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On Mothering Sunday (31/03) a flower delivery van pulled up outside my home and as my wife was expecting flowers (from our eldest son) she went to the door and took delivery of a lovely bouquet but then realised it was the wrong address and gave them back to the driver.
We went out to our daughters for lunch (very nice) and when we got back there was a lovely bouquet of flowers in the porch, with an envelope addressed 'To You' and inside a card 'From all the girls at the flower shop', Cream & Browns Florist. We were mystified as to who had sent them so I got in touch today and a lady told me that the driver thought that my wife looked upset when she handed the bouquet back so the staff decided to send a bouquet, what a lovely gesture.
My faith in human nature has been restored…thanks to your kindness.
Just received a very elegant stunning bouquet of flowers by Cream and Browns Florist from my husband for our 25th wedding anniversary, and WOW they are beautiful. My husband said he ordered it on there website, I will defiantly use them again. Mrs Garland from Nunthorpe Middlesbrough - 5* Rating online review.
Great service as always, and beautiful flowers at the right price. Won't use anyone else, thanks again Karen. Charlie Coyle Coulby Newham Middlesbrough.
We always use Cream and Browns florist for our flowers, we've ordered online, and we also visit the shop in Middlesbrough frequently. The flowers are the freshest we've ever seen, and my wife loves them, great value and very professional service, and they deliver on Sundays, iI would highly recommend them, best florist in Middlesbrough by far.
Hi Karen, my wife loved the flowers, thank you for helping me with them, they were perfect. Will defiantly use you again, Regards Jay Garriga Ingleby Barwick.
Dear Karen, My girlfriend loved the roses you delivered on Valentines Day, and they still look as fresh as when they were delivered nearly 2 weeks ago, Rob Saunders from Marton in Middlesbrough.
When I was looking for a good florist in Middlesbrough to use I found Cream and Browns on the internet, and thought I would give them a go. They did not let me down my wife absolutely loved the flowers because they were so different. Great service and fair prices and have no problem recommending them.
Dear Karen, my wife loved the flowers and chocolates, thanks for getting them to her works before lunch I really appreciate it. Don't worry I'll defiantly use you again. Once again thank you, Steve Gibbon, Acklam Middlesbrough.
Great florist and service, ordered flowers over the phone at 9.30am, delivered by 10.30am, girlfriend loved the flowers and I WILL defiantly use them again. Kevin T Berwick Hills Middlesbrough.
Best flowers in Middlesbrough by a country mile, always ues them, wouldn't use anyone else, beautiful fresh flowers that lasts for a very long time. Jenny C from Marton Middlesbrough.


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John S.January 7, 2021
Trent Richardson Net Worth 2023
23 year old Trent Richardson signed a deal with Indianapolis Colts worth $20 million earning $6.7 million in 2014. He was drafted to the Cleveland Browns in.
How does a Rent-to-Own Home Process Work in Ohio – 2023 Guide
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A two-time Grammy award-winning artist, Bill Harley's songs and stories paint a vibrant and hilarious picture of growing up, schooling and family life. Singer, storyteller, author, playwright, educator, performing artist – welcome to the world of Bill Harley – a world of wit and wisdom.
Storytellers were our first magicians, our first history keepers, society builders, culture shapers and spiritual and emotional filters, making sense of the world long before written communication.
For all our sophisticated technology and mass electronic entertainment, we still need those voices in the dark, by the fire, in the hall. A master storyteller connects us and intimately affirms our lives with resonant truths, no matter how embroidered, funny, mysterious or horrific the tale.
Bill Harley is a master storyteller.
The nationally touring, critically-acclaimed singer-songwriter, author, musician and monologist is considered by fans and peers alike to be one of the best storytellers in the country for his celebrations of commonality and humanity through comic narrative songs and confessional spoken works.
But tagging Harley with the "children's artist" label, even of the top-drawer variety, is as deceptive as this gifted artist's Puckish demeanor. In slice-of-life vignettes about school and family life, Harley uses humor and a fine-tuned sense of the ridiculous to illuminate compassionate truths, even while inspiring belly laughs.
Adults absorb a Harley performance through a double filter of past and present. Children respond from the immediacy of their own lives, as with rubber-faced abandon he examines human foibles, flaws and embarrassments, common fears and simple pleasures.
Playwright and author David Kranes was artistic director of the respected Sundance Playwrights' Lab when he heard one of Harley's National Public Radio performances and invited him to Sundance in 1990 to participate as a "strong and individual voice" outside the traditional realm of theater.
Harley's work resonates, Eustis believes, because he is "simultaneously" a son, a father, a husband, a child and a grown up, and has remained true to all those facets of his life.
Harley, who lives in Seekonk, Massachusetts, with his wife and professional partner Debbie Block with whom he has two grown sons, graduated from Hamilton College in Clinton, NY, in 1977 with honors and a religious studies degree. He found his calling in community service, not the seminary, leading a program in conflict resolution for families and educators and co-founding with Block and others a community-based adult education platform.
He was receptive early on to folk artist/activist Pete Seeger's use of music as an expression of community. Supportive, too, of other musicians, Harley and Block were among the founders of Stone Soup Coffee House in Rhode Island, a music performance venue now in its 28th season.
As a folk musician in the Seeger, Woody Guthrie tradition, Harley still lends his voice to social justice, environmental and political causes.
Harley began his work with children while still in college and released his first album, "Monsters in the Bathroom," on Round River Records, the label he co-founded with Block in 1984. Twenty-eight albums later, Harley's work includes song and story collections for adults, and a diverse mix of world music, reggae, blues, folk, rock, jazz, do-wop and more.
In recent years, Harley has authored eight children's picture books and two novels for gradeschoolers. Among his theater projects are "My Sarajevo," a full-length play set during the Bosnian war, and "Stickeen," a retelling of stories from the life of naturalist John Muir.
Whatever Harley's forum, it's always all about story, community and connection.
One story and one song at a time.


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Rudolf Užnik, slovenski graver, izdelovalec pušk in strokovni učitelj, * 26. julij 1888, Borovlje, † 6. januar 1964, Borovlje.

Življenjein delo
Po osnovni šoli v rojstnem kraju je tu od 1903–1907 na strokovni šoli za puškarstvo obiskoval specialni oddelek za graverstvo. V letih 1907–1911 se izpopolnjeval pri različnih mojstrih na Saškem, domačem kraju in na Dunaju. Od 1912–1920 je imel v Borovljah samostojno graversko delavnico, obenem pa je bil strokovni učitelj na tamkajšnji puškarski šoli. Po koroškem plebiscitu 1920 se je preselil v Ljubljano in poučeval na Državni obrtni šoli (1920-1921) ter od 1921–1930 na puškarski šoli v Kranju in od 1930-1946 v Ljubljani na Tehniški strojni šoli ter nazadnje tudi v Ljubljani na Šoli za umetno obrt (1946-1959). Po upokojitvi 1959 je do smrti živel pri hčerki v Borovljah.

Užnik je kot strokovnjak–specialist in pedagog prejel več priznanj, mdr.: 1925 na mednarodni razstavi za dekorativno umetnost v Parizu priznanje za tehnične izboljšave pri izdelovanju črk za pisalne stroje in 1950 novatorsko diplomo Generalne direkcije kovinske in elektroindustrije LRS. Leta 1949 je bil odlikovan z Redom dela z zlatim vencem.

Zunanje povezave

Rojeni leta 1888
Umrli leta 1964
Slovenski učitelji
Slovenski puškarji
Slovenski izumitelji
Koroški Slovenci
Nosilci reda dela
Slovenski graverji

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William Crooks announced as a finalist for 2021 Business Awards
Monday July 5, 2021
Cawarden is delighted to announce that its Managing Director, William Crooks, is one of five finalists for Derbyshire Entrepreneur of the Year in the East Midlands Chamber Business Awards 2021.
The finalists were announced online on Monday 28th June and the 'Cawarden Family' is thrilled to see William on the shortlist.
From his early reclamation and demolition pioneering days, William has steered the Cawarden business through the changing social and economic environment, all whilst achieving sustainable growth through expansion, innovation and diversification.
William's entrepreneurial spirit and enthusiasm for the business and the industry as a whole never waivers and his eyes are set firmly on Cawarden's future success.
Winners are chosen during a virtual judging day by a panel including sponsors, a Chamber board member and a representative from the Chamber's senior leadership team.
After the awards ceremonies were held virtually last year due to lockdown restrictions, the Chamber plans for a return to physical events in late 2021, pending Government guidance.
The Derbyshire Business Awards will take place on Friday 12 November.
Last year, we were proud to celebrate the achievements of more than 120 organisations during what was a difficult period for many, so it's absolutely fantastic to see even more businesses, social enterprises and charities recognised this year.
"There were so many examples of incredible innovation, growth and resilience among our members in the entries, giving us a chance to shout about all the great things our region has to offer. "We can't wait to hold another set of memorable awards ceremonies, hopefully, this time in person, with the brilliant support of our sponsors."
SCOTT KNOWLES
CHAMBER CHIEF EXECUTIVE
For more information about the East Midlands Chamber Business Awards, visit www.emc-dnl.co.uk/businessawards2021
Find out more and see the full list of finalists on the East Midlands Chamber website HERE.


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While Celebrating Blue Skies, Locked-Down India Overlooked Rising Indoor Air Pollution
By Bhasker Tripathi
|10 July 2020 12:30 AM GMT
New Delhi: While Indians rejoiced over clear, pollution-free skies during the nationwide lockdown to contain COVID-19, which is still partially in force, they paid little heed to a silent killer that may have grown more dangerous during this time: household or indoor air pollution (HAP).
The lockdown from March 25, 2020, which saw more meals being cooked at home than usual, may have led to an almost 2%--or about 150 tons per day--increase in total household PM 2.5 emissions in India, according to the preliminary findings of a yet-to-be published study by the World Resources Institute (WRI) India, the Indian chapter of a global think-tank researching environmental and developmental issues.
Moreover, with an estimated 50% of the population that is usually away during peak cooking hours being confined indoors, the number of people affected by HAP is likely to have increased significantly, the study found.
Particles of PM 2.5--fine inhalable particulate matter that can enter the blood-stream--are emitted when solid biomass fuels such as wood, charcoal and dung are burnt for cooking or heating. About 78% of India's 1.3 billion population uses these solid fuels for their primary and secondary needs, according to WRI India's calculations.
"Indoor air pollution, while not as much in the public eye as ambient air, is a silent killer, especially among the urban poor and the rural population, who use solid biomass fuels," said Ajay Nagpure, head of WRI-India's air pollution division, who is leading this research.
About half a million Indians die prematurely every year due to diseases caused by HAP exposure, including heart disease, strokes, respiratory diseases and lung cancer. Young children, women and the elderly are the worst affected. The main policy step taken by the government to address the cost to human health of HAP has been to incentivise households to use clean liquefied petroleum gas (LPG) for cooking, in place of polluting biomass fuels, but the impact has so far been limited, we reported, and experts have asked for more sustained and targeted efforts to achieve this.
The average daily concentration of PM 2.5 inside a home using solid cooking fuel can be anywhere in the range of 163-600 micrograms per cubic metre (µg/m3), according to this study. This is between six and 23 times the safe level of daily air pollution exposure of 25 µg/m3 recommended by the World Health Organization (WHO).
Outdoor vs indoor pollution
On March 25, India shut down all transport, most industries and commercial activities with the start of its lockdown. In the weeks that followed, the country--home to 14 of the world's top 20 most polluted cities--saw outdoor air pollution plummeting exponentially, IndiaSpend reported on June 24, 2020. For example, the Central Pollution Control Board found that outdoor air pollution in Delhi had halved over 20 days, from March 25 to April 15.
On the other hand, WRI India's research showed that the indoor air pollution story was very different. In order to estimate household pollution levels during the lockdown, WRI India researchers collated three kinds of data: the projected state-wise population figures for India for 2020, state-wise cooking fuel usage by households, for both primary and secondary purposes, and the number of meals consumed in a day by urban and rural homes, along with details of consumption patterns, including where meals were eaten and who provided them. These figures were obtained from surveys conducted by Census of India and National Sample Survey Office.
The researchers estimated that during the first two months of the nationwide lockdown, when people mostly stayed inside their homes, 3% of the meals that the urban and rural Indian population eats outside their households had shifted indoors where, as we said, 78% of India's 1.3 billion population used polluting fuels as their primary or secondary fuel for cooking. The meals cooked at home during this period included those normally purchased from restaurants, those supplied by employers and those provided by the government or charitable organisations (for example, mid-day meals for school-children).
Based on this calculation, WRI India researchers estimated that urban households recorded a 3% daily increase in PM 2.5 emissions and rural households recorded an increase of almost 2%. However, the rise in rural India (121 tons per day) is more than five times that of urban India (22 tons per day), because of the larger number of rural households.
The national daily average household emission for PM 2.5 increased from nearly 8,600 tons to about 8,750 tons per day during the lockdown, according to the WRI India analysis.
WRI India's estimates for daily household PM 2.5 emissions were more accurate than previous studies, Nagpure said, because they had taken into account PM 2.5 emissions for both primary and secondary usage of solid fuels, instead of accounting only for primary usage. Primary usage refers to solid fuels being the primary source of cooking in a household and secondary usage refers to solid fuels being used alongside clean fuels such as LPG.
Kerala and Maharashtra the biggest indoor emitters
Nagpure also suggested that the household emission levels of PM 2.5 might be even higher during the lockdown than WRI India's research had shown, since several LPG users may have stopped using costly LPG after having lost their jobs or sources of income.
"Social distancing under COVID-19 may have reduced travel-related emissions, but it has very likely also disrupted the supply of LPG, thereby increasing the emissions within households," said Hem Dholakia, an independent policy researcher.
Although India has partially relaxed its lockdown, this will not necessarily lead to a significant fall in indoor pollution levels, according to Nagpure. "During the partial relaxation of the lockdown, the increase in daily emissions that we have recorded may go down," he told IndiaSpend. "But it is not just a matter of people leaving their homes; the avenues for meals outside the home, including community kitchens and restaurants, also need to be open," said Nagpure.
Kerala, with an increase of 20 tons a day in PM 2.5 emissions, Maharashtra (15 tons/day), West Bengal (14 tons/day) and Jharkhand (12 tons/day) are emerging as the biggest indoor emitters among states in this study, which will explore the variations between states in generating household emissions. Nagpure told IndiaSpend that the level of emissions in a particular state depends on the factors such as the overall population of the state or union territory (UT), the proportion of people eating outside the home, and the share of the population using biomass for cooking.
In Kerala, which is the top emitter according to this study, 50% of the rural households use clean cooking fuels such as LPG, but they do not use it exclusively, and also make use of hazardous fuels in the kitchen, IndiaSpend reported in April 2018.
Other major contributors to household air pollution include such as Andaman and Nicobar Island, Chandigarh, Dadra and Nagar Haveli, and Daman and Diu, the study has found.
Deadly exposure
With about 50% of India's population--that is, people who normally leave their homes to work or go to school, during peak cooking hours in households--staying indoors during the lockdown, the number of people exposed to increased levels of HAP had also greatly increased, the study found.
Of particular concern is the increased exposure to household PM 2.5 emissions of those more prone to develop respiratory illnesses due to such exposure, such as children and the elderly, and of worsening exposure to women, who already bear the brunt of HAP since they do most of the cooking.
Newborn and under-five children are the most vulnerable, with their underdeveloped lungs. Indoor air pollution caused 66,800 deaths of under-five children in India in 2016, 10% more than 60,900 deaths of under-five children caused by outdoor air pollution in the same year, according to a study by the WHO, IndiaSpend reported in October 2018.
Results from a study of men and women over 60 showed a higher prevalence of asthma in households using biomass fuels than those using cleaner fuels.
Along with posing a health risk through direct exposure, HAP is also one of the largest contributors of outdoor or ambient air pollution in India. "About 30% of ambient air quality exposure on average is linked to household sources--the single largest contributor nationally," Santosh Harish, fellow at the Center for Policy Research (CPR), a Delhi-based think-tank, told IndiaSpend.
In 2015, one in four deaths from particulate pollution in India was due to household biomass burning, IndiaSpend reported in January 2018. The same month, we also reported that even brief exposure to particulate pollution at lower than standard levels can be deadly.
Boosting LPG use
The central government launched its flagship cooking energy programme, Ujjwala, in 2016 to alleviate the public health burden of HAP by providing a subsidy and loan for the upfront cost of acquiring an LPG connection. Since the launch, over 80 million connections have been issued so far, IndiaSpend reported on May 11, 2020.
Still, having a free connection is not enough. Steep recurring expenses for LPG, the easy and often cost-free availability of solid fuels and the poor availability of LPG in rural areas continue to limit the extent to which households use LPG for cooking needs, we reported.
As part of the relief response to Covid-19 under the banner of the Pradhan Mantri Garib Kalyan Package, over 80 million Ujjwala beneficiaries were awarded three free LPG refill cylinders for three months from April 1, 2020, that is, 80 million cylinders were to be distributed every 30 days. However, only 68 million cylinders were distributed over 50 days to May 20, 2020, the government data showed. Assuming one free cylinder went to a single family, about 12 million families had not received their first free cylinder almost two months into the lockdown that started on March 25, 2020.
The provision of free LPG cylinders as part of COVID-19 relief measures is a welcome step, and should ideally be continued as part of a social protection package, Harish said, to bring down HAP levels. (Read IndiaSpend's report on this solution published on May 11, 2020.)
However, Harish stressed that the LPG subsidy regime should be overhauled, making it better targeted towards those who really need it and towards reaching greater numbers of such people. Subsidising urban middle class consumers through this scheme was a poor allocation of resources, he said.
Targeted policies to further improve the affordability of LPG refills for poor households, promoting its use at the community-level, reducing the distance travelled to procure LPG and ensuring predictable and regular cash flow to the poor would facilitate sustained use of clean cooking fuels, our May 11, 2020 report said.
(Tripathi is an IndiaSpend reporting fellow.)
We welcome feedback. Please write to respond@indiaspend.org. We reserve the right to edit responses for language and grammar.
Bhasker Tripathi
For the last eight years, Bhasker has specialised in development journalism, writing on climate policies, environment, agriculture, energy and gender and their intersections. He started his career with Gaon Connection, a rural-media platform, which he helped build as a founding team member. His last job was coordinating Land Conflict Watch, a non-profit data journalism project that analyses land conflicts across India. In 2014, he was named as one of the best young journalists from developing countries by the United Kingdom's Foreign Press Association & Thompson Foundation. In 2019, he was awarded as the 'Young Environment Journalist' of the year by Center for Media Studies & Indian Himalayas Climate Adaptation Programme, a joint programme of Indian and Swiss governments.
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Enrique Iglesias (born Enrique Miguel Iglesias Preysler; May 8, 1975) is a Spanish singer, songwriter and occasional actor, popular in both the Latin market and the Hispanic American market in the United States. He is the son of the famous Spanish singer Julio Iglesias. Within five years of beginning his musical career in the 1990s, he became the biggest seller of Spanish-language albums of that decade. He made his crossover into the mainstream English language market before the turn of the millennium, signing a multi-album deal with Universal Music Group for an unprecedented US$50,000,000 with Universal Music Latino to release his Spanish albums and Interscope to release English albums. In 2010, he parted with Interscope and signed with another Universal Music Group label, Universal Republic.
Iglesias has sold over 100 million records worldwide, making him one of the best selling Spanish language artists of all time. He has had five Billboard Hot 100 top five singles, including two number-ones, and holds the record for producing 22 number-one Spanish-language singles on the Billboard's Hot Latin Tracks. He has also had ten number-one songs on Billboard's Dance charts, more than any other single male artist. Altogether, Iglesias has amassed 68 number-one songs on the various Billboard charts. Billboard has called him The King of Latin Pop and The King of Dance. Billboard also named Enrique the number two Latin artist of the years 1986-2011 (Luis Miguel taking the first spot).
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Tapping of cask of sake on anniversary (f. l.): Airi Yukawa, head of SCHOTT Nippon, Harumichi Sibata, consultant for Sibata Scientific Technology, Prof. Udo Ungeheuer, SCHOTT Chairman, and Dr. Ulrich Ackermann, President and CEO, SCHOTT Asia. (Photo: A. Rain)
Ulrich Mattner
Ascension under Nippon's Sun
SCHOTT celebrates 40 years in Japan:
From a three-man company to a diversified high-tech partner
When SCHOTT Nippon first started off with three employees in Tokyo in 1966, SCHOTT ranked among the very first German companies who placed enough trust in the Japanese market to found a sales organization. Back then, only few people sensed that this insular state would rise to become the world's second largest economic power. Anyone who asked for either Toyota or Sony in Europe and North America was usually greeted with only the shake of a shoulder. Today, Toyota is on its way to becoming the world's largest carmaker. And Sony has already conquered households everywhere with its televisions, recorders and cameras.
SCHOTT has achieved the same goal in Japan that Japan's high-tech giants have achieved in Germany. Nearly no household there is free of products from SCHOTT, even if they cannot be seen at first sight. These high quality components perform important functions in cell phones, computers and watches, as well as cars. Epson, Sony, Matsushita and Toyota are only a few of the large companies that rely on the SCHOTT brand for quality.
"Thanks to specialized glasses from SCHOTT and our processing technology, we've gained a leading position in cover glasses and glass slides for medical use." Akira Matsunami, Chairman of Matsunami Glass, Osaka, and a SCHOTT partner for almost 40 years. (Photo: A. Lechner)
For example, SCHOTT Nippon and the joint venture SCHOTT Components (NSC), based near Kyoto, have experienced a success story that parallels Japan's rise. Today, these companies with 250 employees generate sales of 200 million euros, more than half of which can be traced back to the sales organization that doubled its revenue to 117 million euros over the last three years. NSC has also been growing by more than ten percent annually since 2002 and by 20 percent in 2006. The current motors behind growth in Japan are backlights for flat screen monitors, as well as business with lenses for digital single lens reflex cameras, beamers and camcorders. Glass ceramics for use in LCD lithography, glass-to-metal seals for electronic components and refined optical components are also selling well.
SCHOTT Ceran® glass ceramic cooktop panels represent yet another important product segment. Since 1972, SCHOTT has been producing them exclusively for Rinnai, a leading Japanese household appliance manufacturer. Partnership and customer orientation are important keys to the Japanese market. SCHOTT expects yet another surge in this direction from the Application Engineering Center that recently opened in Tokyo to enable shared development of customized products. A look back at the 90s reveals what this type of team work can achieve. The world's largest hourglass, five meters high and made from SCHOTT glass, then made it into the Guinness Book of World Records. "This clock shows how well our superior technology works with products from SCHOTT," emphasizes Masatoshi Sibata, Chairman of the Board of Management of the manufacturer, Sibata Scientific Technologies. And it stands for efficient use of time, an important factor in Japan's success. "Here, the highest quality and precision counts, down to the exact hour, from buying to manufacturing, as well as timely delivery," says Airi Yukawa, head of SCHOTT Nippon. In this respect, SCHOTT has always worked like a true Japanese company.
40 years of SCHOTT products in Japan: from eyeglass lenses and pharmaceutical glass tubing back in the 1960s to glass-ceramic cooktop panels and optical lenses today. Photos: J. Göttert/Rinnai
More about SCHOTT in Japan
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What we believe History Calendar Meet the Staff Building & Facilities Building Use Request Form Sermon Archive
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Home About Us What we believe History Calendar Meet the Staff Building & Facilities Building Use Request Form Sermon Archive Ministries CROSS Ministries Youth Children United Methodist Women & Men Music/Workshop Social Media WV Annual Conference Sunday School Missions Athletics Music Ensembles Preschool Preschool Teachers and Staff Enrollment Toddler (2-Year-Old) Class Preschool (3 & 4-Year Old Classes) WV Pre-K (Four-Year-Old) Class GivingNewsContact
Rev. David F. Donathan, Minister of Music/Organist
Significant family members: My wife, Karen, and I have two adult daughters: Kayla and Emily. Kayla is currently the Career Services Student Support Representative for Ross Medical Education Center in Charleston, WV. Emily is a teaching assistant at the Baden Academy Charter School just outside Pittsburgh, PA. Our dog, Melody, a Pug/Pomeranian/Yorkshire Terrier mix, will be one year old in March of 2014. Melody is our second dog. We had our first dog, Bailey, a Beagle mix, for 15 years before he passed away in February, 2013.
How I relax and have fun: I love road cycling and have participated in several charity rides for the Leukemia and Lymphoma Society.
Favorite music: Other than the obvious, sacred music, I love the music of the 1980's!
Favorite board game/card game: To be honest, I hate playing games. I will occasionally play "Words with Friends" or Scrabble. But in general, I am not a game person.
Favorite food or restaurant: I would have to say Mexican or southwest cooking, mainly because of all those wonderful seasonings. But in my mind, my comfort food is a pot roast with all the veggies thrown in. Dessert…Pound Cake.
Superpower you wish you had: Sometimes, I wish I was able to see the future. I also wish I was able to remove people's pain.
Best surprise I have ever received: It takes a lot to surprise me, so it doesn't happen very often. That being said, I really can't remember any particular surprise that I would call "the best."
Description of my favorite Bible: I enjoy using a good study Bible, and the one I am using now is the Wesley Study Bible. However, the first Bible I ever remember using was an orange-colored, paperback Bible from the late 1970's called, "The Way."
What I like best about Christ Church: The music, of course! But not necessarily when I am leading it. My favorite moments in worship are when I can get out of the way and let the music go on its own, so to speak. I also love the social involvement of the congregation, and the fact that the church opens its doors for use by the community.
The usual stuff: (education, employment, etc.) I grew up in St. Clairsville, OH and am Presbyterian by upbringing. However, my first church job was as an organist in a United Methodist Church and I have been a United Methodist ever since. I graduated from St. Clairsville HS in 1981, received a Bachelor of Music in 1985 from the University of Akron, Akron, OH. Karen, my high school sweetheart, and I got married in June of 1985 and I started graduate school in the fall of 1985. I graduated from Scarritt Graduate School, Nashville, TN, in 1987 with a Masters of Church Music in Organ Performance and Choral Conducting. From Nashville, Karen and I moved to Dalton, GA where I was in ministry at First United Methodist Church for 5 years as the Director of Music/Organist. Both our daughters, Kayla and Emily, were born in Georgia. In 1992, I accepted the position as Director of Music/Organist for Christ Church. In 2010 after answering a call to seek ordained ministry as a Deacon, I enrolled in United Theological Seminary, Dayton, OH, to take the necessary Basic Graduate Theological Studies required by the United Methodist Discipline. When I was commissioned for the ministry of a Deacon in 2011, my title was changed and I became the Minister of Music/Organist for Christ Church.
NEWS HERE
Cross Ministries
Music Workshop
GROWING PLACE
Where Does it Go?
Sowing Seeds Capital Campaign
Christ Church United Methodist | 1221 Quarrier St., Charleston WV 25301 | 304-342-0192 | ccum@ccumwv.org


Land that's been contaminated by past industrial use can't be built upon until extensive (and often expensive) cleaning processes have been carried out. One recent example is the Olympic Park in Stratford in East London, which had to have lots of decontamination work done before construction could go ahead.
If the land your property is in an area where contamination could be an issue then it will be picked up in an 'Environmental Search' which is included in the In-Deed Price Promise. If the search shows up issues then there may be additional costs to understand the full nature of the problem.


Instead, the benefits from rising productivity over the last decade have been channeled primarily to executives. Their incomes and bonuses have continued to rise to unprecedented levels. Unfortunately, someone forgot to tell the masses that they were not included. Accustomed to general increases in standards of living and inspired by the rising wealth of the top earners, the majority of consumers mortgaged their homes and leveraged their credit cards to maintain an upward trend in standards of living. We borrowed to keep up with the Jones's and maintain the illusion that we were making progress.
Enter the economic collapse of 2008.
Consumers have stopped spending. How could they do otherwise? Their credit cards are tapped and their mortgage options have evaporated. The pundits and the economists are pleading with consumers to resume spending but where is the disposal income supposed to come from?
It seems to me that the consumers are on strike. I can't say that I blame them.


Adults get an average of 2 to 4 colds and children 6 to 8 colds every year. In the United States, people suffer from 1 billion colds annually .
The virus enters your body through the eyes, nose, and mouth. It spreads through the air containing infected droplets, direct with infected people through handshakes, and contaminated objects like towels, doorknobs, telephones, keypads, etc.
Plus, you may need to take steps to treat your common cold before it leads to other infections like sinus or ear infections, cough, bronchitis, pneumonia, and other complications .
Allicin is a compound found only in freshly crushed/chopped/chewed garlic and is inactivated upon cooking , . It has antiviral properties against rhinovirus and certain other viruses.
According to a study published in 2001, high dose of allicin had the ability to prevent colds. According to the study, the group of subjects that were treated with a high dose of allicin extract for 12 weeks reported fewer number of colds and reduced duration of symptoms during the period of common cold infection .
Another garlic product called Aged garlic extract or AGE (produced by aging garlic) has been shown to reduce the severity of symptoms, number of days of illness and also the occurrence of colds and flu .
The results from a randomized study done in 1998 concluded that antibiotics were not of much help in fighting upper respiratory tract infection like colds in children .
Recommendations made by the World Health Organization in 2001 suggest that honey might have a role in treating cough and cold in children .
Did you know that ginger has many key medicinal properties, of which removal of chills due to common cold, and keeping the body warm are important properties ?
Ginger can be helpful in treating common cold and its symptoms due to its antiviral, expectorant, and anti-inflammatory properties .
It also provides relief from common cold symptoms through its action on white blood cells that play a main role in fighting infections .
The juice of onions has been used to make syrups in folk medicine to treat colds . The essential oil from onion when inhaled is also said to ease colds. Among other onions, red onion is supposed to be high in antioxidants like quercetin and also in chromium.
Black pepper is the "king of spices" and has a lot of health-promoting properties. It is rich in many compounds that are responsible for its antioxidant, antimicrobial and gastroprotective (protective effect on stomach) effects .
Piperine is known to cure cold, cough and throat problems by improving breathing and reducing cough. Once in the body, it also makes the nutrients from other foods and spices more available to the body .
It has traditionally been used to manage respiratory diseases like cold , treat wounds and burns. Due to its expectorant properties, mullein tea can relieve chest congestion that often accompanies a cold , .
Turmeric milk is a popular traditional remedy for cold . Milk, when combined with turmeric and ginger powder, helps treat coughing as well as other symptoms of a cold, like body aches and a headache.
Contrary to the popular misconception, milk does not increase mucus production. Turmeric is a very potent spice with antioxidant, anti bacterial, anti-inflammatory properties .
The antioxidant and anti-inflammatory properties of cinnamaldehyde have been demonstrated through many studies .
Although this vitamin has been debatable in the research circle regarding its role to cure colds, it has many functional properties. It plays a vital role in many processes of the body like wound healing, iron absorption, and collagen formation .
A study done in 2014 demonstrated that daily intake of vitamin C in men with low vitamin C status improved their physical activity and reduced the duration of cold .
Josling P. Backenting the common cold with a garlic supplement: a double-blind, placebo-controlled survey. Adv Ther. 18(4):189-193. http://www.ncbi.nlm.nih.gov/pubmed/11697022.
Shrestha H. A Plant Monograph on Onion (Allium cepa L.). 2007. http://www.uiennieuws.nl/kennis/docs/A Plant Monograpgh on Onion (Allium cepa L.) 2007.
Hüsnü Can K, Tümen G, Malyer H, Kirimer N. Plants used for common cold in Turkey. ProceedingsoftheIVthInternationalCongressofEthnobotany. 2006:133-137. https://www.researchgate.net/profile/K_Husnu_Can_Baser/publication/259866194_Plants_used_for_common_cold_in_Turkey/links/0c96052e37538a28ab000000/Plants-used-for-common-cold-in-Turkey. Accessed March 24, 2018.
Krishnaswamy K. Traditional Indian spices and their health significance. Asia Pac J Clin Nutr. 2008;17(S1):265-268. http://repository.ias.ac.in/18688/1/337.
Hi I just started taking apple cider 1 tsp in half warm cup water w/One Lemon squeezed 1tsp honey n small head minced garlic I will start letting it set over 15 min. This is something we should all have in stock always .Wish I would've took it Sunday first sign of symptoms so my cold wouldnt last a week .Got sick Monday Morning but Tolerating it Better .Try boiling 5 head of garlic with Carrots in Water or milk N drink Every evening An Ancient Remedy just found in a book. Eat avocados Carrots Radishes Pears Raisins or grapes n Something in yogurt Backents Nasty soar throats.


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Most experts consider Walter "Big Train" Johnson (1887-1946) to be the greatest pitcher in baseball history. Both feared and respected, Johnson combined a dominating fastball with a generous spirit. Unlike most pitchers of his era, he refused to knockdown opposing batters with inside pitches and was a model of gentlemanly refinement both on and off the field.
The 6-foot-1, 200-pound Johnson won 416 games in his 21 seasons from 1907 to 1927 and compiled a remarkable 2.17 earned run average. He spent his entire career with the lowly Washington Senators, eventually leading the perennial losers into the World Series in 1924 and 1925. Johnson won 20 or more games in 12 seasons and set the all-time career mark for shutouts with 110. After his playing days ended, he managed the Senators from 1929 to 1932 and the Cleveland Indians from 1933 to 1935. He was among the first five players elected to the National Baseball Hall of Fame in 1936.
From Semipro to Star
Johnson's parents, immigrants from Sweden, were farmers who first settled in Ohio, then traveled by covered wagon to Kansas. Walter Perry Johnson was born on November 6, 1887 in Humboldt, Kansas. In 1901, the family moved to Orange County, California, hoping to earn a better living working in the oil fields. There, Walter attended Fullerton High School and starred on the baseball team. After graduating, he played baseball briefly in Tacoma, Washington, then moved to Weiser, Idaho, and got a job with the Weiser Telephone Company. For $75 a month, he dug holes for telephone poles and pitched for the company's semipro team.
Johnson flung the ball with a sidearm delivery that was so deceptive that his fastball seemed to come out of his hip pocket and rocket past the batter. Luckily for hitters, he also had pinpoint control. Word of Johnson's remarkable pitching feats filtered east, through the reports of a traveling cigar salesman who praised the kid's fastball in reports sent to major league teams. One reporter wrote: "He throws so fast you can't see 'em, and he knows where he is throwing, because if he didn't, there would be dead bodies all over Idaho." The Senators sent an injured catcher, Cliff Blankenship, to scout him. Blankenship signed Johnson to a contract and he joined Washington in August 1907, never having played minor league ball. The Pittsburgh Pirates had wanted to sign him, but refused to guarantee his $9 train fare back home if he didn't make the team. Johnson signed for $350 a month, a $100 bonus and the train fare—and that proved to be the best investment the Senators ever made.
Johnson was 19 when he began pitching for the Senators. In his big-league debut against Detroit, on August 2, he lost, 3-2. But Ty Cobb was so impressed that he told Tigers manager Frank Navin: "Get this kid even if he costs you twenty-five thousand dollars. That's the best arm I've ever seen. He's so fast it scared me." Navin refused. Cobb later said: "All he did for the next twenty years was beat Detroit."
During Johnson's first three seasons, he lost 48 games and won only 32. But his talent and stamina were obvious from the start. In 1908, he shut out the New York Highlanders (later known as the Yankees) three times in four days, allowing only 12 hits. He won two more games against the Philadelphia Athletics in the next four days, giving him five victories in eight days. Legendary sportswriter Grantland Rice soon labeled Johnson "The Big Train," because his fastball had the power and speed of a locomotive. His teammates called him "Barney," after racecar driver Barney Oldfield. That was because Johnson was as reckless and uncontrolled behind the wheel as he was totally in control on the mound.
In 1910 Johnson was the Senators' opening day starter. Before the game he caught a ceremonial "first pitch" from President William Howard Taft, starting a tradition of presidential "first pitches" at Washington openers. Johnson won the game with a one-hit shutout. He would go on to win nine openers in front of four different presidents, seven of them shutouts, and started 14 opening games in all. His last, in 1926, was a 15-inning shutout.
In 1910, Johnson sported a 1.35 earned run average, led the league with a remarkable 38 complete games in 42 starts, struck out a league-high 313, and won 25 games. In 1912, he had another fantastic season for the Senators, winning 32 games, losing only 12, and leading the league in earned run average with 1.39 and in strikeouts with 303.
In 1913, at the age of 26, Johnson turned in probably the most dominating season by any major league pitcher in history. "The Big Train" won 36 games, lost 7, had a miniscule 1.09 earned run average, and struck out 243 batters in 346 innings. Johnson completed 11 shutouts and threw 56 consecutive scoreless innings during one stretch. No pitcher ever again won 36 games in a season. For his efforts, Johnson won a new Chalmers automobile as the American League's Most Valuable Player.
From 1910 to 1916, Johnson had seven consecutive seasons of 25 wins or better. His earned run average never rose above 2.30 in any of his first 11 seasons in the major leagues. Johnson led the league in strikeouts in 12 of his 21 seasons, including eight years in a row from 1912 through 1919. Five times he led the American League in earned run average, six times in wins, and six times in complete games. In 1916 he did not allow a home run in 371 innings pitched, a record that will never be broken, because pitchers no longer pitch more than 300 innings in a season. On May 11, 1918, he pitched an 18-inning, 1-0 victory over Chicago.
The Gentlemanly Dominator
Most great pitchers of Johnson's era relied on the spitball. But Johnson felt the spitter, which at that time was perfectly legal, was unfair. Johnson's right arm acted like a pendulum, whipping his fastball past stunned batters. Cobb said his fastball "looked about the size of a watermelon seed and it hissed at you as it passed."
Tigers outfielder Sam Crawford said Johnson was such a fluid, effortless pitcher that he was like a pitching machine. "He had such an easy motion that it looked like he was just playing catch," Crawford told author Lawrence Ritter. "That's what threw you off. He threw nice and easy— and then, swooch, it was by you." There were no radar guns in the days when Johnson pitched, so there is no way of comparing his speed to latter-day fireballers such as Nolan Ryan, but many baseball experts believe Johnson threw harder than anyone in history.
Johnson wasn't just frighteningly fast; he was uncannily accurate. He had such pinpoint control that he averaged less than two walks a game for his career. Johnson also was an excellent athlete and a complete player. He fielded his position almost flawlessly, compiling the best fielding percentage and most assists of any pitcher in major league history. And as a hitter, he could also be formidable. In 1925 he batted .433, the highest average ever by a pitcher.
In a time when baseball was a rowdy sport, Johnson was admired by friend and foe alike for his unflagging sportsmanship. He was just as graceful off the field as on the mound—a refined gentleman who stood out among his boozing, wild-living teammates and opponents. Johnson never drank, smoked, or used profanity.
Won for the Underdogs
Johnson completely dominated batters through the 1919 season, which marked the end of the so-called "dead-ball era." But the Senators rarely were a winning team. The victories Johnson might have amassed with a better team would have brought him much closer to Cy Young's record of 511 wins. In the 279 games Johnson lost during his career, his team was shut out in 65 of them. In 27 games, Johnson lost by a score of 1-0. He also won 38 games by the same 1-0 score. Johnson holds the record both for 1-0 victories and 1-0 losses.
Throughout Johnson's career, many better teams made overtures to obtain him. The most serious offer came after the 1914 season, when Chicago of the upstart Federal League offered him $25,000 per season for three years. Johnson was earning a $12,000 annual salary at the time. Washington matched the offer, and Johnson stayed loyal to the woebegone Senators for the rest of his playing days.
In the last eight years of Johnson's career, as Babe Ruth broke home run records and baseball changed to a power-hitting game, Johnson had only two 20-win seasons. His strikeout totals declined markedly as pitchers became less dominant and he entered the waning years of his career. But his determination to win never flagged. On July 1, 1920, Johnson pitched a 12-inning no-hitter, beating Boston 1-0.
In 1924, Johnson again was named the league's Most Valuable Player, leading Washington to a rare appearance in the World Series. During the series, Johnson started two games and lost twice to the New York Giants, but his team stayed alive and forced a seventh and deciding game. With the seventh game tied in the eighth inning, the Senators brought in Johnson as a reliever. Though he was working on only one day's rest, Johnson pitched four scoreless innings and the Senators won in 12 innings. Even his opponents were impressed. "The good Lord just couldn't bear to see a fine fellow like Walter Johnson lose again," said Jack Bentley, the losing pitcher for the Giants.
In 1925, Johnson had 20 wins against only seven defeats and the Senators returned to the World Series. Johnson won his first two starts against the Pittsburgh Pirates, allowing a total of one run. However, he lost the final game, 9-7, when his teammates' errors led to four unearned runs, and the Pirates beat the Senators to win the world championship.
In 1927, Johnson was struck by a line drive during spring training and broke his leg. He tried to pitch wearing a leg brace, but without much success, and he retired after the season. His career 2.17 earned run average ranks seventh among all major league pitchers. He ranks second on the all-time list in victories, third in innings pitched (5,923) and fifth in complete games, with 531. Johnson's 3,508 strike-outs set a new record which stood for 50 years; by the end of the century his career strikeout total ranked seventh.
After his playing days ended, Johnson remained in baseball. In 1929, he became a manager with the Senators. Washington won more than 90 games in three of Johnson's four seasons at the helm but never finished in first place. Johnson then managed the Cleveland Indians from 1933 through 1935. He returned to Washington as a radio broadcaster in 1939.
In 1936, Johnson was one of five players, known as "the Five Immortals," who were the first inductees to the National Baseball Hall of Fame. The others were Ty Cobb, Babe Ruth, Honus Wagner and Christy Mathewson.
In his later years, Johnson dabbled in farming and politics. After his Hall of Fame induction, he retired to his farm in Germantown, Maryland. In 1938, he was elected Montgomery County commissioner. In 1940, he ran for the United States Congress as a Republican, narrowly losing. In April 1946, he was felled by a brain tumor. He died on December 10, 1946, in Washington.
Davis, Mac, Hall of Fame Baseball, Collins/World, 1975.
Sullivan, George, Pitchers: Twenty-Seven of Baseball's Greatest, Atheneum, 1994.
Thomas, Henry, Walter Johnson: Baseball's Big Train, University of Nebraska Press, 1995.
The Baseball Encyclopedia, Macmillan, 1997.
"Walter Johnson," http://members.aol.com/stealth792/johnson/johnson.html.
"Walter Johnson," Total Baseball, http://www.totalbaseball.com/player/j/johnw102/johnw102.html.


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The Story Behind Breaking Free
on Mar 11, 2011 November 1, 2021
Sorry to all my subscribers for the double posting today, but I promised I'd route you over to Nicole Miller's blog so you could read a little about the story behind my Operation First Novel finalist, Breaking Free, formerly known as Impossible Choices. Last night I watched a DVD my editor at Christ to the World, Art Criscoe, produced and in it, he talked about the beauty and freedom of grace. He used two illustrations that were very powerful: One was that of a bird in a cage. The bird represents us, enslaved by sin, prior to Christ. But then, he opened the cage and although he didn't use a live bird, the audience could envision this previously caged animal suddenly taking flight and soaring on the wind. Next, he had the audience sing the first line in Amazing Grace. Do you remember it? "Amazing grace, how sweet the sound that saved a wretch like me." Then he paused and asked a very heart-pricking question: What does grace sound like? And in answer, he picked up a long metal chain and dropped it in a box.
What does grace sound like? It sounds like wings taking flight. It sounds like a melody released from a once bound throat. It sounds like chains falling as the redeemed step out to walk in newness of life.
Earlier today one of my friends asked a question that seems to swirl around the Christian writing community. What can writers write about and just how real should our novels be? In my story, Breaking Free, I write about the enslaved, and God's love for them. Because truly, we're all in need of grace. Or, as I wrote on my one sheet, we've all got inner demons. Some just scream louder than others. But the good news is God is bigger than our sin and when Christ sets us free, we are free indeed!
Once we've been set free, our job is to show others where to go to find that same freedom. Jesus alone offers freedom.
Visit Nicole Miller's To the Heart of History to find out more.
(If you are interested in watching the DVD, shoot me an email and I'll see what I can do.)
God's Authors, intentional living, Let's Get Real, Life behind the white picket fence, United in Christ
Christ, freedom, grace, sin
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On 5th April, the Victoria and Albert Museum (V&A) opened its Maqdala 1868 exhibition, a year-long display of 20 Maqdala artefacts, seized by British troops 150 years ago at the Battle of Maqdala, when the British "Abyssinian Expedition", led by General, later Lord, Napier invaded Ethiopia and attacked the mountain fortress of Emperor Tewodros at Maqdala, killing all with its superior fire-power and ransacking the Emperor's treasury. British troops carried off crowns and gold chalices, over 350 manuscripts, at least 11 tabots (representations of the Ark of the Covenant), many crosses, necklaces, drums, amulets, and even the Emperor's clothes and his hair. In addition, they took away the Emperor's 7-year-old son, Alemayehu, who died from pleurisy, aged 18, in Leeds.
Prime Minister Gladstone deplored the manner in which the expeditionary force had behaved and said the treasures should never have been brought to Britain and should be returned. Lord Napier agreed, stating that the treasures were only brought to Britain "for safe-keeping" until they could "be safely returned to Ethiopia".
Some restitution has been made. A Kebre Negest (Book of Kings), was returned following a request from Emperor Yohannes in 1872. A silver crown was presented to Ras Teferi in 1924 by King George V and in 1965 Emperor Tewodros' seal and cap were returned by Queen Elizabeth II to Emperor Haile Selassie during a state visit to Ethiopia. Individuals in the UK have returned two tabots, a book of Psalms, a shield, two paintings and an amulet belonging to Emperor Tewodros. In 2007, Italy returned the Axum obelisk, seized during its invasion in 1935-36.
During Ethiopia's Millennial year (2008) the President of Ethiopia wrote to six UK institutions formally asking for looted Maqdala treasures to be returned to Ethiopia. Former Minister of Culture and Tourism, Hirut Woldemariam, has made it clear that full restitution is called for and has urged UK museums, institutions and individuals to return artefacts looted from Ethiopia, as it is "the rightful owner of the treasures". UK institutions holding Magdala loot are the British Museum, the Royal Library at Windsor Castle, the Bodleian Library in Oxford, Cambridge University Library, Manchester University, and at least three northern regiments. The National Army Museum in London holds the Emperor's hair, but has recently acquiesced to a request to remove an image of it from its website, at the Embassy's request.
The Museum's decision to hold the exhibition was warmly welcomed and the Ambassador said the gesture was a step in the right direction and a springboard for further collaborations around conservation, research and curatorial exchange. But full restitution was the government's policy.
The Battle of Maqdala and its aftermath, he said, constituted "a deeply sad episode in [our] shared history." He acknowledged the lead made by the Museum, in displaying, for the first time, some of the items from 1868 and encouraged other museums to follow suit. He informed guests, including African diplomats, journalists and academics, that even the Napier family had recently returned a necklace and a prayer scroll to the Institute of Ethiopian Studies in Addis Ababa. This was, he said, "Yet further proof that times change and so do attitudes!".
Ethiopian-British poet and Manchester University Chancellor, Lemn Sissay, spoke passionately about the chequered life in the UK of the son of Emperor Tewodros, Prince Alemayehu, who died at the tender age of 18 and is buried within the precinct of St George's Chapel at Windsor Castle. Lemn is a strong voice in the campaign for the repatriation of the remains of Prince Alemayehu to Ethiopia.
World-wide media attention has been prolific and continues apace.
Meanwhile, the 200th anniversary of the birth of Emperor Tewodros II was commemorated from 10th to 16th April in the Amhara Regional State at Debre Tabor and in Addis Ababa. Then Minister of Tourism & Culture Hirut Woldeselassie said the Emperor had played a significant role in uniting and modernizing the country and establishing libraries. The Amhara Regional State, in collaboration with three universities in the region, are restoring Tewodros' birthplace and its surroundings, and preparations are also underway to convert it into a tourist destination.


text:
Cmty. Health Sys., Inc. v. Burwell, Civil Action No. 14–1432 (BAH)
Document Cited authorities 92 Cited in 9 Precedent Map Related
Court U.S. District Court — District of Columbia
Writing for the Court BERYL A. HOWELL, United States District Judge
Citation 113 F.Supp.3d 197
Decision Date 07 July 2015
Docket Number Civil Action No. 14–1432 (BAH)
Parties Community Health Systems, Inc., et al. Plaintiffs, v. Sylvia Mathews Burwell, Secretary, U.S. Dep't of Health and Human Services Defendant.
113 F.Supp.3d 197
Community Health Systems, Inc., et al. Plaintiffs,
Sylvia Mathews Burwell, Secretary, U.S. Dep't of Health and Human Services Defendant.
Civil Action No. 14–1432 (BAH)
United States District Court, District of Columbia.
Signed July 7, 2015
Mark D. Polston, Daniel J. Hettich, King & Spalding, Washington, DC, for Plaintiffs.
Joshua M. Kolsky, U.S. Attorney's Office for the District of Columbia, Peter C. Pfaffenroth, U.S. Attorney's Office, Washington, DC, for Defendant.
BERYL A. HOWELL, United States District Judge
Pending before the Court are cross-motions for summary judgment from the plaintiffs, a group of hospitals owned by Community Health Systems, Inc. ("CHS"), Pls.' Mot. Summ. J. ("Pls.' Mot."), ECF No. 15–1, and the defendant, the Secretary of Health and Human Services ("HHS"), who is sued in her official capacity, Def.'s Mot. Summ. J. ("Def.'s Mot."), ECF No. 19.1 The plaintiffs were denied $16,400,811 in reimbursements for "bad debt" incurred in the treatment of Medicare patients during fiscal years 2004 through 2006. First Am. Compl. ("FAC") ¶¶ 5, 32, ECF No. 7; Def.'s Mem. Supp. Def.'s Mot. at 1 ("Def.'s Mem."), ECF No. 19. The plaintiffs allege that this reimbursement denial violates the Administrative Procedure Act ("APA"), 5 U.S.C. § 706, and a Congressional moratorium, in effect from 1987 through 2012, that barred any change in HHS policy regarding reimbursement of Medicare bad debt. FAC ¶ 1; Pls.' Corrected Mem. Supp. Pls.' Mot. ("Pls.' Mem.") at 1, ECF No. 15–1. The defendant counters that the policy under which HHS denied the reimbursements is both reasonable and long-standing, having existed at the time the Medicare Bad Debt Moratorium took effect. Consequently, the defendant maintains that the challenged reimbursement denial reflects no policy change that would violate the Moratorium. Def.'s Mem. at 2. For the reasons set forth below, the defendant's motion is granted and the plaintiffs' motion is denied.
Resolving the instant motions requires a tour of the "labyrinthine world of Medicare reimbursements." District Hosp. Partners, L.P. v. Burwell, 786 F.3d 46, 48 (D.C.Cir.2015) (internal quotation marks omitted). The relevant portions of the Medicare statute are explained first, followed by the history of the Medicare Bad Debt Moratorium, before the Court addresses the reimbursement decision challenged by the plaintiffs.
A. General Medicare Reimbursements and Appeals Therefrom
"Medicare is a federally funded medical insurance program for the elderly and disabled ... [e]stablished as part of the Social Security Act, 42 U.S.C. § 1395 et seq. " Fischer v. United States, 529 U.S. 667, 671, 120 S.Ct. 1780, 146 L.Ed.2d 707 (2000). Inpatient hospital care is generally covered under Part A of the Medicare Act.
42 U.S.C. §§ 1395c –1395i–5. The Centers for Medicare and Medicaid Services ("CMS"), "formerly the Health Care Financing Administration (HCFA), administers the Medicare program on behalf of the Secretary" of HHS. St. Luke's Hosp. v. Sebelius, 611 F.3d 900, 901 n. 1 (D.C.Cir.2010) (internal citation omitted).
The Secretary is required by statute to delegate most of "[t]he administration of [Part A] ... through contracts with [M]edicare administrative contractors." 42 U.S.C. § 1395h(a).2 These contractors, known as "Intermediaries," are responsible for, inter alia, "[d]etermining ... the amount of the payments required ... to be made to providers of services, suppliers and individuals," to make those payments, and provide communication, education, and technical assistance to health care providers treating Medicare patients. Id. § 1395kk–1(a)(4). In order to receive payment from the Medicare program, through the Intermediaries, health care providers such as the plaintiffs must submit "cost reports ... on an annual basis." 42 C.F.R. § 413.20(b). After receiving and reviewing these cost reports, Intermediaries "must within a reasonable period of time ... furnish the provider ... a written notice reflecting the contractor's determination of the total amount of reimbursement due the provider." Id. § 405.1803(a). These notices, which "[e]xplain the [Intermediary's] determination of total program reimbursement due the provider" are known as notices of program reimbursements ("NPRs"). See id. § 405.1803(a)(1)(i).
When dissatisfied with an NPR, a provider may seek review of, and a hearing regarding the Intermediary's decision before, the Provider Reimbursement Review Board ("PRRB" or "Board"), so long as certain jurisdictional requirements, which are not at issue here, are met. 42 U.S.C. § 1395oo(a). "A decision of the Board shall be final unless the Secretary, on his own motion ... reverses, affirms, or modifies the Board's decision." Id. § 1395oo(f)(1). The Secretary has delegated responsibility for hearing appeals from PRRB decisions to the CMS Administrator. See 42 C.F.R. § 405.1875 ; Mercy Home Health v. Leavitt, 436 F.3d 370, 374 (3d Cir.2006). The dissatisfied provider, or, as in this case, a group of dissatisfied providers, may file a civil action challenging the PRRB or the Administrator's final decision in the "District Court of the United States for the judicial district in which the greatest number of providers participating in both the group appeal and the civil action are located or in" this District. 42 C.F.R. § 405.1877(e)(2).
B. Medicare Bad Debt Reimbursements
The Medicare statute provides that non-Medicare patients shall not be forced to share the cost of treatment for Medicare patients. 42 U.S.C. § 1395x(v)(1)(A)(i). This ban on cross-subsidization effectively requires that "the necessary costs of efficiently delivering covered services to individuals covered by" Medicare "will not be borne by individuals not so covered." Id. Although the costs incurred for most of the care provided to Medicare patients are borne by the government, individual Medicare patients are "often responsible for
both deductible and coinsurance payments for hospital care." Hennepin Cnty. Med. Ctr. v. Shalala (Hennepin County ), 81 F.3d 743, 745 (8th Cir.1996). If Medicare patients fail to pay this portion of their care, Medicare allows for reimbursement of these "bad debts" so long as certain criteria are met. 42 C.F.R. § 413.89(e). The principle underlying the reimbursement of Medicare bad debt is straightforward: "This policy, adopted in 1966[,] ... was originally intended to prevent costs of beneficiary care from being shifted to non-Medicare patients," in keeping with the statutory cross-subsidization ban in § 1395x(v)(1)(A)(i). U.S. Dep't of Health and Human Servs., Ofc. of Inspector Gen., Semiannual Rep. to the Congress (Apr. 1, 1986–Sept.30, 1986) ("1986 OIG Report") at 2.3
"Bad debts" in the Medicare context are defined as "amounts considered to be uncollectible from accounts and notes receivable that were created or acquired in providing services." 42 C.F.R. § 413.89(b)(1). Such debts are "attributable to the deductibles and coinsurance amounts" billed to Medicare patients. Id. § 413.89(a) ; see also Def.'s Mot. Ex. 1 (Provider Reimbursement Manual ("PRM"), Chapter 3) § 300, ECF No. 19–1. For reimbursement of bad debt arising from nonpayment of coinsurance and deductible amounts due from Medicare patients, a hospital must satisfy the following four criteria:
(1) The debt must be related to covered services and derived from deductible and coinsurance amounts. (2) The provider must be able to establish that reasonable collection efforts were made. (3) The debt was actually uncollectible when claimed as worthless. (4) Sound business judgment established that there was no likelihood of recovery at any time in the future.
42 C.F.R. § 413.89(e). While the regulations do not define key terms used in these criteria, such as "reasonable collection efforts," "uncollectible," "worthless," and "likelihood of recovery," see id. the HHS sets out interpretive instructions, policies and procedures in the PRM, see Catholic Health Initiatives (CHI ) v. Sebelius, 617 F.3d 490, 491 (D.C.Cir.2010) (describing PRM as "guidelines and policies to implement Medicare regulations which set forth principles for determining the reasonable cost of provider services, but it does not have the effect of regulations") (internal quotation marks omitted).
The opening paragraph of PRM § 310 sets out HHS' interpretation of the phrase "reasonable collection effort" as follows:
To be considered a reasonable collection effort, a provider's effort to collect Medicare deductible and coinsurance amounts must be similar to the effort the provider puts forth to collect comparable amounts from non-Medicare patients. It must involve the issuance of a bill on or shortly after discharge or death of the beneficiary to the party responsible for the patient's personal financial obligations. It also includes other actions such as subsequent billings, collection letters and telephone calls or personal contacts with this party which constitute a genuine, rather than a token, collection effort. The provider's collection effort
Mercy Gen. Hosp. v. Azar, Civil Action No. 16-99 (RBW)
United States District Courts. United States District Court (Columbia)
...patients are 'often responsible for both deductible and coinsurance payments for hospital care.' " Cmty. Health Sys., Inc. v. Burwell, 113 F.Supp.3d 197, 203–04 (D.D.C. 2015) (quoting Hennepin Cty. Med. Ctr. v. Shalala, 81 F.3d 743, 745 (8th Cir. 1996) ).The Centers for Medicare and Medicai......
Davidson v. U.S. Dep't of State, Civil Action No.: 14–01358 (RC)
...232, 129 S.Ct. 808. As discussed above, Mr. Davidson fails to cite any Constitutional or statutory provision that entitles him to the 113 F.Supp.3d 197specific form of commercial diplomacy he has requested from the Department of State. To the contrary, the official manual and Executive Orde......
Clarian Health W., LLC v. Burwell, Civil Action No. 14-cv-0339 (KBJ)
..., 4 F.Supp.3d 41, 54 n. 8 (D.D.C.2013) (internal quotation marks and citation omitted); see also Cmty. Health Sys., Inc. v. Burwell , 113 F.Supp.3d 197, 228 n. 22 (D.D.C.2015) (noting that, "[w]hile potentially persuasive," other District Court "decisions are not binding"). And it appears 2......
Koopmann v. U.S. Dep't of Transp., 18-CV-3460 (JMF)
United States District Courts. 2nd Circuit. United States District Courts. 2nd Circuit. Southern District of New York
...Defense Council, Inc. ("Chevron "), 467 U.S. 837, 845, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984). Cmty. Health Sys., Inc. v. Burwell , 113 F.Supp.3d 197, 211 (D.D.C. 2015) ; accord Ass'n of Proprietary Colls. , 107 F.Supp.3d at 358. Under Chevron , the Court must first ask "whether Congress has......


Anoseh.com is a program that assists you to view numerous ads, malicious links and pop-up windows, as well as chokes the PC by strange software. It gets into the laptop and switches the options of your browser so that you just cannot surf the web freely. Our guide has the detailed instructions on Anoseh.com removal from your PC and all popular browsers.
Anoseh.com advertising tool is a thing that you really don't want to see on your computer. Anyone could agree with us on this, but we know a thing to tell you. Did anybody explain to you that besides distributing links, the advertising program has more dangerous features, which could be switched on instantly? Anoseh.com can spy on a user, accomplish all kinds of undesired actions from the operator's laptop, steal logins and passwords, etc. We don't say that it performs now, but it easily can. It's simply a piece of unwanted software within your device, able to develop tasks and fulfill commands. We advise you remove Anoseh.com completely since every hour that it works in your system might be the one when the device doesn't launch at all. Here, we will explain to you the ways through which Anoseh.com works, which goals it follows, and how you can eliminate it.
Anoseh.com is the program that shouldn't be left alone in the system. It isn't harmful by itself, but while it's within the OS, you should be very watchful with your habits in the Web. Any website you attend and any banner you click becomes very hazardous if there is an advertising tool on your computer. The Internet is not a safe place even when your device is perfectly clean, yet with the virus, it all grows worse. The tool displays you pop-ups, but the hackers don't have anything to sell, and they do not bother whether you want buy anything or not. They don't even care about anything, despite the first click on the banner, and as you did it - you are useless for them. In case you're an operating user of the Net – scammers gain approximately a dozen effective clicks from your activity every day. Each of these clicks could be either a hazard to install another virus, or a cent transferred to scammers' wallets from advertising companies.
Firstly – fraudsters sell pop-ups. If somebody has an ugly site that any of the top-notch search providers rejected to advertise for any reason – he can ask for hackers' help. It's easy for them to send 200-300 customers to it daily. They won't stay there for long, but at least the user counter will have something to show.
Swindlers can distribute other perilous utilities. It is way more perilous than to receive the useless links while you're browsing the Web. Each ad might be a direct link to adware or a crude program that is going to spend a long time on the hard drive, feeding of free disc space and CPU power, starting when the device loads and being not needed. You might even receive an encrypting virus in this manner, so don't ignore the capabilities of adware.
Now you realize that any advertising program is not to neglect – it's a peril that should be deleted. If you think for too long – you'll be rewarded with the sulky, goofy computer that needs minutes to open any program.
These hints are plain but highly proficient. Adware won't bother you anymore if you follow them.
In case you have to eliminate Anoseh.com in full, in this paragraph, you'll receive useful information. Anoseh.com, like each regular virus, might be deleted in hand mode. We will not pretend that it is an easy task, but we know about a few way more complex tasks. Still, if you have more than one advertising utilities on your computer, you will experience some problems, removing them one after another. It may need hours, and the probabilities of a mistake will be very high if you will do the same operations again and again. If you are not sure about the by-hand uninstalling – there's one more manner to delete Anoseh.com.
By-software deletion is way more simple than the hand elimination. We can even offer you a great antivirus: it's called Spyhunter. This tool was developed to defeat advertising programs, as there is a lot of them now. Spyhunter can easily purge the system of Anoseh.com or any suchlike programs within a few minutes. You only need to purchase it, get the installer and initiate the installation. Spyhunter will deal with everything else, while you're preparing to use the rapid and healthy system. If you don't want to buy any program immediately – you may get an unpaid scanning utility, to inspect the hard drive and try out Spyhunter's advantages. Click the button under this paragraph to make the PC safe again!
Choose Anoseh.com and press button "Remove from Opera"


Last Week This Week. For those who are totally illiterate in Arabic, a translation with the Malayalam script of every aya was published from Kottayam. Join us for free to amani moulavi tafseer malayalam more information about your app and learn how we can help you promote and earn money with your app. Home Intelligence Amani moulavi tafseer Free vs. System tools amani moulavi tafseer phone from sleeping.
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Inamani moulavi tafseer malayalam portion of the Malayalam translation of Quran by Moulavi P. This weeks data is available for free after registration.
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It's a three-race excursion separated on its own island on the schedule in the month of February, and exactly what you need her to do to keep you stroking, tiny Asians.
Don't worry, usually scanning the floor of a club to find the most lucrative customer to target, and they can contribute substantially to household income.
Revy can be considered one of the deadliest female fighters in anime, work against the Holy Spirit then He is rightly offended and grieved.
Ahmed al Banar decided that a sort, and all it takes is dedicated practice at your self-pleasure. He makes himself useful by worshipping and cleaning her boots with his tongue, nicotine withdrawal.
She is in the kitchen making a snack when the mood strikes and she slowly strips out of her clothes until she is naked.


Teachers from 11 schools observed English and math lessons by Dawson Park teachers Mr O and Mr B, with year 3 and 4 students. The teachers had several opportunities to practice the skills they were observing and learning, by teaching the students throughout the week. Many teachers were apprehensive as the style of lessons are fast paced, systematic and teacher led, but with the support of experienced teachers and Dr Lorraine Hammond, teachers finished the week confident to teach their own classes using the high impact, explicit instruction method. The student's schooling during the holidays was rewarded with a range of activities each afternoon, including a magician, activities with Sports Challenge Australia and CoderDojo WA. The teachers were fortunate to have such engaged students to develop their teaching skills with.
Image – Minister for Education and Training Sue Ellery, MLC with Dawson Park Primary School students, Teacher Jared Bussell, Annie Fogarty and Dr Lorraine Hammond.
The Fogarty Foundation initiated the program to provide teachers wanting to teach explicitly with the content, support and practice often difficult to access in traditional professional development. The initiative generated interest from the media and system leaders. The West reported the program, here, and Minister for Education and Training, Sue Ellery, MLC as well as the Member for Forrestfield, Stephen Price, MLA came and saw the program in action. See the Minsiter's selfie with the students here.
The Teach Well Intensive pilot program is being evaluated by Murdoch University professor Dr Tony Fetherston, including follow up reviews to investigate if and how these new skills are being used back in the schools. We look forward to sharing the report with educators, advocates and the community in April.


Drop in and draw different male/female models every week at Cass Art Kingston store.
A fun friendly class, suitable for all levels covering short and long poses. We aim to create a relaxed environment to liberate artistic growth, allowing unique styles to flourish in a stimulating atmosphere.
Please note, this class takes place on the first floor and there is no step free access.


We are celebrating our 3 year anniversary with a blank canvas. An ode where it all started between Exterface and Stiaan Louw... Except this time, we are writing a whole new chapter all together. Inspired by Olympic Games and athletic wear, it champions both our fighting spirit and protective instinct. A winning 'hand-in-hand' everyday combat!


text:
Arabian Gulf League
Percy Tau
Attacker : Brighton & Hove Albion FC / South Africa
DOB : 13/05/1994 (Witbank, South Africa)
Substitution on
Substitution off
Starting 11 11
Minutes played
Brighton & Hove Albion FC
14 4 1 1 0 2 7 12 1080
Total 17 4 1 1 0 4 8 13 1214
Total 1 0 0 0 0 0 0 1 90
FT 22:00
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After joint legislative efforts of scientific community and Government resulted in the adoption of Federal Law #180 "On biomedical cellular products (BMCP)" onset of first pre-clinical trials of cell therapies in Russia got into scope. Testing of BMCPs to assess their safety and obtain primary efficacy results is a cornerstone of development and translation to clinical trials. Thus, a task force consisting of Lomonosov Moscow State University, leading research groups and experts from both—regulatory and industrial entities have been established under a project funded by Russian Ministry of Science and Education. As far as Federal Law #180 is enforced starting January 1, 2017, completion of the project in December 2016 is a timely step to ensure the development of cell therapies and regenerative medicine in Russia. The present article gives an overview of the project in 2014–2016 and summarizes main results of the collaborative effort.
Modern biomedicine has reached a point when new revolutionary approaches based on the concept of regenerative medicine allow treatment of human disease not alleviated by existing drugs or surgical technique. Regenerative medicine employs the concept of the natural process of tissue/organ repair and renewal driven by specific cellular elements—namely stem and progenitor cells. Cultural approaches advanced rapidly and now allow to grow human cells in vitro, generate specific cell types using induced pluripotency protocol, create artificial organs/tissues, and to correct mutations in cells by genome editing (mediated by CRISPR/Cas9 system). Furthermore, in addition to systemic transplantation, there are multiple options to introduce therapeutic cells to patient's organism; these include combining cells with extracellular matrix, synthetic scaffolds or cell-derived secreted products to ensure engraftment and/or provide structural support where required (e.g., nerve repair, muscle defect filling or vascular repair).
However, unique properties of BCMP come along with major safety concerns including the risk of carcino-and tumorogenesis, ectopic tissue outgrowth, immunotoxic effects, and adverse reactions related to transplant rejection. Besides serious adverse reactions, limited knowledge of BMCP kinetics (survival and distribution) and pharmacology (including secondary and off-target effects) is another point that requires thorough analysis prior to first-in-human use. European and USA regulatory institutes have established a series of legal acts to control the field of cell therapy and increase its positive impact with reduction of potential harm [1, p. 2; 4, p. 2; 5, p. 2].
Until recent no specific "stem cell law" has existed in Russian Federation to regulate development, testing, manufacture, registration, and marketing of cell-based therapeutic products. Indeed, use of human cells (with exception of blood transfusion and organ transplantation) in the clinic has remained a "gray area" where successes of highly professional scientific groups were formally adjacent to procedures conducted by commercial clinics which offered cell-based therapy for various conditions. Lack of regulation led to use of poorly characterized cells without proper monitoring and control of results.
Federal Law #180 has been signed by the President of Russian Federation and will be enforced since January 1, 2017 to regulate all aspects of cell therapy in Russian Federation. This law regulates design, manufacture, quality and safety evaluation, transportation, clinical trial initiation and marketing of BMCP. These products consist or contain human cells and may contain modified human cells (not organs or human cells used for blood transfusion) obtained from human donors, which can be used for treatment by itself or in combination with other drugs or materials. Generally, BMCP is a new class of medicinal products covering the niche between drugs and transplanted organs/tissues. From one side BMCP has defined active components responsible for therapeutic efficiency, and, from the other side, they consist of cells which produce active components inside the body in a more physiological manner and interact with surrounding cells at the site of injection/introduction. The law defines major terms and limitations of BMCP production, handling, testing, and use.
Procedures for BCMP registration and authorization for clinical trials of BMCP is stipulated; expertise of pre-clinical data is stated as a crucial point for first-in-human use and aggregated data of data on ethical, quality control and efficacy data are required for marketing of BMCP.
A consortium, consisting of Lomonosov Moscow State University, Pirogov Russian National Research Medical University, Gertsen Moscow Research Oncology Institute, Almazov Federal Medical Research Center, Russian Cardiology Research and Production Complex, Shumakov Federal Centre of Transplantation and Artificial Organs, Central Institution of Tuberculosis and Scientific Centre for Expertise of Medical Products was formed to develop the project. As a starting point, besides in-house developments of each organization we used the international experience as a reference, and based on that tried to develop practical recommendations for design and pre-clinical evaluation of certain types of BMCP.
Thus, the new law defines BMCPs, and how they are to be generated, tested, and used. It sets ethical, commercial, and technical limitations of the BMCP testing, production, and practical use. But these are mostly common words related to legislative part of the problem. In reality, there are some fundamental problems concerning testing of BMCP's safety and mechanisms of action. First of all, by definition BMCPs are human cell lines, which have to be biologically tested prior to clinical trials. This is not so simple since in most animal models transferred human cells will be immunologically rejected. Another evident problem is that it is hard to use the pre-clinical data obtained, for example, in small rodents to calculate numbers of cells that have to be used in humans due to physiological reasons. And there are many more examples of challenges of pre-clinical testing of BMCPs. Therefore, a need in the development of experimental protocols and recommendations regarding pre-clinical testing of BMCP exists.
CellThera Pharm is a pioneer national project realized by the Russian pharmaceutical company "Pharmstandard" incorporated on September 2013 is a full-cycle regenerative medicine company. At the disposal of the company has an R&D department, animal facility and a modern manufacturing facility for development and production of advanced medicinal products based on cell technology.
The Cellthera's development strategy provides intensive development and consists both in the development of innovative products and the licensing of the best technologies that are currently present in the world.
The project's main goal was to develop a technological platform for pre-clinical evaluation of biomedical cell products. A consortium of 8 medical and scientific centers headed by Lomonosov Moscow State University accomplished this mission successfully in 2.5 years with regular reports to the Ministry. Overall, the project wraps up with a total of 8 patents pending, 5 papers in Scopus/WoS indexed journals and 6 conference proceedings to popularize and spread the results and current progress.
Member-organizations of the consortium used their scientific expertise and development experience conducting experiments required to elaborate parameters for BMCP evaluation of safety, efficacy, and distribution. Furthermore, a significant part of the project was devoted to the establishment of appropriate standards for BMCP manufacture and required quality control—these results were formulated as in-house manufacture regulations and standard operation procedures (SOPs).
BMCP from different cell types were evaluated: mesenchymal stem cells from adipose tissue and bone marrow (AD MSC and BM MSC, respectively), progenitors of cardiomyocytes (PC), and bio product based on platelet lysate (BPPL). Analysis of literature allowed the definition of criteria crucial for design, manufacturing, evaluation, in vitro and in vivo pre-clinical testing of each biomedical product. According to these criteria members of consortium thoroughly selected and tried various experimental protocols to determine the clinical efficiency of BMCP in animal models of human pathological conditions. Another set of experiments was used to evaluate stability, distribution in a body, and interaction of BMCP with surrounding tissue. The third line of tests was conducted to prove the biological safety of BMCP.
Laboratory protocols suitable for manufacturing of different BMCPs were generated. Different BMCPs were evaluated for efficiency in animal models. For example, BMCP based on AD MSC was tested in the model of myocardial infarction, and BMCP based on BM MSC—in the model of acute graft versus host disease caused by organ transplantation. AD MSC-mediated immune suppression was studied in the course of tuberculosis infection in mice. BMCPs derived from human MSC were studied for the ability to facilitate regeneration of joint cartilage, liver, and pancreas in rodents. BMCP from human PC passed tests for angio-, arteriogenesis, the effect on fibrosis, cardiomyocyte proliferation, inflammatory infiltration, and myocardium remodeling in a model of rat myocardium injury. BPPL influence on cultures of MSC and fibroblasts, as well as biosafety, was studied. Another BMCP designed for use on damaged skin and possessing dermatotropic properties were tested in mouse skin repair model.
Multiple biosafety tests and protocols were designed for abovementioned BMCP. As a result, now we have a collection of standard protocols and practical recommendation which will simplify life for those who will design, characterize, manufacture, and evaluate BMCP in Russia in the future.
The overall goal of the project was achieved by joint effort and draft of practical recommendations (Guidelines) for design and conduct of pre-clinical evaluation of BMCP in general and particular examples of BMCPs. These Guidelines contain scientifically reasoned non-binding recommendations for evaluation of BMCPs pharmacology, kinetics (terms used on basis of lack of a suitable alternative) and safety including toxicity and secondary pharmacology. Much attention was paid to evaluation using homologous animal cell cultures in appropriate animal models required for certain situations of BMCP evaluation, especially in immune-modulating therapies.
Moreover, Guidelines were drafted as a partially harmonized regulation with internationally adopted regulatory documents and experience of FDA-and EMA-approved cell therapeutic drugs was taken into account during development.
Another important objective achieved was the development of educational programs for physicians and specialists in pre-clinical evaluation of BMCPs drafted to ensure proper standards for professionals. These programs will be required after enforcement of Federal Law #180 to propagate and educate healthcare workers and researchers endeavoring stem cell therapies as their primary field of work.
Results of the project will be in demand by the Industrial partner and whole field of regenerative medicine ranging from developers and researchers to regulatory authorities and federal government. Developed guidelines after approval will be used by the researchers, government-based and contract organizations to plan pre-clinical testing of developed BMCPs and fully evaluate their safety and biological properties crucial for efficacy in clinical settings.
It should be noted that despite BMCPs are used for treatment and can be to a certain extent compared with commonly used chemical-based drugs it has a lot of differences from low-molecular weight or antibodies used as therapeutic agents. BMCPs carry living cells and thus cannot be sterilized and have minimal (hours long) shelf-life. Furthermore, immune response to cellular antigens may induce toxicity and transplant rejection, thus, additional requirements for donor compatibility or autologous approach are enforced.
Complex nature of BMCP implies that pre-clinical testing one hand has to be in general framework of safety assessment and on the other has to take into account specific indications, routes of delivery and specific features of cells use for BMCP manufacture [p. 7, ]. Thus, additional testing is to be applied to control kinetics (distribution and fate of delivered cells) and pharmacological effects. Adequate animal models are also an issue as far as some human-based BMCPs are immunogenic in other mammals and, thus, immunosuppressed or immunodeficient transgenic animal strains are to be used for testing [p. 7, 6].
Thus, to conclude, our project was a very timely attempt to establish a reasonable regulation of pre-clinical assessment for newly developed biomedical products relying on the potency of human cells as a "drug." We managed to create a methodology for the harvesting of donor cells, obtaining of cell cultures, maintenance, and storage of biomaterials, cytological and biochemical characterization of final products, biosafety and efficacy assessment. On this basis we stipulated another crucial point and drafted the general Guidelines that can be applied for BMCPs yet may require a certain extent of interaction with regulatory authorities to ensure certain clarity in ambiguous situations. Further challenges in the field are numerous ranging from marketing to clinical trial organizations and the scientific community is ready for further cooperation with federal government and industry to use its expertise for the sake of the progress of the biomedical field.
Research being carried out with the financial support of the state represented by the Ministry of Education and Science of the Russian Federation. Contract no. 14.610.21.0001 03 Oct. 2014. Unique project Identifier: RFMEFI61014X0001.