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A New Standard in Health Care – Farrer Park Hospital, Singapore’s First Fully Integrated Healthcare/Hospitality Complex

Author: Gail S. Thornton, M.A.

Co-Editor: The VOICES of Patients, HealthCare Providers, Caregivers and Families: Personal Experience with Critical Care and Invasive Medical Procedures

Farrer Park Hospital, Singapore’s newest private healthcare service provider, headed by newly appointed Chief Executive Officer Timothy Low, M.D., is a private, acute tertiary institution that represents an innovation in hospital administration, incorporating the latest technology to support better decision making for better patient outcomes and shorter hospital stays along with the beauty of nature and art to enhance the patient experience. The hospital, opened in March 2016, is sited within Singapore’s first, fully integrated healthcare and hospitality complex, called Connexion, which is Asia’s first, integrated lifestyle hub for healthcare and wellness. Connexion houses the 220-bed Farrer Park Hospital with its more than 300-accredited specialists and 18 operating rooms, a 10-floor specialist Medical Center, along with a five-star hotel and spa. In 2016, Farrer Park Hospital was awarded best new hospital of the year in Asia Pacific by Global Health and Travel Awards.

Farrer Park Hospital at Connexion at night

Image SOURCE: Photograph courtesy of Farrer Park Hospital, Singapore. An integrated healthcare and hospitality complex, called Connexion, Asia’s first, integrated lifestyle hub for healthcare and wellness, which includes Farrer Park Hospital.  

The hospital is also a teaching site for undergraduate medical training, providing enhanced medical care, service quality and professional integrity and value. Supported by approximately 600 hospital staff, specialists at Farrer Park Hospital provide a range of services, such as cardiology, oncology, orthopedic surgery, gastroenterology and ophthalmology. A 24-hour emergency department provides attention for acute illnesses and the hospital has the most modern facilities for diagnostic imaging, nuclear medicine, radiotherapy and clinical laboratories.

Image SOURCE: Photographs courtesy of Farrer Park Hospital, Singapore. Left is a deluxe suite, top right is Farrer Park Hospital lobby, bottom right is Farrer Park Hospital building.

 

Medical tourism — the process of traveling outside your country of residence to receive medical care — represents a worldwide, multi-billion-dollar business that is expected to grow considerably in the next decade. Interestingly, Singapore’s medical tourism market is projected to grow by 8.3 percent annually and reach revenue of USD $1.36 billion a year by 2018.

My first question is: Why has Singapore emerged in the past few years as an international healthcare and research hub?

Dr. Low:  With Singapore’s excellent patient services and its dedication to research and wellness, the country continues to remain as the top destination for those seeking medical care. By providing convenience and trust in our medical sector, there is no doubt that it will continue to expand and grow. Our dedication is towards the patient, cutting-edge technology and personalized care. This makes Singapore a multi-faceted medical hub and a center of excellence. Patient can receive excellent standard of medical treatment, comparable to the Europe and the USA.

Currently, we are attracting foreign patients who expect five- or six-star hotel service, because we’re a private hospital. That’s why I’m strict about appearances. We have to look as groomed, and we need to be as personable, as those in hospitality and the airlines.

Please describe the concept behind Farrer Park Hospital as Singapore’s first, fully integrated healthcare and hospitality complex.

Dr. Low: The Farrer Park Hospital was designed and built to be a hospital of the future, combining innovation in medical care and medical education. The hospital was initially created by medical specialists to respond to the growing challenges of healthcare in Singapore and, more broadly, throughout the Asia Pacific region. We have ‘reimagined’ private healthcare in order to enhance medical care, service quality, professional integrity and value.

We are leading the way in healthcare innovation as we are a premier institution for medical care and education that is based upon three important tenets for the patient — comfort, fairness and value. In fact, our top accredited medical staff, along with state-of-the-art equipment and technology, contributes to increased efficiency, reduced cost, and most, importantly improved patient outcomes.

As an innovation in hospital administration, Farrer Park Hospital embraces technology and improves medical care through its state-of-the-art equipment that facilities telemedicine consulting services across the world. To create a conducive environment for medical professionals, the hospital’s 18 operating rooms are linked via fiber-optic connections to various locations through the Connexion complex, including the hospitals’ education center and lecture hall, teaching clinics and tutorial rooms as well as the hotel’s function rooms. In addition to being equipped with the latest in useful medical technology, the hospital has state-of-the-art information technology which enables seamless and rapid flow of information between the admission services, inpatient areas, operating theaters, diagnostic and therapeutic centers, clinical laboratories and medical clinics. We also are the country’s first private hospital to become a teaching site, with the medical students from Lee Kong Chian School of Medicine at Nanyang Technological University.

What is the type of environment you are creating at Farrer Park Hospital?

Dr. Low: Our care philosophy extends beyond healing and the management of disease to engaging with our patients as partners in pursuit of good health and providing an oasis for healing and relaxation. Throughout our facility, patients will find that attention has been given to every aspect and detail of our facility – from the comfort of our patients, to its impact on the environment, to the speed and ease of obtaining medical attention and to the maintenance of hygiene.

As healthcare players go, we are small and that has made us very aware of our challenges. As such, we have encouraged a culture of innovation, to grasp opportunities quickly. Healthcare is a very traditional industry, resistant to change and thus tend to be laggards in technology. Farrer Park Hospital, however, embraces technology. The seamlessness of information flow was the focus at the onset of the project. This hospital was planned technologically to be relevant for the next 20 years.

Being an institution built by healthcare practitioners has its advantages. We achieve painstaking perfection in our attention to detail. The hospital has many practical features that serve the needs of practitioners and patients while the hoteliers add details for comfort, luxury and aesthetics.

Our hospital is also supported by a hospital staff, who provide a range of specialty services, such as cardiology, oncology, orthopedic surgery, gastroenterology and ophthalmology, along with a 24-hour emergency clinic, which provides immediate care for acute illnesses. The hospital also has the most modern facilities for diagnostic imaging, nuclear medicine, radiotherapy and clinical laboratories. There is even a holistic service which focuses on screening, preventive medicine and lifestyle enhancement.

What is your perspective of engaging with patients?  

Dr. Low: The hospital’s care philosophy extends beyond healing and the management of disease to engaging patients in pursuit of good health. Healing does not end after a successful operation. It is not just about coming to the hospital for a procedure and then recuperating at home. It is about having the best and most comfortable services to get the patient on their feet. And having a family support structure close by, where relatives can stay close to the hospital, is essential in the rehabilitation process. That is why, as part of Connexion, the hospital is Asia’s first, integrated lifestyle hub for healthcare and wellness that is linked to a five-star hotel and spa.

Patients are treated by an experienced team of medical and health specialists in an environment meticulously designed to maximize comfort and efficiency while promoting well-being, rest and recovery.

How are you positioned technologically to be a leader in developing first-rate patient care? 

Dr. Low: We have taken the lead in many areas. Our facility is wired completely, any tests and treatments is automated whenever possible and the information is sent in real time to all stakeholders who require it. Our doctors can access this technology and make decisions as if they are in the hospital anywhere in the world.

What type of physician are you attempting to attract?

Dr. Low: The environment at Farrer Park Hospital is about clinical and service excellence, supported by physical and technological constructs that facilitates both these endeavors. We are building a culture of fairness and promoting decision making that is free from self-interest and toward better patient outcome. The doctors who join us must be aware that we take our code of comfort, fairness and value seriously.

What is the thinking behind the philosophy of incorporating nature and art into healthcare in Farrer Park Hospital?

Dr. Low: The architecture of Farrer Park Hospital and Connexion reflects the deep commitment to creating a true learning environment. Synergies between our hospital along with a closely linked hotel stimulate many innovations for improving the healthcare experience. The concept of a hospital near a hotel is not new, however, to integrate it to the level that we have is something novel. We followed a biophilic architecture approach throughout the facility, incorporating nature and art to enhance healing. Hospitals are traditionally not the best place for recuperation. We strive to have the restful ambiance of a hotel, in addition to proximity of doctors and family under the same roof, as well as using technology to enable seamless and speedy decision making; all this in support of better patient outcome and shorter stays.

You could say we are different in how we view private healthcare. A traditional hospital would not carve out 15 gardens at multiple levels throughout the facility so that patients and families can have places to feel the warmth of the sun and breathe fresh air whenever they like. The facility also hosts a private collection of over 700 commissioned Asian paintings meant to enhance the healing environment.

In land-scarce Singapore, a typical businessperson would not have fewer paid parking lots, making them one and a half times the size of a standard lot to allow a patient on crutches to comfortably extend the car door fully to disembark. A standard project manager would not insist that contractors construct a curved sink so that surgeons will not have water dripping down his elbows after scrubbing his or her hands, or a bath bench with a cut out that allows patients to sit while washing themselves. This may seem unnecessary but these innovative approaches translate to actual benefits to people who ‘value’ them.

Everyone has the same end goal, a good experience and better patient outcome. Our strategy is simple. We take our responsibilities to patients, their families and the clinicians seriously. Attend to their needs, anticipate their wants, and find the best way to address these concerns through innovation and technology. This ultimately brings value to patients.

How does nature and art come together at Farrer Park Hospital?

Dr. Low: The hospital, hotel and specialist center share and enjoy 15 gardens created at multiple levels in the building. One of the gardens, The Farm @ Farrer, grows fruits, vegetables and herbs for the hotel kitchens, and at the same time, is a large outdoor green space for recovering patients to stroll and sun. Uniquely, Farrer Park Hospital patients enjoy meals prepared by chefs in the hotel’s kitchens and confectionery.

Our inpatient food service, for example, is also automated, so whatever appears on the electronic screen on a patient’s personal tablet matches their dietary restrictions. The menu is a matrix of over 200 items customized by hotel chefs and our hospital nutritionist. Food that is fresh, delicious and safe for patient consumption is our primary focus.

Not only do we benchmark ourselves with hospitals, but also we take our inspiration from other industries. We believe to be at the top, you need to look beyond, break through and recreate process models and apply them for use in healthcare.

 

Dr. Timothy Low Photo

Image SOURCE: Photograph of Chief Executive Officer Timothy Low, M.D., courtesy of Farrer Park Hospital, Singapore.

Chief Executive Officer of Farrer Park Hospital, Timothy Low, M.D., brings a strong leadership background in managing award-winning hospitals. Prior to his current role, Dr. Low served as CEO of Gleneagles Hospital in Singapore. Through his leadership, the hospital established itself as a six-star private healthcare provider, clinching 14 local and regional awards including the prestigious Asian Hospital Management Award as well as the the ‘National Work Redesign Model Company’ by Spring Singapore, a governing agency for innovation in Singapore. Under his leadership, revenues exceed 42 percent to over USD $100 million.

Having also served in senior management positions for pharmaceutical and medical device industries in the Asia Pacific region, Dr. Low’s breath of exposure allowed him to pioneer the establishment of a global contract research organization, validating Singapore as its regional headquarters.

With more than 28 years of experience in the health care industry with such leading companies as Covidien, Covance and Schering-Plough, Dr. Low brings with him a strong background of leadership within the business and medical community. With his vast experience and contributions to the industry, Dr. Low is listed in the ranks of Stanford Who’s Who.

Dr. Low received his Bachelor of Medicine and Bachelor of Surgery from the National University of Singapore (NUS) and is also a graduate of the NUS Graduate School of Business, Stanford University Executive Program and the Singapore Management University Asia Pacific Hospital Management Program.

 

REFERENCE/SOURCE

Tan, W. (2016). Farrer Park Hospital patients can recuperate at adjoining hotel to ease ward crunch. The Straits Times. Retrieved from  http://www.straitstimes.com/singapore/health/farrer-park-hospital-patients-can-recuperate-at-adjoining-hotel-to-ease-ward-crunch

Tan, W. (2016). New Farrer Park Hospital aims to offer ‘affordable’ private care. The Straits Times. Retrieved from http://www.straitstimes.com/singapore/health/new-farrer-park-hospital-aims-to-offer-affordable-private-care

Anonymous (2012). Singapore Medical Tourism: Farrer Park Healthcare and Hospitality Complex Will Open in 2013. International Medical Travel Journal. Retrieved from http://www.imtj.com/news/singapore-medical-tourism-farrer-park-healthcare-and-hospitality-complex-will-open-2013/

Retrieved from http://news.asiaone.com/news/yourhealth/farrer-park-hospital-appoints-new-ceo

Retrieved from http://today.mims.com/topic/farrer-park-hospital-opened-with-a-call-for-healthcare-changes-to-adapt-for-an-ageing-population-

Retrieved from http://www.farrerpark.com/hospital/Pages/Home.aspx

Retrieved from http://www.straitstimes.com/singapore/health/new-farrer-park-hospital-aims-to-offer-affordable-private-care

Retrieved from http://www.bca.gov.sg/friendlybuilding/FindBuilding/Building.aspx?id=4534

Retrieved from http://www.ttgasia.com/article.php?article_id=23292

 

Other related articles were published in this Open Access Online Scientific Journal include the following: 

2016

Third Annual BioPrinting and 3D Printing in the Life Sciences, 21-22 July 2016 at Academia, Singapore General Hospital Campus

https://pharmaceuticalintelligence.com/2016/01/18/third-annual-bioprinting-and-3d-printing-in-the-life-sciences-21-22-july-2016-at-academia-singapore-general-hospital-campus/

2015

Patient Satisfaction with Hospital Experience

https://pharmaceuticalintelligence.com/2015/11/15/patient-satisfaction-with-hospital-experience/

2013

Cardiac Surgery Theatre in China vs. in the US: Cardiac Repair Procedures, Medical Devices in Use, Technology in Hospitals, Surgeons’ Training and Cardiac Disease Severity 

https://pharmaceuticalintelligence.com/2013/01/08/cardiac-surgery-theatre-in-china-vs-in-the-us-cardiac-repair-procedures-medical-devices-in-use-technology-in-hospitals-surgeons-training-and-cardiac-disease-severity/

Risk Factor for Health Systems: High Turnover of Hospital CEOs and Visionary’s Role of Hospitals In 10 Years

https://pharmaceuticalintelligence.com/2013/08/08/risk-factor-for-health-systems-high-turnover-of-hospital-ceos-and-visionarys-role-of-hospitals-in-10-years/

Hospitals in China

https://pharmaceuticalintelligence.com/options/scientific-delegation/shanghai-may-2013/hospitals-in-china/

 

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Yesterday and today are not the same

Larry H. Bernstein

LPBI

 

The New Generation Gap

https://www.project-syndicate.org/commentary/new-generation-gap-social-injustice-by-joseph-e–stiglitz-2016-03

Joseph E. Stiglitz

Joseph E. Stiglitz, recipient of the Nobel Memorial Prize in Economic Sciences in 2001 and the John Bates Clark Medal in 1979, is University Professor at Columbia University, Co-Chair of the High-Level Expert Group on the Measurement of Economic Performance and Social Progress at the OECD, and Chief Economist of the Roosevelt Institute. A former senior vice president and chief economist of the World Bank and chair of the US president’s Council of Economic Advisers under Bill Clinton, in 2000 he founded the Initiative for Policy Dialogue, a think tank on international development based at Columbia University. His most recent book is Rewriting the Rules of the American Economy.

NEW YORK – Something interesting has emerged in voting patterns on both sides of the Atlantic: Young people are voting in ways that are markedly different from their elders. A great divide appears to have opened up, based not so much on income, education, or gender as on the voters’ generation.

There are good reasons for this divide. The lives of both old and young, as they are now lived, are different. Their pasts are different, and so are their prospects.

The Cold War, for example, was over even before some were born and while others were still children. Words like socialism do not convey the meaning they once did. If socialism means creating a society where shared concerns are not given short shrift – where people care about other people and the environment in which they live – so be it. Yes, there may have been failed experiments under that rubric a quarter- or half-century ago; but today’s experiments bear no resemblance to those of the past. So the failure of those past experiments says nothing about the new ones.

Older upper-middle-class Americans and Europeans have had a good life. When they entered the labor force, well-compensated jobs were waiting for them. The question they asked was what they wanted to do, not how long they would have to live with their parents before they got a job that enabled them to move out.

That generation expected to have job security, to marry young, to buy a house – perhaps a summer house, too – and finally retire with reasonable security. Overall, they expected to be better off than their parents.

While today’s older generation encountered bumps along the way, for the most part, their expectations were met. They may have made more on capital gains on their homes than from working. They almost surely found that strange, but they willingly accepted the gift of our speculative markets, and often gave themselves credit for buying in the right place at the right time.

Today, the expectations of young people, wherever they are in the income distribution, are the opposite. They face job insecurity throughout their lives. On average, many college graduates will search for months before they find a job – often only after having taken one or two unpaid internships. And they count themselves lucky, because they know that their poorer counterparts, some of whom did better in school, cannot afford to spend a year or two without income, and do not have the connections to get an internship in the first place.

Today’s young university graduates are burdened with debt – the poorer they are, the more they owe. So they do not ask what job they would like; they simply ask what job will enable them to pay their college loans, which often will burden them for 20 years or more. Likewise, buying a home is a distant dream.

These struggles mean that young people are not thinking much about retirement. If they did, they would only be frightened by how much they will need to accumulate to live a decent life (beyond bare social security), given the likely persistence of rock-bottom interest rates.

In short, today’s young people view the world through the lens of intergenerational fairness. The children of the upper middle class may do well in the end, because they will inherit wealth from their parents. While they may not like this kind of dependence, they dislike even more the alternative: a “fresh start” in which the cards are stacked against their attainment of anything approaching what was once viewed as a basic middle-class lifestyle.

These inequities cannot easily be explained away. It isn’t as if these young people didn’t work hard: these hardships affect those who spent long hours studying, excelled in school, and did everything “right.” The sense of social injustice – that the economic game is rigged – is enhanced as they see the bankers who brought on the financial crisis, the cause of the economy’s continuing malaise, walk away with mega-bonuses, with almost no one being held accountable for their wrongdoing. Massive fraud was committed, but somehow, no one actually perpetrated it. Political elites promised that “reforms” would bring unprecedented prosperity. And they did, but only for the top 1%. Everyone else, including the young, got unprecedented insecurity.

These three realities – social injustice on an unprecedented scale, massive inequities, and a loss of trust in elites – define our political moment, and rightly so.

More of the same is not an answer. That is why the center-left and center-right parties in Europe are losing. America is in a strange position: while the Republican presidential candidates compete on demagoguery, with ill-thought-through proposals that would make matters worse, both of the Democratic candidates are proposing changes which – if they could only get them through Congress – would make a real difference.

Were the reforms put forward by Hillary Clinton or Bernie Sanders adopted, the financial system’s ability to prey on those already leading a precarious life would be curbed. And both have proposals for deep reforms that would change how America finances higher education.

But more needs to be done to make home ownership possible not just for those with parents who can give them a down payment, and to make retirement security possible, given the vagaries of the stock market and the near-zero-interest world we have entered. Most important, the young will not find a smooth path into the job market unless the economy is performing much better. The “official” unemployment rate in the United States, at 4.9%, masks much higher levels of disguised unemployment, which, at the very least, are holding down wages.

But we won’t be able to fix the problem if we don’t recognize it. Our young do. They perceive the absence of intergenerational justice, and they are right to be angry.

Read more at https://www.project-syndicate.org/commentary/new-generation-gap-social-injustice-by-joseph-e–stiglitz-2016-03#vxQE74VR3kfAWbf1.99

 

 

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Top women in biopharma 2015

Larry H. Bernstein, MD, FCAP, Curator

LPBI

 

Top women in biopharma 2015
http://www.fiercebiotech.com/special-reports/top-women-biotech-2015

 

This year’s fiercest women in biopharma are seemingly doing it all.

Pioneering a fully integrated biotech in China? Check. Leading aging research at Google’s mysterious new life sciences upstart? Check. Changing the game for biotech innovators? Running the world’s largest consumer health player? Blazing the off-P&L financing trail? Check, check, check.

But while at times our 12 honorees have made it look easy, it hasn’t necessarily been that way. Biopharma is still a world dominated by men, which, according to Kleiner Perkins‘ Beth Seidenberg, means women “need to be the champions.”

“It’s a 50-50 world, but we see that 15% of founders or CEOs are women. Only 15% in the 50% that are women have good ideas? Come on,” she says.

Sometimes, though–as several of the women on this list know–being the champions means more than just leading by example, and they’re doing their parts to help others to the same levels of success through recruiting, volunteering and mentoring.

“Leadership is about creating futures that are not a direct path,” says the Broad Institute‘s Samantha Singer. “It’s about being courageous and being willing to speak about and talk about futures that aren’t obvious to other people. Take a stand for a future you can see, one you know can happen even when you can’t see how.”

As for the future we can see? It’s one that includes putting those they’ve inspired on this list sometime soon. — Carly Helfand (email | Twitter)

Revisit our previous Women in Biopharma features: 2014, 2013, 2012, 2011, and 2010.

Samantha Du
China biotech pioneer

Company: ZAI Lab
Title: Chairman and CEO

A lot of people want some of Samantha Du’s time as they pass through China, banking on the depth of her contacts and experience in the pharmaceutical industry’s commercial and regulatory landscape for a clearer path.

For Du, the mother of two sons in addition to her very full-time job as chairman, CEO and adviser at ZAI Lab, her own path to this spot started with a willingness to ask questions during a crucial management stint in licensing at Pfizer ($PFE).

“That was an important job for me professionally and personally,” Du said in a phone interview from Shanghai with FiercePharmaAsia. “I learned to ask questions to establish my own credibility.”

She did indeed manage to establish credibility in the development of multiple early- and late-stage products, two of which were approved and launched globally by Pfizer.

The experience opened up a new direction as managing director for Sequoia Capital China looking at healthcare investments. “That was a big step, making decisions on investments, but I had that other experience as well.”

That would have been as co-founder and effective chief scientific officer atHutchison China MediTech, which she helped lead to a 2006 IPO in London.

“I look back and the reward was always about building an enterprise for China biotech,” she said. “So ZAI Lab is the next stage and the aim is to have a fully-integrated biotech in China. We are not alone. It is so exciting now, so many biotech companies are now in China–and many will not make it. But the drive and building are real.”

That drive sees her sit on the boards of China-focused BGI Tech, JHL Biotech and Beta Pharma–as she easily walks between multinationals and growing companies.

Du holds a doctorate in biochemistry from the University of Cincinnati. She serves as an adjunct professor at Fudan University as well as an adviser to China on broad healthcare issues.

In September, ZAI Lab in-licensed global rights to a first-in-class monoclonal antibody aimed at treating autoimmune and other inflammatory diseases from Belgium’s UCB, following an in-licensed novel multikinase inhibitor aimed at a non-small cell lung cancer target from Sanofi ($SNY) in August.

ZAI Lab also in-licensed China rights to the Phase III liver cancer drug brivanib, an oral kinase inhibitor for oncology indications including hepatocellular carcinoma, from Bristol-Myers Squibb ($BMY) in March.

Overall, the biotech has successfully taken 5 novel drug candidates into clinical trials in China, conducted multiple IND trials in the U.S. and brought the first China-discovered drug into global Phase III trials. Not bad for a company that got its start in 2013.

 

Belén Garijo
From bedside to boardroom

Company: Merck KGaA
Title: CEO of Merck Healthcare

A doctor who entered the Spanish workforce among an oversupply of medical graduates, Belén Garijo practiced medicine for 6 years before joining the pharma industry. There was a “very high output of physicians that couldn’t get jobs easily,” she toldThe Wall Street Journal in a 2014 interview. So, she looked for other avenues to continue helping patients.

“I saw [pharmaceuticals] as an opportunity to continue to develop myself and serve the patients from a different place,” she told the newspaper.

But while the capacity in which she serves patients has changed, her fundamental approach has not. Her experience as a physician has influenced her management style, as CEO first of Merck Serono, and beginning in January this year, CEO of Merck Healthcare.

“I look at the business as I used to look at my patients. I recognize the symptoms. I go to the root cause to treat my business,” Garijo said.

She started out as medical director at Abbott’s ($ABT) Spanish affiliate and then moved to Abbott headquarters in Illinois as director of international medical affairs. In 1996, she joined Rhône-Poulenc Rorer in Spain as director of the oncology business unit. Following Rhône-Poulenc’s merger with Hoechst AG to form Aventis, Garijo then served as global vice president of oncology for the new company in New Jersey.

2003 saw her return to Spain, where she became the general manager of Sanofi-Aventis and led the merger in 2004. From there, she moved on to Paris, trading in Spain for all of Europe as she became Sanofi’s ($SNY) senior vice president of global operations Europe. Garijo oversaw Sanofi’s acquisition of Genzyme as its global integration leader.

In 2011, Garijo joined Merck KGaA as chief operating officer, before rising to president and CEO in less than three years. And barely a year later, she was named CEO of Merck Healthcare, which encompasses its biopharma, consumer health, allergopharma and biosimilars divisions.

When it comes to developing managerial expertise, Garijo brushes aside the idea of a “magic recipe.”

“I learned by making mistakes. I learned by taking risks. I learned by consulting with others. I don’t think it’s a magic recipe, but you know, just being aware of what do you do well and what can you do better?” she told the WSJ. “I think self-awareness is actually something that’s super important. You have to be very self-confident because you have to give this confidence to others every day.

 

Kristen Hege
Complacency is not an option

Company: Celgene
Title: VP of Translational Development, Hematology/Oncology

For Dr. Kristen Hege, Celgene’s ($CELG) San Francisco site lead, the decision to enter the field of biotech and medicine was born of her familial history and a passion for drug discovery. Throughout her career, that passion–in addition to her optimism–has allowed her to navigate the field successfully in spite of challenges along the way.

Hege lost her parents–both physicians–by the age of 20, and her brother in the 1990s AIDS epidemic. The loss of her parents–she thinks of her mother as a “pioneer” in her field–taught Hege to be pragmatic and have a “deep appreciation for good health.” Later in life, she served as her brother’s primary caregiver until his death just one year before effective AIDS meds hit the market.

“That had significant impact on me and how much time matters when you are talking about new drug development,” she told FierceBiotech. “The difference of a year or two in delivery of these significant new drugs to the patient really does matter. Complacency is not an option in this world when there are these real lives that are cut short because they happen to not have a drug approved at that moment in time.”

Hege completed her MD at the University of California, San Francisco, and her residency in internal medicine at Brigham & Women’s Hospital, afterward returning to the Bay Area for her fellowship in hematology and oncology at UCSF. It was during the ’90s, though, that she began to notice a lot of innovation in the biotech sector.

After talking about her interests with her program’s visiting doctor, Stephen Sherwin, the two agreed “basically on a handshake” that she could complete her two years of fellowship research at Sherwin’s biotech, Cell Genesys, Hege explained, a move that would end up sparking her fascination with the industry side of things. Six months after returning to UCSF for the academic career she’d always imagined, she had an epiphany, realizing she was more excited about the company’s technology. It wasn’t long before she ended up at the company where she’d spend 14 years, though she never gave up her UCSF appointment.

 

Cynthia Kenyon
Continuing her life’s work on aging with the power of Google

Company: Calico (Google)
Title: Vice President of Aging Research

Google’s ($GOOG) Calico has kept very quiet in most respects, shrouding its research and business prospects in a blanket of generalities about aging and longevity. What has generated the most excitement, however, is the crack team Calico has assembled over the past couple of years, including one of the foremost experts on aging from the University of California in San Francisco: Cynthia Kenyon.

Kenyon, a renowned geneticist, left UCSF last year for Calico after advising the startup in its first few months, though she has also remained an emeritus professor at the school. She serves as the vice president of aging research at the Google-owned company, joining CEO Art Levinson and R&D chief Hal Barron, in a who’s who of biotech insiders.

At UCSF, Kenyon gained notoriety for decades of work on aging in roundworms, for which her genetic modifications could effectively double the lifespan. Her first foray into clinical therapies was the co-founding of Elixir Pharmaceuticals in 1999, which closed a few years ago after a Novartis ($NVS) buyout fizzled due to cash concerns during the economic recession. And that’s where Google’s deep pockets will likely allow Kenyon and the rest of the team at Calico to reverse course and take their work to the next level.

 

Samantha Singer
Forging a nontraditional path

Company: The Broad Institute
Title: Chief Operating Officer

Samantha Singer’s journey toward becoming chief operating officer at the Broad Institute has followed a unique trajectory. Singer joined the institute in April 2014 after a long tenure at Biogen ($BIIB) and worked in healthcare and biomedical consulting at different points in her career.

“I wanted to follow my interests and passions,” Singer told FierceBiotech. “Because I haven’t had a path that is based on specific expertise, I haven’t had a series of opportunities that someone can map out. It’s not an obstacle or a challenge, but it’s something that has made it more challenging than for someone with a functional expertise.”

Before jumping into the biotech industry, Singer started a PhD program in molecular biology at Rockefeller University. But “working at the lab bench wasn’t for me,” she said, and she decided to complete a master’s degree instead.

From there, Singer started working in management consulting. She concentrated mostly on the research side of things at the global management consulting firm Boston Consulting Group, but found herself acting as a translator between the research and business departments. The experience prompted Singer to get an MBA from Harvard University. “I wanted to think through what strategy and business looked like,” she said.

Singer then decided to pursue an entrepreneurial partnership, which led to her first encounter with her now-employer, she said. Along with her business partner at the time, Singer wrote the Broad’s initial business plan, setting the wheels in motion for not only the institute but also her next career move. “I got really interested less in strategy but in how you execute the strategy. How do you help people execute against a vision you have?” she said.

Soon thereafter, Singer started working for Biogen in the company’s Organization Effectiveness group. During her 7 years at Biogen she led the biotech’s Supply Chain operations for new product launches and also served as chief of staff for CEO George Scangos.

Since joining the Broad a year and a half ago as COO, Singer has worked with different teams to refine the organization’s vision and to make it more effective, she said. In the past year alone, the Broad has inked deals with key biopharma and med tech players, lending its expertise to companies’ R&D initiatives. In March, Bayer said it would use the Broad’s genomic analysis expertise to find new therapies for cardiovascular diseases. In June, the institute announced it would partner with tech titan Google ($GOOG) on a Big Data initiative.

“We have these technological platforms, leading edge organizations that do technological development and we work with scientists across the institute to execute broad ambitions they have. We’re looking ahead over the next 10 years, asking, how do we do that?” Singer said.

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The good, the bad and the ugly of sulfur and volcanic activity

Larry H Bernstein, MD, FCAP, Curator

LPBI

 

Climate change deniers have promulgated much ignorance about the planet and our life on earth.  Nevertheless, I shall deal with geophysical and geochemical issues and indirectly, climate change in this portion of the discussion.  The good, the bad, and the ugly has everything to due with the elements and to life on earth.  This is the case, regardless of claims propagated by the tobacco and the carbon fuels interests.  I shall proceed as I have done in the previous discussions.

Is a Lack of Water to Blame for the Conflict in Syria?

A 2006 drought pushed Syrian farmers to migrate to urban centers, setting the stage for massive uprisings

By Joshua Hammer

SMITHSONIAN MAGAZINE

http://www.smithsonianmag.com/innovation/is-a-lack-of-water-to-blame-for-the-conflict-in-syria-72513729

 

An Iraqi girl stands on former marshland, drained in the 1990s because of politically motivated water policies. (Essam Al-Sudani / AFP / Getty Images)
http://thumbs.media.smithsonianmag.com//filer/Scare-Tactics-Iraqi-girl-631.jpg__800x600_q85_crop.jpg

The world’s earliest documented water war happened 4,500 years ago, when the armies of Lagash and Umma, city-states near the junction of the Tigris and Euphrates rivers, battled with spears and chariots after Umma’s king drained an irrigation canal leading from the Tigris. “Enannatum, ruler of Lagash, went into battle,” reads an account carved into an ancient stone cylinder, and “left behind 60 soldiers [dead] on the bank of the canal.”

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Water loss documented by the Gravity Recovery and Climate Experiment (GRACE), a pair of satellites operated by NASA and Germany’s aerospace center, suggests water-related conflict could be brewing on the riverbank again. GRACE measured groundwater usage between 2003 and 2009 and found that the Tigris-Euphrates Basin—comprising Turkey, Syria, Iraq and western Iran—is losing water faster than any other place in the world except northern India . During those six years, 117 million acre-feet of stored freshwater vanished from the region as a result of dwindling rainfall and poor water management policies. That’s equal to all the water in the Dead Sea. GRACE’s director, Jay Famiglietti, a hydrologist at the University of California, Irvine, calls the data “alarming.”

While the scientists captured dropping water levels, political experts have observed rising tensions. In Iraq, the absence of a strong government since 2003, drought and shrinking aquifers have led to a recent spate of assassinations of irrigation department officials and clashes between rural clans. Some experts say that these local feuds could escalate into full-scale armed conflicts .

In Syria, a devastating drought beginning in 2006 forced many farmers to abandon their fields and migrate to urban centers. There’s some evidence that the migration fueled the civil war there, in which 80,000 people have died. “You had a lot of angry, unemployed men helping to trigger a revolution,” says Aaron Wolf, a water management expert at Oregon State University, who frequently visits the Middle East.

Tensions between nations are also high. Since 1975, Turkey’s dam and hydro­power construction has cut water flow to Iraq by 80 percent and to Syria by 40 percent. Syria and Iraq have accused Turkey of hoarding water.

Hydrologists say that the countries need to find alternatives to sucking the aquifers dry—perhaps recycling wastewater or introducing desalination—and develop equitable ways of sharing their rivers. “Water doesn’t know political boundaries. People have to get together and work,” Famiglietti says. One example lies nearby, in an area not known for cross-border cooperation. Israeli and Jordanian officials met last year for the first time in two decades to discuss rehabilitating the nearly dry Jordan River, and Israel has agreed to release freshwater down the river.

“It could be a model” for the Tigris-Euphrates region, says Gidon Bromberg, a co-director of Friends of the Earth Middle East, who helped get the countries together. Wolf, too, remains optimistic, noting that stress can encourage compromise.

History might suggest a way: The world’s first international water treaty, a cuneiform tablet now hanging in the Louvre, ended the war between Lagash and Umma.

 

http://static.guim.co.uk/ni/1404220722088/Iraq_water_dams.svg

“Rebel forces are targeting water installations to cut off supplies to the largely Shia south of Iraq,” says Matthew Machowski, a Middle East security researcher at the UK houses of parliament and Queen Mary University of London.

“It is already being used as an instrument of war by all sides. One could claim that controlling water resources in Iraq is even more important than controlling the oil refineries, especially in summer. Control of the water supply is fundamentally important. Cut it off and you create great sanitation and health crises,” he said

Isis now controls the Samarra barrage west of Baghdad on the River Tigris and areas around the giant Mosul Dam, higher up on the same river. Because much of Kurdistan depends on the dam, it is strongly defended by Kurdish peshmerga forces and is unlikely to fall without a fierce fight, says Machowski.

Iraqi troops were rushed to defend the massive 8km-long Haditha Dam and its hydroelectrical works on the Euphrates to stop it falling into the hands of Isis forces. Were the dam to fall, say analysts, Isis would control much of Iraq’s electricity and the rebels might fatally tighten their grip on Baghdad.

Isis fighters in Fallujah captured the smaller Nuaimiyah Dam on the Euphrates and deliberately diverted its water to “drown” government forces in the surrounding area. Millions of people in the cities of Karbala, Najaf, Babylon and Nasiriyah had their water cut off but the town of Abu Ghraib was catastrophically flooded along with farms and villages over 200 square miles. According to the UN, around 12,000 families lost their homes.

Earlier, Kurdish forces reportedly diverted water supplies from the Mosul Dam. Equally, Turkey has been accused of reducing flows to the giant Lake Assad, Syria’s largest body of fresh water, to cut off supplies to Aleppo, and Isis forces have reportedly targeted water supplies in the refugee camps set up for internally displaced people.

Iraqis fled from Mosul after Isis cut off power and water and only returned when they were restored, says Machowski. “When they restored water supplies to Mosul, the Sunnis saw it as liberation. Control of water resources in the Mosul area is one reason why people returned,” said Machowski.

Both Isis forces and President Assad’s army are said to have used water tactics to control the city of Aleppo. The Tishrin Dam on the Euphrates, 60 miles east of the city, was captured by Isis in November 2012.

“The deliberate targeting of water supply networks … is now a daily occurrence in the conflict. The water pumping station in Al-Khafsah, Aleppo, stopped working on 10 May, cutting off water supply to half of the city.

https://i.guim.co.uk/img/static/sys-images/Guardian/Pix/pictures/2014/7/2/1404300629581/

A satellite view showing the two main rivers running from Turkey through Syria and Iraq. Credits: MODIS/NASA

The Euphrates River, the Middle East’s second longest river, and the Tigris, have historically been at the centre of conflict. In the 1980s, Saddam Hussein drained 90% of the vast Mesopotamian marshes that were fed by the two rivers to punish the Shias who rose up against his regime. Since 1975, Turkey’s dam and hydropower constructions on the two rivers have cut water flow to Iraq by 80% and to Syria by 40%. Both Syria and Iraq have accused Turkey of hoarding water and threatening their water supply.

http://www.irinnews.org/photo/

The Barada River, shown here in Damascus, is the only notable river flowing entirely within Syrian territory. The city’s water supplies are under huge strain

DAMASCUS, 25 March 2010 (IRIN) – Poor planning and management, wasteful irrigation systems, intensive wheat and cotton farming and a rapidly growing population are straining water resources in Syria in a year which has seen unprecedented internal displacement as a result of drought in eastern and northeastern parts of the country.

In 2007 Syria consumed 19.2 billion cubic metres of water – 3.5 billion more than the amount of water replenished naturally, with the deficit coming from groundwater and reservoirs, according to the Ministry of Irrigation.

Agriculture accounts for almost 90 percent of the country’s water consumption, according to government and private sector.

Agricultural policies encourage water-hungry wheat and cotton cultivation, and inefficient irrigation methods mean much water is wasted.

 

South Asia is a desperately water-insecure region, and India’s shortages are part of a wider continental crisis. According to a recent report authored by UN climate scientists, coastal areas in Asia will be among the worst affected by climate change. Hundreds of millions of people across East, Southeast and South Asia, the report concluded, will be affected by flooding, droughts, famine, increases in the costs of food and energy, and rising sea levels.

Groundwater serves as a vital buffer against the volatility of monsoon rains, and India’s falling water table therefore threatens catastrophe. 60 percent of north India’s irrigated agriculture is dependent on ground water, as is 85 percent of the region’s drinking water. The World Bank predicts that India only has 20 years before its aquifers will reach “critical condition” – when demand for water will outstrip supply – an eventuality that will devastate the region’s food security, economic growth and livelihoods.

Analysts fear that growing competition for rapidly dwindling natural resources will trigger inter-state or intra-state conflict. China and India continue to draw on water sources that supply the wider region, and a particularly concerning flashpoint is the Indus River Valley basin that spans India and Pakistan. The river’s waters are vital to the economies of areas on both sides of the border and a long-standing treaty, agreed by Pakistan and India in 1960, governs rights of access. But during the “dry season,” between October and March, water levels fall to less than half of those seen during the remainder of the year. The fear is that cooperation over access to the Indus River will fray as shortages become more desperate.

http://cdn1.pri.org/sites/default/files/styles/story_main/public/story/images/IMG_5937.jpeg

Farm worker heading for the paddy fields at Gubinder Singh’s farm

The Indo-Gangetic Basin, which lies at the foothills of the Himalayas, is one of the areas in the world facing a huge water crisis.  The Basin spans from Pakistan, across Northern India into Bangladesh. Apart from runoff from mountainous streams and glaciers, it also holds one of the largest underground bodies of water in the world. But it’s also in one of the most populous regions of the world, with more than a billion people living on the subcontinent.  Still, parts of the region are well-resourced when it comes to water supplies – like the Indian state of Punjab, which has three rivers running through it and a network of canals in some parts.

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NASA Satellites Unlock Secret to Northern India’s Vanishing Water

08.12.09

 

NASA Hydrologist Matt Rodell discusses vanishing groundwater in India. Credit:NASA
› Watch Video

http://www.nasa.gov/multimedia/nasatv/index.html

 

soil moisture belt

soil moisture belt

 

Groundwater resides beneath the soil surface in permeable rock, clay and sand as illustrated in this conceptual image. Many aquifers extend hundreds of feet underground and in some instances have filled with water over the course of thousands of years. Credit: NASA
http://www.nasa.gov/images/content/378067main_water_table%20illus_226.jpg

groundwater withdrawals as a percentage of groundwater recharge

groundwater withdrawals as a percentage of groundwater recharge

 

 

The map, showing groundwater withdrawals as a percentage of groundwater recharge, is based on state-level estimates of annual withdrawals and recharge reported by India’s Ministry of Water Resources. The three states included in this study are labeled. Credit:NASA/Matt Rodell

http://www.nasa.gov/images/content/378381main_MattRodell_vid_226.jpg

The averaging function (spatial weighting) used to estimate terrestrial water storage changes from GRACE data is mapped. Warmer colors indicate greater sensitivity to terrestrial water storage changes. Credit: NASA/Matt Rodell

http://www.nasa.gov/images/content/378067main_water_table%20illus_226.jpg

Beneath northern India’s irrigated fields of wheat, rice, and barley … beneath its densely populated cities of Jaiphur and New Delhi, the groundwater has been disappearing. Halfway around the world, hydrologists, including Matt Rodell of NASA, have been hunting for it.

Where is northern India’s underground water supply going? According to Rodell and colleagues, it is being pumped and consumed by human activities — principally to irrigate cropland — faster than the aquifers can be replenished by natural processes. They based their conclusions — published in the August 20 issue of Nature — on observations from NASA’s Gravity Recovery and Climate Experiment (GRACE).

“If measures are not taken to ensure sustainable groundwater usage, consequences for the 114 million residents of the region may include a collapse of agricultural output and severe shortages of potable water,” said Rodell, who is based at NASA’s Goddard Space Flight Center in Greenbelt, Md.

 

https://www.quora.com/Why-are-there-no-earthquakes-or-volcanos-in-the-Himalayas

The Himalayas are representative of a modern and active mountain-building event, called anorogeny in geologic parlance. Both the Himalayas and the Cascade Range are the result of plate-to-plate collision in the Theory of Plate Tectonics.
The difference between the Himalayas and the Cascade Range volcanoes is based on density of the lithospheric plates. Yes. The Cascade Range is caused by subduction of more dense ocean crust into and underneath lighter, lower density continental crust. As the oceanic plate dives deeper and deeper, the ocean crust warms, melts, and rises upward through the overriding continental crust “inland” from the plate collision boundary. As that molten rock punches through the continental crust, a curvilinear series of volcanoes, generally parallel to the plate collision boundary, begins to form.

Cascade Range Subduction

Cascade Range Subduction

 

Cascade Range Subduction from J. Wiley & Sons – 2010
In the case of the Cascade Range, the name of this type of volcanic formation is unique in process, as well as geochemistry, and has been referred to as an Andesitic-type after the Andes Mountains. Regardless, the Cascade Range is comprised of intermediate igneous rocks, with a fairly high silica content. High silica makes for high siliceous acid. That creates “sticky” igneous extrusions that often have quite dramatic eruptions [May 1980 Mt. St. Helens eruption].

 

Igneous Rock Classification

Igneous Rock Classification

Igneous Rock Classification Chart – Public Domain

The Himalayas are also a plate-to-plate collision tectonic boundary. In this case, the Indian Plate [of the Indian Subcontinent] is colliding head-on with the Eurasian Plate. Both plates are comprised of continental lithospheric crust, so there is no appreciable distinction in density. Both have a density of approximately 2.7 g/cm³. This as opposed to ocean crust with a mean density of 3.3 g/cm³. The plates try to compete in the plate-to-plate collision but the equal densities of the two plates cannot push one under the other very deep like that in a subduction zone.  The result is large-scale thickening of the continental crust in the region at and surrounding the collision boundary. Other processes occurring in the Himalayas region associated with the orogeny are metamorphism, thrust [compression] faulting, and plateau uplift.

Depiction of Himalayan Collision

Depiction of Himalayan Collision

Generalized Depiction of Himalayan Collision from FHSU – 2010
A perfect analogy is two trucks of the same make and model colliding head-on. The Himalayan Orogeny is the oft mentioned “crumple zone”. Metal does not deform in a brittle sense like competent rock does, so don’t confuse that too much.

With all that being said, there are tremendous temperatures attained at a continental plate-to-plate collision boundary. However, the crust is simply too thick, and too “squashed together” to allow anything to squeeze up and break through to the surface as volcanic eruptions.
References:

FHSU,  2010.  Image of Himalayan Collision.  Fort Hays State University.  Hays, Kansas.  2010.
Wiley & Sons, J.,  2010.  Image of Cascade Range Subduction Zone.  J. Wiley & Sons.  Hoboken, New Jersey.  2010.

 

Mt. Everest was formed (is forming) by two tectonic plates colliding–the Indo-Australian Plate and the Eurasian plate.

Sometimes, when two tectonic plates collide, volcanoes form (such as the Juan de Fuca plate and the North American Plate forming the Cascades). However, this has to do with one plate–in this case the Juan de Fuca Plate sliding or subducting beneath another–the North American Plate. This happens because the oceanic plate (the Juan de Fuca Plate) is more dense than than the continental plate (the NA Plate). For reasons I won’t get into here, magma forms between the two plates as one subducts beneath the other and volcanoes are formed.

Mt. Everest is formed by two continental plates colliding. Continental plates are generally too buoyant to subduct beneath each other. While some subduction occurred during this collision, most of what happened was crustal shortening. Think about what happens when you have a rug on a wood floor and push two ends toward each other. It buckles and folds up in itself. This is a simplified version of what happened in the Himalaya.

Because little to no subduction is occurring, no magma is forming and Mt. Everest will not become a volcano.

The Himalayas were created by two continental plates colliding. What happens when two masses of rocks with some similarities, like in density, collide? Both of them rise. There is a lot of heat produced. However, there isn’t enough heat to melt rocks completely. For there to be a volcano, there has to be a source of molten rock.

This material can occur if the two masses of rocks have vastly different densities. In this case, the heavier mass will slide above the other. The mass on the bottom will melt. This molten rock material will rise and create a volcano. or two or more. This, however can not happen in the HImalayas. The two masses in action are the Indian Plate and the Eurasian Plate, which have similar rock density.

 

Volcanic Eruptions and the Role of Sulfur Dioxide in Climate Change

In March and April of this year, a series of severe volcanic eruptions shook Alaska’s Mount Redoubt.1  To date, the largest of the eruptions produced an ash plume that reached 50,000 feet above sea level and released a significant amount of sulfur dioxide (CAS Registry Number® 7446-09-5) into the earth’s atmosphere.  According to the Alaska Volcano Observatory, “The main concerns for human health in volcanic haze consist of ash, sulfur dioxide gas (SO2), and sulfuric acid droplets (H2SO4), which forms when volcanic SO2 oxidizes in the atmosphere.”1

While there is obvious reason for alarm among local populations, sulfur dioxide from the Mount Redoubt eruption could also have more widespread impacts, particularly on the climate.  According to a 1997 article published in the Journal of Geology, “The mechanism by which large eruptions affect climate is generally accepted: injection of sulfur into the stratosphere and conversion to sulfate aerosol, which in turn reduces the solar energy reaching the earth’s surface.”2

In the years following a volcanic eruption, sulfate aerosol that remains in the atmosphere is thought to cause surface cooling by reflecting the sun’s energy back into space.  In fact, sulfate aerosol from the massive eruption of Indonesia’s Mount Tambora in 1815 is blamed, at least in part, for the “year without a summer” reported in Europe and North America in 1816:

  • “Daily temperatures (especially the daily minimums) were in many cases abnormally low from late spring through early fall; frequent northwest winds brought snow and frost to northern New England and Canada, and heavy rains fell in western Europe.  Many crops failed to ripen, and the poor harvests led to famine, disease, and social distress…”3

Supporting this claim, sulfate aerosol-related climate changes were also reported after the 1991 eruption of Mount Pinatubo in the Philippines.4  An article published inScience in 2002 summarizes a decade’s worth of research on Pinatubo’s effects on the global climate, highlighting impacts far more widespread and complex than previously thought:

You can use SciFinder® or STN® to search the CAS databases for additional information about sulfur dioxide from volcanic eruptions.  If your organization is enabled to use the web version of SciFinder, you can click the links in this article to directly access details of the substances and references.

 

Volcanic ash vs sulfur aerosols

The primary role of volcanic sulfur aerosols in causing short-term changes in the world’s climate following some eruptions, instead of volcanic ash, was hypothesized by scientists in the early 1980’s. They based their hypothesis on the effects of several explosive eruptions in Indonesia and the world’s largest historical effusive eruption in Iceland.

Scientists studied three historical explosive eruptions of different sizes in Indonesia–Tambora (1815), Krakatau (1883), and Agung (1963). They noted that decreases in surface temperatures after the eruptions were of similar magnitude (0.18-1.3 °C). The amount of material injected into the stratosphere, however, differed greatly. By comparing the estimated amount of ash vs. sulfur injected into the stratosphere by each eruption, it was suggested that the longer residence time of sulfate aerosols, not the ash particles which fall out within a few months of an eruption, was the paramount controlling factor (Rampino and Self, 1982).

In contrast to these explosive eruptions, one of the most severe volcano-related climate effects in historical times was associated with a largely nonexplosive eruption that produced very little ash–the 1783 eruption of Laki crater-row in Iceland. The eruption lasted 8-9 months and extruded about 12.3 km3 of basaltic lava over an area of 565 km2. A bluish haze of sulfur aerosols all over Iceland destroyed most summer crops in the country; the crop failure led to the loss of 75% of all livestock and the deaths of 24% of the population (H. Sigurdsson, 1982). The bluish haze drifted east across Europe during the 1783-1784 winter, which was unusually severe.

Clearly, these examples suggested that the explosivity of an eruption and the amount of ash injected into the stratosphere are not the main factors in causing a change in Earth’s climate. Instead, scientists concluded that it must be the amount of sulfur in the erupting magma.

The eruption of El Chichon, Mexico, in 1982 conclusively demonstrated this idea was correct. The explosive eruption injected at least 8 Mt of sulfur aerosols into the atmosphere, and it was followed by a measureable cooling of parts of the Earth’s surface and a warming of the upper atmosphere. A similar-sized eruption at Mount St. Helens in 1980, however, injected only about 1 Mt of sulfur aerosols into the stratosphere. The eruption of Mount St. Helens injected much less sulfur into the atmosphere–it did not result in a noticeable cooling of the Earth’s surface. The newly launched TOMS satellite (in 1978) made it possible to measure these differences in the eruption clouds. Such direct measurements of the eruption clouds combined with surface temperatures make it possible to study the corrleation between volcanic sulfur aerosols (instead of ash) and temporary changes in the world’s climate after some volcanic eruptions.

 

Hazards Of Volcanic Ash

A multitude of dangerous particals and gases, such as aerosols, are carried in volcanic ash. Some of these include;

  • Carbon dioxide
  • Sulfates (sulfur dioxide)
  • Hydrochloric acid
  • Hydroflouric acid

These each have different but serious effects on human health if exposed, which will be discussed later.

In addition, volcanic ash can cause reduced visibility, and it is recommended that precautions are taken when driving.

Sources: Where Does It Come From?

Figure 1

volcanoes found all over the Earth, particularly at plate boundaries

volcanoes found all over the Earth, particularly at plate boundaries

There are volcanoes found all over the Earth, particularly at plate boundaries (see figure 1). This is due to the collision of plates, which causes uplift in the overlying crust. This uplift results in the formation of mountainous landforms; melting of the crust due to frictional heating is what creates magma, which can erupt out of these mountains when pressure gets too high.

Some of the most notable volcanic eruptions are:

  • the 1783 eruption of Mt. Laki in Iceland
    • released clouds of poisonous flourine and sulfur dioxide which killed off about 50% of the livestock population
    • that summer in Great Britain was known as “sand-summer” due to ash carried over the Atlantic
    • poisonous clouds spread over Europe, and a buildup of aerosols caused a cooling effect in the entire Northern Hemisphere
  • the 1815 eruption of Mt. Tambora in Indonesia
    • gas releases caused the Stratosphere to change drastically
    • noxious ash and poisoned rain clouds killed off vegetation
  • the 1902 eruption of Mt. Pelee in Martinique
    • spewed toxic clouds traveling at speeds of 600mph
    • largest eruption in the 20th century

For further information on volcanoes around the world, visit http://www.mapsofworld.com/major-volcanoes.htm.

http://www.chm.bris.ac.uk/webprojects2003/silvester/Page6Famous.htm

 

  • EEA-33 emissions of sulphur oxides (SOX) have decreased by 74% between 1990 and 2011. In 2011, the most significant sectoral source of SOX emissions was ‘Energy production and distribution’ (58% of total emissions), followed by emissions occurring from ‘Energy use in industry’ (20%) and in the ‘Commercial, institutional and households’ (15%) sector.
  • The reduction in emissions since 1990 has been achieved as a result of a combination of measures, including fuel-switching in energy-related sectors away from high-sulphur solid and liquid fuels to low-sulphur fuels such as natural gas, the fitting of flue gas desulphurisation abatement technology in industrial facilities and the impact of European Union directives relating to the sulphur content of certain liquid fuels.
  • All of the EU-28 Member States have reduced their national SOX emissions below the level of the 2010 emission ceilings set in the National Emission Ceilings Directive (NECD)[1]. Emissions in 2011 for the three EEA countries having emission ceilings set under the UNECE/CLRTAP Gothenburg protocol (Liechtenstein, Norway and Switzerland) were also below the level of their respective 2010 ceilings.
  • Environmental context: Typically, sulphur dioxide is emitted when fuels or other materials containing sulphur are combusted or oxidised. It is a pollutant that contributes to acid deposition, which, in turn, can lead to changes in soil and water quality. The subsequent impacts of acid deposition can be significant, including adverse effects on aquatic ecosystems in rivers and lakes and damage to forests, crops and other vegetation. SO2 emissions also aggravate asthma conditions and can reduce lung function and inflame the respiratory tract. They also contribute, as a secondary particulate pollutant, to the formation of particulate matter in the atmosphere, an important air pollutant in terms of its adverse impact on human health. Furthermore, the formation of sulphate particles in the atmosphere following the release of SO2 results in reflection of solar radiation, which leads to net cooling of the atmosphere.
faults  sn-seafloor

faults sn-seafloor

 

Glacier - Helheim

Glacier – Helheim

 

Making North America

Making North America

 

so2-global-1986

so2-global-1986

 

What caused the Nepal earthquake

What caused the Nepal earthquake

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Mapping the Universe of Pharmaceutical Business Intelligence: The Model developed by LPBI and the Model of Best Practices LLC


Mapping the Universe of Pharmaceutical Business Intelligence: The Model developed by LPBI and the Model of Best Practices LLC

 

Author and Curator of Model A: Aviva Lev-Ari, PhD, RN

Reporter on Model B: Aviva Lev-Ari, PhD, RN

 

This article provides the e-Reader with a MAP for navigation through two different Business Models that Co-exist in the EcoSystem of an industry called Pharmaceutical Business Intelligence.

Model A: is represented by Six Ventures of Leaders in Pharmaceutical Business Intelligence (LPBI), based in Boston, Philadelphia, CT, CA and Israel

Model B: is represented by Best Practices, LLC, headquartered in Chapel Hill, NC, with Offices in NYC and in Mumbai, India.

 

We concluded that the two models are viable, represent fast growth, the models and non-competing and are in full complementarity, thus, expanding the domain and the practice of the industrial sector, aka, Pharmaceutical Business Intelligence.

 

 

Model A:

Leaders in Pharmaceutical Business Intelligence (LPBI),

Boston, Philadelphia, CT, CA and Israel 

Team members

 

Our Growth Needs: Leaders in Pharmaceutical Business Intelligence

 

 Our Business Portfolio

VENTURE #1:

e-Publishing: Medicine, HealthCare, Life Sciences, BioMed, Pharmaceutical

  • Open Access Online Scientific Journal

http://pharmaceuticalintelligence.com Site statistics https://pharmaceuticalintelligence.wordpress.com/wp-admin/index.php?page=stats

  • Scoop.it!.com

  1. http://www.scoop.it/t/cardiotoxicity
  2. http://www.scoop.it/t/cardiovascular-and-vascular-imaging
  3. http://www.scoop.it/t/cardiovascular-disease-pharmaco-therapy

VENTURE #2:

1. BioMedical e-Books e-Series: Cardiovascular, Genomics, Cancer, BioMed, Patient Centered Medicine

https://pharmaceuticalintelligence.com/biomed-e-books/

2. on Amazon’s Kindle e-Books List since 6/2013

3. Plans for Volume 1,2,3 – Hardcover

VENTURE #3:

International Scientific Delegations

https://pharmaceuticalintelligence.com/scientific-delegation/

  • Shanghai, May 2015
  • Barcelona, Spain, November 2015
  • Amsterdam, May 2016
  • Geneva, November 2016

 

VENTURE #4:

Funding, Deals & Partnerships

https://pharmaceuticalintelligence.com/joint-ventures/

 

VENTURE #5:

IP Invented HERE!

1.  Development of a NEW Nitric Oxide monitor to Alpha Szenszor Inc. sensor portfolio. A concept for a low cost POC e-nose, capable of real time ppb detection of Cancer The Cancer Team at Leaders in Pharmaceutical Business Intelligence under the leadership of Dr. Williams

2.  Development of a NEW Nitric Oxide monitor to Alpha Szenszor Inc. sensor portfolio. A concept for Inhaled Nitric Oxide for the Adult HomeCare Market – IP by Dr. Pearlman and Dr. A. Lev-Ari

a.  iknow iNO is i-kNOw – Inhaled Nitric Oxide for the HomeCare Markethttps://pharmaceuticalintelligence.com/2013/10/16/iknow-ino-is-i-know-inhaled-nitric-oxide-for-the-homecare-market/

b. electronic Book on Nitric Oxide by Nitric Oxide Team @ Leaders in Pharmaceutical Business Intelligence (LPBI)

Perspectives on Nitric Oxide in Disease Mechanisms

http://www.amazon.com/dp/B00DINFFY

c. The rationale and use of inhaled NO in Pulmonary Artery Hypertension and Right Sided Heart Failure Larry H. Bernstein 8/20/2012

d. Inhaled Nitric Oxide in Adults: Clinical Trials and Meta Analysis Studies – Recent Findings

Aviva Lev-Ari, PhD, RN, 6/2/2013

e. Clinical Indications for Use of Inhaled Nitric Oxide (iNO) in the Adult Patient Market: Clinical Outcomes after Use, Therapy Demand and Cost of Care

Aviva Lev-Ari, PhD, RN, 6/3/2013

3.  Cancer Genomics for NEW product development in diagnosis and treatment of Cancer Patients using sensory technology with applications for Radiation Therapy –The Cancer Team at Leaders in Pharmaceutical Business Intelligence under leadership of TBA

4.  Developing Mitral Valve Disease: MRI Methods and Devices for Percutaneous Mitral Valve Replacement and Mitral Valve Repair Augmentation of Patented Technology using RF – Dr. Pearlman’s IP Non-Hardware Mitral Annuloplasty – Dr. Justin D. Pearlman

https://pharmaceuticalintelligence.com/joint-ventures/valvecure-llc/non-hardware-mitral-annuloplasty-dr-justin-d-pearlman/

5.  Novel Technology using MRI for Vascular Lesions, Tumors, Hyperactive Glands and non-Surgical Cosmetic Reconstruction – Dr. Pearlman’s IP

http://pharmaceuticalintelligence.com/biomed-e-books/series-a-e-books-on-cardiovascular-diseases/httppharmaceuticalintelligence-combiomed-e-bookscardiovascular-diseases-causes-risks-and-management/cvd-business-affairs/mitral-valve-disease-mri-methods-and-devices/

 

VENTURE # 6:

PRESS Coverage of Conferences

https://pharmaceuticalintelligence.com/press-coverage/

Model B:

 
Best Practices, LLC, Chapel Hill, NC, Mumbai, India, Branch in New York

 

Best Practices, LLC
6350 Quadrangle Drive, Suite 200,
Chapel HillNC 27517

+1 919-403-0251

SOURCE

http://www.best-in-class.com/sitemap

 

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Why did this occur? The matter of Individual Actions Undermining Trust, The Patent Dilemma and The Value of a Clinical Trials


Why did this occur? The matter of Individual Actions Undermining Trust, The Patent Dilemma and The Value of a Clinical Trials

Reporter and Curator: Larry H. Bernstein, MD, FCAP

 

he large amount of funding tied to continued research and support of postdoctoral fellows leads one to ask how following the money can lead to discredited work in th elite scientific community.

Moreover, the pressure to publish in prestigious journals with high impact factors is a road to academic promotion.  In the last twenty years, it is unusual to find submissions for review with less than 6-8 authors, with the statement that all contributed to the work.  These factors can’t be discounted outright, but it is easy for work to fall through the cracks when a key investigator has over 200 publications and holds tenure in a great research environment.  But that is where we find ourselves today.

There is another issue that comes up, which is also related to the issue of carrying out research, and then protecting the work for commercialization.  It is more complicated in the sense that it is necessary to determine whether there is prior art, and then there is the possibility that after the cost of filing patent and a 6 year delay in obtaining protection, there is as great a cost in bringing the patent to finasl production.

I.  Individual actions undermining trust.

II. The patent dilemma.

III. The value of a clinical trial.

IV. The value contributions of RAP physicians
(radiologists, anesthesiologists, and pathologists – the last for discussion)
Those who maintain and inform the integrity of medical and surgical decisions

 

I. Top heart lab comes under fire

Kelly Servick

Science 18 July 2014: Vol. 345 no. 6194 p. 254 DOI: 10.1126/science.345.6194.25

 

In the study of cardiac regeneration, Piero Anversa is among the heavy hitters. His research into the heart’s repair mechanisms helped kick-start the field of cardiac cell therapy (see main story). After more than 4 decades of research and 350 papers, he heads a lab at Harvard Medical School’s Brigham and Women’s Hospital (BWH) in Boston that has more than $6 million in active grant funding from the National Institutes of Health (NIH). He is also an outspoken voice in a field full of disagreement.

So when an ongoing BWH investigation of the lab came to light earlier this year, Anversa’s colleagues were transfixed. “Reactions in the field run the gamut from disbelief to vindication,” says Mark Sussman, a cardiovascular researcher at San Diego State University in California who has collaborated with Anversa. By Sussman’s account, Anversa’s reputation for “pushing the envelope” and “challenging existing dogma” has generated some criticism. Others, however, say that the disputes run deeper—to doubts about a cell therapy his lab has developed and about the group’s scientific integrity. Anversa told Science he was unable to comment during the investigation.

“People are talking about this all the time—at every scientific meeting I go to,” says Charles Murry, a cardiovascular pathologist at the University of Washington, Seattle. “It’s of grave concern to people in the field, but it’s been frustrating,” because no information is available about BWH’s investigation. BWH would not comment for this article, other than to say that it addresses concerns about its researchers confidentially.

In April, however, the journal Circulation agreed to Harvard’s request to retract a 2012 paper on which Anversa is a corresponding author, citing “compromised” data. The Lancet also issued an “Expression of Concern” about a 2011 paper reporting results from a clinical trial, known as SCIPIO, on which Anversa collaborated. According to a notice from the journal, two supplemental figures are at issue.

For some, Anversa’s status has earned him the benefit of the doubt. “Obviously, this is very disconcerting,” says Timothy Kamp, a cardiologist at the University of Wisconsin, Madison, but “I would be surprised if it was an implication of a whole career of research.”

Throughout that career, Anversa has argued that the heart is a prolific, lifelong factory for new muscle cells. Most now accept the view that the adult heart can regenerate muscle, but many have sparred with Anversa over his high estimates for the rate of this turnover, which he maintained in the retracted Circulation paper.

Anversa’s group also pioneered a method of separating cells with potential regenerative abilities from other cardiac tissue based on the presence of a protein called c-kit. After publishing evidence that these cardiac c-kit+cells spur new muscle growth in rodent hearts, the group collaborated in the SCIPIO trial to inject them into patients with heart failure. In The Lancet, the scientists reported that the therapy was safe and showed modest ability to strengthen the heart—evidence that many found intriguing and provocative. Roberto Bolli, the cardiologist whose group at the University of Louisville in Kentucky ran the SCIPIO trial, plans to test c-kit+ cells in further clinical trials as part of the NIH-funded Cardiovascular Cell Therapy Research Network.

But others have been unable to reproduce the dramatic effects Anversa saw in animals, and some have questioned whether these cells really have stem cell–like properties. In May, a group led by Jeffery Molkentin, a molecular biologist at Cincinnati Children’s Hospital Medical Center in Ohio, published a paper in Nature tracing the genetic lineage of c-kit+ cells that reside in the heart. He concluded that although they did make new muscle cells, the number is “astonishingly low” and likely not enough to contribute to the repair of damaged hearts. Still, Molkentin says that he “believe[s] in their therapeutic potential” and that he and Anversa have discussed collaborating.

Now, an anonymous blogger claims that problems in the Anversa lab go beyond controversial findings. In a letter published on the blog Retraction Watch on 30 May, a former research fellow in the Anversa lab described a lab culture focused on protecting the c-kit+ cell hypothesis: “[A]ll data that did not point to the ‘truth’ of the hypothesis were considered wrong,” the person wrote. But another former lab member offers a different perspective. “I had a great experience,” says Federica Limana, a cardiovascular disease researcher at IRCCS San Raffaele Pisana in Rome who spent 2 years of her Ph.D. work with the group in 1999 and 2000, as it was beginning to investigate c-kit+ cells. “In that period, there was no such pressure” to produce any particular result, she says.

Accusations about the lab’s integrity, combined with continued silence from BWH, are deeply troubling for scientists who have staked their research on theories that Anversa helped pioneer. Some have criticized BWH for requesting retractions in the midst of an investigation. “Scientific reputations and careers hang in the balance,” Sussman says, “so everyone should wait until all facts are clearly and fully disclosed.”

 

II.  Trolling Along: Recent Commotion About Patent Trolls

July 17, 2014

PriceWaterhouseCoopers recently released a study about 2014 Patent Litigation. PwC’s ultimate conclusion was that case volume increased vastly and damages continue a general decline, but what’s making headlines everywhere is that “patent trolls” now account for 67% of all new patent lawsuits (see, e.g., Washington Post and Fast Company).

Surprisingly, looking at PwC’s study, the word “troll” is not to be found. So, with regard to patent trolls, what does this study really mean for companies, patent owners and casual onlookers?

First of all, who are these trolls?

“Patent Troll” is a label applied to patent owners who do not make or manufacture a product, or offer a service. Patent trolls live (and die) by suing others for allegedly practicing an invention that is claimed by their patents.

The politically correct term is Non-practicing Entity (NPE). PwC solely uses the term NPE, which it defines as an entity that does not have the capability to design, manufacture, or distribute products with features protected by the patent.

So, what’s so bad about them?

The common impression of an NPEs is a business venture looking to collect and monetize assets (i.e., patents). In the most basic strategy, an NPE typically buys patents with broad claims that cover a wide variety of technologies and markets, and then sues a large group of alleged patent infringers in the hope to collect a licensing royalty or a settlement. NPEs typically don’t want to spend money on a trial unless they have to, and one tactic uses settlements with smaller businesses to build a “war chest” for potential suits with larger companies.

NPEs initiating a lawsuit can be viewed positively, such as a just defense of the lowly inventor who sold his patent to someone (with deeper pockets) who could fund the litigation to protect the inventor’s hard work against a mega-conglomerate who ripped off his idea.

Or NPE litigation can be seen negatively, such as an attorney’s demand letter on behalf of an anonymous shell corporation to shake down dozens of five-figure settlements from all the local small businesses that have ever used a fax machine.

NPEs can waste a company’s valuable time and resources with lawsuits, yet also bring value to their patent portfolios by energizing a patent sales and licensing market. There are unscrupulous NPEs, but it’s hardly the black and white situation that some media outlets are depicting.

What did PwC say about trolls?

Well, the PwC study looked at the success rates and awards of patent litigation decisions. One conclusion is that damages awards for NPEs averaged more than triple those for practicing entities over the last four years. We’ll come back to this statistic.

Another key observation is that NPEs have been successful 25% of the time overall, versus 35% for practicing entities. This makes sense because of the burden of proof the NPEs carry as a plaintiff at trial and the relative lack of success for NPEs at summary judgment. However, PwC’s report states that both types of entities win about two-thirds of their trials.

But what about this “67% of all patent trials are initiated by trolls” discussion?

The 67% number comes from the RPX Corporation’s litigation report (produced January 2014) that quantified the percentage of NPE cases filed in 2013 as 67%, compared to 64% in 2012, 47% in 2011, 30% in 2010 and 28% in 2009.

PwC refers to the RPX statistics to accentuate that this new study indicates that only 20% ofdecisions in 2013 involved NPE-filed cases, so the general conclusion would be that NPE cases tend to settle or be dismissed prior to a court’s decision. Admittedly, this is indicative of the prevalent “spray and pray” strategy where NPEs prefer to collect many settlement checks from several “targets” and avoid the courtroom.

In this study, who else is an NPE?

If someone were looking to dramatize the role of “trolls,” the name can be thrown around liberally (and hurtfully) to anyone who owns and asserts a patent without offering a product or a service. For instance, colleges and universities fall under the NPE umbrella as their research and development often ends with a series of published papers rather than a marketable product on an assembly line.

In fact, PwC distinguishes universities and non-profits from companies and individuals within their NPE analysis, with only about 5% of the NPE cases from 1995 to 2013 being attributed to universities and non-profits. Almost 50% of the NPE cases are attributed to an “individual,” who could be the listed inventor for the patent or a third-party assignee.

The word “troll” is obviously a derogatory term used to connote greed and hiding (under a bridge), but the term has adopted a newer, meme-like status as trolls are currently depicted as lacking any contribution to society and merely living off of others’ misfortunes and fears. [Three Billy Goats Gruff]. This is not always the truth with NPEs (e.g., universities).

No one wants to be called a troll—especially in front of a jury—so we’ve even recently seen courts bar defendants from referring to NPEs as such colorful terms as a “corporate shell,” “bounty hunter,” “privateer,” or someone “playing the lawsuit lottery.” [Judge Koh Bans Use Of Term ” Patent Troll” In Apple Jury Trial]

Regardless of the portrayal of an NPE, most people in the patent world distinguish the “trolls” by the strength of the patent, merits of the alleged infringement and their behavior upon notification. Often these are expressed as “frivolity” of the case and “gamesmanship” of the attorneys. Courts are able to punish plaintiffs who bring frivolous claims against a party and state bar associations are tasked with monitoring the ethics of attorneys. The USPTO is tasked with working to strengthen the quality of patents.

What’s the take-away from this study regarding NPEs?

The study focuses on patent litigation that produced a decision, therefore the most important and relevant conclusion is that, over the last four years, average damages awards for NPEs are more than triple the damages for practicing entities. Everything else in these articles, such as the initiation of litigation by NPEs, settlement percentages, and the general behavior of patent trolls is pure inference beyond the scope of the study.

This may sound sympathetic to trolls, but keep in mind that the study highlights that NPEs have more than triple the damages on average compared to practicing entities and it is meant to shock the reader a bit. One explanation for this is that NPEs are in the best position to choose the patents they want to assert and choose the targets they wish to sue—especially when the NPE is willing to ride that patent all the way to the end of a long, expensive trial. Sometimes settling is not an option. Chart 2b indicates that the disparity in the damages awarded to NPEs relative to practicing entities has always been big (since 2000), but perhaps going from two-fold from 2000 – 2009 to three times as much in the past 4 years indicates that NPEs are improving at finding patents and/or picking battles to take all the way to a court decision. More than anything, this seems to reflect the growth in the concept of patents as a business asset.

The PwC report is chock full of interesting patterns and trends of litigation results, so it’s a shame that the 67% number makes the headlines—far more interesting are the charts comparing success rates by 4-year periods (Chart 6b) or success rates for NPEs and practicing entities in front of a jury verusin front of a bench (Chart 6c), as well as other tables that reveal statistics for specific districts of the federal courts. Even the stats that look at the success rates of each type of NPE are telling because the reader sees that universities and non-profits have a higher success rate than non-practicing companies or individuals.

What do we do about the trolls?

The White House has recently called for Congress to do something about the trolls as horror stories of scams and shake-downs are shared. A bill was gaining momentum in the Senate, when Senator Leahy took it off the agenda in early July. That bill had miraculously passed 325-91 in the House and President Obama was willing to sign it if the Senate were to pass it. The bill was opposed by trial attorneys, universities, and bio-pharmaceutical businesses who felt as though the law would severely inhibit everyone’s access to the courts in order to hinder just the trolls. Regardless, most people think that the sitting Congressmen merely wanted a “win” prior to the mid-term elections and that patent reform is unlikely to reappear until next term.

In the meantime, the Supreme Court has recently reiterated rules concerning attorney fee-shifting on frivolous patent cases, as well as clarifying the validity of software patents. Time will tell if these changes have any effects on the damages awards that PwC’s study examined or even if they cause a chilling of the number of patent lawsuit filings.

Furthermore, new ways to challenge the validity of asserted patents have been initiated via the America Invents Act. For example, the Inter Partes Review (IPR) has yielded frightening preliminary statistics as to slowing, if not killing, patents that have been asserted in a suit. While these administrative trials are not cheap, many view these new tools at the Patent Trial and Appeals Board as anti-troll measures. It will be interesting to watch how the USPTO implements these procedures in the near future, especially while former Google counsel, Acting Director Michelle K. Lee, oversees the office.

In the private sector, Silicon Valley has recently seen a handful of tech companies come together as the License on Transfer Network, a group hoping to disarm the “Patent Assertion Entities.” Joining the LOT Network comes via an agreement that creates a license for use of a patent by anyone in the LOT network once that patent is sold. The thought is that the NPEs who consider purchasing patents from companies in the LOT Network will have fewer companies to sue since the license to the other active LOT participants will have triggered upon the transfer and, thus, the NPE will not be as inclined to “troll.” For instance, if a member-company such as Google were to sell a patent to a non-member company and an NPE bought that patent, the NPE would not be able to sue any members of the LOT Network with that patent.

Other notes

NPEs are only as evil as the people who run them—that being said, there are plenty of horror stories of small businesses receiving phantom demand letters that threaten a patent infringement suit without identifying themselves or the patent. This is an out-and-out scam and a plague on society that results in wasted time and resource, and inevitably higher prices on the consumer end.

It is a sin and a shame that patent rights can be misused in scams and shake-downs of businesses around us, but there is a reason that U.S. courts are so often used to defend patent rights. The PwC study, at minimum, reflects the high stakes of the patent market and perhaps the fragility. Nevertheless, merely monitoring the courts may not keep the trolls at bay.

I’d love to hear your thoughts.

*This is provided for informational purposes only, and does not constitute legal or financial advice. The information expressed is subject to change at any time and should be checked for completeness, accuracy and current applicability. For advice, consult a suitably licensed attorney or patent agent.

 

III. Large-scale analysis finds majority of clinical trials don’t provide meaningful evidence

Ineffective TreatmentsMedical Ethics • Tags: Center for Drug Evaluation and ResearchClinical trialCTTIDuke University HospitalFDAFood and Drug AdministrationNational Institutes of HealthUnited States National Library of Medicine

04 May 2012

DURHAM, N.C.— The largest comprehensive analysis of ClinicalTrials.gov finds that clinical trials are falling short of producing high-quality evidence needed to guide medical decision-making. The analysis, published today in JAMA, found the majority of clinical trials is small, and there are significant differences among methodical approaches, including randomizing, blinding and the use of data monitoring committees.

“Our analysis raises questions about the best methods for generating evidence, as well as the capacity of the clinical trials enterprise to supply sufficient amounts of high quality evidence to ensure confidence in guideline recommendations,” said Robert Califf, M.D., first author of the paper, vice chancellor for clinical research at Duke University Medical Center, and director of the Duke Translational Medicine Institute.

The analysis was conducted by the Clinical Trials Transformation Initiative (CTTI), a public private partnership founded by the Food and Drug Administration (FDA) and Duke. It extends the usability of the data in ClinicalTrials.gov for research by placing the data through September 27, 2010 into a database structured to facilitate aggregate analysis. This publically accessible database facilitates the assessment of the clinical trials enterprise in a more comprehensive manner than ever before and enables the identification of trends by study type.

 

The National Library of Medicine (NLM), a part of the National Institutes of Health, developed and manages ClinicalTrials.gov. This site maintains a registry of past, current, and planned clinical research studies.

“Since 2007, the Food and Drug Administration Amendment Act has required registration of clinical trials, and the expanded scope and rigor of trial registration policies internationally is producing more complete data from around the world,” stated Deborah Zarin, MD, director, ClinicalTrials.gov, and assistant director for clinical research projects, NLM. “We have amassed over 120,000 registered clinical trials. This rich repository of data has a lot to say about the national and international research portfolio.”

This CTTI project was a collaborative effort by informaticians, statisticians and project managers from NLM, FDA and Duke. CTTI comprises more than 60 member organizations with the goal of identifying practices that will improve the quality and efficiency of clinical trials.

“Since the ClinicalTrials.gov registry contains studies sponsored by multiple entities, including government, industry, foundations and universities, CTTI leaders recognized that it might be a valuable source for benchmarking the state of the clinical trials enterprise,” stated Judith Kramer, MD, executive director of CTTI.

The project goal was to produce an easily accessible database incorporating advances in informatics to permit a detailed characterization of the body of clinical research and facilitate analysis of groups of studies by therapeutic areas, by type of sponsor, by number of participants and by many other parameters.

“Analysis of the entire portfolio will enable the many entities in the clinical trials enterprise to examine their practices in comparison with others,” says Califf. “For example, 96% of clinical trials have ≤1000 participants, and 62% have ≤ 100. While there are many excellent small clinical trials, these studies will not be able to inform patients, doctors and consumers about the choices they must make to prevent and treat disease.”

The analysis showed heterogeneity in median trial size, with cardiovascular trials tending to be twice as large as those in oncology and trials in mental health falling in the middle. It also showed major differences in the use of randomization, blinding, and data monitoring committees, critical issues often used to judge the quality of evidence for medical decisions in clinical practice guidelines and systematic overviews.

“These results reinforce the importance of exploration, analysis and inspection of our clinical trials enterprise,” said Rachel Behrman Sherman, MD, associate director for the Office of Medical Policy at the FDA’s Center for Drug Evaluation and Research. “Generation of this evidence will contribute to our understanding of the number of studies in different phases of research, the therapeutic areas, and ways we can improve data collection about clinical trials, eventually improving the quality of clinical trials.”

Related articles

 

IV.  Lawmakers urge CMS to extend MU hardship exemption for pathologists

 

Eighty-nine members of Congress have asked the Centers for Medicare & Medicaid Services to give pathologists a break and extend the hardship exemption they currently enjoy for all of Stage 3 of the Meaningful Use program.In the letter–dated July 10 and addressed to CMS Administrator Marilyn Tavenner–the lawmakers point out that CMS had recognized in its 2012 final rule implementing Stage 2 of the program that it was difficult for pathologists to meet the Meaningful Use requirements and granted a one year exception for 2015, the first year that penalties will be imposed. They now are asking that the exception be expanded to include the full five-year maximum allowed under the American Recovery and Reinvestment Act.

“Pathologists have limited direct contact with patients and do not operate in EHRs,” the letter states. “Instead, pathologists use sophisticated computerized laboratory information systems (LISs) to support the work of analyzing patient specimens and generating test results. These LISs exchange laboratory and pathology data with EHRs.”

Interestingly, the lawmakers’ exemption request is only on behalf of pathologists, even though CMS had granted the one-year hardship exception to pathologists, radiologists and anesthesiologists.

Rep. Tom Price (R-Ga.), one of the members spearheading the letter, had also introduced a bill (H.R. 1309) in March 2013 that would exclude pathologists from the incentives and penalties of the Meaningful Use program. The bill, which has 31 cosponsors, is currently sitting in committee. That bill also does not include relief for radiologists or anesthesiologists.

CMS has provided some flexibility about the hardship exceptions in the past, most recently by allowing providers to apply for one due to EHR vendor delays in upgrading to Stage 2 of the program.

However, CMS also noted in the 2012 rule granting the one-year exception that it was granting the exception in large part because of the then-current lack of health information exchange and that “physicians in these three specialties should not expect that this exception will continue indefinitely, nor should they expect that we will grant the exception for the full 5-year period permitted by statute.”

To learn more:
– read the letter (.pdf)

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Reason in Hobby Lobby

Curator: Larry H. Bernstein, MD, FCAP

 

This is a Part 4 followup of the Hobby Lobby legal precedent.

  • Where has the reason gone?

https://pharmaceuticalintelligence.com/2014/07/07/where-has-reason-gone-2/

  • Justice Ginsberg written dissent – Third Part

https://pharmaceuticalintelligence.com/2014/07/08/justice-ginsberg-written-dissent/

  • The physicians’ view of Supreme Court on an issue of public health

https://pharmaceuticalintelligence.com/2014/07/08/the-physicians-view-of-supreme-court-on-an-issue-of-public-health/

  •  Reason in Hobby Lobby

https://pharmaceuticalintelligence.com/2014/07/08/reason-in-hobby-lobby/

 

 Reason in Hobby Lobby

 

 

Reason #1 SCOTUS Will Regret Hobby Lobby byMan from Wasichustan

After oral arguments in the Hobby Lobby case, I wrote a very misnamed but widely read diary in which I echoed Attorney and Ring of Fire radio host Mike Papantonio’s argument that the SCOTUS would never rule in favor of Hobby Lobby for a really Big Business reason: It pierces the corporate veil.  If Hobby Lobby’s owners can give their Corporation religion, their religion gives Hobby Lobby’s owners–and any other owner, shareholder, officer, whatever–liability for the actions of the corporation.  Mr. Papantonio, who happens to be one of America’s preeminent trial lawyers, sees it as an opportunity to sue owners for the company’s negligence. Some other people, it turns out, agree with his assessment and expand on what it means….

That separation is what legal and business scholars call the “corporate veil,” and it’s fundamental to the entire operation. Now, thanks to the Hobby Lobby case, it’s in question. By letting Hobby Lobby’s owners assert their personal religious rights over an entire corporation, the Supreme Court has poked a major hole in the veil. In other words, if a company is not truly separate from its owners, the owners could be made responsible for its debts and other burdens.  So says Alex Park, writing in Salon today.

“If religious shareholders can do it, why can’t creditors and government regulators pierce the corporate veil in the other direction?” Burt Neuborne, a law professor at New York University, asked in an email. That’s a question raised by 44 other law professors, who filed a friends-of-the-court brief that implored the Court to reject Hobby Lobby’s argument and hold the veil in place. Here’s what they argued: Allowing a corporation, through either shareholder vote or board resolution, to take on and assert the religious beliefs of its shareholders in order to avoid having to comply with a generally-applicable law with a secular purpose is fundamentally at odds with the entire concept of incorporation.

Creating such an unprecedented and idiosyncratic tear in the corporate veil would also carry with it unintended consequences, many of which are not easily foreseen. This is definitely going to complicate things for the religious extremists on the SCOTUS and empire wide as these lawsuits inevitably proliferate.  Putting on the popcorn….now.

George Takei’s blistering response to #HobbyLobby: Could a Muslim Corp impose Sharia Law?

byVyan   THU JUL 03, 2014 AT 09:12 AM PDT “The ruling elevates the rights of a FOR-PROFIT CORPORATION over those of its women employees and opens the door to all manner of claims that a company can refuse services based on its owner’s religion,” Takei wrote.

(O)ne wonders,” he said, “whether the case would have come out differently if a Muslim-run chain business attempted to impose Sharia law on its employees.” “Hobby Lobby is not a church. It’s a business — and a big one at that,” he continued. “Businesses must and should be required to comply with neutrally crafted laws of general applicability.

Your boss should not have a say over your healthcare. Just as Justice Ginsberg and Mr Takei have suggested, the Hyper-Religious are already attempting to capitalize on the SCOTUS new granting of the rights of an individual to a corporate entity. In this decision the SCOTUS Majority opinion claimed that they were not granting the equal legitimacy of such follow on requests, but they’ve kicked open the door. Takei – bless his soul – also pointed out the basic hypocrisy of Hobby Lobby’s business practices in regards to religion.  Noting that… …Hobby Lobby has invested in multiple companies that manufacture abortion drugs and birth control. The company receives most of its merchandise from China, a country where overpopulation has led to mandatory abortions and sterilizations for women who try to have more than one child.

What the battle over birth control is really about     byteacherken

in a 2012 piece at Alternet by Sara Robinson. Conservative bishops and Congressmen are fighting a rear-guard action against one of the most revolutionary changes in human history. Robinson suggests 500 years from now looking back, the three great achievements of the 20th Century are likely to be the invention of the integrated circuit (without which the internet does not exist), the Moon landing (which she thinks will carry the same impact as Magellan’s circumnavigation of the globe), and the mass availability of nearly 100% effective contraception.

 Free Birth Control is Emerging Standard for Women   RICARDO ALONSO-ZALDIVAR, Associated Press       07/07/2014

WASHINGTON (AP) — More than half of privately insured women are getting free birth control under President Barack Obama’s health law, a major coverage shift that’s likely to advance. This week the Supreme Court allowed some employers with religious scruples to opt out, but most companies appear to be going in the opposite direction. Recent data from the IMS Institute document a sharp change during 2013. The share of privately insured women who got their birth control pills without a copayment jumped to 56 percent, from 14 percent in 2012. The law’s requirement that most health plans cover birth control as prevention, at no additional cost to women, took full effect in 2013. The average annual saving for women was $269. “It’s a big number,” said institute director Michael Kleinrock. The institute is the research arm of IMS Health, a Connecticut-based technology company that uses pharmacy records to track prescription drug sales. The core of Obama’s law — taxpayer-subsidized coverage for the uninsured — benefits a relatively small share of Americans. But free preventive care— from flu shots to colonoscopies —is a dividend of sorts for the majority with employer coverage.

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