Blog Archive

Sunday, December 22, 2013

Under the Tuscan Sun: A Company Branches Out


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!

I spent a few days in Florence before 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.

On day four I headed to Lucca, to visit a 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.

Kedrion may be new to the US, but not to 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).

I was thrilled to be offered a tour of 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.

I had dinner the night before the tour 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.

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.

First, a snapshot: Kedrion was founded by 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.

Kedrion experienced enormous growth in the 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.

And hemophilia in Italy? There are 3,481 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.

PLANT TOUR
On a frosty Wednesday morning, I removed my jewelry, washed my hands thoroughly, suited up, and entered the plant with my 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.

It’s not 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.

We watched as lab employees handled the 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.

Speaking of power, the plant must have 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.

The Italian Health System is complex, 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.

One concern is that Italy’s not 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?
So that’s the point of my visit: in April 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.

The name Kedrion comes from the Greek 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.

To learn more about Kedrion: www.kedrionusa.com

Great Book I Just Read
Brunelleschi’s Dome by Ross King [Kindle]


The perfect book for reading while in 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!




Monday, December 16, 2013

HERO: One who is revered for sacrifice, skills, dedication...

I'm in Italy this week on some business, where I am surrounded by Italian heroes, both mythical and real. While here I received notice of some videos you might like to see. These are the latest videos filmed at the US Hemophilia Experiences, Results, and Opportunities (HERO) Summit for Solutions, of which I took part. Some of our top opinion leaders from our community were invited together by Novo Nordisk to brainstorm ways to implement the findings of the HERO study, supported by Novo Nordisk, the largest psychosocial study on hemophilia ever done.

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]
 


Incredible true story of underdogs who go to the Olympics:  the University of Washington’s 1936 eight-oar crew, their amazing and youthful coxswain, their aloof but dedicated coach and a legendary boat builder team together for an epic quest for an Olympic gold medal during the 1936 Olympics in Nazi Germany. The story revolves particularly around one boy, Joe Rantz, abandoned entirely by his family during the depression, who has to survive on his own, put himself through college and discovers his calling rowing crew. He seeks to fill a hole in his life, and learns to trust.  He and his team became national heroes at a time when Germany sought to dominate sports, and eventually the world. It's a lesson in human spirit, indomitable will, teamwork, leadership, strategy, family, optimism and hope. Along the lines of Seabiscuit and Unbroken, both of which happened at the same time as this story. Fantastic writing and story! Five/five stars.

Sunday, December 08, 2013

Inspiring Stories from Students with Hemophilia


I just returned from India, there to check on our scholarship winners from Save One Life, my nonprofit. I was impressed to see such brave young men with hemophilia, most of whom do not often get treatment, attending college and trying to forge a future. They are succeeding. There's so much joy in watching a young person fulfill their educational dreams!

It's the same in the US, where so many with hemophilia are attempting to fulfill their dreams as well. Last week, I recognized 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.

Evan Poole never let hemophilia B get in the way of his schoolwork or athletic pursuits. Evans 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.

His perseverance has paid off. Following in his fathers 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!

Travis Albright, a University of Michigan senior 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 HFMs 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.

Through 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.

Michael 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, its going to work out in the end

I second that from Michael. His mother, back in 1999, actually gave me the idea to start Save One Life, which now provides sponsorships to over 1,000 children with hemophilia in developing countries, and gives scholarships to many young men struggling to make it. It was hard work, but we love it, and we are reaping the rewards in watching young people live and thrive through their education. 

And things are working out for Michael. He is back in the water but in a different way. He is currently pursuing a Masters 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.

While these students have taken different directions in their studies and extracurricular pursuits, they are all shining examples of overcoming challenges to achieve a goal.

We wish them much success in the future and thank them for sharing their stories. Visit 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.

Great Book I Just Read
South African Dispatches by Donald Woods
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.
 
Bayer