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An Orthodox Jewish woman takes the helm of Chicago Divinity School – Religion News Service

Posted: August 29, 2017 at 4:48 pm

(RNS) There is not a minute, an action, a choice, in Laurie Zoloths life she doesnt examine by a linein the Torah, Justice, justice, shall you pursue.

The new dean of the University of Chicago Divinity School a former nurse and union activist who became a nationally respected bioethicist and a professor in multiple fields is an Orthodox Jew. She observes the sacred space and time of Sabbath, declining work from sunset Friday to sunset Saturday, and keeping kosher, the ancient Jewish dietary laws.

For Zoloth, every word and deed, from academia to social action to raising chickens in her backyard, is seen through the prism of Deuteronomy 16:18-20.

I am a lifelong activist from the 60s, said Zoloth, 67. Her antenna always tuned to idealism, she dropped out of Swarthmore to become a licensed practical nurse to care for poor women, boycotted grapes with the United Farm Workers,rallied for civil rights, marched against the Vietnam War and cut sugar cane in Cuba in 1969 to oppose the U.S. trade embargo.

Her move in July to lead one of the nations most prestigious divinity schools comes at a historic moment in our national life, said Zoloth in an interview about how she came to this moment and her ideas for her deanship at thedivinity school.

The questions of religion are at the center of our national life. We see today questions of good and evil, how we ought to live and what we owe one another. Our job is to uncover the truth and ask questions: What does it mean to be a human being? What does it mean to be free? And what must we do about the suffering of others? The university exists to pursue this, she said.

Richard Doerflinger, left, representing the U.S. Conference of Catholic Bishops, and Laurie Zoloth, director of genetic medicine at Northwestern University, appear before the Senate Commerce Science, Technology and Space Subcommittee on Capitol Hill on Sept. 29, 2004, to discuss embryonic stem cell research. (AP Photo/Dennis Cook)

These were the same kind of questions that prompted Zoloth to return to academia in the 1970s, earning bachelors degrees in womens studies and nursing, masters degrees in Jewish studies and in English, and a doctorate in social ethics.

Her academic and social passions converged just as the field of bioethics was developing, with patients and doctors addressing questions about withholding or withdrawing treatment, the right to informed consent in medical research and more. Zoloth joined the ethics committee at Kaiser Permanente in California by convincing the health care organization:You need women. You need Jews. You need nurses. Hire me.

After leading the Jewish studies program at San Francisco State University, she moved on to Northwestern University in Evanston, Ill., where she had dual appointments in the department of religious studies in the Weinberg College of Arts and Sciences and in the Feinberg School of Medicine and led the Faculty Senate.

Along the way, Zoloth served as president of American Society for Bioethics and Humanities and also of the American Academy of Religion.

At AARs 2014 annual meeting, Zoloth said: As scholars and as citizens we must do the work of giving people a full and accurate understanding of our society. We must engage. We must speak out. If we are neutral in a situation of injustice, we have chosen the side of the oppressor.

The Rev. Martin Marty, an emeritus professor at the UC Divinity School, historian of religion and former associate dean, said Zoloths views are exactly the kind of approach that probably made her attractive to the faculty.

Indeed, the news release announcing her appointment pinpointed her work on evolving issues of science and society.

Its not unusual to have Jewish faculty at university-based divinity schools and at independent denominational seminaries. Amy Jill Levine, now a University Scholar at Vanderbilt, describes herself as a Yankee Jewish feminist who teaches in a predominantly Christian divinity school in the buckle of the Bible Belt.

However, Frank Yamada, executive director of the Association of Theological Schools, said hes not aware of someone Jewish as dean of a university divinity school and Zoloth is now leading one of the most prestigious in the country.

Zoloth recalled when the divinity school search committee approached her. I wasnt looking to move but when the University of Chicago calls, you dont say, No.

It is an extraordinarily exciting place, deeply intellectual and full of robust and deep conversations on issues that matter. The great questions that religion raises can be researched and taught and brought to life here, said Zoloth.

Those questions, however, will not be addressed in an academic bubble. Zoloths plan: Wake up every weekday morning for her daily 4-mile run and go to work prompting scholars to be seekers of truth, terrific teachers and great researchers but also to be courageous.

Every gesture is a moral gesture, she said. There is no nowhere. There is no place that you cannot participate.

Not even your backyard.

Consider Zoloths chickens. She first began raising fowl for eggs and composting the waste in her organic garden decades ago in Berkeley when her five children were young.

There will be no chicken coops for her with her move to Hyde Park, home of the University of Chicago. Shes given up coops for a co-op shell share with her youngest child since her husband, Rabbi Dan Dorfman, died last year.

The chickens are being given to friends in Evanston, where Zoloth participated in a 2009 battle to overturn a ban on backyard chickens in the upscale Chicago suburb.

Zoloth told the campus paper at the time that the ban had been aimed at poor immigrants and that it was particularly foolish during a recession when sustainable living becomes not just thinking about carbon footprints. It is also rethinking what your choices are. Rethinking every choice leads you right to what you plant in your front yard or what you eat.

So the chicken cause is a bird of a feather with Zoloths lifelong focus.

Justice, justice, shall you pursue, she said. Its my favorite verse.

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An Orthodox Jewish woman takes the helm of Chicago Divinity School - Religion News Service

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Viewpoint: Can yoga ‘reprogram’ our DNA? Don’t bet on it – Genetic Literacy Project

Posted: August 29, 2017 at 4:48 pm

David Gorski | August 29, 2017

One of the most persistent narratives latched on to by advocates of integrative medicine is that the mind can somehow heal the body. Sometimes, the claim is that such interventionswork through powerful placebo effects. Sometimes it involves the abuse of emerging science, such overblown claims about what can be accomplishedthrough epigeneticmodificationsof DNA and gene expression.

Mind-body therapies, such as mindfulness-based therapies, are very attractive because they are low cost, dont involve pharmaceuticals, and, above all, provide a sense of control to the patient. Indeed, as ever more rigorous clinical trials find that most of the unconventional therapies (i.e., quackery) that integrative medicine integrates with conventional medicine are elaborate placebos, proponents of integrative medicine increasingly fall back to pointing to modalities like yoga, tai chi, and the like and mindfulness.

[Placebo effects can be] misrepresented as the power of the mind over the body. You can see how mindfulness and other mind-body interactions are just as attractive, because many of them involves actual thinking and meditating. Unfortunately, the science does not (as yet) support many of the overblown claims made for these practices. Its not clear whether it ever will. Certainly its unlikely that they reprogram our DNA.

The GLP aggregated and excerpted this blog/article to reflect the diversity of news, opinion, and analysis. Read full, original post:Yawn. Another study tries to convince us that mind-body interventions can reprogram our DNA. It fails.

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Blood Donations Needed Pre and Post Labor Day Holiday – East … – TAPinto.net

Posted: August 29, 2017 at 4:47 pm

NEW JERSEY - New Jersey Blood Services (NJBS), a division of New York Blood Center (NYBC), is urging the public to donate blood as we head into the Labor Day holiday. New Jersey roads are packed with cars heading to the beach and the mountains. With so many people on vacation, blood donations drop significantly the last week of August into the first ten days of September as parents and students prepare for the start of the school year.

The need for blood never takes a holiday. Blood donations are urgently needed this time of year. Not only do we see fewer blood donations, but fewer blood drives are scheduled during this two week period. Patients in local hospitals still need blood for emergencies and regular treatments, however.

NYBC announced a blood emergency in late June which lasted much of the summer. Raising awareness for this critical Labor Day holiday period will help boost blood donations and rebuild the inventory.

Sign Up for E-News

O negative blood donors are considered universal, and their blood type is needed most readily in trauma situations and emergency departments across the country. Due to its high demand, O negative blood is in short supply and NYBC encourages individuals with this blood type to donate today. Our local blood supply has reached a critically low level, with under a two-day supply of O negative, B negative, and A negative.

To donate blood or for information on how to organize a blood drivePlease call Toll Free: 1-800-933-2566Visit: http://www.nybloodcenter.org/blood

In order to maintain a safe blood supply a seven-day inventory of all types must be continually replenished. Companies, organizations, and community groups are also encouraged to step up to host a blood drive in September to help rebuild the blood supply. Hosting a blood drive is easy and NYBCs staff will help every step of the way.

More About Blood Donations

The entire donation process takes less than an hour and a single donation can be used to save multiple lives. Donors with O-negative blood type, or universal donors, are especially encouraged to donate, as their blood can be used in emergencies. Nearly 2,000 donations are needed each day in New York and New Jersey alone. About one in seven hospital admissions requires a blood transfusion, and with a limited shelf life, supplies must be continually replenished.

If you cannot donate but still wish to participate in bringing crucial blood products to patients in need, please consider hosting a blood drive or volunteering at a local blood drive.

Any company, community organization, place of worship, or individual may host a blood drive. Blood donors receive free mini-medical exams on site including information about their temperature, blood pressure and hematocrit level. Eligible donors include those people at least age 16 (parental consent is required for 16-year-olds), who weigh a minimum of 110 pounds, are in good health and meet all Food & Drug Administration and NY or NJ State Department of Health donor criteria. People age 76 or older may donate if they have a doctors note on file with New York Blood Center or if they bring one on the day of the blood drive.

About New York Blood Center

Now more than 50 years old, New York Blood Center (NYBC) is a nonprofit organization that is one of the largest independent, community-based blood centers in the country. NYBCs mission is to serve the 20 million people in the New York metropolitan area and more broadly, our nation and our world by alleviating human suffering and preserving human life using our medical expertise.

Each year, NYBC provides approximately one million blood products to nearly 200 hospitals in the Northeast. NYBC also provides a wide array of transfusion-related medical services. NYBC is also home to the worlds largest public cord blood bank, which provides stem cells for transplant in many countries, and a renowned research institute, which among other milestones developed the hepatitis B vaccine and innovative blood purification technology.

Website: nybc.org

Facebook: http://www.facebook.com/newyorkbloodcenter

Twitter: @NYBloodCenter

Instagram: @newyorkbloodcenter

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Lab-made "mini organs" helping doctors treat cystic fibrosis – New Jersey Herald

Posted: August 29, 2017 at 4:47 pm

Posted: Aug. 23, 2017 8:00 am Updated: Aug. 23, 2017 12:30 pm

UTRECHT, Netherlands (AP) Els van der Heijden, who has cystic fibrosis, was finding it ever harder to breathe as her lungs filled with thick, sticky mucus. Despite taking more than a dozen pills and inhalers a day, the 53-year-old had to stop working and scale back doing the thing she loved best, horseback riding.

Doctors saw no sense in trying an expensive new drug because it hasn't been proven to work in people with the rare type of cystic fibrosis that van der Heijden had.

Instead, they scraped a few cells from van der Heijden and used them to grow a mini version of her large intestine in a petri dish. When van der Heijden's "mini gut" responded to treatment, doctors knew it would help her too.

"I really felt, physically, like a different person," van der Heijden said after taking a drug and getting back in the saddle.

This experiment to help people with rare forms of cystic fibrosis in the Netherlands aims to grow mini intestines for every Dutch patient with the disease to figure out, in part, what treatment might work for them. It's an early application of a technique now being worked on in labs all over the world, as researchers learn to grow organs outside of the body for treatment and maybe someday for transplants.

So far, doctors have grown mini guts just the size of a pencil point for 450 of the Netherlands' roughly 1,500 cystic fibrosis patients.

"The mini guts are small, but they are complete," said Dr. Hans Clevers of the Hubrecht Institute, who pioneered the technique. Except for muscles and blood vessels, the tiny organs "have everything you would expect to see in a real gut, only on a really small scale."

These so-called organoids mimic features of full-size organs, but don't function the same way. Although many of the tiny replicas are closer to undeveloped organs found in an embryo than adult ones, they are helping scientists unravel how organs mature and providing clues on how certain diseases might be treated.

In Australia, mini kidneys are being grown that could be used to test drugs. Researchers in the U.S. are experimenting with tiny bits of livers that might be used to boost failing organs. At Cambridge University in England, scientists have created hundreds of mini brains to study how neurons form and better understand disorders like autism. During the height of the Zika epidemic last year, mini brains were used to show the virus causes malformed brains in babies.

In the Netherlands, the mini guts are used as a stand-in for cystic fibrosis patients to see if those with rare mutations might benefit from a number of pricey drugs, including Orkambi. Made by Vertex Pharmaceuticals, Orkambi costs about 100,000 euros per patient every year in some parts of Europe, and it's more than double that in the U.S., which approved the drug in 2015. Despite being initially rejected by the Dutch government for being too expensive, negotiations with Vertex were reopened in July.

Making a single mini gut and testing whether the patient would benefit from certain drugs costs a couple of thousand euros. The program is paid for by groups including health insurance companies, patient foundations and the government. The idea is to find a possible treatment for patients, and avoid putting them on expensive drugs that wouldn't work for them.

About 50 to 60 patients across the Netherlands have been treated after drugs were tested on organoids using their cells, said Dr. Kors van der Ent, a cystic fibrosis specialist at the Wilhelmina Children's Hospital, who leads the research.

Clevers made a discovery about a decade ago that got researchers on their way. They found pockets of stem cells, which can turn into many types of other cells, in the gut. They then homed in a growing environment in the lab that spurred these cells to reproduce rapidly and develop.

"To our surprise, the stem cells started building a mini version of the gut," Clevers recalled.

Cystic fibrosis is caused by mutations in a single gene that produces a protein called CFTR, responsible for balancing the salt content of cells lining the lungs and other organs.

To see if certain drugs might help cystic fibrosis patients, the medicines are given to their custom-made organoids in the lab. If the mini organs puff up, it's a sign the cells are now correctly balancing salt and water. That means the drugs are working, and could help the patient from whom the mini gut was made.

Researchers are also using the mini guts to try another approach they hope will someday work in people using a gene editing technique to repair the faulty cystic fibrosis gene in the organoid cells.

Other experiments are underway in the Netherlands and the U.S. to test whether organoids might help pinpoint treatments for cancers involving lungs, ovaries and pancreas.

While the idea sounds promising, some scientists said there are obstacles to using mini organs to study cancer.

Growing a mini cancer tumor, for example, would be far more challenging because scientists have found it difficult to make tumors in the lab that behave like in real life, said Mathew Garnett of the Wellcome Trust Sanger Institute, who has studied cancer in mini organs but is not connected to Clevers' research.

Also, growing the cells and testing them must happen faster for cancer patients who might not have much time to live, he said.

Meanwhile, Clevers wants to one day make organs that are not so mini.

"My dream would be to be able to custom-make organs," he said, imagining a future where doctors might have a "freezer full of livers" to choose from when sick patients arrive.

Others said while such a vision is theoretically possible, huge hurdles remain.

"There are still enormous challenges in tissue engineering with regards to the size of the structure we're able to grow," said Jim Wells, a pediatrics professor at the Cincinnati Children's Hospital Medical Center. He said the mini organs are far smaller than what would be needed to transplant into people and it's unclear if scientists can make a working, life-sized organ in the lab.

There are other limitations to growing miniature organs in a dish, said Madeline Lancaster at Cambridge University.

"We can study physical changes and try to generate drugs that could prevent detrimental effects of disease, but we can't look at the complex interplay between organs and the body," she said.

For patients like van der Heijden, who was diagnosed with cystic fibrosis as a toddler, the research has helped her regain her strength. Vertex agreed to supply her with the drug.

"It was like somebody opened the curtains and said, 'Sunshine, here I am, please come out and play.'" she said. "It's strange to think this is all linked to some of my cells in a lab."

___

This Associated Press series was produced in partnership with the Howard Hughes Medical Institute's Department of Science Education. The AP is solely responsible for all content.

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Blood Donations Needed During Labor Day Holiday Season – TAPinto – TAPinto.net

Posted: August 29, 2017 at 4:47 pm

New Jersey Blood Services (NJBS), a division of New York Blood Center (NYBC), is urging the public to donate blood as we head into the Labor Day holiday. New Jersey roads are packed with cars heading to the beach and the mountains. With so many people on vacation, blood donations drop significantly the last week of August into the first ten days of September as parents and students prepare for the start of the school year.

The need for blood never takes a holiday. Blood donations are urgently needed this time of year. Not only do we see fewer blood donations, but fewer blood drives are scheduled during this two week period. Patients in local hospitals still need blood for emergencies and regular treatments, however.

NYBC announced a blood emergency in late June which lasted much of the summer. Raising awareness for this critical Labor Day holiday period will help boost blood donations and rebuild the inventory.

Sign Up for E-News

O negative blood donors are considered universal, and their blood type is needed most readily in trauma situations and emergency departments across the country. Due to its high demand, O negative blood is in short supply and NYBC encourages individuals with this blood type to donate today. Our local blood supply has reached a critically low level, with under a two-day supply of O negative, B negative, and A negative.

To donate blood or for information on how to organize a blood drivePlease call Toll Free: 1-800-933-2566Visit: http://www.nybloodcenter.org/blood

In order to maintain a safe blood supply a seven-day inventory of all types must be continually replenished. Companies, organizations, and community groups are also encouraged to step up to host a blood drive in September to help rebuild the blood supply. Hosting a blood drive is easy and NYBCs staff will help every step of the way.

More About Blood Donations

The entire donation process takes less than an hour and a single donation can be used to save multiple lives. Donors with O-negative blood type, or universal donors, are especially encouraged to donate, as their blood can be used in emergencies. Nearly 2,000 donations are needed each day in New York and New Jersey alone. About one in seven hospital admissions requires a blood transfusion, and with a limited shelf life, supplies must be continually replenished.

If you cannot donate but still wish to participate in bringing crucial blood products to patients in need, please consider hosting a blood drive or volunteering at a local blood drive.

Any company, community organization, place of worship, or individual may host a blood drive. Blood donors receive free mini-medical exams on site including information about their temperature, blood pressure and hematocrit level. Eligible donors include those people at least age 16 (parental consent is required for 16-year-olds), who weigh a minimum of 110 pounds, are in good health and meet all Food & Drug Administration and NY or NJ State Department of Health donor criteria. People age 76 or older may donate if they have a doctors note on file with New York Blood Center or if they bring one on the day of the blood drive.

About New York Blood Center

Now more than 50 years old, New York Blood Center (NYBC) is a nonprofit organization that is one of the largest independent, community-based blood centers in the country. NYBCs mission is to serve the 20 million people in the New York metropolitan area and more broadly, our nation and our world by alleviating human suffering and preserving human life using our medical expertise.

Each year, NYBC provides approximately one million blood products to nearly 200 hospitals in the Northeast. NYBC also provides a wide array of transfusion-related medical services. NYBC is also home to the worlds largest public cord blood bank, which provides stem cells for transplant in many countries, and a renowned research institute, which among other milestones developed the hepatitis B vaccine and innovative blood purification technology.

Website: nybc.org

Facebook: http://www.facebook.com/newyorkbloodcenter

Twitter: @NYBloodCenter

Instagram: @newyorkbloodcenter

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Blood Donations Needed During Labor Day Holiday Season – TAPinto.net

Posted: August 29, 2017 at 4:47 pm

New Jersey Blood Services (NJBS), a division of New York Blood Center (NYBC), is urging the public to donate blood as we head into the Labor Day holiday. New Jersey roads are packed with cars heading to the beach and the mountains. With so many people on vacation, blood donations drop significantly the last week of August into the first ten days of September as parents and students prepare for the start of the school year.

The need for blood never takes a holiday. Blood donations are urgently needed this time of year. Not only do we see fewer blood donations, but fewer blood drives are scheduled during this two week period. Patients in local hospitals still need blood for emergencies and regular treatments, however.

NYBC announced a blood emergency in late June which lasted much of the summer. Raising awareness for this critical Labor Day holiday period will help boost blood donations and rebuild the inventory.

Sign Up for E-News

O negative blood donors are considered universal, and their blood type is needed most readily in trauma situations and emergency departments across the country. Due to its high demand, O negative blood is in short supply and NYBC encourages individuals with this blood type to donate today. Our local blood supply has reached a critically low level, with under a two-day supply of O negative, B negative, and A negative.

To donate blood or for information on how to organize a blood drivePlease call Toll Free: 1-800-933-2566Visit: http://www.nybloodcenter.org/blood

In order to maintain a safe blood supply a seven-day inventory of all types must be continually replenished. Companies, organizations, and community groups are also encouraged to step up to host a blood drive in September to help rebuild the blood supply. Hosting a blood drive is easy and NYBCs staff will help every step of the way.

More About Blood Donations

The entire donation process takes less than an hour and a single donation can be used to save multiple lives. Donors with O-negative blood type, or universal donors, are especially encouraged to donate, as their blood can be used in emergencies. Nearly 2,000 donations are needed each day in New York and New Jersey alone. About one in seven hospital admissions requires a blood transfusion, and with a limited shelf life, supplies must be continually replenished.

If you cannot donate but still wish to participate in bringing crucial blood products to patients in need, please consider hosting a blood drive or volunteering at a local blood drive.

Any company, community organization, place of worship, or individual may host a blood drive. Blood donors receive free mini-medical exams on site including information about their temperature, blood pressure and hematocrit level. Eligible donors include those people at least age 16 (parental consent is required for 16-year-olds), who weigh a minimum of 110 pounds, are in good health and meet all Food & Drug Administration and NY or NJ State Department of Health donor criteria. People age 76 or older may donate if they have a doctors note on file with New York Blood Center or if they bring one on the day of the blood drive.

About New York Blood Center

Now more than 50 years old, New York Blood Center (NYBC) is a nonprofit organization that is one of the largest independent, community-based blood centers in the country. NYBCs mission is to serve the 20 million people in the New York metropolitan area and more broadly, our nation and our world by alleviating human suffering and preserving human life using our medical expertise.

Each year, NYBC provides approximately one million blood products to nearly 200 hospitals in the Northeast. NYBC also provides a wide array of transfusion-related medical services. NYBC is also home to the worlds largest public cord blood bank, which provides stem cells for transplant in many countries, and a renowned research institute, which among other milestones developed the hepatitis B vaccine and innovative blood purification technology.

Website: nybc.org

Facebook: http://www.facebook.com/newyorkbloodcenter

Twitter: @NYBloodCenter

Instagram: @newyorkbloodcenter

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Taconic, Silverstein to build 150000 s/f life science research center – Real Estate Weekly

Posted: August 29, 2017 at 4:47 pm

Taconic Investment Partners and Silverstein Properties announced development plans for the building at 619 West 54th Street, to be named the Hudson Research Center, which includes the creation of over 150,000 s/f of life science wet lab research space.

619 West 54th Street, the home of the New York Stem Cell Foundations recently developed 40,000 s/f research institute and headquarters, features the infrastructure necessary to support life science and medical tenants including 33,000 s/f floorplates, robust electrical capacity, emergency generators, high floor loads, and high ceilings.

In addition, Taconic and Silverstein have plans to invest up to $20 million to further enhance base building infrastructure in order to deliver lab-ready space to research tenants.

New York City has all of the assets to become a major life science hub including world-class medical research institutions, a depth of research talent, presence of big pharmaceutical companies and venture capital, and with recent life science initiatives launched from both New York City and New York State, we feel New York is poised to join cities like Boston and the San Francisco Bay Area as the next big research cluster, said Matthew Weir, vice president of Taconic.

We are offering lab-ready space to a severely supply-constrained market and when combined with the New York Stem Cell Foundation facility in the building, we have the beginnings of a dynamic new life science hub.

The Hudson Research Center contains a total of 330,000 s/f spread over 10 stories and features natural light from multiple exposures and unobstructed views of the Hudson River and the Midtown Manhattan skyline.

Located across from DeWitt Clinton Park, the buildings amenities include onsite gated parking, and a new bike storage and shower facility.

The New York Stem Cell Foundation (NYSCF) opened its Research Institute in April. The facility is one of the largest laboratories in the world devoted to stem cell research.

The glass-enclosed wet lab includes the most advanced technology available for the manufacturing and study of stem cells. The facility includes molecular biology, imaging, and cell sorting and will have a highly-specialized GMP facility.

We are delighted to partner with Taconic to reposition this historic building, said Marty Burger, Chief Executive Officer of Silverstein Properties. Life sciences are a priority for the Governor and the Mayor and research tenants now have the perfect home on the west side of Manhattan.

The landlord has retained Transwestern Consulting Group (TCG) as the exclusive leasing agent for the building. New York City has emerged as a cluster location for the life science industry, said Steve Purpura, TCGs Northeast Market Leader. Hudson Research Centers location is going to be an attractive alternative for the many growing biotech companies looking to tap into the large life science labor pools in New Jersey and Long Island.

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FDA cracks down on stem cell clinics – CNN

Posted: August 29, 2017 at 4:45 pm

California Stem Cell Treatment Centers has not responded to requests for comment.

StemImmune is "fully cooperating with the FDA about the development of its stem cell-based investigational cancer therapy," Ulrike Szalay, a spokeswoman for the company, wrote in an email. "We look forward to continuing our dialogue with the FDA."

"It is inappropriate and harmful to state that our clinic is not sterile as we are completely compliant with the regulations for surgical procedures," she wrote. "The strict regulations mentioned in the warning letter required to manufacture drugs are not applied to clinics or hospitals."

Comella wrote that the surgical procedure used by the clinic is "not subject to the rules for tissue banks which include minimal manipulation and homologous use" as described in current federal regulations. She concluded, "our clinic is not violating the law as it is currently written."

The International Society for Stem Cell Research commended the FDA for its policy direction and enforcement efforts. President Hans Clevers said the society has been "very concerned" about reports of patients using unproven stem cell therapies.

"Many of these patients have suffered great harm, and even death as a result of using unproven stem cell therapies," Clevers said in a statement. "We are hopeful that increased regulatory enforcement against clinics offering unproven treatments will deter this practice and help protect patients."

"I've directed the FDA to launch a new working group to pursue unscrupulous clinics through whatever legally enforceable means are necessary to protect the public health," Gottlieb wrote. "We have examples where some of these unproven treatments have clearly harmed patients."

"I wish it hadn't taken this long," said Leigh Turner, associate professor at the Center for Bioethics at the University of Minnesota. "This is a space where the FDA could have taken action four or five years ago as far as making this a policy priority."

Turner said he sees the steps announced Monday as both important and necessary, yet he remains skeptical.

"There are important distinctions to be made, and the FDA seems to be making these distinctions in terms of suggesting that they are putting together this working group, a task force, going after businesses marketing unproven interventions, going after businesses making illegitimate or unwarranted claims about stem cell treatment," he said.

What will trigger regulation?

Gottlieb wrote in his statement "it's incumbent upon the FDA" to make sure the existing legal and regulatory framework is properly defined, with "bright lines" separating individualized or tailored therapies surgeons are permitted to use from new treatments subject to regulation. Because the field of regenerative medicine is rapidly evolving, he said, close calls may be frequent between what constitutes an individualized treatment and what constitutes an unapproved, possibly harmful medical product.

Turner said Gottlieb's statement allowed for "a bit of slippage as far as what exactly the FDA is going to do and which businesses they are going to target."

Questions remain as to whether the warning letter is a sign of more letters to come and whether we will see "a dramatic increase" in such activities from the FDA, Turner said.

FDA spokeswoman Lyndsay Meyer wrote in an email that the agency "will seek to take additional actions in the coming months as we address this field, and target those who are clearly stepping over the line."

Yet, Turner asked, what is enough to trigger FDA regulation? Are marketing campaigns and commercial activity enough?

"Or do we actually require people being blinded before the FDA does something?" he asked, noting that "there's a considerable amount of uncertainty in terms of what we should expect in the months ahead. The statement itself doesn't provide clear answers to all those questions."

Susan L. Solomon, CEO of the New York Stem Cell Foundation, a nonprofit research organization, said via a spokesman that "the regulation of these clinics is very difficult, so the announcement today that the FDA will be stepping up their oversight should be welcomed and applauded."

Overall, Turner said, the agency's actions should not give all stem cell treatments or doctors performing these regenerative therapies a bad name. There are already effective treatments. "If we think about bone transplants as stem cell transplants, it's standard of care for certain diseases," he said.

Solomon agreed: "There are extremely promising studies and research using stem cells to treat macular degeneration, multiple sclerosis, diabetes and many other devastating diseases. I cannot emphasize enough how exciting and promising the research is.

"However, anyone advertising a 'cure' today is simply taking advantage of patients for their own financial gain," she said.

What patients need to know

Turner acknowledges the difficulty for patients, who may not easily recognize which stem cell therapies are approved and beneficial and which are not.

"If you see a business that's making all sorts of dramatic marketing claims across disease categories, claiming to use fat as a treatment for all sorts of indications, these are all signs to be wary of," he said.

Turner acknowledged stem cell treatments as "a very promising area of research," and over time, he expects to see more FDA-approved therapies in the marketplace. The problem, he said, is that many American businesses making claims about stem cell treatments lack proper scientific safety and efficacy data.

"Why, for example, didn't California Stem Cell Treatment Centers get a warning letter for all the other treatments they are doing? It leaves me a bit perplexed," he said. "Why is the FDA so focused on these vials and not on the broader array of marketing claims that California Stem Cells was making?"

Solomon said that "by providing unproven treatments to chronically ill or injured patients," these clinics are not only taking advantage of patients, they are "muddying the scientific waters of clinical trials that are trying to show whether a treatment does or does not work."

In its statements Monday, the FDA notes the "handful of bad actors" in the stem cell space, Turner observed. (Meyer repeated the FDA's assertion that it's only "a small number of unscrupulous actors who have seized on the clinical promise of regenerative medicine.")

Ultimately, Turner is glad for the FDA's actions.

"I hope this is a sign that the FDA is going to do a lot more and better regulate this market space so we'll see whether or not that happens," he said. "It's easy to make these bold announcements. The question is going to be whether anything really comes of it."

Correction: Previous versions of this story included quotes attributed to David McKeon, a spokesman for the New York Stem Cell Foundation; they should have been attributed to foundation CEO Susan L. Solomon.

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FDA to crack down on ‘unscrupulous’ stem cell clinics – Minneapolis Star Tribune

Posted: August 29, 2017 at 4:45 pm

The U.S. Food and Drug Administration on Monday promised a nationwide crackdown on unscrupulous stem cell clinics, following years of reports that some clinics have offered lofty claims of potential medical benefits with scant, if any, medical evidence.

These dishonest actors exploit the sincere reports of the significant clinical potential of properly developed products, as a way of deceiving patients and preying on the optimism of patients facing bad illnesses. This puts the entire field at risk, wrote FDA Commissioner Dr. Scott Gottlieb, who was appointed in May. Products that are reliably and carefully developed will be harder to advance if bad actors are able to make hollow claims and market unsafe science.

Gottliebs statement, published Monday on the FDAs website, highlighted a warning letter issued to one Florida stem cell clinic on Thursday and the direct seizure of products from another clinic in California on Friday. Gottlieb said the agency is aware of other cases where unproven stem cell treatments have clearly harmed patients, and he promised additional enforcement actions in the coming months.

At the same time, the FDA is planning to unveil new regulatory policy based on medical science and provisions in the 21st Century Cures Act that will allow legitimate research and treatments to be on the right side of the bright lines that the FDA is going to draw in the field. Legitimate researchers, including those at smaller companies, will be able to use a new process that is relatively quick and cheap by normal clinical research standards.

We must put in place the framework to separate the promising treatments from those products that pose significant risks or offer patients little to no chance of benefit, Gottlieb wrote.

Stem cells are the undifferentiated versions of human cells that have the potential to multiply rapidly and grow into other kinds of cells such as bone, blood and organ tissue. Though stem cell transplants are routinely used in hospitals to replace diseased bone marrow, several smaller clinics have cropped up in recent years offering stem cell injections derived from sources such as body fat to treat myriad health problems, from erectile dysfunction to blindness to cancer.

Critics including University of Minnesota bioethicist Leigh Turner have accused some smaller clinics of taking advantage of patients desperation to find new treatments for devastating diseases by charging high rates for unproven therapies.

Turner said some even resort to advertising questionable pay-to-participate research trials on a website run by the National Institutes of Health, even though the treatments carry significant risk and may have minimal oversight. He said he was cautiously optimistic about the FDAs announcements on Monday, but he wondered why it had taken so long.

Theres been about a five-year period where these companies have been making a wide array of claims about stem cell treatments, and doing it on their business websites, in news releases, YouTube videos, Twitter. ..., Turner said. So Im a little perplexed as to why its taken to this point in 2017 for the FDA to act. But I do think its important and it will be interesting to see if there is real enforcement activity.

Gottliebs post said that there are only a small number of unethical clinics today and that the new rules will ensure that the vast majority of responsible researchers understand the regulations governing the emerging field of regenerative medicine.

Its not clear to everyone that the FDA has jurisdiction over the whole field.

For example, some stem cell treatments involve cells taken from donors, while others use autologous cells taken from the patients own body. The FDA said it has jurisdiction over autologous stem cells when they are exposed to more than a minimal level of manipulation outside the body, because that process transforms the cells into a type of biologic drug.

Dr. Ronald Hanson, founder and chief medical officer of OrthoCure Regenerative Orthopedics clinic in Richfield, said some doctors and patients question why the FDA would have oversight over any process in which patients own cells are re-injected into their bodies. The FDA regulates medical products, but it does not control physicians practice of medicine.

From the physicians who have practiced for a long period of time, it seems fairly heavy-handed to call somebodys cells drugs, Hanson said. I have to tell you, 100 percent of the patients who I have told that to cringe that their government would classify their cells as drugs.

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Americans OK with Genetic Modification for Health Care, but Not … – Hoosier Ag Today

Posted: August 29, 2017 at 4:45 pm

More than three-quarters of Americans would accept release of genetically modified mosquitoes to decrease risk of the Zika virus, but fewer than half accept genetic modification (GM) of animals, grain crops and produce, according to a Purdue University study.

Nicole Olynk Widmar, associate professor of agricultural economics, and Wally Tyner, the James and Lois Ackerman Professor of Agricultural Economics, led the study to understand attitudes toward genetic engineering in the wake of last years heightened coverage of the Zika virus. The results suggest people are far more accepting of genetic modifications that benefit human health but are still somewhat wary of modifications to food. Whenever you have a newly perceived health risk, there are calls for technology to solve the problem. If you think about the Ebola virus, everybody said, Wheres an Ebola vaccine? They wanted technology to mitigate the risk, Widmar said. Food is an everyday choice. In some ways, I can understand why people may be more cautious about what theyre ingesting on an ongoing basis.Data also show that acceptance of genetic modification may be related to sex, education, income and awareness of GM technology.

Zika, a virus spread primarily through mosquito bites, can cause severe birth defects including microcephaly and fetal brain defects. The virus was especially prevalent in Brazil during the 2016 Summer Olympics in Rio de Janeiro, and mosquito carriers have been reported in parts of Florida and Texas. Mechanisms developed to control virus include the release of genetically modified mosquitoes that will breed with females to produce eggs that wont hatch or offspring that die before reaching sexual maturity. Widmar and Tyner wanted to assess public opinion of the technologies and understand what drives acceptance of some genetic modifications but not others.

Findings are based on 964 Americans surveyed with a goal of selecting respondents that matched 2014 census estimates for age, gender, income, education, and region of residence. The margin of error was about 3 percent, and results were published in the journal PLoS One.

The survey revealed that 78 percent would support release of genetically modified mosquitoes in the United States. Acceptance of genetic modification is 44 percent for livestock production; 49 percent for grain production; 48 percent for fruit and vegetable production; 62 percent for human medicine; and 68 percent for human health.

Males were more likely to accept genetic modification across all categories. Younger respondents also accepted at higher rates in everything except for human health reasons, in which there was no significant difference amongst age groups.

Higher income groups were more likely to agree with genetic modification for grain, fruit and vegetables, and livestock production than lower income groups. Those with college degrees were more accepting of genetic modification.

Finally, the findings show that those aware of genetically modified mosquito technology were more likely to be accepting of genetic modification in all areas assessed.Widmar said she expected respondents to be more accepting of genetic modification for health and medicine, and she suspects it may have to do with how those technologies have been released. In the case of mosquitoes, Zika was all over the news, as was coverage of companies seeking regulatory permission to release their modified insects for trials. Americans were likely less informed about the release of genetically modified crops and found out about them after they were already a significant part of the food chain.

The perception of choice matters, Widmar said. If you need it to stay healthy, you would probably use it. But if you feel like you were given GMOs and told about it later, that might upset you.

Tyner said there may be a lesson in the data for those who want to develop future GMO technologies. While GMO crops have often been lauded for reducing inputs and lowering costs for growers, people may be more receptive to information about how those same crops allow use of less toxic pesticides. If we can highlight health and environmental benefits, rather than just focusing on the bottom line that might have a positive effect on the public attitude toward GMOs, Tyner said. If you look back, things might have gone differently if we had the first releases in the medical field rather than the food field.

Widmar and Tyner plan to continue work related to the impacts of GMOs on society. Widmar continues to assess consumer acceptance, and demand for, various technologies impacting the human condition through food production and health care.

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