What We Do
2016
Industry
Support
Opportunities
www.ISPE.org
www.ISPE.org/Sponsorships
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Who We Are
ISPE Purpose Statement
Our Members
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www.ISPE.org/Sponsorships
ISPE, the International Society for Pharmaceutical Engineering, is the
world’s largest not-for-profit association serving its Members by leading
scientific, technical and regulatory advancement throughout the entire
pharmaceutical manufacturing, capital investment and quality assurance
lifecycle.
ISPE delivers technical and operational solutions to support our Members
across the global pharmaceutical and biopharmaceutical industry in the
manufacture of quality medicines for patients.
All scientific and technical areas of the pharmaceutical manufacturing
industry are represented among the ISPE Membership. Manufacturing
and production leaders and professionals, supply chain professionals,
engineers, microbiologists, chemists, QA/QC, process development,
pharmacists, regulatory and training personnel, academia, critical
suppliers, and other professionals contribute their expertise to the
industry through their participation in ISPE activities.
What We Do
ISPE’s Core Members are pharmaceutical professionals who
use expert knowledge to create high-quality, cost-effective
GMP solutions.
ISPE is dedicated to helping our Members and their employers
solve the challenges they face today and prepare for the ones
that are expected in the future. In addition, our products and
services exist to help the pharmaceutical manufacturing
profession as a whole ensure the safety of the world’s supply
of medicines. We are committed to creating a forum for uniting
the world’s pharmaceutical manufacturing community.
ISPE delivers technical and operational solutions to support
our Members across the global pharmaceutical and
biopharmaceutical industry in the manufacture of quality
medicines for patients.
ISPE is committed to working with industry to solve the biggest
problems and provide best-practices solutions to help address
the most pressing needs facing us. ISPE initiatives include
Quality Metrics, Drug Shortages Prevention, Data Integrity
and Continuous Manufacturing.
www.ISPE.org/Sponsorships
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ISPE 2016
Core Initiatives
Drug Shortages
The prevention of drug shortages is critically important to public health. As a not-for-profit global organization
with both industry and regulatory members in 90 countries, ISPE is uniquely positioned to facilitate
communication between the different sectors of the pharmaceutical industry and global health authorities,
as it seeks to understand and address this complex problem.
The ISPE Drug Shortages Team focuses on the technical, scientific, manufacturing, quality, and compliance
issues associated with a company’s supply chain and related to its ability to source, manufacture, and
distribute products that have resulted in drug shortages. For example:
I nsufficient manufacturing capacity, exacerbated by industry consolidation, leading to fewer firms making
a product
N
on-robust or stressed supply chain designs leading to reduced flexibility and resilience
Product quality issues that result in temporary or permanent halting of production
L ack of secure, consistent availability of active ingredients, components, containers, or closures of suitable
quality, even reagents for quality control tests, which can be exacerbated by the increasing globalization
of the supply chain for ingredients and manufacturing
S
hifts in demand that arise from shortages of another drug—causing a chain reaction of shortages
U
nexpected market outcomes from new approvals e.g. generic manufacturing capacity does not meet
expectations, manufacturer of newly approved entity does not have sufficient capacity to meet market
demands.
A
ccelerating pipelines require much more flexible and agile supply chains than those designed for mature
or multi-source products.
Through its Drug Shortages Initiative, ISPE will also leverage its international network to lead industry-regulator
collaboration regarding drug shortages through meetings and conferences.
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www.ISPE.org/Sponsorships
ISPE is committed to the long term resolution and management of drug shortages by offering education and
training programs to support implementation and effectiveness across the entire industry.
Quality Metrics
ISPE has been leading the charge to bring industry and
regulators together to discuss quality metrics ever since it
was brought to the forefront of industry thinking in the
Food and Drug Administration Safety and Innovation Act
(FDASIA).
Routine company metrics include number of lot release tests;
out-of-specification results; and lots attempted, rejected,
reworked, and reprocessed. However, each company tends
to collect data in its own way for its own internal use, using
a range of definitions and sampling plans. How firms
measure and define “batch,” “lot,” and even “rejection” can
differ among companies in different sectors, in the same
sector, and even within the same company. Standardization
is needed to ensure that the metrics reported to the FDA
are defined and measured the same way by all.
ISPE has been at the forefront of gathering clear and
objective data through its Quality Metrics Pilot Program. In 2014 – 2015 the QM team designed and undertook an
extensive Pilot Program to test the feasibility of collecting
and reporting a standardized set of quality metrics. This
Wave 1 pilot program addressed many key issues and
components of this initiative. A Wave 2 of the pilot has
commenced, which will enhance understanding of
relationships revealed in Wave 1. Recruiting for Wave 2 is
currently underway and provides participants experience
in preparing for the logistics and efforts associated with
gathering of product-based data, including the FDA
proposed metrics set. Product Quality Lifecycle Implementation
(PQLI®) is ISPE’s Global Industry Initiative for a practical
approach to implementation of International Conference on
Harmonization (ICH) guidances Q8 (R2), Pharmaceutical
Development; Q9, Quality Risk Management; Q10,
Pharmaceutical Quality System; and Q11, Development
and Manufacture of Drug Substances. The Product Quality
Lifecycle Implementation (PQLI) initiative resulted from
the need to help industry find global solutions to
implementation challenges of ICH guidances.
At the request of FDA and under the sponsorship of ISPE’s
PQLI group, an ISPE Quality Metrics working group has
delivered a whitepaper to FDA identifying potential quality
metrics acceptable to industry in support of risk-based
inspections as called for in the US Food and Drug
Administration Safety and Innovation Act (FDASIA). The
recommendations contained in the paper stem from robust
industry/FDA discussions facilitated by ISPE.
www.ISPE.org/Sponsorships
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Our Attendees
ISPE events attract attendees from around the globe who are involved in all
facets of the Pharmaceutical Manufacturing life cycle.
Our events offer a wide range of industry- and career-advancing
opportunities. Network and problem-solve with top pharmaceutical and
biopharmaceutical industry figures, learn about important industry topics,
meet with suppliers, and share best practices with colleagues.
Pharma companies attending our events
Actavis Pharmaceuticals
Merck
AstraZeneca
Novartis
Bristol-Myers Squibb
Pfizer
Gilead Sciences
Roche
GlaxoSmithKline
Sanofi
Johnson & Johnson
Siemens
ISPE Member Industries
Senior Vice President Principal Engineer
Executive Director Senior Director
Director
Vice President
Senior Manager
Validation Manager
QA, QC,
Regulatory
Compliance
18%
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www.ISPE.org/Sponsorships
Who these companies
are sending
Facilities,
Operations,
A&E,
Manufacturing,
Construction
Process
Maintenance
Control
18%
17%
Top industry segments exhibiting at ISPE events
rchitecture/Engineering/Construction
A
C
lean Room Equipment and Supplies
C
onsulting Services (Commissioning, QA Support)
C
ontract Manufacturing
F acility Engineering and Maintenance
I nformation Technology
I nstruments and Controls
P
harmaceutical Related Software
P
rocessing and Manufacturing
V
alidation Support
Validation,
C&Q
14%
Sales,
Marketing
Product
Support
10%
Science
10%
Project
Management
7%
Other
6%
Past Sponsors
www.ISPE.org/Sponsorships
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ISPE Conferences
Aseptic
29 Feb. –­­ 1 March, 2016
Arlington, VA
The Aseptic Processing
Technology Conference is
celebrating its 25th anniversary
with the introduction of new
technological achievements
in the field, such as robotics,
sophisticated dispensing
systems, and disposables.
This year’s conference will
summarize innovative and best
practices recently developed
and employed successfully to
meet the growing complexities
for aseptic processing without
losing focus on classic Aseptic
and Barrier topics.
http://www.ispe.org/
2016-aseptic-conference
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www.ISPE.org/Sponsorships
Europe Annual
Conference
Continuous
Manufacturing
Quality
Manufacturing
Annual Meeting
& Expo
7 – 9 March, 2016
Frankfurt, Germany
20 – 21 April, 2016
Baltimore, MD
6 – 8 June, 2016
Bethesda, MD
18 – 21 Sept., 2016
Atlanta, GA
The Attendees at the ISPE 2016
Europe Annual Conference will
join industry experts and
international regulators to
bring a new understanding of
pharmaceutical operations back
to their organizations. Highlight
your new products or build
brand awareness to this target
audience.
Regulatory agencies have made
a commitment to working
with industry toward effective
implementation of continuous
operations. Their participation
in this conference will
provide delegates with a clearer
understanding of the regulatory
and lifecycle considerations
involved. Continuous unit
operations are being adopted
for drug substance and drug
product manufacturing, in both
small and large molecules, both
of which will be addressed along
with key PAT applications.
ISPE, FDA, and PQRI have joined
forces once again to offer
the most comprehensive
manufacturing quality conference
in the industry. Hearing first
hand from global regulators will
provide attendees with invaluable
insights as they attempt to
navigate the increasingly
complex nature of regulatory
compliance and quality
expectations.
ISPE’s flagship event. Network
and problem-solve with top
pharmaceutical and
biopharmaceutical industry
figures, learn about important
industry topics, meet with
other suppliers, and share
best practices with colleagues.
The Annual Meeting offers
education in six tracks
addressing Facilities and
Equipment, Product
Development and Production
Systems, End-to-End Supply
Chain Management, Regulatory
Compliance and Quality
Information Systems, and
Innovations.
http://www.ispe.org/2016Europe-Annual-Conference
http://www.ispe.org/2016continuous-manufacturing
-conference
http://www.ispe.org/2016quality-manufacturingconference
http://www.ispe.org/
annualmeeting
European
Biotechnology
Manufacturing
Conference
24 – 25 Oct. 2016
Frankfurt, Germany
ISPE in Europe offers a regional
conference in biotechnology hosted
at the Sanofi facilities in Frankfurt.
Focus is on process development,
innovation, new factory concepts
but also addressing the regulatory
framework for biopharmaceuticals
and findings in GMP inspections. Case
studies of new factories or production
suites will complete the program. Tours
of sites into bio-production will be
offered.
Pharma Expo
6 – 9 Nov., 2016
Chicago, IL
Stay on top of the latest processing
and packaging solutions by attending
Pharma EXPO. Pharma EXPO offers
pharmaceutical, biopharmaceutical,
medical device, personal care, and
nutraceutical manufacturers the
opportunity to explore the latest
advances from nearly 300 suppliers
of solutions for: anti-counterfeiting;
cleaning and sterilization;
commissioning and qualification;
controls and robotics; dosing; HVAC;
labeling; operations; packaging;
processing; quality control/quality
assurance; sterilization; track and
trace; and validation.
Facilities of
the Future
Biotechnology
Manufacturing
14 – 15 Nov., 2016
Bethesda, MD
5 – 7 Dec., 2016
San Francisco, CA
New manufacturing challenges, new
technologies, new regulations, and
increasing pressure to stay competitive
and cost-effective is driving innovation
forward. The Facilities of the Future
Conference offers best practices and
benchmark solutions for new as well
as existing facilities. Gain regulatory
insight into trends and observations
related to aging facilities and mitigating
drug shortages.
The Biotechnology Manufacturing
Conference will bring together high
level, established biopharmaceutical
manufacturers to discuss the
important issues to address to bring
the industry forward. Thought
leaders, vendors, and operating
companies will convene in a focused
effort to define and map out the
future capacity challenges.
http://www.pharmaexpo.com
www.ISPE.org/Sponsorships
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Exhibit Packages
All exhibit packages include:
T
wo complimentary exhibitor badges
(fee applies for additional exhibitor badges)
C
ompany listing in the printed exhibitor directory portion
of the event guide (deadlines apply)
Complimentary listing in ISPE’s online searchable exhibitor directory
Two complimentary guest passes for exhibit hall admission
A
ttendance at opening keynote session, as well as welcome reception,
lunch and networking breaks held in exhibit area
North American Conferences
Annual Meeting & Expo
Europe Annual Conference
PACKAGES
CONFERENCES
PACKAGES
PACKAGES
Standard
$1,650/$1,850
Aseptic Processing
Standard
$2,900/$3,100
Standard
¤1,450/¤1,650
Premium
$1,950/$2,150
Quality Manufacturing
Premium
$3,200/$3,400
Premium
¤1,700/¤1,900
Premium Spotlight $2,150/$2,350
Facilities of the Future
9 sqm booth
¤3,250/¤3,500
10’ x 10’ booth
$2,750/$3,000
Booth Spotlight
$3,000/$3,250
Biotechnology Manufacturing
Premium Spotlight $3,650/$3,850
10’ x 10’ booth
$4,400/$4,600
Booth Spotlight
$4,850/$5,050
European Biotechnology
Conference
PACKAGES
Standard
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www.ISPE.org/Sponsorships
¤1,200/ ¤1,400
As a Pinnacle Global Sponsor, your support of ISPE will reach across
all initiatives, education efforts, and member outreach we conduct, to
offer you the maximum visibility possible to our influential audience,
while helping ISPE lead the way to bring our industry forward. Your
sponsorship commitment comes with tremendous benefits. From our
global events, industry leading training, online, and print advertising
placements, you will have unparalled access and promotional
consideration to our influential members and your key target audiences.
What
ISPEWe
Pinnacle
Do
Global Sponsorship
Your commitment of a minimum of $85,000 in sponsorship items in 2016
comes with tremendous added value. We will work with you to craft an
added-value package that addresses your overall marketing goals.
Pinnacle Sponsors enjoy a true partnership with ISPE, working together
to further each other’s goals and improve the quality of information that
ISPE provides to benefit industry as a whole.
Sample of Branding and Advertising Opportunities Available to Support ISPE
with your Pinnacle Global Sponsorship
T
ote Bags
5
K Charity Walk/Run
C
ontinental Breakfast
Exhibit Hall Giveaway
P
adfolio
M
obile Charging Station
B
adge Sponsor
T
uesday Night Party Prize
W
ireless Internet
T
uesday Night Party Sponsor
Refreshments
L anyards
Welcome Reception
Membership Lunch
P
rivate Exhibitor Meeting
Rooms
H
otel Key Card
L eadership Reception
Lunch
S
ponsored Workshops
www.ISPE.org/Sponsorships
www.ISPE.org/Sponsorships
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Universal Additional Benefits
O
pportunity to upgrade to a 10‘x20’ booth at the 2016 ISPE Annual
Meeting and Expo
O
pportunity to upgrade to a 10’x10’ booth at the Aseptic Conference
and Europe Annual Conference
A
Premium Table Top Package at other planned ISPE International Event
Expositions (not applicable to Chapter Events)
Pinnacle logo on all exhibitor listings at ISPE events
C
omplimentary Full-Page Ad in all North American Event Guides where
your company will occupy Exhibit Space (deadlines apply)
V
erbal and logo acknowledgment at Welcome Reception of 2016
Annual Meeting and Expo
F ull-Page “Thank You” shared acknowledgment ad in the related show
issue of Pharmaceutical Engineering
We look forward to working with you to craft the ideal marketing package
tailored specifically to your company’s marketing objectives. Our
influential audience is at your fingertips, and the Pinnacle Program is
the ideal venue through which to reach them, while at the same time
supporting ISPE and our work.
Contact Chris Galione at +1-301-364-9212 or cgalione@ispe.org
for more information on how you can participate, and to begin crafting your
custom program.
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www.ISPE.org/Sponsorships
Sponsorships
All sponsorships include:
R
ecognition on conference sponsor showcase web page
S
ponsor ribbons for exhibiting staff conference badge
Reach a global audience with your brand
through sponsorships at all ISPE 2016 conferences.
C
ompany logo displayed on conference sponsor sign
Global sponsorships available: Lanyards; Padfolio
O
fficial conference sponsor graphic provided for promotional use
F ull-Page “Thank You” shared acknowledgment ad in the related
conference issue of Pharmaceutical Engineering
North American Conferences
SPONSORSHIP OFFERINGS
CONFERENCES
Lanyards
$3,000 (Exclusive)
Welcome Reception $2,995 (Exclusive)
Tote Bag
$2,995 (Exclusive)
Attendee Badge
$1,995 (Exclusive)
Exhibit Hall Giveaway
$1,500 (Limit six sponsors)
Attendee Lunch
$1,500 (Limit two sponsors)
Padfolio
price available upon request (Exclusive)
Networking Breaks
$1,500 (Limit three)
Aseptic
29 Feb. – 1 Mar., 2016, Arlington, VA
Continuous Manufacturing
20 – 21 Apr., 2016, Baltimore, MD
Quality Manufacturing
6 – 8 June, 2016, Bethesda, MD
Top-Tier Sponsorship
Opportunities
H
ost | $16,000
G
old | $12,000
S
ilver | $9,000
B
ronze | $6,000
Facilities of the Future
14 – 15 Nov., 2016, Bethesda, MD
Biotechnology Manufacturing
5 – 7 Dec., 2016, San Francisco, CA
If you don’t see something that addresses
your needs, ask! We would love to customize a
solution to achieve your goals.
www.ISPE.org/Sponsorships
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Annual Meeting & Expo
SPONSORSHIP OFFERINGS
Tote Bags
$14,500 (Exclusive)
Padfolio
$13,500 (Exclusive)
Wireless Internet
$10,000 (Exclusive)
Lanyards
$7,000 (Exclusive)
Hotel Key Card
$6,750 (Exclusive)
5K Charity Walk/Run
$5,000 (Exclusive)
Mobile Charging Station
$4,750 (Exclusive)
Tuesday Night Party
$4,500 (Limit four)
Welcome Reception
$4,500 (Limit two)
Leadership Reception
$3,500 (Limit two)
Conference Badges
$3,995 (Exclusive)
Networking Breaks
$3,250 (Limit three)
Membership Breakfast
$1,800 (Limit four)
Lunch
$2,500 (Limit three)
Exhibit Hall Giveaway
$1,950 (Limit twelve)
Tuesday Night Party Prize
$1,250 (Limit six)
Becoming a sponsor is easy. We offer sponsorships to fit any budget.
Contact us today to discuss your branding needs or to reserve a sponsorship today.
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www.ISPE.org/Sponsorships
Annual Meeting & Expo Pre-Conference Mailing Brochure
Show support for industry education and increase your company’s
visibility to ISPE members and industry stakeholders by placing an ad
in the conference brochure.
Conference Advertising
Full-Page color ad positions:
P
age 3 – $4,000
Centerspread - $4,000 each or $7,000 for both left and right pages
I nside back cover – $4,000
⁄2 Page vertical – $1,600
1
Ad specs vary by brochure size and will be available upon booking.
On-site Event Guides
North American Conferences:
Annual Meeting & Expo:
1/2 page color ad - $1,000
1/2 page color ad - $1,500
Full-page color ad - $1,500
Full-page color ad - $2,500
www.ISPE.org/Sponsorships
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Be sure to review the 2016 Media Kit for all of the advertising
options. Contact Chris Galione, Director of International Sales,
at +1-301-364-9212 or cgalione@ispe.org to discuss your
brand strategy and marketing needs.
Chris Galione
Director of International Sales
+1-301-364–9212
cgalione@ispe.org
Diane Munda
Manager, Sales Operations
+1-813-739–2275
dmunda@ispe.org
Robin Lane
Sales Coordinator
+1-813-960–2105 x235
rlane@ispe.org
ISPE Global Headquarters
7200 Wisconsin Ave., Suite 305
Bethesda, MD 20814 USA
600 N. West Shore Blvd., Suite 900
Tampa, Florida 33609 USA
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+1-813-960-2105
Fax: +1-813-739-2288
www.ISPE.org/Sponsorships
Email: sales@ispe.org
Classroom Training
We draw from the expertise of our members to develop training courses
that address industry demands and deliver in-depth knowledge, utilizing
ISPE Guidance documents, team exercises, and case studies to provide
tangible takeaways.
New for 2016 is the ISPE Training Institute, located in Tampa, FL. Here,
ISPE provides pharmaceutical manufacturing professionals with the high
quality, globally-vetted, in-depth knowledge needed to develop practical
solutions. Take advantage of the opportunity to leverage this high quality
classroom learning environment to strengthen your brand image in the
industry, and support this source of for information.
Other Opportunities
Y
oung professionals and Student Outreach
Reach the future leaders of our industry through focused
opportunities for Young Professionals and Students at our
Annual Meeting & Expo and beyond.
O
nline and Print Advertising
A multi-media approach is essential to developing relationships
with potential clients and remaining competitive in today’s
marketplace. Maximize your exposure and show your support
for ISPE and its members with an advertisement package suited
to your marketing strategy.