DVC Monthly
Program:
Location:
Doubletree Guest Suites - Philadelphia West
Plymouth Meeting, PA
Date:
September 14, 2010
Time: 5:00pm
Directions:
Click Here For Directions |
Upcoming DVC Monthly
Events:
|
|
|
Dear Member:
Welcome to our September program! We are opening the 2010/2011 program year with a presentation that is sure to be interesting and informative.
MannKind is the first Facility of the Year applicant to win in multiple categories, with recognition for process innovation and equipment innovation.
Please see below to register online. Register early, register often and please bring a guest. We look forward to seeing you on September 14th.
Brian White
VP Programs |
|
| Program Details | |
WHEN:
Tuesday, September 14, 2010
WHERE:
Doubletree Guest Suites Philadelphia West
640 W. Germantown Pike
Plymouth Meeting, PA 19462
TIME:
Registration: 5:00 - 6:00pm
Dinner: 6:00 - 7:00pm
Presentation starts: 7:00pm
Members - $60
Non-Members - $85
Students - Free
REGISTRATION:
If you believe there will be a large attendance from your company, please contact Ron Dunn (610-351-3874) to discuss the details of a group rate
|
|
| Program Topic Summary |
MannKind Corporation was awarded two Facility of the Year 2010 category awards for process innovation and equipment innovation. This is the first time in the program's history that the judges have named one project to two categories. While the facility itself is a striking merger of form, function, and efficiency, the Facility of the Year Award judges were most impressed with the custom process line that the facility houses. MannKind engineered an innovative manufacturing process line from start to finish. At every point in this process, MannKind designed new technology or applied innovative adaptations to existing technology to meet their needs.
With its engineering and construction management partners, MannKind Corporation recently completed its manufacturing facility for AFRESA™, an ultra rapid acting inhaled insulin product that has completed Phase 3 trials. Construction in early 2007 and completed in mid-2008, MannKind's $163 million, 23,400 square meter facility was part renovation and part new construction. Roughly 20 percent of the facility is earmarked for future expansion, which MannKind can use to increase production of its insulin therapy or begin production on new Technosphere-based therapies. This armchair tour describes the facility and the success factors that led to completion ahead of schedule, expenditures below budget, and in-specification material produced by the very first batch.
|
| Speaker Bios | |
Speakers:
Stephen Hall, Sr. Director, Project Management, Mannkind Corporation
Paul Skinner, Sr. Associate, CRB Consulting Engineers, Inc.
Steve is responsible for capital project management for MannKind Corporation. He joined the company in February, 2007, just as construction of the new manufacturing facility was commencing. He has over 30 years experience in process engineering and project management in the pharmaceutical industry, and has worked for Owner (SmithKline Beckman, Bristol-Myers Squibb) and engineering (Life Sciences International, AMEC) companies.
He is a chemical engineer (BSChE, University of Pennsylvania) with an MBA (Drexel University). Steve is a member of ISPE and American Institute of Chemical Engineers (AIChE), and a past member of Project Management Institute (PMI) and American Association of Cost Engineers (AACE). He has contributed many technical and managerial articles to publications such as Pharmaceutical Engineering, Chemical Engineering, and Chemical Engineering Progress, and has been a regular speaker at professional events.
Paul C. Skinner, PE
Paul is a Senior Associate and Core Team Leader in CRB's Plymouth Meeting, PA office. He was responsible for all aspects of the facility design from concept through detail design, construction and commissioning support. He has over 20 years experience in the design, commissioning, and qualification of pharmaceutical and biotech projects, having worked for the last 10 years at CRB. Paul is a frequent speaker at professional seminars including ISPE, ASHRAE and the Institute for Validation Technology (IVT), and has been published in The Journal of Validation Technology. He also served as contributing author on the FDA/ISPE Baseline Guide for Oral Solid Dosage Facilities and as co-leader of the FDA/ISPE Baseline Guide for Water and Steam Systems.
Scott Loureiro
Scott is a Project Executive with Torcon, Inc. based in their Red Bank, NJ World Headquarters. He served as the Project Executive for the Mannkind project. Overall he has 28 years of field-oriented management experience (17 involving pharmaceutical facilities) with extensive major project assignments and preconstruction responsibility. His projects encompass a variety of facilities, including technical centers such as research and specialty labs, and process installations. Clients served include Wyeth, Bristol-Myers Squibb, and Merck. Scott has a BS in Construction Technology from Fairleigh Dickinson University and has spoken at several ISPE seminars, both internationally and locally.
About MannKind Corporation: MannKind Corporation (Nasdaq: MNKD) focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes and cancer. Its pipeline includes AFRESA™, which has completed Phase 3 clinical trials, and MKC253, which is currently in phase 1 clinical trials. Both of these investigational products are being evaluated for their safety and efficacy in the treatment of diabetes. MannKind maintains a website at http://www.mannkindcorp.com to which MannKind regularly posts copies of its press release as well as additional information about MannKind. Interested persons can subscribe on the MannKind website to email alerts that are sent automatically when MannKind issues press releases, files its reports with the SEC or posts certain other information to the website. |
|
Program Sponsors | |
Torcon |
|
|
|
