Innovations in HealthCare: New Office to Focus on Clinical Practice

The George Washington University School of Medicine and Health Sciences initiative aims to improve medical care through clinical intervention

A new office housed in the School of Medicine and Health Sciences will serve as a hub for developing and evaluating clinical interventions. The overall goal for the Office of Clinical Practice Innovation is to provide increased knowledge and understanding of structure, processes and effects of health services for individuals and populations.

“Through this new initiative, we hope to unite entities across campus and beyond to spur clinical practice innovation,” said Jesse Pines, director of the Office of Clinical Practice Innovation. “Our goal is that outcomes from our research will not only serve and improve processes within our own clinical entities at GW, but will become benchmarks for medical institutions across the country.”

For example, Dr. Pines and his team are working on proposals that will determine how to better engage patients in quality and safety improvement and are studying new innovations, like clinical decision units, and how they have impacted acute care delivery.

The main objectives of the Office of Clinical Practice Innovation are to:

1. Develop, implement and evaluate clinical initiatives, new practice models and research to improve the quality and value of health care.
2. Spur clinical practice innovation among physicians through collaboration with organizations, including Children’s National Medical Center, Kaiser Permanente Mid-Atlantic, the University of North Carolina, the National Association for Health Care Quality and others, in order to conduct research and introduce novel health care interventions.
3. Work within the university to develop new initiatives that enhance GW funding and collaborations.

“This new initiative represents a bold commitment to finding ways to improve the health care system that we know today,” said Jeffrey S. Akman, vice president for health affairs and dean of the School of Medicine and Health Sciences. “By leveraging our existing partnerships and embarking on collaborations with other, like-minded research institutions, we believe that we will make a positive difference for patients and health care providers.”

The new office will employ assets within GW, including EMR systems used by its clinical partners, and develop a data infrastructure to facilitate the study of local clinical delivery initiatives at GW, as well as work with local partners. The GW Office of Technology Transfer will work to facilitate the development of new clinical innovations. The Office of Clinical Practice Innovation will also develop a fellowship program for physicians and other providers.

GEORGE WASHINGTON TODAY

Rice Hall
Division of External Relations
2121 Eye Street, NW
Washington, DC 20052
Phone: (202) 994-1000
gwtoday@gwu.edu

Global Policy Report on the Prevention and Control of Viral Hepatitis

The five viruses that cause infections of the liver are responsible for a widely prevalent and growing disease burden. No country, rich or poor, is spared. These viruses are important as they cause infectious diseases in their own right. Hepatitis A and E viruses are major foodborne and waterborne infections, which cause millions of cases of acute illness every year, with several months sometimes needed for full recovery. But viral hepatitis also makes a substantial contribution to the burden of chronic diseases and the premature mortality they cause. Worldwide, infections with hepatitis B and C viruses cause an estimated 57% of cases of liver cirrhosis and 78% of cases of primary liver cancer. The availability of a vaccine that confers lifelong protection against infection with the hepatitis B virus gives public health a rare opportunity to prevent a leading cause of cancer, especially in low- and middle-income countries.

The significance of these challenges and opportunities was formally acknowledged in 2010, when the World Health Assembly adopted its first resolution on viral hepatitis. That resolution, which called for a comprehensive approach to prevention and control, opened a new era of awareness about the magnitude of disease caused by viral hepatitis and the need for urgent action on several fronts.

As attention to viral hepatitis continues to build, so has recognition of the many strategies available for prevention and control in all resource settings. Control measures for viral hepatitis fit well with the current drive to strengthen health systems, especially as many measures touch on the fundamental capacities of a well-functioning health system. These include reaching every child with immunization programmes that include hepatitis B vaccine, protecting against mother-to-child transmission of the virus, and ensuring the safety of blood, transfusion services, organ donation, and injection practices. The broad social and environmental determinants of viral hepatitis further call for improvements in housing, sanitation, and food and water safety. The fact that many infections are silent, causing no symptoms until there is irreversible damage to the liver, points to the urgent need for universal access to immunization, screening, diagnosis, and antiviral therapy.

As hepatitis viruses show great diversity in their prevalence and modes of transmission in different parts of the world, policies and strategies for prevention and control need to be tailored to the specific national or sub-national context. The 2010 World Health Assembly resolution urged Member States to generate reliable information as a foundation for building prevention and control measures that match the local epidemiological profi le and health system capacities.

This report is a contribution to that objective. It sets out the results of a survey conducted in mid-2012 by the World Health Organization and the World Hepatitis Alliance. The survey aimed to gather country-specific baseline data on hepatitis policies in WHO Member States in all six regions. Survey data also off er insight into conditions in specific countries that may have hindered past efforts to achieve hepatitis policy objectives. Gaps that need to be filled are identified, as are specific areas of policy development where WHO assistance is needed. Such baseline data will serve as a solid benchmark as countries, supported by WHO and its partners, seek to make the “silent” epidemic of viral hepatitis more visible – and more manageable.

Fuente: World Hepatitis Alliance

Estadísticas para la Promoción y Prevención
Principales Causas de Mortalidad en LatAm

47,83% de las muertes en LatAm se deben a 10 causas

7 de las 10 principales causas son enfermedades crónicas

Fuente: Organización Panamericana de la Salud (OPS) - Pan American Health Organization (PAHO)

BioPharma Report: Global Biotech Firms raised $11B in first half of 2013

By Peter Winter, BioWorld Insight Editor

Global biotech companies continued their torrid fundraising pace generating almost $6 billion in the second quarter of 2013, a 20 percent uptick on the respectable $5 billion raised in the first quarter of this year. In the period public companies led the way, taking advantage of their ever improving share values to conduct public financings. When you add 16 global initial public offerings (IPOs) into the mix it was not surprising that public financings represented 61 percent of the total funding raised in the second quarter according to BioWorld Snapshots.

Now that we have reached the half-point of the year global biotechs have pocketed almost $11 billion, a 37.6 percent increase of the total raised in the same period of 2012. Approximately 63 percent of the 2013 total came from public offerings and this amount was 72 percent higher than the year earlier total.

In all there were 29 public offering transactions generating $3.6 billion in the second quarter.

May was a particularly busy month for biotechs. Elan Corp. plc's $850 million debt offering was completed amid the noise of its bitter and protracted takeover battle with Royalty Pharma. The hostile takeover bid by Royalty was subsequently firmly rejected by shareholders at an extraordinary general meeting held in mid-June.

Array Biopharma Inc., of Boulder, Colo., completed a debt offering of $132.25 million. The company said it expects to use $92.6 million of the net proceeds to repay its outstanding secured indebtedness, with the remaining proceeds to be used for general corporate purposes.

Isis Pharmaceuticals Inc., of Carlsbad, Calif., generated $182.8 million from an underwritten public offering, including the underwriters purchase option. The company pushed out variety of news in the second quarter including the fact that Xenon Pharmaceuticals Inc., of Burnaby, British Columbia, had exercised its option to an exclusive worldwide license to XEN701, an antisense drug candidate designed to inhibit the production of hepcidin. It was discovered in their ongoing R&D collaboration. Xenon plans to initially develop XEN701 for patients with chronic kidney disease who are intolerant of or who are poor responders to erythropoietin therapy. XEN701 is the first drug to enter development from Isis' collaboration with Xenon, entered in 2010. Isis earned a $2 million payment from Xenon as a result of the option exercise.

Ironwood Pharmaceuticals Inc., of Cambridge, Mass., garnered $145 million from a public offering and plans to use the net funds to support the commercial launch of Linzess (linaclotide) in the U.S. and to fund linaclotide development opportunities to strengthen the clinical profile of Linzess and expand the product label for additional populations and indications. Linzess gained FDA approval last year for use in irritable bowel syndrome.

With companies achieving plenty of success with public financings they didn't have to use other financing vehicles as much in the quarter. This is reflected by the 24 percent drop in the total raised from private placements such as registered direct offerings, rights offerings and at-the-market deals with public biotechnology companies raising $982 million in the second quarter of 2013 from these vehicles compared with $1.3 billion in the first quarter of the year.

The largest transaction was a $220 private placement of convertible senior unsecured notes conducted by Vivus Inc., of Mountain View, Calif.

Capital Market Performance

Like the first quarter, public biotech companies remained hot with investors. According to BioWorld Insight analysis, 53 large biotech companies, with market caps greater than $1 billion, collectively saw their share prices jump by an average of 15 percent in the second quarter and 47 percent year-to-date.

It is interesting to note that over the past 12 months the number of "billion dollar" market cap biotech companies has increased by 51 percent.

The BioWorld Stock Report has recorded an average 21 percent share price increase in 2013 for the 249 public biotechnology companies, which the report tracks. This performance overshadowed the Dow Jones Industrial average, which recorded a 13.8 percent increase, while the NASDAQ Composite index was up 12.8 percent during the same period.

IPOs Take Off

U.S. biotech IPOs were flying off the runway in the second quarter. No less than 14 companies successfully went public, compared to just four in the first quarter. The amount raised from the second quarter IPOs was just over $1 billion.

Plymouth, Mich.-based Esperion Therapeutics Inc. put an exclamation point on an exceptional quarter, pricing its IPO to support midstage testing of its lead compound, ETC-1002, as an alternative to statin therapy in lowering LDL-cholesterol (LDL-C).

Esperion increased the number of shares offered from 4.5 million to 5 million, pricing them at $14 each, the midpoint of its anticipated range.

The offering followed in the footsteps of upsized IPOs from PTC Therapeutics Inc. and Bluebird Bio.

According to BioWorld Today contributing writer Brian Orelli, VCs are still participating in these IPO rounds, so it isn't an exit yet, but at least the potential to return capital to limited partners is in sight.

This situation could come sooner than predicted given the excellent post-IPO performance of these newly minted companies, which collectively have recorded an average 33 percent pop in their share prices.

Epizyme Inc., for example, has seen its shares jump more than 87 percent since its IPO hit the top end of the pricing range. The Cambridge, Mass.-based firm, which had planned to sell about 4.29 million shares at a range of $13 to $15 each, placed about 5.9 million shares for $15 each. The company will use the proceeds for ongoing Phase I work with EPZ-5676 in mixed lineage leukemia (MLL), a particularly virulent subtype of the most common forms of leukemia.

The hyperactivity with biotech IPOs is in keeping with a sharply accelerated activity in the overall US IPO market. As described in Renaissance Capital's 2Q 2013 US IPO Review, 61 companies raised $13 billion. The report said it was the most active quarter for US IPOs in nearly six years. "As the stock market continued to climb higher, investors shifted from the yield plays that dominated the 1Q13 to biotechs and fast-growing technology companies. The average total return improved to 21 percent, with the consumer, technology and health care sectors, the lifeblood of the US IPO market, producing the highest gains," the survey noted.

Hostile Moves

Although investors are continuing to place their bets on biotech companies they believe are most likely to be future acquisition candidates, the quarter was notable for the absence of any marquee M&A transactions. However, it wasn't for the want of trying.

Royalty Pharma, for example, tried to land Elan with a hostile bid of $13 per share plus a contingent value right of up to $2.50 per share, for a potential value of $8 billion. Although the bid was subsequently nixed by shareholders at an extraordinary general meeting, Elan has put itself up for sale, citing its receipt of several expressions of interest.

On the first day of the new quarter, Onyx Pharmaceuticals Inc. said it had rejected an unsolicited $10 billion bid from Amgen Inc. and would seek other potential offers.

Amgen's offer valued South San Francisco-based Onyx at $120 per share, a 38 percent premium over the end of the quarter day closing price, putting it slightly above the 35 percent median for biotech acquisitions over the last several years, according to Deutsche Bank. Nevertheless, Onyx said the Amgen offer "significantly undervalued Onyx and its prospects," and most analysts seemed to agree, not least because Onyx is one of only a handful of biotechs – Seattle Genetics Inc. and Ariad Pharmaceuticals Inc. are other possibilities – with wholly owned products and revenue streams significant enough to entice large-cap interest.

The view from the Street is that the second half of the year we will see several potential M&A deals.

According to Credit Suisse analyst Ravi Mehrotra writing in a research note, "M&A speculation has been to date a relatively small part of the unprecedented 130 percent bull run (since August 2011). The announcement that Amgen had made a $10 billion bid for Onyx is likely to catalyze a certain level of M&A bid speculation/premium for the whole biotech sector, in our view."

Pharmas and large biotechs also have large cash bank balances, which can be deployed to strengthen product pipelines through strategic acquisitions.

Fuente: BioWorld

A New Target in the Fight against Tuberculosis

Cynthia Dowd, Assistant Professor of Chemistry at The George Washington University, leads new study that identifies potential new route for attacking tuberculosis

by Danny Freedman

Researchers have identified a potential new route for attacking tuberculosis that may hold promise against drug-resistant strains of the disease and even dormant TB infections.

In a new study, led by Cynthia Dowd, assistant professor of chemistry, researchers designed and tested molecules that work like a chemical Trojan Horse, sneaking past the defenses of TB-causing bacterial cells and, once inside, blocking functions essential for survival.

The study appears in the July 1 edition of the medicinal chemistry journal MedChemComm.

“TB remains a huge threat to global public health,” Dr. Dowd said. “… New therapeutics are essential for combating drug-resistance and staying one step ahead of the bug, so to speak. Our work seeks to validate a drug target that is not used by current drugs”.

The effects of tuberculosis—a chronic bacterial infection, usually of the lungs—hang over thousands in the United States and millions worldwide. Though rates are improving, there were an estimated 8.7 million new cases of TB in 2011 and 1.4 million deaths, according to the World Health Organization. About one-third of the world population is thought to have latent TB, an inactive infection that carries no TB symptoms and cannot be spread unless it becomes activated.

In the new study, the chemicals targeted an enzyme known by the abbreviation Dxr. Enzymes drive life-sustaining chemical reactions inside cells and are common targets for drug treatments. Operating like a lock-and-key mechanism, enzymes like Dxr have openings that fit complementary-shaped molecules. Once they attach to the enzyme, molecules are broken down or combined to forge yet other molecules for use inside the cell.

Enzyme inhibitors, like those created by the research team, act as false keys and block that process. “The key doesn’t open the lock, the key gums up the lock,” Dr. Dowd said. “It occupies the lock so the right key can’t fit in there”.

The team set out to hamper two of those locks, or binding sites, on the Dxr enzyme: one for fosmidomycin, a proven disruptor of Dxr that is repelled by the cell wall of the bacteria that causes TB; and the binding site for a molecule called NADPH.

Building on their previous work showing that a molecule can be chemically disguised to gain entry into the TB cell, the researchers mimicked both fosmidomycin and NADPH in a masked, two-pronged key that stretched from one binding site to the other. The two-pronged approach, rather than two separated chemicals, can offer a tighter fit into the binding sites, Dr. Dowd said.

The work was a success, and a surprising one at that—the false key for NADPH actually missed its mark and landed in another, unrecognized binding site on the enzyme.

The discovery marks the first time the Dxr enzyme has been used to kill TB, Dr. Dowd said, lending hope that the findings could be used to sidestep resistance TB has built up along other drug pathways. And since Dxr is involved in basic, root-level functions of cells, she said, it may also prove useful against dormant TB infections.

The team is now trying to determine exactly how the chemical works and how to sharpen its potency.

Already the team has “newer compounds that have better [results] than this,” she said.

And whatever anxiety may have been caused by scientific serendipity now has been replaced with the excitement of seeing a new angle on an old problem. “It helps us move into an area where nobody else is,” Dr. Dowd said. “… It forces you to think outside the box and think about things in a new way”.

GEORGE WASHINGTON TODAY

Rice Hall
Division of External Relations
2121 Eye Street, NW
Washington, DC 20052
Phone: (202) 994-1000
gwtoday@gwu.edu

Despite lavish spending, Health of the US Population has fallen behind of Economic Peers

The United States is falling behind its economic peers in most measures of health, despite making gains in the past two decades, according to a sweeping study of data from 34 countries

Although Americans are living longer, with overall US life expectancy increasing to 78.2 in 2010 from 75.2 in 1990, increases in psychiatric disorders, substance abuse and conditions that cause back, muscle and joint pain mean many do not feel well enough to enjoy those added years of life.

“Despite a level of health expenditures that would have seemed unthinkable a generation ago, the health of the US population has improved only gradually and has fallen behind the pace of progress in many other wealthy nations,” Dr. Harvey Fineberg of the Institute of Medicine in Washington, D.C., wrote in an editorial published this week with the study in the Journal of the American Medical Association.

The study by the Institute for Health Metrics and Evaluation at the University of Washington in Seattle is the first comprehensive analysis of disease burden in the United States in more than 15 years. It includes estimates for death and disability from 291 diseases, conditions, and injuries as well as 67 risk factors.

It is one of three new papers by the institute being released simultaneously at the request of first lady Michelle Obama, who plans to present the findings to mayors of US cities in an invitation-only event at the White House as part of her campaign to improve the nation's health.

They add to a growing pile of research showing that despite lavish spending on healthcare in the United States, Americans are failing to make significant gains in many measures of overall health.

In a 2010 report by the non-profit Commonwealth Fund, the United States, despite spending twice as much on healthcare, came in dead last compared with six peers - Britain, Canada, Germany, Netherlands, Australia and New Zealand.

Fuente: MercoPress

Envisioning a "Culture of Health":

What does it look like?

The Robert Wood Johnson Foundation (RWJF) describes an ideal future and how to get there in this new 3 minute video

Fuente: The George Washington University School of Public Health and Health Services

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US Study quantifies the Human Genome Project's huge Economic Impact

The $14.5 billion investment by the U.S. in the Human Genome Project, completed a decade ago, has paid off more than 60-fold in new jobs, drugs and a rapidly expanding genetics industry, an analysis has found.

The endeavor to map human DNA in its entirety created $966 billion in economic impact and $59 billion in federal tax revenue, according to the study released today by United for Medical Research and Battelle, two research advocacy groups.

Dozens of companies have started with the knowledge gained from the project, leading to new diagnostic tests and development of medicines that can be matched with gene variants linked to disease. The project triggered a new era in the life sciences, with new oncology drugs and screenings among the early developments in the field, said Greg Lucier, chief executive officer of Life Technologies Corp. (LIFE)

“Up until that time, the pharmaceutical industry was able to have major impact on human health through blockbuster drugs that in retrospect were relatively simple,” he said in a telephone interview. “The ushering in of the genomic era was the beginning of truly reducing science to engineering, in terms of the understanding of life,” he said.

Life Technologies also provided funding for the study. The Carlsbad, California-based maker of gene-sequencing machines agreed to be bought by Thermo Fisher Scientific Inc. (TMO) for $13.6 billion last April. Other companies that provide sequencing services or equipment include Illumina Inc. (ILMN) and Oxford Nanopore Technologies Ltd. The Human Genome Project also spurred consumer-focused genetics companies such as 23andMe Inc. that let people find out what diseases they might be at risk for or where their ancestry lies.

Cheaper, Faster

While it took almost $15 billion and more than a decade for the government-funded DNA effort to fully sequence a human genome for the first time, companies can now sequence a whole genome for about $1,000 and do it in a day.

“The Human Genome Project was the starting point of that magnificent, incredible effort,” Lucier said.

The market for gene tests may expand to $25 billion from $5 billion within a decade as more doctors use a patient’s genetic makeup to tailor treatments, according to a report last year from UnitedHealth Group Inc. (UNH), the largest U.S. health insurer.

“This report illustrates the vital role that key federal research funding plays in growing the U.S. economy, creating new industries and innovative technologies and producing the diagnostics and treatments that can save lives,” Carrie Wolinetz, president of United for Medical Research, said in a statement. She called the now-complete project the biggest undertaking in the history of the life sciences.

Oncology Innovations

Some of biggest innovations have been in the field of oncology. The actress Angelina Jolie recently became the new face of breast cancer, after announcing that she’d had a double-mastectomy upon discovering that she carried a gene that predicts about a 60 percent chance of developing the disease.

Thanks to the advances in genetic screening, drug developers also now look for genetic mutations in tumors that can explain why they grow and metastasize, and create drugs to specifically target that aspect of the disease.

“I think in the next decade, we’ll be able to -- in many cancers -- change that disease from being terminal to chronic, and that’s a complete outgrowth of the human genome project and our knowledge of genomics,” Lucier said.

Fuente: Drew Armstrong, for Bloomberg

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US BIOPHARMA: 215 CARDIOVASCULAR DRUGS NOW IN R&D.

US BioPharmaceutical companies are currently developing 215 new medicines for heart disease and stroke, according to new industry data.

All of the new treatments are now either in human clinical trials or under review at the US Food and Drug Administration (FDA), according to the research, which has been released by the Pharmaceutical Research and Manufacturers of America (PhRMA).

The potential new treatments include:

• 30 new medicines for heart failure, which impacts an estimated 5.1 million US citizens;
• 29 for lipid disorders, such as high cholesterol, which affect nearly 100 million Americans;
• 19 for stroke, which affects more than 22,000 people each year in the US;
• 17 each for hypertension, which impacts around 78 million Americans, and for ischaemic disorders;
• 15 for peripheral vascular disease;
• 14 for pulmonary vascular disease:
• 13 for thrombosis –in 2009,  pulmonary embolism (PE) accounted for 7,040 US deaths and 2,452 deaths from deep vein thrombosis (DVT);
• 12 each for acute coronary syndrome, atherosclerosis and heart attack, affecting an estimated 7.6 million people;
• nine each for adjunctive therapies and imaging agents; and
• eight for coronary artery disease, affecting 6.8 million.

Many of these potential new medicines use cutting-edge technologies and new scientific methods, such as: - a gene therapy that uses a patient's own cells to treat heart failure; - a medicine that blocks the transfer of good high-density lipoprotein (HDL) cholesterol to bad low-density lipoprotein (LDL); and - a genetically-engineered product that dissolves clots to treat stroke.

Cardiovascular diseases (CVD) cost the US some $312.6 billion in 2009, and an estimated 83.6 million Americans - more than one in three - have one or more types of CVD, according to PhRMA. Also, 6.8 million Americans are estimated to have suffered a stroke, with about 795,000 experiencing a new or recurrent strike every year, and a death from the condition occurring once every four minutes, on average. The American Heart Association (AHA) projects that the future annual costs of stroke-related care will increase 129% to $240.6 billion by 2020 - yet 80% of strokes are preventable through control of hypertension, high cholesterol, diabetes and obesity, says the industry group.

Additionally, the cost of congestive heart failure (CHF) could more than double to $70 billion by 2030, with a projected 46% increase in incidence, from five million in 2012 to eight million in 2030. This could result in every US taxpayer - not just those with CHF - paying $244 annually for CHF expenses, in 2030, warns PhRMA.

The group points to a new study published in the American Journal of Managed Care, which finds that improved adherence to medication following the expansion of drug coverage under the federal Medicare health insurance programme's prescription drug benefit (known as Part D) has led to nearly $2.6 billion savings in medical expenditures annually among beneficiaries with CHF. However, despite the improvements in adherence following the introduction of Part D, medication use remains suboptimal, it says, and the study estimates that improving adherence to recommended levels could save Medicare another $1.9 billion annually, totalling $22.4 billion over 10 years.

Fuente: Lynne Taylor, for PharmaTimes

TENDENCIAS DEMOGRÁFICAS EN LatAm: IMPACTO DEL CÁNCER DE PULMÓN EN LAS AMÉRICAS.

El cáncer de pulmón es el tercer tipo de cáncer más frecuente y la primera causa de muerte relacionada con cáncer en las Américas, con más de 300.000 nuevos casos y cerca de 250.000 muertes cada año

Link al Informe de la Organización Panamericana de la Salud: http://new.paho.org/hq/index.php?option=com_docman&task=doc_view&gid=22071&Itemid

Fuente: Organización Panamericana de la Salud (OPS) - PanAmerican Health Organization (PAHO)