Published by the ISPE PNW Chapter
Serving Washington and Oregon
Editor: Association Office: ISPEPNW@AMInc.org
Ph 1.877.460.5880 Fax 1.253.265.3043
MAY 2014 NEWSLETTER
IN THIS ISSUE
ISPE & OBA Event
PAGE 1
President’s Letter
PAGE 2
Welcome New Members
PAGE 2
Golf Is Now Open
PAGE 2
BioForum: ISPE and Oregon Bio at Genentech!
Thursday, May 8!
The Oregon Bioscience Association has teamed up with the Pacific NorthWest
Chapter of the International Society for Pharmaceutical Engineers (ISPE) and
Genentech to bring you this exciting event - a first of its kind!
Join us to tour the Hillsboro Technical Operations (HTO) facility and learn about the
latest innovations in aseptic processing, automated inspection, packaging and
serialization, and more. There will be ample opportunity for networking and learning
more about the Oregon Bio and ISPE.
Sponsorship Packages
PAGE 3
May Anniversaries
PAGE 3
Communities of Practice
PAGE 3
Agenda: 6:00 - 6:30: Networking and registration
6:30 - 7:30: Formal presentations
7:30 - 9:00: Open house/window tour and networking
ISPE International News
PAGE 4-5
Location: Genentech, 4625 NW Brookwood Parkway Hillsboro, OR 97124
Submit Your Articles!
Parking: available in paved lots in front of Genentech; additional parking is available in
Click here to submit your
articles for next month’s
Newsletter. All suggestions
will be reviewed by the Board
of Directors.
______________________
Become a Leader in the
Industry - Join a
Committee!
Your Board needs your help.
Contact the Association at
ISPEPNW@AMInc.org
if you are interested in
joining a committee!
Click here for directions.
the gravel lot off of Evergreen Parkway.
Cost: $45 – ISPE PNW & Oregon Bio Members / $70 - Non-Members / $15 - Students
Attendees must present a government issued photo ID upon arrival at the event. Entry will
not be allowed without a valid ID.
Click here to Register!
Thank you to our Sponsors!
Interested in Sponsoring? Contact Oregon Bio by email or 503-548-4432!
ISPE PACIFIC NORTHWE ST CHAPTER
NEWSLETTER May 2014
PAGE 1
President’s Message
ISPE PNW President, Bob Mackey
We have some particularly exciting events this year; a
BioForum: ISPE & Oregon Bio tour at Genentech on
May 8, 2014! We will also include collaboration with
the Washington Biotechnology & Biomedical
Association (WBBA) at South Lake Union for a
summer biotech walking tour. Watch your emails for
these events and much more.
As we schedule this year’s events, your input is critical
to how we set up programs and serve our members.
I also invite our members to volunteer to participate in
some of our programs. These range from helping at
events to special programs. This involvement is also
the best way to gain eligibility for new ISPE board
membership. Please contact Katie Bohocky Toll Free
1-877-460-5880 or katie@aminc.org for details.
Join Us Friday, July 25
2:00 pm Shotgun Start - Eagle's Talon
Make someone's day! Bring along a colleague,
employee, family member or friend!
All Guests Welcome - No age requirement!
Agenda:
12:30 pm Golfer Check-In, Driving Range, Putting
& Chipping Contest
2:00 pm Shotgun Start
7:00 pm Awards Dinner
Cost:
Golf: $125/person
Dinner only: $40/person
Super Tickets: $25/ticket
Click here to Register to Play Today!
_____________________________________
Interested in becoming a Golf Sponsor?
Click here for sponsorship options and
details!
Welcome New Members!
Kim Christianson, Jubilant HollisterStier
John Espana, Bend Research
Cheri Fox, Seattle Genetics
Chamila Marasinghe, Seattle Genetics
Alexander B. Pearson, Montana State University


183 active members as of May 5, 2014
ISPE PNW - Serving the biopharmaceutical
industy since the mid-nineties.
ISPE PACIFIC NORTHWE ST CHAPTER
Sponsors will receive special recognition at the Golf
Tournament including signage, recognition at dinner,
in our monthly newsletter & on our
ISPE PNW Chapter website!
NEWSL ETTER May 2014
PAGE 2
Sponsorship Packages Now Available!
$1100 Platinum Package – Only 1 Available!
(One sold to Endress+Hauser, Inc.)
-Sponsorship of three (3) events or tours
-Hole Sponsorship with foursome at the Golf Tournament
-Company logo & website link on website for all of 2014
-Newsletter Advertisement (10 Newsletters!)
(Value of $1900!)
$950 Gold Package – Only 2 Available!
(One sold to Commissioning Agents, Inc.)
-Sponsorship of two (2) events or tours
- Hole Sponsorship with foursome at the Golf Tournament
-Company Logo & website link on website for all of 2014
-Newsletter Advertisement (10 Newsletters!)
(Value of $1600!!)
$600 Silver Package – Only 3 Available!
(One sold to Harris Group)
-Sponsorship of one (1) event or tour
- Hole Sponsorship alone at the Golf Tournament
-Company Logo & website link on website for all of 2014
-Newsletter Advertisement (10 Newsletters!)
(Value of $900!!)
Click here for more information.
or
Click here to secure your Sponsorship today!
Our May Anniversaries!
24 Years – Robert B. Woolfenden, II
18 Years – Cecilia D. Taylor
13 Years – Steven L. Powers & Tim D. Andrews
10 Years – Mr. Aaron Molskness
8 Years - David N. Price
6 Years - Ben R. Chen
3 Years – Paul Lundy
2 Years - Paul Chamberlain & Keith W. Miller
1 Year – Jasmin Smith, Dan Millington, James C.
Wong, Kari A. Frantzen & Jay Millwater
ISPE PACIFIC NORTHWE ST CHAPTER
ISPE’s Communities of Practice (CoPs)
Connect with like-minded pharmaceutical industry
professionals through one of our 19 interactive online
communities
offering
exclusive
global
networking
opportunities and access to a community-specific body of
knowledge.
CoPs are now only available to ISPE Members. Join ISPE
today to ask questions and share your expertise in online
discussions and access technical articles, e-newsletters and
other valuable resources that will assist you in increasing
your effectiveness.
Click here to join a CoP today!
NEWSLETTER May 2014
PAGE 3
ISPE International Press Release
ISPE Announces Development of New Drug
Shortages Prevention Plan for the
Pharmaceutical Industry
Featured Member Benefit
Networking
with
professionals!
dedicated
like-minded
ISPE offers some of the best networking opportunities
you will find in the industry. Whether it's through our
extensive international network of Affiliates and
Chapters, our discipline-specific Communities of
Practice, volunteering on ISPE initiatives or at
dedicated
networking
events
during
ISPE
conferences, ISPE is your gateway to connecting with
the top technical minds in your region and all over the
world. Learn more
The International Society for Pharmaceutical
Engineering (ISPE) is an international society
consisting of more than 20,000 members in 90
countries. ISPE facilitates venues for
networking, interaction, and information sharing
within the region and provides publications,
conferences, and trainings on a wide variety of
topics from Good Engineering Practices to Quality
Risk Management. Our membership constituency
is made up of professionals from the
biotechnology, pharmaceutical and medical
device manufacturers and other supporting
industries such as academia, equipment
manufacturers, and construction/architecture.
ISPE PACIFIC NORTHWE ST CHAPTER
(TAMPA, FLORIDA, USA, 28 April 2014)— ISPE, the
International Society for Pharmaceutical Engineering,
announced today that it will work with stakeholders
world-wide to produce a Drug Shortages Prevention
Plan to guide the pharmaceutical and
biopharmaceutical industry in establishing reliable,
robust and resilient supply chains that provide quality
medicines to patients without interruption. The Plan,
which will be based on ISPE research with the input of
its membership, company leaders and regulators, will
serve as a roadmap that when implemented, can
significantly reduce drug shortages. The Plan will
address optimal organizational strategies, such as
aligned governance and communication practices,
effective manufacturing and quality systems, and
appropriate measures of supply chain robustness and
quality. This effort addresses rising concerns around
drug shortages within companies, among global health
authorities, and for patients who depend on a reliable
and available supply of quality medicines.
The ISPE Drug Shortages Prevention Plan will be the
Society’s second major output on this topic since
launching its Drug Shortages Initiative in 2012. This
second phase of the Initiative is aimed at addressing
the root causes of drug shortages to prevent delay of
supply. The 2013 survey provided clear evidence that
mitigating shortages requires a holistic approach that
encompasses both the organizational and technical
issues affecting drug manufacturing and quality. “How
much of the increasing number and severity of
incidents of drug shortages within our industry are
fundamentally tied to a lack of understanding, or even
concern for, the risk profiles of our current supply
chain structure?” commented Andy Skibo, Regional
VP, Biologics Supply, AstraZeneca/MedImmune. “I
therefore welcome ISPE’s initiative to tackle the root
causes of shortages for the benefit of all
stakeholders—ISPE Members, industry companies,
regulators and health authorities, third-party providers
and patients.”
The ISPE Drug Shortages Prevention Plan will provide
a key component of the Society’s input to a European
multi-association task force, moderated by ISPE,
which intends to provide EMA a proposal and plan that
address the prevention of drug shortages due to
manufacturing quality issues. “I’m delighted to be
collaborating with colleagues from the Parenteral Drug
Association to deliver our proposal to the EMA later
this year, and appreciate the support we are receiving
from EFPIA, EGA, AESGP and PPTA as well as
NEWSLETTER May 2014
PAGE 4
regulators representing the EMA, the UK, Irish,
Spanish and French national agencies,” said Dr. John
Berridge, ISPE’s Advisor and inter-Association task
force moderator.
In 2012, ISPE formed a Drug Shortage Task Force in
order to help stakeholders better understand the root
causes of global drug shortages and to define
mitigation strategies that can help prevent drug
shortages. In ISPE’s initial approach to this challenge,
the group led a comprehensive survey in 2013 that
revealed multi-factorial causes of drug shortages, as
well as success strategies for avoiding supply
interruptions. Those companies that have adopted
organizational drug shortage prevention strategies,
including contemporary governance, progressive
cultures and effective quality systems, were
successful in the avoidance of drug shortages and
supply interruptions. “Our research findings indicated
that, while shortages are often the result of quality
systems or related deficiencies, what was equally
profound was that those companies with dedicated
and sophisticated systems for avoiding drug shortages
were clearly more successful in avoiding supply
disruptions and shortages,” said Nancy Berg, ISPE’s
President and CEO. “Recognizing the impact of these
success strategies motivated ISPE to develop its Drug
Shortages Prevention Plan and to develop guidance
on organizational strategies for drug shortages
prevention, which include the engagement of company
leadership and execution of governance, culture,
especially a culture of quality risk management
throughout the supply chain, and insightful quality
metrics.”
ISPE’s Drug Shortages Prevention Plan will feature an
organization and product lifecycle approach to
ensuring a more reliable supply of medicines through
development of company-wide drug shortages
strategic plans, aligned governance, good
communication, ongoing capability building (which
includes training), proactive regulatory interaction and
integrated quality systems. The development of
industry-wide quality metrics is being addressed by
the Society through a parallel Quality Metrics Initiative,
led by another ISPE expert team recommending to
FDA and other health authorities a set of common
metrics on which the health and reliability of a
company’s production and quality systems and
products can be assessed.
For more information on ISPE’s Drug Shortages
Prevention Plan or other ISPE Initiatives, contact Ms.
Carol Winfield, Director of Regulatory Operations, at
cwinfield@ispe.org.
ISPE PACIFIC NORTHWE ST CHAPTER
NEWSLETTER May 2014
PAGE 5