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Agenda

Applying the Latest Technical and Process Innovations to Achieve Commercially Viable Products and Efficacious Patient Outcomes

March 26-27, 2018
  • Washington, DC

Agenda

Want more agenda details? Download the brochure.

DAY ONE | Monday, March 26, 2018

7:00

Registration and Continental Breakfast

8:00

Chairperson’s Welcome and Opening Remarks

Anthony Davies, PhD
Founder & Executive Chairman
Dark Horse Consulting Inc.

8:15

OPENING KEYNOTE ADDRESS Global Cell Therapy Manufacturing —
The Past, Present and Future for Next Gen Therapies

Robert A. Preti, PhD
General Manager, Hitachi Chemical Regenerative
Medicine Business Sector, President and CEO
Hitachi Chemical Advanced Therapeutics Solutions, LLC

Key Bottlenecks in Current Manufacturing Systems
and Goals for Innovation

9:00

Designing Technologies to Meet Manufacturing Needs

Rodney Rietze, PhD
Enabling Technology and Strategic Development, Cell and Gene Technologies
Novartis

9:30

NEW UNPUBLISHED DATA Connecting Innovation and Manufacturing — How Tool Providers are Racing to Improve the Cell and Gene Therapy Manufacturing Workflow

Phil Vanek, PhD
General Manager, Cell Therapy Growth Strategy
GE Healthcare

10:00

Networking Refreshment Break and Exhibit Viewing

Characterization, Analytics and Potency Assays

10:30

Genomics and Gene Editing Tools in Developing Pluripotent Stem Cell Therapies

Robert Deans, PhD
Chief Technology Officer
BlueRock Therapeutics

11:00

Translation of Analytics to GMP Manufacturing

Andrew Beavis, PhD
Director, Analytical R&D, Cell Process Development
Celgene

11:30

CASE STUDY | NEW UNPUBLISHED DATA Potency Assays — Justification of Specifications

Marc-Olivier M. Baradez, PhD
Lead Scientist, Analytical Development
Cell and Gene Therapy Catapult, United Kingdom

12:00

Rapid Fire Presentations During this 30 minute session, three 10 minute talks will be
delivered by technology developers.

For More Information and to Get Involved Contact:

Karen Hanover
Senior Business Development Manager
+1-339-298-2184
[email protected]

12:30 – 1:45

SELECT ONE OF THE FOLLOWING LUNCHEON DISCUSSIONS

Collectively share perspectives and ideas with your peers. On day two, a representative from each discussion presents their group’s key takeaways and next steps.

1 ROUNDTABLE DISCUSSION

Optimizing CAR T Cell Expansion

MODERATOR:

David Stroncek, PhD
Medical Director
NIH

2 ROUNDTABLE DISCUSSION

What Are the Least Risky Strategies for Commercialization?

MODERATOR:

Eytan Abraham, PhD
Head of Research & Technology for Emerging Technologies
Lonza

3 ROUNDTABLE DISCUSSION

Collaboration Between Industry and Vendors —
What are the Biggest Problems that Need Partnerships to Solve?

MODERATOR:

Phil Vanek, PhD
General Manager, Cell Therapy Growth Strategy
GE Healthcare

4 ROUNDTABLE DISCUSSION

Outsourcing Manufacturing Vs Staying in House —
At What Stage? What Are the Costs?

MODERATOR:

Jason Carstens, PhD
Principal Consultant, Cell Therapy and
Biologics Manufacturing & Development
Cyathlon Bioscience, LLC

1:15

Chairperson’s Opening Remarks

Eytan Abraham, PhD
Head of Research & Technology for Emerging Technologies
Lonza

Comparability and Technology Transfer

2:00

CASE STUDY | NEW UNPUBLISHED DATA Apples, Oranges and Product Comparability

Andrew T. Steinsapir
Consultant
Dark Horse Consulting Inc.

2:30

Operational Setup and Technology Transfer Strategy for Flexible
Multi- Product Contract Cell Therapy Manufacturing

Senthil Ramaswamy, PhD
Director of Cell Therapy Operations
Lonza Walkersville

3:00

Networking Refreshment Break and Exhibit Viewing

Standardization and Development by Design

3:30

NEW UNPUBLISHED DATA Program to Standardize Methods for Counting Cells and the Use of Reference Standards

Sumona Sarkar, PhD
Biomedical Engineer, Biosystems and Biomaterials Division
National Institute of Standard and Technology

4:00

Development by Design, a Business Extension of QbD for Commercially Viable Manufacturing

Brian Hampson
Vice President, Global Manufacturing Sciences and Technology
Hitachi Chemical Advanced Therapeutics Solutions

4:30

PANEL DISCUSSION Raw Materials — Making the Grade

MODERATOR:

Scott R. Burger, MD
Principal
Advanced Cell & Gene Therapy, LLC

PANELISTS:

To be announced. Check back for program updates.

5:00

Close of Day One

Networking Cocktail Reception
and Exhibit Viewing
immediately following the final session on day one

DAY TWO | Tuesday, March 27, 2018

8:00

Continental Breakfast

8:30

EYE-OPENER RAPID FIRE BREAKFAST PRESENTATIONS During this 30 minute session, three 10 minute talks will be
delivered by technology developers.

For More Information and to Get Involved Contact:

Karen Hanover
Senior Business Development Manager
+1-339-298-2184
[email protected]om

9:00

Chairperson’s Opening Remarks

Jason Carstens, PhD
Principal Consultant, Cell Therapy and Biologics Manufacturing & Development
Cyathlon Bioscience, LLC

Morning Keynote Address

9:15

NEW UNPUBLISHED DATA Bioprinting — Latest Advances in Process Development and What’s Next

Julie Allickson, PhD
Director, Regenerative Medicine Clinical Center,
Wake Forest Institute for Regenerative Medicine
Wake Forest University School of Medicine

Process Development —
Achieving Commercially Ready Processes Through Automation and Novel Technology Implementation

10:00

Product Innovations to Radically Shorten the Development Timelines of hMSCbased Therapies

Jon Rowley, PhD
Founder and CTO
RoosterBio Inc.

10:30

Networking Refreshment Break and Exhibit Viewing

11:00

NEW UNPUBLISHED DATA Overcoming Process Development Challenges in Cell Therapy

Alan K. Smith, PhD
Executive Vice President, Technical Operations
Bellicum Pharmaceuticals

11:30

Development of Large Scale Stem Cell Production System

Wen Bo Wang
Senior Vice President, Cell Therapy Research and
Development, Therapeutics Division
Cellular Dynamics International, a Fujifilm company

12:00

PANEL DISCUSSION How Can We Achieve Process Robustness and Scalability in a More
Cost-Efficient Manner? How Do We Drive Down COGs?
What are the Key Obstacles That Limit Cost Reduction?

MODERATOR:

Jon Rowley, PhD
Founder and CTO
RoosterBio Inc.

PANELISTS:

To be announced. Check back for program updates.

12:30

Luncheon and Short Presentations Recapping Key Insights/Takeaways from Day One Luncheon Discussions

Process Development —
Achieving Commercially Ready Processes Through Automation and Novel Technology Implementation (Cont.)

1:40

Chairperson’s Remarks

Aby Matthew, PhD
Senior Vice President & Chief Technology Officer
BioLife Solutions, Inc.

1:45

Closed Processing and Automation

Brian Hampson
Vice President, Global Manufacturing Sciences and Technology
Hitachi Chemical Advanced Therapeutics Solutions

Regulatory Pathways

2:15

Regulatory Perspective from Industry

Keith Wonnacott, PhD
Executive Director, Regulatory Affairs
Pfizer Inc (invited)

2:45

PANEL DISCUSSION Regulatory Considerations

MODERATOR:

Anthony Davies, PhD
Founder & Executive Chairman
Dark Horse Consulting Inc.

PANELISTS:

To be announced. Check back for program updates.

3:15

Closing Remarks and Look Ahead

Jason Carstens, PhD
Principal Consultant, Cell Therapy and Biologics Manufacturing & Development
Cyathlon Bioscience, LLC

3:30

Close of Conference

Agenda

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

DAY ONE | Monday, March 26, 2018

7:00

Registration and Continental Breakfast

8:00

Chairperson’s Welcome and Opening Remarks

Anthony Davies, PhD
Founder & Executive Chairman
Dark Horse Consulting Inc.

8:15

OPENING KEYNOTE ADDRESS Global Cell Therapy Manufacturing —
The Past, Present and Future for Next Gen Therapies

Robert A. Preti, PhD
General Manager, Hitachi Chemical Regenerative
Medicine Business Sector, President and CEO
Hitachi Chemical Advanced Therapeutics Solutions, LLC

Key Bottlenecks in Current Manufacturing Systems
and Goals for Innovation

9:00

Designing Technologies to Meet Manufacturing Needs

Rodney Rietze, PhD
Enabling Technology and Strategic Development, Cell and Gene Technologies
Novartis

9:30

NEW UNPUBLISHED DATA Connecting Innovation and Manufacturing — How Tool Providers are Racing to Improve the Cell and Gene Therapy Manufacturing Workflow

Phil Vanek, PhD
General Manager, Cell Therapy Growth Strategy
GE Healthcare

10:00

Networking Refreshment Break and Exhibit Viewing

Characterization, Analytics and Potency Assays

10:30

Genomics and Gene Editing Tools in Developing Pluripotent Stem Cell Therapies

Robert Deans, PhD
Chief Technology Officer
BlueRock Therapeutics

11:00

Translation of Analytics to GMP Manufacturing

Andrew Beavis, PhD
Director, Analytical R&D, Cell Process Development
Celgene

11:30

CASE STUDY | NEW UNPUBLISHED DATA Potency Assays — Justification of Specifications

Marc-Olivier M. Baradez, PhD
Lead Scientist, Analytical Development
Cell and Gene Therapy Catapult, United Kingdom

12:00

Rapid Fire Presentations During this 30 minute session, three 10 minute talks will be
delivered by technology developers.

For More Information and to Get Involved Contact:

Karen Hanover
Senior Business Development Manager
+1-339-298-2184
[email protected]

12:30 – 1:45

SELECT ONE OF THE FOLLOWING LUNCHEON DISCUSSIONS

Collectively share perspectives and ideas with your peers. On day two, a representative from each discussion presents their group’s key takeaways and next steps.

1 ROUNDTABLE DISCUSSION

Optimizing CAR T Cell Expansion

MODERATOR:

David Stroncek, PhD
Medical Director
NIH

2 ROUNDTABLE DISCUSSION

What Are the Least Risky Strategies for Commercialization?

MODERATOR:

Eytan Abraham, PhD
Head of Research & Technology for Emerging Technologies
Lonza

3 ROUNDTABLE DISCUSSION

Collaboration Between Industry and Vendors —
What are the Biggest Problems that Need Partnerships to Solve?

MODERATOR:

Phil Vanek, PhD
General Manager, Cell Therapy Growth Strategy
GE Healthcare

4 ROUNDTABLE DISCUSSION

Outsourcing Manufacturing Vs Staying in House —
At What Stage? What Are the Costs?

MODERATOR:

Jason Carstens, PhD
Principal Consultant, Cell Therapy and
Biologics Manufacturing & Development
Cyathlon Bioscience, LLC

1:15

Chairperson’s Opening Remarks

Eytan Abraham, PhD
Head of Research & Technology for Emerging Technologies
Lonza

Comparability and Technology Transfer

2:00

CASE STUDY | NEW UNPUBLISHED DATA Apples, Oranges and Product Comparability

Andrew T. Steinsapir
Consultant
Dark Horse Consulting Inc.

2:30

Operational Setup and Technology Transfer Strategy for Flexible
Multi- Product Contract Cell Therapy Manufacturing

Senthil Ramaswamy, PhD
Director of Cell Therapy Operations
Lonza Walkersville

3:00

Networking Refreshment Break and Exhibit Viewing

Standardization and Development by Design

3:30

NEW UNPUBLISHED DATA Program to Standardize Methods for Counting Cells and the Use of Reference Standards

Sumona Sarkar, PhD
Biomedical Engineer, Biosystems and Biomaterials Division
National Institute of Standard and Technology

4:00

Development by Design, a Business Extension of QbD for Commercially Viable Manufacturing

Brian Hampson
Vice President, Global Manufacturing Sciences and Technology
Hitachi Chemical Advanced Therapeutics Solutions

4:30

PANEL DISCUSSION Raw Materials — Making the Grade

MODERATOR:

Scott R. Burger, MD
Principal
Advanced Cell & Gene Therapy, LLC

PANELISTS:

To be announced. Check back for program updates.

5:00

Close of Day One

Networking Cocktail Reception
and Exhibit Viewing
immediately following the final session on day one

DAY TWO | Tuesday, March 27, 2018

8:00

Continental Breakfast

8:30

EYE-OPENER RAPID FIRE BREAKFAST PRESENTATIONS During this 30 minute session, three 10 minute talks will be
delivered by technology developers.

For More Information and to Get Involved Contact:

Karen Hanover
Senior Business Development Manager
+1-339-298-2184
[email protected]

9:00

Chairperson’s Opening Remarks

Jason Carstens, PhD
Principal Consultant, Cell Therapy and Biologics Manufacturing & Development
Cyathlon Bioscience, LLC

Morning Keynote Address

9:15

NEW UNPUBLISHED DATA Bioprinting — Latest Advances in Process Development and What’s Next

Julie Allickson, PhD
Director, Regenerative Medicine Clinical Center,
Wake Forest Institute for Regenerative Medicine
Wake Forest University School of Medicine

Process Development —
Achieving Commercially Ready Processes Through Automation and Novel Technology Implementation

10:00

Product Innovations to Radically Shorten the Development Timelines of hMSCbased Therapies

Jon Rowley, PhD
Founder and CTO
RoosterBio Inc.

10:30

Networking Refreshment Break and Exhibit Viewing

11:00

NEW UNPUBLISHED DATA Overcoming Process Development Challenges in Cell Therapy

Alan K. Smith, PhD
Executive Vice President, Technical Operations
Bellicum Pharmaceuticals

11:30

Development of Large Scale Stem Cell Production System

Wen Bo Wang
Senior Vice President, Cell Therapy Research and
Development, Therapeutics Division
Cellular Dynamics International, a Fujifilm company

12:00

PANEL DISCUSSION How Can We Achieve Process Robustness and Scalability in a More
Cost-Efficient Manner? How Do We Drive Down COGs?
What are the Key Obstacles That Limit Cost Reduction?

MODERATOR:

Jon Rowley, PhD
Founder and CTO
RoosterBio Inc.

PANELISTS:

To be announced. Check back for program updates.

12:30

Luncheon and Short Presentations Recapping Key Insights/Takeaways from Day One Luncheon Discussions

Process Development —
Achieving Commercially Ready Processes Through Automation and Novel Technology Implementation (Cont.)

1:40

Chairperson’s Remarks

Aby Matthew, PhD
Senior Vice President & Chief Technology Officer
BioLife Solutions, Inc.

1:45

Closed Processing and Automation

Brian Hampson
Vice President, Global Manufacturing Sciences and Technology
Hitachi Chemical Advanced Therapeutics Solutions

Regulatory Pathways

2:15

Regulatory Perspective from Industry

Keith Wonnacott, PhD
Executive Director, Regulatory Affairs
Pfizer Inc (invited)

2:45

PANEL DISCUSSION Regulatory Considerations

MODERATOR:

Anthony Davies, PhD
Founder & Executive Chairman
Dark Horse Consulting Inc.

PANELISTS:

To be announced. Check back for program updates.

3:15

Closing Remarks and Look Ahead

Jason Carstens, PhD
Principal Consultant, Cell Therapy and Biologics Manufacturing & Development
Cyathlon Bioscience, LLC

3:30

Close of Conference