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Facility Focus

DME Facility Focus—It’s Time For Dialog

New Challenges Require a Different Mindset

At INTERPHEX 2016, DME introduced Facility Focus. It was designed to create a dialog within the industry regarding how we are going to meet the new challenges for practical facility designs.

We are continuing the dialog at INTERPHEX 2017, March 21-23.  We are again asking the question, “How are we going to be able to meet these challenges with the pressures we have on our businesses?” As we did for INTERPHEX 2016, we are getting the perspectives of those who are intimately involved in the industry. Through our surveys, we are hoping to draw out a better understanding of how the industry is evolving so we can better forecast what a future facility might look like.

The Panel Discussions for 2017 are:

cGMP Facility Modernization: New Solutions for Aging Facilities: This will be moderated by David M. Marks, President of DME. It will be held on Wednesday, March 22, 10:30-11:30 AM in Meeting Room 1.

  • Panelists include Ken Fontaine, Sr. Director/FMC Facilities & Engineering at AstraZeneca Biologics; Dan D’Aquila, Sr. Director Manufacturing Operations, Biopharm at GSK and Kevin Walsh, Director of Site Technical Engineering and Validation at sanofi pasteur.

The second panel, Next Generation Aseptic Manufacturing: An Eye-opening Peek into the Future, will be moderated by Hite Baker.  The time for this session is Wednesday, March 22, 1:00-2:00 PM in Meeting Room 1.

  • Panelists will be Alex Haig, Director of Engineering at Cook Pharmica; Matthew VonEsch, Sr. Director, Manufacturing at Exelead; John Barnes, Sr. Engineering Manager at Northstar Medical Radioisotopes and John Erdner, Director of Sales, Liquid Fill at SP Scientific.

What’s in it for INTERPHEX Attendees?

  • A better understanding of the trends shaping our industry, what’s driving change, how competitors are responding and how others are turning problems into opportunities
  • Advice on how to approach the regulatory questions regarding compliance facilities and producing safer, higher quality products
  • An understanding of priorities across the industry—from manufacturers, regulatory authorizes, academia, and service providers

If you would like to receive future emails about Facility Focus and other DME events, please contact us at

To learn more about Aseptic Technology Trends in Sterile Product Facility Design, click here to download a copy of Hite Baker’s white paper, Modernizing Non-Compliant Sterile Facilities. This paper is based on an industry-wide survey as part of Facility Focus. Hite is a Principal Process Engineer at DME and a leader of Facility Focus.

As a note, Hite Baker is quoted in the article “Parenteral Advisory: Outmoded Fill/Finish Technology” in the September ’16 issue of BioPharm International. Hite was referenced about single-use in sterile fill/finish systems and about a promising strategy of the increased use of robots in gloveless isolators for aseptic filling. Click here to read the complete article.





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