Last opportunity to get onto the programme. Key sessions: • Upstream process development for gene therapies • Upstream process development for cell based therapies • Downstream processing considerations • Analytics - tackling measurement assurance for advanced cellular therapeutics • Insights into Business Development and Reimbursement • Regulatory perspectives

1. For more information please contact Tony at tony.couch@amnmconferences.comFor more information please contact Tony at tony.couch@mnmconferences.com
Bioprocessing of Advanced
Cellular Therapies Congress
2 - 3 June 2016, London, UK
The quest for cures as opposed to mitigation of diseases and the huge potential for improving quality of life that cellular and gene
therapeutics offer, are the main reasons behind the growth of this industry.
But for the industry to actually take-off and sustain itself over the years, it needs to be cost-effective, robust and safe. Maintaining the
critical quality attributes (CQAs) and paramount biological functions whilst processing at varying scales and locations in the world is far
from trivial.
To overcome the economic, technical, and regulatory challenges for successful adoption of cell and gene therapies,
The Bioprocessing of Advanced Cellular Therapies Congress, organized by MnM Conferences taking place on the 2-3 June
2016 in London (UK), strives to facilitate links between experts in the field to encourage collaborations and debate ways forward in
finding novel strategies and technologies, identifying trends and generally working towards more cost – effective solutions.
Key sessions:
 Upstream process development for gene therapies
 Upstream process development for cell-based therapies
 Downstream processing considerations
Analytics - tackling measurement assurance for advanced cellular therapeutics
 Insights into business development and reimbursement
 Regulatory perspectives
Bioprocessing of Advanced
Cellular Therapies Congress
2 - 3 June 2016, London Heathrow Marriot Hotel, London, UK
Event overview:
MnM CONFERENCES

2. For more information please contact Tony at tony.couch@amnmconferences.comFor more information please contact Tony at tony.couch@mnmconferences.com
Bioprocessing of Advanced
Cellular Therapies Congress
2 - 3 June 2016, London, UK
Gold Sponsors:
Sponsors & Exhibitors
Media Partners:
Supporting Association:

3. For more information please contact Tony at tony.couch@amnmconferences.comFor more information please contact Tony at tony.couch@mnmconferences.com
Bioprocessing of Advanced
Cellular Therapies Congress
2 - 3 June 2016, London, UK
Bioprocessing of Advanced
Cellular Therapies Congress
Speaker Panel:
Ivan Wall
Senior Lecturer, Cell Therapy
Bioprocessing
University College of
London, UK
Mark McCall
Enterprise Fellow, Centre for
Biological Engineering
Loughborough University,
UK
Marc Baradez
Lead Scientist Analytical
Development
Cell Therapy Catapult, UK
Olive Sturtevant
Administrative Director of Connell
& O’Reilly Families
Dana Farber Cancer Institute,
USA
Damian Marshall
Head of Analytical Development
Cell Therapy Catapult, UK
Katharina Winnemöller
Marketing Manager,
Miltenyi Biotec, UK
Qasim Rafiq
Assistant Professor, Bioprocess
engineering, Aston Medical
Research Institute, Aston
University, UK
Jennifer Moody
Vice President, Commercialization
Centre for Commercialization
of Regenerative Medicine,
Canada
Peter Jones
Head of Manufacturing
Development
Oxford BioMedica,
UK
Michael S. Kallos
Associate Director of the
Pharmaceutical Production
Research Facility
University of Calgary, Calgary
(AL), Canada
Margarida Menezes-Ferreira
National Scientific Advice
Coordinator, Senior Assessor/
Medicines Evaluation Department
INFARMED, Portugal
Kevin Murray
VP Global Sales
BioSpherix
Robert J Thomas
Reader in Manufacturing for
Cell Based Therapies, Centre for
Biological Engineering (CBE),
Loughborough University, UK
Nina Kotsopoulou
Director,
Process Development
Autolus Ltd, London, UK
Steve Oh
Director Stem Cell Bioprocessing,
BIP Programme Director &
Senior Principal Scientist, Stem
Cell Group, Bioprocessing
Technology Institute, Singapore
Bo Kara
Head Process Development,
Advanced Therapy Delivery
GlaxoSmithKline, UK
Otto-Wilhelm Merten
Head of the Applied
Vectorology and Innovation
Généthon, France
Jurjen Velthuis
Vice President CMC
Kiadis Pharma,
Netherlands
John Gray
VP, R&D
Audentes Therapeutics,
USA
Sven Kili, MD
VP, Head of Gene Therapy
Development, R&D Rare Disease Unit
GlaxoSmithKline, UK
Paula Alves
Chief Executive Officer
Instituto De Biologia
Experimental e Tecnológica,
Portugal
Anne Plant
Program Director for Biosciences
National Institute of
Standards and Technology,
USA
Stephen Minger
Member of the Board of Directors
Centre for Commercialization
of Regenerative Medicine,
Canada
Advisory Panel:
Fernanda Masri
Process Development Engineer
Centre for Commercialization
of Regenerative Medicine,
Canada
Otto-Wilhelm Merten
Head Of The Applied
Vectorology And Innovation
Généthon, France
Bo Kara
Head Process Development,
Advanced Therapy Delivery
GSK, UK
Anita Joshi
Biotechnology
Consultant
MarketsandMarkets, India
Ana Sofia Coroadinha
Head of Cell Line Development
& Molecular Biotechnology
IBET/ITQB-UNL,
Animal Cell Technology Unit
Portugal
MnM CONFERENCES

4. For more information please contact Tony at tony.couch@amnmconferences.comFor more information please contact Tony at tony.couch@mnmconferences.com
Bioprocessing of Advanced
Cellular Therapies Congress
2 - 3 June 2016, London, UK
Day 1, 2nd
June, Thursday
08:00 Registration and Coffee
08:50 MnM Conferences’ Welcome Address
08:55 Opening remarks by the Chair
09:00 From translation to commercialisation of advanced cellular therapies
• An overview of where the field is at and the ongoing efforts to commercialise cutting edge products.
• This talk will help us identify strategies to accelerate the development and success of novel cell and gene therapies as well as address key topics that
are the foundation for this 2 day congress.
• What are the major hurdles identified by the industry that are slowing the success of these therapies and how are addressing them?
Invited: Enrico Bastianelli, CEO, Bone Therapeutics
Upstream Process Development of Gene Therapies
Chair: Otto-Wilhelm Merten, Head of the Applied Vectorology and Innovation, Généthon, France
09:30 An overview of state of the art upstream processes for gene therapies
• Updates on ongoing upstream processes to render manufacturing more efficient and apt to provide gene therapy medicaments at the required quantity and quality.
• Current hurdles that need to be addressed will be defined and ways to overcome them will be proposed:
- Increase in product quantity
- Increase in product quality
- Reduction in production costs
Otto-Wilhelm Merten, Head of the Applied Vectorology and Innovation, Généthon, France
09:55 Strategies for efficient cell line selection and optimal stable cell line development
• Challenges of stable virus vector production as distinct from recombinant proteins
• Lessons learned from lentivirus producer cell line engineering
• Leveraging new technologies for optimization of cell line derivation
John Gray, VP, Research and Development, Audentes Therapeutics, USA
10:20 Challenges and solutions for establishing commercial manufacturing processes for ex-vivo cell- gene therapies
• Expression and manufacturing platforms for lentivirus production and cell processing
• Commercilaisation – supply chain and manufacturing models
Bo Kara, Head of Process Development, GSK, UK
10:45 Company Introduction: Chemometec
Ben Mantle, Area Manager, Chemometec A/S, UK
10:50 Morning Refreshments – Networking – Poster presentation and One to One meetings
11:35 Cell therapy manufacturing - making the future now
• Introduction of the T cell transduction Porcess on the CliniMACS Prodigy
• Data of robustness of the process and preclinical outlook
• Glimpse into the future of process development on the CliniMACS Prodigy Platform
Katharina Winnemöller, Marketing Manager, Miltenyi Biotec, UK
Upstream Process Development of Cell-Based Therapies
Chair: Steve Oh, Director, Stem Cell Bioprocessing, BTI, Bioprocessing Technology Institute, Singapore
11:55 Establishing the four pillars of stem cell bioprocessing
• Addressing the four main issues pertinent to stem cell bioprocessing:
- Fluorescent probes for identification of potent and senescent stem cell populations.
- Developing integrated stem cell expansion and differentiation processes in bioreactors.
- Biodegradable microcarriers for implantation of stem cells post expansion.
- Reprogramming technologies that can be automated at higher throughput for selecting fast growing and differentiating stem cell populations.
Steve Oh, Director, Stem Cell Bioprocessing, BTI, Singapore
12:20 Advanced optimisation and process control strategies for haematopoietic cell therapies
• Specific challenges and approaches to production of red cells, megakaryocytes and haematopoietic progenitors in conventional bioreactors.
• Process models and process/bioreactor modifications that enable targeting limitations of production efficiency and cell quality.
• Adherent cell bioreactor development work for MSCs.
Robert J Thomas, Reader in Manufacturing for Cell Based Therapies, Loughborough University, UK

5. For more information please contact Tony at tony.couch@amnmconferences.comFor more information please contact Tony at tony.couch@mnmconferences.com
Bioprocessing of Advanced
Cellular Therapies Congress
2 - 3 June 2016, London, UK
12:45 Bioprocess Development Using Stirred Suspension Bioreactors
• Bioreactor modelling: Shear can influence pluripotent stem cell phenotype
• Expanding skin derived Schwann cells on microcarriers
Michael S. Kallos, Associate Director of the Pharmaceutical Production Research Facility, University of Calgary, Canada
13:10 Process development strategies towards scalable and consistent manufacture of stem cells
• Control of raw materials significantly reduces variation and improves process consistency
• Development of suitable small-scale models allows for process optimisation
• Advances in technology and process understanding will facilitate scale-up and enable successful translation
Qasim Rafiq, Assistant Professor, Bioprocess engineering, Aston Medical Research Institute, Aston University, UK
13:30 Lunch – Networking – Poster presentation and One to One Meetings
Moving away from clean rooms to modular closed manufacturing
14:35 Features for next generation bioprocesses: modular, closed, scalable and compliant manufacturing systems
• Developing fully closed automated end-to-end cellular bioprocessing technology
• Get rid of the humans in the processing of cells
• Developing next generation tissue/organoid products
Keynote: Stephen Minger, Member of the Board of Directors, CCRM
15:00 Panel discussion - Modular closed manufacturing: issues and approaches
• Operating principles
• Converting existing assets
• Current facilities
1. Jürgen Velthius, Vice President CMC, Kiadis Biopharma
2. Robert Thomas, Academic Fellow, Loughborough University
3. Stephen Minger, Member of the Board of Directors, CCRM
15:30 Modular Closed Platform for Total Quality Cell and Gene Therapy Production
• A total quality approach produces a safer, more consistent product
• Modular closed systems offer dramatic advantages over clean rooms
• Fast, efficient scale up/scale out capabilities
Kevin Murray, VP Global Sales, BioSpherix
16:00 Afternoon Refreshments – Networking and One to One Meetings
Downstream Processing Considerations
Chair: Paula Alves, Chief Executive Officer of IBET, Portugal
16:50 Overview to downstream processing strategies and needs for cell and gene therapies
• As the upstream technologies mature, critical downstream processing steps need to have the capacity to handle large volumes of product.
• After harvest, the cells or viral vector typically need a combination of the following operations: concentration, washing, formulation for
cryopreservation, mixing and vialling into final containers.
• With such labile products, these are far from trivial operations and small variations can have a significant impact on product quality and/or
recovery. This talk will present an overview of the considerations during downstream processing for both cell and gene therapies.
Paula Alves, Chief Executive Officer, IBET, Portugal
17:15 Overcoming challenges in large-scale downstream processing of lentiviral vector-based gene therapies
• Industrialisation of process development and manufacturing technologies to deliver production systems for lentiviral vectors.
• Delivering commercially viable and regulatory compliant platforms for lentiviral vectors.
Peter Jones, Head of Manufacturing Development, Oxford BioMedica, UK
17:40 Process Development for CAR-T therapies
• Considerations for early phase processes for vector and T cell production
• Implementing process changes for later stage development/commercial
• Drug Product release and characterisation testing and managing comparability studies
Nina Kotsopoulou, Director, Process Development, Autolus Ltd.
18:05 Closing remarks by the chair
18:10 Short Talk by CCRM (Drinks Reception Sponsor)
Jennifer Moody, Vice President, Commercialization, CCRM, Canada
18:15 Networking and drinks reception

6. For more information please contact Tony at tony.couch@amnmconferences.comFor more information please contact Tony at tony.couch@mnmconferences.com
Bioprocessing of Advanced
Cellular Therapies Congress
2 - 3 June 2016, London, UK
Day 2, 3rd
June, Friday
08:15 Registration and Coffee
08:50 Opening remarks by the Chair
Anne Plant, Chief, Biosystems and Biomaterials Division, NIST, USA
09:00 Opening Keynote: Measurement Challenges for Cell Therapies
• Robust and meaningful assays that provide metrics of safety and effectiveness are needed for characterization of product, and for release assays.
• As manufacturing processes mature, it becomes increasingly important to establish comparability between product produced at different times and
places and after changes in the manufacturing process.
• A key is to apply the principles of measurement assurance, supporting data, and documentation to provide confidence in the comparability of
measurements. Examples in cell counting, flow cytometry, and quantitative imaging will be presented.
Anne Plant, Chief, Biosystems and Biomaterials Division, NIST, USA
Analytics – tackling measurement assurance for advanced cellular therapeutics
Chairperson: Damian Marshall, Head of Analytical Development, CT Catapult, UK
09:30 Evolving strategies for cell therapy product characterisation
• Emerging approaches for cell therapy characterisation with an emphasis on:
- The role of QbD in defining a characterisation strategy
- The challenge of multiplexed data analysis during product characterisation
- Emergent approaches for characterising cell therapy products
Damian Marshall, Head of Analytical Development, CT Catapult, UK
09:55 Developing potency assays and making appropriate measurements of function for clinical application of stem cells
• Challenges of measuring potency in MSCs
• Developing suites of assays that corroborate function
• Ensuring assays are linked to physiologic scenarios
Ivan Wall, Senior Lecturer, Cell Therapy Bioprocessing, UCL, UK
10:20 Analytical Challenges for the development of Cell Therapies
• Requirements for product characterisation
• Analytical strategies to de-risk cell therapy development
• The convoluted road to standardisation
Marc Baradez, Lead Scientist Analytical Development, CT Catapult, UK
10:45 Morning Refreshments – Networking – Poster presentation and One to One meetings
11:30 Solution Provider Presentation; Please contact Steve Hambrook at steve.h@mnmconferences.com
Insights into Business Development and Reimbursement
11:45 The relevance of cost modelling tools for bioprocessing
• Tools to confidently predict and reduce cell therapy cost of goods and associated manufacturing of regenerative medicine products.
Mark McCall, Enterprise Fellow, Centre for Biological Engineering, Loughborough University, UK
12:10 Evaluation of early stage technologies and strategies for advancement and partnership
• How can translation centres de-risk and advance technologies along the commercial path?
• This talk will address some key points the CCRM’s team considers during the assessment of incoming technologies.
Jennifer Moody, Vice President, Commercialization, CCRM, Canada
12:35 Developing market access strategies for cell-based and gene therapies: reimbursement pathways, price strategy and decision
making for profitable therapies
• Reimbursement is not everything, but it does play a crucial role in the success of a therapy.
• This talk will present different price strategies and decision making for profitable enterprises.
Speaker: TBA
13:00 Lunch – Networking – Poster presentation
14:00 CAR-T mock example for reimbursement – what is the optimum business model for CAR-T therapy space today?
• This case study will look into reimbursement strategies of major players.
• Participants will be grouped to compare and contrast approaches, rationale, challenges faced and end game of these key player’s strategies.
Invited: Christian Homsy, CEO, Ceylad

7. For more information please contact Tony at tony.couch@amnmconferences.comFor more information please contact Tony at tony.couch@mnmconferences.com
Bioprocessing of Advanced
Cellular Therapies Congress
2 - 3 June 2016, London, UK
Regulatory Perspective
Chairperson: Margarida Menezes-Ferreira, National Scientific Advice Coordinator, Senior Assessor, Lisbon, Portugal
14:30 Regulatory environment for cell and gene therapy medicinal products
• Efforts and progress towards a consolidated regulatory framework for these innovative medicines has recently led to many discussions and
developments in this area.
• This talk will give an overview of the European regulatory environment for cell and gene therapy.
Margarida Menezes-Ferreira, National Scientific Advice Coordinator, Senior Assessor, INFARMED, Portugal
14:55 Understanding the regulatory space and strategies, specific for gene therapy products
• This talk will address strategies for regulatory compliance, value creation, risk management and product safety for gene therapies.
Sven Kili, VP and Development Head for the Gene Therapy Division, GSK, UK
15:20 Practical considerations when designing a clinical trial to enhance trial compliance and patient safety
• Review current applications for the use of Novel Cellular Products in various clinical trials while also addressing some of the trial design strategies,
considerations and unique features that create operational and logistical issues.
• Discuss some of the unique manufacturing challenges in using autologous and directed allogeneic cellular products verses off-the-shelf standardise
materials
• Review the need for and obstacles in capturing data both during and after the clinical trial
Olive Strurtevant, Administrative Director, Cell Manipulation Core Facility, Dana Farber Cancer Institute, USA
15:45 Chair’s closing remarks
15:50 Afternoon refreshments and end of conference
MnM CONFERENCES