ONLINE STRATEGY · Guadalupe Hayes - Global Supply Direc. Ultragenyx Rakes Banka - Director Pfizer...
Transcript of ONLINE STRATEGY · Guadalupe Hayes - Global Supply Direc. Ultragenyx Rakes Banka - Director Pfizer...
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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BIOMANUFACTURINGBIOMANUFACTURINGCELLANDGENETHERAPY
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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.
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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.
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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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ROUND TABLE TOPIC CONFIRMED FOR SPONSOR
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
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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.)
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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
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PROVENTAI N T E R N A T I O N A L5
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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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SPEAKER TBC TBC TBC
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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
PROVENTAI N T E R N A T I O N A L8 GO TO MENU NEXT PAGEPREVIOUS PAGE
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
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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
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CELLANDGENETHERAPY
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TRACK 12 EMERGING BIOPHARMA
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TIME SLOT (*E.T.)
Marc WolfgangVP Technical Operations
Neon Therapeutics
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SPEAKER TBC TBC TBC
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ROUNDTABLE TOPIC
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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
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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
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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
CELLANDGENETHERAPY
CELLANDGENETHERAPY 2019 ATTENDEES p.3
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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
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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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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 TITLECELLANDGENETHERAPY
CELLANDGENETHERAPY