Agenda

Session I: PAT/QbD, Motivation and Perspectives 

Morning Session Chair: Thomas Ryll, Ph.D., Sr. Director of Cell-Culture Development, Biogen Idec (8:40 – 8:50 a.m.)

PLENARY PRESENTATION:
“Challenges and Opportunities for Continuous Pharmaceutical Manufacturing in QbD framework”(8:50 - 9:30 a.m.)
Christine Moore, Ph.D., Program Director of FDA/CDER

“Application of PAT to support QbD in Bioprocessing”
Jeff Doyle, Manager of Process Analytical Sciences (9:30 - 10:00 a.m.)

"Real-time cell culture control in a integrated benchtop platform: implications for research"
Jean-Francois P Hamel, Ph.D., MIT/Chem Engineering (10:20-10:50 a.m.) 

"Improved Measurements and Standards to Support the Development of Protein Therapeutics"
Michael Tarlov, Ph.D., Chief, Biomolecular Measurement Division, NIST (10:50-11:20 a.m.) 

PANEL DISCUSSION (11:20 a.m. – Noon) 

Panelists: Thomas Ryll, Ph.D.,  (BiogenIdec) and Speakers

Session II: Challenges and Practices 

Afternoon Session Chair: Michael Tarlov, Ph.D., Chief, Biomolecular Measurement Division, NIST 

PLENARY PRESENTATION 2:“PAT, Future of Biotechnology”
Kurt Brorson, Ph.D., Head, Division of Monoclonal Antibody, FDA/CDER (1:30 - 2:00 p.m.) 

“Rapid Development and Scale-up of Therapeutic Antibodies - A QbD Perspective with a Case Study for a Biosimilar Trastuzumab”
Kumar Dhanasekharan, Ph.D., Director of Process Development, Cook Pharmica LLC,(2:00-2:30) 

“Biologics Advanced Process Control at BiogenIdec”
LiLong Huang, Ph.D., Sr. Engineering, Manufacturing Sciences, BiogenIdec, (2:30 - 3:00 p.m.)

"Perspective in QbD in Drug development and Manufacturing"
Bert Frohlich, Ph.D., Director of Bioengineering, Shire (3:10 - 3:40 p.m.) 

"Using QbD and PAT to Develop Adaptive Manufacturing Processes"
Jose Gomes, Ph.D., Principal Engineer, Pfizer (3:40 - 4:10 p.m.) 

“Development application and single use probes for building Design Space of live cell concentration by dielectric spectroscopy”
John Carvell, Ph.D., Managing Director, Aber Instrument (4:10-4:40 p.m.)

Panel Discussion (4:40 – 5:20 p.m.)
Panelists: Michael Tarlov and Speakers

Reception and Networking Poster Session 

Session III: Challenges and Practices 2 (8:20 - 8:30 a.m.)

Morning Session Chair: Jack Prior, Sc.D., Sr. Director of Manufacturing Sciences and Technology, Genzyme

"QbD in Drug Product Formulation"
Andrew Cowen, CEO of Biopharma Technology Ltd. (8:30 - 9:00 a.m.)

"Exploring the linkage between cell culture and downstream processing via statistical design"
Erik Read, Ph.D., Principal Scientist, Division of Monoclonal Antibody, CDER/FDA (9:00 - 9:30 a.m.)

"Raman spectroscopy applied to monitoring, modeling and control of biologics production"
John-Paul Smelko, Sr. Engineer, Cell-Culture Development, BiogenIdec, (9:30 - 10:00 a.m.)

"QbD in Continuous mAb production"
Tim Johnson, Ph.D., Associate Director, Commercial Cell-Culture development (10:00 - 10:30 a.m.)

Session IV: Biopharmaceutical Consortium Session - Driving for Future
Session Chair: Kevin Bittorf, Ph.D., VP of LivingProof Inc. (Advisory Board) (10:40 - 10:50 a.m.)

"Consortium Research Update", Consortium Faculty (10:50 - 11:20 a.m.)

"Consortium Graduate Research Update", Graduate Students (11:20 - 11:50 a.m.)

"Core Research Facility and Cleanroom Facility", Graduate Students (11:50 - 12:00 a.m.)

Session V: Path-forward

Session Chair: Kevin Bittorf, Ph.D., VP of LivingProof Inc.

"Systems Technology in Biologics QbD Implementation"
Richard Braatz, Ph.D., Professor, Chemical Engineering, MIT (1:30 - 2:00 p.m.)

"Regulatory Perspective on Implementation of MSPC for Pharmaceutical Manufacturing" 
Bogdan Kurtyka, Ph.D., Review Chemist, FDA/CDER/ONDQA (2:00 - 2:30 p.m.)

"Understanding the effects of process conditions on protein glycosylation and proteoglycan synthesis"
Susan Sharfstein, Ph.D., Associate Professor, Chemical Engineering, SUNY Albany (2:30 - 3:00 p.m.) 

"QbD in Continuous Manufacturing of mAb"
Maurizio Cattaneo, Ph.D., CEO of Biovoutions (3:00 - 3:30 p.m.)

PANEL DISCUSSION (3:30 - 4:00 p.m.)
Panelists: Kevin Bittorf and Session V Speakers