HAPPY THANKSGIVING DAY 2013

Dear GW Professors, Colleagues and Friends !!!

224 years of Thanksgiving, brought to you by President George Washington.

Original Thanksgiving Proclamation, published October 3, 1789:

By the President of the United States of America, a Proclamation.

Whereas it is the duty of all Nations to acknowledge the providence of Almighty God, to obey his will, to be grateful for his benefits, and humbly to implore his protection and favor—and whereas both Houses of Congress have by their joint Committee requested me to recommend to the People of the United States a day of public thanksgiving and prayer to be observed by acknowledging with grateful hearts the many signal favors of Almighty God especially by affording them an opportunity peaceably to establish a form of government for their safety and happiness.

Now therefore I do recommend and assign Thursday the 26th day of November next to be devoted by the People of these States to the service of that great and glorious Being, who is the beneficent Author of all the good that was, that is, or that will be—That we may then all unite in rendering unto him our sincere and humble thanks—for his kind care and protection of the People of this Country previous to their becoming a Nation—for the signal and manifold mercies, and the favorable interpositions of his Providence which we experienced in the course and conclusion of the late war--for the great degree of tranquility, union, and plenty, which we have since enjoyed--for the peaceable and rational manner, in which we have been enabled to establish constitutions of government for our safety and happiness, and particularly the national One now lately instituted—for the civil and religious liberty with which we are blessed; and the means we have of acquiring and diffusing useful knowledge; and in general for all the great and various favors which he hath been pleased to confer upon us.

and also that we may then unite in most humbly offering our prayers and supplications to the great Lord and Ruler of Nations and beseech him to pardon our national and other transgressions— to enable us all, whether in public or private stations, to perform our several and relative duties properly and punctually—to render our national government a blessing to all the people, by constantly being a Government of wise, just, and constitutional laws, discreetly and faithfully executed and obeyed—to protect and guide all Sovereigns and Nations (especially such as have shewn kindness unto us) and to bless them with good government, peace, and concord—To promote the knowledge and practice of true religion and virtue, and the encrease of science among them and us—and generally to grant unto all Mankind such a degree of temporal prosperity as he alone knows to be best.

Given under my hand at the City of New York the third day of October in the year of our Lord 1789.

Go: Washington

with The George Washington University, GW School of Public Health and Health Services, The George Washington University School of Medicine & Health Sciences,George Washington University Hospital, The George Washington University, George Washington Today, GW Americas Alumni Network, GW Alumni and Gwu Hsml.

Biogen’s Tecfidera is Top Potential Moneymaker of 2013 Drugs - for now

Biogen Idec’s multiple sclerosis drug, Tecfidera, tops the list of the biggest potential revenue-generating drugs launched so far this year in the U.S., with expected sales of $2.9 billion by 2018, according to a report by EP Vantage.

The estimated sales over the next five years from the much-anticipated launch of Tecfidera in March beats out other drugs approved by the U.S. Food and Drug Administration this year by Big Pharma giants like Roche, Johnson & Johnson, Sanofi and GlaxoSmithKline.

However, if Gilead’s hepatitis C drug, sofosbuvir, is approved as expected before Dec. 31, it will just edge out Tecfidera, with $3 billion in expected revenues by 2018.

Overall, while the number of drugs expected to be approved by the FDA before the end of the year will not reach 2012’s record of 43 drug approvals (it will likely be 34), the report finds that the potential revenue from the drugs approved in 2013 in five years will likely hit a record of $18.7 billion. That number assumes the expected approval of sofosbuvir as well as six others before the end of the year.

That sales estimate is up 14 percent from the estimated five-year revenues of drugs approved in the U.S. in 2012, and up four-fold from the most recent low of $4.4 billion in 2007.

Tecfidera, which generated $286 in revenue in the most recent quarter ending in September, is the company’s first oral medicine - and its third overall - for multiple sclerosis, an autoimmune disease that affects the brain and spinal cord and affects about 2.1 million people worldwide. The company says the drug is now the leading oral multiple sclerosis drug in the U.S.

The EP Vantage report on year-to-date FDA approval rates is based on data from EvaluatePharma.

Fuente: BioFlash, MASS HIGH TECH

2013 FDA Approval Rates suggest Record Year for Post-Launch Success

A focus on hard to treat or specialist diseases is set to result in record post-launch sales for new drugs in 2013, according to newly-released report, “FDA Approval Rates: Niche Products Driving Record Success” from EP Vantage, the editorial arm of Evaluate.

While the total tally of approved drugs and biologics for 2013 is not forecast to match last year’s record of 43, the combined US sales for this year’s approved products could surpass $18 billion five years after launch.

The report, based on market intelligence and analysis from EvaluatePharma, can be downloaded at http://www.evaluategroup.com/EPVantage-FDA-Approvals.

From January 1, to November 11, 2013, the FDA approved 27 new compounds with another seven hopefuls awaiting approval.

Key findings:

• Of the 27 drugs approved so far, combined fifth-year U.S. sales are forecast to reach $13.9bn.
• Assuming all products awaiting regulatory decisions get a green light, 2013’s fifth-year sales could total $18.7bn, breaking the 2012 record of $16.4bn.
• Tecfidera ranks No. 1 among top five approvals of 2013 (January to November, 11) with sales estimated at $2.9bn by 2018.
• If approved in 2013, Gilead Sciences’ sofosbuvir stands to become this year’s most valuable new molecule, with fifth-year US sales estimated at almost $3bn

“Increased efforts on the part of the FDA to speed up drug development and also companies choosing to expand into rare diseases or niche patient populations is having a big impact on productivity,” said Lisa Urquhart, EP Vantage Editor.

“One example of this is the earlier-than-expected approval of Roche’s Gazyva, which was the first drug to reach the market under the breakthrough therapy designation scheme. We have also seen the approval of big ticket drugs such as Tecfidera this year and are still waiting one of the industry’s biggest drugs, sofosbuvir. Barring any upsets this will make 2013 a year to remember in terms of future blockbuster sales.”

Fuente: BusinessWire

MassBio: Biotech CEOs reflect on past failures

por Julie M. Donnelly

MassBio last Thursday convened a panel of biotech CEOs to talk about failures and setbacks in their businesses. The executives talked about the importance of not just money and good science – but board relations, building the right team, asking for help and the cruel luck of timing.

One of the key takeaways from the group was, ask for more money when you can, because you’ll need it. Carolyn Green, President of Newton, Mass.-based Atreaon, Inc, is the former CEO of Foxboro-based Logical Therapeutics. Green said raising $30 million before the recession helped the company to avoid having to look for cash when investors were reeling after 2008. Logical Therapeutics suffered a major disappointment when it failed to get its pain killer approved by the U.S. Food and Drug Administration, at a time when concern about safety risks with painkiller Vioxx were at fever pitch.

Another theme was, protect your assets. Indu Javeri was the CEO of Andover, Mass.-based contract manufacturing company Formatech, which filed for bankruptcy in 2011 after a number of manufacturing problems. Javeri said if she had it all to do over again, she would have spun off a company that included the firm’s one drug asset, so it wouldn’t have been sold off once she filed for Chapter 7 liquidation. She also said she wished she would have reached out to her network in search of funding when times got rough. She said two weeks after filing for bankruptcy, a large pharmaceutical company client said it would have been willing to invest to save Formatech.

Bonnie Fendrock, who left her CEO post at Medford, Mass.-based Hepregen Corp. after a number of setbacks, said she had underestimated the importance of finessing and managing the board. And she said “always always always under-promise and over-deliver." She also advised colleagues to think hard when building their team and to think about what kind of people you need for he future, not just where the company is now.

And Michael Koeris founder of Sample6, said always be ready to pivot when you hit a roadblock. Sample6, a tools company based in Boston's Seaport district, first went after an application for the oil and gas industry. But after realizing the company would have to purchase an oil field in order to test the technology, the company changed tacks, instead retrofitting the instrument to measure food safety.

Lou Arcudi, the Chief Financial Officer of Cambridge, Mass.-based Idera Pharmaceuticals, was also hit hard by bad timing. The company abandoned work on its potential therapy for hepatitis C after Merck and Co. and Vertex Corp. beat Idera to market with similar drugs. He said that while conventional wisdom says it’s important as a company to have multiple shots on goal, sometimes you have to re-trench and focus on fewer products. Idera decided to put other programs on hold while it focused all its money and energy on pushing forward two compounds as potential treatments for autoimmune diseases and a certain type of lymphoma.

Fuente: Boston Business Journal

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INICIA Lunes 21 de Abril de 2014 en UTN, Universidad Tecnológica Nacional

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Entrevista: “El Sistema Nacional de Trazabilidad es un modelo que llegó para quedarse”

La Dra. Estela Izquierdo dialoga sobre la seguridad del paciente, los avances en la aplicación del SNT y las propuestas vigentes para la optimización del sistema

por Rocío Bao

Estela Izquierdo es jefa y directora técnica del Servicio de Farmacia del Sanatorio Güemes de Buenos Aires. Además, se desempeña como vicepresidenta de la Asociación Argentina de Auditoría y Gestión Sanitaria (SADAM). Recientemente ha presidido la IV Conferencia: “Avances y Soluciones Técnicas en la Implementación del Sistema Nacional de Trazabilidad de Medicamentos”.

En una entrevista exclusiva para E-Health Reporter Latin America, dialoga acerca de la seguridad del paciente, de los avances en la aplicación del SNT y de las propuestas vigentes para la optimización del sistema.

En el encuentro “Medicamentos: Trazabilidad y seguridad del paciente”, afirmó que la Ley de Trazabilidad de Medicamentos es una oportunidad para mejorar la seguridad del paciente. ¿Considera que la normativa actual suple esta área? 

La seguridad del paciente no sólo tiene relación con los temas vinculados a la trazabilidad del  medicamento. Lo que nos permite la implementación del Sistema Nacional de Trazabilidad (SNT) es asegurar la procedencia del medicamento a lo largo de toda la cadena de comercialización e implementar los medios necesarios -dentro de los tiempos de cada lugar de internación- para llegar al pie de cama del paciente y, con esto, verificar los 5 pasos correctos: paciente correcto, hora correcta, medicamento correcto, dosis correcta y vía de administración correcta.También mencionó que para que los procesos de trazabilidad se puedan llevar adelante en las instituciones es necesario rever la cultura de cada lugar.

¿Qué aspectos considera que hay que rever?    

La implementación del sistema de trazabilidad en una institución es un proyecto que involucra a todos; desde la dirección hasta los distintos sectores que estén en algunas de las etapas de la cadena de flujo del medicamento; desde su adquisición hasta la administración a los pacientes. Para poder llevar adelante los cambios necesarios para la implementación de la trazabilidad, hay que rever procesos  en los distintos sectores, los cuales deben ser consensuados (aquí entra en juego la cultura de cada lugar), y el personal debe ser capacitado para que se llegue con éxito a la implementación.

Ante el panorama de crecimiento de la ANMAT, ¿cuál es su perspectiva de mejoras para los próximos años? 

Considero que el SNT es un modelo que llegó para quedarse, que irrumpió en nuestro país ante situaciones de falsificación, irregularidades y robos, pero que a medida que se vaya avanzando se irán superando y acomodando muchos procesos que se realizaban en la cadena de comercialización y que no estaban dentro de los lineamientos correctos. Para poder trazar productos de uso masivo se va a requerir de una adaptación general  de toda la cadena de comercialización, dado el volumen importante de unidades a las que nos estamos refiriendo, como así también en el área asistencial va a ser necesario que las ampollas y comprimidos vengan identificados desde sus laboratorios de origen; de lo contrario, cada centro asistencial se tendría que transformar en una línea de producción de reenvasado y reetiquetado.

Según la ANMAT, sólo se podrían hacer devoluciones en el sistema dentro de las dos horas. ¿Cómo se manejan en estos casos desde el Sanatorio Güemes?

En el Sanatorio Güemes estamos  informando a la ANMAT la recepción y estamos comenzando a informar el paciente sólo en los casos en los que nos aseguramos que él mismo lo recibe en el momento, y esto es confirmado. En la mayoría de los lugares asistenciales que están trazando, lo hacen con la recepción, y algunos pocos lo realizan para pacientes puntuales, de medicación de alto costo y baja incidencia. Cada institución tendrá que evaluar en qué momento informa a la ANMAT qué medicación fue consumida por cada paciente, teniendo en cuenta que si el dato no es seguro y luego hay una devolución, se corre el riesgo de tener que descartar la medicación.

¿Tienen pensado extenderse en el sistema de trazabilidad, es decir, llegar al pie de cama del paciente?

Sí, en el Sanatorio estamos realizando en el Hospital de Día Oncológico nuestra primera prueba de pie de cama: al paciente en admisión se le coloca una pulsera identificatoria con sus datos (incluido el tipo de esquema que se viene a aplicar).Por otro lado, tenemos la trazabilidad interna de toda la medicación oncológica y de alto costo enviada por terceros, como así también la que adquiere el Sanatorio. Luego, preparamos las mezclas en nuestra propia área de fraccionamiento de citostáticos asignándole a cada mezcla un código Data Matrix y este código lo hacemos viajar a nuestra indicación de la historia clínica electrónica de ambulatorio. De esta forma, cuando el paciente se sienta en el sillón de HDO, se verifica la correlación entre el esquema de medicación, el paciente y la enfermera que la va a administrar. Una vez que todo es confirmado, comienza la infusión y se informan a la ANMAT los medicamentos que fueron administrados.

Fuente: E-Health Reporter LatAm

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INICIA Lunes 21 de Abril de 2014 en UTN, Universidad Tecnológica Nacional

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To determine Link between Humans and Neanderthals, keep digging

Researchers find that ancient species suspected of being last common ancestor all miss the mark

by Danny Freedman

It’s a gap between teeth that will need much more than braces to fix: A new study of ancient teeth finds that none of the species suspected of being the ancestral link between modern humans and Neanderthals quite fits the bill.

The study, conducted by an international team of scholars that included a George Washington University researcher, was published online Monday in the Proceedings of the National Academy of Sciences. Among its findings, the study also suggests that the two species may have diverged hundreds of thousands of years earlier than previously thought.

“The last common ancestor of Neanderthals and modern humans may have been located in Africa around 1 million years ago,” said lead researcher Aida Gómez-Robles, a postdoctoral scientist at GW’s Center for the Advanced Study of Hominid Paleobiology. “If those fossils are found, they will be the ones that can give us a clearer answer to this problem.”

That may mean finding new species or simply better-preserved fossils. African populations dating back 1 million years—which were not included in the study due to the scarcity of dental fossils, Dr. Gómez-Robles said—are “the most promising source of candidates,” the researchers wrote.

The hardness and small size of teeth make them a well-preserved and very common line of evidence, Dr. Gómez-Robles said, offering a good representation of many early species in the human family tree.

The research team included scientists from Indiana University, Austria and Spain, where Dr. Gómez-Robles conducted the research as a graduate student.

Scientists think modern humans and Neanderthals evolved in Africa and Europe, respectively, once they separated from their common ancestor. Genetic studies vary on the timing of that separation, ranging from 300,000 to 850,000 years ago, the researchers wrote.

The team analyzed 1,200 teeth representing 13 types of ancient human, including species that have been proposed as that common ancestor, such as Homo heidelbergensis, Homo antecessor and Homo erectus. Using a dozen evolutionary scenarios the team loosely estimated the features of the common ancestor’s teeth and looked for a match.

The results, they wrote, were “striking.” The chances of any of those species being the shared ancestor are “at best, weak.”

Among the lot, the best fit was an African group known as Homo ergaster(considered by some to be simply an ancient form of Homo erectus), despite it having lived far outside the time period of 500,000 to 1 million years ago in which researchers expected to find a match.

The team also found that the European fossils all appeared more closely related to Neanderthals than to modern humans, leading them to suggest the two species separated earlier than suspected, around 1 million years ago.

Meanwhile the study itself, they wrote, also demonstrates the utility of this type of analysis, which Dr. Gómez-Robles said is common in the study of other species but rarely for human evolution.

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