant, and what are the more permanent aspects to consider for consumable ware and hardware? How this enables a facility that is both flexible and future-proofed.
How ‘universal’ control systems help standardise data capture and analysis systems and provide a future design blueprint that can be applied across the plant. A concept most easily implemented and sustained when component parts are single-use.David Valentine, Principal Scientist,
Manufacturing Science and Technology,
|15.10 – 15.25||Coffee break / refreshments|
|15.25 – 16.10||Panel Discussion: Smart Technologies – The
next-generation smart biomanufacturing facility
Dramatic increases in yields from cell lines and the increasing popularity of single-use technologies. Will they change the way we look at future bioprocessing facilities and process designs?
How will new and emerging smart technologies for bioprocessing impact the industry?
Preparing for the future through smart technologies with practical examples
What will it look like in the near future?
What role will the regulatory bodies play in shaping facilities in the next 5 to 10 years?
David Valentine, Principal Scientist,
Jonathan Souquet Ph.D.,
|16.10 – 16.20||Closing remarks|
Please note: Agenda and speakers are subject to change.