S A N F R A N C I S C O / B AY A R E A
THE SOCIETY
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Volume 11, No. 2, 2003
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President’s Message
Ed Shea
n February, Max Yonker, Melody Spradlin and I journeyed to sunny Tampa, FL to attend the ISPE Winter
Conference. I have always wondered why they have
meetings in temperate places with lots of sunshine and then make
you sit indoors for the week. If you have the answer let me know.
Photo of Paul Crissman of ITT Industries at Vendor
Night on March 27th. Additional VN photos inside.
June 5th Meeting
Industry Growth Initiatives
for BioTech
O
n June 5th, the ISPE San Francisco/Bay
Area Chapter will offer a dinner meeting
focusing on growth for the biotech industry. Sue Markland Day, Director, Government
Relations, and former President, Bay Area
Bioscience Center will present to the Chapter. The
meeting will be held at the Marriott, San Francisco
Airport.
Reported late last year in San Francisco Chronicle’s
Technology and Business section by Tom Abate, the
Bay Area boasts one of the biggest concentrations
of biotech firms, venture capital networks and premier research institutes in the world. The continued
growth of the biotech industry is challenged though
by high housing prices and long commutes, allowing
other metropolitan areas to attract the biotech
industry. To respond to these challenges, over 100
business, academic and political leaders met to
begin crafting a regional strategy to encourage
(continued on Page 11)
As you may have noticed, the SF Chapter is putting a great deal of
time and effort into the formation and cultivation of student chapters. Melody, almost single-handedly, has been leading the effort
with the ISPE Student Chapter at Stanford and Rick Dean, Ajay
Kshatriya and Greg Banks are in the process of establishing the
same at University of California, Berkeley. Stanford’s Chapter held
their first meeting on January 22nd at CEO night in which we had
20 student attendees. UCB had their first meeting on March 31st.
Recently, Rick, Ajay and I had the opportunity to speak to the
Berkeley class and discuss ISPE, what our organization is all
about and what we as a Chapter and International organization
can provide to the students. At first we were met with blank stares,
which of course was a bit unsettling, but after the class a number
of students came up to us and began great conversation. As a
Chapter we see this as an opportunity to introduce the next generation of scientists, chemists, process engineers and so on to our
industry. This is also an avenue for employers to scope out
prospective interns and employees. It also provides the students
significant insight into the marketplace which typically isn’t provided in a classroom setting. Greg, Rick, Ajay and Melody have done
a fantastic job and the Chapter is grateful for all of their efforts.
On March 6th, the Chapter held a Commuter Conference at Alza –
Vacaville on the topic of “Basis of Design”. The members discussed why you develop one and when it is useful and when not.
It was a lively discussion to a full crowd. March 27th was the 12th
annual Vendor Night at the South San Francisco Conference
Center. John Kelley assembled an impressive group who hailed
from Chiron, Alza and Genentech. The team discussed “Annual
Facility Shutdowns,” something many of us are involved with.
Thank you for your continued interest and support, if you have
input or a suggestion, please do not hesitate to contact me at
ed_shea@domeconst.com or 415-641-0800.
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No. 2, 2003
VENDOR NIGHT 2003 PHOTOS
DID YOU KNOW?
FREQUENTLY ASKED
QUESTIONS
Submitted by:
John Kelley, Facilicorp
W
here’s the next commuter conference? When is the next
commuter conference? You can get the latest up to the
minute Commuter Conference topic and location information from the Calendar of Events button on the San Francisco ISPE
Chapter Home web page, www.ispe-sf.org.
I need five hours of GMP training this year, what can I sign up for, what
classes are being offered where? When and where is the ISPE
Annual Meeting? Is there a Northwest Chapter? What is on their calendar, who are the contacts? Want to know what classes are being
offered by ISPE across the world or when any event hosted by an
ISPE chapter is going to take place, open the ISPE web site
www.ispe.org and click on Education and Events on the left hand banner. The following page will have a Global Calendar link. Click on it
and you will be provided with the entire calendar of any event that is
being hosted by ISPE as well as each regional and International affiliate. This calendar is comprehensive and includes links to international
and local training classes, international meeting details and links to
regional chapter calendars and web sites.
O
ver 400 people attended this year’s Vendor
Night at the South San Francisco
Conference Center. The technical session
on Annual Facility Shutdowns was very informative and
had over 100 in attendance.
The proceeds from Vendor Night help the group offer
technical sessions free of charge during the year - the
Commuter Conferences and also provide funding for
additional Chapter offerings.
Thank you to the presenters:
Facilitator:
John Kelley, Sr. Project Manager,
Facilicorp
Presenters:
Al DeGroot, Associate Director,
Facilities Operations, Chiron
Rick Bible, Maintenance Supervisor,
ALZA
George Rally, Senior Manager,
Facility Services, Genentech
Also a huge thank you to CUPERTINO ELECTRIC for
providing the electrical set-up! And to the 99 exhibitors
who help support the Chapter on a regular basis.
Comments on Vendor Night (location, ideas for future
topics, etc.) are welcomed. Please email your suggestions to the Vendor Night Chair, John Kelley at
johnk@facilicorp.com
ISPE San Francisco Bay Area Chapter’s
9th Annual Fun Day
Charity Event: All Proceeeds going to the Lance Armstrong Foundation
Thursday, August 14, 2003
Golf Tournament
at Stone Tree Golf
Course in Novato
&
Sonoma
Winery Tour
http://www.stonetreegolf.com
The golf tournament is a sell-out event each year. Reservations are made on a First Come, First Serve Basis.
There are 128 spots for golf and only 40 for the winery tour. So don’t wait, sign up today. During the golf tournament, a group of ISPE members will be touring local wineries. At the end of the day, both groups will meet for
an awards banquet at the golf course.
8:00 - 9:00 am
8:30 - 9:00 am
10.00am - 3:30pm
9:30 am
4:00 - 6:00 pm
Sponsor Breakfast
Registration
Golfers Ready to Start (BBQ Lunch provided)
Bus Ready To Leave from Stone Tree to Sonoma Wine Tour.
Lunch will be provided. If you’re late, see you at dinner.
Reception/Dinner/Awards
Best Ball Scramble
Longest Drive
Closest to the Pin
DIRECTIONS TO STONE TREE GOLF COURSE:
Stone Tree Golf Course, 9 StoneTree Lane, Novato, California 94945 (415) 209-6090
From San Francisco area: Take Hwy 101 to HWY 37 east toward Napa/Vallejo. Proceed 2-1/2 miles on HWY 37 to the Atherton exit.
Take Atherton exit, turn right into main StoneTree entrance.
From Vallejo area: Take Hwy 37 west to Atherton/BlackPoint exit. Take exit to stop sign, turn right to stop sign under highway. Continue
straight through StoneTree main entrance.
REGISTRATION
FORM
CREDIT CARD INFORMATION
TO PAY BY CREDIT CARD: Please fax your completed form with credit
card information to 925-855-9102. Tel 925-855-9100.
Circle One
TO PAY BY CHECK: Please fax your completed form to Angela Jones or
Name on Card:
Corey Veverka at 925-855-9102. Then mail your check payable to
Credit Card #:
ISPE San Francisco Chapter c/o Total Validation Services, Inc.,
Exp Date:
2092 Omega Road, Suite I, San Ramon, CA 94583-1230.
Signature:
Submit one copy for each person attending.
Confirmations will be sent after payment is received. Register early, space is limited for Golf and Wine Tour.
Wine Tasting
Golf ❑ $200 per person
Sponsorships Are Available, Please contact Angela Jones or Corey Veverka at TVS: 925-855-9100.
NAME:
TITLE:
COMPANY:
ADDRESS:
CITY:
STATE:
PHONE:
FAX:
WEBSITE:
E-MAIL:
ZIP:
❑
$200 per person
No. 2, 2003
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West Coast Offices: Downey (Corp) • Livermore, CA • San Diego, CA
T
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www.greene-engineers.com
AT
1933 O’ Toole Ave., Suite 104
San Jose, CA 95131
Tel: (408) 435-9119
Fax: (408) 435-1155
L
9265 Dowdy Drive, Suite 114
San Diego, CA 92126
Tel: (858) 566-5442
Fax: (858) 566-5564
E
DAVID P. SISTO
949/366-1056
WE DELIVER CUTTING-EDGE FACILITIES
OR
CONTACT: GREG BURG
(408) 988-4200 • WWW.HDCCO.COM
$140/ISSUE. SEE CALENDAR FOR NEXT NEWSLETTER DEADLINE. TO PLACE AN AD CALL 888/275-0189
LOS ANGELES
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Visit our Website at: www.puritysystems.com
NEWSLETTER ADS AVAILABLE
GENERAL CONTRACTORS • CM/GC
CONSTRUCTION MANAGEMENT • DESIGN/BUILD
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Corporate Facilities
Interiors and Renovations
Advanced Technology Facilities
Higher Education/Institutional
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No. 2, 2003
5
Overview of January 15, 2003 Commuter Conference on
“Drug Development”
Presented by Tom Yonker of InterMune and Hosted by Aradigm
Photos (L-R) 1. Tom Yonker of InterMune presents to ISPE members.
2. Commuter Conference Committee member, Thomas Main, International Process Solutions presents a certificate of appreciation to Tom Yonker.
3. The social/networking portion of each Commuter Conference helps facilitators/presenters to interact with members and for members to meet
one-another and share industry experiences.
T
hank you to Tom Yonker of InterMune for providing what has been described as a university level course on Drug Development. Yonker,
nicknamed Professor Yonker after this presentation, provided a detailed lecture on the topic.
Slides of Tom Yonker’s presentation are available on the
Chapter website (Chapter Calendar/Past Events). Here is
an Overview of Drug Development from Toxicology to
CTD:
• Toxic effects
• Safety margin
• Dosage responses
• Determination of safety
• How good is good enough?
• Can your drug be too safe?
Yonker also provided an outline of how R&D resources
are spent including the timeline and criteria for the development of a drug product.
He also explained the FDA Review Process from Consumer Safety
Officer to:
• Biostatistics Review
• Pharmaco-kinetics and Metabolism
• Chemistry Review
• Pharmacology Review
• Medical Review
• Division Director
and finally the FDA Advisory Committee.
Special thank you to Aradigm in Hayward for hosting the sell-out
member only event.
The Commuter Conference Committee has been offering technical
discussion groups about every other month for the past several
years. Each meeting is free to attend and are open to ISPE members only. Most of the time the events are only promoted via email
to members. To receive notices of future Commuter Conferences,
join ISPE San Francisco/Bay Area Chapter today! To download an
ISPE member application, please see the following link:
http://www.ispe-sf.org/member.htm
CHAPTER ADVISORY COUNCIL
CHAIR: W. Michael Edwards, Retired (formerly with Genentech)
CHAPTER LIAISON: Sue Cost, Bus Development Mgr, Kinetics Biopharm
COUNCIL:
Martin Fischer, Assistant Professor Construction Engineering/Management Program, Stanford University
Ed Fried, Senior Director Manufacturing, Dey Laboratories
Dale Hanson, Executive Director Facilities, Berlex Biosciences
Jean Huxsoll, Director Regulatory Affairs, Bayer Corporation
Dr. Frank Menkel, Head of Program Management, Bayer Pharmaceuticals
Mike Ramsay, Vice President Sourcing, Cell Genesys
Vic Warren, Associate Director Engineering, Corporate Facilities Management, Chiron
No. 2, 2003
6
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NEWSLETTER ADS AVAILABLE
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FTC and FDA Crackdown on
Internet Marketers of Bogus
SARS Prevention Products
Deceptive and Misleading Claims Must be
Removed Immediately
T
he Federal Trade Commission and the Food and
Drug Administration (FDA) are warning Web site
operators, manufacturers and distributors who
suggest that their products will protect against, treat, or even
cure Severe Acute Respiratory Syndrome (SARS), that they
are aware of no scientific proof for such claims and that the
Web site operators must remove any misleading or deceptive claims from the Internet. A coordinated Internet "surf"
found 48 sites touting a wide variety of SARS treatment or
prevention products. The FTC also retrieved seven promotions for SARS products from its spam database. The two
agencies sent warnings to Web site operators, and e-mail
solicitors, cautioning that it is against the law to make claims
about SARS protection or treatment, or any other health
benefit, without rigorous scientific support. FDA has sent 8
warning letters to manufacturers and distributors who are
making misleading claims.
CASCADE
CONTROLS
THE SOCIETY FOR LIFE SCIENCE PROFESSIONALS
ISPE San Francisco/Bay Area Chapter
Industry Growth Initiatives for BioTech
Thursday, June 5, 2003
Reception
Dinner
Presentation
Marriott - San Francisco Airport
1800 Old Bayshore Hwy
Burlingame, CA 650-692-9100
4:30 - 5:30 pm
5:30 - 6:30 pm
6:30 - 8:00 pm
Presenter: Sue Markland Day
Director, Government Relations & former President - Bay Area Bioscience Center
Sue Markland Day stepped aside as President on May 1, 2003 to establish and manage a new
BayBio division focused on state and federal government/Northern California bioscience community
relations. She joined the Bay Area Bioscience Center as its President in January 1998, and was
instrumental in refocusing BayBio's activities, with a greater emphasis on the regional bioscience
community - how its complex membership energizes and supports new and existing life science
research, development, and manufacturing institutions - and the importance of working with external
audiences (e.g. local governments, health care givers, patient advocacy groups, and the public).
Prior to her position with the Center, Day had managed three non-profits, worked on biotech-related
public policy issues at the state and national levels, and served as a bench scientist. Early in her
career, she supervised commercial, patient care and academic research laboratories. Day organized the first organ transplantation laboratory at the University of Texas/Houston Medical School and worked in the Department of Developmental Therapeutics at M.D.
Anderson Hospital and Cancer Institute in the Texas Medical Center. She served as a staff person for the U.S. House of
Representatives Committee on Agriculture, was a Congressional liaison for the State of California, represented the Association of
Biotechnology Companies before Congress, and held public policy appointments at the University of Tennessee (Center for
Environmental Biotechnology) and the University of California (UC Systemwide Biotechnology and Research and Education Program).
Ms. Day has written more than 30 peer-reviewed publications, including book chapters and federal legislation. She was also the
Executive Director of the California Alliance for Jobs.
Directions to San Francisco Airport Marriott: From San Jose - Take US-101 Northwest. Exit 101,Bayshore Fwy via ramp at sign
reading "Broadway" and go Northwest for 0.3 miles. Turn left on Bayshore Hwy and go Northwest for 1.1 miles to Marriott San
Francisco Airport. From San Francisco - Take US-101 South. Exit 101 via ramp to E Millbrae Ave and go Southeast for 0.5 miles.
Continue on E Millbrae Ave and go Northeast for 0.3 miles. Turn right on Bayshore Hwy and go Southeast for 0.3 miles to Marriott
San Francisco Airport.
REGISTRATION FORM
ISPE San Francisco/Bay Area Chapter
Industry Growth Initiatives for BioTech - June 5, 2003
To register, please complete the registration form with your credit card information and fax it to (949) 366-1057 or fax the form then
mail your check made payable to ISPE San Francisco/Bay Area Chapter by June 1, 2003 (after June 1, please bring payment with
you) then mail check and original registration form to: ISPE San Francisco Bay Area Chapter, 111 E. Avenida San Gabriel,
San Clemente, CA 92672. Chapter Tax ID #68-0282494 • Phone: (888) 275-0189 or (949) 366-1056 • www.ispe-sf.org
Submit one copy for each person attending. Receipts for payment & name badges will be provided on-site.
Dinner Meeting
❑
❑
ISPE Members.....$50
Non-Members.....$70
ISPE Member No. _______________ Chapter Affiliation _____________________❑ Vegetarian Meal Requested
If paying by credit card, please check type of card:
❑
VISA
❑
MASTERCARD
❑
AMERICAN EXPRESS
Name on Card:____________________________ Card #:_________________________________________________
Expiration Date:___________________________ Signature:______________________________________________
NAME:
TITLE:
COMPANY:
E-MAIL:
ADDRESS:
CITY:
PHONE:
STATE:
FAX:
ZIP:
No. 2, 2003
8
Welcome New Chapter Members
February - May 2003
Boon H. Lim, Student, Stanford University
Jason Aaron, Owner/President, Advanced Validation Consult.
Joseph Magee, Estimator, DPR Construction Inc
Victor Acdan, Systems Specialist, Flow Solutions
Brian McCutcheon, Regional Sales Manager, CLEANPAK
James B. Ahearn, Engineer
Gabriel Gustavo
Peter Aronson, Sr. Automation Engineer, Eichleay Engineers
Mejia Manriquez, Student, Stanford University
Josefita K. Atencio, Validation Specialist, Dey LP
John Mica, Sr. GMP Facilities Engineer, Nektar Therapeutics
Abhijit Banerjee, Sr Process Engineer, Advent Engineering
Emmanuelle L. Miller, Validation Scientist, DEY LP
Shea K. Barber, Validation Associate, Total Validation Services
David J. Morton, Sr Microbiologist, Alza Corp
Jorge E. Basso, Sr. Dir Pharma Engineering, Aradigm Corp
Soechgen Mulia, Project Engineer, DPR Construction Inc
Robert S. Bea, Principal/PCS Engineer, Bayer Corporation
Matthew P. Mullinax, Associate Engineer, Dey LP
David A. Bendet, Architect, MBT Architecture
Ahmet M. Odabasi, Civil Engineer, Dome Construction
Jeremy Brack, Account Mgr, Emerson Process Management
Brian T. OKelly, Superintendent, DPR Construction Inc
David Brake, R&D Instrumentation Manager, Chiron Corp
Hamdy Osman, Sr. Vice President, SWAT Engineering Group
Michael Cahalen, Facilities Engineer, Nektar Therapeutics
Eric A. Osterling, Facilities Engineer, Kosan Biosciences
Duke Chalker, Applications Engineer, Novasep Inc.
Michael Pattinson, Add Inc
Russell A. Chu, Validation Specialist, Total Validation Services
John Peery, Director, Tech Development, Pharmacontrol LLC
Matt Costick, Project Engineer, ACCO Engineered Systems
Christian Perizzola, Student, Stanford University
Timothy Curtin
Mitchell Pernisie, Regional Sales Mgr, Ionics Instrument
Andy De Lucio, Engineering Manager, Fluor
Scott Pisani, Senior Project Engineer, XL Construction
Mark K. Donnelly, Plant Engineer, Bayer Corporation
Jody Quinton, Senior Project Manager, DPR Construction Inc
Duygu Ener, Student, Stanford University
Khalid Radwan, Senior Control Systems Engineer, Biotrol
Jorge M. Ferrer, QA Release Coordinator, Berlex Biosciences
Jeffrey Robinson, Mgr, Tech Transfer, Schering-Plough
Simon Forder
William Rondeau, Engineering Mgr, Allergan Pharmaceutical
Michael Foster, Biotechnology Engineer, Berlex Biosciences
Julio J. Salceda, Student, Stanford University
Randy T. Furuta, Sr. Project Manager, FaciliCorp
Flavio Santini, COO, SWAT Enterprise Inc.
Jose K. Garcia-Aranda, Student, Stanford University
Jeff R. Scott, Ind Hygiene Specialist, Safebridge Consultants
Nancy J. Gieske, Validation Mgr, Chiron Corp
Joe Seiwert, III, Project Director, Automation, VaxGen
Quentin R. Grady, Vice-President, Queue Systems
Sepideh Shooshtarian, Process Engineer, Fluor Daniel
Charles Gwinji, Ops Mgr, Service Performance Corp (Alza)
Michael Shulim, Director of Engineering, DST Controls
Min S. Ha, Validation Specialist, DEY LP
Jeremy Southgate, Add Inc
Ann M. Hanley, Marcom Coordinator, Blach Construction Co.
Andrew Sweeney, Compliance Engineer, Medtronic
Shawn Inks, QA Engineer, Chiron Corp
Suesan W. Taylor, SWT Consulting
Emma Johnsen, Project Coordinator, Summit Pharmaceuticals
Nathan Temple, Validation Engineer, Commissioning Agents
Heikki Jouttijarvi, Director, U.S. Pharma Operations, Santen
Geraldine Thomas, Student, Stanford University
David Jubera, Regional Sales Manager, Domnick Hunter
Leilani Tootoo, Consultant, The Weinberg Group Inc
Kevin J. Kalinowski, Genentech Inc
John J. Turanin , Aradigm Corporation
Jessica B. Kelley, Project Engineer, Southland Industries
Richard E. Unvarsky, XL Construction
Chris Knese, Sales Manager, BBI - B Braun Biotech
Barbra VillamorSupervisor, Alza Corp
Ines Lam, Student, Stanford University
Adele Ward, Sales Engineer, OSIsoft, Inc.
Alvin Lee, Total Validation Services, Inc. (TVS)
Louis David Wilson, Senior Validation Engineer, Genentech
James Leung, Western Account Manager, Novazone
Heinz I. Windt, Manager Engineering, Bayer Corporation
Terry Lew, ADD Inc
Tracy L. Wonnell, Senior Process Engineer, BioKinetics
Thomas Lewis, Sr. Account Manager, CDI Professional Services
Michael Yoshida, Manager- Purification Ops, Abgenix Inc.
Allen T. Li, Manufacturing Associate, Cell Genesys Inc.
Mark I. Zhadan, DEY LP
Wendy X. Li, Student, Stanford University
John M. Lindsay, President, Aseptic Solutions, Inc.
No. 2, 2003
STUDENT CHAPTER UPDATE BY JOHN KELLEY
9
UC BERKELEY
Greg Banks, of BänzigerBanks, facilitated a
seminar series class for the Bioengineering
Department at UC Berkeley this past spring.
The one credit, semester-long class,
Bio190C, focused on career opportunities
within the Biotech/Pharmaceutical industry.
The class was supported by 17 ISPE
Chapter members from nine Bay Area ISPE
member companies along with two ISPE
member consultants. The series included a
tour of the Genentech and Alza facilities in
Vacaville and ended with a highly attended
career day supported by nine ISPE member
companies.
The Berkeley ISPE student Chapter was
formed through the spring semester with an
initial enrollment of 15 with five officers elected. Ajay Kshatriya, of bioKinetics, serves as
the ISPE sponsor with Rick Dean of Dey
Labs as co-sponsor. The Chapter is sponsored through the UC Berkeley
Bioengineering department, Dr. Dorian
Liepmann serves as the faculty advisor. The
Berkeley Student Chapter is busy developing
its poster session contest and plans for the
Fall semester recruitment program.
Students attended an all day plant tour of Genentech and ALZA Corporations on March 17.
STANFORD
Melody Spradlin Principal Project Manager at Genentech, taught the graduate level
Integration of Design and Engineering class in the Stanford Department of Civil and
Design Engineering. The class challenged the students to provide solutions to a real life
Retirement Community master plan. The students were mentored through the design budgeting solution process by ISPE members representing nine ISPE member companies.
The Stanford ISPE Student Chapter was established during the Winter quarter. The
Chapter attended the annual CEO Night and Vendor Night. The Chapter is sponsored by
the Department of Civil and Environmental Engineering. Dr. Bob Tatum serves as the faculty advisor. John Foster, of Genentech, serves as the ISPE sponsor.
ISPE San Francisco / Bay Area Chapter Committees
Program Committee
Chair:
Rob Lynch, Dome Construction
Vice Chair:
Mike Britting, Lem Construction Inc. (LCI)
Volunteer:
Linda Karr, Chiron Corp
Membership Committee
Chair:
Diane Bottini, Dome Construction
Volunteers:
Philip Henry, Philip Henry Architecture
Frank Menkel, Bayer Corp
Steve Kaplan, Johnson Controls Inc
W. Michael Edwards, Retired
Newsletter Committee
Chair:
Jon Sheh, Johnson & Johnson
Vice Chair:
Rob Zwolinski, Aradigm
Volunteers:
John Kelley, Facilicorp
Linda Karr, Chiron Corp
Bob Garcia, Turner Construction Co
Vendor Night Committee
Chair:
John Kelley, Facilicorp
Vice Chair:
Greg Burg, Hathaway Dinwiddie Construction
Volunteers:
Bob Garcia, Turner Construction Co
Jeff Jul, Entegris Inc
Fun Day Committee
Chair:
John Hughes, Total Validation Services Inc
Vice Chair:
Mike Britting, Lem Construction Inc
Volunteers:
Barbara Lambing, HDR Architecture Inc
Charity Committee
Chair:
Scott Laskey, Bay-Tec Engineering
Vice Chair:
Haleh Banisadr-Hughes, Total Validation Services
Volunteers:
Sue Cost, bioKinetics
Jon Sheh, Johnson & Johnson
Advisory Committee
Co-Chairs:
W. Michael Edwards, Retired
Sue Cost, bioKinetics
Student Affairs
Chair:
Vice Chair:
Volunteers:
Committee
John Kelley, Facilicorp
Greg Banks, BanzigerBanks
Greg Burg, Hathaway Dinwiddie Construction
Rick Dean, DEY LP
Ajay Kshatriya, bioKinetics
Martin Quan, DEY LP
Melody Spradlin, Genentech
Commuter Conference Committee
Chair:
Mark Hannon, Genentech, hannon@gene.com
Vice Chair:
Mike Faber, ALZA Corporation
Volunteers:
Derrick Eggers, Siemens Building Technologies
June Jenkins, Oxford & Associates
Kelly Keen, Webcor Builders ICG
Thomas Main, International Process Solutions
Melody Spradlin, Genentech
Liaison Committee
Chair:
Ed Shea, Dome Construction Corp.
Vice Chair:
Max Yonker, Geron Corporation
Volunteers:
Andy Nelsen, ALZA Corp
Scott Laskey, Bay-Tec Engineering
Haleh Banisadr-Hughes, Total Validation Services
Sue Cost, bioKinetics
Website
Chair:
Vice Chair:
Joe Tarantino, Nektar Therapeutics
Andy Nelsen, ALZA Corp
10
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NEWSLETTER ADS AVAILABLE
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No. 2, 2003
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Control Systems Engineering
System Integration
Instrumentation
Panel Fabrication
Installation/Commissioning
Validation
Bay-Tec Engineering Inc.
535 Airpark Road
Napa, California 94558-7514
telephone 707.252.6575
facsimile 707.252.2027
e-mail: slaskey@bay-tec.com
Webcor Builders
General Contractor - Construction Management
Design Build - Cost Analysis
California Offices
Contact
San Francisco
Bill Kalff
San Mateo
415.773.2370
Los Angeles
bkalff@webcor.com
Hayward
www.webcor.com
No. 2, 2003
11
Chapter Calendar 2003
www.ispe-sf.org
JUNE 5
Dinner Meeting: Industry Growth Initiatives for BioTech
Presenter: Sue Markland Day, Director, Government
Relations (former President), Bay Area Bioscience Center
at San Francisco Airport Marriott
JULY 15
Newsletter Deadline Issue #4, 2003
JULY
Commuter Conference
AUGUST 14
Fun Day Golf Tournament/Wine Tour
Stone Tree Golf Course in Novato with Sonoma Winery
Tour
SEPT 5
Dinner Meeting
SEPT 24-25
INTERPHEXCalifornia, San Jose
Wednesday, September 24, 2003
Seminars on:
1. GMP for Pharmaceutical & Biotech Industries
2. Engineered Solutions to Environmental Issues in
Research Facilities
• Energy Solutions with Low Flow Hoods
Presenter: Gerhard Knutson, Knutson Ventilation
• Corralling solvents within Fire Code Limits: Solvent
Waste & Solvent Distribution
Presenter: Jeff Tarter, Principal Chemical Engineer,
Integrated Engineering Services
Panel discussion to follow with the additional panelists:
Jim Messelbeck: Director EHS, Genentech
Melody Spradlin: Senior Manger Labs & Office Group,
Genentech
3. Greater Los Angeles Chapter Presenting:
Global Standardization
• How do companies with multiple locations standardize
their operations?
Registration Form in next newsletter.
OCTOBER 1
Newsletter Deadline Issue #5, 2003
NOVEMBER 2-6
ISPE Annual Meeting, New Orleans Marriott
www.ispe.org
NOVEMBER 10
Newsletter Deadline Issue #6, 2003
DECEMBER
Dinner Meeting
San Diego Chapter Web site:
www.ispe.org/sandiego
Greater Los Angeles Chapter Web site:
www.ispe.org/greaterla
June 5th Meeting
Industry Growth
Initiatives for
BioTech (continued)
growth of the Bay Area’s biotech
industry. The gathering was organized by a variety of groups, including the California Department of
Technology, Trade and Commerce
and the Bay Area Bioscience Center.
The goal of this panel is to develop a
plan utilizing the synergies of the
biotech industry already present in
the area and to attract new companies, with the organizers targeting to
present a wish list to city, county and
state lawmakers this spring.
Sue Markland Day will discuss the
activities of the panel since the inaugural meeting last Fall, and discuss
some of the ideas being developed
to meet the regional challenges and
encourage growth in the Bay Area’s
biotech industry.
For those traveling to the Bay Area
for this meeting, a complimentary
shuttle service is available from San
Francisco International Airport 24
hours a day.
To register, please see registration
form inside the newsletter.
ISPE Your
Strategic Partner
for Lifelong
Learning
I
SPE is the Society of
choice for nearly 20,000
Life Science professionals in 75 countries. Founded in 1980,
ISPE aims to enhance industry practices by providing members with
opportunities to develop technical
knowledge, exchange practical experience, and collaborate with global
regulatory agencies. Visit
www.ispe.org for additional Society
news and information.
ISPE San Francisco / Bay Area Chapter
The Society for Life Science Professionals
c/o Attention To Detail
111 E. Avenida San Gabriel
San Clemente, CA 92672
949/366-1056
TOLL FREE CHAPTER PHONE NUMBER
(888) 275-0189
Meeting notices are sent via email
To update your mailing address or information or to receive
Chapter information, please email us
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ADDRESS CORRECTION REQUESTED
San Francisco / Bay Area Chapter
2003 Board of Directors
OFFICERS
President:
Ed Shea, Dome Construction Corp.
ed_shea@domeconst.com
(415) 641-0800
fax (415) 642-2812
Vice President:
Melody Spradlin, Genentech
melodys@gene.com
(650) 225-1799
fax (650) 225-8544
Treasurer:
Andy Nelsen, ALZA Corporation
andy.nelsen@alza.com
(650) 564-5011
fax (650) 564-5129
Secretary:
Greg Burg, Hathaway Dinwiddie Construction
burgg@hdcco.com
(650) 725-7800
fax (650) 725-7810
DIRECTORS
Greg Banks, BanzigerBanks, gbanks@banzigerbanks.com
Diane Bottini, Dome Construction, Diane@domeconst.com
Mike Britting, Lem Construction Inc. (LCI), mikeb@lcilem.com
Michael Faber, ALZA Corporation, michael.faber@alza.com
Mark Hannon, Genentech, hannon@gene.com
John Hughes, Total Validation Services, Inc., johnhughes@tvsinc.com
Linda Karr, Chiron Corporation, linda_karr@chiron.com
John Kelley, Facilicorp, johnk@facilicorp.com
Rob Lynch, Dome Construction, rob@domeconst.com
Joe Tarantino, Nektar Therapeutics, jtarantino@ca.nektar.com
Rob Zwolinski, Aradigm, zwolinskiR@aradigm.com
Past President:
ISPE Liaison:
Jon Sheh, Johnson & Johnson, jsheh@corus.jnj.com
Max Yonker, Geron Corporation, MYonker@Geron.com
Chapter Past Presidents:
Jon Sheh, Johnson & Johnson
2002
Scott Laskey, Bay-Tec Engineering
2001
Haleh Banisadr-Hughes,
Total Validation Services, Inc.
2000
Jeff Hargroves, Ivy Animal Health
1999
Sue Cost, bioKinetics
1998
John Sugerik, Retired
1997
Dennis Mosher, Bay-Tec Engineering
1996
Ian MacLaren, Kinetics
1995
Pete MacArthur, ALZA Corporation
1994
Burt Van Loon
1993