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

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