DAY ONE Wednesday October 17, 2018
7:00
Conference Registration and Continental Breakfast
8:00
Chairman’s Welcome and Opening Remarks
Greg Zarbis-Papastoitsis
Vice President, Process & Manufacturing
Compass Therapeutics LLC
8:15
KEYNOTE PRESENTATION Current Trends in Biopharmaceutical Development & Operations
Jens H. Vogel, PhD
President & CEO
Boehringer Ingelheim Fremont Inc.
Managing Economics —
Biologics Commercialization
9:00
Accelerated Timelines for Complete IND Submissions
Dan Garcia
Senior Director, Business Management – Bioprocess Sciences
Patheon
9:45
Networking and Refreshment Break
10:15
Strategic Collaboration with CMOs for Accelerated IND Filing
Yanhuai (Richard) Ding, PhD
Director, Downstream Process Development and Manufacturing Operations
Anaptysbio, Inc.
11:00
Can Pre-Clinical Development Increase Clinical and Commercial Success Rates?
Nicholas Angell, PhD
Director of Process Development - Attribute Sciences
Amgen Inc.
11:45
LUNCH AND LEARN ROUNDTABLE DISCUSSION The Future of Biological Drug Development Impact of New Therapeutic Modalities
12:45
AUDIENCE DISCUSSION Speed to IND Versus Speed to Market
MODERATOR:
Gene W. Lee, PhD
Senior Director and US Site Head of Discovery Technologies,
Protein and Cell Sciences
EMD Serono Inc
1:30
From DNA to IND in 9 Months —
How Organizations Worked Together to Meet a National Healthcare Initiative
Jie Chen, MD, MS
Vice President, CMC Management
WuXi Biologics
Managing Process — Analytical &
Process Development and Design Operations
2:15
Speed to IND Impact of Organizational Structure and Agility
Dot Reilly, MS
Technical Development Leader
Genentech, Inc.
3:00
Networking and Refreshment Break
3:30
Beyond “Well-Behaved” Biologics
Sheldon Oppenheim, PhD
Associate Engineering Fellow
Takeda
4:15
Strategies to Manage "Phase Appropriate" Development
Greg Zarbis-Papastoitsis
Vice President, Process & Manufacturing
Compass Therapeutics LLC
5:00
Tox to Phase 1/2 Comparability — Balancing Scientific Rigor and Speed
Mark Panek, PhD
Principal Scientist – Large Molecule Method Development
Janssen Research & Development LLC.
5:45
Close of Day One
Networking, Wine and Cheese Reception immediately following the final session on day one
DAY TWO Thursday October 18, 2018
7:30
Continental Breakfast
8:00
Chairman’s Review of Day One
Greg Zarbis-Papastoitsis
Vice President, Process & Manufacturing
Compass Therapeutics LLC
Managing the Biology —
Advances in Cell Line and Media Development
8:15
CASE STUDY Accelerate the Cell Line Development Process Close to the Biological Speed Limit
Zorica Dragic
Team Head, Cell Line Development
Novartis
9:00
Investigate the Impact of Targeted Integration on Speed and Cost
Barry Morse
Principal Research Scientist
Janssen Research & Development, LLC
9:45
Networking and Refreshment Break
10:15
ROUNDTABLE DISCUSSION Optimize Production Cost and Quality Through Cell Culture Manipulation
MODERATOR:
Gene W. Lee, PhD
Senior Director, U.S. Site Head of Discovery Technologies,
Protein and Cell Sciences
EMD Serono Inc
11:00
The case for an alternative expression system to CHO longer term. C1 - the most advanced option
Mark Emalfarb
Chief Executive Officer
Dyadic International Inc.
11:45
Networking Luncheon
Managing the Tools —
High-Throughput Systems, Data and Analytics
1:00
The Role of Knowledge Management in Speed and Cost of Development
Bert Frohlich, PhD
Principal Consultant & Owner
BioPharm Designs, LLC
1:45
CASE STUDY
Integration of Data, Information and Knowledge Systems in High Throughput Processes
Nicole A. Bleckwenn, PhD
Associate Director, Cell Culture and Fermentation Sciences – Tech Transfer
MedImmune, LLC.
Robert C. Heckathorn, PhD
Associate Director, R&D for BPD Informatics and Software Engineering
MedImmune, LLC.
2:30
Networking and Refreshment Break
3:00
Enable Product-Specific Formulations During Speed to IND —
Current State, Challenges and Opportunities
Santosh Thakkar, PhD
Senior Scientist – Large Molecule Drug Product Development
Janssen Research & Development LLC.
4:15
CASE STUDY & NEW UNPUBLISHED DATA Speeding Up Purification Process Development
James Dvornicky
Engineer II – Purification Development
Genentech, Inc.
4:30
Close of Conference
DAY ONE Wednesday October 17, 2018
7:00
Conference Registration and Continental Breakfast
8:00
Chairman’s Welcome and Opening Remarks
Greg Zarbis-Papastoitsis
Vice President, Process & Manufacturing
Compass Therapeutics LLC
8:15
KEYNOTE PRESENTATION Current Trends in Biopharmaceutical Development & Operations
Jens H. Vogel, PhD
President & CEO
Boehringer Ingelheim Fremont Inc.
Managing Economics —
Biologics Commercialization
9:00
Accelerated Timelines for Complete IND Submissions
Dan Garcia
Senior Director, Business Management – Bioprocess Sciences
Patheon
9:45
Networking and Refreshment Break
10:15
Strategic Collaboration with CMOs for Accelerated IND Filing
Yanhuai (Richard) Ding, PhD
Director, Downstream Process Development and Manufacturing Operations
Anaptysbio, Inc.
11:00
Can Pre-Clinical Development Increase Clinical and Commercial Success Rates?
Nicholas Angell, PhD
Director of Process Development - Attribute Sciences
Amgen Inc.
11:45
LUNCH AND LEARN ROUNDTABLE DISCUSSION The Future of Biological Drug Development Impact of New Therapeutic Modalities
12:45
AUDIENCE DISCUSSION Speed to IND Versus Speed to Market
MODERATOR:
Gene W. Lee, PhD
Senior Director and US Site Head of Discovery Technologies,
Protein and Cell Sciences
EMD Serono Inc
1:30
From DNA to IND in 9 Months —
How Organizations Worked Together to Meet a National Healthcare Initiative
Jie Chen, MD, MS
Vice President, CMC Management
WuXi Biologics
Managing Process — Analytical &
Process Development and Design Operations
2:15
Speed to IND Impact of Organizational Structure and Agility
Dot Reilly, MS
Technical Development Leader
Genentech, Inc.
3:00
Networking and Refreshment Break
3:30
Beyond “Well-Behaved” Biologics
Sheldon Oppenheim, PhD
Associate Engineering Fellow
Takeda
4:15
Strategies to Manage "Phase Appropriate" Development
Greg Zarbis-Papastoitsis
Vice President, Process & Manufacturing
Compass Therapeutics LLC
5:00
Tox to Phase 1/2 Comparability — Balancing Scientific Rigor and Speed
Mark Panek, PhD
Principal Scientist – Large Molecule Method Development
Janssen Research & Development LLC.
5:45
Close of Day One
Networking, Wine and Cheese Reception immediately following the final session on day one
DAY TWO Thursday October 18, 2018
7:30
Continental Breakfast
8:00
Chairman’s Review of Day One
Greg Zarbis-Papastoitsis
Vice President, Process & Manufacturing
Compass Therapeutics LLC
Managing the Biology —
Advances in Cell Line and Media Development
8:15
CASE STUDY Accelerate the Cell Line Development Process Close to the Biological Speed Limit
Zorica Dragic
Team Head, Cell Line Development
Novartis
9:00
Investigate the Impact of Targeted Integration on Speed and Cost
Barry Morse
Principal Research Scientist
Janssen Research & Development, LLC
9:45
Networking and Refreshment Break
10:15
ROUNDTABLE DISCUSSION Optimize Production Cost and Quality Through Cell Culture Manipulation
MODERATOR:
Gene W. Lee, PhD
Senior Director, U.S. Site Head of Discovery Technologies,
Protein and Cell Sciences
EMD Serono Inc
11:00
The case for an alternative expression system to CHO longer term. C1 - the most advanced option
Mark Emalfarb
Chief Executive Officer
Dyadic International Inc.
11:45
Networking Luncheon
Managing the Tools —
High-Throughput Systems, Data and Analytics
1:00
The Role of Knowledge Management in Speed and Cost of Development
Bert Frohlich, PhD
Principal Consultant & Owner
BioPharm Designs, LLC
1:45
CASE STUDY
Integration of Data, Information and Knowledge Systems in High Throughput Processes
Nicole A. Bleckwenn, PhD
Associate Director, Cell Culture and Fermentation Sciences – Tech Transfer
MedImmune, LLC.
Robert C. Heckathorn, PhD
Associate Director, R&D for BPD Informatics and Software Engineering
MedImmune, LLC.
2:30
Networking and Refreshment Break
3:00
Enable Product-Specific Formulations During Speed to IND —
Current State, Challenges and Opportunities
Santosh Thakkar, PhD
Senior Scientist – Large Molecule Drug Product Development
Janssen Research & Development LLC.
4:15
CASE STUDY & NEW UNPUBLISHED DATA Speeding Up Purification Process Development
James Dvornicky
Engineer II – Purification Development
Genentech, Inc.
4:30
Close of Conference