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DAY 1TUESDAY 25 APRIL
7.30 – 8.30 Registration and breakfast
8.30 – 8.40 Welcome and introduction

Barbara A. Paldus, Ph.D.,
Vice President & General Manager,
Finesse, part of Thermo Fisher Scientific

8.40 – 9.15 Life sciences market overview

Investors perspective on the current state
of the pharma and biotech sectors

Generics and biosimilars segment

Navigating market dynamics

Deep analysis of the myths, misconceptions
and realities of investment in the sector

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,
N-1 perfusion, and “HIPCOP” control of perfusion

Revolutionary perfusion in the production bioreactor
and an integrated downstream

Jon Coffman,
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
- Cell retention system
- Waste removal

Maaike Poppema,
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:

  • Vector and cell process considerations for Phase I/II trials
  • Vector process improvements to optimize scale,
    yield and T cell transduction
  • Cell process improvements and automation
    to increase reproducibility and robustness of
    the manufacturing process
  • Comparability strategies when introducing
    process changes
Marc Better,
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
many cell types, but in human T cells Cas9 efficiency had
been limited and Cas9 had not allowed targeted nucleotide replacements

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
of genetic mechanisms that control T cell function and
HIV pathogenesis

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
for a flexible manufacturing plant

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,
President of Life Sciences Group,
Thermo Fisher Scientific

Alexander Marson,
Assistant Professor,
Microbiology and Immunology,
UCSF School of Medicine

Marc Better,
Executive Vice President R&D,
Kite Pharma

16.30 Closing remarks
18.30 Cocktail reception
19.30

Dinner

Keynote: Colloidal nonlinear optics for
pico-liter protein characterization

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 2WEDNESDAY 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
the performance of FDA?

What are the factors that will impact
FDA leadership in 2017?

What are the issues that may impact FDA’s
quality and compliance priorities and functions?

Will the election result in fundamental
change in FDA’s priorities?

John Taylor, President and Principal,
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
and single-use technology

Claire Walsh,
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
capacity using multiple 1,000L and 2,000L single-use
bioreactor trains

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
and commercialization vis-a-vis healthcare reform
and rising costs

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
for approving biosimilars

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,
flasks and glass bioreactors

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
data integrity

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
a key enabler of production control and increase
"right first time"

Robert Perks
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
single-use over the last two decades.

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,
Manufacturing Science and Technology,
Lonza Biologics

Jon Coffman,
Director of Bioprocess Engineering,
Boehringer-Ingelheim

Carrier Li, 
Director for Global Asset Planning 
Amgen

Berthold Boedeker, 
Chief Scientist, 
Bayer Pharma AG

16.10 – 16.20 Closing remarks

 

Please note: Agenda and speakers are subject to change.