Outgoing President`s Message

Transcription

www.ispe.org/sanfrancisco
Published by ISPE San Francisco/Bay Area Chapter
Serving Northern California
Editor: Kimberly Syre
Email: [email protected]
Information: Phone 1.949.387.9046
Fax 1.949.266-8461
NEWSLETTER
Volume 16, No. 6
In this issue
Outgoing President’s Message
PAGES 1-2
10 September Contract Manufacturing
and Technology Transfer
PAGES 3-4
ISPE Annual Meeting Key Note Speakers
PAGE 5
Fun Day Overview
PAGE 6
Thank You Fun Day Sponsors
PAGE 7
Thank You Winery Tour Sponsors
PAGE 11
Congratulations to the 1st Place Winning Golf Team:
Advance Design Consultants, Inc. (ADC)
(L-R): Andrea Zarour of Greater Bay Mechanical,
Renato O’Neal of ADC, Nichole Stephenson of Teledata
and Lorenzo Rios of ADC.
Overview of Amgen Tour
PAGE 12
15 Sept Supply Chain Management
PAGES 13-14
See This Year’s Fun Day Golf Tournament and Winery Tour
Photos Throughout The Newsletter
Overview of May Vaccine Meeting
PAGE 15
7 October New Member Breakfast
PAGE 16
Outgoing President’s Message
Volunteer Appreciation Day
PAGE 17
Members Select Email Preferences
PAGE 19
Student Leadership Forum
PAGE 20
Industry News
PAGES 23-24
Welcome New Members
PAGE 26
Chapter Committees
PAGE 27
Board of Directors List
PAGE 28
Share Your Knowledge
LEED Training
PAGE 29
Chapter Calendar
PAGE 30
A
by Greg Banks of Banks Integration Group
s I am winding down my activities as President, I want to personally thank all
of you who served on the various Committees. This has been a very rewarding
year for me, and I thank all of you for your participation. For your information,
approximately 80 individuals volunteered their time to bring the ISPE programs to you
locally. The variety of programs this past year included six commuter conferences, four
dinner programs, two facility tours, Vendor Night, Fun Day Golf Tournament and Winery
Tour, two New Member Breakfasts, and 10 community outreach programs. Every month
of the year there is an ISPE activity available to you in the SF Bay Area.
In July, I had the unique opportunity to participate in the International ISPE Strategic
Planning Meeting. This was an intense four day session of discussion and reflection on
where ISPE has come from and where it is going. As the pharmaceutical and related
(continued on next page)
November
Commuter
Conference:
Outgoing
President’s
Message
(continued)
November
Commuter
Conference:
Medical
Devices
and Facilities
Facilities
and
industries have been hit hard by the Medical
global economicDevices
downturn,
T
ISPE he
willNovember
be forced to
make some
major changes
in on
order
to
Commuter
Conference
focused
on
Medical
Devices
he
November
Commuter
Conference
focused
on Medical
Medical
Devices
he
November
Commuter
Conference
focused
Devices
and
Facilities.
Thank
you
to
our
presenters
Charles
Parnham,
PhD,
and
Facilities.
Thank
you
to
our
presenters
Charles
Parnham,
PhD,
weather
the
current
storm.
The
goal
of
these
changes
will
be
and Facilities. Thank you to our presenters Charles Parnham, PhD,
PE,
Principal
of
Parnham,
Inc,
and
Donan
Donnelly,
Director
of
PE,
Principal
of
Parnham,
Inc,
and
Donan
Donnelly,
Director
of
PE,
Principal
of
Parnham,
Inc,
and
Donan
Donnelly,
Director
of
designed to strengthen the organization and add value to our
Manufacturing
Engineering
for
Inc.
Manufacturing
Engineering
for Intuity
Intuity Medical,
Medical, Inc.
Inc.
Manufacturing
Engineering
Intuity
Medical,
Members. At the
conclusionfor
of the
meetings,
Bob Best, ISPE
President/CEO,
seclusion to summarize
the
ses- compoMedical
products
with
pharmaceutical
and
medical
device
compoMedical
products
with
bothinto
pharmaceutical
and medical
medical
device
compoMedical
productsretreated
with both
both
pharmaceutical
and
device
nents
are
finding
their
way
into
the
market.
This
presentation
provided
nents
are
finding
their
way
into
the
market.
This
presentation
provided
sion
and
write
the
coming
year’s
business
plan.
An
overview
of
nents are finding their way into the market. This presentation provided
an
overview
of
medical
device
Design
Control
process
as
applies
to
an
of
the
medical
device
Design
Control
process
as ititit applies
applies to
to
an
overview
of the
the
as
theoverview
plan should
be medical
availabledevice
by theDesign
Annual Control
Meetingprocess
in Novemthe
design
of
medical
devices,
the
design
of
the
manufacturing
process
the
design
of
medical
devices,
the
design
of
the
manufacturing
process
the design of medical devices, the design of the manufacturing process
ber.
of
design.
was
noted
that
of
medical
devices,
and the
the impact
impact on
on facilities
facilities design.
design. ItItIt was
was noted
noted that
that
of medical
medical devices,
devices, and
and
the
impact
on
facilities
the
outweigh
the
additional
reguthe
advantages
of
combination products
products far
far outweigh
outweigh the
the additional
additional regureguthe advantages
advantages of
of combination
combination
products
far
latory
however,
as
project
team
is
latory
burden;
however,
the
burdens
as aaa project
project team
team is
is
One ofburden;
the main
topics ofunderstanding
discussion, forthe
theburdens
area I participated
understanding
the
burdens
as
aa challenge
that
must
be
addressed
as
a
team.
Specific
examples
were
challenge
that
must
a
team.
Specific
examples
were
be
addressed
as
a
team.
Specific
examples
were
in, included a reflection on young professionals. ISPE as an
discussed,
an
implantable
medical
discussed, including
including an
an injectable
injectable medical
medical device,
device, an
an implantable
implantable medical
medical
medical
device,
organization
has
a large gap
between
our strong
Student
device,
in-vitro
diagnostic,
and
drug
delivery
system,
and
the
device,
in-vitro
diagnostic,
trans-dermal
drug
delivery system,
system, and
and the
the
and a
a trans-dermal
trans-dermal
drug
delivery
Chapterthat
program
the mid
career
professional.
As a result,
impacts
these
products
had
on
design.
impacts
that
theseand
products
had
on facilities
facilities
design.
facilities
design.
Photo
(L-R):
Charles
Parnham
of
Parnham,
Inc,
Photo(L-R):
(L-R): Charles
CharlesParnham
Parnhamof
ofParnham,
Parnham,Inc,
Inc,
Photo
we will be focusing on strengthening this area in the coming
Paul
Gillick
of
LifeScan,
and
Donan
Donnelly
Paul
Gillick
of
LifeScan,
and
Donan
Donnelly
of
Paul
Gillick
of
LifeScan,
and
Donan
Donnelly
ofof
A
special
thank
you
to
Paul
Gillick
and
Christine
Phillips
at
LifeScan
for
A
special thank you to opportunities
Christine Phillips
Phillips at
at LifeScan
LifeScan for
for
Paul Gillick and
year. There will be big
for Christine
young professionals
Intuity
Medical,
Inc.
Intuity
Medical,
Inc.
Intuity Medical, Inc.
coordinating,
coordinating, hosting,
hosting, and
and sponsoring
sponsoring event
event in
in Milpitas.
Milpitas.
Greg Banks and his golf team at Fun Day. (L-R) Kristen
(including professionals transitioning into the industry) to get
Dezzani, Mike Lindsey, Greg Banks and Derek Hansen.
involved in developing the programs that would most interest
them. Our SF Bay Area Chapter has volunteered to organize a
pilot program to help identify and/or develop a set of programs
designed specifically to Classroom
meet the needs Training
of young professionals.
ISPE
ISPE
Lower
Production
Costs,
Improve
Process
Efficiency,
LowerProduction
ProductionCosts,
Costs,Improve
ImproveProcess
ProcessEfficiency,
Efficiency,
Lower
Increase
Production
Quality,
and
Meet
Regulatory
Requirements
IncreaseProduction
ProductionQuality,
Quality,and
andMeet
MeetRegulatory
RegulatoryRequirements
Requirements
Increase
Lower
Costs,
Process
Lower Production
Costs, Improve
Process Efficiency,
I look forward
to Production
continuing
my Improve
participation
inEfficiency,
our local
ChapIncrease
Production
and
Requirements
Increase
Quality,
and Meet
Meet Regulatory
Regulatory
Requirements
Production Quality,
ter, and I hope to see as many of you as possible at this year’s
Chicago
Classroom Training
Chicago Classroom
Training
Annual Meeting
in San
11-14
2009
2009Diego.
11-14 May
May
Hyatt
Hyatt Rosemont,
Rosemont,
Chicago,
Illinois, USA
Chicago, Illinois,
USA
www.ISPE.org/chicagotraining
Greg Banks
Sponsorships
Available
Sponsorships Available
Classroom Training
Training
Classroom
09
Philadelphia
Classroom
Training
Philadelphia
PhiladelphiaClassroom
ClassroomTraining
Training
5-8
October
2009
5-8
5-8October
October2009
2009
Hilton
Philadelphia
Airport,
Hilton
HiltonPhiladelphia
PhiladelphiaAirport,
Airport,
Philadelphia,
Pennsylvania,
USA
Philadelphia,
Philadelphia,Pennsylvania,
Pennsylvania,USA
USA
www.ISPE.org/philadelphiatraining
Sponsorships
Available
Sponsorships
SponsorshipsAvailable
Available
09
Validation Equipment
Calibrations
In
In A
A Sea
Sea
two to three-day typical turnaround
Of
Of Change,
Change,
Validator
2000
& Digi Strips
Some
Things
Some
Things
IRTD, HTR, LTR, CTR
Are
Are Constant.
Constant.
RH/CO2 Sensors
Hart/Fluke Meters & Probes
Carsten
Carsten Nicolia
Nicolia Petersen
Petersen
Coast
Branch
Branch Director
DirectorWest
West Coast
NNEPharmaplan
Pharmaplan
NNE
NNE
Pharmaplan
3583Investment
Investment Blvd.,
Blvd., Suite
Suite
3583
3583
Investment
Blvd.,
Suite 15
15
Hayward,CA
CA94545,
94545, USA
USA
Hayward,
Hayward,
CA
94545,
USA
Tel.:+1
+1(866)
(866)810-4073
810-4073
Tel.:
Tel.:
+1
(866)
810-4073
Cell: +1
+1(510)
(510) 586-7621,
586-7621, Fax:
Fax:
Cell:
Cell:
+1
(510)
586-7621,
Fax: +1
+1 (510)
(510) 783-4345
783-4345
ALLEGHENY
BRADFORD
ALLEGHENY
BRADFORD
ALLEGHENY
BRADFORD
CORPORATION
CORPORATION
CORPORATION
ValidationManager
and
Calibration
Services
Regional
- --Dori
Carlson
Regional
Manager
Dori
Carlson
Regional
Manager
Dori
Carlson
[email protected] www.nnepharmaplan.com
[email protected]
[email protected]
www.nnepharmaplan.com
1522
1522
South
Ave.,
Lewis
Run,
PA
16738
1522South
SouthAve.,
Ave.,Lewis
LewisRun,
Run,PA
PA16738
16738
Skids
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Tanks
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Skids•••Tanks
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Building Great Things.
MM
. ..
MTTTI II CCCAAALLLI IIFFFOO
ORRRNN
NI IIAAA, ,, I IINN
NCCC
Scott
Scott
McDonald,
President
ScottMcDonald,
McDonald,President
President
smcdonald@[email protected]
[email protected]
ca.com
Main:
Main:
(925)
937
1500
Fax:
(925)
937
8518
Main:(925)
(925)937
9371500
1500 Fax:
Fax:(925)
(925)937
9378518
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www.mti-ca.com
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152
Specializing
Specializing
in
Control
Systems
Specializingin
inControl
ControlSystems
Systems
Design
Design
Validation
Design&&
&Validation
Validation
Contract Manufacturing and Technology Transfer
Dinner Meeting on September 10, 2009
Herwig Kapeller studied Biotechnology at the Technical
University Graz (Austria). After a post graduate fellowship with the Institute of Food Research in Reading,
England, he started working for a pharmaceutical company in Austria.
Join us on Thursday, September 10th at the Vacaville
Opera House in Vacaville where we will feature two
industry speakers on Contract Manufacturing and
Technology Transfer.
Dan Moskey, Associate Director at Genentech,
Vacaville Technology will present Contract
Manufacturing in Biotechnology.
In 1996 he joined Sandoz (Novartis subsidiary) in
Austria where he held several positions involving
responsibilities in large scale fermentation of small molecules and recombinant proteins, scale-up and tech
transfer activities. Currently he is enjoying his international assignment with Novartis Vacaville, where he is
responsible for the Manufacturing Technology group
Alpha
Innotech
and
the
transferCorp.
of two microbial recombinant proteins
Has the
entered
into a five
into
Vacaville
site.year Strategic Supplier Alliance
dustry The
News
second speaker, Herwig Kapeller, Director of
Industry News (continued)
Manufacturing Technology at Novartis Pharmaceuticals
edlin ofwillSani-tech
West
present Technology Transfer
Biotechnology.
byinSandra
Medlin, Sani-tech West
med at
es. As
ctions
gen
er four
za-
gram
een-
ww.
for
liver
m to
nsand
aghe
arded
roxin
’s
XOMA
Ltd Inc.
Affymetrix
About
the Presenters:
Has
been awarded
$65 millionamultiple
year
contract
from
Announced
thathas
theaover
PhyloChip,
Affymetrix
microarDan Moskey
15 yearscustom
experience
in the
biothe
National
Institute
of
Allergy
and
Infectious
Diseases
ray developedindustry
by Lawrence
Berkeley
National and
Laboratory,
won
tech/pharma
focusing
on
transfer
opera(NIAID),
a component
of2008
the National
Institutes
ofTechnology
Health, to
the
bronze
prize
in
the
Wall
Street
Journal
tion of biologic
processes.
As Tech of
Transfer
Lead for
support
XOMA’s
ongoing
development
drug candidates
Innovation
Awards.
The PhyloChip
helps researchers
identify
a majorclinical
insourcing
project
enteringofthe
CCP2poisoning,
facility in
towards
trials
in
the
treatment
botulism
dangerous pathogens before they can affect humans. The
has
been
responsible
forinoverall
impleaVacaville,
potentiallyhe
deadly
muscle
paralyzing
disease.
contract
PhyloChip
was
the only
biotech
company
theThe
top three
to
is
the
third
that
NIAID
has
awarded
to
XOMA
for
the
developmentation.
He
is
also
the
Engineering
Core
Team
be recognized. There were 700 total entrants.
ment
of botulinum
antitoxins andrequired
brings the
total to
Leader
for the modifications
to program’s
support the
nearly
$100
million.
project.
Dynavax technologies Corporation
Agreement with GE Healthcare. This agreement is a continuation and expansion of the previous OEM Agreement signed
between the two companies in April of 2005.
Driving Directions to Vacaville Opera House
From
Sacramento:
Gilead Sciences, Inc
33.9
Miles
Announced that the company has completed its acquisition
Take
I-80 westbound
to theInc.
Mason
Street Exit.
from Electronics
For Imaging,
of a building
located at 301
Merge
St. land in Foster City. The acquisiVelocityonto
Way Depot
and adjacent
tion covers
existing
301go
Velocity
Wayto
building
Turn
Left atthe
Mason
and
3 Streets
Davis of
St.approximatelyRight
163,000
squareSt.
feet and approximately 30 acres
Turn
at Davis
designed to
accommodate
an additional
square
Vacaville
Opera
House isuponto the
corner of542,000
Davis and
feet
of
office
space.
The
building
and
associated
land
border
Main St.
Announced it has been awarded a $17 million contract to
BioMarin
Inc.
develop
advanced
technolFor
the 5itsPharmaceutical
years
priorimmunostimulatory
to Vacaville,
Mr. sequences
Moskey was
an
Has
opened
a new office
in Brisbane,
California,
to expand
its
ogy
using
Toll-Like
Receptor
9
agonists
as
vaccine
adjuvants.
Associate Director in Manufacturing Collaborations out
drug
development
operations
and
better
meet
the
increasing
This
five-year
contract
was
awardedHe
by led
the multiple
National Institutes
of
South
SFthe
as
well as
Boston.
demands
of
company’s
product
pipeline. biologic
The comof Health’s
National
Institutegrowing
of Allergy
and Infectious
tech will
transfers
toapproximately
CMOs on the
east square
coast and
pany
occupy
20,000
feet Europe,
of office
Diseases to develop novel vaccine adjuvant candidates
that
including
3 years
transferring
and supporting
the manuspace
of theofSan
International
signallocated
throughnorth
receptors
the Francisco
innate immune
system. Airport
The
facture
of
Rituxan
at
the Lonza
Biologics
manufacturing
at
2000 Sierra
Point
Parkway,
adjacent
tofor
Highway
101.
Theas
contract
supports
adjuvant
development
anthrax
as well
facility
will
house
staffNH.
in biostatistics,
statistical
programming,
site
Portsmouth,
Dan’s prior
experience
includes
otherindisease
models.
clinical
data management,
medical
writing
and other clinical
development,
manufacturing,
and
management
posidevelopment
functions.
The
new
Brisbane
office isBiologics
part of a
Baxter
International
Inc.
tions
with
BASF Bioresearch,
Massachusetts
larger
expansion
that
has progressed
throughout the
Mayorcorporate
Richard and
M.
Daley
and
Chicago
Public Schools
Laboratories,
Abbott
Laboratories.
past
two years
includes
the recent
of 300
Bel
announced
thatand
Baxter
International
Inc.purchase
will donate
$5 milMarin
Keys
Boulevard
in Novato.
A multinational
company,
lion
over
five
years
to
support
CPS
district
science
initiatives
He earned a BS in Bioengineering from Western
BioMarin
Pharmaceutical
officeseducation
in the United
States,
— the first
program ever operates
to fund biotech
in CPS
New England
College,
and
MS inEast,
Engineering
United
Brazil and
thean
Middle
with employees
in
history.Kingdom,
This significant
contribution
has the potential
to impact
Management
from
Tufts
University.
more
dozen
morethan
thana450
CPScountries.
teachers through professional development and 75,000 students — all at the(continued
junior highon
and
high
next
page)
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.
VALIDATION
TRAINING
Gilead’s Foster City campus, the company’s headquarters
since 1988.
From San Francisco:
65.8
Miles
Bayhill
therapeutics, Inc.
Take
US-101
North.
Joins the
Juvenile
Diabetes Research Foundation, the world’s
Continue
on I-80funder
Eastbound
leading charitable
of typeto1 Vacaville.
diabetes research, in a
partnership
to support
Exit
onto Davis
ST. Bayhill’s ongoing Phase I/II human clinical trial
of to
BHT-3021,
a DNA St.
vaccine to reverse the immune
Turn
Left
stay on Davis
response
that
causes
type
1
diabetes.
Slight Left at E. Main St.
Vacaville Opera House is on the corner of Davis and
The source of this information is the ISPE Web site, conMain St.
firmed on company websites.
Be sure to look up driving directions
from your own starting point.
COMMISSIONING
Steven R. Page
AUDITS
Business Development Manager
500 Airport Blvd, Suite 100 • Burlingame, CA 94010
(888)
242-0559 • Office (650) 320-1788 • [email protected]
Fax (650) 320-1789
phToll-Free
+1 (925)
771-1119
cell +1 (925) 639-7997
5099 Commercial Circle, Suite 102
www.propharmagroup.com
fax +1 (925) 937-8875
Concord, California 94520 USA
3
Skanska USA Building based in Oakland, performs
construction management, general contracting,
design-build and project financing services.
ISPE San Francisco/Bay Area Chapter
Contract Manufacturing
and
Technology Transfer
Dinner Meeting
Thursday, September 10, 2009
Vacaville Opera House
560 Main Street
Vacaville, CA 95688
Tel: (707) 453-0393 Reception
Dinner Presentations
4:30 - 5:30 pm
5:30 - 6:30 pm
6:30 - 8:30 pm
I-80 to Vacaville, corner of Davis/Main St.
PRESENTERS:
Contract Manufacturing in Biotechnology
Dan Moskey
Associate Director
Genentech, Vacaville Technology
Technology Transfer in Biotechnology
Herwig Kapeller
Director of Manufacturing Technology
Novartis Pharmaceuticals
R E G I S T R A T I O N
F O R M
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Signature:
I
NASA, World Health Organization, and Harvard Representative to
Give Keynotes at Annual Global ISPE Event
SPE has announced that it has secured Samuel Bogoch
MD, PhD, a faculty member at both Harvard Medical
School and the Boston University School of Medicine,
Lembit Rägo MD, PhD, Coordinator of Quality Assurance and
Safety: Medicines Essential Medicines and Pharmaceutical
Policies at the World Health Organization (WHO), and Antonio
J. Ricco, PhD, Chief Technologist for Small Payloads and
Instrumentation in NASA Ames Research Center’s Small
Spacecraft Division to give keynote presentations at the ISPE
2009 Annual Meeting November 8-11 in San Diego.
Antonio J. Ricco, PhD, is Chief Technologist for Small
Payloads and Instrumentation in NASA Ames Research
Center’s Small Spacecraft Division, on loan from Stanford
University’s Department of Electrical Engineering and Center
for Integrated Systems. At NASA, Ricco develops remote,
autonomous bioanalytical systems for fundamental space biological studies; serves as chief technologist for the GeneSat,
PharmaSat, and O/OREOS flight projects; and is instrument
lead for the MEMS-based NIR spectrometer on the LCROSS
lunar impactor. Ricco is Vice President of the Transducer
Research Foundation and a member of NASA’s Lunar
Exploration Analysis Group.
“The Keynote Session—with its impressive list of highly
respected and credentialed speakers—is just one of the many
opportunities at ISPE 2009 Annual Meeting for pharmaceutical professionals to learn about emerging global industry
trends and practices,” said Robert P. Best, President and
CEO of ISPE. “The meeting’s content-rich education sessions
also provide critical information and interaction with industry
experts and regulatory authorities. This year’s theme, ‘Thriving
in a Survival Environment,’ will resonate with industry professionals around the globe and is the Society’s ‘do not miss’
event of the year.”
ISPE 2009 Annual Meeting Highlights
Education sessions at the 2009 ISPE Annual Meeting will
follow 11 tracks of interest: Survival, Product Development,
Facilities and Equipment, Information Systems, Supply
Chain Management, Production Systems, Regulatory
Compliance, Quality Systems, Investigational Products, Project
Management, and Supplier-focused. Networking activities,
exhibits, and special events will also allow for one-on-one time
with colleagues for further knowledge and best practice sharing.
Information About the Speakers
Samuel Bogoch MD, PhD, is chairman of Replikins, Ltd., in
Boston, Massachusetts, USA, and faculty at both Harvard
Medical School and the Boston University School of Medicine.
Dr. Bogoch’s areas of research include chemical structure and
virus receptor properties of brain gangliosides, inhibition of
virus attachment to brain cells, structure and function of brain
glycoproteins, biochemistry of cancer, serum antibodies to
cancer antigens, the replikins, genomic peptides associated
with rapid replication, quantitative relation of replikins to virus
outbreaks, and advance warning of H5N1.
2009 Facility of the Year Award Winner Announcement. In
addition to the educational offerings, the overall 2009 Facility
of the Year Award winner will be announced for the first time
during the Keynote Address. Category winners for 2009
are Aseptic Technologies - Equipment Innovation Winner;
Centocor Biologics Ireland - Sustainability Winner; Centocor
R&D Schaffhausen - Facility Integration Winner, Hameln
Pharma - Operational Excellence Winner, Orchid Chemicals
& Pharmaceuticals - Regional Excellence Winner, and Roche
Pharma Biotech Production Basel - Project Execution Winner.
ISPE Membership and Awards Ceremony will be held 10
November, and reveal the winners of the ISPE Member of the
Year, Company of the Year, Chapter or Affiliate of the Year,
International Student Poster Competition winner, among many
others.
Lembit Rägo MD, PhD, is Coordinator, Quality Assurance and
Safety: Medicines Essential Medicines and Pharmaceutical
Policies at the World Health Organization (WHO) in Geneva,
Switzerland. In December 1999, he joined the WHO in the
Department of Essential Drugs and Medicines Policy where
the areas of medicine nomenclature, quality standards,
regulatory guidelines, safety and pharmacovigilance, are
addressed. Since 2000, he has been the WHO observer to
the International Conference on Harmonization of Technical
Requirements for Registration of Pharmaceuticals for Human
Use (ICH) Steering Committee.
Certified Pharmaceutical Industry Professional™ (CPIP™)
introduction workshops will be held 9-10 November to provide
information about this program and examination overview.
How-to workshops will be held 9-11 November to provide information on how to submit a CPIP eligibility application and prepare for the CPIP examination.
2nd Annual COP Night will be held 9 November. ISPE’s 19
Communities of Practice (COPs) are teaming up to offer
attendees an experience customized to their interests where
friends and colleagues can network in a fun-filled, relaxing
atmosphere.
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Table Top Exhibition will be held 8-10 November to showcase
products and services from the industry. For information, contact Dave Hall at (813) 960-2105 or visit
www.ISPE.org/AnnualMeeting/exhibits.
5
You can also call (813) 960-2105 for more information or to
register for this premiere event.
Fun Day Overview
by Tara Davis of Bayer
T
he ISPE San Francisco Chapter hosted the 15th annual
‘Fun Day’ golf tournament and wine tasting event on
Thursday, July 30th at the Chardonnay Golf Club in Napa,
California. The event attracted more than 200 golfers and 100
wine participants representing clients and suppliers.
Golfers enjoyed playing at the Chardonnay Golf Club, a 27
hole golf facility where the tournament was played on three 9
hole courses (everyone played two of the three tracks). The
golf course was awarded four stars by Golf Digest Magazine.
The winning foursome of the tournament was Advance Design
Consultants, Inc.
Wine tour participants enjoyed wine tastings and wine maker
presentations at the Madonna Estate Vineyard, Truchard, Folio
and Artesa wineries in the Carneros region. The highlight of
the day was an outdoor lobster banquet at Artesa Winery, with
sweeping views of the valley and North Bay.
Thank you to Therma for donating the 42” flatscreen tv that
was raffled off at Fun Day.
Sponsors and prizes were awarded at a banquet reception
following the golf tournament, which provided an opportunity for
golfers and wine tour participants to socialize and network.
Due to the generous support of our event sponsors, we were
able to raise $15k to finance a new “Member Fund” that will
support our Members who do not have the financial means to
pay for ISPE events or to fund their annual membership. This
fund will be administered by the active past presidents and will
be in place by end-September 2009.
ISPE recognizes and understands that the nature of the
economy is extraordinarily difficult for many of our Members.
Some are unemployed yet still want to stay connected to the
industry. Others who are employed are experiencing company
restrictions on spending for outside meetings and events such
as ISPE dinners and tours. The Member Fund supports individuals who have been ISPE members for three or more years
and who want to stay connected to ISPE. We feel strongly
that while we are living in extremely tough times, we need to
support those who have been faithful to ISPE in the past so
that we all can come out of these uncertain economic times
stronger and better educated.
Congratulations to second place golf team:Yonkers Industries,
Jeff Butler and Jason Beck of Yonkers, George Paganini of
BD Biosciences and Pete Shea of Genentech.
Please mark your calendar’s for next year’s Fun Day:
Thursday, July 29th, 2010!
Hundreds of Fun Day photos, both wine and golf, have been posted online by Cynthia Wiggins-Wyrick, the link to the site is:
http://picasaweb.google.com/cwigginswyrick/ISPEFunDay2009July312009?feat=email#
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6
Thank You To This
Year’s Fun Day
Sponsors
Gold Sponsors:
AEPC Group
DES Architects + Engineers
DPR Construction, Inc.
Fluor Corporation
Hyde Engineering + Consulting, Inc.
Novo Construction
Silver Sponsors:
Eichleay Engineers
Kinetics
Navitas/Syserco
Rockwell Automation
Reception Sponsor:
CRB Engineers + Builders
Golf Tournament
Sponsors
Cart Sponsors
E.R. Martinez Consulting
Orcas Project Controls
Pick Your Theme Hole Sponsors
DST Controls
Rudolph and Sletten, Inc.
Beverage Sponsors
Banks Integration
Steris Corporation
Yonkers Industries
Longest Drive Sponsor
Skanska
Putting Contest Sponsor
XL Construction
Closest to the Pin Sponsors
Dome Construction
Technical Safety Services
Therma
Tee Sponsors
Bay-Tec Engineering
ProPharma Group
RS Calibration Services, Inc.
Siemens Building Technologies
Southland Industries
VDK Architects
Photography Sponsor
Cogent Energy, Inc.
7
Fun Day Golf Photos
by Cynthia Wiggins-Wyrick of Cogent Engery
8
Fun Day Golf Photos
9
Fun Day Winery Tour Photos
by Irene Lauren of Forell/Elsesser Engineers
Christy Pavano of CRB Engineers + Builders
Harvey Steinhaus of Dome Construction
and Kimberly Syre, Chapter Manager
10
Thank You
To This Year’s
Fun Day
Winery Tour
and Bus
Sponsors
ACCO Engineered Systems
Affiliated Engineers, Inc.
Bovis Lend Lease, Inc.
Commissioning Agents, Inc.
DeBella Mechanical, Inc.
Duncan Enterprises
Greene Engineers
ISEC, Inc.
M+W Zander
Stantec
Turner Construction
Wine Raffle Sponsors:
Affiliated Engineers
Code Resource
Consolidated Engineering
Decker Electric
Flad & Associates
GCI Construction
Gicklhorn Lazarrotto Partners
Intergrated Engineering Services
Johnson and Fain
Pivote Furniture
11
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.
Gilead Sciences, Inc
Announced 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 acquisiDynavax technologies Corporation
tion covers the existing 301 Velocity Way building of approxiAnnounced it has been awarded a $17 million contract to
develop its advanced immunostimulatory sequences technolmately 163,000 square feet and approximately 30 acres
ogy using Toll-Like Receptor 9 agonists as vaccine adjuvants.
designed to accommodate up to an additional 542,000 square
This five-year contract was awarded by the National Institutes
feet of office space. The building and associated land border
Gilead’s Foster City
campus,
the company’s
headquarters
of Health’s National Institute of Allergy and Infectious
Mr. Burrill spoke on “Biotech/Healthcare
2009:
Navigating
the Sea Change”.
With
Among
the challenges that the project team faced:
n to
May
28, 2009,
70vaccine
Members
of the ISPE
SF/Bay
Diseases
develop
novel
adjuvant
candidates
thatfinancialsince
the world
wide
crisis1988.
healthcare systems around the world are reforming.
Area Chapter
participated
in the
annualsystem.
Facility Tour.
signal through
receptors
of the innate
immune
The aging The
population creates a high demand for new technology but it is too expen• 152 Turnover Packages (TOPs)
year’sadjuvant
tour wasdevelopment
held at Amgen’s
Fremont
contract This
supports
for anthrax
asFacility
well
as
Bayhill
therapeutics,
Inc.
sive to treat
everyone.
The impact
of the US election
and the Obama administration
• 132 System Starts
and
featured
the
newly
constructed
and
validated
West
Train.
other disease models.
Joins the
JuvenileMedicare
Diabetesnegotiating
Research Foundation,
world’s
will include stricter regulatory
oversight,
what it pays the
for drugs,
• Approximately 50 Change Controls
leading charitable
of type
1 diabetes
in a
and more generics. Healthcare
costs arefunder
unevenly
distributed
withresearch,
0.5% of patients
• As-built drawings that did not reflect interstitial spaces to
Amgen,International
one of the pioneering
and most successful biotechBaxter
Inc.
to support
Bayhill’s
ongoing
Phase I/II
human
consuming 25% of thepartnership
healthcare budget,
10%
of patients
consuming
70%
of theclina high enough degree of accuracy, requiring the use of a
nology
companies,
acquired
the
Fremont
facility
as
part
of
Mayor Richard M. Daley and Chicago Public healthcare
Schools budget andical
trialofof
BHT-3021,
a DNA vaccine
to reverse
immune
75%
the
cost of healthcare
is for patients
withthe
chronic
Building Information Management System to 3-D model the
Abgenix, Inc.
in Baxter
2006. The
facility manufactures
the human
announced
that
International
Inc. will donate
$5 milresponse
that causes
diabetes.detection and intervendiseases.
Modern healthcare
delivery
focus type
is on 1late-stage
areas
therapeutic
for the
treatment
of metastatic
lion
over fiveantibody
years toVectibix®
support CPS
district
science
initiatives
tion, medical
professionals are paid for illness rather than wellness and there are
colorectal
cancer.
sourceincentives
of this information
is theWe
ISPE
Web
site, con— the first program ever to fund biotech education
in CPS
inadequate
social and The
economic
for wellness.
arewithin
now confronting
Nonetheless,
project cost
was reconciled
10% at timethe
to
history. This significant contribution has the potential
to impact
firmed
on company
websites.
imbalance
between infinite
demand
and
finite
resources.
The
three
forces
shap= 0, 30%, 60%, and 100% completion.
Activities commenced with a catered registration/networkmore than 450 CPS teachers through professional
ing thedevelopevolution of healthcare are: access, cost and quality of care, molecular and
ing reception, featuring a particularly tasty selection of hors
ment and 75,000 students — all at the junior personalized
high and highmedicine, and proficient use of information.
The Facility Tour then began with participants assembled into
d’oeuvres and beverages.
school level — who by the year 2012 will benefit from the new
four groups and led by Amgen tour guides. The tour included
innovative schools, enhanced teacher skill set,
materials,inand
Healthcare
2020 willamove
to consumer
distribution
centers
staffed
byand
nurse
pilot plant
area, existing
operation
of the
plant,
thepracThe presentation began with Chapter President Greg Banks
direct interaction with Baxter scientists and engineers.
titioners with testing and
pharmacy
facilities,
there
will
be
specialized
delivery
centers
project-specific areas.
awarding certificates of appreciation to both Amgen and
for comprehensive cancer and cardiovascular needs, with home diagnostics and
Projects Director Scot Thomas for organizing the ISPE tour.
monitoring. Medical devices
and telecommunications
technologies
areAmgen
converging
ISPE SF/Bay
Area Chapter would
like to thank
for to
develop
monitoring
devices
for
patients
with
chronic
diseases.
With
genetic
testing
VALIDATION
COMMISSIONING
organization and hosting such a memorable tour, and most
Scot
provided an outline of the West Train
project, which was
and understanding
of the
biochemical
of most diseases, there will be a
especially
Scot mechanisms
Thomas.
a bulk manufacturing expansion to support increased
ferpersonalization
of
healthcare.
The
development
and
validation of biomarkers in drug
mentation and purification capacity. Among the design goals
of the project was to maintain the aesthetics development
of the originalwill greatly enhance the personalization of healthcare.
CEO Night
May Facility
TourOverview
of Amgen(continued)
Fremont Facility
By LeRoy
GinnCooper
of ACCO
Systems
by Michael
of Engineered
Bayer HealthCare
O
Abgenix facility, including viewing corridors for regulatory
Healthcare will move from sickness to wellness with personalization, prediction,
agencies to observe manufacturing flow.
prevention and patient responsibility. The big new biotech markets are Alzheimer’s
and memory,
obesity, diabetes, metabolic disease, anti-aging, anti infectives, and
Working with general contractor Fluor Enterprises,
the project
TRAINING
AUDITS
wellness
(preventatives).
The government is also working on wellness with patent
was completed in 15 months on budget and with zero lost
reforms,
increased
FDA
resources,
medicare prescription Drug Price Negotiation Act,
time accidents.
funding of stem cell research, and passing of the Genetic Information NonToll-Free (888) 242-0559 • Office (650) 320-1788 • Faxfederal
(650) 320-1789
Discrimination Act as some examples. The world market for health and wellness is
www.propharmagroup.com expanding and governments worldwide are taking part.
The financial implosion has changed things, development
money
in Oakland,
performs
S p e c i a l i z i n g i n B Skanska
i o p hUSA
aBuilding
r misbased
Pavailable
ro
c e sbut
ses
constructionapproval,
management, general
contracting,efexpensive, few IPOs, more PIPEs, higher bar for regulatory
and capital
design-build
andisproject
financing services.
ficiency is required. But the rate of start-ups around the
world
increasing.
Skanska Life Sciences is consistently ranked in the
top five in the Pharmaceuticals category of
Mr. Burrill made predictions for biotech in 2009. Among his predictions were a bio-cleantech boomEngineering
in non-food
crops, that clusters
News-Record’s Top 400 Contractors.
will be redefined – away from geography to virtual clusters (diseases, markets,
industry segments), business models will continue
Brian Vaughn
For more information please contact:
of Business
Detail Design Specifications
to evolve, industry consolidation will continue to occur and startups will Director
continue
to findDevelopment
capital.
Drew Smith, Project Executive
Ext. 223
Skanska USA Building
1999 Harrison Street, Suite 1950
 Electrical
 Chemical
Thank youMechanical
to our Membership
Committee
for greeting everyone and handling the registration for the
meeting: Ulrike Ruppelt of
Oakland, CA 94612
Ticular Strategies for Success, Steve Walker of RJA & Associates, Cynthia Wiggins of ES Geotechnologies
and Cindy Reginato of
Ph: 510.285.1800
510.285.1801
1740 Technology
Dr.Suite 210San
JoseCA95110
Hathaway
Dinwiddie Construction
Co (see photo
above). And thank you to Andy Nelsen for takingFax:photos
during the evening.
Tel: 408−200−7200  Fax: 408−200−7201
www.greene−engineers.com
10
Christy Pavano
[email protected]
Phone: 408-367-2050 Cell: 760-685-6232
www.crbusa.com www.crbbuilders.com
CONSULTING n DESIGN n CONSTRUCTION n COMMISSIONING n QUALIFICATION
1312
6
E-mail: [email protected]
C o n t rwww.skanska.com
ol System Engineering
APICS/ISPE Supply Chain Management Conference
Operational Economics of SCM & Cold Chain Supply
September 15th at Genentech
Presented by APICS Golden Gate University Student Chapter
and ISPE San Francisco/Bay Area Chapter
B
* Distribution hazards and environmental profiles
* The newest, most efficient, and cost effective packaging
materials and components
* The latest monitoring devices and Time Temperature Indicating equipment
* The elements of a sound strategy for validating protective
packaging in domestic and global applications
* Documentation (protocols, SOPs and reports) required for
validations and shipping instructions
* The regulatory implications of a weak cold chain management system
ridge the gap between the business units of supply
chain management and manufacturing collaborations
to the engineering fields for facility design and management! This presentation starts at a very high level of the
economics of our industry, looking at the key drivers. What you
will see is a consistency in values from the top of the value
chain and if the company is implementing processes correctly,
you will see the same values reflected in the smaller departments of the organization. The challenge is to have the entire
company thinking of the same vision for their future and understanding the industry to know what their part of the supply
chain means to producing products for the patients.
Attendees will come away with a better understanding of thermal packaging issues and be able to evaluate the strength of
their Cold Chain Management Systems and the Economics of
the BioPharmaceutical Industry.
Information will include:
* The Importance of Collaborations
* Manufacturing Overview
* Materials Management
* Logistics
* Internal Distribution/GDP
* Purchasing & Procurement
* Total Cost of Ownership
* IT and Linking the Suppliers
* GMP Standards and Engineering Practices The Presenters:
Andy Malcolm, P.E., has been a Packaging Engineering
Consultant to the bio-pharm industry on a wide variety of
projects for over thirteen years, the past ten as president of P.
Andrew Malcolm Consulting, Inc. Clients include Genentech,
Bayer, Nektar (Novartis), and ALZA Corporation (J&J), among
others. He also represents Thermal Packaging Solutions, LLC,
a Cold Chain Consultancy to the Healthcare, Pharmaceutical,
and Perishable Goods Industries. They specialize in package design, thermal package testing development, cold chain
management, controlled shipping methods, and regulatory
documentation.
How Strong is Your Cold Chain? The possibility that products
may be exposed to hazardous temperatures and humidity
during shipping and storage is a major concern. The FDA is increasing its scrutiny of the processes and procedures used to
protect sensitive products under its jurisdiction. Companies are
being required to support their shipping methods and demonstrate that a robust, validated Cold Chain Management System
is in place ‘from dock to doc’. The professionals responsible for
safe domestic and global distribution require an understanding
of the processes and resources available to them. Additionally,
key players in the bio-pharmaceutical arena are discovering
that refining their cold chain can also save them money.
Kelly Keen, Sr PM at Genentech, has over 15 years experience in the Biotech Industry and is obtaining an MBA in International Business focusing on SCM, Operational Excellence
and Manufacturing Collaborations. She is President of the
Golden Gate student Chapter of APICS, the Treasurer of the
ISPE SF Chapter and on the ISPE International Training Committee. Her clients have included Genentech, Chiron/Novartis,
Alza, Exilexis & Intermune.
This presentation will assist in understanding the following:
* The physical and environmental stresses on sensitive
products during shipping and storage and how they are quantified
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Commuter
Conference
Commuter Conferences provide an interactive educational forum
for ISPE members, facilitated by local industry experts to discuss
issues critical to our industry. Discussions will generally focus on
the identification of tools, tips, and/or strategies for addressing
these issues. Please be prepared to share your experiences,
successes, and lessons learned.
APICS/ISPE Supply Chain
Management Conference
Agenda:
Hosted and Sponsored by Genentech, Inc.
Tuesday, September 15th, 4:00-7:00 pm
at Genentech, South San Francisco, CA
Operational Economics of SCM & Cold Chain Supply
Presenters:
Kelly Keen, Sr Project Manager, Genentech
Andrew Malcom, PE,, P. Andrew Malcolm Consulting
4:00-4:30 Welcome and Registration
4:30-5:30 Panel Discussion
5:30-6:15 Questions & Answers
6:15-7:00 Networking
Save These Dates:
November 3, 2009 at Amgen
Cosmeceuticals, Neutraceuticals
February 23, 2010
Maintenance Panel, Location TBD
June 8, 2010
GAMP5, Location TBD
Commuter Conference Committee
Chair:
David Bendet, Perkins+Will. [email protected]
Volunteers:
June Jenkins, Oxford. [email protected]
Jesse Villar, Amyris. [email protected]
Gavin Keith, DPR. [email protected]
Stephen Johnson, AB. [email protected]
Rick Ginn, XL. [email protected]
David O’Connell, DCE, [email protected]
Open to APICS and ISPE Members Only
REGISTRATION FORM
Email your registration to [email protected] or fax to (949) 266-8461
If you are not an ISPE member, applications may be obtained at www.ispe.org/sanfrancisco
Space is limited, so sign-up early
PLEASE PROVIDE THE FOLLOWING INFORMATION:
ISPE MEMBER NUMBER:
E-MAIL:
NAME:
TITLE:
COMPANY:
ADDRESS:
CITY:
STATE, ZIP:
PHONE:
FAX:
(Registration confirmation and directions will be sent prior to the meeting)
FREE
14
r 11 Dinner
Meeting (continued)
Overview
of May Commuter Conference on Vaccines
hyde Engineering + Consulting
by Jesse Villar of Ameryis
D
he bioability
t revxal in
ed
ign
s,
ccess
o
portive
• Immunogenic as compared to live
attenuated virus vaccines which are
highly immunogenic
• Inexpensive manufacturing with cell
culture
• Yeast-derived VLP vaccines are
currently marketed products (HPV, HBsAg)
• Rapid turn-around time to construct vaccine strains (<3mo.) could be critical in pandemic flu outbreak situation
• Currently being used to develop vaccine
for Norwalk Virus (Novartis)
According to figures from Dr. Chien, the vaccine business is
currently a $10 Billion business worldwide and expected to
double in the next 5-10 years. Historically, the vaccine busiMs.
presented
the size
between
nessKeen
model
was oneslides
of lowon
profits
and difference
high liabilities.
Typical
cost per dose
for vaccines
is $100
treatments
standard
modules
(those that
go ontoa $200
truck versus
(4 meters
x 4.5
on the order
of Genentech
$20K to $30K.
meters)
vs. the
super modules (9 meters x 9
meters). Also presented were the challenges associated with
Recent geopolitical events (9/11) and global disease outthe interconnects between the modules.
breaks (SARS and now swine flu) have changed the vaccine
business model as the U.S. Government is looking at vaccines
Milestones
for the of
project
as follows:
within the context
publicare
safety
and national defense.
•
All modules on site
April 08
•Current
Mechanical
trends inComplete
the industry include the following: July 08
licensing of technologies between industry and
•• Cross
OQ complete
Novgov08
ernment
to
ensure
availability
of
vaccines
•
Engineering Runs
Dec 08
from
egg based manufacturing to cell culture Jan
based
•• Shift
Qual
Lots
09
technologies
•
Licensure
Oct 09
• Capping of liabilities of vaccine developers and manufacturers
Numerous
slides
were presented
on the logistics
of transport• Profitability
resulting
from government
purchasing
contracts
ing
ship andinmoving
themarketing
modules. Additional slides showed
andby
reduction
need for
the
buildclass
of the
andcalled
the placement
of the modules on
• New
of facility
vaccines
immunotherapies
the site. Of interest was the fact that Genentech secured a
second party shipping company to take care of the cargo
move. Once in Tuas, a detailed route had to be planned to
move the modules from the docks to the site. Fortunately, all
roads in Tuas are also designed to serve as runways in case
of a national emergency so there was plenty of room to move
the modules down the road!
ximMs.
e Red
mix of
ges to
nwith
part as
ide
for
pace
ace
inch
astso
n with
Case Study 2 Highlights
AIDSVAX Development by Vaxgen
• Research started at Genentech in 1984 and continued by
Vaxgen in 1997
• Phase 3 trials; randomized double-blind placebo controlled
initiated in 1998-1999
• Results showed no overall efficacy but suggested subgroup
efficacy
• Cost of development: $280 million
• Further development continued by Global Solutions for
Infectious Diseases
Global Solutions for Infectious Diseases is a non-profit started
by Dr. Francis to develop vaccines for less developed countries. Projects include HIV (vaccine trial, data bases, specimen banks), Dengue Vaccines (PDVI), WHO (polio, influenza),
and Diagnostics.
®
The Commuter Conference Committee would like to thank
Drs. Chien and Francis, and would also like to acknowledge Stephen Johnson and Frank Chiu of Life Technologies
(Applied Biosystems) for hosting and sponsoring the commuter
conference and also the Chapter’s Commuter Conference
Committee member David O’Connell of DC Engineering for
moderating the conference.
Thanks to Dr. Rudi Grimm and Ms. Kelly Keen for presenting
to the ISPE San Francisco Chapter! And thank you to Andy
Nelsen for taking photos of the event.
neering
Products, knowledge, and quality
Valin delivers
itecture
hnology
Valin is the West’s leading supplier of fluid
handling, measurement, process heating,
filtration, motion control and automation
products for a wide range of bio-pharm and
bio-tech applications.
omation
egration
gement
ssioning
urement
gement
Case Study 1 Highlights
Development of Novel Vaccine
Platform Using “Virus Like Particles”
r. David Chien presented an overview of the vaccine
industry and case study on a novel platform technology he helped develop (Virus Like Particles) and use
of the platform to develop a vaccine for the Norwalk Virus. Dr.
Donald Francis presented a case study on the work done at
Vaxgen on an AIDS vaccine and on his recent work with his
non-profit start-up, Global Solutions for Infectious Diseases
(GSID).
12
Call us today: 1-800-774-5630
Visit us at: www.valin.com
or email: [email protected]
555 E. California Ave. / Sunnyvale, CA 94086
Main: 408.730.9850 / Fax: 408.730.1363
15
New Member Breakfast Networking Event
FREE NEW
NETWORKING
FreeMEMBER
to All New
Members EVENT
Complimentary Breakfast provided
Wednesday, October 7th, 2009
7:30am – 9:30am
Doubletree Hotel Berkeley Marina
200 Marina Blvd, Berkeley, CA 94710
Space is Limited!
Please RSVP to Edda Mihaescu
[email protected]
or call 510-705-4782
•
•
•
Meet other new members to the ISPE SF/Bay Area Chapter
Meet Chapter President Linda Karr and the Membership Committee
Learn about local events:
- Chapter Dinners
- Commuter Conferences
- CEO Night
- Facility Tours
- Vendor Night
- Student Leadership Forum
- and Fun Day
- Learn more about ISPE International events, classes, and benefits
DIRECTIONS
DoubleTree Hotel Berkeley Marina
200 Marina Blvd, Berkeley, CA 94710
(510) 548-7920
From San Francisco: Take I-80 across the Bay Bridge. Follow I-80 East to Berkeley.
Exit University Ave. Drive into left lane and proceed to first stop light at 6th Street.
Make a U-turn at 6th Street and proceed on University Ave. (West) to Marina Blvd.
Turn right on Marina Blvd., the hotel is on the left side of the street and is hidden from
immediate view by trees.
Be sure to look up driving directions from your own starting point .
16
8
Volunteer Appreciation Day Write-Up
by John Kelley of Genentech
Photos by Tara Davis of Bayer
F
or our Volunteer Appreciation Day this year we invited
all of the volunteers who have contributed throughout
the year in support of our events and outreach to the
students to a San Francisco Giants Ball Game. Everyone’s
family was invited. It provided an opportunity for everyone
to enjoy a Saturday afternoon in beautiful PacBell Park next
to McCovey Cove and yes one did land in the Cove! We
had 112 people signed up for the event, the San Francisco Giants against the Colorado Rockies. It was a treat
to see the families of the people we have worked so hard
with throughout the year enjoying themselves with their
spouses, friends and their children. The lunch before the
game, over looking the bay, provided a great opportunity for
everyone to get to know one another and get psyched up
for the big game!
Photo on Top: John Kelley enjoying a beer with his
granddaughter
Photo to the Left: Tyler Davis (son of Tara & Matt Davis)
swinging at the tee-ball.
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Equipment
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Validation and Equipment Rentals
888-433-MASY (6279)
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December
Meeting Overview
More Fun Day
Winery Dinner
Tour Photos
by Simon Forder of hyde Engineering + Consulting
N
mones ($0.62 bln). Dr. Grimm predicted that an estimated $1.6
billion dollars could be saved by patients buying biosimilars
(assuming a 20% reduction in cost). The EU has embraced
the development of biosimilars and provided guidance on
manufacturing and licensure.
early 150
people
showed
up at the
Doubletree Hotel
Berkeley Marina
in the evening to enjoy drinks, networking, a fabulous dinner,
and two great presentations. Before the presentations started,
incoming ISPE Chapter President Greg Banks of Banks
Integration presented John Kelley of Genentech with a plaque
and the group thanked him for his tireless service to the ISPE
as the Past President of the Chapter.
Dr. Grimm then went on to discuss the development and timeline of EPO alfa Hexal biosimilar project. Biosimilar ERYPO
was settled on as the first candidate because of the 11 bln
dollar market. The opportunity to capture even a small part of
the market would provide a nice return on investment. Also,
the EU provided guidance on a regulatory strategy and clinical program for the biosimilars product. For the clinical part of
EPO biosimilars, the guidance recommends comparative single-dose pharmacokinetic study including pharmacodynamics
to demonstrate bioequivalence. Hexal conducted five phase 1
studies.
Dr. Rudolf Grimm, Proteomics and Metabolomics Market
Development Manager at Agilent Technologies in Santa Clara
presented a review of the Biosimilars market and provided
a case study in the development of a biosimilar product that
has been developed and is currently licensed for sale in the
European market. Dr. Grimm began his presentation with a
review of the biopharmaceutical market. To date, it is estimated that 500 million patients have been helped by biotechnological medicines. The biopharmaceutical market is expected
to encompass half of all medicines prescribed by 2010.
Development of the Hexal biosimilars began with a rigorous
characterization of the reference product (ERYPO). The characterization involves development and use of numerous analytical techniques. Rentschler Biotechnology was chosen as a
strategic partner for cell line development, process development, and bulk material production. Dr. Grimm then presented
numerous analytical test data demonstrating near equivalence
(and hence the biosimilars name) of the ERYPO product and
the Hexal EPO.
In 2005, the top six off patent bio-therapeutics had 6.7 billion
dollars in sales in the EU market. These products included:
Insulin ($2.7 bln), EPO ($2.3 bln), Interferon beta ($1.2 bln),
CSF ($0.74 bln), Interferon alpha ($0.65 bln) and growth hor-
Fluor in San Francisco...Proudly supporting our West Coast clients since 1996 with:
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www.fluor.com
18
11
16
W
Customize Your ISPE Email!
e have recently upgraded our systems to provide you with more flexibility in setting your email preferences for receiving
ISPE news, information, and resources. Now you may indicate your Area(s) of Interest to receive specific topical information and select a variety of email settings.
To customize your settings, please take a moment to go online and update your ISPE Member Profile, which can be found at
www.ISPE.org/emailpreferences.
When you update your Member profile, you can tell us:
• Your Area(s) of Interest.
• From which groups within ISPE you would like to receive email (Affiliate and Chapters, International, etc.)
• Alternative contact information in case you relocate or change jobs. Remember, your ISPE membership is “portable” and
goes with you wherever you work in the industry.
Updating your profile takes only a few minutes. If you need assistance accessing your account online, please contact ISPE
Member Services Department by tel: 813-960-2105 or email: [email protected]. Thank you for making ISPE your Society of Choice.
Fun Day Golf Photos
19
News (continued)
West Coast Presents 2009 Student Leadership Forum
Medlin, Sani-tech West
By David Mourra, Bayer Technology Services
croarry, won
ology
entify
he
ee to
to
chnoluvants.
titutes
that
The
well as
miltives
PS
impact
elophigh
he new
s, and
NING
DITS
89
95110
T
AlphaheInnotech
Corp.ISPE West Coast Student Leadership
fourth annual
Has entered
into atook
five year
Supplier
Alliance
Forum (SLF)
placeStrategic
on Saturday,
February
7th, 2009
Agreement
with GE Healthcare.
a continuat the International
House atThis
UCagreement
Berkeley, inisBerkeley,
ationApproximately
and expansion
the previous
OEM Agreement
CA.
84ofstudents
participated,
along withsigned
34
betweenprofessionals.
the two companies
in April
of 2005. at this event
industry
Universities
represented
included the University of California- Berkeley, University of
Gilead Sciences,
IncJose State University, University of
CaliforniaDavis, San
Announced
that the Pennsylvania
company hasState
completed
its acquisition
Southern
California,
University,
and Solano
from Electronics
For Imaging, Inc. of a building located at 301
Community
College.
Velocity Way and adjacent land in Foster City. The acquisition focus
covers
301toVelocity
Way building
of approxiThe
ofthe
theexisting
event was
help students
learn about
career
mately
square feet
and approximately
acres
paths
in 163,000
the life sciences
industry,
teaching them30
networking
designed
to accommodate
up to anThis
additional
542,000 square
skills,
and critiquing
their resumes.
was accomplished
feet
of
office
space.
The
building
and
associated
landGreg
border
with presentations by industry professionals including:
Gilead’s
Foster
City of
campus,
headquarters
Banks
(The
Benefits
ISPE), the
Taracompany’s
Davis (Empowerment
since 1988.
Skills),
Melissa Chong (ISPE Success Story), Sean McCannel and Paul Lauer (Resumes and Interviewing), Steve Walker
Bayhill therapeutics,
Inc. Humphrey (Mock Interview).
(Resume
Review), and Chris
Joins the Juvenile Diabetes Research Foundation, the world’s
leading charitable
funder
of type
diabetes research,
in a
Scattered
throughout
the day
were1 networking
breaks for
partnership
support Bayhill’s
ongoing
Phase
I/IIthe
human
clinstudents
andtoprofessionals
to mingle.
The
goal of
networkicalbreaks
trial ofwas
BHT-3021,
a DNA
vaccine
to reverse
the immune
ing
for students
to learn
to feel
more comfortable
response that
causes
1 diabetes. as they launch into
approaching
and
talkingtype
to professionals
the career world.
The source of this information is the ISPE Web site, confirmed everyone
on company
websites.
Nearly
left the
event believing that it was a great
success and would return again the following year. All of the
attendees surveyed considered the event valuable. After the
event, one student said “I had a great time. It’s a valuable experience! Especially for networking and resume critiques!”
Student Reflection on Poster Contest
I
magine spending countless hours on a project, many
more preparing a poster board with pictures and results
as well as a five minute presentation, to drive maybe
two hours away for an area wide competition. Once you
get to your destination, there are only two other students
(who will be competing against you) and the judges. Noone from your school has come to support you, and aside
from the judges there are no industry representatives curious about you, your project, or your school.
In recent years, the ISPE SF Bay Area Student Poster
Competition has garnered little interest among both students and professionals, as with the theoretical example
above. However, with such great resources as the local
universities, students, and so many companies on the
cutting edge of their fields, there is no reason why the Bay
Area competition could not be a wonderful opportunity. A
few students and a very eager Student Chapter Industry
Advisor spread enthusiasm and recruit participants, student attendees, and industry professionals starting months
prior to the event. The hard work paid off with 10 poster
entrants evenly split between undergraduate and graduate students, 14 student visitors, 8 judges (from industry),
two mentors, and three industry professionals including
the competition sponsor and organizer. Gilead Sciences
in Foster City graciously provided a facility where all the
posters could be displayed while allowing enough space
for viewing, judging, and networking when the schedule
permitted. A great improvement and maybe next year will
be even better.
Event sponsors included CRB Consulting Engineers, Bayer
Healthcare, Hyde Engineering + Consulting, Banks Integration
Group, Biokinetics, ISPE San Francisco/ Bay Area Chapter,
ISPE Greater Los Angeles Area Chapter, DST Controls, and
Rolf Jensen & Associates. Thank you for your support.
As a participant, and never having been to a poster
competition before, I did not know what to expect. I had
helped in the organization of the event and therefore knew
there were four other undergraduate posters besides
mine, though I did not remember the subjects or who
was presenting, aside from one of my classmates. The
entire day was very organized which helped with the flow
of traffic during registration and the event schedule. This
organization also helped to relieve stress relating to the
presentations. As participants arrived, they chose a letter
out of a hat which designated the judging team and time
for their poster therefore interspersing graduate and undergraduate posters at random throughout the day. A benefit
to this presentation schedule was that the later posters
would have more support, instead of half the visitors leaving at the lunch break. The ability to network was also a
wonderful addition to the event, letting everyone take full
advantage of this opportunity to learn about people, other
companies, and universities. Overall, the event was a success and though I did not win, much was gained from the
experience.
We would like to thank all those who participated on the West
Coast and within the San Francisco Bay Area Chapter for their
time and support in planning this successful event.
The ISPE West Coast Chapters anticipate hosting another
Student Leadership Forum in the first quarter of 2010. We invite
students, industry professionals and Faculty Advisors from all
these ISPE Chapters. If you wish to participate in this event,
please contact Chris Humphrey at [email protected].
Skanska USA Building based in Oakland, performs
construction management, general contracting,
design-build and project financing services.
Skanska Life Sciences is consistently ranked in the
top five in the Pharmaceuticals category of
Engineering News-Record’s Top 400 Contractors.
For more information please contact:
Drew Smith, Project Executive
Skanska USA Building
1999 Harrison Street, Suite 1950
Oakland, CA 94612
Ph: 510.285.1800
Fax: 510.285.1801
10
E-mail: [email protected]
www.skanska.com
20
Heather Bennett
May 2009 graduate of Chemical Engineering
San Jose State University
SJSU Student Chapter President 2008-2009
More Fun Day Winery Tour Photos
21
More Fun Day Photos
VALIDATION
COMMISSIONING
SPECIALTIES
Ralf Elsaesser
Biotech Focus Group Leader
415 516 5752 | cell
We have construction down to a
TRAINING
SCIENCE
AUDITS
Toll-Free (888) 242-0559 • Office (650) 320-1788 • Fax (650) 320-1789
www.propharmagroup.com
22
HEADQUARTERS
2121 Oakdale Avenue
San Francisco, CA 94124
415 641 0800 | tel
www.domeconst.com
SAN JOSE
560 S. Winchester Blvd.
Suite 500
San Jose, CA 95128
408 938 5770 | tel
cGMP Manufacturing
Biofuel Facilities
Clean Rooms
Central Plants
Laboratories
Environmental Rooms
Pilot Plants
R&D
Offices
Warehousing
Seismic Upgrades
Industry News
by Sandra Medlin of Sani-Tech West
Bio-Rad Laboratories, Inc. helped raise approximately $1.1
million during the Napa Valley Tour de Cure, which took place
on May 3 to benefit the American Diabetes Association. As
the Presenting Sponsor at this year’s Napa Valley Tour de
Cure, Bio-Rad’s “friends and family” team of 146 riders was
the largest of the 162 teams participating in the Napa Valley
event. Bio-Rad riders raised $73,055, exceeding its total last
year of $66,500, setting a new company record. The team
was also named one of the Top 10 fundraising teams in the
U.S. Bio-Rad also hosted teams in Long Beach, California,
and Redmond, Washington. The Tour de Cure is a series of
80 cycling events that occur each year in different locations
across the United States.
Facebook has hired the former chief financial officer of
Genentech as its CFO, filing a spot that has been empty for
about three months. Facebook said on Monday that David
Ebersman will join the company in September. Ebersman
served as CFO of Genentech from 2006 until April this year,
when the biotech company was acquired by Roche Holding.
Shrink Nanotechnologies, Inc has announced that Dr.
Michelle Khine, Ph.D., the scientific founder of Shrink’s nanofabrication platform, was named by MIT Technology Review
as one of the top 35 global innovators under the age of 35.
The award is provided to an elite group of accomplished
young innovators who exemplify the spirit of innovation
and whose work spans medicine, computing, communications, nanotechnology, and more. Dr. Khine will be honored
at Technology Review’s EmTech09 Conference at MIT in
September.
Fluxion Biosciences, has received a $1.8 million NIH grant
for the development of a high-throughput screening platform
for anti-microbial drug discovery. The Phase II grant will
enable the company to further develop its innovative microfluidic platform for cellular research and drug discovery.
Dey L.P., a subsidiary of Mylan Inc. issued an advisory
regarding two lots of its Albuterol Sulfate Inhalation Solution,
0.083%, unit-dose vials. The lots were on a tractor-trailer that
was stolen in McKinney, Texas. The products in the stolen
cartons could represent a health risk because the required
temperature-controlled supply chain may have been broken.
Products from these lots should not be dispensed, sold or
used. Dey discourages patients from purchasing any medication sold outside of legitimate channels.
Genentech - Roche began to cut rank-and-file jobs as it folds
the South San Francisco biotech firm into its global operations. Genentech, which was founded in 1976 and went public
in 1980, was acquired by Roche in March for $46.8 billion.
“Roche has always communicated that it expected some
redundancies in certain areas of the business,” Genentech
spokeswoman Caroline Pecquet said. She said the reductions
that have occurred so far have affected “less than 1 percent”
of Genentech’s 8,250 Bay Area employees. She could not
say how many employees would ultimately be affected or how
long it will take to complete the cuts. The reductions, which
are occurring through a combination of voluntary buyouts and
layoffs, focus on late stage drug development and corporate
administration. Pecquet said departing Genentech employees
will be kept on the payroll for 60 more days and given help to
look for a new job. They will also get a cash severance package and paid health coverage in amounts and durations that
vary with length of service. She said there would be “little to
no” job loss in manufacturing and that all six of Genentech’s
manufacturing and distribution sites, including those in South
San Francisco and Vacaville, would continue. In April, Roche
replaced key local managers including former Genentech chief
executive Arthur Levinson and ex-Chief Operating Officer
Susan Desmond-Hellmann, but the Swiss drug firm also kept
some top scientific leaders including Richard Scheller and
Marc Tessier-Lavigne.
Maxygen, Inc. has announced that Astellas Pharma Inc. and
Maxygen have executed an agreement to establish a joint
venture focused on the discovery, research and development of multiple protein pharmaceutical programs, including
Maxygen’s MAXY-4 program and other early stage programs.
As part of the arrangement, Maxygen will provide Astellas
with an option to acquire all of Maxygen’s ownership interest
in the joint venture within three years after establishment of
the joint venture. The joint venture arrangement represents a
significant expansion of the existing collaboration agreement
between the parties for the development and commercialization of MAXY-4 program candidates for autoimmune diseases
and transplant rejection.
Gilead Sciences Inc., is closing its offices in Boulder and
Westminster and laying off at least 66 people by year’s end.
In A Sea
Of Change,
Some Things
Are Constant.
ALLEGHENY BRADFORD
CORPORATION
Regional Manager - Dori Carlson
Skids • Tanks • Valves • Pumps
Heat Exchangers • Filter Housings
1522 South Ave., Lewis Run, PA 16738
800-542-0650 • www.alleghenybradford.com
23
Industry News (continued)
Welcome New Chapter Members Decem
by Sandra Medlin of Sani-Tech West
Michele
Alm, Sr.said
Manager,
Supply Chain M
“Our economic challenges are dire
and urgent,”
Gardner.
Manager, Abbott D
“Legislators should spend the final weeks Sonji
of thisBennett,
legislative
session acting in the best
interests
of California’s
workers and Manager,
Kristofer
Bullock,
Staff Engineer/Accounts
communities by asking themselves ‘How will this bill impact
Jose Chang, Clean Room Manager, University
job creation, innovation, and entrepreneurship in my district
Cikowski,
Coordin
and throughout the state?’ Local leaders Kristin
and experts
can Facilities
play
a vital role in helping legislatorsSophia
answerCuriel,
that question.”
Chemical Engineering Stude
BayBio, Northern California’s life sciences association, joins
business leaders at the State Capital to promote innovation,
research and development as a cost-effective building block
to the Golden State’s economic future. The coalition calls on
policymakers to make a concerted effort to develop a manufacturing policy to capture the potential the life sciences offers
to California workers.
Madhu Ganesan, Student, San Jose
Oxford BioTherapeutics in San Jose signing a deal worth
Gee, Student,
up to $370 million with GlaxoSmithKline.Desmond
This is another
step San Jose
by GSK to bolster its early-stage pipeline
cancer
drugs. GxP Systems,
Bruce of
Griffin,
Manager,
The strategic alliance covers thePeter
discovery
andSr.
development
Groner,
Project Manager, Custom
of new therapeutic antibodies for treating primary, metastatic
Hanson,
and recurring forms of cancer, with GlaxoMatthew
developing
drugsEstimator, Dom
Yi-Hwa Hwang,
Graduate
Student Researcher, U
against selected targets identified
by Oxford
BioTherapeutics.
Oxford
will also Gary
develop
one antibody
through Rubber Fa
Johnson,
Sales Manager,
XOMA BioTherapeutics
Ltd
to
clinical
of concept,
at which
point year
Glaxocontract
will have
an
Has
beenproof
awarded
a $65 million
multiple
Ryoko Kataoka, from
Student, San Jose
option
to license
it. of Allergy and Infectious Diseases
the National
Institute
Cashier,
Solano Co
(NIAID), a component of the National Maecyn
InstitutesLandrith,
of Health,
to
Bayer
HealthCare
Pharmaceuticals
has
announced
that
Kelby
Lau,
Genentec
support XOMA’s ongoing development of drug candidates
the
U.S. Food
Drug
Administration
approved
a
3000
towards
clinicaland
trials
in the
treatmentChristopher
ofhas
botulism
poisoning,
Law, Director Project Se
IU
(international
unit)muscle
vial size
of Kogenate®
FS,The
antihemoa potentially
deadly
paralyzing
disease.
contract
Mimi
Le,
Student,
University
of Cal
philic
TheNIAID
new vial
offerstogreater
for
is thefactor.
third that
hassize
awarded
XOMAconvenience
for the developpatients
hemophilia
A who
require
athe
higher
dose.
The
Judy
Leung,
Quality
Abbo
ment of with
botulinum
antitoxins
and
brings
program’s
total Engineer,
to
3000
vial may
eliminate the
need for Low,
combining
smaller
nearlyIU$100
million.
Samantha
Project
Manager, Hathaway D
vials and may allow some patients to achieve more precise
George
Martinez,
dosing.
The
availability of Kogenate
FS
in a 3000
IU vialPlant Engineer, B
BioMarin
Pharmaceutical
Inc.
Sean
McNary,
Grad
Student,
demonstrates
commitment
to adolescent
and
adult
Has opened aBayer’s
new office
in Brisbane,
California, to
expand
its University
patients,
who
are
more
likely
to
have
a
need
for
higher
doses
Davidoperations
Morgan, Sales
Director,
Life
Industry, Comos
drug development
and better
meet
theSciences
increasing
and
who will
appreciate
the greater
of theThe
larger
demands
of the
company’s
growingconvenience
product
pipeline.
Krista Murphy,
ProjectcomManager, Affili
vial.
pany will occupy approximately 20,000 square feet of office
Amy Nguyen, Sr Quality Assurance As
space located north of the San Francisco International Airport
Baxter
International
Inc.
has
announced
definitive
agreeKieran
O’Donoghue,
Manager, CMC,
at 2000 Sierra Point Parkway, adjacent
to aHighway
101.
The
ment
Lifesciences
Corporation
under
which
facilitywith
willEdwards
house staff
in biostatistics,
statistical
programming,
Ralf Oelschlager, President, IPT
Baxter
acquire
certain assets
related
Edwards’
hemoclinical will
data
management,
medical
writingtoand
other clinical
Madonna
Ohaeri,
GMP Sys. Compl. Te
filtration
product
line,
also
known
as
Continuous
Renal
development functions. The new Brisbane office is part of a
Replacement
Therapy.The
is expected
to closeMarlon
in
larger corporate
expansion transaction
that has progressed
throughout
the Orlina
the
of 2009,
pending
regulatory
approvals.
pastthird
two quarter
years and
includes
the recent
purchase
of 300
Bel San Jose S
Ankit
Patel,
Student,
Marin Keys Boulevard in Novato.Kinjan
A multinational
company,
Patel, Chemical
Eng’g Student, Sa
The
source
of this information
is theoffices
ISPE Web
confirmed
BioMarin
Pharmaceutical
operates
in thesite,
United
States,
Rano
Perrizo,
Owner,
on
company
websites.
United
Kingdom,
Brazil and the Middle East, with employees
in North Cur
David Powell, Process Engineer,
more than a dozen countries.
“We need California to get its priorities right,” said Matt
Gardner, president and CEO of BayBio. “Promoting investment in the innovation economy is rightfully a main concern,
but we ignore the fruits of that research by letting small, growing companies expand in neighboring states with favorable
economic development strategies. This does an enormous
disservice to the fiscal health of the state and job opportunities
for
Californians.”
Avigen,
Inc.
Announced a significant restructuring of the company aimed at
California
are responsible
for 1,200opportunities.
approved treatpreservingcompanies
cash and reassessing
its strategic
As
ments
another
210 that are
on will
track
to be staff
in thereductions
hands
a resultand
of the
restructuring,
which
involve
of
the next
fivecompany’s
to 10 years.
In total,
there are
738
of patients
over 70 in
percent
of the
total
workforce,
Avigen
treatments,
diagnostics
and
technologies
that couldfor
reach
expects to have
sufficient
cash
to fund operations
over four
patients
years. within 15 years.
Industry News
by Sandra Medlin of Sani-tech West
Already,
companiesPharmaceuticals,
are determining where
to manufacture
Bayer healthCare
Inc. and
Onyx
this
influx of new therapies.
California’s life sciences industry
Pharmaceuticals,
Inc.
will
invest
$50
to develop
these 210
new treatments.
Have
joined
in billion
partnership
with leading
advocacy
organizaBayBio
is working
with
other
business leaders
promote
tions - the
American
Liver
Foundation
and VitaltoOptions
the
Agenda for
Economic
Recovery
to capture
this– incredible
International
- to
launch Living
with Liver
Cancer
a program
investment.
designed to educate patients and caregivers about liver
cancer signs and symptoms, risk factors, diagnosis, screenProposed
action items
to capture
the The
$50 centerpiece
billion investment
in
ing and available
treatment
options.
of
California:
the program is the Living with Liver Cancer Web site (www.
•LivingwithLiverCancer.com),
Create an economicwhich
development
plan
to retain and
serves as
a resource
for
attract
companies.
peoplenew
seeking
more information about liver cancer and liver
•disease. Establish
a process
to analyze
andofreport
on the ecoTo expand
access and
availability
the program
to
nomic
impact
of
legislation,
regulation
and
administrative
decia wider audience, information on the Web site will be transsion
in order
to identify
impact including
on job creation.
latedmaking
into several
different
languages,
Chinese and
•Spanish.Improve
the600,000
state’s economic
environment,
restore
More than
cases of liver
cancer are
diag- its
competitive
position
andyear,
facilitate
high-wage
creation.
nosed worldwide
each
including
15,000job
cases
in the
•United States.
Enact a statewide strategy for math and science
teacher attraction and retention.
•WaferGen
Incentivize
local Inc.
communities to zone biotech regions
Biosystems,
in
their
local
general
plan
master
planning.
Announced that the National
Institutes
of Health has awarded
a team of researchers at University of Pittsburgh an approximately $3 million grant to conduct novel gene expression
research in the area of lung disease involving WaferGen’s
SmartChip(TM) Real-Time PCR System.
Erin Scholz,
Serv
(continued
on next Architectural
page)
Nader Shakerin, Student, San Jose
Kseniya Zakharyevich, PhD, Student, Unive
AD-CA-NYC-2009JAN06-P2V1
Strategic Solutions for the
Life Sciences Industry
Stantec provides Engineering, cGMP Facility Design, Compliance,
Process Design, and Control System Integration to companies
involved in the discovery, research and development,
and commercial-scale manufacturing of pharmaceutical,
biotechnology, and medical device products.
In California, call (415) 946-6861 or email
[email protected]
One Team. Infinite Solutions.
24
ph +1 (925) 771-1119
Simon
E.J. Forder
cell +1 (925) 639-7997
Principal
Consultant
and CEO
fax +1 (925)
937-8875
400 Oyster Point Blvd, Suite 520
South San Francisco,
CAR.
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Steven
Page
650.588.2660
office
Business Development
Manager
650.588.2857 fax
415.748.8753 cell
[email protected]
[email protected]
5099 Commercial
Circle, Suite 102
www.hyde-ec.com
Concord, California
94520 USA
19
manufacturing and licensure.
Hotel
Marina
nner,
tarted,
The second presenter, Kelly Keen of Genentech presented
an overview of Genentech recent expansion (ECP1) into
the Asian market. Genentech recently completed the design
and build of a modular E. Coli fermentation facility in Tuas,
Singapore. Genentech chose Singapore because of its access
to patients for clinical trials in the Asia Pacific region. Also
Singapore has a great Asia Pacific talent pool and a supportive
business environment and modern infrastructure.
Dr. Grimm then went on to discuss the development and timeline of EPO alfa Hexal biosimilar project. Biosimilar ERYPO
was settled on as the first candidate because of the 11 bln
dollar market. The opportunity to capture even a small part of
the market would provide a nice return on investment. Also,
the EU provided guidance on a regulatory strategy and clinical program for the biosimilars product. For the clinical part of
EPO biosimilars, the guidance recommends comparative single-dose pharmacokinetic study including pharmacodynamics
to demonstrate bioequivalence. Hexal conducted five phase 1
studies.
More Fun Day Winery Tour Photos
plaque
ISPE
t
Clara
ed
that
the
ha
timathnoected
The Tuas business park was selected because of its proximity to peer companies including Lonza, GSK, and others. Ms.
Keen presented an overview of Singapore (known as “The Red
Dot”) because of its size on a world map. Singapore is a mix of
cultures and languages and this presented some challenges to
the Genentech build team.
Development of the Hexal biosimilars began with a rigorous
characterization of the reference product (ERYPO). The characterization involves development and use of numerous analytical techniques. Rentschler Biotechnology was chosen as a
strategic partner for cell line development, process development, and bulk material production. Dr. Grimm then presented
numerous analytical test data demonstrating near equivalence
(and hence the biosimilars name) of the ERYPO product and
the Hexal EPO.
illion
ed:
bln),
h hor-
Validation Services
Numer
ing by
the bu
the site
second
move.
move t
roads
of a na
the mo
Project delivery consisted of two build teams: one state side
(South Carolina) and one on location in Tuas. The basis for
design was two runs per week in a 1000 L Fermentor. Space
has been provided for a second Fermentor. Additional space
was needed for a central utility building, warehouse, administration, and the manufacturing suite. A modular approach
was taken to save time. The ECP1 project has been the fastest project to date for Genentech. A modular approach also
allowed quality control of the process module construction with
qualified personnel in a controlled environment.
Fluor in San Francisco...Proudly supporting our West Coast clients since 1996 with:
Procurement
Milesto
•
Al
•
M
•
O
•
En
•
Q
•
Li
Jacobs (design and modules) and Bovis Lend Lease (construction) provided the bulk of the support for the project with
numerous other South City service providers chipping in.
The project team was global and finding times where all parties could be on the phone was yet another challenge but as
explained by Ms. Keen, a serious consideration.
Engineering
Ms. Ke
standa
meters
meters
the inte
Manufacturing & Life Sciences
West Coast Regional Operations
395 Oyster Point Boulevard, Suite 321
South San Francisco, CA 94080
Copyright © 2008 Fluor. All Rights Reserved. FLUOR is a registered service mark of Fluor Corporation.
650.742.4316 tel
650.742.4301 fax
[email protected]
www.fluor.com
Thank
to the
Nelsen
Engineering
Architecture
Process Technology
Process Automation
Systems Integration
Nino Borsoni, PMP - Senior Vice President
[email protected]
p. 925.363.3112
f. 925.689.7006
11
Serving the Biotech Industry since 1979
John M. Gordon, Principal
[email protected]
Procurement
Project Management
Serving the Biotech
John
M. Gordon, Principal
Industry
since 1979
[email protected]
L5%3)!*$!/#$!L)#$'*0'3GGGM)3%?5N!0%773)(*$+!3%)!1.0(!23#0(!'5*.$(0!0*$'.!9BBD!O*(PQ
John M. Gordon, Principal
[email protected]
1282 Folsom Street
San Francisco, CA 94103
Tel:
415.552.1622
Fax: 415.861.4257
Startup & Commissioning
147 Beacon Street
S. San Francisco, CA 94080
Tel: 650.635.1390
Fax: 650.635.173
S$+*$..)*$+
23$0()%'(*3$!"#$#+.K.$(
M)3'%).K.$(
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237N)*+P(!T!F::B!L5%3)!23)73)#(*3$G!U55!4*+P(0!4.0.)>.?G!U;VR:AEA:EG
25
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12
Welcome New Chapter Members June - August 2009
Micahel Alagna, Packaging Analyst, ADCO Manufacturing
Michael Bove, Market Leader, Affiliated Engineers Inc
Janet Burlinson, Dir of Marketing/Sales, Customized Performance
Linn Chie, Student, University of California San Diego
Ronald Chisolm, Director, Facilities Operations and Maintenance, Genentech
Andy Chong, Automation Engineer, NNE Pharmaplan
Theresa De Guzman, Consultant, Rolf Jensen & Associates
Chuck Flynn, Marketing Manager, NOVO Construction, Inc.
Arthur Folse, Senior Automation Engineer, NNE Pharmaplan
David Francis, Planner Supervisor, Genentech
Kris Glick, President, Vactorr
David Hale, Project Leader, Baxter BioScience
Lisa Helmonds, Manager, Quality Assurance/Regulatory Affairs, SBIO INC.
Ron Huang, Quality Engineer II, Genentech
Rick Johnston, CEO, Bioproduction Group
Richard Kiehle, Data Analyst, Genentech
Georgina Lo, Bayer Tech. Services
Daniel Moskey, Associate Director, Vacaville Technology, Genentech, Inc.
Thomas Nollie, Senior Manager, Genentech Inc
Niall O’Regan, Project Manager, Total Validation Services
Jeffrey Ouano, Associate Director, QA, Exelixis
Anupreet Parmar, University of Maryland, College Park
Eric Samuli, Project Executive, Skyline Construction
Janette Santana, Automation Engineer
Christopher Schreil, Sr. Manager Automation Engineering, Genentech, Inc.
Matt Smyers, Training Safety Manager, Techinical Safety Services, Inc.
George Swartz, Sr Indutrial Controls Engineer, Alza
Kenji Sytz, President, CKC Engineering
Ronald Taticek, Director, Genentech
Jim Thurman, Technical Sales, Darcoid Nor-Cal Seal
Michael Trzepacz, Partner, Syska Hennessy
Chengben Wang, CEO, ADDS Pharmaceuticals, LLC
Norman Warkentin, Facilities Senior Technical Manager, Genentech
Charles Wyatt, Associate Director, Genentech Inc
ISPE
Annual Meeting
w w w. I S P E . o r g / a n n u a l m e e t i n g
Special Thanks to Our Current Sponsors
Thriving In A Survival Environment
8 - 11 November • Manchester Grand Hyatt San Diego • San Diego • California, USA
Sponsorship and Exhibit Opportunities Available
26
ISPE San Francisco / Bay Area Chapter Committees
Program Committee
Chair: Simon Forder, Hyde Engineering + Consulting
Volunteers: Tareq Barakzoy, ACCO Engineered Systems
Kevin Collins, The Collins Group
Michael Cooper, Bayer HealthCare
Leroy Ginn, ACCO Engineered Systems
Steve Mullen, Kling
Andy Nelsen
Brian Vaughn, Banks Integration Group, Inc.
Commuter Conference Committee
Chair:
David Bendet, Perkins+Will
Volunteers: Rick Ginn, XL Construction
June Jenkins, Oxford & Associates
Stephen Johnson, Applied Biosystems
Gavin Keith, DPR Construction
David O’Connell, DC Engineering
Jesse Villar, Amyris Biotechnologies
Membership Committee
Chair:
Edda Mihaescu, PhD, Bayer HealthCare LLC
Vice Chair: Cindy Reginato, Hathaway Dinwiddie
Volunteers: Mike Britting, Hathaway Dinwiddie
Dave Edgar, Iron Construction
Ulrike Ruppelt, Ticular Market Consultants
Glenn Samuels, Alexza
Cynthia Wiggins, Cogent Energy, Inc.
Fun Day Committee
Chair:
Kim Duncan, Duncan Enterprises
Golf:
Sandra Medlin, Sani-Tech West
Volunteers: Adam Beatty, Bay-Tec Engineering
Doug Bibby, Bibby LLC
Mike Britting, Hathaway Dinwiddie
Tara Davis, Bayer HealthCare LLC
John Kelley, Genentech
Patti Larson, DPR Construction
Ed Shea, Dome Construction
Randy Thatcher, Bay-Tec Engineering
Corey Veverka, TVS, Inc.
Vendor Night Committee
Chair: Jeff Jul, J2 Biosystems
Volunteers: Heather Bennett, San Jose State University
John Kearns, Particle Measuring Systems
Kelly Keen, Genentech
Cynthia Wiggins, Cogent Energy, Inc.
Karl Wilks, Gilead
Sokhorn Yim, Genentech
Community Relations
Chair:
Patti Larson, DPR Construction
Vice Chair: Bob McCollough, Cytokinetics
Volunteers: Germaine Bickel, Genentech
Ian Larson, Baxter Bioscience
John Lohnes, Austin AECom
Mike Marston, DPR Construction
Gordon Zagar, XenoPort Inc.
Liaison Committee
Chair: Sue Cost, Biokinetics Inc.
Volunteers: Ed Shea, Dome Construction
Melody Spradlin, Dome Construction
Newsletter/Web Site Committee
Chair:
Bill Chestnut, cGMP Validation, LLC
Volunteers: Sandra Medlin, Sani-Tech West
David O’Connell, DCE Consulting, Inc.
Charity Committee
Chair: Ed Shea, Dome Construction
Volunteers: Haleh Banisadr-Hughes, TVS, Inc.
Greg Burg, Genentech
Sue Cost, Biokinetics Inc.
Advisory Committee
Chair:
Sue Cost, Biokinetics, Inc.
Liaisons:
Mark Hannon, Genentech
Ed Shea, Dome Construction
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, Nektar Therapeutics
Scot Thomas, Amgen
Klaus Weisenberger, Bayer HealthCare
Gordon Zagar, XenoPort Inc.
Student Affairs Committee
Chair:
Chris Humphrey, ACCO Engineered Systems
Volunteers: Steve Baker, DST Controls
Fion Cheng, Hyde Engineering + Consulting
Bill Chestnut, cGMP Validation, LLC
Stacey Cox, Genentech
Kristen Dezzani, ALZA Corp./J&J
LeRoy Ginn, ACCO Engineered Systems
Peter Hawes, Vanir Construction Mgmt
Ryan Hill
David Mourra, Bayer HealthCare
Drew Reed, PDL Biopharma, Inc
Bill VanDerVoort, DST Controls
Steve Walker, Rolf Jensen & Associates
Henry Zhang, Eichleay Engineers
Faculty:
Carl Cimino, Pipe Trades Training Center
Jim DeKloe, Solano College
Claire Komives, San Jose State University
Dr. Dorian Liepmann, UC Berkeley
Dr. Karen McDonald, UC Davis
27
Recognition Committee
Chair: Greg Banks, Banks Integration Group
Volunteers: Greg Burg, Genentech
Rob Lynch, Dome Construction
Andy Nelsen
Officers
ISPE San Francisco / Bay Area Chapter
Board of Directors
President:
Linda Karr, Genentech
Email
Telephone
[email protected]
(650)225-4985
Vice President:
Corey Veverka, TVS, Inc.
[email protected]
(925) 855-9100
Treasurer:
[email protected]
(650) 303-8912
Secretary:
Ian Larson, Baxter Healthcare
[email protected]
(510) 723-2094
Directors
David Bendet, Perkins+Will, [email protected]
Bill Chestnut, cGMP Validation, LLC, [email protected]
Tara Davis, Bayer Healthcare, [email protected]
Kristen Dezzani, ALZA / Johnson & Johnson, [email protected]
Kim Duncan, Duncan Enterprises, [email protected]
Chapter Past Presidents:
Greg Banks, Banks Integration Group
2009
2008
Rob Lynch, Dome Construction Corp.
2007
Mark Hannon, Genentech
2006
2005
Melody Spradlin, Dome Construction
2004
Ed Shea, Dome Construction 2003-2004
Simon Forder, Hyde Engineering + Consulting, [email protected] Jon Sheh, Johnson & Johnson
Chris Humphrey, ACCO Engineered Systems, [email protected]
2002
Scott Laskey
2001
Jeff Jul, J2Biosystems, [email protected]
Haleh Banisadr-Hughes, TVS, Inc.
2000
Jeff Hargroves, ProPharma Group
1999
Sue Cost, Biokinetics Inc.
1998
John Sugerik, JTS Enterprises
1997
Dennis Mosher, Bay-Tec Engineering
1996
Ian MacLaren, Southland Industries
1995
Burt Van Loon 1993
Patti Larson, DPR Construction, [email protected]
Edda Mihaescu, PhD, Bayer Healthcare, [email protected]
Challenges, Future Opportunities
BayBio - GeneAcres17: Current Challenges, Future Opportunities
28
http://www.baybio.org/wt/home/GeneAcres17
Pete McArthur, Amylin Pharmaceuticals
1994
http://w
Enter your search term
Search
Contact
Members Sign-in Enter your sear
ABOUT BAYBIO Current Challenges, Future Opportunities
GeneAcres17:
GeneAcres17: Current Challenges, Future Opportunities
GET INVOLVED
Gene Acres is a one-day facilities conference featuring timely analysis of issues by professionals from multiple perspectives.
From facilities design to security, and from regulatory
to international
Acres
conference
Gene certification
Acres is a one-day
facilitiesoperations,
conferenceGene
featuring
timely
analysisprovides
of issues by professionals fro
EVENT CENTER
insights into the challenges faced by life scienceFrom
companies
every
day.
A
closing
reception
will
provide
a
perfect
to operations, Gene A
facilities design to security, and from regulatory certificationopportunity
to international
network
your peers.
insights into the challenges faced by life science companies every day. A closing reception will provid
BAYBIOwith
CALENDAR
ast Series
network with your peers.
Annual Gene Acres Conference
HotWhat:
Topic 17th
Series
Series
What:
17th Annual Gene Acres Conference
When:
8:30am
- 5:30pm,
Wednesday, September
30, 2009
Medical
Device
Breakfast
Series
When:
8:30am
- 5:30pm,
SeptemberCA
30,Directions
2009
Where:
South
San
Francisco
Conference
Center,
255
South
Airport
Blvd.,Wednesday,
South San Francisco,
Executive Series
22-2009
Challenges,
Where: South San Francisco Conference Center, 255 South Airport Blvd., South San Francisc
Parking: Multiple Lot Options
Therapeutic Breakfast Series
Parking: Multiple Lot Options
Getting There: Public Transportation Information
BayBio Open House 7-22-2009
Getting There: Public Transportation Information
Attire: Business Attire Suggested
GeneAcres17: Current Challenges,
I
ISPE Asks Pharma Professionals to Share
Their Knowledge!
SPE is accepting proposals from pharmaceutical professionals for content that can be included in a variety of its educational
resources.
“As a membership organization, ISPE truly relies on the contributions of dedicated and altruistic pharmaceutical professionals
to advance their industry,” said Robert P. Best, ISPE President and CEO. “Not only do these professionals enhance their credentials by contributing to Society publications, presentations, and resources, but the knowledge they share makes a significant
impact to benefit pharmaceutical manufacturing globally.”
ISPE is currently accepting proposals for webinar content, conference session topics; training courses; Pharmaceutical
Engineering magazine and the Journal of Pharmaceutical Innovation articles; and technical document topics and materials.
Submissions are expected to shed light on current, topical issues, and address knowledge gaps within the pharmaceutical science and manufacturing industry.
In exchange for sharing knowledge, submitters will have the opportunity to network with, and learn from, fellow subject matter
experts; gain additional experience and develop new skills; receive recognition from industry colleagues; and contribute to innovation while improving the efficiency of pharmaceutical industry processes.
Contributions can be made by downloading the ISPE Proposal Form at www.ISPE.org/education. For more information, go to
www.ISPE.org and click on Education and Training/Overview.
Distinguish Yourself with LEED Credentials
2009 LEED accreditation has 2 tiers: LEED Green Associate and
LEED AP. It is essential that you take both classes to become a
LEED AP.
Course Benefits:
 Get the edge you need to confidently pass the LEED exam the first time
 Learn from skilled and experienced LEED faculty members
 Break down the complex LEED system into “plain language”
 Explore real world projects to help you better understand and remember
the material and put the concepts to practice
 Gain eligibility to take the Green Associate LEED exam
Session I – LEED Green Associate Exam
Thursday, September 17th, 2009
Prep
This credential focuses on basic knowledge of green
design, construction, and operations. Participants will receive an eligibility certificate to
take the Green Associate LEED exam upon completion of this course.
Session II – LEED Building Design/Construction Exam
Prep
Thursday, December 3rd, 2009
Replacing the LEED AP for New Construction exam track, this specialty provides a
standard for professionals participating in the design and construction phases of highperformance, healthful, durable, affordable, and environmentally sound commercial,
institutional, and high-rise residential buildings. Pre-requisite: LEED Green Associate
Exam Prep course.
Location for both sessions is the Pipe Trades Training Center, 780 Commercial St., in San Jose. Cost for EACH SESSION IS $50 for Local 393 members and contractors and $200 per session for all other industry associates. Includes handouts and lunch. Each session begins at 8:30 a.m. and concludes at 5 p.m. Class space is limited. Presented by USGBC‐Northern California Faculty Member and Expert, Alex Spilger and the South Bay Piping Industry. You can reserve space by calling Anita Woodson at South Bay Piping, (408)970‐
8578, or email [email protected]. Questions welcomed! 29
ISPE 2009 Event Calendar
10 September
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
15 September
Commuter Conference
Topic: Supply Chain Management:
Operations Economics of SCM
& Cold Chain Supply
Joint Event With APICS
(The Association for Operations Management)
30 September
BayBio Gene Acres
South San Francisco Conference Center
October
Oktoberfest Social Event (TBD)
3 November
Commuter Conference
Topic: Neutraceuticals: Wellness vs Treatment
Cosmeceuticals
7 October
New Member Breakfast
8-11 November
ISPE Annual Meeting in San Diego
3 December
Dinner Meeting
For additional ISPE Educational
Offerings and Publications
www.ispe.org
ISPE is a global, not-for-profit
membership organization that
provides education, training, and
technical publications to
pharmaceutical
manufacturing professionals.
Technical Articles
High Quality ISPE Event Photos
Welcomed For Future Newsletters
Please submit them Via Email to
Bill Chestnut, Newsletter Chair
[email protected]
Dinner Meeting
Contract Manufacturing & Technology Transfer
ISPE 2010 Event Calendar
23 February
Commuter Conference
Topic: Maintenance Panel Discussion:
Operations, QA/QC, Preventative Maintenance,
Scheduling, Inventories
1 April
Vendor Night
South San Francisco Conference Center
8 June
Commuter Conference
Topic: Good Automated Manufacturing Process (GAMP5) / Electronically Compliant
Manufacturing
29 July
Fun Day Golf Tournament and Winery Tour
24 August
Commuter Conference
Topic: Diagnostics
3 November
Commuter Conference
Topic: Future Facilities:
Future of Manufacturing
Where will we be in 5 Years?
More Events To Be Announced At A Later Date.
All events subject to change due to availability of venue and speakers.
30
For more details please visit ISPE San Francisco/Bay Area Web site
ISPE’s Global Calendar: www.ispe.org

Outgoing President`s Message

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