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Agenda

Increasing Flexibility and Automation to Maximize Efficiency || Facility Utilization & Overcoming the Gaps, Bottlenecks, and Scalability Issues to Achieve Robust and Reliable Commercial Biomanufacturing

December 11-13, 2017
  • San Diego, CA

Agenda

Want more agenda details? Download the brochure.

DAY ONE Monday, December 11, 2017

7:00

Conference Registration and Coffee

8:00

Chairperson’s Welcome and Opening Remarks

Bert Frohlich, PhD
Principal Consultant & Owner
Biopharm Designs, LLC

8:15

MORNING KEYNOTE ADDRESS Redefining Competition — Thinking about our Industry in a Revolutionary Way

Kimball Hall
Senior Vice President and Head of Drug Substance Manufacturing,
Pharma Technical Operations
Genentech, Inc.

Achieving Efficiency Through Facility Design

8:55

Achieving Efficiency Through Flexible Facilities

Troy Simmons, MBA
Director, Business Development
G-CON Manufacturing

9:20

CASE STUDY J.Pod™ Next-Generation Biologics Manufacturing (Hangzhou, China Facility)

Brian Horman, MBA
Vice President, Facilities & Engineering
Just Biotherapeutics

9:45

Networking Refreshment Break in Exhibit Hall

10:15

CASE STUDY Efficiency by Design — Case Study for a Hybrid Clinical Manufacturing Facility

Sourav Kundu, PhD
Senior Director, Process Development and Clinical Manufacturing
Teva Pharmaceuticals

10:40

Analysis of Economic Feasibility for Single Use Facilities

Ken Hamilton, PhD
Senior Principal Engineer, Manufacturing Science and Technology
Genentech, Inc

11:05

FEATURED PRESENTATION Disruptive Innovations to Lower Healthcare Costs

Govind Rao, PhD
Professor and Director, Center for Advanced Sensor Technology and
Department of Chemical, Biochemical, and Environmental Engineering
University of Maryland, Baltimore County

11:30

PANEL DISCUSSION Reducing the Cost of Manufacturing — From Design to Commercial Operations

MODERATOR:

Duncan Low, PhD
Scientific Executive Director
Amgen

PANELISTS:

Chris Antoniou, MSc
Distinguished Process Engineer, Global Process Engineering
Biogen

Adam Goldstein, MS
Single Use Lead, Roche, Inc.;
Global Manufacturing Sciences, Genentech, Inc.

Nuno Fontes, PhD
Executive Director, Process Science
Boehringer Ingelheim

John Moscariello, PhD
Vice President, Process Development
CMC Biologics

Parrish Galliher, MS
Chief Technology Officer, Upstream
Xcellerex Inc., a GE Healthcare Life Sciences Company

12:00

Technology Workshops

12:30

Luncheon in the Exhibit Hall

1:40

Chairperson’s Remarks

Russell Wong, PhD
Senior Manager, Manufacturing Sciences
Bayer

Efficiency Through Innovation and Targeted Process Development

1:45

NEW DATA Rapid Access Affinity Resins — A Precise Enabling Technology for Efficient Bioprocessing

Karol Lacki, PhD
Vice President, Technology Development
Avitide, Inc.

2:10

CASE STUDY & NEW DATA The Synergy of Technology, Engineering and Business Processes to Meet Demand for
High-Volume Therapeutic Proteins

Matthew Johnson, PhD
Principal, Global Process Engineering
Biogen

2:35

The Use of Single-Use Technology to Drive Efficiencies and Client Value —
A CDMO's Perspective

John Moscariello, PhD
Vice President, Process Development
CMC Biologics

3:00

Networking Refreshment Break in Exhibit Hall

3:35

NEW DATA How Can Continuous Bioprocessing Deliver the Flexibility and Cost Gains Promised by
its Champions?

John Bonham-Carter
Director, Commercial
Repligen

4:00

PANEL DISCUSSION Contending with All the “What Ifs?”

MODERATOR:

Susan Dexter
Managing Director, Commercial Business
Latham Biopharm Group

PANELISTS:

Carnley Norman, PhD
Vice President, Manufacturing Operations
KBI Biopharma

Mark Petrich, PhD
Director, SUS Engineering, Sterile & Validation COE
Merck & Co., Inc

Ken Green, PhD
Head of Manufacturing Science and Technology
Shire

5:00

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO Tuesday, December 12, 2017

7:00

Continental Breakfast

8:00

Chairperson’s Welcome and Opening Remarks

Chris Antoniou, MSc
Distinguished Process Engineer, Global Process Engineering
Biogen

8:10

PLENARY KEYNOTE ADDRESS Application of Frontier Science —
Lessons from Implementation of Next Generation Manufacturing at Amgen’s Singapore Facility

Jim Weidner, MBA
Executive Director, Process Development
Amgen

8:50

CASE STUDY & NEW DATA — PLENARY KEYNOTE ADDRESS Achieving Efficiency Through a Comprehensive Approach to Facility, Organization and
Process Design

Jason Bock, PhD
Vice President, Global CMC Biologics
Teva Biopharmaceuticals

9:30

Networking Refreshment Break in Exhibit Hall

Chairperson's Remarks

Chris Antoniou, MSc
Distinguished Process Engineer, Global Process Engineering
Biogen

Efficiency Through Operational Excellence

10:00

CASE STUDY Facility Utilization and Efficiency — A Case Study

Speaker TBA

10:25

NEW DATA Tech Transfer Simplified with Model-Based Process Fit and Process Control

Jean Bender, MS
Senior Director, BioProcess Engineering
MedImmune

Steven Rose, MS
Director, BioProcess Engineering
MedImmune

10:50

CASE STUDY & NEW DATA Risks and Benefits of Concurrent Multi-Product Manufacturing

Parrish Galliher, MS
Chief Technology Officer, Upstream
Xcellerex Inc., a GE Healthcare Life Sciences Company

11:15

Evolution of a Flexible Development Facility to Accommodate the Increasingly Fast-Paced
Pharmaceutical Landscape

Paul Ko, PhD
Senior Scientist, Cell Technologies, API Large Molecule
Janssen R&D (A Pharmaceutical Company of Johnson & Johnson)

11:40

Technology Workshop

12:10

Luncheon in the Exhibit Hall and Moderated Discussions Focused on the Horizon

1 The Future of Single Use Systems — Upstream

2 The Future of Single Use Systems — Downstream

3 The Future of Single Use Systems — Supply Chain

4 The Future of Single Use Systems — Sensors and Analytics

1:25

Chairperson’s Remarks

Eric Langer
Managing Partner
BioPlan Associates, Inc.

1:30

FEATURED PRESENTATION — CASE STUDY & NEW DATA Limitations of Single Use Technologies — Where Are the Problems and Solutions?

Adam Goldstein, MS
Single Use Lead, Roche, Inc.;
Global Manufacturing Sciences, Genentech, Inc.

Supply Chain and Lifecycle Management of Single Use Components

1:55

Improving Supply Chain Efficiency Through Collaboration

Todd Roman, MA
Senior Manager, Supply Chain
Bayer

2:20

Establishment of Efficient Cell Culture Supply Chain Through Partnerships

Jeff Carter, PhD
Strategic Projects Leader, BioProcess Marketing
GE Healthcare

2:45

Critical Consumable Materials Management in Biopharmaceuticals

Zhaoli “Jolie” Zhou, PhD
Manager, Manufacturing Technology/Process Technology
Sanofi Pasteur

3:10

PANEL DISCUSSION Controlling Costs of Single Use Systems

MODERATOR:

Sourav Kundu, PhD
Senior Director, Process Development and Clinical Manufacturing
Teva Pharmaceuticals

PANELIST:

Jeffrey Johnson
Director and New Technology Lead, Global Engineering Solutions
Merck & Co., Inc.

3:50

Chairperson’s Closing Remarks

Eric Langer
Managing Partner
BioPlan Associates, Inc

4:00

Afternoon Activities

DAY ONE Tuesday, December 12, 2017

8:00

Chairperson’s Welcome and Opening Remarks

Chris Antoniou, MSc
Distinguished Process Engineer, Global Process Engineering
Biogen

8:10

MORNING KEYNOTE ADDRESS Application of Frontier Science —
Lessons from Implementation of Next Generation Manufacturing at Amgen’s Singapore Facility

Jim Weidner, MBA
Executive Director, Process Development
Amgen

8:50

PLENARY KEYNOTE ADDRESS Achieving Efficiency Through a Comprehensive Approach to Facility, Organization and
Process Design

Jason Bock, PhD
Vice President, Global CMC Biologics
Teva Biopharmaceuticals

9:30

Networking Refreshment Break in the Exhibit Hall

Chairperson's Remarks

Carnley Norman, PhD
Vice President, Manufacturing Operations
KBI Biopharma

Emerging Applications and the Future of Single Use Systems

10:00

NEW DATA BPOG Five Year Technology Road Map and How to Unleash the Full Benefits of Disposables

Weibing Ding, PhD
Principal Scientist, Process Development
Amgen

10:25

NEW DATA Probing for Solutions — Evaluating New pH Sensors for Single Use Applications

Nicholas Rummel, MS
Technology Development Engineer, Process Development Engineering
Genentech, Inc.

10:50

CASE STUDY & NEW DATA Evaluation of Disposable Harvest Technologies — Acoustic Wave System vs. Gravity Settling

Diana Lok
Engineer, Process Development Engineering
Genentech, Inc.

11:15

Large Scale Single Use Bulk Drug Substance Freeze and Thaw Platform

Jeffrey Johnson
Director and New Technology Lead, Global Engineering Solutions
Merck & Co., Inc.

11:40

Technology Workshops

12:10

Luncheon in the Exhibit Hall and Moderated Discussions Focused on the Horizon

1 The Future of Single Use Systems — Upstream

2 The Future of Single Use Systems — Downstream

3 The Future of Single Use Systems — Supply Chain

4 The Future of Single Use Systems — Sensors and Analytics

1:25

Chairperson's Remarks

Eric Langer
Managing Partner
BioPlan Associates, Inc.

1:30

FEATURED PRESENTATION — CASE STUDY & NEW DATA Limitations of Single Use Technologies — Where Are the Problems and Solutions?

Adam Goldstein, MS
Single Use Lead, Roche, Inc.;
Global Manufacturing Sciences, Genentech, Inc.

Supply Chain and Lifecycle Management of Single Use Components

1:55

Improving Supply Chain Efficiency Through Collaboration

Todd Roman, MA
Senior Manager, Supply Chain
Bayer

2:20

CASE STUDY & NEW DATA Establishment of Efficient Cell Culture Supply Chain Through Partnerships

Jeff Carter, PhD
Strategic Projects Leader, BioProcess Marketing
GE Healthcare

2:45

Critical Consumable Materials Management in Biopharmaceuticals

Zhaoli “Jolie” Zhou, PhD
Manager, Manufacturing Technology/Process Technology
Sanofi Pasteur

3:10

PANEL DISCUSSION Controlling Costs of Single Use Systems

MODERATOR:

Sourav Kundu, PhD
Senior Director, Process Development and Clinical Manufacturing
Teva Pharmaceuticals

PANELIST:

Jeffrey Johnson
Director and New Technology Lead, Global Engineering Solutions
Merck & Co., Inc.

3:50

Chairperson's Closing Remarks

Eric Langer
Managing Partner
BioPlan Associates, Inc

4:00

Afternoon Activities

DAY TWO Wednesday, December 13, 2017

8:00

Chairperson’s Remarks

John Moscariello, PhD
Vice President, Process Development
CMC Biologics

8:10

MORNING KEYNOTE ADDRESS Future Facility Design Considerations with Single Use Based on Prior Experience

Ken Green, PhD
Head of Manufacturing Science and Technology
Shire

Lifecycle Management of Single Use Components

8:55

How to Deploy Single Use Technology Quickly and Accurately

Mark Petrich, PhD
Director, SUS Engineering, Sterile & Validation COE
Merck & Co., Inc.

9:20

CASE STUDY & NEW DATA Using an Integrated Design Approach to Upgrade an End-to-End Single Use Drug Substance Facility to be Commercial Manufacturing Ready

Carnley Norman, PhD
Vice President, Manufacturing Operations,
Development/Manufacturing (Mammalian Cell Culture)
KBI Biopharma

9:45

Networking Refreshment Break in the Exhibit Hall

Small Scale Development and Scaling Up to Commercial Production

10:15

CASE STUDY & NEW DATA Developing Scale-Down Models for Drug Substance Manufacturing —
Challenges and Approaches

Lakshmi “Prasad” Pathange, PhD
Senior Manager, Manufacturing Sciences, PD Labs
Bayer Pharmaceuticals

10:40

CASE STUDY & NEW DATA Scale-Down of a Stainless Steel Process to an All Single Use Process

Trishna Ray-Chaudhuri, PhD
QC Senior Scientist, Global Analytical Science & Technology (gASAT) – QC Direct Materials
Genentech, Inc.

11:05

NEW DATA Single Use Technologies for the Scale-Up and Scale-Out of Cell Therapies —
Opportunities and Challenges

Senthil Ramaswamy, PhD
Director, Cell Therapy Operations
Lonza Walkersville

11:30

PANEL DISCUSSION Component Engineering — Standardization and Connectivity —
Improving and Modifying Connectivity to Create More Standardized Assemblies —
Why Do We Need Standardized Connectivity?

MODERATOR:

Russell Wong, PhD
Senior Manager, Manufacturing Sciences
Bayer

PANELISTS:

Trishna Ray-Chaudhuri, PhD
QC Senior Scientist, Global Analytical Science & Technology (gASAT) – QC Direct Materials
Genentech, Inc.

Weibing Ding, PhD
Principal Scientist, Process Development
Amgen

Mark Petrich, PhD
Director, SUS Engineering, Sterile & Validation COE
Merck & Co., Inc.

12:15

Networking Luncheon in the Exhibit Hall

1:25

Chairperson's Remarks

Bert Frohlich, PhD
Principal Consultant & Owner
Biopharm Designs, LLC

Achieving Continuous Manufacturing with Single Use Systems

1:30

Continuous or Isolated — Not Feasible without Single Use

Klaus Kaiser, PhD
Head of Downstream, Biological Development
Bayer AG, Germany

1:55

NEW DATA A Stackable, Single Use Chromatography Cassette Enhancing Continuous Antibody Capture and Enabling High Productivity

Marty Siwak
Chief Technology Officer, Bioprocess Life Sciences
JSR Life Sciences

2:20

CASE STUDY & NEW DATA How to Make Hybrid Facilities More Suitable for In-Market Supply and
Continuous Manufacturing

David Wolton
Operations Consultant, Technology
PM Group

2:45

Chairperson’s Recap and Look Ahead

Bert Frohlich, PhD
Principal Consultant & Owner
Biopharm Designs, LLC

3:00

Close of Conference

Agenda

Want more agenda details? Download the brochure.
Want more agenda details? Download the brochure.

DAY ONE Monday, December 11, 2017

7:00

Conference Registration and Coffee

8:00

Chairperson’s Welcome and Opening Remarks

Bert Frohlich, PhD
Principal Consultant & Owner
Biopharm Designs, LLC

8:15

MORNING KEYNOTE ADDRESS Redefining Competition — Thinking about our Industry in a Revolutionary Way

Kimball Hall
Senior Vice President and Head of Drug Substance Manufacturing,
Pharma Technical Operations
Genentech, Inc.

Achieving Efficiency Through Facility Design

8:55

Achieving Efficiency Through Flexible Facilities

Troy Simmons, MBA
Director, Business Development
G-CON Manufacturing

9:20

CASE STUDY J.Pod™ Next-Generation Biologics Manufacturing (Hangzhou, China Facility)

Brian Horman, MBA
Vice President, Facilities & Engineering
Just Biotherapeutics

9:45

Networking Refreshment Break in Exhibit Hall

10:15

CASE STUDY Efficiency by Design — Case Study for a Hybrid Clinical Manufacturing Facility

Sourav Kundu, PhD
Senior Director, Process Development and Clinical Manufacturing
Teva Pharmaceuticals

10:40

Analysis of Economic Feasibility for Single Use Facilities

Ken Hamilton, PhD
Senior Principal Engineer, Manufacturing Science and Technology
Genentech, Inc

11:05

FEATURED PRESENTATION Disruptive Innovations to Lower Healthcare Costs

Govind Rao, PhD
Professor and Director, Center for Advanced Sensor Technology and
Department of Chemical, Biochemical, and Environmental Engineering
University of Maryland, Baltimore County

11:30

PANEL DISCUSSION Reducing the Cost of Manufacturing — From Design to Commercial Operations

MODERATOR:

Duncan Low, PhD
Scientific Executive Director
Amgen

PANELISTS:

Chris Antoniou, MSc
Distinguished Process Engineer, Global Process Engineering
Biogen

Adam Goldstein, MS
Single Use Lead, Roche, Inc.;
Global Manufacturing Sciences, Genentech, Inc.

Nuno Fontes, PhD
Executive Director, Process Science
Boehringer Ingelheim

John Moscariello, PhD
Vice President, Process Development
CMC Biologics

Parrish Galliher, MS
Chief Technology Officer, Upstream
Xcellerex Inc., a GE Healthcare Life Sciences Company

12:00

Technology Workshops

12:30

Luncheon in the Exhibit Hall

1:40

Chairperson’s Remarks

Russell Wong, PhD
Senior Manager, Manufacturing Sciences
Bayer

Efficiency Through Innovation and Targeted Process Development

1:45

NEW DATA Rapid Access Affinity Resins — A Precise Enabling Technology for Efficient Bioprocessing

Karol Lacki, PhD
Vice President, Technology Development
Avitide, Inc.

2:10

CASE STUDY & NEW DATA The Synergy of Technology, Engineering and Business Processes to Meet Demand for
High-Volume Therapeutic Proteins

Matthew Johnson, PhD
Principal, Global Process Engineering
Biogen

2:35

The Use of Single-Use Technology to Drive Efficiencies and Client Value —
A CDMO's Perspective

John Moscariello, PhD
Vice President, Process Development
CMC Biologics

3:00

Networking Refreshment Break in Exhibit Hall

3:35

NEW DATA How Can Continuous Bioprocessing Deliver the Flexibility and Cost Gains Promised by
its Champions?

John Bonham-Carter
Director, Commercial
Repligen

4:00

PANEL DISCUSSION Contending with All the “What Ifs?”

MODERATOR:

Susan Dexter
Managing Director, Commercial Business
Latham Biopharm Group

PANELISTS:

Carnley Norman, PhD
Vice President, Manufacturing Operations
KBI Biopharma

Mark Petrich, PhD
Director, SUS Engineering, Sterile & Validation COE
Merck & Co., Inc

Ken Green, PhD
Head of Manufacturing Science and Technology
Shire

5:00

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO Tuesday, December 12, 2017

7:00

Continental Breakfast

8:00

Chairperson’s Welcome and Opening Remarks

Chris Antoniou, MSc
Distinguished Process Engineer, Global Process Engineering
Biogen

8:10

PLENARY KEYNOTE ADDRESS Application of Frontier Science —
Lessons from Implementation of Next Generation Manufacturing at Amgen’s Singapore Facility

Jim Weidner, MBA
Executive Director, Process Development
Amgen

8:50

CASE STUDY & NEW DATA — PLENARY KEYNOTE ADDRESS Achieving Efficiency Through a Comprehensive Approach to Facility, Organization and
Process Design

Jason Bock, PhD
Vice President, Global CMC Biologics
Teva Biopharmaceuticals

9:30

Networking Refreshment Break in Exhibit Hall

Chairperson's Remarks

Chris Antoniou, MSc
Distinguished Process Engineer, Global Process Engineering
Biogen

Efficiency Through Operational Excellence

10:00

CASE STUDY Facility Utilization and Efficiency — A Case Study

Speaker TBA

10:25

NEW DATA Tech Transfer Simplified with Model-Based Process Fit and Process Control

Jean Bender, MS
Senior Director, BioProcess Engineering
MedImmune

Steven Rose, MS
Director, BioProcess Engineering
MedImmune

10:50

CASE STUDY & NEW DATA Risks and Benefits of Concurrent Multi-Product Manufacturing

Parrish Galliher, MS
Chief Technology Officer, Upstream
Xcellerex Inc., a GE Healthcare Life Sciences Company

11:15

Evolution of a Flexible Development Facility to Accommodate the Increasingly Fast-Paced
Pharmaceutical Landscape

Paul Ko, PhD
Senior Scientist, Cell Technologies, API Large Molecule
Janssen R&D (A Pharmaceutical Company of Johnson & Johnson)

11:40

Technology Workshop

12:10

Luncheon in the Exhibit Hall and Moderated Discussions Focused on the Horizon

1 The Future of Single Use Systems — Upstream

2 The Future of Single Use Systems — Downstream

3 The Future of Single Use Systems — Supply Chain

4 The Future of Single Use Systems — Sensors and Analytics

1:25

Chairperson’s Remarks

Eric Langer
Managing Partner
BioPlan Associates, Inc.

1:30

FEATURED PRESENTATION — CASE STUDY & NEW DATA Limitations of Single Use Technologies — Where Are the Problems and Solutions?

Adam Goldstein, MS
Single Use Lead, Roche, Inc.;
Global Manufacturing Sciences, Genentech, Inc.

Supply Chain and Lifecycle Management of Single Use Components

1:55

Improving Supply Chain Efficiency Through Collaboration

Todd Roman, MA
Senior Manager, Supply Chain
Bayer

2:20

Establishment of Efficient Cell Culture Supply Chain Through Partnerships

Jeff Carter, PhD
Strategic Projects Leader, BioProcess Marketing
GE Healthcare

2:45

Critical Consumable Materials Management in Biopharmaceuticals

Zhaoli “Jolie” Zhou, PhD
Manager, Manufacturing Technology/Process Technology
Sanofi Pasteur

3:10

PANEL DISCUSSION Controlling Costs of Single Use Systems

MODERATOR:

Sourav Kundu, PhD
Senior Director, Process Development and Clinical Manufacturing
Teva Pharmaceuticals

PANELIST:

Jeffrey Johnson
Director and New Technology Lead, Global Engineering Solutions
Merck & Co., Inc.

3:50

Chairperson’s Closing Remarks

Eric Langer
Managing Partner
BioPlan Associates, Inc

4:00

Afternoon Activities

DAY ONE Tuesday, December 12, 2017

8:00

Chairperson’s Welcome and Opening Remarks

Chris Antoniou, MSc
Distinguished Process Engineer, Global Process Engineering
Biogen

8:10

MORNING KEYNOTE ADDRESS Application of Frontier Science —
Lessons from Implementation of Next Generation Manufacturing at Amgen’s Singapore Facility

Jim Weidner, MBA
Executive Director, Process Development
Amgen

8:50

PLENARY KEYNOTE ADDRESS Achieving Efficiency Through a Comprehensive Approach to Facility, Organization and
Process Design

Jason Bock, PhD
Vice President, Global CMC Biologics
Teva Biopharmaceuticals

9:30

Networking Refreshment Break in the Exhibit Hall

Chairperson's Remarks

Carnley Norman, PhD
Vice President, Manufacturing Operations
KBI Biopharma

Emerging Applications and the Future of Single Use Systems

10:00

NEW DATA BPOG Five Year Technology Road Map and How to Unleash the Full Benefits of Disposables

Weibing Ding, PhD
Principal Scientist, Process Development
Amgen

10:25

NEW DATA Probing for Solutions — Evaluating New pH Sensors for Single Use Applications

Nicholas Rummel, MS
Technology Development Engineer, Process Development Engineering
Genentech, Inc.

10:50

CASE STUDY & NEW DATA Evaluation of Disposable Harvest Technologies — Acoustic Wave System vs. Gravity Settling

Diana Lok
Engineer, Process Development Engineering
Genentech, Inc.

11:15

Large Scale Single Use Bulk Drug Substance Freeze and Thaw Platform

Jeffrey Johnson
Director and New Technology Lead, Global Engineering Solutions
Merck & Co., Inc.

11:40

Technology Workshops

12:10

Luncheon in the Exhibit Hall and Moderated Discussions Focused on the Horizon

1 The Future of Single Use Systems — Upstream

2 The Future of Single Use Systems — Downstream

3 The Future of Single Use Systems — Supply Chain

4 The Future of Single Use Systems — Sensors and Analytics

1:25

Chairperson's Remarks

Eric Langer
Managing Partner
BioPlan Associates, Inc.

1:30

FEATURED PRESENTATION — CASE STUDY & NEW DATA Limitations of Single Use Technologies — Where Are the Problems and Solutions?

Adam Goldstein, MS
Single Use Lead, Roche, Inc.;
Global Manufacturing Sciences, Genentech, Inc.

Supply Chain and Lifecycle Management of Single Use Components

1:55

Improving Supply Chain Efficiency Through Collaboration

Todd Roman, MA
Senior Manager, Supply Chain
Bayer

2:20

CASE STUDY & NEW DATA Establishment of Efficient Cell Culture Supply Chain Through Partnerships

Jeff Carter, PhD
Strategic Projects Leader, BioProcess Marketing
GE Healthcare

2:45

Critical Consumable Materials Management in Biopharmaceuticals

Zhaoli “Jolie” Zhou, PhD
Manager, Manufacturing Technology/Process Technology
Sanofi Pasteur

3:10

PANEL DISCUSSION Controlling Costs of Single Use Systems

MODERATOR:

Sourav Kundu, PhD
Senior Director, Process Development and Clinical Manufacturing
Teva Pharmaceuticals

PANELIST:

Jeffrey Johnson
Director and New Technology Lead, Global Engineering Solutions
Merck & Co., Inc.

3:50

Chairperson's Closing Remarks

Eric Langer
Managing Partner
BioPlan Associates, Inc

4:00

Afternoon Activities

DAY TWO Wednesday, December 13, 2017

8:00

Chairperson’s Remarks

John Moscariello, PhD
Vice President, Process Development
CMC Biologics

8:10

MORNING KEYNOTE ADDRESS Future Facility Design Considerations with Single Use Based on Prior Experience

Ken Green, PhD
Head of Manufacturing Science and Technology
Shire

Lifecycle Management of Single Use Components

8:55

How to Deploy Single Use Technology Quickly and Accurately

Mark Petrich, PhD
Director, SUS Engineering, Sterile & Validation COE
Merck & Co., Inc.

9:20

CASE STUDY & NEW DATA Using an Integrated Design Approach to Upgrade an End-to-End Single Use Drug Substance Facility to be Commercial Manufacturing Ready

Carnley Norman, PhD
Vice President, Manufacturing Operations,
Development/Manufacturing (Mammalian Cell Culture)
KBI Biopharma

9:45

Networking Refreshment Break in the Exhibit Hall

Small Scale Development and Scaling Up to Commercial Production

10:15

CASE STUDY & NEW DATA Developing Scale-Down Models for Drug Substance Manufacturing —
Challenges and Approaches

Lakshmi “Prasad” Pathange, PhD
Senior Manager, Manufacturing Sciences, PD Labs
Bayer Pharmaceuticals

10:40

CASE STUDY & NEW DATA Scale-Down of a Stainless Steel Process to an All Single Use Process

Trishna Ray-Chaudhuri, PhD
QC Senior Scientist, Global Analytical Science & Technology (gASAT) – QC Direct Materials
Genentech, Inc.

11:05

NEW DATA Single Use Technologies for the Scale-Up and Scale-Out of Cell Therapies —
Opportunities and Challenges

Senthil Ramaswamy, PhD
Director, Cell Therapy Operations
Lonza Walkersville

11:30

PANEL DISCUSSION Component Engineering — Standardization and Connectivity —
Improving and Modifying Connectivity to Create More Standardized Assemblies —
Why Do We Need Standardized Connectivity?

MODERATOR:

Russell Wong, PhD
Senior Manager, Manufacturing Sciences
Bayer

PANELISTS:

Trishna Ray-Chaudhuri, PhD
QC Senior Scientist, Global Analytical Science & Technology (gASAT) – QC Direct Materials
Genentech, Inc.

Weibing Ding, PhD
Principal Scientist, Process Development
Amgen

Mark Petrich, PhD
Director, SUS Engineering, Sterile & Validation COE
Merck & Co., Inc.

12:15

Networking Luncheon in the Exhibit Hall

1:25

Chairperson's Remarks

Bert Frohlich, PhD
Principal Consultant & Owner
Biopharm Designs, LLC

Achieving Continuous Manufacturing with Single Use Systems

1:30

Continuous or Isolated — Not Feasible without Single Use

Klaus Kaiser, PhD
Head of Downstream, Biological Development
Bayer AG, Germany

1:55

NEW DATA A Stackable, Single Use Chromatography Cassette Enhancing Continuous Antibody Capture and Enabling High Productivity

Marty Siwak
Chief Technology Officer, Bioprocess Life Sciences
JSR Life Sciences

2:20

CASE STUDY & NEW DATA How to Make Hybrid Facilities More Suitable for In-Market Supply and
Continuous Manufacturing

David Wolton
Operations Consultant, Technology
PM Group

2:45

Chairperson’s Recap and Look Ahead

Bert Frohlich, PhD
Principal Consultant & Owner
Biopharm Designs, LLC

3:00

Close of Conference