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2015 Summit

FOURth Annual BIOPHARMACEUTICAL Summit

May 18-20, 2015: Workshop on “Process Control of Raw Material Variability in Biotherapeutics Production”
May 20-22, 2015: Advanced Training on PAT and QbD Principles in Biopharmaceuticals
Location: Inn & Conference Center (Lowell, Mass.), University of Massachusetts Lowell
Hosted by Biopharmaceutical Process and Quality Consortium (BPQC), Massachusetts BioManufacturing Center (MBMC), University of Massachusetts Lowell, MassBiologics (UMass Medical School)


Summit Theme

During the summit, the focus will be on the following subtopics:

  • Challenges of raw material variability in biopharmaceutical industry
  • Industry Practices
  • Technologies and methodologies of process control
  • Path-forward

In addition, the following areas of interest will be discussed:

  • Process Analytical Technology in the Biopharmaceutical industry
  • Quality by Design in the Biopharmaceutical industry
  • Continuous bioprocessing infrastructure (Upstream and downstream)
  • Systems technology for continuous bioprocessing
  • Current practices and progress within the industry

Who will be participating?

The five-day summit (two-day workshop and three-day training) will mark the fourth annual event of the Biopharmaceutical Process and Quality Consortium. Expected summit participants are scientists and engineers from biopharmaceutical manufacturers, technology/system providers, raw material suppliers and agencies in the areas of development, manufacturing, and engineering. Via this workshop, we hope professionals and leaders of biopharmaceutical industry will be able to get together and talk about next-generation biopharmaceutical process. It will also be a great chance to network with professionals from major biopharmaceutical manufacturers and various technology providers such as Biogen Idec, Genzyme, Pfizer, Momenta, Millipore, BMS, GE, SAFC and many others.


Featured Speaker and Presentations:

  • Michael Butler, Ph.D., Scientific Director of MabNet, University of Manitoba, Canada
  • Rajesh Beri, Ph.D., Head of Site R&D, Lonza Biologics, Portmouth, N.H.
  • Mark D. Leney, Ph.D., Deputy Director of Quality & Regulatory Affairs, MassBiologics lab, M.A.
  • Brian Fahie, Ph.D., Director of Technical Development, Biogen, M.A.
  • Kelvin Lee, Ph.D., Professor, University of Delaware, D.E.
  • Seshu Tummala, Mammalian Manufacturing R&D, Lonza Biologics, N.H.
  • Jeff Doyle, Manager, Process Analysis Sciences Group, Pfizer, M.A.
  • Terrence Dobrowsky, Ph.D., Scientist, Biogen, M.A.
  • Tony Wang, Ph.D., Sr. Engineer, Amgen, C.A.
  • Dave Kolwyck, Director of Global MS, Raw Material Global Process Ownder, Biogen, M.A.
  • Sean M. McCarthy, Ph.D., Waters
  • Amr Ali, Scientist, Biogen, M.A.
  • Jessica Mondia, Scientist, Biogen, M.A.
  • Carson Tran, Ph.D., Scientist, Biogen, M.A.
  • Alexis Bossie, Ph.D., Director of Raw Materials, Lonza Biologics, Portsmouth, N.H.
  • Sun Koo Kim, Ph.D., Bayer Healthcare, San Francisco, Calif., and Founder of QbD works
  • Steven Mehrman, Ph.D., Scientist, Johnson & Johnson, P.A.
  • Kumar Dhanasekharan, Ph.D., Director of Process Development, Cook Pharmica, Bloomington, Ind.
  • In addition, scientists and engineers from BiogenIdec, Genzyme, Pfizer, Shire, BMS, Merck, Amgen, GE, SAFC, Life Tech, and others. 20-30 Posters by graduate students and researchers of the Biopharmaceutical consortium.

Registration:

To register, email the BPQC or you can register on-line. For questions and special registration, email bpqc@uml.edu with your contact information (name, company, title, email and phone number). The registration fee for the entire 5-day summit is $2,100 per person. The registration fee for the workshop only is $500, and for the training, $1,850. Early bird registration is available until April 30th with a discount of $100 for the workshop


Accommodations

Multiple rooms at the UMass Lowell Inn and Conference Centerhave been reserved for the summit attendees. When you make a reservation, please mention that you are attending Biopharmaceutical summit to get special rate.


Summit Chair

  • Rajesh Beri, Head of Site R&D, Lonza Biologics, Portsmouth, N.H. (Chair)
  • Seongkyu Yoon, Assistant Professor of Chemical Engineering, UMass Lowell (Co-Chair)

Summit Scientific Committee

  • Seongkyu Yoon, Assistant Professor of Chemical Engineering, UMass Lowell
  • Carl Lawton, Associate Professor of Chemical Engineering, UMass Lowell
  • Jin Xu, Assistant Professor of Chemistry, UMass Lowell
  • Kevin Bittorf, Pharmaceutical Executive in Residence, UMass Lowell
  • Hyunmin Yi, Associate Professor of Chemical and Biological Engineering, Tufts University
  • Sanjeev Manohar, Professor of Chemical Engineering, UMass Lowell
  • Sadettin Ozturk, Ph.D., MassBiologics, UMass Medical School, Head of Development and Analytical Technology

Industry Advisory Board

(For question about the industry advisory board, please contact BPQC,bpqc@uml.edu)

  • Kevin Bittorf, Pharmaceutical Executive in Residence, UMass Lowell (Chair)
  • Neil Schauer, VP of Technical Operations, Avaxia Biologics Inc.
  • Thomas Ryll, Sr. Director of Cell-Culture Development, BiogenIdec
  • Jack Prior, Sr. Director of Bioprocess Engineering, Genzyme
  • William Thomas, VP of Process Development, MassBiologics
  • Tom Porter, Sr. Director of Analytical Research & Development, Global Biologics, Pfizer

SPONSORSHIP

For any questions about the sponsorship, please contact BPQC:bpqc@uml.edu.

Platinum Sponsorship (US $4,000)
The sponsoring company can have a choice of either luncheon or reception. Four complimentary passes to the workshop will be provided. Signs with company name and logo will be placed throughout sponsored events. The company can display a pop-up banner if available. A company flyer (provided by sponsor) will be included with the conference registration packet. Company logo will be in the conference brochure and booklet. Special recognition will be made during the conference.

Gold Sponsorship (US $3,000)
The sponsoring company can have a venue choice of breakfast, morning or afternoon break. Three complimentary passes to the workshop will be provided. Signs with company name and logo will be placed throughout sponsored events. The company can display a pop-up banner if available. A company flyer (provided by sponsor) will be included with conference registration packet. Company logo will be in the conference brochure and booklet. Special recognition will be made during the conference.

Silver Sponsorship (US $2,000)
Two complimentary passes to the workshop will be provided. Signs with company name and logo will be placed throughout sponsored events. Company flyer (provided by sponsor) will be included with conference registration packet. Company logo will be in conference brochure and booklet. Special recognition will be made during the conference.