| 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 investment Elizabeth Mily,Managing Director, 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, Boehringer-Ingelheim |
| 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, Merck |
| 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, Janssen Biologics |
| 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, Kite Pharma |
| 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 disease Alexander 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 out Ohad Karnieli (PhD, MBA),CEO, Atvio Biotech |
| 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 engineering Carrier Li,Director for Global Asset Planning Amgen |
| 14.45 – 15.20 | Process automation for autologous manufacturing – a mid-term view on commercial sustainability Autologous manufacturing scope Commercial implications Unit operations and cost drivers Cocoon technology – capabilities and must-haves Initial data review Nina Bauer,Commercial Development, Autologous Manufacturing, Lonza |
| 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. Mark Stevenson, Alexander Marson, Marc Better, |
| 16.30 | Closing remarks |
| 18.30 | Cocktail reception |
| 19.30 |
Dinner 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 lysates Nabil 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 processing Berthold Boedeker,Chief Scientist, 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, Janssen Sciences |
| 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 times Fjalar Kristjansson,Chief Operating Officer, Alvotech |
| 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 biosimilars Emmanuelle Lepine,General Manager, mAbxience |
| 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 align Adriana Kiędzierska-Mencfeld,Production Director, Polpharma Biologics |
| 12.25 – 13.00 | Case study: Tech transfer of mammalian cell culture process from lab scale to production scale using disposable technology 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 bioreactor Dawid Suwala,Mammalian Cells Bioprocess Coordinator, Polpharma Biologics |
| 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, Werum |
| 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, Lonza Biologics |
| 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, Jon Coffman, Carrier Li, Berthold Boedeker, |
| 16.10 – 16.20 | Closing remarks |
Please note: Agenda and speakers are subject to change.