December 2013
Under the Tuscan Sun: A Company Branches Out
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Beautiful hills of Tuscany |
If you’re my Facebook fan, you might know
I spent last week in Italy. I know, poor me. It was quite a change from two
weeks in India. All I need is Indonesia and I will have done my Eat, Pray, Love
hemophilia pilgrimage. Except I managed to eat in India, pray in Italy…. The
rest has yet to be seen!
heading slightly north for the real purpose of my trip. Florence is a city I studied
intensely as a teen. While other girls were going to dances, I studied the
Renaissance and became quite an “expert” at a young age. I copied paintings of
the masters, as I loved art, and when I first arrived at age 17, knew more
about where to go than our high school guide. So returning for my fourth time,
I resolved to wander the streets and churches, revisit the masters, and stand
in awe of the treasures of Italy. Nothing man-made captures my stunned, silent
respect and worship like the statue of David.
pharmaceutical company called Kedrion. Kedrion came to our attention in the US a few years ago when it was contracted by Grifols to handle distribution of Koate-DVI, a
plasma-derived factor VIII product. Originally produced by Bayer, it was
divested, along with all the Bayer plasma division, to Talecris. Eventually
Talecris was bought by Grifols. But the US government, leery that Grifols now
had two plasma derived FVIII products, required Grifols to have a different
company handle distribution of Koate-DVI. Enter Kedrion.
Europe. Kedrion is a leading global pharmaceutical company specializing in the
development, production and distribution of a wide range of protein products
derived from human plasma. The company’s products are used to treat hemophilia,
immune deficiencies, infectious diseases and other serious medical conditions in
over 60 countries. The company owns four production facilities: two in Italy,
one in Hungary and one in the United States (currently leased to Grifols).
the production plant. The plant is nestled among the Tuscany hills in Lucca, an ancient
city famed for its fortress-like walls that protect the denizens, once Romans
in 180 BC. The scenery—snow capped mountains rolling away to the sea; petite,
puffy clouds touching down on factories and churches— is breathtaking from the
patio of the Renaissance (how appropriate) hotel, perched on a mountain and once
owned by the Marcucci family, which also owns Kedrion.
with Paolo Marcucci, CEO of Kedrion, and wife Paola Pardini, whom I have met
before and who sponsor 17 children through Save One Life. With us was also
Danilo Medica, Italy country manager for Kedrion, who I had also met before at
a WFH event. Social events are always lovely with Italians, who know the fine
art of socializing, eating and drinking, and offering sincere and mutual respect
and hospitality.
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Laurie at Kedrion plant, with Charles Waller |
So my purpose in visiting was to see the
plant, and learn more about this newcomer to the US market. Also, Kedrion has
been for a few years now our largest single donor of factor products to
Project SHARE, my factor donation program. We are now collaborating on ways to
secure even more factor to donate to the regions of the world where the 75%
live—those people with hemophilia with little or no access to treatment. Like…
some of the places I had just seen in India.
the Marcucci family; current CEO Paolo is son of the founder. It offers technology transfer of plasma collection to Macedonia,
Turkey, and Iran, as well as plasma-derived product sales to about 60 countries. It has 15 plasma
collection centers (nine of which are in the US). About 95% of its products are
plasma derived. Kedrion is one of the few factor manufacturers that is
considered part of a government healthcare system. About 75% of the company
is owned by the Marcucci family; 25% is owned by government.
past few years. Its business used to be only in Italy until just 2007; now it’s
been global for five years. A dominant 60% of its business is international,
part of this switch attributed to production acquisition sites in the US. It
has a FV product in the pipeline, even though there are only 5-6 patients with
FV deficiency in Italy. Clearly, Kedrion continues to have its eyes set on the
world.
hemophilia A patients; 1,688 are severe, 1,320 mild, and 473 moderate. In 2013,
FVIII consumption was about 555 million IU, with plasma-derived product use
actually increasing, driven by IT therapy for inhibitor patients. Still, recombinant products dominate the
hemophilia market, at 66% of sales.
TOUR

hosts, to tour how plasma products are made. The plant fractionates 1 million
liters (about 264,172 gallons) every year, using 24,000 liter tanks. First I
watched a film on the plant: how plasma arrives, is checked, monitored and
inventoried. How plasma is separated by centrifuge creating cryo paste for
fractionation. There are 480 employees in Lucca, and the plant operates 7 days
a week, 24 hours a day. It will be closed over Christmas for maintenance and
cleaning. The instruments and suites where products are made are cleaned daily.
On this tour I was able to watch albumin
being made. Albumin is the part of plasma used to bulk-up factor concentrates,
to allow them to be injectible. Alessandro, plant manager and our guide, explained
about different classes assigned to manufacturing suites (A-D), based on sterility
and cleanliness. As each product goes through each manufacturing phase, the
requirements for cleanliness gets more and more complex.
just that things must be sterile. In the suite, people come and go; there is
air, exhalations, and ventilation. The air itself, pressurized like in an
airplane, to push air out if there is a breach, must be monitored constantly. You
want a low level of environmental pollutants such as dust,
airborne microbes, aerosol particles and
chemical vapors. Levels of contamination are specified by the number of
particles per cubic meter at a specified particle size. Instruments protruding
out of the wall measure constantly the ambient air, and would signal an alarm
if the air contained undesirable things in it at a level considered potentially
harmful.

sterile vials into which the albumin would be placed, all by machine to reduce
human contact. The rubber stoppers were placed, and the machines sealed it with
the foil. I learned something new: I always
thought the rubber stopper might be at risk to cause a breach of integrity of the vial
if the vial got too hot or cold. But Alessandro assured me these stoppers are
powerful and not likely to contract or expand with different temperature. It
really is about temperature control to keep the protein from degredating and
becoming less effective, less powerful.

power at all times. What of there was a black out, someone asked? Kedrion is
self-sufficient in power, Alessandro explained. They produce energy themselves
using methane gas production.
Last, we learned about the “KQP”: Kedrion
Quality Program, an eight step system, using among other things, regular
qualified donors, NAT testing, pathogen inactivation, and TSE agents, to assure
that the products are safe.

making me realize we aren’t the only ones with healthcare budgetary woes. With 19
regions that are traditionally independent, 645 public
hospitals, 50 HTCs, and an ongoing economic crisis, the federal government is trying
to consolidate hospitals, and is asking for additional cost reductions from
industry. And yet Kedrion must continue to fractionate Italian blood and return
plasma-derived products back to the various regions.
self-sufficient in any product. Consumption is growing faster than production, but
consumption includes imported products at much higher per unit prices. In the
face of an economic crisis, slashed healthcare budgets, the question is: can
Italy use the products it has already to alleviate demand?
2013, Italian laws have changed regarding plasma. Previously Italian plasma had
to be used by Italians, but now the law allows Italian regions to recover costs
by selling the plasma products to other countries. Or maybe, donating? To India,
to Africa? We will see.
language for lemon tree (or juniper or citrus, depending on your source). Its
symbol represents the deep roots Kedrion has in Italy, where the company was
built on Italian plasma and by a family dyanasty, and its branches go out into
the air, the world. I’m hoping they continue to branch towards developing
countries, to patients waiting to know this unique company and benefit from its
products.

Florence. My hotel was about 200 feet from Santa Maria del Fiore, and when I
stepped into the cobblestone streets each morning, the massive façade, capped by the
astounding dome, greeted me. This book goes into great detail about what it
took to create the 37,000 ton dome, one of the largest cupolas in the world,
completed in 1436. It took 16 years to complete (over 100 for the Cathedral itself!),
and the architectural construction was filled with competition, craftiness and creativity. Brunelleschi
invented all kinds of new ways to transport marble, to hoist the marble. He was
a genius of architecture, and this Dome today still awes and impresses. This
story is compelling, and shows the potential of man to create and persist. Brunelleschi
was foiled many times, faced many obstacles, but finished it, leaving behind
one of the most prominent and important symbols of the Renaissance. A must read
for anyone going to Florence. But a fabulous book on any account. I climbed the
436 stairs to the top and was rewarded with a breathtaking view of Florence, one
of my favorite cities. It boggles the mind how this could have been created, at
such a time, with such vision. You’ll never look at a church steeple or
basilica the same again once you read this. Five/five stars!
HERO: One who is revered for sacrifice, skills, dedication…
Please feel free to view!
The HERO Initiative: Improving Understanding of the Burden of Hemophilia on Families <https://www.youtube.com/watch?v=YJTD3HMVxU8> ” focuses on our discussion in Workshop 2 around how hemophilia can affect the entire family in different ways, including emotionally, financially, and professionally. This video includes the following US HERO Summit participants:
· Mary-Jane Frey, Nurse Coordinator, Children’s Hospital of Michigan
· Chris Guelcher, Nurse Practitioner, Children’s National Medical Center
· Dana Kuhn, PhD, President and Founder, Patient Services, Inc.
· Dawn Rotellini, Director of Chapter Development and Training, National Hemophilia Foundation
· Michelle Witkop, Bleeding Disorders Nurse Practitioner, Northern Regional Bleeding Disorder Center
The HERO Initiative: Working to Understand and Improve Pain Management in Hemophilia <https://www.youtube.com/watch?v=keRjwamm67Y> ” focuses on our discussion in Workshop 3 around the impact of pain on the daily lives of people with hemophilia and approaches to better evaluate and manage this common complication. The following US HERO Summit participants appear in this video:
· Mary-Jane Frey, Nurse Coordinator, Children’s Hospital of Michigan
· Neil Frick, Vice President for Research and Medical Information, National Hemophilia Foundation
· Chris Guelcher, Nurse Practitioner, Children’s National Medical Center
· Michelle Witkop, Bleeding Disorders Nurse Practitioner, Northern Regional Bleeding Disorder Center
To view all the videos, visit the Novo Nordisk YouTube Channel <http://www.youtube.com/user/novonordisk/videos> , and please feel free to share them with your friends, family, and organization members!
Great Book I Just Read
The Boys on the Boat by Daniel Jay Brown [Kindle]

Inspiring Stories from Students with Hemophilia

the
17 winners of the Soozie Courter Hemophilia
Scholarship, a Pfizer- sponsored tuition assistance
program. This week I am pleased to spotlight the stories of three recipients who are working
hard to achieve
their dreams while living with hemophilia.
get in the way of his schoolwork or athletic pursuits. Evan’s condition forced him to challenge himself. When a
bad
bleed meant
missing school,
he always made sure to stay on top of his assignments. And he found athletic passions, such as golf, that he was able to pursue.
Following in his father’s footsteps, Evan
is
a freshman studying engineering at Trine University. He was also
recently selected to take part in the National Hemophilia Foundation’s National
Youth Leadership
Institute (NYLI), based, in part, on
his significant involvement in the
hemophilia community. While Evan
initially had
some anxieties
about starting
school, including managing his condition
without his parents, he is now excited and up for the challenge!
with
hemophilia A, first became
involved in the hemophilia
community when
he was 10 years old and attended Camp Bold Eagle in
Muskegon, Michigan, run
by
the Hemophilia Foundation
of
Michigan (HFM). His commitment to the community steadily evolved year after year as he too
became involved with the NYLI, as well
as the HFM’s MYLIFE youth
leadership group. Through his leadership work, Travis quickly became a mentor to youth with
hemophilia and
encouraged
peers to educate themselves about ways to
successfully live with hemophilia.
his
experiences, Travis became an advocate for
people living with
hemophilia.
Following his passion to educate
policymakers about hemophilia
and advocate for access to
treatment, Travis landed an
internship in Washington, D.C., where
he
assisted Rep. Gary
Peters and was invited to
speak at NHF’s annual
Washington Days event. He is now working
to complete a major in public policy.
O’Connor, a graduate
student with hemophilia
B,
says he thinks of his life with
hemophilia
in two phases: before and
after he
started swimming. Swimming became both a passion and
a way to help
him
get in tune with
his
body and better manage his condition. He
swam competitively for many years and also started coaching. Michael was approached by a mother who
had seen him speak about the importance
of
staying active
and asked
if he would
give lessons to her 10 year old
son
with hemophilia. He jumped at the opportunity, and was able to
combat the uncertainty of living with
a bleeding disorder by being
a role model for others.
Michael believes that if you
are
smart about yourself and your body, you
work hard, and you do what you love, it’s going to
work out in the end.
working out for Michael. He is back in the water – but in
a different way. He
is currently pursuing
a Master’s degree
in
geosciences at The University of Texas at Austin
and taking part in a research project
that often brings him to Louisiana. His work focuses on quantifying the role of coastal delta islands in filtering
out
nitrogen in the
Mississippi River before
it
reaches the Gulf of Mexico
and causes ecological
damage.
taken different directions in
their studies and extracurricular pursuits,
they are all shining examples of overcoming challenges to achieve
a goal.
Hemophilia Village and the
site’s Facebook page for more information on the
Soozie Courter Hemophilia
Scholarship program and to see video clips about these recipients.
Donald Woods rocketed to fame when his young daughter was burned from an acid-laced t-shirt sent by the South African police in the 1970s, where Woods was an outspoken white editor and critic of the brutal apartheid policy of the South African government that treated black people like subhumans. This collection of his best publications, short 500-800 word articles, makes him a South African Mark Twain. Scathing wit, brilliant commentary in the fewest possible words, brimming with carefully-veiled loathing, and as the articles build on over time, direct attacks to the government jugular. The wit and clever turn of phrases disappears when his friend, Steve Biko, the leader of the black nationalist movement, is killed while in police custody. This little gem of a book is incredible; my best literary find of the year. Watch “Cry Freedom,” starring Denzel Washington as Biko, and Kevin Kline as Woods; great movie that captures the dark and brutal Afrikaners regime, and black struggle for self-rule. Five/five stars.
Recognizing the “Class of 2013” – The Soozie Courter Hemophilia Scholarship Winners

year now in full
swing, I’d like to recognize the “Class of 2013” winners of the Soozie Courter Hemophilia
Scholarship –
a group of students with hemophilia who are
dedicated
to
their education and to making
a difference in our community.
happens to be named after a woman
that I had the pleasure of knowing years ago.
Soozie Courter, who lived in the town next to me and who would share rides with me sometimes, worked in the hemophilia division at Genetics Institute (now at Pfizer) would
be proud of this year’s winners and the continued
emphasis placed on
supporting academic excellence
among
the hemophilia
community.
numerous scholarships available
to current and future US college students with bleeding disorders. Costs like tuition, books and supplies, room and board, health
insurance and transportation
can add up quickly and
the Soozie
Courter Hemophilia Scholarship program aims to help
address these challenges. Scholarships are
awarded
to applicants who present the best combination of a creative and
persuasive
essay, excellent recommendations and superior academic standing.
2013-2014 academic year, Pfizer awarded
$50,000 in scholarships to 17 US graduate and undergraduate
students with hemophilia. Through
their involvement in local hemophilia chapters
and mentorships, and their commitment to future plans, these students personify what it means
to overcome
challenges to
make a difference
in
their communities.
like to congratulate all
the scholarship recipients—many of whom I have known since they were kids— and wish them much
luck in the coming
school year and
beyond!
Michael Bennett Alexander Kattenbaugh
Michael Bishop Shawn Whelan
William Bowles Lynden Prior
Andrew-Paul Deeb Evan Poole
Jorge de la Riva Michael O’Connor
Calvin
Dutcher Hunter Montgomery
Clayton Lynn Adam Mier
BoDean Messier
Soozie Courter Hemophilia
Scholarship program,
and check back here next week to learn more
about three
of
this year’s winners!
