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

AGENDA CELL AND GENE THERAPY

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

2020JUNESTRATEGY 3rdONLINE MEETING

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 ONCOLOGY, ONCOLYTIC VIRUSES & mRNA

BASED TECHNOLOGIES

INVESTMENT & VENTURE CAPITAL

AGENDA BIOMANUFACTURING

TRACK 10 TRANSPORT LOGISTICS / PATIENT DELIVERY

SPONSORS

Amnon Eylath VP Head of Quality Axcella

Catalina Driscoll Global Head New Product Planning Sanofi

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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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

Astarte Biologics was founded in 2004 with one focus: to provide the highest quality immune cell products. From donor testing and consent to detailed Certificates of Analysis and fast, reliable shipping, we do everything in our power to ensure you receive viable, functional cells every time. When you order from Astarte, you can be confident that your cells and reagents will arrive on time, be the correct cell count as seen on the Certificate of Analysis, and perform as expected. We test all of our cryopreserved cells upon thawing, so we can evaluate the cells in the same conditions as you do.

VISIT WEBSITE

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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.VISIT WEBSITE VISIT WEBSITE

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.

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PRO-PARTNERS

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AGENDA

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ROUNDTABLE TOPIC CONFIRMED FOR SPONSOR

ROUNDTABLE TOPIC CONFIRMED FOR SPONSOR

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ROUNDTABLE TOPIC CONFIRMED FOR SPONSOR

ROUNDTABLE TOPIC CONFIRMED FOR SPONSOR

KEYNOTE PRESENTATION KEYNOTE PRESENTATIONKEYNOTE PRESENTATION

Improving Process Design, QbD Process Validation Acceleration

Strategies and PAT Incorporation.

Leveraging quality by design and PAT downstream of drug

substance

Industrial and regulatory perspectives on QbD & PAT in pharmaceuticals & (bio)

pharmaceutical development

Process Intensification: Implementation of Continuous Manufacturing in

Upstream Processing

Cell Culture Process Intensification: A Combined Lab-Scale, Modeling &

Engineering Approach

Opportunities and Challenges for Continuous Biomanufacturing

Current processes and future considerations for Upstream and

Downstream Viral Vector Production

Cost efficiency and performance increase of continuous capture step for Protein A

in the mAb process

Current processes and future considerations for Upstream and

Downstream Viral Vector Production

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

company

Utilizing IoT for a centralized data platform and quality management

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 predictive analytics can improve the maintenance process

A Single-Use Strategy to Enable Manufacturing of Affordable Biologics

Addressing Regulatory Requirements for Filter Integrity Testing

Implementing a Membrane Absorber for Downstream Process Intensification of

Adenovirus

Strategies for managing consumable/disposable components in a clinical/

commercial environment

Kartik Subramanian - Director AbbVie

Amnon Eylath - VP Head of QualityAxcella

Blair McNeill - VP, Head of BiologicsSumitovant Biopharma

Guadalupe Hayes - Global Supply Direc. Ultragenyx

Rakes Banka - Director Pfizer

QbD/PAT CONTINUOUS MANUFACTURING UPSTREAM PROCESSING DOWNSTREAM PROCESSINGQMSINDUSTRY 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 - G.M.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. )

KEYNOTE PRESENTATION KEYNOTE PRESENTATIONKEYNOTE PRESENTATION

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

Susanne Rommel - Executive DirectorGilead Sciences

Siddhartha Jain - Director MSAT & Mahsa Hadidi - Downstream Scientist

Sanofi

Mukta Gupta - GMP Clinical Quality Lead Takeda

PROVENTAI N T E R N A T I O N A L3

ROUNDTABLE TOPIC CONFIRMED FOR SPONSOR

ROUND TABLE TOPIC CONFIRMED FOR SPONSOR

ROUNDTABLE TOPIC CONFIRMED FOR SPONSOR

ROUNDTABLE TOPIC CONFIRMED FOR SPONSOR

KEYNOTE PRESENTATION KEYNOTE PRESENTATIONKEYNOTE PRESENTATION

KEYNOTE PRESENTATION KEYNOTE PRESENTATIONKEYNOTE PRESENTATION

Catalina Driscoll - Global Head Sanofi

CELL & GENE THERAPY VECTORS

CAR-T, TCR & T CELL IMMUNOTHERAPIES

CELL & GENE GMP MANUFACTURING EMERGING BIOPHARMA

The Importance of Early Product Differentiation for Cell

& Gene Therapy Programs

Next Generation OV and New Combinational Approaches for

Treatment of Solid Tumors

Strategies to address dosing and immune response issues

in gene therapy vectors

1007 08 09 11 12

Challenges for point of care manufacturing

Development, Clinical Results and Translational Analysis of a T Cell Product

for Mantle Cell Lymphoma

Strategies for implementation of a universal “off-the-shelf” adopted T Cell

therapy

Applying effective and scalable sanitization /decontamination

technology to prevent/remediate cleanroom contaminations

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

Strategies for Patient Delivery Methods and Potential Toxicity

Associated with RNA Technologies

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

strategies associated

mRNA Cancer Therapeutic Vaccines

Cell based therapies for Cancer: Journey from Innovation to

Translation

Antibody Targeted Viruses: The Next Generation of Oncolytics

The challenges aligned with clinical trial planning through to trial design implementation & how an integrated

CRO with therapeutically focused expertise can help?

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?

TRANSPORT LOGISTICS PATIENT DELIVERY

Michael Lotze - Vice Chair Surgery Dep. University of Pittsburgh

Weiyong Sun - Senior DirectorDaiichi Sankyo Group

Marc Wolfgang - VP Tech. Ops Neon Therapeutics

ONCOLYTIC VIRUSES & mRNA BASED TECHNOLOGIES

David Sherris - CEO GenAdam Therapeutics

David Townson - Executive Oncology Bayer

Khalid Shah - Vice Chair Research Harward Medical School

Devyn Smith - Chief Operating Officer Sigilon Therapeutics Inc.

AGENDA

08:00 - 08:30

10:30 - 11:30

09:30 - 10:30

08:30 - 09:30

11:30 - 13:30

TRACK & ROOM( *TIME - G.M.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

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Amnon Eylath - VP Head of QualityAxcella

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.

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Introducing The New ‘Investment & Venture Capital’ Track - Proventa International’s latest evolutionary step in developing our signature Strategy Meetings. Now not only providing essential operational strategy solutions but also aiding in equally important fund raising and investment seeking strategy.

SPEAKER TBC TBC TBC

Allocating an adequate yet conservative CMC budget from investment fund, investor

recommendations.

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

SPEAKER TBC TBC TBC

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

SPEAKER TBC TBC TBC

TIME SLOT (*E.T.)

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

SPEAKER TBC TBC TBC

SPONSOR ROUNDTABLE TOPICTBC

Key considerations when approaching investors - investor insights

How a shared-risk partnership model can reduce the cost of outsourcing manufacturing

- advantages and disadvantages

INVESTMENTS & VENTURE CAPITAL

8:30 - 9:30

14:00 - 15:00

10:30 - 11:30

15:20 - 16:20

LEARN MORE ABOUT OUR SPEAKERS

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PROVENTAI N T E R N A T I O N A L5

BIOMANUFACTURING

Kartik SubramanianDirector Process Sciences

AbbVie

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

SPEAKER TBC TBC TBC

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

Martin Gadsby CEO and Director

Optimal Industrial Technologies and Optimal Industrial

AutomationTIME SLOT (*E.T.)

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

SPEAKER TBC TBC TBC

SPONSOR ROUNDTABLE TOPIC

Current industrial and regulatory perspectives on QbD and PAT in pharmaceuticals and (bio)

pharmaceutical development

Current perspectives on the use of QbD and PAT in pharmaceuticals and (bio)pharmaceutical

development and manufacturing

Improving Process Design, QbD Process Validation Acceleration Strategies and PAT Incorporation.

Leveraging quality by design and PAT downstream of drug substance

TRACK 1 QbD/PAT

8:30 - 9:30

14:00 - 15:00

10:30 - 11:30

15:20 - 16:20

LEARN MORE ABOUT OUR SPEAKERS

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BIOMANUFACTURING

SPEAKER TBC TBC TBC

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

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ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

SPEAKER TBC TBC TBC

TIME SLOT (*E.T.)

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

Rakesh BankaDirector, Portfolio and

Project Management, Global Product Development

Pfizer

SPONSOR ROUNDTABLE TOPIC

Opportunities and Challenges for Continuous Biomanufacturing

Developing a fully automated, flexible and integrated continuous downstream purification

platform and process intensification

Process Intensification: Implementation of Continuous Manufacturing in Upstream

Processing

Cell Culture Process Intensification: A Combined Lab-Scale, Modeling and Engineering Approach

TRACK 2 CONTINUOUS MANUFACTURING

8:30 - 9:30

14:00 - 15:00

10:30 - 11:30

15:20 - 16:20

LEARN MORE ABOUT OUR SPEAKERS

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BIOMANUFACTURING

Blair McNeillVP, Head of Biologics and Gene

Therapy Sumitovant Biopharma

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

SPEAKER TBC TBC TBC

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

SPEAKER TBC TBC TBC

TIME SLOT (*E.T.)

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

SPEAKER TBC TBC TBC

SPONSOR ROUNDTABLE TOPIC

Current processes and future considerations for Upstream and Downstream Viral Vector

Production

Current processes and future considerations for Upstream and Downstream Viral

Vector Production

Current processes and future considerations for Upstream and Downstream Viral Vector

Production

Cost efficiency and performance increase ofcontinuous capture step for Protein A in the

mAb process

TRACK 3 UPSTREAM PROCESSING

8:30 - 9:30

14:00 - 15:00

10:30 - 11:30

15:20 - 16:20

LEARN MORE ABOUT OUR SPEAKERS

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BIOMANUFACTURING

Amnon Eylath VP Head of Quality

Axcella

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

SPEAKER TBC TBC TBC

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

SPEAKER TBC TBC TBC

TIME SLOT (*E.T.)

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

Susanne Rommel Executive Director Development

& Commercial Quality Gilead Sciences

SPONSOR ROUNDTABLE TOPIC

Selecting performance metrics for timely data-driven decisions using

Quality Management Review (QMR)

Leveraging digital solutions to ensure QMS requirements are met while achieving rapid

release of biological products

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

Utilizing IoT for a centralized dataplatform and quality management

TRACK 4 QMS

8:30 - 9:30

14:00 - 15:00

10:30 - 11:30

15:20 - 16:20

LEARN MORE ABOUT OUR SPEAKERS

PROVENTAI N T E R N A T I O N A L9 GO TO MENU NEXT PAGEPREVIOUS PAGE

BIOMANUFACTURING

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

Manufacturing Leader Ultragenyx

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

SPEAKER TBC TBC TBC

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

SPEAKER TBC TBC TBC

TIME SLOT (*E.T.)

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

Siddhartha Jain Director MSAT Sanofi

Mahsa Hadidi Downstream Scientist Sanofi

SPONSOR ROUNDTABLE TOPIC

A Single-Use Strategy to Enable Manufacturing of Affordable Biologics

How real-time Manufacturing Execution Systems can optimise production by analysing conditions

in the manufacturing facility and maximise overall equipment effectiveness.

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

manufacturing systems while simultaneously maximizing productivity Single-Use System

How predictive analytics can improve the maintenance process

TRACK 5 INDUSTRY 4.0 / SINGLE USE TECHNOLOGIES

8:30 - 9:30

14:00 - 15:00

10:30 - 11:30

15:20 - 16:20

LEARN MORE ABOUT OUR SPEAKERS

PROVENTAI N T E R N A T I O N A L10 GO TO MENU NEXT PAGEPREVIOUS PAGE

BIOMANUFACTURING

Mukta Gupta GMP Clinical Quality Lead

Takeda

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

SPEAKER TBC TBC TBC

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

SPEAKER TBC TBC TBC

TIME SLOT (*E.T.)

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

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

SPONSOR ROUNDTABLE TOPIC

Strategies for managing consumables/disposables in a dynamic processing

environment with extended lead times and decreased supplier flexibility

TOPIC TBCAddressing Regulatory Requirements for Filter Integrity Testing

Implementing a Membrane Absorber for Downstream Process Intensification of

Adenovirus

TRACK 6 DOWNSTREAM PROCESSING

8:30 - 9:30

14:00 - 15:00

10:30 - 11:30

15:20 - 16:20

LEARN MORE ABOUT OUR SPEAKERS

PROVENTAI N T E R N A T I O N A L11

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

Catalina DriscollGlobal Head New Product

Planning, Rare Blood Disorders Sanofi TIME SLOT (*E.T.)

David Sherris CEO

GenAdam Therapeutics

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

TIME SLOT (*E.T.)

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

SPEAKER TBC TBC TBC

SPEAKER TBC TBC TBC

Strategies to address dosing and immune response issues in gene therapy vectors

Sourcing appropriate materials for the development of cell therapies

The Importance of Early Product Differentiation for Cell & Gene Therapy Programs

Next Generation OV and New Combinational Approaches for Treatment of Solid Tumors

GO TO MENU NEXT PAGEPREVIOUS PAGE

ROUNDTABLE TOPIC SPONSOR ROUNDTABLE TOPIC

8:30 - 9:30

14:00 - 15:00

10:30 - 11:30

15:20 - 16:20

LEARN MORE ABOUT OUR SPEAKERS

CELLANDGENETHERAPY

PROVENTAI N T E R N A T I O N A L12

TRACK 8 CAR-T, TCR & T CELL IMMUNOTHERAPIES

Michael LotzeVice Chair Department

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

SPEAKER TBC TBC TBC

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

SPEAKER TBC TBC TBC

TIME SLOT (*E.T.)

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

SPEAKER TBC TBC TBC

Strategies for implementation of a universal “off-the-shelf” adopted T Cell therapy

TOPIC TBCChallenges for point of care manufacturing

Development, Clinical Results and Translational Analysis of a T Cell Product for Mantle Cell

Lymphoma

GO TO MENU NEXT PAGEPREVIOUS PAGE

ROUNDTABLE TOPIC SPONSOR ROUNDTABLE TOPIC

8:30 - 9:30

14:00 - 15:00

10:30 - 11:30

15:20 - 16:20

LEARN MORE ABOUT OUR SPEAKERS

CELLANDGENETHERAPY

PROVENTAI N T E R N A T I O N A L13

TRACK 9 CELL & GENE GMP MANUFACTURING

Weiyong Sun Senior Director, Specialty Medicine

Search & Evaluation, Global Business Development

Daiichi Sankyo GroupTIME SLOT (*E.T.)

David TownsonExecutive, Oncology Research

& Development. Immuno-Oncology / Cell Therapy

Bayer

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

SPEAKER TBC TBC TBC

TIME SLOT (*E.T.)

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

Amnon EylathVP Head of Quality

Axcella

Applying effective and scalable sanitization/decontamination technology to prevent/

remediate cleanroom contaminations

Commercial-scale manufacturing at lower COGS

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

GO TO MENU NEXT PAGEPREVIOUS PAGE

ROUNDTABLE TOPIC SPONSOR ROUNDTABLE TOPIC

8:30 - 9:30

14:00 - 15:00

10:30 - 11:30

15:20 - 16:20

LEARN MORE ABOUT OUR SPEAKERS

Anne LodgeChief Science and Innovation

Officer Astarte Biologics

TOPIC TBC

CELLANDGENETHERAPY

PROVENTAI N T E R N A T I O N A L14

TRACK 10 TRANSPORT LOGISTICS / PATIENT DELIVERY

TIME SLOT (*E.T.)

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

SPEAKER TBC TBC TBC

TIME SLOT (*E.T.)

Darren DasburgBiotech Executive

Contango Ventures Inc.

International shipping logistics strategies and addressing regulations associated

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

TOPIC TBC

SPEAKER TBC TBC TBC

Strategies for Patient Delivery Methods and Potential Toxicity Associated with RNA

Technologies

GO TO MENU NEXT PAGEPREVIOUS PAGE

ROUNDTABLE TOPIC SPONSOR ROUNDTABLE TOPIC

8:30 - 9:30

14:00 - 15:00

10:30 - 11:30

15:20 - 16:20

LEARN MORE ABOUT OUR SPEAKERS

CELLANDGENETHERAPY

PROVENTAI N T E R N A T I O N A L15

TRACK 11 ONCOLOGY, ONCOLYTIC VIRUSES & mRNA BASED TECHNOLOGIES

SPEAKER TBC TBC TBC

TIME SLOT (*E.T.)

Khalid Shah Vice Chair of Research,

Director Center for Stem Cell Therapeutics and Imaging Associate Professor HMS

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

SPEAKER TBC TBC TBC

TIME SLOT (*E.T.)

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

SPEAKER TBC TBC TBC

Antibody Targeted Viruses: The Next Generation of Oncolytics

TOPIC TBCmRNA Cancer Therapeutic Vaccines

Cell based therapies for Cancer: Journey from Innovation to Translation

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ROUNDTABLE TOPIC SPONSOR ROUNDTABLE TOPIC

8:30 - 9:30

14:00 - 15:00

10:30 - 11:30

15:20 - 16:20

LEARN MORE ABOUT OUR SPEAKERS

CELLANDGENETHERAPY

PROVENTAI N T E R N A T I O N A L16

TRACK 12 EMERGING BIOPHARMA

SPEAKER TBC TBC TBC

TIME SLOT (*E.T.)

Marc WolfgangVP Technical Operations

Neon Therapeutics

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

SPEAKER TBC TBC TBC

TIME SLOT (*E.T.)

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

SPEAKER TBC TBC TBC

TOPIC TBC

TOPIC TBCThe challenges aligned with clinical trial planning through to trial design

implementation and how an integrated CRO with therapeutically focused expertise

can help?

Small Scale Personalised Manufacturng - In-House & Outsourced Strategies & Challenges

GO TO MENU NEXT PAGEPREVIOUS PAGE

ROUNDTABLE TOPIC SPONSOR ROUNDTABLE TOPIC

8:30 - 9:30

14:00 - 15:00

10:30 - 11:30

15:20 - 16:20

LEARN MORE ABOUT OUR SPEAKERS

CELLANDGENETHERAPY

PROVENTAI N T E R N A T I O N A L17

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

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PROVENTAI N T E R N A T I O N A L18

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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

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2019 ATTENDEES p.2BIOMANUFACTURING

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PROVENTAI N T E R N A T I O N A L19

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

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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

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PROVENTAI N T E R N A T I O N A L20

2019 ATTENDEES p.4

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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

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CELLANDGENETHERAPY