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

Kelly Neelon Vice President Technical OperationsPhoenix Tissue Repair

Rajesh Beri Vice President & Head of CMC Immunovant

James Marshall Head of Supply Chain Bristol-Myers Squibb

Kunal Jaiswal Senior Director & Product Quality Leader Celgene

Amnon Eylath VP Head of Quality Axcella

Brandon Varnau Head of Quality Operations Biologics Platform & Global Quality Genzyme

Geny Doss Vice President Operational Quality GXP Vertex Pharmaceuticals

Paul Dawidczyk Sr. Director Regulatory Affairs CMC Moderna Therapeutics

SPONSORS

HOTEL & TRAVEL

BOSTON CAMBRIDGE

2020

OUR UNIQUE MEETING FORMAT

Roundtable Discussions These 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 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 out of the office 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 suggests a suitable time and place, all you need to do is grab the coffee.

Strategic NetworkingStrategic networking opportunities form a key benefit of the meeting. Our proven format for building and strengthening alliances is underscored by a host of networking programmes, from a buffet breakfast through to evening drinks, make lasting connections that benefit you.

CONTRIBUTORS TO THE AGENDA

3rd JUNESTRATEGY MEETING USA

AGENDA

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BIOMANUFACTURINGBIOMANUFACTURING

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

BIOMANUFACTURINGBIOMANUFACTURINGSTRATEGY MEETING USA

1 - 1 MEETING *10:20-10:40 1 - 1 MEETING *10:40-11:00

04

Leveraging quality by design and PAT downstream of drug substance

Quality by Design for Effective Bioprocess Characterisation and Validation

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

KEYNOTE PRESENTATION

AFTERNOON COFFEE BREAK

DRINKS & CANAPE RECEPTION

Process Intensification: Implementation of Continuous Manufacturing in Upstream Processing

Cell Culture Process Intensif ication: A Combined Lab-Scale, Modeling & Engineering Approach

Developing a fully automated, flexible & integrated continuous downstream purification platform and process intensif ication

Addressing early viral safety development process by way of high-temperature short-time (HTST) system

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

Leveraging digital solutions to ensure QMS requirements are met while achieving rapid release of biological products

Utilizing IoT for a centralized data platform and quality management

Selecting performance metrics for timely data-driven decisions using Quality Management Review (QMR)

Are ‘Smart Factories’ the future of Biomanufacturing? What is a ‘SMART FACTORY’ ? What needs to change in our Industry?

Are “Smart Factories” the Future of Bioprocessing? - What Needs to Change to Accommodate?

How industry 4.0 can help manufacturers increase revenue by reducing cost & increasing strategic thinking

Addressing Regulatory Requirements for Filter Integrity Testing

Implementing a Membrane Absorber for Downstream Process Intensification of Adenovirus

Strategies to Make Downstream Processing Continuous and Robust

TRACK & ROOM

08:00 - 08:30

QbD/PAT

16:30 - 17:30

08:30 - 09:00

17:30 - 19:00

09:00 - 10:00

10:00 - 11:00

11:00 - 12:00

12:00 - 13:00

13:00 - 13:30

13:30 - 14:30

14:30 - 15:00

15:00 - 16:00

16:00 - 16:10

16:10 - 16:30

REGISTRATION & BREAKFAST NETWORKING

WELCOME SPEECH & KEYNOTE PRESENTATION : is AI the Present and the Future of Biotech ?

CONTINUOUS MANUFACTURING UPSTREAM PROCESSING DOWNSTREAM PROCESSING

01 02 03 05 06

NETWORKING BREAK1 - 1 MEETING *10:00-10:20

NETWORKING BREAK

1 - 1 MEETING *20min 1 - 1 MEETING *20min1 - 1 MEETING *20min

NETWORKING LUNCH

1 - 1 MEETING *12:00-12:20 1 - 1 MEETING *12:20-12:40 1 - 1 MEETING *12:40-13:00

1 - 1 MEETING *13:30-13:50 1 - 1 MEETING *13:50-14:10 1 - 1 MEETING *14:10-14:30

GO TO MENU

NETWORKING BREAK

NETWORKING BREAK

NETWORKING LUNCH

KEYNOTE PRESENTATIONKEYNOTE PRESENTATION

KEYNOTE PRESENTATION KEYNOTE PRESENTATIONKEYNOTE PRESENTATION

AFTERNOON COFFEE BREAK

DRINKS & CANAPE RECEPTION

Geny Doss - Vice President Vertex Pharmaceuticals

REGISTRATION & BREAKFAST NETWORKING

QMS INDUSTRY 4.0

Mark Zieg - Sr. Director Vertex Pharmaceutical

Brandon Varnau - Head of Quality Sanofi Genzyme

Rajesh Beri - VP & Head of CMC Immunovant

Kelly Neelon - VP Tech Operations Phoenix Tissue Repair

Kunal Jaiswal - Sr. Director Celgene

Paul Dawidczyk - Sr. Director Moderna Therapeutics

ROUNDTABLE TOPIC CONFIRMED FOR SPONSOR

ROUNDTABLE TOPIC CONFIRMED FOR SPONSOR

ROUNDTABLE TOPIC CONFIRMED FOR SPONSOR

ROUND TABLE TOPIC CONFIRMED FOR SPONSOR

ROUNDTABLE TOPIC CONFIRMED FOR SPONSOR

ROUNDTABLE TOPIC CONFIRMED FOR SPONSOR

James Marshall - Head of Supply Bristol-Myers Squibb

Amnon Eylath - VP Head of Quality Axcella