Published by ISPE San Francisco/Bay Area Chapter
Serving Northern California
Editor: Kimberly Syre
Email: ksyre@cox.net
Information: Phone 1.949.387.9046
Fax 1.949.266-8461
www.ispe.org/sanfrancisco
NEWSLETTER
Volume 18, No. 3
In this issue
Vendor Night Information
PAGES 1, 3-5
ISPE Vendor Night 2012
Factories of the Future
Chocolate Factory Program
PAGE 2
by Karl Wilks, Vendor Night Chair
Industry News
PAGES 6-8
I
SPE Vendor Night 2012 is right around the corner, on
Thursday, March 29. This is shaping up to be our largest event ever! And, of course, the most fun too. We
expect close to 1000 people to be in attendance.
Join Member Benefits
PAGE 9
Donations Needed for
ISPE Relay Team
PAGE 10
What's new this year, you may ask? Actually, there are
several things that will be new and different. First of all,
there is a fun new theme… “Factories of the Future We've Got an App for That”. This theme is closely tied to
the presentations in the technical session. The technical
session will highlight what we might be seeing in the future. How about an iPhone app to manage your inventory
or to process batch records? What will manufacturing of
Biologics look like?
Welcome New Members
PAGE 11
Technical Article: Cryonic Ice Fog
as a Means to Induce Uniform Ice
Nucleation during Lyophilization
PAGES 12-13
Overview of CEO Night 2012
PAGE 14
ISPE’s Focus on
Young Professionals
PAGE 15
February Commuter Conference
Presentation Available for Download
Framework for Technology Transfer
to Satisfy the New Process
Validation Guidance
PAGE 16
UC Berkeley and ISPE SF
Collaborative BioEngineering Class
PAGE 17
Chapter Committee List
PAGE 18
Board of Directors List
PAGE 19
Chapter Calendar
PAGE 20
President’s Message
PAGE 21
Then there are the costumes to go with the Factory of the Future theme. We are excited
about the costumes. You'll probably see Spock, Warf, Yoda, Luke and many more. Maybe
even George Jetson or Astro, ‘Rut Ro’.
There is also the Silent Auction. Vendors will bring prizes to donate, and they will want you
to come by their table in order to record your written bid. I think we will see some good gifts
again this year to bid on - TVs, iPads, vintage wine, and more. The proceeds from this
fundraising event will benefit the Chocolate Factory. So, peruse the vendor tables and record
your silent auction bids.
Finally, we started something new with regard to vendor tables. We now offer a 10' x 10' ‘Super Premium’ booth for large display, vendor equipment. This idea is similar to INTERPHEX,
which no longer conducts a West Coast event.
We are excited about ISPE Vendor Night 2012. Please come and join
us to network, catch up with old friends, and capture ideas for future
business opportunities.
See you there!
ISPE Vendor Night Committee
The President’s Message
has been moved to the last
page of the newsletter.
Silent Auction at This Year’s Vendor Night
Proceeds Help Fund the Chocolate Factory Outreach
by Germaine Bickel of Genentech
We need your help!
Please join us on March 29 at Vendor Night to participate in a silent auction. Exhibitors will be donating prizes that the attendees can bid on.
Your money goes to good use helping to fund the Chocolate Factory (see
details below) and you get to go home with a nice prize.
Over the past 6 years, ISPE has teamed with local companies,
including Amgen and Genentech, and the South San Francisco
Unified School District to create the chocolate factory outreach
program for 5th graders.
What is it?
Each school year volunteers from pharmaceutical, general construction,
architectural, and engineering firms visit the nine elementary schools in
South San Francisco leading small groups of 5th graders in learning about
construction, biology and teamwork. The outcome: a chocolate factory.
The ingredients: Teamwork, fun, pure imagination and
popsicle sticks, pipe cleaners, colored paper, glue, modeling clay.....
Benefits
A hands-on, real-life exercise with the goal of getting kids excited about
science and engineering. The chocolate factory exercise is extremely
popular with the kids. Most have heard about the program and can’t
wait for the day they get to participate. It’s also an incredibly rewarding
experience for the volunteers who work with the kids. The imagination and
thought that goes into their designs is amazing. And every volunteer gets
a personal thank you letter from each of the kids in their group.
How your company can help
1. The purchase of materials to build the chocolate factories makes up
a substantial part of the program’s annual budget. The program serves
approximately 750 students each year. Any donation of materials would
be greatly appreciated (see supply list in column two).
2. Make a monetary donation. Make checks payable to South San
Francisco USD (write Chocolate Factory in memo line) and mail to the
attention of Christine Gong or Susan Mar at 398 B Street, South San
Francisco, CA 94080. School board will send a thank you letter with
amount of donation for tax purposes. NOTE: May 1, 2012, is the deadline
for monetary donations for the 2012-2013 school year.
3. Sponsor a school. The cost per school is $1,200 (for materials and the
teacher to run the program). An even better way to get the full chocolate
factory experience is to also volunteer at the school you sponsor. An average of 10 volunteers are needed per school.
4. Make an annual contribution of your choice.
2
An average of 7
chocolate factories are
made at each school
event; approximately
60 factories each
school year.
“I learned a lot about how to make a factory and
you helped us work as a team. It was so much
fun having you come to Sunshine Gardens...”
(excerpted from a thank you letter)
Chocolate Factory Supply List
• Styrofoam 1x6x12 inch blocks
• Jumbo craftsticks
• Regular craftsticks
• Tissue Paper 12x18 inches
• Corrugated Paper 12x16 inches
• Foamboard 20x30 or 16x20 inches
• Student size Scissors (preferably with pointed
tips so students can “dig” trenches with them)
• Pipe cleaners – assorted colors
• Crayola model magic – assorted colors
• Artstraws 4mm
• Tape (masking and/or duct tape)
• Markers
• X-ACTO knives
• Richeson disposable cups (The cups measure
1-1/16" (2.7 cm) deep × 2-3/16" (5.6 cm)
diameter)
• Glue – either Elmer’s white glue or craft glue,
but no glue sticks
• Aluminum foil
For questions about the supply list or where
to drop-off a donation, please contact Kristen
Sevillia at ksevillia@ssfusd.org
NOTE: May 1, 2012, is the deadline for supply
donations for the 2012-2013 school year.
ISPE San Francisco/Bay Area Chapter
21st Annual
Vendor Night Exhibit Show
Thursday, March 29, 2012
This Year’s Theme:
Factory of the Future
We’ve Got an App for That
160 Exhibitors
Over 800 Attendees
Best Theme Dressed Person Wins Cash!
Best Decorated Table Wins Cash!
• Free To Attend Exhibit Show
• Complimentary Appetizers
• Great Networking
• Silent Auction
• Free Parking at Venue
Bring your business cards
3
J
Factory of the Future - We’ve Got An App For That
Technical Session for Vendor Night Announced
oin us for this year’s Vendor Night technical
session featuring talks from Bayer and Genentech.
ABOUT THE PRESENTERS:
Karl Curtis, Director, Enhanced
Information Solutions (EIS)
Karl is a manufacturing computer systems
expert currently focused on mobile apps and
the broad impact they will have on life science
manufacturing. Karl’s background includes
both management consulting and industry
roles in the life science space. His focus has
been on manufacturing computer systems,
including a position as the technical lead
for Genentech’s worldwide manufacturing
execution system (MES). Karl obtained his
undergraduate degree in Information Systems
at Ohio State and he earned an MBA from
Oxford in the United Kingdom.
Thomas Daszkowski, V.P., Bayer
Technology Services (BTS) Technology
Healthcare
Thomas holds a Ph.D. in chemical engineering from the University of Stuttgart in
Germany. He joined Bayer in Leverkusen in
1991, spent 5 years in the Central Technology
Department and moved on to become a
production lead for the Polyester unit in
Dormagen (Germany). In 1999 he got an
assignment in the CESRO office in Baytown,
TX and became 2002 Head of the Process
Technology Group of Bayer Technology
Services in America.
3:00 - 4:00 pm
Ideas and Concepts for a Biotech Factory of
the Future
Presenter: Thomas Daszkowski, V.P., Bayer
Technology Services (BTS) Technology Healthcare
Production Technology and Cell Biology is developing
rather quickly while current Biotech Facilities once constructed and in operation are rather difficult to change. The
presentation will try to address the changes seen in Biotech
production and will evaluate how modern facility concepts
maybe able to address ongoing and future changes.
4:00 - 5:00 pm
Manufacturing 2020: Exploring Big Picture
Trends That Will Shape the Factory of the
Future
How trends such as the iPad and mobile apps will lead
to more efficient manufacturing
Presenters:
Karl Curtis, Director, Enhanced Information Solutions
Alan Pruitt, Automation Technology Mgr, Genentech
In today’s world, we are continually inundated with headlines about mobile apps, tablet functionality and the rise of
smartphones. The increase in mobility enabled by devices
such as the iPad is just one of a number of big picture
trends that will impact life science manufacturing in the
coming years. This presentation will look at five big picture trends that will impact the factory of the future; plus
how these trends are converging to create a manufacturing
environment that will facilitate the gathering of business
intelligence, while providing greater visibility of shop floor
operations. Mobility and tablets, such as the iPad, will play
a key role in these trends. We will also explore how life
science companies can incorporate apps to implement a
mobile strategy which maximizes the benefits of the latest
technologies. Further, the presentation will provide an industry case study
on how Genentech is leading the way with tablet utilization on the shop floor. Some life science companies have
started using iPads to view SOPs within manufacturing
suites, but we will explore how a proof-of-concept currently
underway at Genentech is going beyond this, investigating
the use of mobile apps to execute recipes and use logs in
clinical manufacturing and the advantages this will allow.
Since 2007 he is heading the BTS Product
Group Applied Science and Biotechnology.
Consolidating and streamlining the efforts of
the BTS-Healthcare activities he relocated
2009 to Bayer’s Biotech production location
in Berkeley California and became V.P. of
BTS-A Process Technology Healthcare.
4
Alan Pruitt, Automation Technology
Manager, Genentech
Alan is an automation technology manager in
the South San Francisco manufacturing facility. His background is in developing and maintaining automation systems. Alan manages a
group of engineers that develop and maintain
manufacturing computer systems including
MES, PDM, data historian, and data analysis
and reporting tools. He received his undergraduate degree in Chemical Engineering at
Purdue University, IN and his MBA from St.
Mary’s College in Moraga, CA.
ISPE San Francisco/Bay Area Chapter
www.ispe.org/sanfrancisco
21st Annual Vendor Night
Thursday, March 29, 2012
South San Francisco Conference Center
255 South Airport Blvd.
South San Francisco, CA 94080
(650) 877-8787 FREE PARKING
Exhibitor Set-Up Technical Session
Exhibits Open, Free Complimentary Appetizers
2:30-4:30 pm
3:00-5:00 pm
5:00-8:00 pm
6:00-8:00 pm
EXHIBITOR REGISTRATION FORM
For an immediate receipt and confirmation, please use the on-line registration system:
http://www.atdevents.net/ispesanfrancisco.php
Register online or Fax This Form To: (949) 266-8461. Include your credit card information or fax the registration first, then mail
your check (and original registration form) made payable to ISPE San Francisco/Bay Area Chapter to 5319 University Dr., Suite 641,
Irvine, CA 92612. For questions email Kimberly Syre, Chapter Manager at: ksyre@cox.net or call (888) 275-0189 or (949) 387-9046.
Federal Tax ID #68-0282494. Cancellations must be received by March 19, 2012 for a refund. Payments for tables must be received
by March 19, 2012. NOTE: If you do not have time to register for the technical session or to walk the show, please email
Rob Fleming (rob.fleming@yahoo.com) asking him to add you to the list for name badges for the ISPE SF Vendor Night. We
will prepare a badge for you. Any payments can be accepted at the event.
❑
❑
❑
Table Selection: Using the
table diagram, please select
your top 10 table locations
in your table category
1.
6.
2.
7.
3.
8.
4.
9.
5.
10.
Free To Walk Show and Visit Exhibits
$20 Technical Session
Free Technical Session for Students
Exhibitor Table Tops (Electrical Included)
❑
$2,000 Super Premium: 10’ x 10’ Booth
❑
❑
❑
❑
or Truck/Van Display in Parking Lot
$895
Platinum Table
$795
Premium Table (near food and technical session)
$695 Regular Table (inside tables)
$200
Food Sponsor (sign by food, no table)
SOLD OUT
All tables are 6’ x 2.5’. Max Height 60”. Max Width 72”.
Everything must fit on your table top. No items can be displayed on the floor or on the wall.
FIRST NAME:
Silent Auction Items Wanted. If You Have a
Silent Auction Item, Please Bring it With You
and List What You Anticipate Bringing:
CREDIT CARD PAYMENT
Type of Credit Card
Circle One
Name on Card:
LAST NAME:
Credit Card #:
TITLE:
Exp Date:
COMPANY:
Signature:
E-MAIL:
ADDRESS:
CITY:
STATE:
PHONE:
ZIP:
If purchasing a table top, please List Your Company
Coordinator. We will copy your coordinator with
the email confirmation package
(table diagram/shipping and set-up instructions).
Name:
Coordinator Email:
Industry News
by Sandra Medlin of Sani-Tech West
Biotech industry tries to cut hurdles to approval
Looking over the agenda items of this year’s biotech industry
conference, one theme emerges loud and clear: how to cut
through various obstacles and get drug advances to patients
faster and more cheaply. Faster than the 10 to 15 years it
currently takes to bring a new drug to market in the United
States, and cheaper than the $1 billion-plus each individual
effort entails.
FDA panel backs effort to lift class hold on anti-NGF pain
drugs
Clearing a major roadblock that’s keeping Big Pharma from a
megablockbuster drug market, a group of FDA experts voted
unanimously to allow Pfizer and several other developers
to resume testing a new generation of pain medications for
osteoarthritis.
The potential benefits of experimental anti-nerve growth
factor drugs clearly outweighed the risks associated with
the treatments, the panel concluded in a 21 to 0 vote. But
now the FDA will be expected to weigh in with its own final
decision, adding critical judgments on dosing and drug
study designs for anyone looking to re-start testing. Those
decisions will have the biggest impact on Pfizer , which wants
to ramp up a new late-stage study of tanezumab. Regeneron
Pharmaceuticals, Johnson & Johnson and AstraZeneca
--which voluntarily halted its own work on an anti-NGF
treatment drug after the FDA issued a clinical hold for the
class--all have their own programs to consider as well. J&J is
still studying its pain drug in a group of cancer patients.
For all the advances made in drug therapies in recent years,
the time and money spent on making them available is
actually increasing, says Gail Maderis, CEO of BayBio, the
Northern California industry group co-sponsoring the twoday conference, which opens Thursday in San Francisco.
“We’re in a position now where aspirin would probably not be
approved by the FDA because of the risk factors associated,”
she said.
That particular obstacle will probably be addressed by
keynote speaker Andrew von Eschenbach, former FDA
commissioner under President George W. Bush, and by Rep.
Brian Bilbray, R-Carlsbad (San Diego County), who introduced
federal legislation last month eliminating state inspections of
biotech facilities that essentially duplicate the FDA’s function.
Assemblyman Jerry Hill, D-San Mateo, has introduced a
similar measure in the state Legislature.
Tanezumab had looked like an up-and-coming blockbuster
drug in the fall of 2010, when investigators found an alarming
need for joint replacement surgeries among patients taking
the drug. Now regulators will consider whether Pfizer can
go back to the head of the pack with a new Phase III trial
adjusted to account for the threat to joints, or start at the
beginning with new safety studies.
California would be the only state affected by the legislation,
because it’s the only state in the nation that has a food and
drug oversight agency that duplicates the FDA’s functions,
performed by an agency you may not have heard of - the
California Food and Drug Branch.
Two other bills in Congress, one by Sen. Kay Hagan, D-N.C.,
the other co-sponsored by Rep. Cliff Stearns, R-Fla., and Rep.
Edolphus Towns, D-N.Y., would accelerate FDA approval of
certain drugs that single out rare diseases, others that affect a
particular subgroup of the population, and diseases for which
there are no known treatments - for example, specific types of
brain and ovarian cancer.
The three federal bills have bipartisan support, but in an
election year, there’s no knowing what will happen to them.
(continued on next page)
Specializing in Biopharm Processes
Brian Vaughn
Director of Business Development
Ext. 223
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Industry News
by Sandra Medlin of Sani-Tech West (continued)
FDA nudged to treat antibiotics like rare disease drugs
A research group wants the FDA to give applications for
new antibiotics some of the same treatment now lavished on
rare disease drugs, aiming to address a well-known lack of
antibiotics development across the biopharma industry.
“This proposal creates a new mechanism, similar to the
orphan drug act (for rare diseases),” Robert Guidos, IDSA’s
vice president of public policy and government relations, told
Reuters. “It’s a game-changer.”
Novartis cancer drugs stymie deadly Ebola virus
A pair of Novartis leukemia drugs effectively attacked the
highly lethal Ebola virus in lab tests, providing clues about
what it might take to finally march forward with a treatment
against the killer bug.
Researchers worry that investments in creating new antibacterial drugs are relatively tiny in the face of the big problem
of antibiotic-resistant superbugs. The Infectious Diseases
Society of America yesterday asked Congress to consider a
proposal that would let the FDA allow developers of antibiotics
to enroll fewer patients in clinical trials and get speedy
responses from the agency--two of the benefits that rare
disease drugmakers have enjoyed for decades.
NIH researchers tested the Swiss drug giant’s blood
cancer remedies--Gleevec and Tasigna--in lab dishes
containing cells infected with Ebola, showing that the drugs
were able to block the spread of viral particles from the
cells, Bloomberg reported. It turns out that a force behind
reproduction of the virus is a tyrosine kinase known as
c-Abl1, a close relative of Bcr-Abl, a protein that both
Gleevec and Tasigna block. “Drugs that target [the release
of viral particles] would be expected to reduce the spread
of infection, giving the immune system time to control the
infection,” the study authors wrote, as quoted by Pakistan’s
International News Network. “Our results suggest that shortterm administration of [Tasigna] or [Gleevec] may be useful
in treating Ebola virus infections.”
This special treatment has helped turn rare diseases from
a backwater of drug development into a hot area of R&D
for many biopharma outfits. Whether the same perks that
helped rare disease drugs will benefit antibiotics is an open
question. Many rare disease treatments such as Genzyme’s
enzyme therapies are chronic use drugs, making them more
lucrative than antibiotics that are given to patients only until
their infections are eradicated. Yet there’s no denying that the
antibiotics field has only a few Big Pharma players. Reuters
reports that the only major drugmakers with antibiotics units
are GlaxoSmithKline and AstraZeneca. Others have opted
to invest in antibiotics development via deals with outside
companies or have abandoned the field completely. And
the IDSA thinks that the regulatory changes would spur a
turnaround for antibiotics development.
(continued on next page)
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Industry News
by Sandra Medlin of Sani-Tech West (continued)
Tasigna stymied reproduction of the virus by 10,000-fold, the
news service reported, but researchers say that new drugs
could be designed to target c-Abl1 specifically. That could be
good news for victims of Ebola, which triggers hemorrhagic
fevers that cause bleeding and eventually death in 9 out of
10 victims, according to the International News Network’s
article on the findings. The NIH has been a big supporter of
repurposing existing drugs to fight new diseases, sometimes
ones very different than the original ailment for which the drug
was developed. Repurposing drugs is expected to benefit
from scientists’ deeper understanding of the mechanisms and
genes involved in diseases.
“We believe EDP-239 has great potential as a potent
ingredient in combination drug therapy, and our preclinical
studies have demonstrated high potency against multiple
genotypes of the virus, excellent safety profile and a
preclinical pharmacokinetic profile amenable to once-a-day
dosing in humans,” says Enanta CEO Jay Luly, Ph.D., in a
statement.
The NS5A target is a hot one in hep C. Developers at this
stage of the game are looking for treatments that have a
broad effect across all three genotypes. They also want to
find new cocktails that can beat down the virus and eliminate
any signs of it without having to resort to interferon.
Bionovo slashes bulk of staff, cuts costs as cash runs
out
Work seems to be coming to a close at Bionovo. The
Emeryville, CA-based biotech says that without the money
it needs to pay its bills, it is axing 90% of its remaining
workforce, reducing compensation for the skeletal executive
crew remaining on duty and considering the fate of an
ongoing study for its lead drug.
FDA releases long-awaited rules for the biosimilars
business
The FDA has finally issued its eagerly anticipated draft of
rules governing the development of biosimilars, laying out a
roadmap for a multibillion-dollar industry that’s been rapidly
taking shape under the wing of big biopharma companies
and a slate of multinational players.
“The company does not currently have adequate internal
liquidity to meet its cash needs,” the biotech said in a
statement. “If sufficient additional funds are not received
in the near term, the company may not be able to execute
its business plan and may need to further curtail or cease
operations.”
Analysts quickly concluded that the rules largely fit a broad
framework that FDA officials have been outlining for months
now. Regulators will typically require developers to provide
clean animal data on toxicity and compelling PK and PD
data from human studies. Additional studies may be required
before a developer can win approval for an “interchangeable”
therapy, which would allow payers and pharmacists to
automatically switch a patient to a less expensive copy.
The FDA was very careful to detail a high standard for
biosimilars. Faced with the challenge of evaluating copies of
complex biologics, which can be altered simply by changing
manufacturers, regulators made it clear that these new drugs
will typically require expensive late-stage human studies.
The science behind the target will be understood, and the
discovery and early-stage work largely unnecessary, but
they left an exacting hurdle for developers to clear. And each
program will have to be tailored to fit the FDA’s requirements.
Bionovo announced in January that it would delist voluntarily
from Nasdaq. Its announcement of a strategic review came
soon after. Bionovo set out to develop new treatments for
women’s health, zeroing in on a drug for menopause. Its
lead drug, Menerba, is in Phase III for hot flashes and the
company lists three treatments in the pipeline
Novartis enters the hep C game with a $440M pact
to license a preclinical NS5A drug from Enanta
Pharmaceuticals.
As part of the deal, Watertown, MA-based Enanta will get
$34 million upfront, $406 million on a full slate of milestones,
potential double-digit royalties on EDP-239 and some fresh
backing on its related discovery work in the field. Novartis is
taking on all development costs for the program.
COMPLIANCE SERVICES
The biosimilar industry taking shape, then, is likely to offer
new products which are, at least initially, not interchangeable.
Due to the heavy cost of development, these new biosimilars
will be offered at a discount of around 10% to 20%, but
without the drastic markdowns that obliterate a small
molecule’s retail value in months. And that will be welcome
news inside many biopharma companies, which can now
look forward to managing more limited competition after a
long period of exclusivity on the market.
VALIDATION
The source of this information is the ISPE website, confirmed
on company websites.
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events. IPS, USA
Andrewonline
A. Signore,
CPIP,
President,
Knowledge
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You can connect with ISPE Members in your area with your complimentary
membership in one of ISPE’s Affiliates or Chapters – there is no additional
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Membership!
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Pharmaceutical Engineering Magazine
This Members-only bi-monthly publication features articles that provide practical
application and specification information on the design, construction, supervision,
and maintenance of process equipment, plant systems, instrumentation, and
facilities. Available in three formats:
“Over the years, the body of knowledge that has been
developed by ISPE is second to none. If you are looking
for answers, this is the place to come and find them.”
Andrew A. Signore, CPIP, President, IPS, USA
Jo
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The Relay May 5 – May 6, 2012
by Heather Bennett, ACCO Engineered Systems
I
t’s that time again! The ISPE Running Squad is training and
fund-raising for The Relay! The 2012 event is May 5-6 and
will take the 12 intrepid members of this year’s team 194
miles from Calistoga to Santa Cruz (even through the night), to
raise funds and awareness for Organs ‘R’ Us. Organs ‘R’ Us
helps people and families of loved ones that are in need of an
organ or tissue donation. Every day 20 people die before an
organ is found. As professionals in ISPE, we are in the business of improving lives through our work. Whether we work
for a company that creates new technologies/ drugs, builds the
facilities these are manufactured in, or supports the industry in
some way shape or form, we are making patients’ lives better.
Please support our team, as well as those people and families
that are waiting for the lifesaving gift of an organ.
You can also write a check payable to:
Organs R Us, 570 El Camino Real, Suite 150-330, Redwood
City, CA 94063 (make sure to write our team name “…And
You Shall Know Us by the Trail of Drugs” on the bottom of the
check).
Thanks!
Jason Beck - Evergreen EDC
http://www.crowdrise.com/ISPESF/fundraiser/jasonbeck
Lupita Beck – iPurity
Heather Bennett - ACCO Engineered Systems
http://www.crowdrise.com/ISPESF/fundraiser/heatherbennett
To donate online please see the list of our team members and
their respective fund-raising pages below.
David Sax - Baxter
http://www.crowdrise.com/ISPESF/fundraiser/davidsax
Amanda Jurinen
http://www.crowdrise.com/ISPESF/fundraiser/amandajurinen
SF Bay Area
STERIS Corporation
Matthew Lomas - Delta PM
http://www.crowdrise.com/ISPESF/fundraiser/mathewlomas
Rick Metz-Capital Equipment
Rick_Metz@steris.com
(916) 201-7644
Jordan Eger - Yonkers Industries
http://www.crowdrise.com/ISPESF/fundraiser/jordaneger
Robin Johnston - Consumables
Robin_Johnston@steris.com
(415) 308-4656
Patti Larson - XL Construction
http://www.crowdrise.com/ISPESF/fundraiser/pattilarson
To Tran - Dome Construction
http://www.crowdrise.com/ISPESF/fundraiser/totran
Nolan Graf
http://www.crowdrise.com/ISPESF/fundraiser/nolangraf
Tina Garcia - Davis & Associates Communications
http://www.crowdrise.com/ISPESF/fundraiser/tinagarcia1
Kelley Byars - Hathaway Dinwiddie
Volunteers
Peter Graham - Marone Bio Innovations
Grace Choi - CRB Consulting Engineers
10
Gilead Sciences, Inc
Announced that the company has completed its acquisition
from Electronics For Imaging, Inc. of a building located at 301
Dynavax Technologies Corporation
Velocity Way and adjacent land in Foster City. The acquisition covers the existing 301 Velocity Way building of approxiAnnounced it has been awarded a $17 million contract to
develop its advanced immunostimulatory Welcome
sequences technolmately 163,000
square feet and approximately 30 acres
New Chapter
Members
ogy using Toll-Like Receptor 9 agonists as vaccine adjuvants.
designed to accommodate up to an additional 542,000 square
JanuaryThis five-year contract was awarded by the National
Institutes March
feet of2012
office space. The building and associated land border
of Health’s National Institute of Allergy and Infectious
Gilead’s Foster City campus, the company’s headquarters
since 1988.
Diseases to develop novel vaccine adjuvant candidates that
Robert Barulich,
Manager, Genentech
signal through receptors of the innate immune
system. Procurement
The
contract supports adjuvant development
for
anthrax
as
well
as
Bayhill
Therapeutics,
Matthew Chen, Student, University of California
BerkeleyInc.
other disease models.
Joins the Juvenile Diabetes Research Foundation, the world’s
Lawrence D’Arcangelis P.E., Vice President, SyCal Engineering Inc.
leading charitable funder of type 1 diabetes research, in a
Bayer Healthcare
Pharmaceuticals
to support
Bayhill’s ongoing Phase I/II human clinBaxter International Inc.Angela Green, Senior Validation Engineer, partnership
ical trial
of BHT-3021,
DNA vaccine to reverse the immune
Mayor Richard M. Daley and Chicago
Public Schools
John Grunkemeier,
Director of Validation,
Bayer
Healthcarea LLC
announced that Baxter International
Inc.
will
donate
$5
milresponse
that
causes
type
Joe Hanley, VP of Project Management, S3H Inc. Mechanical 1 diabetes.
lion over five years to support CPS district science initiatives
Kevin
Hicks, in
Project
NOVO
Construction
— the first program ever to fund biotech
education
CPS Manager,The
source
of this information is the ISPE Web site, conLamont
Humphrey,
Innovations
history. This significant contribution
has the
potentialBusiness
to impactUnit Manager,
firmed onGlobal
company
websites.
more than 450 CPS teachers through professional
developLaurie Johnston,
Principal, Degenkolb Engineers
ment and 75,000 students — all at the junior high and high
Mike Kawano, QA Specialist III, Gilead Sciences
school level — who by the year 2012 will benefit from the new
Craig
Kimber,
Associate
innovative schools, enhanced teacher skill set,
materials,
and Director, Turner & Townsend
direct interaction with Baxter scientists
andKora,
engineers.
Janakidevi
SQA Engineer, Lighthouse Worldwide Solutions
PhyloChip was the only biotech company in the top three to
be recognized. There were 700 total entrants.
Thomas Lautenschlager, Sales, IPT Group LLC
VALIDATION
Renato O’Neal, VP of Business Development and Planning, Advance Design Consultants Inc.
COMMISSIONING
Eric Ovalle, University of California, Davis
Dharti Pancholi, Senior Process Engineer, NNE Pharmaplan
Vadim Rabinovici, Capital Project Manager, Bayer HealthCare
Chris Sanders, Director Project Development, S3H
Nirpal Sihota, Account Manager, Rockwell Automation
Jose Tavarez, eQuadrato, LLC
TRAINING
AUDITS
Joanna Tong, Engineer, Genentech Inc
500 Airport Blvd, Suite 100 ( Burlingame, CA 94010
Toll-Free (888) 242-0559 ( Office (650) 320-1788 ( Fax (650) Matthew
320-1789
Trujillo, Genentech
Richard Weeks, Reg Sales Manager, Alfa Laval
www.propharmagroup.com
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joe.mulvey@stantec.com
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11
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TECHNICAL ARTICLE
Cryogenic Ice Fog
as a Means to Induce Uniform Ice Nucleation during Lyophilization
by Frank Demarco of IMA Life North America
L
yophilization is an important downstream process for stabilizing pharmaceutical compounds. It involves removing
water and solvents from a product by sublimation and
desorption to levels which will not support biological or chemical reaction. It is an excellent method to extend the shelf life
of sensitive compounds for storage and transportation without
subjecting them to detrimental high temperatures, and the only
method available for a majority of compounds of biological
origin. Consequently, lyophilization continues to be indispensable to the pharmaceutical industry despite its high cost and
complexity.
tate improved control of key process parameters. Controlling
ice nucleation during the freezing cycle of lyophilization is
one such parameter that is currently under investigation as a
means towards more robust and scalable lyophilization cycles.
Importance of ice nucleation temperature
The onset of freezing or ice nucleation is one of the most
important steps in the lyophilization cycle. For non-aseptic
systems it is often a particle or impurity that serves as the
nucleation point allowing ice crystals to grow and the product
to freeze. However, in aseptic systems of high purity it is not
uncommon for the product to cool well below its freezing temperature without ice crystal formation as there are no particulates available for ice nucleation― a process known as supercooling. Substances that cool below the freezing temperature
without becoming solid are referred to as supercooled. The
degree of supercooling determines the ice crystal structure
which in turn characterizes product resistance (resistance to
water vapor flow through the product) during the drying cycle.
Increased supercooling has been shown to form more numerous, smaller, ice crystals, resulting in higher product resistance
and hence increased drying times. Studies have shown a 1
- 3% increase in primary drying time for every 1°C decrease
in ice nucleation temperature1,2. Supercooling of vials during
freezing can thus increase cycle times and operating costs.
Lack of uniformity in ice nucleation temperature caused by
product supercooling can lead to vial-to-vial variability in ice
crystal structure. Product vials which nucleate at higher temperatures dry faster than the ones that nucleate at lower temperatures, making it difficult to have a drying cycle that is optimal to all vials. This causes problems like vial breakage and
melt back, and decreases overall yield and product uniformity.
The process of lyophilization consists of two major steps:
freezing of solutions, and drying of the frozen solid under vacuum via sublimation and desorption. The drying step is further
divided into two phases: primary drying (ice sublimation) and
secondary drying (desorption). A successful lyophilization cycle
can be defined by dried product that is visually and functionally acceptable, with short reconstitution times, potent active
ingredients and increased shelf life. Control and repeatability
of the cycle is inherently critical towards achieving consistently
good product quality. Lyophilization technology is seeing a
growing demand for improved process control due to the high
value of the drugs being lyophilized as well as FDA initiatives
like Quality by Design and PAT. Consequently, the industry
has been quick to adopt and develop technologies that facili-
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(continued on next page)
Foster Wheeler Biokinetics, Inc.
Susanne Lage’ Cost
VP, Business Development, Western Region
Walnut Creek, CA 94597
Phone: 925.256.2003
sue.cost@fwbiok.com
•
•
•
•
•
•
•
Process Development & Scale-Up
Critical Utility Design
cGMP Upgrades
cGMP Facility Design
Debottlenecking
Custom Process Equipment
Commissioning/Qualification/Validation
12
Cryogenic Ice Fog
as a Means to Induce Uniform Ice Nucleation during Lyophilization
(continued)
Ice fog as a means to induce uniform vial to vial ice
nucleation
One approach for reducing supercooling and controlling ice
nucleation temperature is to introduce nucleating particles into
the supercooled solution. A particularly advantageous nucleating
particle is ice in the form of an ‘ice fog’ introduced into the freezing
chamber3. The concept of temperature-controlled ice nucleation
was earlier suggested by T.W. Rowe in 19904. A cryogenically
created fog containing microscopic ice crystals is introduced into
the lyophilization chamber after the vials have achieved the temperature at which nucleation is desired. The ice crystals subsequently make their way into the vials, and induce nucleation inside
the vial. Although this technique has found success on a laboratory scale it has proven difficult to scale up to commercial lyophilizers. The difficulty is not only forming the ‘ice fog’ and ensuring it
is sterile, but also uniformly distributing the ice fog rapidly throughout the freezing chamber so that all vials are properly seeded with
nucleating ice particles.
novel means to produce and distribute a sterile ice fog
that is applicable to laboratory, pilot, and product scale
lyophilizers. This scalable cryogenic ice fog technology provides a much-needed degree of control during
lyophilization and thus facilitates application of Quality
by Design principles in this crucial downstream operation. The ice fog is created external to the chamber
and is introduced and circulated through the chamber.
The ice fog apparatus uses an ejector circuit consisting of a port for introducing ice fog into the freezing
chamber and another port for recycling fog out of the
chamber, with the ejector motivating the gas flow, and
liquid nitrogen being the cold energy source.
The collaborative work of Linde and IMA Life has been to develop
a means to produce and distribute an aseptic ice fog that nucleates all vials in a short time frame. This work has resulted in a
Guidance Documents
The method can be retrofitted to existing freeze dryers
and does not require the freeze dryer chamber to be a
pressure vessel.
Update your library
with these new releases!
Conclusion
In summary, ice nucleation during vial freezing in
lyophilization is an important process parameter that
should be controlled. The scalable cryogenic ice fog
technology as described here, can be utilized on laboratory, pilot, and production scale lyophilizers to induce
uniform ice nucleation and eliminate vial to vial variability. Testing conducted by IMA Life and Linde using
excipients such as mannitol and sucrose as well as
actual customer product has shown clear indication of
the positive impact of induced nucleation.
ISPE Good Practice
Guide: Applied Risk
Management for
Commissioning and
Qualification
ISPE Baseline® Guide:
Sterile Product
Manufacturing
Facilities
(Second Edition)
ISPE Good Practice
Guide: Project
Management for the
Pharmaceutical Industry
ISPE Baseline® Guide:
Water and Steam
Systems Guide
(Second Edition)
ISPE Good Practice
Guide: Interactive
Response Technology
ISPE Guide Series:
(PQLI®)
Part 1 – Product
Realization using QbD,
Concepts and
Principles
Part 2 – Product
Realization using QbD,
Illustrative Example
(electronic format only)
About the author
Frank Demarco is Product Manager, Freeze Drying
Systems for IMA Life North America, based in
Tonawanda, NY. Frank has managed engineering and
technology groups within IMA (formerly BOC Edwards)
for the past 20 years. He can be reached at frank.
demarco@imalife.com.
Order today, or view a full
catalog of ISPE publications at
www.ISPE.org/Guidance-Documents
13
1 Roy, M. L. and Pikal, M. J., J Parenter Sci
Technology 43, 60 (1989).
2 Searles, J. A., Carpenter, J. F., and Randolph, T.
W., J Pharm Sci. 90, 860 (2001).
3 Rambhatla, S., Ramot, R., Bhugra, C., and Pikal, M.
J., AAPS PharmSciTech 5 ( 4) (2004).
4 Rowe, T. D., in International Symposium on
Biological Product Freeze-Drying and Formulation
(Geneva, Switzerland, October 26, 1990).
Overview CEO Night 2012
by Michael Cooper, Bayer HealthCare
O
n January 19th, the SF/Bay Area Chapter hosted its
annual CEO Night at the South San Francisco Conference Center. Over 90 ISPE members attended the
presentations by this year’s featured speakers.
In 1990, Schering AG/Berlex acquired two biotech companies, Codon and Triton Biosciences. The Richmond campus
was purchased from Chevron Research in 1992 to consolidate staff from the acquisition. In addition, research staff from
Berlex New Jersey were relocated here. Bayer came into
possession of the site due to the 2006 merger with Schering
AG.
Dr. David C. Spellmeyer, Chief Technology Officer and Chief
Informatics Officer for Nodality, Inc., kicked off the evening
with an overview of this South San Francisco company and its
proprietary Single Cell Network Profiling (SCNP) technology.
The decision to move to Mission Bay was made for several
reasons: a change in emphasis on therapeutic areas, a more
appropriate sized facility for the current headcount, and the
Mission Bay environment – a cluster of academic research,
biotech companies, clinical care, and venture capital. The US
Innovation Center (USIC) is being configured to house three
organizations over two floors of lab space:
Nodality licenses the SCNP technology from Stanford University, where it was originally developed. SCNP is used to both
(1.) improve the outcome of clinical tests and (2.) facilitate drug
development, through characterization of how disease-specific,
cellular pathways react to therapeutic drugs (“functional pathway analysis”). SCNP is currently being used in research for
oncology (acute myeloid leukemia, myelodysplastic syndrome,
and chronic lymphocytic leukemia) and autoimmune disease
(rheumatoid arthritis and systemic lupus erythematosus).
•
•
Dr. Spellmeyer discussed building up Nodality’s integrated
scientific data infrastructure (where he credited ISPE’s GAMP
5 guidance for providing valuable assistance!), implementing
quality systems at an earlier stage than required, and maintaining a solid, shared vision by focusing on the people, not the
technology.
•
•
•
•
•
Next Dr. Spellmeyer discussed Nodality’s unique layout of
laboratories and resource sharing. In a traditional facility
layout, the Research lab (preclinical studies), GLP lab (clinical
studies), CLIA lab (clinical studies), and GMP lab exist as separate entities with their own instruments, processes, controls,
software, reagent manufacture, and systems. At Nodality,
these resources are shared as much as possible. Benefits of
this model include greater flexibility and redundancy in operations. Transfer of assays and knowledge across labs is also
facilitated.
Dr. Terry Hermiston, Vice President of Biologics Research
for Bayer HealthCare spoke next. Dr. Hermiston heads the
Mission Bay-based US biologics research team for Bayer’s
world-wide pharmaceutical research organization. He began
his presentation with an overview of the 53 acre Richmond site
where Bayer’s biologics research team originated.
•
Biologics Research. 40 FTEs focusing on:
Global Immunoprofiling and Bioanalytical assays
Pharmacokinetics (BA/PK) for Global Biologics up to
development
Identification and development of next generation biologics across therapeutic areas
Hematology Research. 30 FTEs focusing on:
Delivering development candidates
Science Hub. 5 FTEs focusing on:
identifying innovation in the US academic and biotech
sectors
Managing collaborate research projects between Bayer
scientists and external partners
The design and construction team was comprised of members from Bayer, ARE, BNBuilders, ACCO, Cupertino Electric,
Roundtree Plumbing, Flad Architects, and Xnth Engineering.
14
Lastly Dr. Hermiston spoke on his project to build a 6,000 sq
ft incubator known as “The CoLaborator” for startup companies in Mission Bay, similar to those already developed
by Fibrogen and QB3. The goal is to bring in early stage
companies in Bayer interest areas and help speed up evaluation of their technology/therapeutics. Tenants will have basic
lab infrastructure already in place, access to Bayer personnel
and equipment, and access to the greater Mission Bay community and resources.
ISPE’s Young Professionals (YP)
Detailed Outreach Program
Young Professionals Value Statement
To create a welcoming, comfortable environment at all levels
of ISPE wherein young professionals have unrestricted opportunities to network with peers, mentors and other professionals;
gain fundamental and advanced knowledge about the industry
and their area of professional interest; and to grow their skills
as needed to become industry professionals and the ISPE
leaders of tomorrow.
should be considered to start up meetings and support a few
events. This has been the case at some of the pilot Chapters
and has worked well. Alternately, a short-term goal of the local
Young Professionals Committee might be to have sponsors for
their meetings.
Are we creating a group that will be separate from existing
activities within a local Affiliate or Chapter?
No! A local YPC will tailor their socials and activities to the
needs of the local young professionals. Such events might be
freestanding or part of regular Chapter and Affiliate events
What Defines an ISPE Young Professional?
Any person who has just graduated college or is transitioning to our industry with less than 10 yrs of experience can be
considered a Young Professional. Typically, Chapters and
Affiliates allow local members to self identify as Young Professionals (YP). A YP member is not a student member.
What about the current Student Affairs Committees that
we support?
The International YPC encourages all Chapters and Affiliates to
continue supporting their local student affairs committees. This
is also an important element in teaching and recruiting young
professionals who are the future of this industry. It is encouraged that strong collaboration between the local SAC and the
YPC occur to help transition students into YP members of the
Society.
Is the Young Professionals Group limited to just Young
Professionals?
The intent of the YP initiative is to create opportunities for YPs
to develop networks with their peers, to engage in programs
that are focused on their specific training and educational
needs, to encourage them to develop social networks as YPs
and to engage with other ISPE members through Chapter and
Affiliate programs. In general, this means that YP members
along with mentors and other interested members will be on
the forefront of YP programming.
Should we cut our student programs?
International is not encouraging any student programs to be
cut. However, the addition of a Young Professionals Committee could oblige all other local committees to share their
budgets until the new group is self funded by sponsorships.
How can my Chapter or Affiliate get involved?
Each Chapter or Affiliate is encouraged to create a committee targeted at Young Professionals. This committee will be
assisted by the International Young Professionals Committee
which will facilitate the sharing of YP business plans and best
practices from the 5 pilot Chapters currently executing Young
Professional groups locally.
What ways can local Chapters and Affiliates engage Young
Professionals?
• Ask them to join a committee.
• Delegate tasks to help plan an event/meeting, etc.
• Create a mentor relationship with the YPs in the area.
• Ask them to share ideas about their needs with other
members.
• Encourage YPs to network not only with their peers but
also other members as well.
• Provide a place for YPs to have discussions and share
resources/information.
• Promote real member benefits.
• Reduced prices on training, Pharmaceutical Engineering
Magazine subscription, local social events, networking opportunities, leadership roles for professional development,
etc.
Should Young Professionals have a special rate for local
events?
For a regular event, Chapters and Affiliates are encouraged to
establish a special rate for Young Professionals. Many YPs
are in entry level positions and can find the registration fee to
be too expensive for their budgets. Also, many YPs are not
reimbursed by their employers for attending an ISPE event.
Do Young Professional activities limit attendance to only
YPs?
If an activity is planned specifically for Young Professionals and
there is space available for other members interested in attending, then they are encouraged to attend and support the new
initiative. YP focused classes have been held at one of the
Chapter pilot groups and half of the attendees were non-young
professionals interested in the specific topics.
Where do you find Young Professionals in your area?
Online – On Social Networking Sites
Ask local ISPE Student Chapters for list of recent graduates
Contact ISPE HQ for a list of recent graduates or new professionals entering industry.
Word of mouth at local companies looking to develop their
young professionals.
Where is this initiative in the Society’s priorities?
The development of actions that encourage recruitment of
Young Professionals into ISPE is one of the six major priorities
in the Society’s 2010 Business Plan. Pilot YP initiatives have
begun at five Chapters this year. It is anticipated that Young
Professionals should receive special attention in every Affiliate
and Chapter in future years. However, YP activities are not to
replace the student activities! The YP activities should be developed in addition to the Student Activities Committee locally.
How should a Chapter or Affiliate fund this initiative?
This is based entirely on the financial stability of the Chapter
or Affiliate. A small budget provided by the Chapter/Affiliate
What help can the International YPC provide to Chapters
and Affiliates?
The YPC will provide support by sharing best practices of pilot
groups, providing ideas of how to get started with your local
group, creating the opportunity for local groups to engage in
monthly meetings with other YP committees and establishing a
network of YP resources and contacts across the Society. This
group will also provide a foundation for ways to integrate YPs
into ISPE.
15
For further information and links to volunteers involved
in Young Professionals activities, please contact Tracey
Ryan at ISPE (tryan@ispe.org).
February Commuter Conference Overview
By Aaron Louyeh, Bayer HealthCare
A
n ISPE commuter conference was held in February at
the offices of Hyde Engineering + Consulting in South
San Francisco. Over 30 ISPE Members were in attendance to hear Bikash Chatterjee of Pharmatech Associates,
who presented “Framework for Technology Transfer to Satisfy
the New Process Validation Guidance.” The presentation
provided a comparison of New Guidelines to 1987 Guidance,
a road map on how to comply with the new guidelines, a case
study and other considerations for the emerging markets such
as China. A copy of this presentation can be found at
On a personal note, it is a rare occasion when I can use the
material given in a speech on the projects which I am working
on the very next day. It was also very comforting and educational to know how the other folks in the industry may deal with
similar issues and an expert advice on the reasonable approaches which can be taken.
A special thank you goes to Maura Lynch of Hyde for being a
gracious host and taking care of the details for the event.
Commuter Conferences are open to ISPE Members only. They
provide an interactive educational forum for 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. Attendees are asked to come prepared to share their experiences, successes, and lessons learned with the rest of the group.
http://www.ispe.org/san-francisco/technical-articles-presentations.
Mr. Chatterjee presented a very well thought-out framework
that Device Manufacturing and Biotech companies can implement in order to stay compliant with the latest regulations.
Northern California/Hawaii NEBB
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Engineering
Architecture
Process Technology
Process Automation
Systems Integration
Construction Management
400 Oyster Point Blvd, Suite 520
South San Francisco, CA 94080
650.588.2660 office
650.588.2857 fax
646.283.7987 cell
Maura Lynch
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Nino Borsoni, PMP - Senior Vice President
borsoni@eichleay.com
p. 925.348.2157
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Startup & Commissioning
Procurement
Project Management
maura.lynch@hyde-ec.com
www.hyde-ec.com
George Sheaffer
1860 S. 10th Street
San Jose, CA 95112
Phone 408-298-3134
Fax 408-298-2132
www.sprigelectric.com
Member of N.E.C.A. • CA Lic# 296728-C10 • NV Lic# 57803-C2
VP Business Development
Office: 480.471.7486
gesheaffer@validation.org
VALIDATION TECHNOLOGIES INCORPORATED ®
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UC Berkeley and ISPE Collaborate on BioEngineering Class
U
C Berkeley’s Bioengineering department and ISPE SF/Bay Area Chapter are collaborating on a spring-semester class
designed to bridge industry and academia. BioEngineering 25 is a seminar-style class that introduces students to careers in
the vast world of biotech.
Scientists, engineers, project managers and other professionals from all aspects of the industry are invited to speak to a class of
about 200 students every Monday from 4-5pm in 100 Lewis Hall at the UC Berkeley campus.
“There is no other class at Berkeley like BioE 25 where students can learn about ‘real’ jobs and meet professional engineers,” said
faculty sponsor, Professor Dorian Liepmann.
SF/Bay Area Chapter ISPE members are free to sit in on these classes during the semester.
ISPE Coordinators for the class are David Mourra with Bayer Technology Services and Kelly Keen with Genentech. This spring
semester schedule of speakers is listed below:
DATE
TOPIC
SPEAKER
BUSINESS TITLE
COMPANY
(Wed)
4 to 5 pm
Introduction to ISPE and Biotech Kelly Keen
President of ISPE
Genentech
23-Jan
Process Development
Scientist
Bayer Healthcare
30-Jan
Radiation Biology and Modeling Sylvain Costes
Biophysics Scientist
Lawrence Berkeley Lab
6-Feb
Sterilization in GMP
Biomanufacturing
Bioprocess Engineer
Bayer Technology
Services
13-Feb
Drug Development
Jolene Ignowski
David Mourra
President’s Day
Project Manager
No Class
20-Feb
Drug Delivery
Dorian Liepmann
Professor of
Bioengineering
UC Berkeley
27-Feb
Genentech Rotational Program
Scott Revelli
Technical Operations
Genentech
5-Mar
Drug Discovery
Kathryn
Vanderlaag
Research Scientist
Novartis
12-Mar
Medical Devices
Ian Larson
Engineer
Baxter Life Sciences
19-Mar
Spring Break
No Class
26-Mar
Design of Pharmaceutical
Facilities
David Bendet
Architect, Project
Manager
Perkins + Will
2-Apr
Brewery Engineering
Nishant Bhatia
Engineer
Advent Engineering
9-Apr
Engineering in Capital Projects
Kevin Sorenson
Process Engineer
Hyde Engineering
Consulting
16-Apr
Sustainability
Engineering
Bayer
23-Apr
Sustainability technologies and Anamica
Engineers without Borders
Srinivasaragavan
17
ISPE San Francisco / Bay Area Chapter Committees
Vendor Night Committee
Karl Wilks
Chair: Volunteers:Heather Bennett, ACCO Engineered Systems
Germaine Bickel, Genentech
Janet Burlinson, Customized Performance
Meriber Gonzalez, Gilead
Matt Hanson, Dome Construction
Jeff Jul, J2 Biosystems
Melody Spradlin, Dome Construction
Cynthia Wiggins, VERSA Engineering/Technology
Sokhorn Yim, Genentech
Program Committee
Chair: Brian Vaughn, Banks Integration Group, Inc.
Volunteers: Jeremy Agraz, Flad Architects
Michael Cooper, Bayer HealthCare
Sue Cost, Foster Wheeler Biokinetics
Ralf Elsaesser, Dome Construction
Simon Forder, Hyde Engineering + Consulting
Leroy Ginn, ACCO Engineered Systems
Andy Nelsen, Bay Area Engineers
Corey Veverka, TVS, Inc.
Commuter Conference Committee
Chair:Tareq Barakzoy, ACCO Engineered Systems
Vice Chair: Andrea Zarour, Greater Bay Mechanical, Inc.
Volunteers: Rick Ginn, XL Construction
Aaron Louyeh, Baxter Healthcare Corp.
Harvey Steinhaus, Dome Construction
Membership Committee
Chair:Ulrike Ruppelt, ticular - Strategies for Success
Volunteers: Mike Britting, D.F. Pray
Dave Edgar, Iron Construction
Edda Mihaescu, PhD, Bayer HealthCare LLC
Cindy Reginato, Hathaway Dinwiddie
Glenn Samuels, Alexza
Cynthia Wiggins, VERSA Engineering/Technology
Newsletter/Web Site Committee
Chair:
Jeff Jul, J2 Biosystems
Volunteers: Sandra Medlin, Sani-Tech West
David O’Connell, DCE Consulting, Inc.
Young Professionals/Student Affairs Committee
Chair:
David Mourra, Bayer Technology Services
Committee Vice Chairs:
YP:
Fion Cheng, Novartis
Students: Marlene Meza, Novartis
Volunteers: Nick Armstrong, Genentech
Heather Bennett, ACCO Engineered Systems
Bill Chestnut, Independent Consultant
Stacey Cox, Banks Integration Group
Triet Nguyen, Bayer Technology Services
Bill VanDerVoort, DST Controls
Steve Walker, Hyde Engineering + Consulting
Faculty:
Jim DeKloe, Solano College
Claire Komives, San Jose State University
Dr. Dorian Liepmann, UC Berkeley
Dr. Karen McDonald, UC Davis
Charity Committee
Chair: Ed Shea, BNBuilders
Volunteers: Greg Burg, Genentech
Sue Cost, Foster Wheeler Biokinetics
Volunteer Appreciation Committee
Chair: Linda Karr, Genentech
Volunteers: Corey Veverka, TVS
Fun Day Committee
Co-Chairs: Kim Duncan, Duncan Enterprises
Chris Humphrey, CRB
Volunteers: Arnold Asuncion, TVS
Adam Beatty, Emerson Process Systems
Mike Britting, D.F. Pray
Ed Shea, BNBuilders
Community Relations
Chair:
Germaine Bickel, Genentech
Vice Chair:Heather Bennett, ACCO Engineered Systems
Volunteers: Charlie Allnutt, DPR Construction
Trevor Auer, CRB
Jason Beck, Evergreen EDC
Kelley Byars, Hathaway Dinwiddie
Grace Choi, CRB
John Lohnes, AECOM
Advisory Committee
Chair:
Sue Cost, Foster Wheeler Biokinetics
Liaisons:
Greg Banks, Banks Integration Group, Inc.
Greg Burg, Genentech
Mark Hannon, Gilead Sciences
Linda Karr, Genentech
John Kelley, Genentech
Ed Shea, BNBuilders
Council:
Sandy Baker, GBSC/Johnson & Johnson (Alza)
Mike Batie, Bayer HealthCare Pharmaceuticals
Paul Bezy, Genentech
Kaye Cowen, Bayer HealthCare Pharmaceuticals
Al Dadson, XOMA
John Ducote, Bayer HealthCare Pharmaceuticals
Rex Eicher, Bayer Technical Services
Scott Foell, GBSC/Johnson & Johnson (Alza)
Ross Graves, Amgen
David Harris, Genentech
Paul Lauer, Biomarin
Bihn Le, Gilead Sciences
Todd Lopeman, Novartis Vaccines/Diagnostics
Dietrich Pampus, Bayer HealthCare Pharma
Phil Roberts, Exelixis Inc.
Jaime Romo, Novartis Pharma
Steve Sharon, Genentech
John Simpson, Genentech
Joe Tarantino, Novartis Pharmaceuticals
Karl Wilks
18
ISPE San Francisco / Bay Area Chapter
Board of Directors
Officers
President:
Kelly Keen, Genentech
Email
Telephone
keen.kelly@gene.com
(650) 467-5044
Vice President:
Ian Larson, Baxter Healthcare
ian_larson@baxter.com
(510) 723-2094
Treasurer:
David Bendet, Perkins+Will
david.bendet@perkinswill.com
(415) 217-9150
Secretary:
Simon Forder, Hyde Engineering + Consulting simon.forder@hyde-ec.com
(650) 588-2660
Chapter Past Presidents:
Directors
Tareq Barakzoy, ACCO Engineered Systems, tbarakzoy@accoes.com
Germaine Bickel, Genentech, bickel.germaine@gene.com
Kim Duncan, Duncan Enterprises, mkduncan@flash.net
Chris Humphrey, CRB, chris.humphrey@crbusa.com
Jeff Jul, J2Biosystems, jeff@j2biosystems.com
David Mourra, Bayer Tech Services, david.mourra@bayertechnology.com
Ulrike Ruppelt, ticular - Strategies For Success, ulrike.ruppelt@ticular.com
Brian Vaughn, Banks Integration Group, brianvaughn@banksintegration.com
Karl Wilks, kawilks@comcast.net
Planning • Programming • Permitting
Project Management • Construction Management
Full Service Design
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Corey Veverka, TVS, Inc.
2011
Linda Karr, Genentech
2010
Greg Banks, Banks Integration Group
2009
John Kelley, Genentech
2008
Rob Lynch, Dome Construction Corp.
2007
Mark Hannon, Genentech
2006
Greg Burg, Genentech
2005
Melody Spradlin, Dome Construction
2004
Ed Shea, BNBuilders 2003-2004
Jon Sheh, Johnson & Johnson
2002
Scott Laskey
2001
Haleh Banisadr-Hughes, TVS, Inc.
2000
Jeff Hargroves, ProPharma Group
1999
Sue Cost, Foster Wheeler Biokinetics
1998
John Sugerik, JTS Enterprises
1997
Dennis Mosher, Bay-Tec (retired)
1996
Ian MacLaren, Southland Industries
1995
Pete McArthur, Amylin (retired)
1994
Burt Van Loon 1993
astropak.com
Oscar Garcia
Technical Sales Representative
Sandra Medlin
Technical Sales Representative
Bob Miller
(323) 252-1110 Cell
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Call Today! 703.542.0608
5319 University Dr., Suite 641
Irvine, CA 92612
Chapter Hotline:
(888) 275-0189
or
(949) 387-9046
Fax:
(949) 387-9047
or
(949) 266-8461
For advertising deadlines/costs:
www.ispe.org/SanFrancisco
For additional ISPE Educational
Offerings and Publications
www.ispe.org
ISPE is a Society of
pharmaceutical professionals
who use expert knowledge to
create high-quality, cost-effective
GMP solutions.
Technical Articles
High Quality ISPE Event
Photos Welcomed For Future
Newsletters
Please submit them via Email to
Jeff Jul, Newsletter Chair
jeff@j2biosystems.com
Cover Photos from Fotolia.com
Photographers:
© sfmthd
© innovari
ISPE 2012 Calendar
29 March
Vendor Night and Student Poster Contest
18 April
New Member Breakfast
TBD April
Facility Tour
2 May
Evening Meeting
5-6 MayThe Relay
15 May
Commuter Conference
24 May
Young Professionals Happy Hour
4-7 June
2012 Baltimore Training Series
Redefining the “C” in CGMP Conference
Co-Sponsored by FDA
GMP Hot Topics
Supply Chain Network
TBD June
Facility Tour/ Dinner Meeting
19 July
Fun Day Golf Tournament and Winery Tour
Livermore, CA
TBD August
Commuter Conference
27 September
Evening Meeting
TBD September
Commuter Conference
18 October
Oktoberfest at Thirsty Bear in SF
8 November
New Member Breakfast
11-14 November
ISPE Annual Meeting at Marriott Marquis
San Francisco
All events subject to change due to availability of venue and speakers.
For more details please visit ISPE San Francisco/Bay Area Web site
www.ispe.org/sanfrancisco
ISPE’s Global Calendar: www.ispe.org/globalcalendar
Additional Photos by:
Kelly Keen, Genentech
Andy Nelsen, Bay Area Engineers
20
President’s Message
Kelly Keen, Sr PM Genentech, Inc.
Proust Questionnaire
Anyone who has ever read Vanity Fair knows about the last
page of questions accompanied by a caricature drawing.
Thought it would be a nice way for you to get to know me a
little better. Some questions have been changed to protect the
innocent. Caricature compliments of Dome Construction event
at the SF Cartoon Museum.
What is your perfect happiness?
Balance between work, play, and travel.
What is your greatest fear?
Fish. It is hard for me to be in water where I cannot see bottom. Has to do with the muskies up in Northern Wisconsin.
If you were to die and come back as something else, what
would it be?
Monitor Lizard on a beach in the Pacific Rim. Nobody messes
with a thing that looks that scary on a white sand beach.
Which historical figure do you identify with most?
Marquise de Pompadour
What is your most treasured possession?
My home.
Which living person do you most admire?
Madonna. I think she is a fabulous businesswoman and I am
impressed at how she can keep reinventing herself.
Where would you like to live?
Right where I am at with a view of the bay and redwoods in my
backyard.
Which trait do you deplore in yourself the most?
Lack of empathy.
What is your favorite occupation?
Architecture – it shaped my life and I still embark on pilgrimages to see amazing structures.
What trait do you deplore in others?
Laziness
What is your most marked characteristic?
Blonde hair.
On what occasion do you lie?
To protect someone’s feelings
What do you value most in your friends?
Adventure and the ability to look 10 years younger than they
are.
What is your greatest extravagance?
Travel
Who are your favorite writers?
Paulo Coelho, Chuck Klouserman, Khaled Hosseini
What is your favorite journey?
Singapore Air Business Class across the Pacific or my commute over the Bay Bridge on a sunny morning.
Who is your favorite hero of fiction?
Lisbett Salander
Which phrase do you overuse most?
‘Whatever’..or maybe it is ‘yes’ since I tend to overcommit
myself sometimes.
What are your favorite names?
Kilimanjaro, Titicaca, and Galapagos
What is your greatest regret?
Not buying Google stock at IPO, but I sometimes wonder what
my life would be like if I would have married the Frenchman.
What is it you dislike most?
Eel
How would you prefer to die?
Doing something I love, but quickly.
When and where were you happiest?
Eating my lunch in the Gardens of Versailles during architecture school.
What is your motto?
I have three…
1.) Work hard. Play harder.
2.) Travel is the best investment you can make in yourself.
3.) Take the path of most resistance.
Which talent would you most like to have?
To be invisible
Most people don’t know I can’t….
Swim…must have to do with the fish fear.
What do you consider your greatest achievement?
Having my first two houses that I drafted built at age 17.
NOTE: We hope you like this new feature of the newsletter.
Stay tuned for ISPE SF Member profiles in future newsletters.
21