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PROVENTAI N T E R N A T I O N A L

2020JUNESTRATEGY 3rdONLINE MEETING

AGENDA CELL AND GENE THERAPYKEYNOTE PRESENTATION

TRACK 2 CONTINUOUS MANUFACTURING

TRACK 1QbD/PAT

TRACK 4 QMS

TRACK 3 UPSTREAM PROCESSSING

TRACK 6 DOWNSTREAM PROCESSSING

TRACK 5 INDUSTRY 4.0 / SINGLE USE TECHNOLOGIES

2019 ATTENDEES

TRACK 8 CAR-T, TCR & T CELL IMMUNOTHERAPIES

TRACK 7CELL & GENE THERAPY VECTORS

TRACK 9 CELL & GENE GMP MANUFACTURING

TRACK 12 EMERGING BIOPHARMA

TRACK 11 IMMUNOLOGIC & ONCOLYTIC TECHNOLOGIES

AGENDA BIOMANUFACTURING

TRACK 10 TRANSPORT LOGISTICS / PATIENT DELIVERY

SPONSORS

Click here to find out what our clients think about our Strategy Meetings

Amnon Eylath VP Head of Quality Axcella

Susanne Rommel Executive Director Development& Commercial Quality Gilead Sciences

Kartik SubramanianDirector Process SciencesAbbVie

Devyn Smith Chief Operating Officer Sigilon Therapeutics Inc.

Guadalupe Hayes-MotaGlobal Supply Director | E2E Supply Chain | Ops & Manufacturing Leader Ultragenyx

Weiyong SunSenior Director, Specialty Medicine Search & Evaluation, Global Business DevelopmentDaiichi Sankyo Group

Khalid Shah Vice Chair of Research, Director Center for Stem Cell TherapeuticsHarvawrd Medica School

David Sherris CEO GenAdam Therapeutics

Rakesh BankaDirector, Portfolio and Project Management, Global Product Dev. Pfizer

David Townson Executive Oncology Research & Development Bayer

OUR UNIQUE ONLINE MEETING FORMAT CONTRIBUTORS TO THE AGENDA

Roundtable DiscussionsThese interactive and informal discussion groups are the hallmark of the meeting. The brightest minds in the industry are brought together in 60-minute sessions that enable participants from all over the world to share ideas, challenges and lessons learned.

Personalised AgendaEach delegate receives a personalised agenda with the roundtable discussions that you choose. You only attend sessions and meetings that fit your challenges and interests, ensuring your time spent on the online platform is focused and well-utilised.

One-to-one MeetingsThe most effective and time efficient way to assess potential partners at a strategic level. Gain access to our exclusive networking app to identify the people that you need to meet. The app will allow for instant anddirect messaging to organise online meetings during the dedicated time to most benefit you.

Strategic NetworkingStrategic networking opportunities form a key benefit of the meeting. Our new online format for building and strengthening alliances to make lasting connections that benefit you.

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PROVENTAI N T E R N A T I O N A L1

SPONSORS

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CO-HOST

TRAC is recognized AUTOMATION SOLUTION PROVIDER for pharmaceutical and biotechnology industry. 25 years of partnership with major pharma companies and more than 500 successfully finished projects allow us to provide the best automation solutions for our partners. Our latest product is FMAP – Flexible Modular Automation Platform which addresses manufacturing challenges of the biotech processes and cell & gene therapies.

VISIT WEBSITE

Skyland Analytics helps Biomanufacturers secure, streamline and control their product and process data management by offering software solutions to ensure compliance, accuracy, and efficiency throughout their manufacturing operations, while significantly simplifying what is historically a time-consuming and costly process. Skyland PIMS® data collaboration platform is the first purpose-built solution for product, process and batch data management, analytics and business and regulatory reporting. Easy to deploy and validate, PIMS serves as the master repository throughout the product lifecycle. PIMS cloud-based workspace is licensed by product with unlimited user seats, improving visibility, productivity and collaboration throughout internal and external teams.VISIT WEBSITE

At Proventa Talent, we always look ahead to ensure that the service we deliver to you is second to none, both now and in the future. Proventa Talent based around our three key principles of commitment, intelligence and partnership ensures an unparalleled recruitment solution in the industry. We work with the leading talent in the field to offer a service of high quality, efficiency and transparency. In addition to this, our relationship with many organisations across the Life Sciences sector means that we are constantly developing our recruitment services to offer market-leading solutions including Contingency, Executive Search, Contract and fully integrated Recruitment Process Outsourcing to suit your short, medium and long term needs.VISIT WEBSITE

Pall Biotech offers a blend of innovative traditional, single-use and continuous processing technologies and services to create scalable bioprocessing solutions that are flexible to each type of manufacturer’s process. From concept through to design, validation and production, our team leverages best-in class technologies with industry-leading support for all bioprocessing applications. Whether that means fast-tracking a new drug, helping to ensure regulatory compliance, or making existing processes easier, faster and better, we are ready to fulfill your unique needs. Want to learn more about how Pall Biotech can enhance your bioprocesses from start to finish? Please visit www.pall.com/biotech.VISIT WEBSITE

Emerson (NYSE: EMR), headquartered in St. Louis, Missouri (USA), is a global technology and engineering company providing innovative automation solutions for Life Sciences customers. We help customers improve manufacturing reliability and repeatability, increase right first time production, and help reduce the time required to bring new manufacturing processes on-line. For more information visit http://www.emerson.com/en-us/industries/automation/life-sciences-medical

VISIT WEBSITE

BIA Separations is the leading developer and manufacturer of CIM® (Convective Interaction Media) monolithic chromatographic columns for production, purification, and analytics of large biomolecules. Our highly skilled team has more than two decades of accumulated knowledge in downstream processing and HPLC analytics. BIA Separations innovations include: • CIM® Monolith columns developed to resolve stubborn difficulties encountered by traditional particle based chromatography and results in significant valuable improvements in yield, quality and costs in downstream processing of viruses, VLPs, phages, pDNA, and large proteins. CIM monolithic columns are distinguished for their flow independent performance, resulting in fast separation, concentration, purification, removal, and analytics;• Based on 20 years of experience with over 500 running projects Purification Process Development for clinical phase trials and market supply of AAV (all serotypes), Flu virus (all serotypes), Adeno, Vaccinia/MVA, exosome, pDNA, RNA and many other complex biomolecule based biopharmaceuticals;• PATfixTM, unique Critical Quality Attributes (CQA) analyser based on HPLC principle combined with CIM® columns and advanced multivariate data analysis algorithms to track host cell impurities in a timely manner.Our mission is to develop and produce CIM monolithic columns of the highest quality, and to provide superior method development services for purification and HPLC analytics of biopharmaceuticals. For more information, please visit www.biaseparations.com.VISIT WEBSITE

Cellero delivers the most reliable biomaterials and custom research services to advance the discovery and development of new treatments and cures. Our unrivaled expertise in immune cell biology, biomaterial collections, cell characterization, and functional analysis makes Cellero an indispensable partner from early-stage research and drug development through clinical trials, manufacturing, commercialization, and treatment delivery to patients. We streamline discovery by delivering highly characterized fresh and cryopreserved immune cells, mobilized and non-mobilized leukapheresis products, and comprehensive consultative expertise for product and assay development. Our comprehensive services are provided with the highest levels of customer service and responsiveness.VISIT WEBSITE

Within the Optimal group we have more than 30 years’ experience in the automation and optimisation of control and data management systems for the pharmaceutical, biotech and life science industries. The demands being placed on manufacturers in relation to getting products to market sooner, minimising development and production costs together with increasing product quality and business sustainability are ever increasing; hence, the company’s primary aim is to deliver measurable improvements in all these target areas. In addition to practical automation and system integration expertise, Optimal Industrial Technologies has also developed the world-leading PAT Knowledge Management software platform – synTQ® which is used by over 60% of the world’s leading pharmaceutical and biotech companies. It has been a proven enabler of QbD via PAT by significantly increasing productivity and quality whilst reducing time to market, waste plus time to manufacture for batch and continuous processes. It is being applied from the laboratory through to full GMP manufacture in small and large molecule drug substance and drug product processes.

Industrial Technologies

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Oxford Biomedica is a pioneer of gene and cell therapy with a leading position in lentiviral vector research, development and bioprocessing. We have 20 years of experience in the field of gene and cell therapy, and we were the first organisation to treat humans with in vivo lentiviral-based vectors. Our LentiVector platform of exclusive, cutting-edge technologies produces gene and cell-based therapies for us and a range of partners.

PRO-PARTNERS

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Purolite Life Sciences brings Purolite’s innovative thinking and distinguished history of resin technology expertise to the global Life Sciences marketplace. Over three decades, Purolite has grown into the world’s premier resin technology manufacturer and innovation leader, with production plants and advanced research labs across the globe. Providing APIs, enzyme carriers and immobilized enzymes, and resins for purification and separation to support research and development, and production-scale applications in pharmaceuticals, protein purification, food production, bioprocessing, fine chemical and additional markets. With a team of world-class researchers and scientists, we develop novel, high-demand and customized products to meet customer needs.VISIT WEBSITE

ChemoMetec delivers automated cell counters, analyzers, and advanced image cytometers for Cell and Gene Therapy. Our technology is the gold standard for CAR-T cell therapy: Our instruments deliver the highest level of precision and are 21CFR part 11 ready for secure and traceable operation. Via-Cassette™ technology eliminates user errors from sample handling, counting and analysis. Individual volume-calibration ensures accurate calculation of cell concentration. This eliminates inter-user and inter-instrument variation between your CAR-T research team, manufacturing, and QC monitoring of end-product. Known for robustness, high precision, and user-friendly interface, our instruments streamline research, process development, and manufacturing processes for maximum efficiency.

VIRTUAL EXHIBITOR

VISIT WEBSITEVISIT WEBSITE

http://trac.si/

http://skylandanalytics.net

https://proventainternational.com/talent-acquisition/


http://www.emerson.com/en-us/news/corporate/emerson-accelerates-new-era


https://cellero.com/

http://optimal-ltd.co.uk/syntq

https://www.oxfordbiomedica.co.uk/

https://www.bataviabiosciences.com/

http://www.miltenyibiotec.com/GB-en/

https://www.roche.com/

https://www.tosohbioscience.com/

https://www.gyrosproteintechnologies.com/

https://www.cytivalifesciences.com/en/us

https://www.novotek.com/en/

https://www.purolite.com/life-sciences

https://chemometec.com/

https://cellgenix.com/

http://www.hamiltoncompany.com

2 PROVENTAI N T E R N A T I O N A L

AGENDA


0401 02 03 05 06

ROUNDTABLE TOPIC CONFIRMED FOR SPONSOR



Improving Process Design, QbD Process Validation Acceleration

Strategies and PAT Incorporation.

Metabolism Driven Biomanufacturing

Opportunities and Challenges for Continuous Biomanufacturing

Current processes and future considerations for Upstream and

Downstream Viral Vector Production

Mitigating challenges associated with raw material supply chains

Selecting a right-sized and cost-effective eQMS for the smaller

company

Selecting performance metrics for timely data-driven decisions using

Quality Management Review (QMR)

Industrial Internet of Things (IIoT) insights and intelligence to minimize waste within manufacturing systems

while simultaneously maximizing productivity Single-Use System

How real-time Manufacturing Execution Systems can optimise production

by analysing conditions in the manufacturing facility and maximise

overall equipment effectiveness.

A Single-Use Strategy to Enable Manufacturing of Affordable Biologics

Addressing Regulatory Requirements for Filter Integrity Testing

Strategies for managing consumable/disposable components in a clinical/

commercial environment

Kartik Subramanian - Director AbbVie

Athanasios (Sakis) Mantalaris - Prof. Georgia Institute of Technology &

Emory University

Amnon Eylath - VP Head of QualityAxcella

Blair McNeill - VP, Head of BiologicsSumitovant Biopharma

Guadalupe Hayes - Global Supply Direc. Ultragenyx

Anthony Colenburg - Dir. of Quality Adicet Bio

Rakes Banka - Director Pfizer

QbD/PAT CONTINUOUS MANUFACTURING UPSTREAM PROCESSING DOWNSTREAM PROCESSINGQMS INDUSTRY 4.0 SINGLE USE TECHNOLOGIES

James Marshall - Head of Supply ChainBristol-Myers Squibb

08:00 - 08:30

10:30 - 11:30

09:30 - 10:30

08:30 - 09:30

11:30 - 13:30

TRACK & ROOM( *TIME - B.S.T. )

13:00 - 13:30

13:30 - 14:30

14:30 - 15:30

15:30 - 16:30

16:30 - 18:30

13:30 - 14:0018:30 - 19:00

14:00 - 15:0019:00 - 20:00

15:00 - 15:2020:00 - 20:20

15:20 - 16:2020:20 - 21:20

TRACK & ROOM( *TIME - E.T. )

1 - 1 MEETING *09:30-09:50 E.T. 1 - 1 MEETING *09:50-10:10 E.T. 1 - 1 MEETING *10:10-10:30 E.T.NETWORKING BREAK NETWORKING BREAK

1 - 1 MEETING *11:30-11:50 E.T. 1 - 1 MEETING *12:10-12:30 E.T. 1 - 1 MEETING *12:50-13:10 E.T.1 - 1 MEETING *11:50-12:10 E.T. 1 - 1 MEETING *12:30-12:50 E.T. 1 - 1 MEETING *13:10-13:30 E.T.

1 - 1 MEETING *15:00-15:20 E.T.


Martin Gadsby - CEO and Director Duncan Low, Independent Bus. OwnerBob Lenich - Life Sciences Business Dir.

Susanne Rommel - Executive DirectorGilead Sciences

Ronald Bates - Director, MST Bristol-Myers Squibb

Siddhartha Jain - Director MSAT & Mahsa Hadidi - Downstream Scientist

Sanofi

Mukta Gupta - GMP Clinical Quality Lead Takeda

KEYNOTE PRESENTATION Benefits of modular automation in biopharma processes

Tomaz Resetic, CTO & Owner, TRAC



KEYNOTE PRESENTATION CIMmultus™ Monoliths – tailored to accelerate process development and address large scale manufacturing of ATMPs like AAV, pDNA, mRNA or Exosomes

Ingo S. Nagler, Co-founder and co-owner, BIA Separations



10

AGENDA

08:00 - 08:30

10:30 - 11:30

09:30 - 10:30

08:30 - 09:30

11:30 - 13:30

TRACK & ROOM( *TIME - B.S.T. )

13:00 - 13:30

13:30 - 14:30

14:30 - 15:30

15:30 - 16:30

16:30 - 18:30

13:30 - 14:0018:30 - 19:00

14:00 - 15:0019:00 - 20:00

15:00 - 15:2020:00 - 20:20

15:20 - 16:2020:20 - 21:20

TRACK & ROOM( *TIME - E.T. )

Darren Dasburg - Biotech Executive Contango Ventures Inc

Jichao (Jay) Kang - Tech. Program Lead Legend Biotech

Marc Wolfgang - VP Tech. Ops Neon Therapeutics

Michael Lotze - Vice Chair Surgery Dep. University of Pittsburgh

Next Generation OV and New Combinational Approaches for

Treatment of Solid Tumors

IMMUNOLOGIC & ONCOLYTIC TECHNOLOGIES

GO TO MENU

David Sherris - CEO GenAdam Therapeutics

Geert Mudde - Founder and CSO TYG Oncology Ltd

NEXT PAGE

Khalid Shah - Vice Chair Research Harward Medical School

Challenges for point of care manufacturing

PREVIOUS PAGE

Targeted immunotherapy does not mean tumour specific

immunotherapy. How can we do better than that?

Addressing challenges in TCR and CAR-T manufacturing with standardized characterization

Weiyong Sun - Senior DirectorDaiichi Sankyo Group

Applying effective and scalable sanitization /decontamination

technology to prevent/remediate cleanroom contaminations

Devyn Smith - Chief Operating Officer Sigilon Therapeutics Inc.

Anne Lodge, PhD - Chief Science and Innovation Officer

David Townson - Executive Oncology Bayer

Cell therapy transition challenges – Moving from early to late stage

development

Commercial-scale manufacturing at lower COGS

International shipping logistics strategies and addressing

regulations associated

When & how to go from fresh to cryo products and supply chain

strategies associated

Amnon Eylath - VP Head of QualityAxcella

Abhishek Srivastava - Senior Director Axis Therapeutics

Cell based therapies for Cancer: Journey from Innovation to

Translation

Strategies & Best Practices for Outsourcing Cell & Gene Therapy

Manufacturing to CMOs





Small Scale Personalised Manufacturing- In-House & Outsourced

Strategies & Challenges

How a shared-risked partnership model can improve the success rates

of getting to IND and beyond?

1 - 1 MEETING *09:30-09:50 E.T. 1 - 1 MEETING *09:50-10:10 E.T. 1 - 1 MEETING *10:10-10:30 E.T.NETWORKING BREAK NETWORKING BREAK

1 - 1 MEETING *11:30-11:50 E.T. 1 - 1 MEETING *12:10-12:30 E.T. 1 - 1 MEETING *12:50-13:10 E.T.1 - 1 MEETING *11:50-12:10 E.T. 1 - 1 MEETING *12:30-12:50 E.T.

TRANSPORT LOGISTICS PATIENT DELIVERY

CELL & GENE THERAPY VECTORS

1 - 1 MEETING *13:10-13:30 E.T.

1 - 1 MEETING *15:00-15:20 E.T.

CAR-T, TCR & T CELL IMMUNOTHERAPIES

CELL & GENE GMP MANUFACTURING EMERGING BIOPHARMA

07 08 09 11 12

Bob Di Scipio, CEO & ChairmanJonas Marstrand la Cour, PhD - ManagerDr. Clive Glover - Director, Strategy Andy Lewin, VP, Bussiness Dev. – Manu.

KEYNOTE PRESENTATION CIMmultus™ Monoliths – tailored to accelerate process development and address large scale manufacturing of ATMPs like AAV, pDNA, mRNA or Exosomes

Ingo S. Nagler, Co-founder and co-owner, BIA Separations


Tomaz Resetic CTO & Owner

TRAC

AFTERNOON KEYNOTEMORNING KEYNOTE

TIME SLOT (*E.T.)TIME SLOT (*E.T.)

Benefits of modular automation in biopharma processes

Advanced biopharma processes incorporate large number of equipment and often require flexible configurations to support production of different therapeutics. Modular automation is key enabler of flexible processes and allows individual production steps to be linked together in a standardized way. We will look how modular and intelligent automation can address everlasting challenges of:

• Quality and patient safety• Control of process variabilities• Process robustness• Production cost Join me for a presentation on practical example of cost-effective solution for modular automation.

CIMmultus™ Monoliths – tailored to accelerate process development and address large scale manufacturing of ATMPs like AAV, pDNA, mRNA or

Exosomes

• Illustration of the enabling differentiators of CIM® - Convective Interaction Media.• The power of orthogonal HPLC based analytics as basis for process development.• Existing and novel tools for scalable purification of AAV and mRNA.

KEYNOTE PRESENTATION

13:30 - 14:0008:00 - 08:30

LEARN MORE ABOUT OUR SPEAKERS

Ingo S. Nagler Co-founder and co-owner

BIA Separations


http://proventainternational.com/events/manufacturing/online/online-biomanufacturing-and-cell-and-gene-therapy/


Kartik SubramanianDirector Process Sciences

AbbVie

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

Martin Gadsby CEO and Director Optimal Industrial

Technologies and Optimal Industrial Automation

TIME SLOT (*E.T.)

SPONSOR ROUNDTABLE TOPICCurrent perspectives on the use of QbD and

PAT in pharmaceuticals and (bio)pharmaceutical development and manufacturingImproving Process Design, QbD Process

Validation Acceleration Strategies and PAT Incorporation.

• Leveraging prior knowledge in early Process Design• QbD strategies to accelerate process validation• Incorporating PAT across the life cycle

TRACK 1 QbD/PAT

08:30 - 09:30

Athanasios (Sakis) Mantalaris Professor, W.H. Coulter Department

of Biomedical Engineering Georgia Institute of Technology

& Emory University

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

Metabolism Driven Biomanufacturing• Cellular therapeutics have been gaining increasing clinical traction; however, there are inherent challenges in their biomanufacturing, including donor and tissue source variability, handling, storage and transportation variability, as well as variability in culture conditions and platforms that limit their robustness in terms of safety and efficacy as well as increase manufacturing-associated costs, both of which pose serious obstacles in the wide clinical translation of cell-based therapies.• Metabolism plays a central role in cell physiology; it is widely established that metabolites do not only change in response to alterations in cellular state but are also important modulators of cell proliferation, differentiation, and apoptosis.• Metabolomics has the potential to be the protagonist in therapeutic cell biomanufacturing by leading the quality assurance (QA) and quality control (QC) of the cellular input, bioprocess and the cellular output by providing biomarkers that will identify the “control space”, enabling robust control strategies.

14:00 - 15:00

10:30 - 11:30



• The industry trends on the take-up and use of QbD and PAT• QbD and PAT in small molecule development and manufacture• QbD and PAT in large molecule development and manufacture



PROVENTAI N T E R N A T I O N A L6 GO TO MENU NEXT PAGEPREVIOUS PAGE

TRACK 2 CONTINUOUS MANUFACTURING

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

Rakesh BankaDirector, Portfolio and

Project Management, Global Product Development

Pfizer

Opportunities and Challenges for Continuous Biomanufacturing

• Processes• Infrastructure• Quality and Regulations

15:20 - 16:20


Bob Lenich Life Sciences Business Director

EmersonTIME SLOT (*E.T.)

SPONSOR ROUNDTABLE TOPIC

10:30 - 11:30

Digital Transformation for Continuous ManufacturingAs the Life Sciences industry pushes for faster time to market, flexible and continuous manufacturing methods are becoming more and more common. These methods require advanced automation and control in order to deliver the required consistent quality. Please join this round table discussion to learn about:• Direction and best practices for PAT applications in continuous manufacturing• How plug and play technologies are creating key building blocks to make flexible manufacturing easy• How knowledge management applications with a recipe development focus can tie all of this together



TRACK 3 UPSTREAM PROCESSING

Blair McNeillVP, Head of Biologics and

Gene Therapy Sumitovant Biopharma

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

Current processes and future considerations for Upstream and Downstream Viral Vector

Production

• Adherent vs suspension cultures in the expression/ development of both AAV and LVV expression system • Purification of LVV – development of a robust chromatography process • How to achieve high percent full capsids using available methods in a manufacturing setting – is this needed?

14:00 - 15:00

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

Ronald Bates Director, MST

Bristol-Myers Squibb

Mitigating challenges associated with raw material supply chains

• How to robustly operate with key raw materials being single sourced• Understanding the sensitivity of cultures to trace impurities found in raw materials• Long-lead time of disposable components.

15:20 - 16:20




TRACK 4 QMS

Amnon Eylath VP Head of Quality

Axcella

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

Selecting a right-sized and cost-effective eQMS for the smaller company

• Scope of Quality Systems for a Biopharma company• Benefits of moving from paper systems to and eQMS• How an eQMS can ensure business continuity for QMS processes, especially during COVID-19 mitigation practices being applied in the workplace, across the world.

08:30 - 09:30

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

Susanne Rommel Executive Director Development

& Commercial Quality Gilead Sciences

Selecting performance metrics for timely data-driven decisions using

Quality Management Review (QMR)

• What QMR related performance metrics matter – internally and externally?• Scorecards for internal and external performance metrics• Moving from manual to system-supported processes for data gathering

15:20 - 16:20




Anthony Colenburg Director of Quality

Adicet Bio

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

Siddhartha Jain Director MSAT Sanofi

Mahsa Hadidi Downstream Scientist Sanofi

A Single-Use Strategy to Enable Manufacturing of Affordable Biologics

• How much reduction in cost of goods have different companies experienced with SUT through lower CAPEX, higher OPEX and lower batch losses? - look at past.• The goal of affordability is linked to accessibility including in developing countries. How can SUT transform Biologics manufacturing to bring the cost (and price) down by 2-5x in 5-10 years? - look to the future.• Understand what are the biggest drivers for transition to SUT in manufacturing and where does cost and affordability rank within that discussion. With focus on China, is SUT a big enabler if that? - look at present.

How real-time Manufacturing Execution Systems can optimise

production by analysing conditions in the manufacturing facility and maximise

overall equipment effectiveness.

TRACK 5 INDUSTRY 4.0 / SINGLE USE TECHNOLOGIES

Guadalupe Hayes-MotaGlobal Supply Director, E2E Supply Chain, Operations &

Manufacturing Leader Ultragenyx

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

Industrial Internet of Things (IIoT) insights and intelligence to minimize waste within

manufacturing systems while simultaneously maximizing productivity Single-Use System

• The benefits of IIoT adoption.• How to utilize IIoT to offer smart solutions for the detection and monitoring of potential damage, malfunctions, and breakdowns.• The implementation and strategy of the current industry to implements IIoT into its biomanufacturing floors

08:30 - 09:30

14:00 - 15:00 15:20 - 16:20




Mukta Gupta GMP Clinical Quality Lead

Takeda

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

Duncan Low Independent Business Owner

Claymore Biopharm LLC (for Purolite) TIME SLOT (*E.T.)


Resin supply: Mitigating potential bottlenecks, and alternate sources

Addressing Regulatory Requirements for Filter Integrity Testing

• Strategies for filter Integrity Testing• Phase appropriate filter validation requirements• Regulatory Agencies expectations

TRACK 6 DOWNSTREAM PROCESSING

08:30 - 09:30 10:30 - 11:30

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

James (Jim) MarshallHead of Supply Chain Bristol-Myers Squibb

Strategies for managing consumables/disposables in a dynamic processing

environment with extended lead times and decreased supplier flexibility

• Production scheduling and lead time horizon planning• Establishing a consumable platform to build consistency in requirements• Partnering with the supply base to manage constraints and consistent supply

15:20 - 16:20


• Risks to supply• The regulatory path forwards• Case studies and practical alternatives



TRACK 7 CELL & GENE THERAPY VECTORS (I.E. AAV & LENTIVECTORS)


David Sherris CEO

GenAdam Therapeutics

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

Next Generation OV and New Combinational Approaches for Treatment

of Solid Tumors

• Immuno-oncology therapy has curative potential but remains elusive• Novel technologies aimed to circumvent immuno-oncology deficits will be discussed

14:00 - 15:00


TIME SLOT (*E.T.)

Dr. Clive Glover Director, Strategy Pall Corporation


10:30 - 11:30

Improving viral vectors for cell and gene therapy• Challenges with existing viral vectors for therapeutic use• Methods to improve safety and efficacy of viral vectors• Implications for manufacturability of therapies



TRACK 8 CAR-T, TCR & T CELL IMMUNOTHERAPIES

Michael LotzeVice Chair Department

of Surgery University of Pittsburgh TIME SLOT (*E.T.)

Geert Mudde Founder and CSO TYG Oncology Ltd

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

Jonas Marstrand la Cour, PhD Scientific Operations

Manager Chemometec TIME SLOT (*E.T.)

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

Abhishek Srivastava Senior Director, Immunotherapy

Axis Therapeutics

Addressing challenges in TCR and CAR-T manufacturing with standardized

characterization

• What are current challenges and opportunities in CAR-/TCR-T cell manufacturing?• What are some of the latest progress being made to overcome current challenges?• How will T cell manufacturing look in future?

Setting standards for cell counting in the clean room and across departments

Challenges for point of care manufacturing

• Current logistics with centralized manufacturing• Comparison to bone marrow and solid organ transplantation chain of custody issues• Current industrial and academic applications; role of fda, ema and other regulatory agencies

Targeted immunotherapy does not mean tumour specific immunotherapy. How can

we do better than that?• 1st generation IT (accompanied by biomarkers) is tumor specific, but not maximally efficacious.• 2nd generation IT has no reliable biomarker is not tumor specific and causes autoimmune disease.• Cell therapy, like 1st generation IT, is tumor specific, comes with biomarkers but control of the response is still an issue and so is pricing.• 3rd generation IT, with active control over positive and negative checkpoints, combines the benefits of the 1st and 2nd IT without the drawbacks. Why is this not in the clinic?


ROUNDTABLE TOPIC SPONSOR ROUNDTABLE TOPIC

08:30 - 09:30

14:00 - 15:00

10:30 - 11:30

15:20 - 16:20


• Weighing the cell – setting the standard• Making it count – optimizing efficiency• Scaling up – tech transfer



Weiyong Sun Senior Director, Specialty

Medicine Search & Evaluation, Global Business Development

Daiichi Sankyo GroupTIME SLOT (*E.T.)

Commercial-scale manufacturing at lower COGS

• Commercial-scale manufacturing at lower COGS• Essential Elements of Technology Transfer to CMOs• Analytical Support of Manufacturing from Early Phase to Commercial

ROUNDTABLE TOPIC

TRACK 9 CELL & GENE GMP MANUFACTURING

Andy Lewin Vice President, Business

Development – Manufacturing Oxford Biomedica TIME SLOT (*E.T.)

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)



David TownsonExecutive, Oncology

Research & Development, Immuno-Oncology / Cell Therapy

Bayer

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

Cell therapy transition challenges – Moving from early to late stage development

Cell therapies offer one of the most promising areas in oncology research in recent years but these treatments come with challenges. With hundreds of companies now operating in the cell therapy space and thousands of clinical trials being conducted many organizations are facing the challenges associated with transitioning early stage assets through larger scale development, not to mention potential commercialization. This session will consider:• Challenges moving from early/small scale clinical research to later/larger scale development• Challenges in shifting from US-based development to global development• Logistical lessons and solutions

08:30 - 09:30 10:30 - 11:30

15:20 - 16:20


Lentiviral Vector GMP manufacture: Achieving Lower COGS and Shorter Time to Clinic

Anne Lodge, PhD Chief Science and Innovation Officer

Cellero

Sourcing appropriate materials for the development of cell therapies

14:00 - 15:00

• We will help guide you and answer questions regarding logistics of fresh leukopaks, and choice of fresh vs. frozen• Commercialization concerns and the ability to get your patients leukapheresed, for allogeneic therapies; which will be the appropriate donors? Autologous therapies what specifications can be met?• Support manufacturing needs; process development, training and validation.



TRACK 10 TRANSPORT LOGISTICS / PATIENT DELIVERY


TIME SLOT (*E.T.)

Darren DasburgBiotech Executive

Contango Ventures Inc.

International shipping logistics strategies and addressing regulations associated

• Promise of an engineered immune system• Patient in and of a supply chain• Criticality of chain of custody, condition and identity

ROUNDTABLE TOPIC

08:30 - 09:30

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

Devyn Smith Chief Operating Officer

Sigilon Therapeutics Inc.

When & how to go from fresh to cryo products and supply chain strategies

associated

• What are benefits of switching from fresh to frozen product in cell based therapies• What is the right strategy to do so?• How to manage the switch while maintaining current CMC and supply chains?

15:20 - 16:20




TRACK 11 IMMUNOLOGIC & ONCOLYTIC TECHNOLOGIES


Khalid Shah Vice Chair of Research,

Director Center for Stem Cell Therapeutics and Imaging Associate Professor HMS

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

Cell based therapies for Cancer: Journey from Innovation to Translation

• Current innovations in cell therapy for cancer• Status of cell based therapies in pre-clinical models• Bottlenecks in translating cell based therapies into clinics• Safety

14:00 - 15:00




TRACK 12 EMERGING BIOPHARMA

Jichao (Jay) Kang Technical Program Lead

Legend BiotechTIME SLOT (*E.T.)

Marc WolfgangVP Technical Operations

Neon Therapeutics

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

Bob Di Scipio CEO & Chairman

Skyland AnalyticsTIME SLOT (*E.T.)

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

Right Time, Right Place, Right Size: Adopting a Digital Process Data Management System that Drives Economic, Operational and

Regulatory Success Throughout your Product Lifecycle and Across Internal and External NetworksStrategies & Best Practices for Outsourcing

Cell & Gene Therapy Manufacturing to CMOs

• Opportunities of utilizing CMO for process development• Managing the quality and timeline• Testing strategy

Small Scale Personalised Manufacturing - In-House & Outsourced Strategies &

Challenges

• Strategies to ensure efficient and successful small scale, personalized manufacturing• Addressing challenges associated with small scale, personalized manufacturing• Outsourcing vs. in-house manufacture of individualized therapies


ROUNDTABLE TOPIC SPONSOR ROUNDTABLE TOPIC

08:30 - 09:30

14:00 - 15:00

10:30 - 11:30

15:20 - 16:20


Amnon EylathVP Head of Quality

Axcella

Applying effective and scalable sanitization/decontamination technology to prevent/

remediate cleanroom contaminations

• Common sanitization and decontamination technologies used for aseptic areas and isolators• Pros and cons of these methods• Selecting the most effective, non-damaging, and easy to validate and monitor method for your needs.

• Speeding the development of process control strategies, tech transfer, batch analysis and trending• Increasing data integrity and gain better visibility into process performance• Meeting 21 CFR Part 11 compliance and validation guidelines• Accelerating commercial release• Addressing growth and scale needs regardless of existing IT landscape• Providing immediate value at low total cost of ownership (TCO)



COMPANY

AbbvieAbimmune Biotherapeutics LLCActinium Pharmaceuticals, Inc.AffigenAgenus BioAlexion PharmaceuticalsAlexion Pharmaceuticals Inc.AllakosAmpliPhi BIosciencesAnimal BiosciencesAnimal BiosciencesAOBiome TherapeuticsAOBiome TherapeuticsAscentage PharmaBeam TherapeuticsBiogenBiogenBioverativBioverativBioverativBioverativBrainStorm Cell TherapeuticsBrainStorm Cell TherapeuticsBristol-Myers SquibbBristol-Myers SquibbBristol-Myers SquibbCBT Pharmaceuticals CelgeneCelgeneCelgene

JOB TITLE

Director, Biologics CMCCEO and PresidentHead of Process Development and ManufacturingVP of ManufacturingVice President, Global Antibody Manufacturing & Site HeadExecutive Director, Country QualityExecutive Director, Quality Systems,Standards and ComplianceVice President, Technical OperationsVice President of Chemistry, Manufacturing and ControlsVP R&DVP Supply Chain and OperationsSVP, ManufacturingHead of QualityRegulatory Affairs, Associate DirectorVP, Pharmaceutical Sciences and Delivery TechnologiesVice President, Protein DevelopmentGlobal Reg CMC Commercial BiologicsAssociate Director Engineering and FacilitiesExecutive Director External ManufacturingExecutive Director, External ManufacturingPurification Leader, Technical Development and Manufacturing SciencesChief Executive OfficerChief Commercial OfficerAssociate Director, Process AnalyticsVice President, Head Biologics DevelopmentHead of Supply ChainSenior Vice President, Process Development and ManufacturingVice President, Biologics QualityDirector Biologics Development & ManufacturingDirector-Supply Chain Excellence Investigational Material Supply Chain

CelgeneCelgene CorpCompass TherapeuticsCurisDaiichi Sankyo, Inc.Daiichi Sankyo, Inc.Daiichi Sankyo, Inc.Fate TherapeuticsFinch TherapeuticsFrequency Therapeutics, Inc.Gilead SciencesGlaxoSmithKlineImmunovantInfinity PharmaceuticalsIronwood PharmaceuticalsIronwood PharmaceuticalsKeryx BiopharmaKiniksa PharmaceuticalsKiniksa PharmaceuticalsKyn TherapeuticsLife BiosciencesMassachusetts Institute of TechnologyMerckMerkMersana TherapeuticsMersana TherapeuticsMersana TherapeuticsModerna IncModerna TherapeuticsModerna TherapeuticsModerna Therapeutics

Strategic Program (Director) ManagerSenior Director, Strategic Program Management, IMSCSenior Vice President, Process and ManufacturingAssociate Director, CMCDirector, CMCAssociate Director, CMC Management and OperationsDirector Regulatory Affairs CMCSenior Vice President, Technical OperationsVice President of Bioprocess and Analytical DevelopmentVP, Pharmaceutical DevelopmentSenior Vice President, Quality AssuranceVP Target to Patient Supply ChainVice President, Head of CMC/Analytical Development/ QCDirector, Pharmaceutical DevelopmentHead of QualityHead of Pharm Dev and Manufacturing SciencesVP OperationsSenior Director, Cell Culture Development Director, CMC Program Management and Business OperationsHead of CMC OperationsVP of CMCDirector, Drug Development Pipeline ResearchAssociate Principal ScientistExecutive DirectorAssociate DirectorDirector, CMC Process Engineering and BioConjugationAssociate Director, Drug Substance CMCHead of Analytical DevelopmentDirectorSr. Director Regulatory Affairs CMCHead, Drug Substance Process Development

COMPANY JOB TITLE


2019 ATTENDEES p.1


COMPANY

Moderna TherapeuticsNortheastern UniversityNorthern BiologicsNovartisNovartisNovartisNovartisNovartisNovartisOtsukaPalleon Pharmaceuticals Inc.Phoenix Tissue Repair, Inc.Pieris Pharmaceuticals, Inc.Prevail TherapeuticsPromedior, Inc.Rubius TherapeuticsRubius TherapeuticsSanofiSanofiSanofiSanofiSanofiSanofiSanofiSanofiSanofiSanofiSanofiSanofiSanofi GenzymeShireSigilon Therapeutics, Inc.

JOB TITLE

Vice President Technical Development and ManufacturingDepartment Chair Quality Assurance and Advanced Manufacturing SystemsVice President, CMC DevelopmentHead of Emerging TechnologiesHead, Quality Management Systems & ComplianceDirectorGlobal Head, Chemical & Pharmaceutical ProfilingHead, Operations and External Service, QualityDirector DP compliance & Info SecSVPSVP of Discovery and Early Product DevelopmentVice President, Technical OperationsExecutive Director, CMCDirector External ManufacturingSenior Director, AnalyticalDirector of ManufacturingAssociate Director of ManufacturingSenior DirectorHead, North America Technical Operations - EMGHead of Quality Operations Biologics Platform, Global QualityDirector, Network StrategyAssociate Director DSP Continuous ManufacturingHead of Continuous Manufacturing Skill CenterSenior DirectorDirector, Global MSATAssociate Director Quality AssuranceDownstream ScientistProcess EngineerProcess Engineer II Analytical Scientist AssociateLead, Principal Associate, RA-CMCSenior Vice President, Global QualityChief Strategy Officer and Head of Operations

Sigilon Therapeutics, Inc.Solid BiosciencesSolid BiosciencesSolid BiosciencesSynlogic TherapeuticsTakedaTakedaTakedaTakeda

TakedaTakedaTakedaTakedaTakeda PharmaceuticalsTorque TherapeuticsTranslate BioTranslate BioTranslate BioTranslate BioUltragenyx Pharmaceutical, Inc.Ultragenyx Pharmaceutical, Inc.Unum TherapeuticsVertex PharmaceuticalsVertex PharmaceuticalsVertex PharmaceuticalsVertex PharmaceuticalsVir BiotechnologyZafgenZiopharm Oncology

SVP, Head of ManufacturingChief Operating Officer VP, ManufacturingDirector, Manufacturing Science and TechnologyLead EngineerAssociate Director, Upstream Process DevelopmentDirector, Biologics Global StewardshipGMP Clinical Quality LeadSenior Director,Head of product development and Clinical Manufacturing, Cell TherapyGlobal Regulatory CMC, ManagerAssociate Director, Upstream Process DevelopmentResearch Investigator CMCHead of Downstream Process DevelopmentAssociate Director Biologics Drug Product and Device DevelopmentVP of Biologics ManufacturingVice President, CMCAssociate DirectorAssociate DirectorSr. Director, QAVice President, Head of CMC/Analytical Development/ QCVP Gene Therapy ManufacturingChief Technology OfficerScientific Fellow II (Director)Biologics Process Development Technical LeadAssociate DirectorSr. Scientific FellowVP, QualityDirector, QAVice President, Technical Operations

COMPANY JOB TITLE

2019 ATTENDEES p.2



2019 ATTENDEES p.3


COMPANY

AbbVie VenturesAdicet BioAegerion Agios PharmaceuticalsAlnylamAlnylam PharmaceuticalsAlnylam PharmaceuticalsAmicus TherapeuticsAminex TherapeuticsAmorsa TherapeuticsAnika TherapeuticsApic BioAsklepios BioPharmaceutical, Inc.Astellas Institute for Regenerative MedicineAstellas PharmaAstraZenecaAstrazenecaBavarian NordicBayerBayerBayerBayerBellicumBICYCLE THERAPEUTICSBiogenBiogenBiogenBiogenBiogenBioverativbluebird bio

JOB TITLE

DirectorChief Business OfficerManager Global Regulatory AffairsHead of CMC; DHODH Program LeaderAssociate DirectorSenior Director, Regulatory AffairsDirector Manufacturing Technical ServicesAssociate Director of Medical Affairs, Medical Science Liaison Chairman, Clinical and Scientific Advisory BoardCOOChief Technology & Strategy OfficerChief Technology OfficerChief Executive OfficerDirector, Clinical and Program ManagementAssociate Director, Clinical Study Management, AIRMAssociate Principal ScientistVice PresidentChief Medical OfficerDeputy Director Strategic Pricing and ReimbursementImmuno-oncology Global Program HeadDirector, Market AccessSenior DirectorExecutive Vice President, Technical OperationsAssociate Principal ScientistPrincipal ScientistDirector, Analytical DevelopmentSenior ScientistSenior Associate ScientistDirector, ADPM, Gene TherapyExec Dir External MfgSenior Director Lentiviral Vector Process Development

bluebird bioBluebird BioBluebird BioBluebird BIoBluebird bioBlueRock TherapeuticsBoehringer Ingelheim Pharmaceuticals IncCARSgen TherapeuticsCasebia TherapeuticsCelgeneChugaiCollegium Pharmaceutical, Inc.CRISPR TherapeuticsCRISPR TherapeuticsCRISPR Therapeutics IncDaichii SankyoDaiichi SankyoEisai incERYTECH PharmaFinch TherapeuticsFlexion TherapeuticsGemini TherapeuticsGemini TherapeuticsGenoceaGenoceaGenoceaGenocea BiosciencesGenocea BiosciencesGenocea BiosciencesGlaxoSmithKlineHarvard Medical SchoolJanssen Biotech

Vice President Chief Technology and Manufacturing OfficerDirector Regulatory cmcAssociate Director ImmunotherapyDirectorSenior Vice President of ImmunologyGlobal Regulatory Lead, ImmunologySenior Vice President, Clinical DevelopmentVice President, Head of OphthalmologyAssociate Director, BiostatisticsHead of RA & PVSenior DirectorDirector CMO Operations (US)Head of Clinical Operations, Data Management and Medical WritingSenior Director GMP Manufacturing and Technology DevelopmentDirectorSenior DirectorSenior DirectorVice President of Commercial Strategy VPSVP Business DevelopmentChief Technology OfficerScientist, Gene therapySenior Research Associate IDirector of DiscoveryDirector of Technical OperationsSr. Director, Pharm Sci & Mfg.Principal ScientistDirector Pharm. Sci.Director of Strategy and PlanningVice Chairman/DirectorAssoc. Director Clinical Supplies Integrator

COMPANY JOB TITLE


2019 ATTENDEES p.4

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COMPANY

Johnson & JohnsonJounce TherapeuticsKLUS PharmaMassachusetts General Hospitals/HarvardMustang BioNeon TherapeuticsNovartisNovartisNovartisNovartisNovartis Institutes for Biomedical ResearchNovartis Institutes for BioMedical Research (NIBR)

Novartis Precision MedicineOncorusONCORUSOncorusPfizer/HarvardPTC TherapeuticsReplimuneRubius TherapeuticsSanofi

SanofiSanofi

SanofiSanofiSanofi GenzymeSelecta BiosciencesSelecta Biosciences Inc.Selecta Biosciences, Inc.Semma TherapeuticsShireShire

JOB TITLE

Senior DirectorSenior DirectorVPInstructor/Senior Principal ScientistChief Technology OfficerVPGlobal Quality HeadDirectorInvestigatorScientist IIResearch Investigator IIIGlobal Head, Search and Evaluation, Business Development and LicensingLead, Clinical Assay Standards Senior Vice PresidentVP, Molecular Biology and VirologyScientist IIMedical Director/FellowGlobal Head, Market Access & New Products Chief Business OfficerSenior Scientist, Translational MedicineVP, Head of Development for Rare Diseases, Head of Translational Gene TherapyHead BD, Technology PlatformsHead of Business Development, Rare Diseases & Rare Blood Disorders Global Business Development & LicensingAssociate Director, CMCMedical DirectorHead of Business Development, Rare DiseasesSenior DirectorCSOVP, Process Development and ManufacturingDirector, Cell Therapy DevelopmentGlobal Clinical Development LeadDirector and Team Lead of Biostatisticshain

Sigilon Therapeutics, IncSigilon Therapeutics, IncSorrento Therapeutics

Spark TXStoke TherapeuticsStoke TherapeuticsTakedaTakedaTakedaTakedaTakedaTakedaTakedaTakeda PharmaceuticalsTakeda PharmaceuticalsTakeda PharmaceuticalsTakeda PharmaceuticalsTocagenTranslate BioTranslate BioUltragenyxUltragenyx Gene TherapyUltragenyx Gene TherapyUltragenyx Gene TherapyUltragenyx Gene Therapy UniQureUniversity of PittsburghUniversity of PittsburghUnum TherapeuticsUnum TherapeuticsUnum TherapeuticsVertexVoyager TherapeuticsVoyager Therapeutics

Chief Strategy Officer and Head of OperationsSVP, Head of ManufacturingChief Medical Officer and President of Clinical Research, Medical Affairs and RegulatoryGene Therapy Director, Commercial, and Federal accountsExecutive Vice President, Head of Research and Preclinical Development Chief Medical OfficerAssociate DirectorAssociate DirectorAssoc. Director, Oncology Translational MedicineSr. ScientistAssociate ScientistScientist/Team LeaderSenior Scientist/Project LeadAssociate Director, Scientific IntelligenceHead of Gene Therapy Research, US Research, R&DImmuno-Oncology Lead/ScientistAssociate Director, Global Regulatory Affairs CMCExecutive Vice President, Pharmaceutical DevelopmentSenior Director, Research Discovery & Process DevelopmentAssociate DirectorProject ManagerSenior Director, Quality ControlSenior Director of Program ManagementDirector, Quality ControlVice President and Global Head of QualityDirectorEmeritus Chair and Professor of Microbiology and Molecular GeneticsVice Chair Department of Surgery, Sr. Advisor ITTCChief Technology OfficerDirector of Immunopharmacology Associate Director-Translational MedicineScientific Fellow IIManager Analytical Sciences / Head of Process AnalyticsDirector, CMC

COMPANY JOB TITLE

agenda biomanufacturing our unique online meeting … · center for stem cell therapeutics harvawrd...

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