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Key Sessions

Liz Lewis

KEYNOTE PRESENTATION: Building Value Through External Stakeholder Engagement

Takeda Oncology

Sep 28
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7:30am - 8:00am 30 mins
Main agenda
Breakfast & Technology Workshop: Addressing the Risk of Bioburden and the Need for Increased Productivity in Protein A Chromatography
  • Jonathan Royce - Business Leader - Chromatography Resins, GE HealthCare Life Sciences
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Please note: The exhibit hall is not open following this talk. The exhibit hall opens today at 10:20am

Historically, the alkali stability of Protein A chromatography resins has lagged behind other resins used in downstream purification of antibody therapeutics. This fact, combined with the high nutrient load to which Protein A resins are exposed, introduces a larger risk of column contamination when compared with secondary and tertiary chromatographic operations. In this presentation, we present a newly designed protein A resin which offers alkali stability on par with ion exchange and hydrophobic interaction chromatography resins. Data on binding capacity, caustic stability and resin cleanability will be presented.

9:50am - 10:20am 30 mins
Technology Workshop
Bioseparation Media by Mitsubishi Chemical
  • Mayumi Kiyono-Shimobe, Ph.D. - Business Development Manager, Separation Materials Department, Mitsubishi Chemical America, Inc.
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Brought to you by BPI Sponsor: Mitsubishi Chemical

For >70 years Mitsubishi Chemical has been manufacturing industrial separation media for peptides and small to large molecules. Our newest media, MabSpeed™(protein A) and ChromSpeed™ (ion exchange) are specially designed for purification of biopharmaceuticals (antibody-drugs, protein-drugs, etc.) as well as large oligonucleotides for high throughput processing. The details of these products will be introduced during the seminar.

9:50am - 10:20am 30 mins
Technology Workshop
Thirty Years of mAbs and Protein A: A Retrospective Look at 30 Years of Synergies
  • Geoff Hale, Ph.D. - Director, Absolute Antibody Ltd
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Brought to you by BPI Sponsor: GE Healthcare

Thirty years ago, monoclonal antibodies were mainly research projects which were barely represented in pharmaceutical sales. Today, mAbs represent 50% of all biological sales and the pipeline of future mAbs and other antibody constructs is rich. Dr. Hale, who was involved in the development of one of the first mAbs, Campath, will look back on the dramatic success of our industry and how the developments of antibody and protein A technologies have followed a synergistic path to bring the industry to its current state.

9:50am - 10:20am 30 mins
Technology Workshop
Solutions for Maximizing Binding Capacity of Intact mAb and mAb Fragments Purification with Minimal Impurity Levels
  • J. Kevin O'Donnell, Ph.D. - Process Chromatography Support Manager, Tosoh Bioscience LLC
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Protein A and Protein L chromatography resins are used as a capture step for intact mAbs, antibody fusion proteins and mAb fragments.  Because of their unique specificity, these resins are capable of adequately removing most process impurities.  They also exhibit the highest binding capacity, the widest range of mAb subclass specificity and are resistant to alkaline cleaning.


9:50am - 10:20am 30 mins
Technology Workshop
Monitoring and Controlling Viable Biomass in Bioprocesses Using Dielectric Spectroscopy for PAT Control
  • Aditya Bhat, Ph.D. - Director of Technology, Aber Instruments, Inc.
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The radio-frequency impedance method for real time detection of viable biomass is established in biopharmaceutical applications. This method provides real time information of live biomass and is used extensively to monitor processes and make process decisions. This presentation covers the principle behind the impedance method, its benefits, and applications of the technology across processes, making it a robust PAT tool.

9:50am - 10:20am 30 mins
Technology Workshop
Overcoming Validation Challenges in a Single-Use World
  • Derek Pendlebury, Ph.D. - OEM Channel Manager, Bioproccessing, CPC - Colder Products Company
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The presentation panel discusses the three perspectives (bioprocessing company, system integrator, component manufacturer) of validation methodology for single-use systems as the bioprocessing industry is confronted with producing safe therapies and vaccines while meeting government regulations and constant pressure to lower cost per dose. It takes a look at the challenges in implementation and adoption of validation methodology and the benefits of collaboration.


10:20am - 11:00am 40 mins
Main agenda
Refreshment Break in the BWB Poster & Exhibit Hall
10:30am - 11:30am 60 mins
Main agenda
Correspondents Panel Discussion: State of the Life Sciences 2018 and Views on the Landscape Ahead
  • Panelist Alex Lash - National Biotechnology Editor, Xconomy
  • Panelist Luke Timmerman - Founder and Editor, Timmerman Report
  • Panelist Rebecca Robbins - Business Reporter, STAT News
  • Moderator Alex de Winter - Managing Director, GE Ventures
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Moderator:

Alex de Winter, Managing Director, GE Ventures

Panelists:

Alex Lash, National, Biotechnology Editor, Xconomy

Luke Timmerman, Founder and Editor, Timmerman Report

Rebecca Robbins, Business Reporter, STAT News

12:00pm - 1:00pm 60 mins
Mass BIO CRO/CMO Symposium
Registration and Lunch
1:00pm - 2:00pm 60 mins
Mass BIO CRO/CMO Symposium
Opening Remarks & Panel Discussion: Different Perspectives on Acquisitions: Vendors & Sponsors Evaluate the Pros and Cons
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While it is somewhat common for established pharma and biotech companies to acquire CROs, industry professionals have different perspectives on the subject. When is consolidation the right choice for companies and how does this affect the company and industry landscape? Representatives from both vendor and sponsor companies will share their experiences in consolidations, the challenges and benefits, and risk and reward.

  • Peter Meltzer, CEO, Organix
  • EVan Guggenheim, Biogen (Moderator)

And additional expert speakers from small & large biotech, pharma and CRO/CMO companies

2:00pm - 2:45pm 45 mins
Mass BIO CRO/CMO Symposium
Breakout/Roundtable Sessions 1
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  • The Responsive Vendor: Developing Strong Sponsor-CRO Relationships
    • Stacey Lindey, QuintilesIMS
  • Minimizing Risk in Outsourcing: How to Benefit from an Enhanced Integrated Preclinical Program
    • Sam Chuang, Charles River Labs
    • Keith Giza, Principal Research Associate Scientist, Moderna Therapeutics
    • Damon Demady, Director of Toxicology, Mersana
  • Partnerships, Global vs. Local: Finding the Right Sourcing Partner
  • Sourcing for Start-ups and Early Stage Firms
3:15pm - 4:00pm 45 mins
Mass BIO CRO/CMO Symposium
Breakout/Roundtable Sessions 2
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  • Workshop
    • Don Dickison, Juniper Therapeutics
  • New Platforms: Eliminating Administrative Friction in Outsourcing
    • Mary Kachinsky, Vice President, Strategic Sourcing and Operations, Forma
  • From Startup to Second Stage
    • Gerry Cox, Chief Operating Officer, Velesco Pharma
  • Global Manufacturing 
  • Managing a Complex CMO Network
4:00pm - 5:00pm 60 mins
Mass BIO CRO/CMO Symposium
Closing Panel: Relationships: Sponsors, Consultants and CROs & CMOs
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The relationships between sponsors, consultants and CROs & CMOs are becoming increasingly complex, as more companies, both large and small, interface with consultants. How do companies effectively manage relationships, ensuring seamless communications between sponsoring companies, service providers and consultants? How can you strike a balance between micromanaging these relationships and offering full autonomy? When is it appropriate to engage outside consultants, and what is the proper way to navigate the partnerships?

  • Wes Westlin, Senior Vice President, Preclinical Research & Early Development, Nimbus Discovery
  • Jeff Saunders, Co-founder, JOSC LLC
  • Michael Settles, Owner, TGA Biosciences
  • Colin Minchom (Moderator)
5:00pm - 6:00pm 60 mins
Mass BIO CRO/CMO Symposium
Cocktail Reception
12:30pm - 1:15pm 45 mins
Main agenda
Networking Luncheon in the BWB Poster & Exhibit Hall
1:15pm - 1:20pm 5 mins
Main agenda
Chairperson's Remarks
  • Robert Coughlin - President and CEO, MassBio
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1:20pm - 2:00pm 40 mins
Main agenda
KEYNOTE PRESENTATION: Building Value Through External Stakeholder Engagement
  • Liz Lewis - Chief Counsel and Head of Patient Advocacy, Takeda Oncology
more
2:00pm - 2:15pm 15 mins
Main agenda
BWB Passport Prizes Announced from Keynote Stage
2:15pm - 2:15pm 0 mins
Main agenda
Close of Conference and BWB Poster & Exhibit Hall