Roche pone fin a su intención de adquirir Illumina 

El responsable de la farmacéutica suiza dio por cerrada la intensión de quedarse con la compañía, por la que realizó varias ofertas hostiles en 2011. Por el momento, la firma se quedará con su subsidiaria 454

El COE de la farmacéutica Roche, Severin Schawn, confirmó, en declaraciones al semanario suizo Sonntag, que la compañía que dirige “ha decidido poner fin al tira y afloja” que ha mantenido con la dirección de Illumina, que rechazó la oferta realizada (51 dólares por acción) bajo el pretexto de que no se ajustaba al valor real de la compañía en el mercado. 

En la información, recogida por el portal especializado FierceBiotech, se alude a la posibilidad de que la firma con sede en Basilea desarrolle sus propias investigaciones en el área de la secuenciación genética, o bien establezca acuerdos de colaboración con otras compañías en este campo. 

En este sentido, cabe destacar que Roche ya es propietaria de 454, una empresa con sede en Bradford (Connnecticut) que opera en esta misma área de actividad aunque a una escala mucho menor de lo que lo hace Illumina.

Fuente: MiradaProfesional.com

Donación voluntaria de sangre, el progreso en los Países de LatAm: el ejemplo Nicaragüense

Todos los países deben tener un servicio nacional de sangre bien coordinado que permita mantener un suministro suficiente de sangre segura para todos los pacientes que requieran una transfusión. La mejor manera de lograr que los países tengan un suministro fiable de sangre segura consiste en obtener la totalidad de las donaciones de donantes voluntarios no remunerados. En 2008, 62 países habían alcanzado esta meta (por comparación con 39 en 2002) y muchos otros están avanzando rápidamente.

He aquí algunos ejemplos de países que han aumentado considerablemente la donación voluntaria de sangre y mejorado los sistemas de tamizaje, elaboración, almacenamiento y distribución de la sangre donada.

Nicaragua: 100% de donaciones voluntarias: gracias a los jóvenes

En el mismo año se aprobó la Ley 369 “Seguridad Transfusional” que establece la donación de sangre voluntaria, altruista y no remunerada en el país como fuente de donación de sangre que será destinada a las transfusiones.Con el objetivo de suministrar en forma gratuita y oportuna sangre y hemoderivados de calidad a los pacientes que requieren productos sanguíneos para su tratamiento, el Ministerio de Salud de Nicaragua, acogiendo las recomendaciones de la Organización Panamericana de la Salud OPS/OMS, elaboró en 2000 el Plan Nacional para el desarrollo de un nuevo modelo de gestión para los servicios de sangre.

Gracias al apoyo de la Cruz Roja Nicaragüense, se formó en 2006 el Club 25, cuyos socios son jóvenes entre los 17 y 25 años comprometidos con la donación voluntaria 2 veces al año con el objetivo de dar 20 unidades de sangre antes de su 26 cumpleaños.

Hace 10 años el país tenía un espacio físico en cada hospital que funcionaba como Banco de Sangre, sin contar con el equipamiento y los recursos humanos adecuados para garantizar sangre segura. A partir del 2006 el Ministerio de salud (MINSA ) firma un convenio de cooperación con la cruz roja Nicaragüense (CRN) para fortalecer y mejorar el abastecimiento y la calidad de la sangre y sus hemoderivados, con el apoyo del Gobierno del Gran Ducado de Luxemburgo se inició la construcción, equipamiento de tres bancos de sangre en el país y la trasformación paulatina de los “bancos de sangre hospitalarios” a servicios de medicina transfusional, a lo cual se añade la formación de personal técnico y profesional.

Sin embargo, y a pesar de los retos y las dificultades, los esfuerzos de Nicaragua para proporcionar productos sanguíneos de calidad a sus ciudadanos han dado sus frutos:

• 100% de donaciones voluntarias y altruistas
• 70 000 unidades de sangre recolectadas por año

Pero todavía queda mucho por hacer. Hay que fortalecer los servicios de medicina transfusional, consolidar el sistema de garantía de calidad de la sangre, capacitar a los recursos humanos e implementar el plan de manejo de residuos biológicos peligrosos.

Fuente: Organización Mundial de la Salud

Innovation at the Top 10 Global Drug Companies over the last 15 years

Over the last 15 years, according to Forbes, the pharmaceuticals industry has been undergoing somewhat of a drought when it comes to innovation and the creation of groundbreaking new products. However, when looking at the top 10 companies in the world, it is clear to see that some have still been working tirelessly to provide new products over the period. We take a look at the list of leaders

1. Novartis

Novartis is a Swiss-based company that is best known for its production of Methylphenidate, or Ritalin, the psychostimulant drug which helps to calm those who suffer from Attention Deficit Hyperactivity Disorder (ADHD). Over the course of the last 15 years, the company has released no fewer than 21 products.

These include Glivec, a drug which restricts the functionality of the receptor tyrosine kinase enzyme in cells to combat chronic myelogenous leukaemia (CML) and gastrointestinal stromal tumors among other diseases. Such was the success of the product that it has now been certified by the FDA to treat no fewer than 10 cancers.

Novartis hit its highest point in financial terms during May of last year, when stock prices were at a peak of $61.84, a month in which the company was given a boost when its Votubia drug was the first to be approved in Switzerland for the treatment of a benign brain tumour related to tuberous sclerosis. 

2. Merck & Co.

Despite being one of the world's biggest drug companies, Merck & Co. fell some way behind the leader Novartis in terms of how many drugs it has released in the last 15 years, clocking up a total of 16.

Perhaps one of its biggest areas of innovation in the period has been the development and release of Gardasil, which is the world's only vaccine to protect against Human Papillomavirus (HPV), one of the leading causes of cervical cancer in young women.

In 1999, the stock of Merck & Co. Soared to an unprecedented level of $119.186, after it received an investment of $1.8 billion following the joint venture between itself and the merged companies of Astra, as well as the introduction of the arthritis medication Vioxx.

3. J&J

Johnson & Johnson (J&J) is an American company which is ranked as the world's most respected by Barron's Magazine. Its pharmaceuticals division was launched in 2001, and it has since released 15 products into the market.

Its top drugs include such items as Combantrin, a Pyrantel pamoate product which is used in the treatment of pinworms in people.

One of the peaks over the last ten years for J&J came when it hit the headlines in June 2001, after a merger was approved with Alza Corporation, the company which manufactures chemotherapy drug Doxil. At this time, the stock for J&J would reach an all-time high of $84.71.

4. Pfizer

Pfizer has released a number of high-profile drugs throughout the last 15 years. However, perhaps its biggest success during this time has come in the form of Aricept, a drug which is designed to improve the cognitive functions of people with a mild form of Alzheimer's Disease. It is the biggest selling product of this type on the market, and one of the 14 that Pfizer has released over the last 15 years.

The height of the last 15 years for Pfizer came during June 1999, following a second quarter of that year throughout which the company reported a high level of revenues, with its products such as Lipitor, Aricept, and Celebrex selling particularly well.

5. Wyeth

Coming in just below Pfizer is the company which it bought out in 2009, Wyeth. Before it was made a part of Pfizer, Wyeth contributed to innovation in the pharmaceutical market with 13 drugs between 1997 and its takeover, including Enbrol, a TNF inhibitor which helps to treat auto-immune disease by targeting tumour necrosis factors in the brain.

Wyeth was merged in 2009 with Pfizer, which brought to an end the production of its own drugs.

6. Bristol-Myers Squibb

A relative newcomer when compared to other companies in the top 10, Bristol-Myers Squibb was formed as recently as 1989 after a merger of its predecessors.

Of its 11 drugs released in the last 15 years, one of its biggest has been the 2006-approved Atripla, a drug which helped in the treatment of HIV by becoming one of the first combined daily-dosage drugs.

A peak in its stock prices was seen for Bristol-Myers Squibb in February of 1999, when it reached the height of $93.16. During this month, the company and EntreMed Inc. modified their research program into cancer treatments. It also first saw the operation of a new investment company it had spent $30 million setting up in Shanghai the month before.

7. Hoffmann-La Roche

Having also released 11 drugs in the period, Swiss pharma firm Hoffmann-La Roche is another which has had considerable success with new products since 1997.

It is best known as the maker of the anti-depressant Valium, but in the last 15 years it has released such medication as Xenical, an anti-obesity product which is sold mostly over the counter around the world.

One highlight in terms of stock prices for the Swiss firm came in December 2004, a year during which Hoffmann-La Roche was granted FDA approval for the use of its AmpliChip for in vitro diagnostic use as opposed to simply for research.

8. Lilly

Eli Lilly and Company is an Indiana-based firm, founded by the chemist of the same name, which sells products in over 125 nations worldwide, and has also released 11 drugs over the past 15 years.

Its innovations include such products as Ciallis, a PDE5 inhibitor which is used in many countries as a treatment for the common issue of erectile dysfunction.

Eli Lily's most successful period over the last 15 years came at the very beginning of the period in 1997. In October, the stock price reached $98.19, just ahead of the company being given approval for its Evista drug, used in the treatment of Osteoporosis.

9. GlaxoSmithKline

Despite being perhaps the most well known of all pharma firms worldwide, GlaxoSmithKline has released just 10 drugs in the last 15 years, leaving it a distance behind many others.

The newer products from the company include such drugs as Coreg, a Carvedilol-based product which is used by doctors to treat congestive heart failure as a beta-blocker.

In July 2007, the price of shares in GlaxoSmithKline hit an eight-year high when the company announced the extension of a buy back scheme for the two years which were to follow.

10. Abbott

The final company to make the top 10 is Abbot Laboratories, an American firm which has managed to release nine drug products across the globe throughout the last 15 years.

One of its biggest innovatory products is Humira (adalimumab), a treatment for rheumatoid arthritis which was the third TNF inhibitor approved in the US.

Abbot has recently enjoyed a soaring price in its stocks which saw investors welcoming the best returns in 14 years in early May, despite the fact that the company had to come to a settlement of $1.5 billion dollars relating to drug marketing earlier this month.

Fuente: Pharma IQ, a division of IQPC

As Medical Tattoos gain popularity, Guidelines should establish Standards and Consistency

PHILADELPHIA -- Medical tattoos, a permanent bodily mark used to indicate the illnesses or allergies an individual has, are gaining momentum and popularity. However, a review of medical literature indicates a lack of established guidelines in the medical community on how medical tattoos should be administered and effectively used, according to an expert today at the American Association of Clinical Endocrinologists (AACE) 21^st Annual Meeting & Clinical Congress in Philadelphia.

Medical jewelry, primarily necklaces and bracelets, has traditionally been worn by patients to indicate they have a particular medical condition, such as diabetes, heart disease or high blood pressure. This identification is crucial should a medical emergency occur. In patients with diabetes, for example, emergency personnel know that one of the first steps with an unresponsive subject is to check their blood sugar level and, if it is found to be low, to immediately treat with glucose. In such emergencies, medical jewelry is an effective tool because first responders have been trained to know where to look for it and what the various engraved symbols mean.

However, as medical tattoos are being used more and more by patients to replace medical jewelry, no appropriate medical standards exist to regulate them, according to Dr. Saleh Aldasouqi, FACE, ECNU.

“The medical community, and particularly endocrinologists as diabetes experts, should establish guidelines regarding medical tattoos,” said Dr. Aldasouqi. “Specifically, patients who want a medical tattoo need guidance on how to get it safely, where it should be located on their body and what it should look like.”

One concern that guidelines should address for patients with diabetes is to stress the importance of having their blood glucose and A1C levels in a normal range prior to getting a tattoo. This is an important step in reducing the risk of poor healing or infection. Guidelines also should address the standards of tattoo administration, including the use of sterile tools to prevent complications such as local skin infection and transmission of communicable infections. But perhaps most importantly, according to Dr. Aldasouqi, is the need to establish a consistent bodily location and appearance for medical tattoos so medical personnel can be properly trained to respond to this emerging form of identification.

“Each minute and each second will count, as far as survival is concerned, for a patient in a diabetic coma,” said Dr. Aldasouqi. “Accordingly, the medical community must take seriously the opportunity and responsibility to establish medical tattoo guidelines.”

Fuente: The American Association of Clinical Endocrinologists (AACE)

Read more here: http://www.miamiherald.com/2012/05/24/2815193/as-medical-tattoos-gain-popularityguidelines.html#storylink=cpy

Read more here: http://www.miamiherald.com/2012/05/24/2815193/as-medical-tattoos-gain-popularityguidelines.html#storylink=cpy

Resistencia Microbiana: crece en el Mundo el miedo a quedarse sin Medicamentos 

BRUSELAS: Las bacterias que resisten el accionar de los fármacos es uno de los principales problemas que afronta el planeta. Esta semana, las advertencias cayeron sobre dos males concretos: la tuberculosis y la gonorrea. El problema podría generar mayor mortalidad de estas enfermedades

Desde hace años, la resistencia a los medicamentos potenció varias enfermedades, que van camino a no quedarse sin tratamientos efectivos en el corto plazo. Esta idea, que alerta a las autoridades, obliga a los especialistas a mejorar las formas de usar los remedios, y a concientizar a la gente sobre el peligro de la automedicación. Esta semana, los casos de tuberculosis super resistentes en China y una alerta de la ONU sobre la gonorrea resistente vuelven a poner el tema en la agenda científica mundial. 

En el primero de los casos, un estudio publicado en Estados Unidos es concluyente: China se enfrenta a una "seria epidemia" de tuberculosis resistente a fármacos. "En 2007, un tercio de los pacientes con nuevos casos de tuberculosis y una mitad de los pacientes previamente tratados de tuberculosis tenían el tipo de enfermedad resistente al fármaco", afirmó el estudio en el New England Journal of Medicine.

Incluso la prevalencia de la tuberculosis con resistencia múltiple a varios fármacos (MDR) en nuevos casos (5,7 por ciento) fue casi el doble de la media global, afirmó el estudio.

El estudio, que utilizó datos de la Organización Mundial de Salud (OMC) como base para la comparación, afirmó que "China tiene el mayor número de casos de tuberculosis MDR en el mundo, un cuarto de los casos a nivel mundial". Los datos fueron recabados en un estudio a más de 4.600 chinos que habían sido recientemente diagnosticados o tratados de tuberculosis.

En China se producen un millón de casos nuevos cada año, que representa una gran parte de los nueve millones estimados que se diagnostican en el mundo anualmente. Conocida formalmente como Mycobacterium tuberculosis, la enfermedad se transmite por el aire cuando la gente infectada tose y escupe la bacteria. La tuberculosis mata a 1,5 millones de personas en todo el mundo cada año.

Aunque con frecuencia puede ser curada con antibióticos, incluso cuando la disponibilidad de los fármacos es limitada en los países en desarrollo, algunas veces los pacientes no siguen el tratamiento por completo, lo que puede alentar el avance de cepas resistentes.

Según un editorial a cargo de Richard Chaisson, especialista de enfermedades infecciosas de la Johns Hopkins University (Maryland, noreste de Estados Unidos), el crecimiento de la tuberculosis resistente a fármacos supone "un gran desafío".

Pero más preocupante es el hecho de que la mayoría de los 110.000 casos de tuberculosos resistentes fueran pacientes nuevos diagnosticados con la enfermedad, lo que sugiere que la virulenta bacteria se está transmitiendo de una persona a otra y no se desarrolla únicamente como resultado de que un individuo deje de tomar el tratamiento antes de tiempo.

Chaisson afirma que los resultados ponen de manifiesto la necesidad de realizar más pruebas, y para los nuevos casos hacer pruebas de resistencia al fármaco.

En cuanto a la segunda enfermedad, la Organización Mundial de la Salud (OMS) advirtió esta semana que la gonorrea, una de las enfermedades de transmisión sexual más extendida, se está convirtiendo en una importante amenaza para la salud pública mundial por su resistencia a tratamientos.

Manjula Lusti-Marasimham, investigadora del Departamento de Salud Reproductiva de la OMS dijo a la prensa que Australia, Francia, Japón, Noruega, Suecia y el Reino Unido están reportando casos de resistencia a la cefalosporina, el antibiótico al que mejor responde la enfermedad.

La experta señaló que el uso incorrecto de los antibióticos está contribuyendo al fracaso de los tratamientos de la gonorrea y subrayó que si esa infección se hace intratable, las implicaciones serían desastrosas para los 106 millones de personas que la contraen anualmente.

“Los hombres y las mujeres que la padecen quedarían infértiles, las gestantes correrían el riesgo de tener embarazos ectópicos o abortos espontáneos. Los niños que nacieran de madres contagiadas sin tratamiento, desarrollarían infecciones graves de los ojos que podrían terminar en la ceguera”, dijo.

La OMS anunció un plan de acción global que llama a los países a aumentar la vigilancia de la gonorrea y el fortalecimiento de las capacidades de los laboratorios.

Argentina será el primer País de LatAm que producirá Anticuerpos Monoclonales
La inauguración de una planta productora permitirá al país tener medicamentos nacionales contra varios tipos de cáncer y contra otras enfermedades inmunes. El legado de Cesar Milstein detrás de este importante avance

Se puso en marcha la primera planta nacional que fabricará anticuerpos monoclonales, que permitirá al país producir medicamentos necesarios para tratar enfermedades complejas como la artritis o varios tipos de cáncer. La iniciativa pondrá al país a la vanguardia en materia sanitaria, ya que será el primero en Sudamérica en fabricar este tipo de fármacos.

“Esta planta va a permitir producir un medicamento que es altamente costoso y que para ciertos grupos de pacientes es inaccesible”, dijo el ministro de Ciencia y Tecnología, Lino Barañao. "Sólo en anticuerpos monoclonales, una de las cosas que se van a producir aquí, Argentina importa hoy medicamentos por 250 millones de dólares al año; producirlo aquí no sólo va a bajar muchísimo su costo, sino que también a través de la exportación van a entrar divisas al país", señaló el funcionario.

La fábrica, cuya primera producción estará lista a fines de julio, producirá en principio los anticuerpos monoclonales para utilizar en tratamientos contra el Linfoma de Hodgkin, el cáncer de mama, pulmón y colon, y contra la artritis reumatoidea. "La ventaja que tienen estos tratamientos es que son estrategias por blancos celulares, es decir, van dirigidas específicamente a las células malas, lo que produce mucho menos efectos secundarios que la quimioterapia o los rayos", explicó Esteban Corley, director de Desarrollo de Negocios de PharmADN, la empresa que creó la planta.

El especialista explicó que "no obstante, en el cáncer se atacan varios blancos a la vez, por lo que estos tratamientos se utilizan junto a los otros, y no de forma excluyente". En Argentina el 100 por ciento de los tratamientos que se realizan con anticuerpos monoclonales es importado, lo que genera para el Estado y los sistemas de seguridad social un gasto de 250 millones de dólares anuales.

El ministro de Ciencia afirmó que "esta es la primera etapa de una serie de proyectos similares que se están llevando a cabo en el país, con tecnología desarrollada en gran parte por científicos locales, para ser un país que no sólo produzca alimentos o minerales, sino también la forma más sofisticada de la industria farmacéutica que es la biotecnología".

Barañao contó que "esta planta es el primer caso exitoso de una nueva manera de financiar la ciencia, a través de una modalidad focalizada sectorialmente y aplicada en momentos y oportunidades precisas; este caso se enfoca en la ciencia y la medicina a través de la biotecnología".

En ese sentido añadió que "la otra novedad es que estamos financiando consorcios públicos-privados, es decir que ya no se financia por separado, sino que se los financia juntos para que vengan a dar una respuesta aplicable con un cronograma rigurosamente inspeccionado".

"Esta es una manera de arraigar a los científicos formados por nuestras universidades públicas, la universidad no sólo debe dar posibilidades de perfeccionamiento, sino también crear puestos de trabajo de calidad", finalizó Barañao.

Por su parte, el ministro de Salud, Juan Manzur, dijo que "esto es un hito para la salud argentina, estamos hablando de enfermedades como el cáncer o autoinmunes, de medicamentos que hasta ahora sólo podíamos importar, y esta es una manera de hacer un justo homenaje a un argentino como Cesar Milstein, quien descubrió los monoclonales y revolucionó la medicina en todo el mundo".

"Hoy Argentina da un paso adelante, y todos estos científicos, orgullosos egresados de universidades públicas, nos ponen a la vanguardia de la medicina", remarcó el funcionario. "Argentina es el único país de América Latina que tiene tres premios nobel en ciencia y eso habla de la calidad de nuestros científicos y académicos, y poder abrir hoy una planta pionera en América del Sur es una muestra clara del rumbo que el país eligió", finalizó.

Legado de Milstein

A la hora de explicar qué es un anticuerpo monoclonal, Mauricio Seigelchifer, director de Investigación y Desarrollo de PharADN, describió que "cuando uno se infecta el cuerpo se defiende con distintos mecanismos. Uno de ellos es la generación de decenas de anticuerpos, que son proteínas, contra ese elemento extraño que se denomina antígeno. Entonces, el anticuerpo es, en principio, una molécula específica que ataca un antígeno".

Seigelchifer detalló que "el cuerpo desarrolla anticuerpos policlonales, es decir que contra un virus el cuerpo desarrolla decenas de clases de anticuerpos producidos por distintas células".

"Lo que el Milstein logró fue aislar líneas celulares que producían un solo tipo de anticuerpos e inmortalizar estas células. A esto lo llamó `hibridomas originales` que producen anticuerpos monoclonales. Conceptualmente sería un solo tipo de anticuerpos que atacan un solo antígeno", explicó.

El especialista señaló que "inmediatamente Milstein se dio cuenta de que si esos anticuerpos eran dirigidos contra un virus, células oncogénicas o cualquier otra podían tener una aplicación en la industria farmacéutica muy importante".

“No obstante -aclaró Seigelchifer para demostrar la grandeza del Premio Nobel- Milstein decidió por una cuestión ideológica no patentar su descubrimiento porque consideró que debía ser patrimonio de la humanidad”. 

Al describir este proceso en la actualidad, y específicamente en la planta de PharmADN, el científico señaló que "hoy estos anticuerpos se producen usando ingeniería genética". "Lo que se hace es inmortalizar en laboratorios células que derivan de ovarios de hámster chino, por eso se llaman células CHO (Chinesse hamster ovary), que van a un banco celular donde uno compra cuando quiere producir anticuerpos monoclonales", explicó.

La tarea que realizarán en el nuevo laboratorio es "modificar el ADN de las CHO con la estructura que elijamos (que va a depender de la enfermedad que se quiera atacar) obligándolas a que ellas produzcan el anticuerpo monoclonal", informó.

“Es decir que esa modificación del ADN se hace con un solo tipo de gen por vez y, por lo tanto, se genera un solo tipo de anticuerpo por lote, aunque la plataforma (equipamiento más personal) luego sirva para fabricar otros tipos”, aclaró. Finalmente, se filtran esos anticuerpos y se purifican, "y de ahí obtenemos la materia prima para los medicamentos", describió sintéticamente.

Pfizer's Future Vision for Clinical Trials

There are mounting challenges around  the sustainability of clinical trials as the pharmaceutical industry is faced with increasingly complex and expensive trials. But new models and collaberations are emerging, creating new opportunity around ways data is being captured and around the efficacy and safety of new medicines through novel collaberations which will help ensure the sustainability and delivery of new medicines for the patients of the future. Craig Lipset, Head of Clinical Innovation at Pfizer speaks to Pharma IQ.

Pharma IQ: I'd like to start, Craig, by asking you to give an overview of the clinical trial scene today and what the future holds?

C Lipset: I think that we're certainly at an interesting time when it comes to clinical trials. The data is known to most of the folks in this field around the mounting challenges of sustainability of the current clinical trial model and we're faced with increasingly complex and expensive clinical trials to conduct. We're juxtaposing that against an environment where reimbursement for medicines, as they become available, is increasingly in doubt. And so the models we've had to date are often looked as unsustainable. 

However, we’re seeing new models and collaborations emerge, and so the future is not as dim as we might have thought. There are opportunities for us to reinvent how we’re capturing data, on the efficacy and safety of our new medicines, and to do that in novel collaborations which, ideally, will  help ensure the sustainability of the work that we're doing and ensure the sustainability of the delivery of new medicines for patients in need.

Pharma IQ: What’s Pfizer's vision for the future of clinical trials?

C Lipset: There is an important role for collaboration with a range of stakeholders as never before; we see that embodied in the range of collaborations that Pfizer is executing today. We have created collaborations with academic medical centres through Pfizer, at our centre for therapeutic innovation, where we have shared space, intellectual property and transformational new collaboration models.

We are also partnering with other peers in the pharmaceutical industry; companies with whom we would have once exclusively viewed as competitors, we're now looking at as collaborators to make this sustainable.

We have formed alliances with non-profit organisations and patient groups and have found new ways of partnering with CROs, where once they were viewed as vendors, they are now considered partners in the process.

So the future vision state that we’re trying to achieve is really one of convergence between clinical research and healthcare. But, healthcare is almost disrupted by the notion of clinical research; such research stops healthcare in order to get aid and participation, which is a challenge. The future that Pfizer would like to try to work towards is one where research can be integrated as a natural part of healthcare.

We need to look at ways to enable a future where each interaction of a patient with their healthcare provider, is also an opportunity to inform the next generation of new medicines and development. It's an opening to capture data that may be of importance to research, or an opportunity for that patient end-provider to directly participate in a research study.

Pharma IQ: Thank you, Craig. What challenges do you think are affecting innovation in clinical trials, and how can these be overcome?

C Lipset: Historically, one of the biggest challenges is ‘ourselves.’ We were comfortable with the existing processes, and because we work in an industry that is so highly regulated, so process-driven, there is a perception that we can’t innovate; we could only achieve a gold standard of operational excellence. We could try to execute against our processes, but we could really go no further than those boundaries.

Today there is a much greater sense of urgency than ever before, we’ve moved on. We really need to work together to push boundaries to ensure that we're able to fulfil our moral, ethical and legal obligations to patients. But at the same time we need to find creative new ways to work with patients, investigators and other stakeholders to understand efficacy and safety.

That sense of urgency is going to help become an important driver for innovation in our space.

Pharma IQ: Craig, you've spoken a lot in the past about the e-patient. Can you perhaps explain how an e-patient and clinical trials can be brought to work together effectively today?

C Lipset: The notion of an e-patient can mean a lot of different things to different people. For some, when they hear the term, they think just about a patient who is online and accessing information on the Internet, that’s a part of it. But, the ‘e’ is really about engagement.

The notion of an e-patient goes a step further into the realm of participatory medicine, where the patient isn't looking to displace their healthcare provider; instead, the patient is at the table with a voice, able to say that they do have information. They have experiences to share, to complement the decisions that are being made about their health. When the patient has a voice in that plan, they’re better engaged and they're more likely to persist and to follow that regime. And ultimately, they see better outcomes.

Now, when we look at that notion of an e-patient and look at the traditional subject in a clinical trial, there's an interesting misalignment. A subject in a clinical trial is inherently not well informed. We take their name, we give them a number, and we assign them a blinded drug. We extract information from them to aggregate in our study database. But traditionally there's not very much that they're getting back in terms of being an engaged participant in that study. And so I think that for us to be able to keep the patient of tomorrow engaged in research, we are going to have to be creative in finding new ways to ensure that they have that same sense of engagement. Otherwise, I think, we're going to marginalise and lose those patients, moving forward.

So if the trends are all pointing in the direction of greater use of the Internet, greater numbers of patients taking on this highly engaged and participatory role in their health, I think it's important for us to keep pace in terms of how we are looking at ways to engage those folks in research. And that means engaging them in terms of making them aware, through patient recruitment straight through to the life of the study and beyond, ways in which we're engaging, keeping them informed whilst still maintaining the scientific integrity of the study.

Pharma IQ: We've come a long way since the first clinical trial was started by James Lendemer. What’s your vision of clinical trial say for 2020?

C Lipset: Clinical trials have and will continue to move forward in three domains, which all carry some level of convergence.

·    We see the changes in healthcare around patients and patient engagement.

·   There are opportunities for changes that relate to our interaction with investigators in the studies as we execute clinical trials at a system's level, rather than conducting each individual clinical protocol as an instance.

·   And we have unprecedented levels of electronic data, increasingly growing in healthcare, as a result of electronic health records maturing in their implementation, seeing greater uptake on a global basis.

And so when we see these movements happening around patients, the investigator and access to data, I think that they are all important enablers of that future state of convergence between research and healthcare, of opportunities for every healthcare interaction to be an opportunity for research participation.

Pharma IQ: We look forward to seeing what the future holds. Thank you so much, Craig Lipset, Head of Clinical Innovation at Pfizer, for your time today.