ISPE San Francisco/Bay Area Chapter
http://www.atdevents.net/register.php
A Pharma Biologics Industry Sea Change
Three different approaches to aspects of project management
From three leading voices in the biopharmaceutical industry
Commuter Conference
Tuesday, May 19, 2015
5:00 - 8:00 pm
Location:
Baxter Healthcare
1978 West Winton Ave, Hayward, CA 94545
Presenters:
Geoff Middleton, Director IDEA2.0, LLC
The discussion centers on cause and effects of what is now an undeniable change underway in the Pharma-Biologics space
that will have profound effects on the full range of future manufacturing, extending from capital project design and delivery,
through the operating life of manufacturing facilities.
Geoff Middleton is Director and founder of IDEA2.0, LLC; a company providing in depth design review services to regulated
industries with the goal of maximizing capital and operating efficiencies. Geoff has over 30 years of design experience across
the full gamut of FDA, EMA regulated industries and products, and has completed projects in the US, South America, Europe,
India and Asia.
Brady Cole, VP Commercial Operations, ABEC
ABEC’s Integrated Solutions approach addresses the chronic communication and accountability challenges so many projects
face. The approach can reduce the risk of the budget misses that are common in the industry. ABEC will discuss how they
developed this unique concept, which combines all the elements of the bulk bioprocess - upstream, downstream, and Clean
Utilities - into a single scope of supply, providing a fixed price for the entire bulk process prior to project approval for
construction.
Brady Cole has over 20 years of technical and commercial experience in high technology industries. He began his career
developing plasma deposition and etch processes for advanced microelectronics. He later moved on to product management
roles in the semiconductor capital equipment industry at Mattson Technology and MKS Instruments. Since joining ABEC in
2002, Brady has held leadership positions in sales and product management. In 2012 he established ABEC's China business
unit, and he currently oversees global sales, marketing, and applications.
Barry Holtz, Klyo Collaborative
With engineering resources at record lows and pressure to deliver on product pipelines at record highs, having the support of
successful and experienced third parties has become a necessity. Klyo Collaborative, a collaboration of Rockwell Automation,
The Beck Group, EEA Consulting Engineers, CBR International, and three other companies have come together to resolve
complex project challenges - a full-service model with A-team only resources necessary to implement creative project
solutions.
Barry Holtz is a career biotech entrepreneur. His background in drug development projects focuses on bioreactor based
cellular manufacturing systems and plant-based biopharmaceutical systems. Barry has led the clinical development and
manufacturing of cancer vaccines and was one of the founders of Large Scale Biology, InterevXion Therapeutics, G-CON
Manufacturing and Caliber Biotherapeutics. He has founded the Klyo Collaborative which assembles seven key disciplines to
address drug delivery solutions from bench to bedside.
ISPE San Francisco/Bay Area Chapter
http://www.atdevents.net/register.php
A Pharma Biologics Industry Sea Change
Three different approaches to aspects of project management
From three leading voices in the biopharmaceutical industry
Commuter Conference
Tuesday, May 19, 2015
5:00 - 8:00 pm
Free to Attend for ISPE Members and Baxter Healthcare Employees
Commuter Conference:
Commuter Conferences provide an interactive educational forum for ISPE members, facilitated by local industry
experts to discuss issues critical to our industry. Discussions will generally focus on the identification of tools,
tips, and/or strategies for addressing these issues. Please be prepared to share your experiences, successes,
and lessons learned.
Commuter Conference Committee Chair:
Ulrike Ruppelt, ticular, Ulrike.ruppelt@ticular.com
Commuter Conference Committee Volunteers:
Jack Commins, Clipper Controls
Raffy Espiritu, Impec Group
Teresa Johnk, ProPharma Group, Banks Integration Group and Owens Design
Harvey Steinhaus, Dome Construction
Stacy Stocki, Parker Domnick Hunter
ISPE San Francisco/Bay Area Chapter
http://www.atdevents.net/register.php
A Pharma Biologics Industry Sea Change
Commuter Conference
Tuesday, May 19, 2015
5:00 - 8:00 pm
REGISTRATION INSTRUCTIONS
Register Online or Via Email:
http://www.atdevents.net/register.php
ISPE LA, SD, SF Members: If you are an ISPE Member in California, please do not set up a new account, you should already
be in our system. Your ISPE Member number is your username, however, your password used on the ISPE site is not the
same on this site. Please email Rob Fleming (rob.fleming@yahoo.com) to reset your password.
ISPE Members of other Chapters:If you are a Member of another ISPE Chapter, please fax your registration with your
Member number and Chapter affiliation.
Host Employees: Please register online. If you do not have an account on our system, you can set one up on the site using
letters (not numbers) as your username. If you need help setting up your account or if you are having problems with the site or
need a new password, please email Rob Fleming (rob.fleming@yahoo.com) for assistance.
Non Members: If you do not have an account on our system, you can set one up on the site using letters (not numbers) as
your username.
FAX REGISTRATION: Complete the Registration Form with payment and Fax the relevant page(s) to (949) 266-8461.
PAY BY CHECK: If paying by check, please bring the check with you to the event. Make check payable to:
ISPE SAN FRANCISCO/BAY AREA CHAPTER, 5319 University Dr., Suite 641, Irvine, CA 92612.
Chapter Tax ID #68-0282494. Contact Kimberly Syre: ksyre@cox.net with any questions. Tel: (949) 387-9046.
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