Published by ISPE San Francisco/Bay Area Chapter
Serving Northern California
Editor: Kimberly Syre
Email: ksyre@cox.net
Information: Phone 1.949.387.9046
Fax 1.949.266-8461
IN THIS ISSUE
www.ispe.org/sanfrancisco
NEWSLETTER
Volume 18, No. 1
INSIDE: Event Photos from First Half of the Year
Outgoing President’s Message
PAGES 1-2
22 September Alzheimer’s Research
PAGES 3-4
CEO Night Photos
PAGE 5
YPLF Write up and Photos
PAGE 6
6-9 November is ISPE Annual Meeting
PAGE 7
Project Management COP Photos
PAGE 8
Vendor Night Overview and Photos
PAGES 9-10
14 Oct Deadline Facility of the Year
PAGE 11
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.
Chapter Donates $2000 for Japan
Relief
PAGE 12
Chapter’s Relay Team Finishes Big!
PAGE 13
ISPE Partners with EPA
PAGE 14
Welcome New Members
PAGE 15
Stem Cell Research Facility Tour
PAGES 16-17
Process Control Guide® 2nd Edition
PAGE 18
Chapter Committee List
PAGE 19
Board of Directors List
PAGE 20
Chapter Calendar
PAGE 21
W
Outgoing President’s Message
by Corey Veverka of TVS, Inc.
e 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 prosper 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.
(continued on next page)
Outgoing President’s Message (continued)
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
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Alzheimer’s Research Meeting
at The J. David Gladstone Institute
Thursday, September 22, 2011
Presenter:
John M. Whiting
Vice President and Chief Financial Officer
Gladstone Institutes
REGISTRATION INSTRUCTIONS:
To Register and receive an immediate receipt,
use our on-line registration:
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, purchasing, and enterprise business systems.
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.
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 leading the long-range planning, budgeting and
forecasting processes. He is a financial executive with broad experience in a host of areas,
including strategic and operational planning,
financial modeling, the construction of scalable
financial processes and controls, investor relations, treasury and risk management, mergers
and acquisitions, procurement, alliance and
collaboration management, tax, financing and
operations support.
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.
Prior to joining Genentech, Mr. Whiting worked
at Arthur Young for eight years as an auditor.
He is a Certified Public Accountant (inactive).
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.
Mr. Whiting received both a bachelor’s degree
in molecular biology and an MBA from the
University of Oregon.
Name badges will be given at the
on-site registration desk.
3
ISPE San Francisco/Bay Area Chapter
www.ispe.org/sanfrancisco
Alzheimer’s Research
Evening Meeting
Thursday, September 22, 2011
The J. David Gladstone Institute
1650 Owens Street
San Francisco, CA 94158
Tel: (415) 734-2000
http://www.gladstone.ucsf.edu
Registration and Reception
Presentations
4:30 - 6:30 pm
6:30 - 8:00 pm
PRESENTER:
John M. Whiting
Vice President and Chief Financial Officer, Gladstone Institutes
Note: A second speaker will be announced
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://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 registration 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:
If an ISPE Member, please supply membership Information
LAST NAME:
Member #:_______________Chapter:________
TITLE:
COMPANY:
ADDRESS:
Member Cost: ❑ $65
Non Member Cost: ❑ $90
MAIL CODE:
CREDIT CARD INFORMATION
Type of Credit Card
CITY:
Circle One
STATE:
PHONE:
ZIP:
Name on Card:
Credit Card #:
FAX:
Exp Date:
E-MAIL:
Signature:
January CEO Night Photos
O
by Andy Nelsen, Bay Area Engineers
ur 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 economy, 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.
5
YPLF Brings Leadership Development and Networking to the SF Bay Area
Chapter Young Professionals
by Fion Cheng, Novartis Diagnostics
T
he 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 technologies. 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.
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.
SF Bay Area Chapter President
Corey Veverka talked about the
benefits of ISPE.
Volunteer Heather Bennett and our industry panelists Gabe Orosco, Paul Lauer, Heike Abeck and Rick
Johnston sharing with young professionals their thoughts
on various topics.
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6
Groups of participants designed and built production plants
using just straws, notecards and post-it.
2011 ISPE Annual Meeting:
Preparing Professionals and
organizations for Rapid Change
The future is now, and ISPE Members
are leading the charge!
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
6-9 November
Industry Experts and Regulators Present
Register Early and save!
Early Bird Pricing Ends 10 October
www.ISPE.org/2011AnnualMeeting
GayloRd TExaN
dallas/FT. WoRTh (GRaPEvINE)
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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.
Pinnacle Programme Global Sponsor
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Gold
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Engineering
Architecture
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Construction Management
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Detail Design Specifications
Control System Engineering
I
March Commuter Conference Photos
by Harvey Steinhaus, Dome Construction
n 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 Engineering 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 Pharmatech Associates for sponsoring the meeting and to Genentech, the speakers, facilitators and Members who joined the
conference.
Master the Details
of Medical Device
Development
extension.berkeley.edu/sciences
8
I
ISPE has a “Roaring” Vendor Night
by Vendor Night Chair Karl Wilks, Gilead Sciences
SPE 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 featuring 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 continue 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 several 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 Charlestonstyle 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.
9
Vendor Night Photos
by Nicole Hall, Commissioning Agents, Inc.
To View Nicole Hall’s Vendor Night Slide Show:
http://gallery.me.com/nickihall1#100035
10
8
The Facility of the Year
Awards program is an
annual program that
recognizes state-ofthe-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.
www.FacilityOfTheYear.org
Facility of the
Year Awards
2012
2012 Call for Entries
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!
14 October 2011
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 Knowledge
Strategic Solutions for the
Life Sciences Industry
AD-CA-NYC-2009JAN06-P2V1
Deadline For Submissions:
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In California, call (415) 946-6861 or email
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One Team. Infinite Solutions.
11
O
ISPE Bay Area Chapter Donates $2000 for Japan Relief
n 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 Affiliates/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 Connection
Each 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 support, we would not be able to provide important resources like
this.
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The Relay: April 30-May 1 2011
by Heather Bennett, ACCO Engineered Systems
s with every year, The Relay comes with
its own unique challenges. This year illness, 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 Organs ‘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 completed 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 – iPurity
Heather Bennett – ACCO Engineered Systems
Jeff Jul – J2 Biosystems
Ryoko Kataoka – Novozymes
Patti Larson – XL Construction
John McPeake – McPeake Consulting
Dan Restivo – Novo Construction
Dave Sax – Baxter BioScience
Sergio Yoc – SJSU Student Chapter
13
Volunteers
Germaine Bickel – Genentech
Peter Graham – UC Davis Student Chapter
ISPE Announces Partnership with US EPA
--Sustainable Facilities Community of Practice to Spearhead Involvement--
I
SPE 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 exposure 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.”
ISPE
Headquarters
Has Moved!
He
H
The ENERGY STAR Challenge for Industry calls upon businesses to create a five-year plan to reduce energy intensity by 10% or more. Companies 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 participation will be the Sustainable Facilities Community of Practice (COP).
Interested parties may join the Sustainable Facilities COP to gain information, 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 :
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Tampa, Florida 33609 • USA
You can still reach us via telephone
at: +1-813-960-2105 and
via fax at: +1-813-264-2816
Connecting a World of
Pharmaceutical Knowledge
www.ISPE.org
www.ISPE.org
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Fax 408-298-2132
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650.588.2660 office
650.588.2857 fax
646.283.7987 cell
Maura Lynch
West Coast Operations Manager
maura.lynch@hyde-ec.com
www.hyde-ec.com
14
Member of N.E.C.A. • CA Lic# 296728-C10 • NV Lic# 57803-C2
6
Industry
News
(continued)
Welcome New
Chapter
Members
by
Sandra
Medlin,
Sani-Tech
West
Farshad
Altafi, Senior
Associate, GL
Planning & Design,
Inc.
Mike Avram, C&Q Manager, Bayer Business and Technology
Affymetrix Inc.
Corp.
Corinne Blankenship, Senior Engineer,Alpha
CoriumInnotech
International
Mfg Group
Announced that the PhyloChip,
a
custom
Affymetrix
microarHas
entered
into
a fiveMechanical
year Strategic Supplier Alliance
Caasi Bonura, Sales/Marketing Representative, Western Allied
ray developed by Lawrence BerkeleyRaul
National
Laboratory,
won
Agreement
with
GE
Healthcare.
This agreement is a continuBrena, R&D QA Specialist III, Santen Incorporated
the bronze prize in the 2008 Wall Street
Journal
Technology
ation and
expansion of the previous OEM Agreement signed
Andrea
Canavero,
Product Manager,
Genentech/Roche
Innovation Awards. The PhyloChip
researchers
identify
between
two companiesInc
in April of 2005.
Katiehelps
Chaddock,
Director
of Operations,
Mylanthe
Pharmaceuticals
dangerous pathogens before they can affect
humans.
The
Arthur Chen, Automation Engineer, Genentech Inc
PhyloChip was the only biotech company in the top three to
Gilead Sciences, Inc
Steven Chen, Process Engineer, Foster Wheeler Biokinetics
be recognized. There were 700 total entrants.
Announced that the company has completed its acquisition
Clarissa Chiang, Business Development Coordinator, Thornton Tomasetti
from Electronics For Imaging, Inc. of a building located at 301
Christopher Ian Cruda, Student, San Jose State University
Velocity Way and adjacent land in Foster City. The acquisiDynavax Technologies Corporation
Matt Darrah, Equipment Engineer, Alza Corp
tion covers the existing 301 Velocity Way building of approxiAnnounced it has been awarded a $17 million contract to
Scott Donald, Principal Process Engineer, Novartis
develop its advanced immunostimulatory sequences technolmately 163,000 square feet and approximately 30 acres
Cannon Faasse, District Manager, ABM Engineering
ogy using Toll-Like Receptor 9 agonists
as vaccine adjuvants.
designed to accommodate up to an additional 542,000 square
Senior
Associate, GL
DesignThe
Inc building and associated land border
This five-year contract was awardedJerrold
by the Fox,
National
Institutes
feetPlanning
of office&space.
Kristine
Golveo,
Manager,
Elan
Pharmaceuticals
Gilead’s Foster City campus, the company’s headquarters
of Health’s National Institute of Allergy and Infectious
Fred Hahn,
Associate
Gilead
Sciences, Inc.
since
1988.
Diseases to develop novel vaccine adjuvant
candidates
that Director,
Eric
Hice,
Senior
Designer,
Novartis
Pharmaceutical
Corp.
signal through receptors of the innate immune system. The
John
Home,
Senior
Project
Manager,
Rudolph
&
Sletten
contract supports adjuvant development for anthrax as well as
Bayhill Therapeutics, Inc
Inc.
Russell Jones, Partner, Joins
Deloitte
Touche Diabetes Research Foundation, the world’s
other disease models.
the& Juvenile
Caroline Kim, Graduate Student, University
of California-Davis
leading charitable
funder of type 1 diabetes research, in a
Mark Lanpher, Business Development,
Cupertino
Electric
partnership
to support
Bayhill’s ongoing Phase I/II human clinBaxter International Inc.
Larin, Process Engineer,
ical trial Novartis
of BHT-3021, a DNA vaccine to reverse the immune
Mayor Richard M. Daley and Chicago Public Jose
Schools
Ekta
Mahajan,
Senior Engineer,
Genentech
announced that Baxter International Inc. will
donate
$5 milresponse
that causes type 1 diabetes.
McCormack, Genentech
lion over five years to support CPS district scienceJon
initiatives
Rinaeducation
McPherson,
Student, University
of California
Davis
The source
of this information
is the ISPE Web site, con— the first program ever to fund biotech
in CPS
Millan, Engineer,
ACCOfirmed
Engineered
Systems
history. This significant contribution hasBob
the potential
to impact
on company
websites.
more than 450 CPS teachers through professionalJacquelyn
develop- Misero, Genentech
ment and 75,000 students — all at theJeanette
junior high
and high
Motzer,
Principal Business Systems Analyst
school level — who by the year 2012 will benefit
theCT,
new
Jim from
Murray,
US Data Management
innovative schools, enhanced teacher skill
set,Nguyen,
materials,
and
Lana
University
of California-Berkeley
direct interaction with Baxter Hector
scientists
andSr.
engineers.
Olson,
Manager, QA, Bayer Healthcare Pharmaceuticals, Inc.
Chirag Patel, Design Engineer, Acco Engineered Systems
Jim Perko, President, Absolute Filtration
Denton
Perreault, Sr. PE, Rudolph & Sletten Inc
VALIDATION
COMMISSIONING
Trishna Ray-Chaudhuri, Member - Manager, Trishna LLC
Jason Roberts, Student, Solano Community College
Chinmoy Roy, Consultant, Self Employed
David Seals, Staff Validation Engineer, Alza
Wendy Shieu, ORDP Analyst, Genentech
Konstantinos Spetsieris, Bayer Technology Services
Sarah Stanly, Solano Community College
TRAINING
AUDITS
Michael Taylor, Executive Director, Biopharm Services Ltd.
500 Airport Blvd, Suite 100 ( Burlingame,
94010 VP. Quality/Compliance, STTPharma
Kim CA
Valkner,
Toll-Free (888) 242-0559 ( Office (650) 320-1788 ( Fax (650) 320-1789
Eric Wood, Specialist I, Gilead Sciences, Inc
Pauline Zamora, Director of Quality Assurance, BioMarin Pharmaceutical
www.propharmagroup.com
Qing Zhang, Novartis
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Stanford Lokey Stem Cell Research Facility Tour Overview
By Brian Vaughn, Banks Integration Group
T
hanks 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 architect. 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 bamboo 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.
(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.
SF Bay Area
STERIS Corporation
astropak.com
Rick Metz-Capital Equipment
Rick_Metz@steris.com
(916) 201-7644
Robin Johnston - Consumables
Robin_Johnston@steris.com
(415) 308-4656
est. 1959
16
Call Today! 703.542.0608
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
ISPE Releases GAMP® Good Practice
Guide: A Risk-Based Approach to GxP
Process Control Systems, 2nd Edition
--Guide Updated to Align with Recent
I
Commuter Conference
Committee
Seeks Volunteers
If you are interested in joining an ISPE SF
Committee, the Commuter Conference Committee is looking for more volunteers.
Regulatory and Industry Developments--
SPE 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) Process 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 specification 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 support documentation. The Guide promotes the leveraging of supplier documentation 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
Commuter Conferences are technical presentations with a focused topic. They are
open to ISPE Members only and are scheduled 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 encourage participation in COPs, this year we have
focused our topics on ISPE Communities
of Practice. COP leaders are the presenters 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 Committee Members.
If you are interested, please contact Rick
Ginn at: rginn@xlconstruction.com
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 emerging 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.
COMPLIANCE SERVICES
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VALIDATION
An Integrated Approach to Meet the Challenges
of the Biotech / Pharma Industry
AUTOMATION
– cGMP Facilities
– Class 100, 10,000 & 100,000
– Utility and Process Design Cleanrooms
– Vivaria
– Wet & Dry Labs
PROGRAM/PROJECT
MANAGEMENT
www.propharmagroup.com
18
Smart Solutions for Smart Buildings
ARCHITECTURE • ENGINEERING • CONSTRUCTION
ISPE San Francisco / Bay Area Chapter Committees
Program Committee
Chair: 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 Committee
Chair:
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 Committee
Chair:
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 Biosystems
Volunteers: Sandra Medlin, Sani-Tech West
David O’Connell, DCE Consulting, Inc.
Young Professionals/Student Affairs Committee
Chair:
David Mourra, Bayer Technology Services
Committee Vice Chairs:
YP:
Fion Cheng, Novartis
Students: Marlene Meza, Novartis
Volunteers: 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 + Consulting
Faculty:
Jim DeKloe, Solano College
Claire Komives, San Jose State University
Dr. Dorian Liepmann, UC Berkeley
Dr. Karen McDonald, UC Davis
Charity Committee
Chair: Ed Shea, BNBuilders
Volunteers: Greg Burg, Genentech
Sue Cost, Foster Wheeler Biokinetics
Volunteer Committee
Chair: Linda Karr, Genentech
Volunteers: Greg Banks, Banks Integration Group, Inc.
Greg Burg, Genentech
Sue Cost, Foster Wheeler Biokinetics
Mark Hannon
John Kelley, Genentech
Ed Shea, BNBuilders
Vendor Night Committee
Chair: Karl Wilks, Gilead
Volunteers: 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 Committee
Co-Chairs: Kim Duncan, Duncan Enterprises
Chris Humphrey, CRB
Volunteers: Arnold Asuncion, TVS
Adam Beatty, Emerson Process Systems
Mike Britting, D.F. Pray
Ed Shea, BNBuilders
Community Relations
Chair:
Germaine Bickel, Genentech
Vice Chair: Heather Bennett, ACCO Engineered Systems
Volunteers: Trevor Auer, CRB
Ian Larson, Baxter Bioscience
John Lohnes, AECOM
Mike Marston, DPR Construction
Bob McCollough, Cytokinetics
Gordon Zagar, Cornerstone Integrated
Advisory Committee
Chair:
Sue Cost, Foster Wheeler Biokinetics
Liaisons:
Greg Burg, Genentech
Mark Hannon
John Kelley, Genentech
Ed Shea, BNBuilders
Council:
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
Board of Directors
Officers
President:
Kelly Keen, Genentech
Email
Telephone
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
Chapter Past Presidents:
Directors
Tareq Barakzoy, ACCO Engineered Systems, tbarakzoy@accoes.com
Germaine Bickel, Genentech, bickel.germaine@gene.com
Kim Duncan, Duncan Enterprises, mkduncan@flash.net
Chris Humphrey, CRB, chris.humphrey@crbusa.com
Jeff Jul, J2Biosystems, jeff@j2biosystems.com
David Mourra, Bayer Tech Services, david.mourra@bayertechnology.com
Ulrike Ruppelt, ticular - Strategies For Success, ulrike.ruppelt@ticular.com
Brian Vaughn, Banks Integration Group, brianvaughn@banksintegration.com
Karl Wilks, Gilead Sciences, kwilks@gilead.com
Planning • Programming • Permitting
Project Management • Construction Management
Full Service Design
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Technical Sales Representative
Sandra Medlin
Technical Sales Representative
Bob Miller
(323) 252-1110 Cell
(510) 290-1232 Cell
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Technical Sales Representative
(510) 967-9397 Cell
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High Purity Liquid Handling Products
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20
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
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
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 Calendar
www.ispe.org
ISPE is a Society of
pharmaceutical professionals
who use expert knowledge to
create high-quality, cost-effective
GMP solutions.
Technical Articles
High Quality ISPE Event
Photos Welcomed For Future
Newsletters
Please submit them via Email to
Jeff Jul, Newsletter Chair
19 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 site
www.ispe.org/sanfrancisco
ISPE’s Global Calendar: www.ispe.org/globalcalendar
jeff@j2biosystems.com
Cover Photo from Fotolia.com
Photographer: Antroxu
M T I
C A L I F O R N I A,
I N C.
Scott McDonald, President
smcdonald@mti- ca.com
Main: (925) 937 1500 Fax: (925) 937 8518
www.mti-ca.com
21
Specializing in Control Systems
Design & Validation