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3D Isolated Human Cell Background.

2017 Summit Agenda

Biomanufacturing Summit, May 22-23, 2017

Dates:

  • May 22-23, 2017: Summit on “beyond mAbs"
  • May 24-26, 2017: Advanced Bioprocessing Training

Location: UMass Club, 1 Beacon St., Boston, Mass.

Hosted by: The Biomanufacturing Science and Technology Consortium (BSTC),Massachusetts BioManufacturing Center(MBMC) and University of Massachusetts Lowell

Part I. SUMMIT

Monday, May 22, 8 a.m. - 5:30 p.m.

Time Event
8 a.m. Registration
8:30 a.m. Welcome and Introduction (UMass Lowell and organizer)
Mr. Travis McCready, CEO and President, Mass Life Science Center
8:40 a.m. Session I: Cell therapeutics Dev. and Manufacturing - Advances and Challenges
Session Chair: John Pieracci, Biogen (8:40 – 8:50 a.m.)
T1: "Manufacturing Solutions for Industrializing Cellular Therapeutics", Julie Murrell, Head of Cell therapy Bioprocessing, MilliporeSigma (8:50 - 9:10 a.m.)
T2: "Biomanufacturing from a Regenerative Medicine Perspective", Caroline Dugopolski, VP, Technical Operations, Histogenics (9:10 - 9:30 a.m.)
T3: "Cell Therapy Development and Manufacturing. Regulatory / Quality Challenges", Karen Nichols, Chief Regulatory Officer, ISCT (9:30 - 9:50 am)
9:50 a.m. BREAK
10:10 a.m.
Research Snapshot Presentation I (10:10 - 10:20 a.m.)
William Stuart, MarkHenry Kamga, Alessandro Mora (UMass Lowell)
10:20 a.m. PLENARY PRESENTATION:
T4: "Building Toward a Modern Pharmaceutical Manufacturing Sector: Encouraging Development and Adoption of Emerging Technology", Lucinda Buhse, Director, Office of Testing and Research, FDA, CDER, Office of Pharmaceutical Quality (10:20 - 11 a.m.)
T5: "Ex vivo expanded allogeneic NK cell as new modality for cancer treatment", Yu-Kyeong Hwang, R&D Head, Green Cross LabCell (South Korea) (11-11:20 a.m.)
Panel Discussion (11:20 a.m. - Noon)
NOON NETWORKING LUNCH
1:25 p.m. Session II: S2. Biomanufacturing Innovation
Session Chair: Cyrus Agarabi, OBP/CDER/FDA/DBRR-II (1:25 - 1:30 p.m.)
T6: "Opportunities for Collective Advancement in the Biopharmaceutical Manufacturing Community", Kelvin H Lee, Professor, NIIMBL Director, Univ of Delaware (1:30 - 2 p.m.)
T7: "Advanced Regenerative Manufacturing Institute: Challenges and opportunities in manufacturing engineered tissues", Tom Bollenbach, Chief Technology Officer, Advanced Regenerative Manufacturing Institute (2-2:20 p.m.)
T8: "Tough Sledding: Unique Challenges Faced by Candidates with Associate Degrees in the Biomanufacturing Job Market", Mark Bruso, Manager of Labor Market Research, MassbioEd Foundation (2:20 - 2:40 p.m.)
T9: Improved expression of recombinant proteins from mammalian cells by utilizing non-coding RNAs: microRNA and siRNA, Joseph Shilolach, Director of the Biotechnology Core Laboratory, NIDDK/NIH (2:40 - 3 p.m.)
3 p.m. BREAK
3:20 p.m. Research Snapshot Presentation II (3:20 - 3:30 p.m.)
Hemlata Bhatia, Sha Sha, Nicholas Trunfio (UMass Lowell)
3:30 p.m. T10: Model-based product and process development and optimization: Can the pharmaceutical industry achieve what other process manufacturing industries have?” Sean Bermingham, VP - Life Sciences and Principal Consultant, Process Systems Enterprise Ltd (PSE) (3:30 - 3:50 p.m.)
Panel Discussion (3:50 - 4:30 p.m.)
4:30 - 5:30 p.m. Reception and Networking Poster Session 20-30 posters will be presented

Tuesday, May 23, 8 a.m. – 5 p.m.

Time Event
8 a.m. REGISTRATION
8:30 a.m. Next Year Theme (UMass Lowell and organizer)
8:40 a.m. Session III: Protein therapeutics Dev. and Manufacturing
Advances and Challenges
Session Chair: Jack Prior, Sanofi (8:40 – 8:50 a.m.)
PLENARY PRESENTATION:
T11: "Challenges associated with the development of a complex portfolio of Biologics", Morrey Atkinson, Vice President, Biologics Development and Clinical Manufacturing, Bristol-Myers Squibb, (8:50 - 9:30 a.m.)
T12: "Process Analytical Technologies in Mammalian Cell-Culture Bioreactors", Cyrus Agarabi, Regulatory Research Officer, OBP/CDER/FDA/DBRR-II (9:30 - 9:50 a.m.)
T13:"How Computational Fluid Dynamics (CFD) Modeling Addresses Process Development and Manufacturing Challenges", Armin Opitz, Sr. Scientist, Sanofi (9:50 - 10:10 a.m.)
10:10 a.m. BREAK
10:30 a.m. Research Snapshot Presentation III (10:30 - 10:40 a.m.)
Ketki Behere, Zhuangrong Huang, Seoyoung Park (UMass Lowell)
10:40 a.m. T14: "What does success mean when developing newer modalities?", Palani Palaniappan, Head, Biologics & New Modalities Development, Pharmaceutical Sciences, Takeda Boston (10:40-11 a.m.)
T15: "Next Generation Bioprocessing", Roger Hart, Scientific Director, Drug Substance Process Development, Amgen (11-11:20 a.m.)
Panel Discussion (11:20 a.m. - Noon)
Noon NETWORKING LUNCH
1:25 p.m. Session IV: Gene therapeutic Dev. and Manufacturing- Advances and Challenges
Session Chair: Alan Gilbert, Biogen (1:25 - 1:30 p.m.)
T16: "Beyond mAbs, Viral and Non-Viral Vectored Delivery of Antibodies", Dr. Mark Klempner, Executive Vice Chancellor-MassBiologics, Professor of Medicine, UMass Medical School, (1:30-2 p.m.)
T17: "Design of Multiproduct Single Use Gene Therapy Manufacturing Facility", Paul Fleming, Sr. Project Manager, Lonza Biologics (2-2:20 p.m.)
T18: "Development challenges of Gene Editing with CRISPR/Cas9", Michael Mccaman, Vice President - Process Sciences, Intellia Therapeutics (2:20 - 2:40 p.m.)
2:40 p.m. BREAK
3:00 p.m. T20: "Cell Culture Process Development for AAV gene therapy vectors", Ying Jing, Sr. Director of Cell-line and Cell Culture, Dimensiontx (3:00-3:20 p.m.)
T21: "Enabling Large-Scale Manufacturing of rAAV Gene Therapy Vectors in Insect Cells", David Dismuke, Director of Vector Production, Voyager Therapeutics, Inc. (3:20-3:40 p.m.)
Panel Discussion (3:40 - 4:20 p.m.)
4:20 p.m. CLOSING REMARKS

Part II. BPQC Business Meeting and Reception

Wednesday, May 24, 8 a.m. - 5 p.m.

Time Event
9 a.m. (Location TBD) Business meeting with consortium member companies. For appointment, RSVP (bpqc@uml.edu, or Seongkyu Yoon (Seongkyu_yoon@uml.edu, 978-934-4741)

Part III. TRAINING on Advanced Industrial Bioprocessing

Day 1: Wednesday May 24, 8 a.m. - 5 p.m.

M1: Upstream Bioprocessing

Time Description Type Instructor
8 a.m Cell-Culture Development I Lecture CL (UMass Lowell)
9 a.m Cell-Culture Development II Lecture CL (UMass Lowell)
10 a.m Cell-Culture Development III Lecture CL (UMass Lowell)
11 a.m Cell-Culture Development IV Case Study CL (UMass Lowell)
Noon LUNCH

M2: Downstream Bioprocessing

Time Description Type Instructor
M2: Downstream Bioprocessing
1 p.m Downstream Development I Lecture MH, AG, MG (MilliporeSigma)
2 p.m Downstream Development II Lecture MH, AG, MG (MilliporeSigma)
3 p.m Downstream Development III Lecture MH, AG, MG (MilliporeSigma)
4 p.m Downstream Development IV Case Study MH, AG, MG (MilliporeSigma)

DAY 2: Thursday May 25, 8 a.m. - 4 p.m.

Module Number and Time Description Type Instructor
M3: Analytical Technology in Bioprocessing
8 a.m Analytical Development I Lecture JS, Pfizer
9 a.m Analytical Development II Lecture
10 a.m Analytical Development III Tutorial
11 a.m Analytical Development IV Tutorial
Noon LUNCH
M4: Gene Therapy
1 p.m Gene Therapeutics I Lecture GG (UMMS)
2 p.m Gene Therapeutics II Lecture
3 p.m Gene Therapeutics III Lecture
4 p.m Gene Therapeutics IV Lecture

DAY 3: Friday MAY 26, 8 a.m. - 2 p.m.

Module Number and Time Description Type Instructor
M5: Cell Therapy
8 a.m Cell Therapeutics I Lecture TH, ML, KL, JF (MilliporeSigma)
9 a.m Cell Therapeutics II Lecture
10 a.m Cell Therapeutics III Lecture
11 a.m Cell Therapeutics IV Case Study
Noon LUNCH
M6: Process Analytics in Bioprocessing
1 p.m Process Analytics I Lecture SY (UMass Lowell)
2 p.m Process Analytics II Case Study

Questions

For questions please email: bpqc@uml.edu, or Seongkyu Yoon (Seongkyu_yoon@uml.edu) or call: 978-934-4741.