www.ispe.org/sanfrancisco

Published by ISPE San Francisco/Bay Area Chapter Serving Northern California Editor: Kimberly Syre Email: [email protected] Information: Phone 1.949.387.9046 Fax 1.949.266-8461

In this issue

NEWSLETTER

Volume 17, No. 1

Win n e r of IS P E ’s 2009 P latinum Outstanding Awar d for E xc el l ence

President’s Message PAGES 1-2 3 December Meeting PAGES 3-4 Oktoberfest Overview PAGE 3 Wrap Up of September Meeting PAGE 5 1 April Reserve Your Table Now for Vendor Night PAGE 6 Students Tour Genentech PAGE 7 ISPE West Coast Resource Directory 15 January is Deadline PAGE 8 July Roundtable Provides Valuable Feedback PAGE 9

Chapter takes high honor at ISPE Annual Meeting. See article inside recapping this year’s ISPE Annual Meeting in San Diego.

Welcome New Members PAGE 10 New Member Breakfast Overview PAGE 11 ISPE Adjusts Online Learning Pricing PAGE 11 September Write Up from Supply Chain Management Meeting PAGES 12-13 Report from ISPE Annual Meeting and Photos PAGES 14-15 Chapter Committees PAGE 16 Chocolate Factory Held at Local Shelter PAGE 17 Board of Directors List PAGE 18 Chapter Calendar PAGE 19

I

President’s Message by Linda Karr of Genentech

must start by thanking our outgoing president, Greg Banks, for his dedication and service to the organization, not just in the last year but over the last decade. Greg’s accomplishments for ISPE are impressive at both the local and international level.

They include starting up multiple Student Chapters in the Bay Area, leading the International Student Development Committee, and initiating both the UC Berkeley BioE 25 course and the West Coast Student Leadership Forum. These programs, all of which carry on successfully today, will become Greg’s legacy. I hope to be able to continue with all the valuable programs and events that our ISPE Chapter offers, including some new ones we will be trying out next year, so please stay tuned…

(continued on next page)

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President’s Message (continued) Ms. presented slides on the size difference NowKeen I would like to share some highlights from thebetween past year. standard modules (those that go on a truck (4 meters x 4.5 meters) vs. the Genentech super modules (9 meters x 9 The ISPEAlso Sanpresented Francisco/Bay Chapter excels at bringing meters). wereArea the challenges associated with together two important elements of ISPE: technical training the interconnects between the modules.

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you can submit a request form available from the Chapter Manager, Kimberly Syre, at [email protected].

and networking with peers. The Chapter offers training in the Milestones for the project are as follows: BioPharm industry’s best practices and new technologies, • All modules on site April 08 many events focus on the networking component. •whileMechanical Complete JulyThe 08 wascomplete full of activities including six Commuter Conferences, •yearOQ Nov 08 •four Engineering Runs two Facility Tours, Vendor Night, Dec 08 Dinner Programs, Fun • Qual Lots Jan 09 Day, two New Member Breakfasts, Student Leadership Forum, • Licensure Oct 09 ten Community Outreach events, plus multiple programs for

Many people ask about volunteer opportunities within ISPE.

college students. Wow!presented Over 80 volunteers (Board DirecNumerous slides were on the logistics of of transporting ship and moving the modules. Additional slidesforums showed torsby and Committee Members) plan these educational the build of the facility and the placement of the modules on and various activities to help our Members grow in their profesthe site. Of interest was the fact that Genentech secured a sional careers. second party shipping company to take care of the cargo move. Once in Tuas, a detailed route had to be planned to move the modules from the docks to the site. Even in this economically challenging year, weFortunately, were able toall roads in Tuas are also designed to serve as runways maintain our Chapter’s tradition of charitable donationsinbycase of a national emergency so there was plenty of room to move contributing over $12,000 to Organs-R-Us from the Community the modules down the road! Outreach Committee’s 199-mile Relay event. Also, the Fun

[email protected], who leads the community outreach commit-

Last year I volunteered on one of the Chocolate Factory events for the first time. The group helped 5th grade classes build miniature factories from pipe cleaners, cardboard, and Styrofoam. At the end of four hours I had made a few new industry friends, and it was rewarding and fun working with the kids! No training is required, so please contact Patti Larson at PATRItee, for more information if you are interested. I look forward to serving the Chapter and its members in the coming year and beyond. I have been inspired by John Kelley, our recent past president, who is proof that you never really “retire” from ISPE. John continues to organize and lead events like Genentech plant tours for university students and local ISPE community outreach programs, and he is a valuable advi-

Thanks to Dr. Rudi Grimm andgoMs. Kelly Keenorganizations, for presenting Day proceeds, which typically to charitable to the ISPE San Francisco Chapter! And thank you to Andy will be used next year to fund local educational opportunities Nelsen for taking photos of the event. for our unemployed members. If you are a member with more

neering

sor and mentor for the Chapter.

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December Meeting Focuses On Mission Bay Development Join us on December 3rd for an evening reception and hear from a developer and the City of San Francisco about development in Mission Bay. The meeting will take place in Mission Bay at UCSF conference center. About the Speakers: Steve Richardson is a Senior Vice President for Alexandria Real Estate Equities, Inc. He is responsible for Alexandria’s San Francisco Bay Area office/laboratory real estate portfolio including the Alexandria Center for Science and Technology at Mission Bay. He has led the growth of the region for nearly 10 years, from an existing asset base of 500,000 square feet to approximately 2.2 million square feet and a development pipeline of 3.2+ million square feet. Steve has 26 years of experience in the commercial real estate and high technology industries, negotiating complex transactions with a value in excess of $1 billion. He is a graduate of Santa Clara University’s graduate business program and Claremont McKenna College.

Oktoberfest 2009! by Tareq Barakzoy of ACCO Engineered Systems

T

he ISPE SF Bay Area Chapter introduced a new social event this year. An “Oktoberfest” party and networking reception was held in October at

Gordon Biersch Brewery in San Francisco. The setting and menu were well suited for the event and provided a great opportunity for networking among our colleagues in the BioPharm industry. There was an excellent mix of familiar Members along with some new faces with about 75 attendees in all. The attendees sipped a selection of traditional German style brews and munched on appetizers like chicken skewers, veggies, and potstickers. The latest industry and economic news was discussed in lively

Todd Rufo is the Director of Business Development in the San Francisco Office of Economic and Workforce Development where he oversees business attraction and retention in the City. Todd leads the City’s efforts to retain and grow critical sectors of San Francisco’s economy including biotech, cleantech, new media, financial services, light industrial, retail and tourism. Since 2007, Todd has spearheaded the City’s Biotech Initiative to recruit, retain and support the growth of the life sciences industry in San Francisco. Todd is a graduate of UC Davis and studied urban planning at New York University.

groups. In addition to networking, an employment drive

To register online, please go to:

become an annual event.

http://event-confirmation.com/ispesf_meetings.htm

was held at the event where potential employees and employers got a chance to exchange information. Thank you to all of the volunteers and especially Hyde Engineering + Consulting for their support in organizing this program. Despite some other competing events, this event managed to get a large share of attendees. With the popularity of this first Oktoberfest, we hope it can

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ISPE San Francisco/Bay Area Chapter

www.ispe.org/sanfrancisco

Mission Bay Development Update

Evening Reception Thursday, December 3, 2009

Mission Bay Conference Center at UCSF Reception 1675 Owens St., San Francisco, CA 94143 Presentations http://www.ahl-missionbay.com/directions.cfm

5:00 - 6:30 pm 6:30 - 8:30 pm

PRESENTERS: Stephen (Steve) Richardson, Alexandria Real Estate and Todd Rufo, Director of Business Development Office of Economic and Workforce Development, City of San Francisc

R E G I S T R A T I O N

F O R M

Please link to our processing site for an immediate receipt: http://event-confirmation.com/ispesf_meetings.htm If using this form, please fax to: (949) 266-8461 or (949) 387-9047. Include your credit card information or fax the registration first, then mail your check and original registration form made payable to ISPE San Francisco/Bay Area Chapter. Make sure to mail it at least one week prior to the event or bring it with you to the meeting. Checks should be mailed to: 5319 University Dr., Suite 641, Irvine, CA 92612. For questions email Kimberly Syre, Chapter Manager at: [email protected] or call (888) 275-0189 or (949) 387-9046. Cancellations must be received in writing via fax or email by November 23, 2009 for a refund. Federal Tax ID #68-0282494. If an ISPE Member, please supply Membership Information

FIRST NAME: LAST NAME: TITLE:



Member #:______________________________



Chapter:________________________________



COMPANY:



Member Cost: ❑ $65 Non Member Cost: ❑ $90

ADDRESS: MAIL CODE:

CREDIT CARD INFORMATION Type of Credit Card

CITY: STATE: PHONE: FAX: E-MAIL:

ZIP:

Circle One Name on Card: Credit Card #: Exp Date: Signature:

September Meeting Overview By Brian Vaughn of Banks Integration Group

I

n September, the Chapter hosted a dinner program at the Vacaville Opera House on the topics of Contract Manufacturing and Technology Transfer. Over 70 industry professionals attended this dinner program held in Vacaville for the first time in the history of the Chapter.

Linda Karr, the incoming Chapter President, opened the evening by recognizing last year’s Chapter President, Greg Banks, for his many years of volunteering and commitment to ISPE at both the Chapter and international level. A plaque was presented to Greg (photo to the right) in commemoration of his accomplishments.

Herwig Kappeller, Head of Manufacturing Technology for Novartis in Vacaville, gave a presentation on the topic of Technology Transfer, defining the various types of technology transfers, strategies, and organization structures. The presentation relied heavily on his extensive experience with technology transfers and included two case study examAvigen, Inc. ples: one transfer that failed with thea reasons why and one transfer was ultimately Announced significant restructuring of the that company aimed at successful with a description of thecash stepsand taken that led toits the success. preserving reassessing strategic opportunities. As a result of the restructuring, which will involve staff reductions Dan Moskey, Associate of Director-Vacaville for Genentech in Vacaville, over 70 percent Technology of the company’s total workforce, Avigen followed with a presentation on Contract Manufacturing in fund Biotechnology on four expects to have sufficient cash to operationsbased for over his broad experience inyears. the industry. The presentation discussed the business model of Contract Manufacturing and the reasons why companies consider it. Criteria for selecting a successful manufacturing partner, various challenges to the partnerBayer healthCare Pharmaceuticals, Inc.related and Onyx ship, and strategies thatPharmaceuticals, lead to a successful relationship between the two parties were Inc. discussed. A discussionHave on the benefits joined in partnership with leading advocacy organizaand potential drawbacks to outsourcing the manufacturing of a product tionswere - theclearly American Liver Foundation and Vital Options addressed and discussed in the context of the presentation. International - to launch Living with Liver Cancer – a program designed to educate patients and caregivers about liver The Chapter would like to thank our guest speakers for their informative presentations cancer signs and symptoms, risk factors, diagnosis, screenand also extends gratitude to our attending professionals for makinging theand firstavailable dinner treatment options. The centerpiece of program held in Vacaville a huge success. the program is the Living with Liver Cancer Web site (www. LivingwithLiverCancer.com), which serves as a resource for people seeking more information about liver cancer and liver disease. To expand access and availability of the program to Engineering a wider audience, information on the Web site will be transArchitecture lated into several different languages, including Chinese and Process Technology Spanish. More than 600,000 cases of liver cancer are diagnosed worldwide each year, including 15,000 cases in the Process Automation United States. Systems Integration

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WaferGen Biosystems, Inc. Announced that the National Institutes of Health has awarded a team of researchers at University of Pittsburgh an approximately $3 million grant to conduct novel gene expression research in the area of lung disease involving WaferGen’s SmartChip(TM) Real-Time PCR System.

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ISPE San Francisco/Bay Area Chapter

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19th Annual Vendor Night Thursday, April 1, 2010



South San Francisco Conference Center Exhibitor Set-Up 255 South Airport Blvd. Technical Session South San Francisco, CA 94080 Exhibits Open, Free to Attend (650) 877-8787 FREE PARKING Reception with Complimentary Appetizers

2:30-4:30 pm 3:00-5:00 pm 5:00-8:00 pm 6:00-8:00 pm

2010 Theme is Country Western EXHIBITOR

REGISTRATION

For an immediate receipt and confirmation, please use the on-line registration system: http://event-confirmation.com/ispesf_meetings.htm

FORM ISPE CAREER FAIR

Bring your resume as we will have To Register, Fax This Form To: (949) 266-8461 or (949) 387-9047. Include your credit card several companies at Vendor Night information or fax the registration first, then mail your check (and original registration form) with job opportunities. made payable to ISPE San Francisco/Bay Area Chapter to, 5319 University Dr., Suite 641, Irvine, CA 92612. For questions email Kimberly Syre, Chapter Manager at: [email protected] or call (888) 275-0189 or (949) 387-9046. Federal Tax ID #68-0282494. Cancellations must be received by March 25, 2010 for a refund. Payments for tables must be received by March 25, we can only accept technical session payments at the door.

Vendor Table Tops: ❑ $695

Door Prizes Wanted (no exhibit table necessary) If You Are Bringing A Door Prize Please Bring it With You and List What You Anticipate Bringing:

(Tables are 6’ long x 2.5’ wide, includes electricity, Max Height 60”, Max Width 72”, Everything must fit on your table top (not on the floor or wall)

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Free to Attend (View Table Tops Only)

NOTE: Technical Session Information To Be Announced FIRST NAME:

Type of Credit Card Circle One

LAST NAME:

Name on Card:

TITLE:

Credit Card #:

COMPANY:

Exp Date:

E-MAIL:

Signature:

ADDRESS: CITY: STATE: PHONE: FAX:

CREDIT CARD PAYMENT

ZIP:

If purchasing a table top, please List Your Company Coordinator. We will copy your coordinator with the email confirmation package (table diagram/shipping and set-up instructions).

Name:

Coordinator Email:



Welcome New Chapter Members Decem

Michele Alm, Sr. Manager, Supply Chain M

Sonji Bennett, Manager, Abbott D Kristofer Bullock, Staff Engineer/Accounts Manager,

Jose Chang, Clean Room Manager, University

Kristin Cikowski, Facilities Coordin

Sophia Curiel, Chemical Engineering Stude

Madhu Ganesan, Student, San Jose Desmond Gee, Student, San Jose Bruce Griffin, Manager, GxP Systems,

Peter Groner, Sr. Project Manager, Custom

Matthew Hanson, Estimator, Dom

Yi-Hwa Hwang, Graduate Student Researcher, U

Gary Johnson, Sales Manager, Rubber Fa

Ryoko Kataoka, Student, San Jose

Maecyn Landrith, Cashier, Solano Co

Kelby Lau, Genentec On October 30 Genentech hosted a group of San Jose State and UC Berkeley students from their respective ISPE Student Chapters. The tour of Genentech’s Pilot Plant was given by recently hired students, which gave the presentation a unique Christopher Law, Director Project Se slant, as students’ peers were conducting the tours. Thank you to Genentech for their support of the local ISPE Chapter as well Mimi Le, Student, University of Cal as our Student Chapters. Judy Leung, Quality Engineer, Abbo

Samantha Low, Project Manager, Hathaway D

George Martinez, Plant Engineer, B

Sean McNary, Grad Student, University

David Morgan, Sales Director, Life Sciences Industry, Comos

Krista Murphy, Project Manager, Affili

Amy Nguyen, Sr Quality Assurance As Kieran O’Donoghue, Manager, CMC,

Ralf Oelschlager, President, IPT

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Ankit Patel, Student, San Jose S

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Rano Perrizo, Owner, North Cur David Powell, Process Engineer,

Erin Scholz, Architectural Serv

Nader Shakerin, Student, San Jose

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