Published by ISPE San Francisco/Bay Area Chapter Serving Northern California

Editor: Kimberly SyreEmail: ksyre@cox.net

Information: Phone 1.949.387.9046Fax 1.949.266-8461

IN THIS ISSUE

We have had an exciting year so far in our Chapter by the Bay this year.

This May our growing Young Professional Group had a get together at Pyramid Brewery in Berkeley, CA which brought together over 50 young professionals as well as some more seasoned industry professionals to network and share ideas about how to pros-per in today’s environment as well as just have a great time. I encourage everyone to pass the word (in a tweet, text, IM, share on Linked-in or Facebook or even, gasp…by talking to people) about this growing community of like-minded Young Professionals.

INSIDE: Event Photos from First Half of the Year

NEWSLETTERVolume 18, No. 1

www.ispe.org/sanfrancisco

Outgoing President’s Messageby Corey Veverka of TVS, Inc.

(continued on next page)

Outgoing President’s MessagePAGES 1-2

22 September Alzheimer’s Research PAGES 3-4

CEO Night PhotosPAGE 5

YPLF Write up and PhotosPAGE 6

6-9 November is ISPE Annual MeetingPAGE 7

Project Management COP Photos PAGE 8

Vendor Night Overview and PhotosPAGES 9-10

14 Oct Deadline Facility of the Year PAGE 11

Chapter Donates $2000 for Japan Relief

PAGE 12

Chapter’s Relay Team Finishes Big!PAGE 13

ISPE Partners with EPAPAGE 14

Welcome New MembersPAGE 15

Stem Cell Research Facility Tour PAGES 16-17

Process Control Guide® 2nd EditionPAGE 18

Chapter Committee ListPAGE 19

Board of Directors ListPAGE 20

Chapter CalendarPAGE 21

David Mourra (left), Bayer Technology Services, receives a $1000 check on behalf of the ISPE SF/Bay Area Young Professionals Committee from INTERPHEX Vice President RJ Palermo (right) at the INTERPHEX trade show on March 29th at the Javits Convention Center in Manhattan, New

York. INTERPHEX is a top trade show for the biotech and pharmaceutical industries. ISPE members receive discounted registration and other benefits

at INTERPHEX events.

We also held a commuter conference on GAMP 5 at Baxter Healthcare in Hayward, CA. Robert Mackey of the Harris Group and Fred Bickel of ProPharma Group, Inc. facilitated a lively discussion and information sharing session around the ever-evolving world of automation design and testing and the latest guidelines in GAMP 5.

On June 30th the Chapter’s program committee held a facility tour at the new Stem Cell Research Building at Stanford University. Presentations by Chris Shay of the Stanford team, Chris Dockstater of Whiting-Turner and Andrew Peas of ACCO on the design aspects of the facility kicked off the event followed by guided tours through the new building.

This summer’s highlight for the San Francisco Chapter was our annual Fun Day event. We moved to a new location this year, heading out to the Livermore Wine Country where we played 27 sold out holes of golf and sent over a hundred people on a wine tour. A full day got kicked off with a networking breakfast for the nearly 350 ISPE folks. The Winos and Golfers went off to do their thing, and it was wrapped up with a banquet at the Poppy Ridge Golf Course clubhouse.

We are looking forward to kicking off the 2011/2012 year with a new membership drive. With a general slow down of projects in our area, the number of members in our Chapter has dropped a bit. As we are now starting to see signs of work picking up again, the Chapter has set a goal of bringing in (and getting back) 200 members for the Chapter. Lots of incentives are being offered so if you know of people who have not renewed or are interested in becoming new members, contact Kimberly Syre or me, Corey Veverka. Now is the time to start making those connections and getting involved in all that ISPE has to offer. Stay tuned for more details.

Corey

Outgoing President’s Message (continued)

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Alzheimer’s Research Meetingat The J. David Gladstone Institute

Thursday, September 22, 2011

Presenter:John M. WhitingVice President and Chief Financial OfficerGladstone Institutes

About the Presenter: John M. Whiting is the Vice President and Chief Financial Officer at the Gladstone Institutes. He has primary responsibility for accounting, information technology, purchas-ing, and enterprise business systems.

Before joining Gladstone in 2010, Mr. Whiting was at Genentech Inc. for more than 20 years, most recently as Deputy Chief Financial Officer. There, Mr. Whiting’s responsibilities included accounting and reporting, and lead-ing the long-range planning, budgeting and forecasting processes. He is a financial execu-tive with broad experience in a host of areas, including strategic and operational planning, financial modeling, the construction of scalable financial processes and controls, investor rela-tions, treasury and risk management, mergers and acquisitions, procurement, alliance and collaboration management, tax, financing and operations support.

Prior to joining Genentech, Mr. Whiting worked at Arthur Young for eight years as an auditor. He is a Certified Public Accountant (inactive).

Mr. Whiting received both a bachelor’s degree in molecular biology and an MBA from the University of Oregon.

REGISTRATION INSTRUCTIONS:

To Register and receive an immediate receipt, use our on-line registration:

http://www.atdevents.net/ispesanfrancisco.php

If you have an account on our system, please log on and register.

If you do not have an account, you can set one up on the site using letters (not numbers) as your username.

If are an ISPE Member in California, you may already be in our system. Your ISPE Member number is your username. The website will email you your password or username if you do not know them.

Registrations can also be faxed using the form on page 4 with credit card payment. Fax to 949-266-8461 or 949-387-9047.

If paying by check, please mail your check made payable to:

ISPE SAN FRANCISCO/BAY AREA CHAPTER 5319 University Dr., Suite 641, Irvine, CA 92612.

Chapter Hotline: (800) 869-9621 or (949) 387-9046

ISPE San Francisco/Bay Area Chapter Tax ID#68-0282494.

Contact Kimberly Syre: ksyre@cox.net with any questions.

Cancellations must be received in writing by September 15, 2011 for refund. After the cancellation date if you have reserved a space but do not attend, your payment MUST be remitted, however, an alternate person may attend in your place. If the alternate is not a Member, they will need

to join.

Name badges will be given at the

on-site registration desk.

3

ISPE San Francisco/Bay Area Chapterwww.ispe.org/sanfrancisco

Alzheimer’s reseArch

Evening Meeting Thursday, September 22, 2011 The J. David Gladstone Institute Registration and Reception 4:30 - 6:30 pm1650 Owens Street Presentations 6:30 - 8:00 pmSan Francisco, CA 94158 Tel: (415) 734-2000 http://www.gladstone.ucsf.edu

Please link to our processing site for an immediate receipt: http://www.atdevents.net/ispesanfrancisco.php

See previous page for instructions to use our new online registration system.

If using this form, please fax to: (949) 266-8461 or (949) 387-9047. Include your credit card information or fax the registra-tion first, then mail your check by September 12 (with original registration form) made payable to: ISPE San Francisco/Bay Area Chapter, 5319 University Dr., Suite 641, Irvine, CA 92612. For questions email Kimberly Syre, Chapter Manager at: ksyre@cox.net or call (888) 275-0189 or (949) 387-9046. Federal Tax ID #68-0282494.

Cancellations must be received in writing via fax or email by September 12, 2011 for a refund.

FIRST NAME:

LAST NAME:

TITLE:

COMPANY:

ADDRESS:

MAIL CODE:

CITY:

STATE: ZIP:

PHONE:

FAX:

E-MAIL:

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

CREDIT CARD INFORMATIONType of Credit Card

Circle One

Name on Card: Credit Card #: Exp Date:

Signature:

If an ISPE Member, please supply membership Information

Member #:_______________Chapter:________

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

PRESENTER:John M. WhitingVice President and Chief Financial Officer, Gladstone Institutes

Note: A second speaker will be announced

January CEO Night Photosby Andy Nelsen, Bay Area Engineers

5

Our annual CEO night was held on January 20th with presentations by Alan Trounson, President of the California Institute for Regenerative Medicine in San Francisco and Melinda Richter, founder and CEO of Prescience International. Dr. Trounson spoke on the topic of the California Stem Cell Initiative and its impact on the local econo-

my, along with an overview of CIRM, its mission, and current initiatives.

Ms. Richter’s presentation focused on the commercialization of startup biotechnology firms and the role that her organization plays in supporting these firms. She also provided an introduction to the San Jose BioCenter which has won the 2009 NBIA Randall Whaley Award for Best Incubator of the Year and the 2009 NBIA Technology Incubator of the Year Award.

The 2nd annual Young Professional Leadership Forum (YPLF) was held on March 5th, 2011 at the UC Berkeley International House. Many young (0-5 years in the industry) and experienced professionals gathered for a full day of

industry hot topics, leadership workshops, roundtable discussions and networking. This year’s technical sessions featured speakers Rick Johnston from Bioproduction Group on the topic of Disposable Bioreactors, Gabe Orosco from Reglera on Gathering Regulatory Knowledge, and Heike Abeck from Novartis on Project Management. The young professionals were introduced to different leadership styles and some tips on how to manage up from a talk given by Ann Yolish and Fion Cheng from Novartis. The young professionals also had the opportunity to ask their own questions of our Industry Panelists (Paul Lauer from BioMarin, Johnston, Abeck and Orosco) who provided many insights on topics such as career development, hiring trends and the latest tech-nologies. The day concluded with young professionals getting some pointers from the experienced professionals on their personal resumes and job interview techniques. The YPLF was hosted by the SF Bay Area chapter and was free for the participants thanks to our platinum sponsor BioMarin; gold sponsors ACCO Engineered Systems, Alza, Baxter, Bayer Healthcare, Genentech, Gilead, and Novartis; and silver sponsors Dome Construction, Advent Engineering Services and Banks Integration Group.

YPLF Brings Leadership Development and Networking to the SF Bay Area Chapter Young Professionals

by Fion Cheng, Novartis Diagnostics

Event volunteers from left: Fion Cheng, David Mourra, Bill Chestnut, Stacey Cox, Triet Nguyen, Bill VanDerVoort, Marlene

Meza, Steve Walker, Malini Murlikrishnan and (not in photo) Heather Bennett.

Volunteer Heather Bennett and our industry panel-ists Gabe Orosco, Paul Lauer, Heike Abeck and Rick

Johnston sharing with young professionals their thoughts on various topics.

Groups of participants designed and built production plants using just straws, notecards and post-it.

SF Bay Area Chapter President Corey Veverka talked about the

benefits of ISPE.

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Industry Experts and Regulators Present

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Join us at Annual Meeting to connect and engage with industry leaders and contribute to the advancement of your industry.• 30+ education sessions and three training courses • More than 250 exhibitors from around the world• Networking Opportunities including: Activities for Young Professionals and Students Community of Practice (COP) Special Events 3rd Annual Charity 5K Race

2011 Annual Meeting Sponsorship and Exhibit Opportunities are Available!

For details contact Daniel Murphy at dmurphy@ispe.org or John Phillips at jphillips@ispe.org.

Register Early and save! Early Bird Pricing Ends 10 Octoberwww.ISPE.org/2011AnnualMeeting

2011 ISPE Annual Meeting:Preparing Professionals and organizations for Rapid Change

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March Commuter Conference Photosby Harvey Steinhaus, Dome Construction

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In March the Chapter held a Commuter Conference with an interactive format. ISPE’s Project Management Community of Practice (COP) was the topic. The session began with

presentations by John Honey, Associate Director, Facilities Engi-neering at Genentech and Keith Gibbs, Corporate Manager C&Q for Yonkers Industries.

After the presentations, the group broke into several targeted discussion groups facilitated by Samar Adranly of Eichleay Engineers, Kevin Ng of XL Construction, Tom Shih of Genentech, Dan Stoddard of HiTech Construction Management and Linda Karr of Genentech.

The meeting was a free event for ISPE Members and the event host, Genentech of South San Francisco. Thank you to Phar-matech Associates for sponsoring the meeting and to Genen-tech, the speakers, facilitators and Members who joined the conference.

ISPE has a “Roaring” Vendor Night by Vendor Night Chair Karl Wilks, Gilead Sciences

ISPE Vendor Night is the Bay Area Chapter’s premier event of the year. Although other venues are fun and garner excellent participation, such as Fun Day, Vendor Night provides fun for all while bringing together four Chapter

activities. It is also the Chapter’s biggest revenue generating event of the year. This year set an all time record for the Bay Area Chapter’s fund raising. A giant “thank you” goes to all of the vendors and Members that support the Vendor Night event. These vendors are colleagues that we do business with here in the Bay Area and we encourage you to support them when possible.

This year, Vendor Night brought together four key activities; the Technical Session, Student Poster Competition, Silent Auction, and the Vendor Exhibition. This was the first year for conducting the Student Poster Competition at Vendor Night, and the second year for holding the Silent Auction. Both of these have turned into great successes.

Vendor Night started in the early afternoon with the Technical Session featur-ing two excellent speakers; Jean Bender from Genentech and David March from Rockwell Automation. Jean talked about Genentech’s rich history of innovation involving key contributions from chemical engineers in the purification process area. Jean has been a long time Member of ISPE and also takes a leadership role in the chemical engineering society AIChE. David talked about the key technologies available in the Bay Area and how this confluence of technologies bodes well for strong growth of the BioPharma industry here. The Technical Session was well attended in general, and we had a large turn out of students from several universities. We will con-tinue to make the Technical Session free to students.

As the Vendor Night session was starting, the Student Poster Competition was being held in the lobby area. The posters were on display for ISPE Members to review and discuss. Six students presented posters from sev-eral Bay Area universities: University of California, Davis, Solano Community College, San Jose State University and University of California, Berkeley. Bill Chestnut, the ISPE lead for the Student Poster Competition assembled a panel of judges to review the posters. The winner in the Graduate category was Lucas Arzola from UC Davis; “An Innovative Technology Platform for Manufacturing High-Value Therapeutic Proteins in Tobacco Plants.” The winner in the Undergraduate category was Melinda Mendolla from San Jose State University; “Analysis of Aromatic Amino Acid Solubilities with a Bulk Water-Dependent Desolvation Energy Model.” Both students will be sent to the International competition in Dallas, Texas this Fall. Congratulations to our student winners.

The Vendor Night session was such a blast! The theme for the event was the “Roaring 20’s” to celebrate the Chapter’s 20th Anniversary. Participants and vendors embraced the theme by dressing up in speak easy-type costumes and Charleston-style dresses with similar decorations for the vendor booths. The award for best vendor booth went to Iron Construction (see photo above) for their best overall dress and decorations to support the theme. The award for best individual costume went to Lynn Gemberling of Milton S. Frank Co. (shown in top photo with Vendor Night Committee Chair, Karl Wilks). Roaring 20’s music was provided by Cynthia Wiggins-Wyrick of VERSA Engineering & Technology and Meriber Gonzalez of Gilead.

As part of Vendor Night, ISPE conducted a Silent Auction, which was lead by Matt Hanson of Dome Construction. This is the second year for the Silent Auction at Vendor Night. The auction raises money for charity. In this case, over $1,000 was raised to support the Chocolate Factory, which is also supported by ISPE Members outside of the Vendor Night event. Thank you to all of the vendors who donated gifts for the Silent Auction. And thank you to those of you that supported the charity through your purchases.

Vendor night is such a rich event that brings together the diverse Membership of ISPE in the Bay Area to reconnect, network, and enjoy each other’s company. It’s less about selling and more about bonding. Thank you to all who participated. See you next year on March 29 Vendor Night 2012.

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Vendor Night Photosby Nicole Hall, Commissioning Agents, Inc.

To View Nicole Hall’s Vendor Night Slide Show: http://gallery.me.com/nickihall1#100035

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Facility of the Year Awards2012 Call for Entries

The Facility of the Year Awards program is an annual program that recognizes state-of-the-art pharmaceutical manufacturing projects that utilize new and innovative technologies to both improve the quality of the project and to reduce the costs of producing high-quality medicines. The Awards program provides a platform for the pharmaceutical manufacturing industry to showcase its new products and accomplishments in facility design, construction, and operation.

Projects from around the world have already been named Category Award Winners in the annual Facility of the Year Awards program, and we would like to receive a submission from you. The Facility of the Year Awards program, co-sponsored by ISPE, INTERPHEX, and Pharmaceutical Processing magazine, recognizes projects that demonstrate global leadership by showcasing cutting-edge engineering, innovative new technology, or advanced applications of existing technology.

Don’t let your company pass up this outstanding opportunity to showcase its new or renovated facility!

For additional information about the Awards program and submission procedures, visit www.FacilityOfTheYear.org. You may also contact Scott Ludlum, ISPE Director of Business Initiatives, by tel: +1-813-739-2284 or by email: sludlum@ispe.org.

Connecting a World of Pharmaceutical Knowledgewww.FacilityOfTheYear.org

2012

Deadline For Submissions:14 October 2011

11

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On behalf of the entire Bay Area Chapter, we are thrilled that the participation of our Members and the success of our Chapter has allowed us to make a $2000 contribution to our ISPE Affiliate in Japan. ISPE has collected donations from ISPE Chapters and Affiliates across the globe. Half of the funds will be disbursed on behalf of ISPE and its global Affili-

ates/Chapters to the Japan Red Cross for ongoing relief work. The other half will be held in a special “Japan Relief Fund” at ISPE Headquarters to offset costs incurred by the Japan Affiliate to engage speakers or provide programs later in the year.

The ConnectionEach year the Bay Area Chapter hosts representatives from the Japan Affiliate for facility tours and social events prior to the ISPE Annual Meeting. We consider the Japan Affiliate as our sister Chapter abroad, as many of our current and past presidents have hosted the Japan Affiliates for facility tours, BBQ’s and dinners in the Bay Area. One of our former Members, Mason Waterbury, is now living in Tokyo and is active in the Japan Affiliate. Mason is the key component for communication between the two groups. Bay Area representatives to attend the Japan Affiliate’s 10th Annual Meeting in Tokyo. Greg Banks, Past-President, Corey Veverka, 2011 President and 2012 President, Kelly Keen were to attend. Kelly had been scheduled to present on ECP1, the INTERPHEX Facility of the Year winner for 2010.

Unfortunately, the devastating earthquakes and tsunami hit only a month before the event. We were saddened to hear about the losses the country suffered and contacted our peers there immediately. We were happy to hear that they and all their loved

ones were safe but the country as a whole is working hard to repair the damages. Hopefully we can rejoin them in 2012 to celebrate a year of resurrection. We were amazed at how the Japanese society pulled together as a united front to repair their losses.

Thank you all for your participation in ISPE. Without your sup-port, we would not be able to provide important resources like this.

ISPE Bay Area Chapter Donates $2000 for Japan Relief

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As with every year, The Relay comes with its own unique challenges. This year ill-ness, injury, and team member retention

was not going to stop the 2011 ISPE SF relay team from completing the 194 miles they signed up for. Though this race in itself is not an event for the faint of heart, some still conquer with more heart than health going for them. This race does not focus on the individual team member, even though finishing one leg can sometimes be a feat, but on the team and more importantly on the men, women, and children that we run for.

The Relay is a running (or walking) event that takes place in the Spring, raising funds for Or-gans ‘R’ Us, an organization that is dedicated to increasing awareness of the importance of organ donation. Starting in Calistoga (north of Napa) Saturday morning and running straight through the night until reaching Davenport (a beachside farm community on highway 1 next to Santa Cruz); the 194 miles of the 2011 course was com-pleted by our 11 person team in 29:48:50. By running these miles, we not only raise awareness by our fundraising but also raise our visibility in the communities that we pass through across the two days of The Relay. As many as 100,000 people are awaiting transplants, and this event aims to decrease that number through awareness.

Before ISPE SF was involved in The Relay, many teams would not raise much higher than the minimum required for participation in the event. Four years ago our team spurred other teams to raise more, far beyond the minimum team requirement. Even with the excitement of four years ago toned down a bit, the bar has been raised and more teams are stepping up to the challenge to really [fund]raise awareness. ISPE has a mission for Members to work together to make the industry better. This in turn improves patient’s lives. If one person decides to become an organ donor from the message of The Relay, this also will improve patients’ lives. Please take a moment to decide if organ donation is right for you. If not, you can still support the cause by joining our team for 2012 or helping our team raise funds and awareness. Without your help, the ISPE SF relay team would not have been able to raise over $2,000 for Organs ‘R’ Us this year. The 2011 relay team thanks everyone for your continued support, especially our volunteers Germaine and Peter, as well as our team sponsors: ACCO Engineered Systems, Novo Construction, and Novasep/

TangenX, and J2Biosystems.

2011 Relay Team Elisa Aguilar – Eichleay Engineers Jason Beck – Novo Construction Lupita Beck – iPurityHeather Bennett – ACCO Engineered SystemsJeff Jul – J2 BiosystemsRyoko Kataoka – NovozymesPatti Larson – XL ConstructionJohn McPeake – McPeake ConsultingDan Restivo – Novo ConstructionDave Sax – Baxter BioScienceSergio Yoc – SJSU Student Chapter

VolunteersGermaine Bickel – GenentechPeter Graham – UC Davis Student Chapter

The Relay: April 30-May 1 2011by Heather Bennett, ACCO Engineered Systems

13

ISPE Announces Partnership with US EPA --Sustainable Facilities Community of Practice to Spearhead Involvement--

ISPE has partnered with the U.S. Environmental Protection Agency (EPA) on its successful ENERGY STAR Program. Through participation in the program, ISPE aims to improve pharmaceutical industry expo-

sure to the program and help ISPE Members drive cost savings and green initiatives for their companies.

“Sustainability and environmental stewardship have long been a part of the ISPE culture and goals,” said Bob Best, ISPE President and CEO. “And helping our Members to deliver cost effective GMP solutions has always been an integral part of ISPE’s mission. Therefore, the ENERGY STAR Program is a perfect fit for us. By helping to disseminate the ideas behind the program, we hope that our Members around the globe will be more successful in improving energy efficiency throughout the industry.”

The ENERGY STAR Challenge for Industry calls upon businesses to cre-ate a five-year plan to reduce energy intensity by 10% or more. Compa-nies that publicly join the Challenge and meet the goal are recognized by the U.S. EPA for their efforts, and gain the right to capitalize on one of the most recognizable names in energy efficiency by communicating publicly that they have completed the ENERGY STAR Challenge.

The driving force within ISPE for ENERGY STAR information and par-ticipation will be the Sustainable Facilities Community of Practice (COP). Interested parties may join the Sustainable Facilities COP to gain informa-tion, engage in conversation, share best practices, and report progress on the Challenge. More information on the Sustainable Facilities COP can be found at www.ispe.org/sustainablefacilities. More information on the ENERGY STAR Challenge can be found at www.energystar.gov/index.cfm?c=industry_challenge.industry_challenge.

Please send all mail correspondence to :

600 N. Westshore Blvd. • Suite 900Tampa, Florida 33609 • USA

You can still reach us via telephone at: +1-813-960-2105 and

via fax at: +1-813-264-2816

www.ISPE.org

ISPE Headquarters Has Moved!

Connecting a World of Pharmaceutical Knowledge

www.ISPE.org

Please send all mail correspondence to :

600 N. Westshore Blvd. • Suite 900Tampa, Florida 33609 • USA

You can still reach us via telephone at: +1-813-960-2105 and

via fax at: +1-813-264-2816

www.ISPE.org

ISPE Headquarters Has Moved!

Connecting a World of Pharmaceutical Knowledge

www.ISPE.org

Please send all mail correspondence to :

600 N. Westshore Blvd. • Suite 900Tampa, Florida 33609 • USA

You can still reach us via telephone at: +1-813-960-2105 and

via fax at: +1-813-264-2816

www.ISPE.org

ISPE Headquarters Has Moved!

Connecting a World of Pharmaceutical Knowledge

www.ISPE.org

1860 S. 10th StreetSan Jose, CA 95112

Phone 408-298-3134Fax 408-298-2132

www.sprigelectric.com

Member of N.E.C.A. • CA Lic# 296728-C10 • NV Lic# 57803-C2West Coast Operations Manager

400 Oyster Point Blvd, Suite 520South San Francisco, CA 94080

650.588.2660 of�ce650.588.2857 fax646.283.7987 cell

maura.lynch@hyde-ec.comwww.hyde-ec.com

Maura Lynch

14

Farshad Altafi, Senior Associate, GL Planning & Design, Inc.Mike Avram, C&Q Manager, Bayer Business and Technology

Corinne Blankenship, Senior Engineer, Corium International Mfg GroupCaasi Bonura, Sales/Marketing Representative, Western Allied Mechanical

Raul Brena, R&D QA Specialist III, Santen IncorporatedAndrea Canavero, Product Manager, Genentech/Roche

Katie Chaddock, Director of Operations, Mylan Pharmaceuticals IncArthur Chen, Automation Engineer, Genentech Inc

Steven Chen, Process Engineer, Foster Wheeler BiokineticsClarissa Chiang, Business Development Coordinator, Thornton Tomasetti

Christopher Ian Cruda, Student, San Jose State UniversityMatt Darrah, Equipment Engineer, Alza Corp

Scott Donald, Principal Process Engineer, NovartisCannon Faasse, District Manager, ABM Engineering

Jerrold Fox, Senior Associate, GL Planning & Design IncKristine Golveo, Manager, Elan Pharmaceuticals

Fred Hahn, Associate Director, Gilead Sciences, Inc.Eric Hice, Senior Designer, Novartis Pharmaceutical Corp.

John Home, Senior Project Manager, Rudolph & Sletten IncRussell Jones, Partner, Deloitte & Touche

Caroline Kim, Graduate Student, University of California-DavisMark Lanpher, Business Development, Cupertino Electric

Jose Larin, Process Engineer, NovartisEkta Mahajan, Senior Engineer, Genentech

Jon McCormack, GenentechRina McPherson, Student, University of California Davis

Bob Millan, Engineer, ACCO Engineered SystemsJacquelyn Misero, Genentech

Jeanette Motzer, Principal Business Systems AnalystJim Murray, CT, US Data Management

Lana Nguyen, University of California-BerkeleyHector Olson, Sr. Manager, QA, Bayer Healthcare Pharmaceuticals, Inc.

Chirag Patel, Design Engineer, Acco Engineered SystemsJim Perko, President, Absolute Filtration

Denton Perreault, Sr. PE, Rudolph & Sletten IncTrishna Ray-Chaudhuri, Member - Manager, Trishna LLC

Jason Roberts, Student, Solano Community CollegeChinmoy Roy, Consultant, Self Employed

David Seals, Staff Validation Engineer, AlzaWendy Shieu, ORDP Analyst, Genentech

Konstantinos Spetsieris, Bayer Technology ServicesSarah Stanly, Solano Community College

Michael Taylor, Executive Director, Biopharm Services Ltd.Kim Valkner, VP. Quality/Compliance, STTPharma

Eric Wood, Specialist I, Gilead Sciences, IncPauline Zamora, Director of Quality Assurance, BioMarin Pharmaceutical

Qing Zhang, Novartis

15

Welcome New Chapter Members

Affymetrix Inc. Announced that the PhyloChip, a custom Affymetrix microar-ray developed by Lawrence Berkeley National Laboratory, won the bronze prize in the 2008 Wall Street Journal Technology Innovation Awards. The PhyloChip helps researchers identify dangerous pathogens before they can affect humans. The PhyloChip was the only biotech company in the top three to be recognized. There were 700 total entrants.

Dynavax Technologies Corporation Announced it has been awarded a $17 million contract to develop its advanced immunostimulatory sequences technol-ogy using Toll-Like Receptor 9 agonists as vaccine adjuvants. This five-year contract was awarded by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases to develop novel vaccine adjuvant candidates that signal through receptors of the innate immune system. The contract supports adjuvant development for anthrax as well as other disease models.

Baxter International Inc.Mayor Richard M. Daley and Chicago Public Schools announced that Baxter International Inc. will donate $5 mil-lion over five years to support CPS district science initiatives — the first program ever to fund biotech education in CPS history. This significant contribution has the potential to impact more than 450 CPS teachers through professional develop-ment and 75,000 students — all at the junior high and high school level — who by the year 2012 will benefit from the new innovative schools, enhanced teacher skill set, materials, and direct interaction with Baxter scientists and engineers.

Alpha Innotech Corp. Has entered into a five year Strategic Supplier Alliance Agreement with GE Healthcare. This agreement is a continu-ation and expansion of the previous OEM Agreement signed between the two companies in April of 2005.

Gilead Sciences, IncAnnounced that the company has completed its acquisition from Electronics For Imaging, Inc. of a building located at 301 Velocity Way and adjacent land in Foster City. The acquisi-tion covers the existing 301 Velocity Way building of approxi-mately 163,000 square feet and approximately 30 acres designed to accommodate up to an additional 542,000 square feet of office space. The building and associated land border Gilead’s Foster City campus, the company’s headquarters since 1988.

Bayhill Therapeutics, Inc.Joins the Juvenile Diabetes Research Foundation, the world’s leading charitable funder of type 1 diabetes research, in a partnership to support Bayhill’s ongoing Phase I/II human clin-ical trial of BHT-3021, a DNA vaccine to reverse the immune response that causes type 1 diabetes.

The source of this information is the ISPE Web site, con-firmed on company websites.

www.propharmagroup.com

500 Airport Blvd, Suite 100 Burlingame, CA 94010Toll-Free (888) 242-0559 Office (650) 320-1788 Fax (650) 320-1789

VALIDATION COMMISSIONING

TRAINING AUDITS

10

Industry News (continued)by Sandra Medlin, Sani-Tech West

Thanks to Stanford University’s facilities team for hosting a tour for ISPE Members. The group toured the new Stem Cell building at Stanford. The $200 million Stem Cell Research Building is the largest research facility of its kind. Lorry I. Lokey, the Business Wire founder who got his start in journalism as editor of the Stanford Daily in 1949, gave $75 million to the

University. Another $43 million was provided by the California Institute for Regenerative Medicine, the State stem cell agency which is funded by California’s Proposition 70 .

Chris Shay from Stanford gave a presentation about the facility, which broke ground in 2008 and was completed in 2010. The Lokey Building houses 45 faculty members and 450 students. The State contributed $39 million for construction and $4 million for equipment. The General Contractor for this facility was Whiting Turner, and Zimmer Gunsul Frasca Architects LLP was the archi-tect. Over 1000 tradesmen were on the construction project for the 206,000 square foot building.

The building consists of 65% lab space with RO/DI water system, utilities basement with a modular lab building design and bam-boo finishes. It’s a sustainable building with an efficiency rating of 63%. BIM modeling helped to plan the coordination of trades. Mechanical, Electrical and Plumbing systems (MEP) was on a design/assist program and all systems were prefabricated.

Stanford Lokey Stem Cell Research Facility Tour OverviewBy Brian Vaughn, Banks Integration Group

Call Today! 703.542.0608

est. 1959

astropak.comSF Bay AreaSTERIS Corporation

Rick Metz-Capital EquipmentRick_Metz@steris.com(916) 201-7644

Robin Johnston - ConsumablesRobin_Johnston@steris.com(415) 308-4656

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(continued on next page)

Membership Committee Registration Team (L-R): Edda Mihaescu, PE, PhD from Bayer, Cynthia Wiggins-Wyrick from VERSA Engineering and new Board Member Ulrike

Ruppelt of ticular - Strategies for Success.

Stanford Facility Tour Overview (continued)By Brian Vaughn, Banks Integration Group

Stanford is equivalent of a LEED Silver level building but is not accredited. Stanford University has its own program which exceeds LEED guidelines.

A second presentation was made by Andrew Pease of ACCO Engineered Systems, the installing mechanical contractor. He added that the building uses 100% outside air and is considered state-of-the-art in terms of energy use. This building utilizes far less chilled water and steam than other buildings of its size.

17

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www.propharmagroup.com

COMPLIANCE SERVICES VALIDATION

AUTOMATION PROGRAM/PROJECTMANAGEMENT

ARCHITECTURE • ENGINEERING • CONSTRUCTION

Smart Solutions for Smart Buildings

1245 Pear Ave. Mountain View, CA 94043

(650) 335-1990www.gordonprill.com

An Integrated Approach to Meet the Challenges of the Biotech / Pharma Industry

– cGMP Facilities – Class 100, 10,000 & 100,000 – Utility and Process Design Cleanrooms – Vivaria – Wet & Dry Labs

ISPE has recently released GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (Second Edition). The Guide, which provides guidance on how to achieve process control systems that

are fit for intended use and meet current regulatory requirements, has been significantly updated to align with the concepts and terminology of recent regulatory and industry developments.

Developed by the GxP Process Control Systems Document Revision Task Team and members of the ISPE GAMP Community of Practice (COP) Pro-cess Control Special Interest Group (SIG), the Guide recognizes that Good Engineering Practice meets most of the applicable compliance requirements. The Guide also emphasizes that in order to be efficient, appropriate specifica-tion and verification activities should be an integral part of the normal system life cycle. The Guide recognizes that many suppliers of systems now have mature quality management systems and system development, test, and sup-port documentation. The Guide promotes the leveraging of supplier documen-tation and activities to avoid unnecessary duplication, cost, and waste.

Concepts addressed by the new Guide include the International Conference on Harmonisation (ICH) Guidance setting out expectations for the application of science- and risk-based approaches to drug development and manufacture supported by pharmaceutical quality systems and ISPE’s Product Quality Lifecycle Implementation® (PQLI®) global initiative for a practical approach to implementation of ICH guidances Q8 (R2), Pharmaceutical Development, Q9, Quality Risk Management, and Q10, Pharmaceutical Quality System. FDA cGMPs for the 21st Century Initiative and other emerg-ing industry standards also were influences as the Guide was developed.

The GAMP Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems will be available for purchase in book form and is available as a downloadable PDF. The cost of the document is US$145/€115 for ISPE Members and US$405/€345 for non-members. More information can be found at www.ISPE.org/GuideanceDocs/GAMP-GxP-Process-Control-Systems.

ISPE Releases GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems, 2nd Edition

--Guide Updated to Align with Recent Regulatory and Industry Developments--

If you are interested in joining an ISPE SF Committee, the Commuter Conference Com-mittee is looking for more volunteers.

Commuter Conferences are technical pre-sentations with a focused topic. They are open to ISPE Members only and are sched-uled to take place during rush hour traffic. For those commuting to these meetings, the idea is to arrive prior to rush hour and end after rush hour traffic. To align the Chapter with ISPE International goals and to encour-age participation in COPs, this year we have focused our topics on ISPE Communities of Practice. COP leaders are the present-ers and facilitators of this year’s Commuter Conferences. An operating company hosts these events by providing the facility, food and beverages and materials are subsidized by the Chapter when necessary.

ISPE Membership is required for all Commit-tee Members.

If you are interested, please contact Rick Ginn at: rginn@xlconstruction.com

Commuter Conference Committee

Seeks Volunteers

Program CommitteeChair: Brian Vaughn, Banks Integration Group, Inc.Volunteers: Jeremy Agraz, Flad Architects Michael Cooper, Bayer HealthCare Sue Cost, Foster Wheeler Biokinetics Ralf Elsaesser, Dome Construction Simon Forder, Hyde Engineering + Consulting Leroy Ginn, ACCO Engineered Systems Andy Nelsen, Bay Area Engineers Corey Veverka, TVS, Inc.

Commuter Conference CommitteeChair: Tareq Barakzoy, ACCO Engineered Systems Vice Chair: Andrea Zarour, Greater Bay Mechanical, Inc.Volunteers: Rick Ginn, XL Construction Aaron Louyeh, Baxter Healthcare Corp. Harvey Steinhaus, Dome Construction Membership CommitteeChair: Ulrike Ruppelt, ticular - Strategies for Success Volunteers: Mike Britting, D.F. Pray Dave Edgar, Iron Construction Edda Mihaescu, PhD, Bayer HealthCare LLC Cindy Reginato, Hathaway Dinwiddie Glenn Samuels, Alexza Cynthia Wiggins, VERSA Engineering/Technology

Newsletter/Web Site Committee Chair: Jeff Jul, J2 BiosystemsVolunteers: Sandra Medlin, Sani-Tech West David O’Connell, DCE Consulting, Inc.

Young Professionals/Student Affairs CommitteeChair: David Mourra, Bayer Technology ServicesCommittee Vice Chairs: YP: Fion Cheng, NovartisStudents: Marlene Meza, NovartisVolunteers: Nick Armstrong, Genentech Heather Bennett, ACCO Engineered Systems Bill Chestnut, Independent Consultant Stacey Cox, Banks Integration Group Triet Nguyen, Bayer Technology Services Bill VanDerVoort, DST Controls Steve Walker, Hyde Engineering + ConsultingFaculty: Jim DeKloe, Solano College Claire Komives, San Jose State University Dr. Dorian Liepmann, UC Berkeley Dr. Karen McDonald, UC Davis

Charity CommitteeChair: Ed Shea, BNBuildersVolunteers: Greg Burg, Genentech Sue Cost, Foster Wheeler Biokinetics

Volunteer CommitteeChair: Linda Karr, GenentechVolunteers: Greg Banks, Banks Integration Group, Inc. Greg Burg, Genentech Sue Cost, Foster Wheeler Biokinetics Mark Hannon John Kelley, Genentech Ed Shea, BNBuilders

Vendor Night CommitteeChair: Karl Wilks, GileadVolunteers: Heather Bennett, ACCO Engineered Systems Germaine Bickel, Genentech Andy Brewer, Genentech Janet Burlinson, Customized Performance Matt Hanson, Dome Construction Jeff Jul, J2 Biosystems Melody Spradlin, Dome Construction Cynthia Wiggins, VERSA Engineering/Technology Sokhorn Yim, Genentech

Fun Day CommitteeCo-Chairs: Kim Duncan, Duncan Enterprises Chris Humphrey, CRBVolunteers: Arnold Asuncion, TVS Adam Beatty, Emerson Process Systems Mike Britting, D.F. Pray Ed Shea, BNBuilders

Community RelationsChair: Germaine Bickel, GenentechVice Chair: Heather Bennett, ACCO Engineered SystemsVolunteers: Trevor Auer, CRB Ian Larson, Baxter Bioscience John Lohnes, AECOM Mike Marston, DPR Construction Bob McCollough, Cytokinetics Gordon Zagar, Cornerstone Integrated

Advisory CommitteeChair: Sue Cost, Foster Wheeler BiokineticsLiaisons: Greg Burg, Genentech Mark Hannon John Kelley, Genentech Ed Shea, BNBuildersCouncil: Sandy Baker, GBSC/Johnson & Johnson Ruediger Ciesinski, Bayer HealthCare Sean Clemenza, GBSC/Johnson & Johnson Kaye Cowen, Bayer HealthCare Al Dadson, XOMA John Ducote, Bayer HealthCare Scott Foell, GBSC/Johnson & Johnson David Harris, Genentech Diane Johnson, Novartis Jeff Lang, Gilead Sciences Bob Litwin, XOMA Brian Oppendike, Elan Pharmaceuticals Mike Ramsay, Cell Genesys Phil Roberts, Exelixis Inc. Chris Stubbs, Genentech Hank Szeto, BioMarin Pharmaceutical Joe Tarantino, Novartis Pharmaceuticals Scot Thomas, Amgen Klaus Weisenberger, Bayer HealthCare Gordon Zagar, XenoPort Inc.

19

ISPE San Francisco / Bay Area Chapter Committees

ISPE San Francisco / Bay Area ChapterBoard of Directors

Officers email TelephOnePresident:Kelly Keen, Genentech keen.kelly@gene.com (650) 467-5044

Vice President: Ian Larson, Baxter Healthcare ian_larson@baxter.com (510) 723-2094

Treasurer:David Bendet, Perkins+Will david.bendet@perkinswill.com (415) 217-9150

Secretary: Simon Forder, Hyde Engineering + Consulting simon.forder@hyde-ec.com (650) 588-2660

DirecTOrs Tareq Barakzoy, ACCO Engineered Systems, tbarakzoy@accoes.comGermaine Bickel, Genentech, bickel.germaine@gene.comKim Duncan, Duncan Enterprises, mkduncan@flash.netChris Humphrey, CRB, chris.humphrey@crbusa.comJeff Jul, J2Biosystems, jeff@j2biosystems.comDavid Mourra, Bayer Tech Services, david.mourra@bayertechnology.comUlrike Ruppelt, ticular - Strategies For Success, ulrike.ruppelt@ticular.comBrian Vaughn, Banks Integration Group, brianvaughn@banksintegration.comKarl Wilks, Gilead Sciences, kwilks@gilead.com

Chapter Past Presidents:

Corey Veverka, TVS, Inc. 2011

Linda Karr, Genentech 2010

Greg Banks, Banks Integration Group 2009

John Kelley, Genentech 2008

Rob Lynch, Dome Construction Corp. 2007

Mark Hannon, Genentech (retired) 2006

Greg Burg, Genentech 2005

Melody Spradlin, Dome Construction 2004

Ed Shea, BNBuilders 2003-2004

Jon Sheh, Johnson & Johnson 2002

Scott Laskey 2001

Haleh Banisadr-Hughes, TVS, Inc. 2000

Jeff Hargroves, ProPharma Group 1999

Sue Cost, Foster Wheeler Biokinetics 1998

John Sugerik, JTS Enterprises 1997

Dennis Mosher, Bay-Tec (retired) 1996

Ian MacLaren, Southland Industries 1995

Pete McArthur, Amylin (retired) 1994

Burt Van Loon 1993

20

Oscar Garcia Technical Sales Representative (323) 252-1110 Cell ogarcia@sani-techwest.com

Sandra Medlin Technical Sales Representative (510) 290-1232 Cell smedlin@sani-techwest.com

Bob Miller Technical Sales Representative (510) 967-9397 Cell bmiller@sani-techwest.com

www.sani-techwest.com www.sanisure.com

High Purity Liquid Handling Products Engineered Single Use Solutions

. 1629 Telegraph Avenue, Suite 200 Oakland, CA 94612 . T: 510 272 0654 . w w w . R P R a r c h i t e c t s . c o m

Tom Ramsey: T E R @ R P R Architects.com

Planning • Programming • PermittingProject Management • Construction Management

Full Service Design

SERVING THE LIFE SCIENCE COMMUNITY SINCE 1991

5319 University Dr., Suite 641 Irvine, CA 92612

Chapter Hotline:(888) 275-0189

or (949) 387-9046

Fax:(949) 387-9047

or(949) 266-8461

For advertising deadlines/costs:www.ispe.org/SanFrancisco

For additional ISPE Educational Offerings and Publications

www.ispe.org

ISPE is a Society of pharmaceutical professionals who use expert knowledge to

create high-quality, cost-effective GMP solutions.

Technical ArticlesHigh Quality ISPE Event

Photos Welcomed For Future Newsletters

Please submit them via Email toJeff Jul, Newsletter Chair

jeff@j2biosystems.com

Cover Photo from Fotolia.comPhotographer: Antroxu

ISPE 2011 Calendar

22 September Alzheimer’s Research Evening Meeting at The J. David Gladstone Institute in San Francisco

27 October Oktoberfest Social Event Thirsty Bear in San Francisco

6-9 November ISPE Annual Meeting Dallas/Ft. Worth (Grapevine) Texas

15 November Commuter Conference

8 December Big Pharma Evening Meeting Bay Area Welcomes New Companies to the Area

ISPE 2012 Calendar19 January CEO Night

29 March Vendor Night at South San Francisco Conference Center

All events subject to change due to availability of venue and speakers.

For more details please visit ISPE San Francisco/Bay Area Web sitewww.ispe.org/sanfrancisco

ISPE’s Global Calendar: www.ispe.org/globalcalendar

21

M T I C A L I F O R N I A , I N C .

Scott McDonald, Presidents m cd o n a l d @ m t i - ca . co m

Main: (925) 937 1500 Fax: (925) 937 8518www.mti-ca.com

Specializing in Control SystemsDesign & Validation