
Facilities Summit: Innovation and Ultra Fast Delivery (E02)
| 2-3 June 1.2 CEUs |
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Working Agenda Current as of 1 May 2008 Download Working Agenda |
Why does it take the industry so long to design, construct, commission and qualify (IQ/OQ) a new or renovated facility? No one can afford to spend a dollar that is not absolutely necessary. Reducing risk is a key goal.
Biopharmaceutical companies are delaying capital approvals later than ever. Companies are reluctant to commit significant capital funding until results from clinical trials provide the evidence of a potential winner. The consequence of this is that commitment to the design or renovation of a facility can occur as a late as phase 2B clinical trial. With the normal requirement to produce phase 3 clinical trial material in the new or renovated facility, and, reducing the time to market, the pressure on the owners engineering team and service providers is greater than ever. Current project delivery strategies employed by the industry are clearly not meeting this new business environment.
This two day summit will address these issues and feature interactive workshops given by senior industry professionals representing owner companies, engineering designers, construction managers, vendors and automation providers to address this question and, with the input of participants, consider new ideas to modify the current project delivery paradigm to meet this immediate business need. Perspectives and insight from other related industries will provide insight on how those industries have been able to deliver their facilities ultra fast.
Finally, the ISPE 2008 Facility of the Year Category Winners have been invited to explain what they learned, what made their projects unique, and why they excelled.
Program Committee
- Mark Butterworth, Project Manager, GlaxoSmithKline, Canada
- Mirko Hofmann, Schering-Plough, USA
- John Holton, PE, Associate Director Engineering, Cephalon, USA
- Terry Jacobs, AIA, Principal, Jacobs/Wyper Architects, LLP, USA, Planning Committee Chair
- Linda McBride, RPh, RAC, Senior Director Regulatory Affairs, Enturia, Inc., USA
- Clive Mullins, Vice President, Foster Wheeler, UK
How You Will Benefit
At the conclusion of this session, participants will be able to:
- Understand problems and challenges with the current project delivery model;
- Identify opportunities to shorten the project delivery time line without incurring excessive risk; and
- Learn from other industries on how they deliver facilities ultra fast.
Who Should Attend
Vice presidents and senior vice presidents from owner companies, project managers, finance directors, architects, automation professionals, engineers, members of construction companies, and vendors
Communities of Practice (COPs)
All COP members will benefit, especially those from Project Management (PM) and the newly forming Sustainable Facilities COP
Related Technical Documents Available from ISPE - www.ISPE.org/publications
Baseline® Guide Series
Seminar Leaders
- Terry Munson, Technical Vice President, Parexel Consulting
- Manmohan Sihra, Director Aseptic Process Design, Bristol-Myers Squibb
Speakers
- James Akers, PhD, President, Akers Kennedy and Associates Inc.
- Betzaida Castilla, Director, Policies & Compliance Support, Bristol-Myers Squibb
- Michael De La Montaigne, President, Eisai Machinery USA Inc
- Leslie Edwards, Chief Executive Officer, Isogen
- Mark Ehlert, President, 315 Ventures, Ltd.
- Tara Gooen, LT, PHS, Compliance Officer, FDA/CDER/DMPQ
- Christa Hartmann, PhD, Director, Corporate Quality, Genentech
- Jack Lysfjord, Principal Consultant, Lysfjord Consulting LLC
- Jerold Martin, Sr VP, Global Scientific Affairs, Pall Life Sciences
- Christopher Procyshyn, Chief Executive Officer, VanRx Inc.
- James Vogel, Technical Consultant, Metall & Plastic
- Joerg Zimmermann, Head of Production, Vetter

