VIAGRA "complemento alimenticio"...

Después de que OCU denunciara hace un mes que dos productos que se vendían como “complemento alimenticio” contenían sildenafilo -el principio activo de la popular Viagra-, y pidiéramos que se retiraran del mercado, la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) finalmente ha ordenado la retirada de AUMVA cápsulas, además de otro producto similar, PUSHER cápsulas. 

Ambos se vendían como complemento alimenticio pese a contener sildenafilo y yohimbina, lo que les convierte en medicamentos ilegales, pero estos principios activos ni figuran ni se declaran en sus etiquetados. 

Los productos retirados los comercializaba una empresa rumana llamada Hilcon S.R.L., y contienen sildenafilo y yohimbina en cantidades suficientes como para tener efecto farmacológico, y estarían contraindicados en pacientes con infarto agudo de miocardio, angina inestable, angina de esfuerzo, insuficiencia cardiaca, arritmias incontroladas, hipotensión, hipertensión arterial no controlada, historia de accidente isquémico cerebral (ictus isquémico), pacientes con insuficiencia hepática grave o personas con antecedentes de neuropatía óptica isquémica anterior no arterítica o con trastornos hereditarios degenerativos de la retina. (Más)

Ver también:

Sanidad...potente en la "impotencia".

The Seven Deadly Sins of Product Launches (VII): Sin #7 Failing with “Launch Excellence Programs.”

By Stan Bernard

Failing with “Launch Excellence Programs.” 

The most egregious sin of all is companies and consulting firms that actively perpetuate and promote the first six sins in so-called “Launch Excellence Programs.” Increasingly, companies are recognizing that many of their product launches have failed to meet corporate and market expectations. As a result, they hire consulting firms or initiate internal launch excellence centers to try to counter this trend. These training programs often teach and embed across the organization the very Pharma 1.0 launch strategies and tactics that caused previous product launches to fail. Consequently, many of these “Launch Excellence Programs” are in actuality “Launch Failure Programs.” 

Pharma professionals and brand teams that avoid or at least learn from these seven potential sins will dramatically enhance product launch success. As Malcolm Forbes so eloquently stated, “Failure is success if we learn from it.”

Ver anterior:
 The Seven Deadly Sins of Product Launches (VI): Sin #6 Failure to pressure-test the pre-launch plan.

Belén Garijo, CEO Merck KGaA Healthcareuna española entre las "Top women in biopharma 2015"

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 told The 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 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 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. But at the same time, if you cross the line of going from self-awareness and self-confidence to egocentrism, then you lose it."(Ver)

The Seven Deadly Sins of Product Launches (VI): Sin #6 Failure to pressure-test the pre-launch plan.

By Stan Bernard

Failure to pressure-test the pre-launch plan. 


One essential way to prepare for counter-launches and overall product launch success is to conduct a series of competitive simulations or business war games 2.0. The new competitive simulations go way beyond traditional war games to incorporate multiple issues, competitors, landscapes, stakeholders, and market factors. Brand teams role-play their competitors and themselves to identify not only competitive insights but—more importantly—a few prioritized strategies and executable action steps to help launch products win in the market. 

The best pharma competitors start conducting these simulations in late Phase II trials or early Phase III and continue to conduct them every three to six months in key markets to ensure that the entire, extended launch team is fully prepared for both the launch and competitive counterlaunches. 

These companies usually take a “Multi-Level Competition” approach by considering ways not only to win at the brand level but also at their or their competitors’ franchise, portfolio, and corporate level. They may also use simulations for global, regional, or local markets; specific situations, such as the release of new clinical data or a major professional conference; or with certain departments/functions or stakeholder groups, such as medical affairs or payers.

Ver anterior:
 The Seven Deadly Sins of Product Launches (V): Sin #5 Not anticipating competitive counter-launches.

UK: Sanidad estudia vetar homeopatía por ineficaz

Doctors could be banned from prescribing homeopathy on the NHS under a consultation set to be launched by the Government.

Ministers say they will consult next year on whether the controversial practice should remain as an option for GPs.

Homeopathy is a “treatment” based on the use of highly diluted substances, which practitioners claim can cause the body to heal itself.

The bulk of scientific opinion however considers homeopathy to be a pseudoscience with no grounding in fact.

 “With rising health demands, we have a duty to make sure we spend NHS funds on the most effective treatments,” George Freeman, the Minister for Life Sciences, told the BBC.

Más

El sistema público de salud británico (NHS) estudia vetar las prescripciones de productos homeopáticos ante la falta de evidencia sobre su eficacia, informó ayer el Ministerio de Sanidad del Reino Unido. 

 "Ante la demanda cada vez mayor que soporta el sistema sanitario, tenemos el deber de gastar el dinero público en los tratamientos más efectivos”, afirmó el secretario de Estado para la Ciencia y la Biología, George Freeman, según medios británicos. "Actualmente estamos considerando si los productos homeopáticos deberían continuar estando disponibles a través de prescripciones del sistema público”, dijo George Freeman. 

La sanidad británica gasta cada año unos 4 millones de libras (5,64 millones de dólares) en homeopatía, un tratamiento alternativo a la medicina cuyos principios afirman que, cuanto más diluida está una sustancia, mayor es su efecto sobre el organismo. La página web del sistema sanitario británico NHS Choices señala que hubo numerosos estudios sobre esos remedios y que "no hay pruebas de su calidad”.(Ver)

The Seven Deadly Sins of Product Launches (V): Sin #5 Not anticipating competitive counter-launches.

By Stan Bernard

Not anticipating competitive counter-launches. 


In elections, it is typical for opponents to attack their rivals preemptively, especially early in the campaign when voters are beginning to form their initial impressions of candidates. In fact, many candidates will seek to be the first to pre-position and create a negative impression of their opponent(s), often by negative campaigning and pulling proverbial skeletons out of their rival’s closet. 

Not surprisingly, the same occurs in new pharmaceutical product launch campaigns. Savvy, aggressive companies—most notably Bristol-Myers Squibb and Novo Nordisk—form teams and plans to “counter-launch” against potential new products that threaten their current or future product sales and market shares. Most commonly, rivals will try to form the early first perception of a competitive product by pre-positioning the product in a negative light. 

Counterlaunching companies may deploy many other strategies or actions to preempt new product launches, including legal, regulatory, or payer limitations on market access or specific stakeholder communications and activities. 

Many launch teams fail to anticipate these counter-attacks until it’s too late. In many cases, launch teams and their partners erroneously want to wait until they have completed most of their clinical trials or product positioning studies before establishing their communication campaign or product positioning. Unfortunately, competitors will not wait to pre-position their new rival. In fact, these counter-launch attacks may come as early as late Phase II or early Phase III of a new product launch. It is essential to prepare for and counter these assaults as early as possible.

Ver anterior:
 The Seven Deadly Sins of Product Launches (IV): Sin #4 Focusing on traditional customers.

Humor...es lunes: Hoy no estamos para ello: "Je suis Paris..."

 
En enero, recuerdas, eras «Charlie Hebdo». Eso pusiste en las redes sociales: je suis Charlie. Pero no, tú no eras Charlie. Porque tú estabas vivo y Charlie, los charlies, estaban muertos, como los guardias y los judíos del supermercado de los que nadie se acordó en la solidaridad plañidera del pensamiento débil. Muertos como los del viernes, tirados en la calle mientras tú corrías a cambiar la foto del perfil de Twitter y de Facebook. ¿Y ahora qué nombre vas a poner? ¿Bernard, Marion, Lucien, Françoise, Phillipe? Tienes 130, elige. Ah, bien, je suis Paris, qué hermoso; qué bonita esa torre Eiffel enmarcada en el símbolo hippie de la paz. Sólo que no estamos en paz. Y que tú tampoco eres París. (...) 

Ese bonito emblema de la torre Eiffel no te va a proteger. Ni el pacifismo samaritano, ni las palabras emotivas, ni las cadenas de cibermensajes, ni el ritual de las firmas, las velas y las flores. Vienen a por nosotros, jesuis, y más vale que te vayas enterando. Te diré lo que eres: la próxima potencial víctima. Así que cuando subas a Facebook una velita por los muertos de París, sube otra por ti. 
Y acuérdate de por quién doblaban las campanas de Hemingway. 

Ignacio Camacho ABC, 15/11/2015

CPhI Madrid 2015: Creatividad TADALAFIL

Museu da Farmácia Lisboa: Carteles

El Museo de la Farmacia, (en portugués Museu da Farmácia) es un museo ubicado en Santa Catarina y  actualmente es albergado en el edificio de la Asociación Nacional de Farmacias y se abrió al público en junio del año 1996.

Conformado por donaciones de diversa procedencia, a la Asociación Nacional de Farmacias, la primera de ella provino del Dr. Salgueiro Basso. A través de una visita a este museo se podrán rememorar más de 5000 años de la historia de la salud y la colección se compone de importantes piezas provenientes de lugares como Egipto, Roma, la Mesopotamia etc.

Uno de los detalles más llamativos está dado por cuatro farmacias antiguas reconstruidas, como la de Macau, además de una farmacia portátil que data del siglo XVIII. También se pueden apreciar diversos elementos y maquinaria utilizada para la fabricación de medicamentos, envases, botellas de vidrio, etc. 

Este museo ha sido galardonado en los años 1996,1997 y 1998 como el mejor museo de Portugal y en el año 1999 como el mejor Proyecto Farmacéutico. (Más)

A destacar su colección de carteles:

Big Pharma: The game. (I)

 Big Pharma Gets Played 

As the industry makes its video game debut, the big question is: will you prioritize patients over profit? Here’s our big review.

In October 2014, we reported on the development of Big Pharma, a video game that allows you to take the reins of your own pharmaceutical company (see tas.txp.to/1014/biggame). 

Ver:

Big Pharma: The game.

The aim of the game is simple: rid the world of disease and make a successful business in the process! But is being altruistic the best business plan? Released recently on the PC (an iPad version is being considered), the game is as much about solving puzzles as it is about running a business and making profits – not unlike the real thing. 

On launch, there’s a detailed tutorial to get you up to speed on how to play the game. In brief, you have a factory floor space where you must install production lines that will manufacture your medicines. The basic gameplay mechanics are not difficult, although at first you might be a little disorientated as you figure out how to lay your conveyor belts effectively and place equipment. There’s a lot of freedom in what kind of company you create. For example, some of the medicines come with horrible side effects that you can remove, but doing so may cut into your profits. To make your drug, you must import the necessary ingredient into your factory. Each ingredient has a starting number assigned to it and to activate a particular therapeutic effect, you need to increase or decrease the number by running the ingredient through various pieces of equipment. Once you’re reached the right therapeutic number – voila! – your drug is ready to hit the market, and you have the privilege of naming it. 

 Only basic equipment and a few ingredients are available at first, but you can unlock more as you progress through the game, which allows you to make more complex medicines. You can also upgrade current medicines and remove unwanted side effects, which is where the puzzle element comes in. The main challenge is making best use of your (limited) factory floor space; your production lines can get very long as you try to juggle the numbers and effects needed to make the desired medicine. And it’s easy to make a mistake and create a “sugar pill” instead. In addition, your ingredients can only enter your factory through specific entry portals that appear on some of the walls. The production line also needs to finish at a portal before you can export your drug. It sounds simple enough, but when you’re building a complex line it always seems to end nowhere near a portal. To be successful, you really need to think and plan ahead. Once again, much like the real deal. 

This isn’t a game you can pick up and instantly become an expert, and it’s probably a bit too complicated for younger children. But it is fun and addictive, particularly if you enjoy puzzles and strategizing. You’ll certainly need to have some patience because you’re likely to run out of money and fail on your first few attempts... Sound familiar? 

The game’s creator, Tim Wicksteed, isn’t looking to demonize the industry – he merely wanted to make a novel game and was fascinated by the pharma industry because of the moral intricacies of balancing people’s health with making a profit. That said, there is certainly an element of dark humor to the game; its website keeps track of how players are doing by clocking up the total amount of revenue generated, the number of seizures averted, and the number of comas caused. The Medicine Maker team hasn’t contributed much to revenues, but is pleased to announce that it is has helped to prevent several seizures. Let us know how you get on with your own company – in the game or the real world.(Ver)

Ratón de biblioteca: Marijuana a medicina proibida / Lester Grinspoon & James B. Bakalar

A Esfera dos Livros acaba de lançar uma segunda edição, revista e aumentada, da obra «Marijuana, a medicina proibida», da autoria de Lester Grinspoon e James B. Bakalar. O livro defende o uso da cannabis com fins terapêuticos e apresenta casos de sucesso. 

Segundo Lester Grinspoon, nos últimos anos “tornou-se claro que a cannabis é um medicamento seguro e notavelmente versátil”. Daí que esta edição da obra desenvolva mais a fundo “a análise científica e sociopolítica das perspectivas de aceitação da marijuana pela Medicina”. 

O livro inclui várias histórias de pessoas que utilizaram a marijuana com objectivos terapêuticos, obtendo resultados positivos: uma mulher com esclerose múltipla, por exemplo, afirma que a marijuana não lhe aliviava apenas os espasmos musculares, mas que também lhe conferia um grau de controlo da bexiga que lhe garantiu uma renovada liberdade social. 

Apesar da ilegalidade e do preconceito associados ao consumo daquela substância, Lester Grinspoon reconhece que um grande número de norte-americanos usa cannabis com alguma regularidade, a maior parte deles acreditando que ela melhora as suas vidas: “um tema raramente discutido na imprensa”. 

O autor assegura que, em mais de duas décadas de pesquisa, leu “muito sobre a potencial nocividade da cannabis, sobretudo disparates, e muito pouco sobre o seu valor. Embora ele tenha vários aspectos, o uso clínico é um dos mais importantes e dos mais negligenciados. Cheguei à conclusão de que, se qualquer substância tivesse revelado potencialidades terapêuticas semelhantes, de par com um registo de segurança similar, os profissionais e o público teriam mostrado muito mais interesse nela”, disse. 

 Lester Grinspoon é médico e professor na Harvard Medical School, e James B. Bakalar é sub-editor da Harvard Mental Health Letter e lecciona matérias jurídicas no departamento de Psiquiatria da escola. Ambos editaram uma primeira versão desta obra, intitulada «Marijuana reconsidered», em 1971

Hoy el ratón...
aconseja "No fumar"

The Seven Deadly Sins of Product Launches (IV): Sin #4 Focusing on traditional customers.

By Stan Bernard

Focusing on traditional customers. 

• Election strategists know that they cannot win by simply focusing on voters; they have to impact voter influencers or campaign constituents such as the media, political pundits, and major campaign contributors. Similarly, product launch teams need to focus beyond their traditional customer triad of 


• physicians, 
• patients, and 
• payers 

to engage many other stakeholders. 
Stakeholders can be defined as those constituents who can influence the perception, access, and utilization of pharmaceutical products. 

Stakeholder Management 2.0 consists of several key principles. 

• First, there are numerous types of stakeholders, including but not limited to government agencies, patient advocacy groups, media, analysts, regulatory authorities, politicians, policymakers, professional and lay associations, and many others. 


• Second, their influence can be very different in diverse competitive landscapes and lifecycle stages. For example, Pre-Launch stakeholders are often very different from Post-Launch stakeholders.

Most importantly, today’s pharma stakeholders do not exist in silos but rather in a

“Stakeholder Ecosystem.” 

They routinely influence and are influenced by other types of stakeholders. Sharing of extensive product information and perceptions has been cultivated by the Internet, which breaks down traditional stakeholder silos and offers timely, comprehensive data to all audiences. 

The most successful launch teams identify, prioritize, and address the stakeholder segments and networks most vital to the launch of their and their competitors’ products.

Ver anterior:
 The Seven Deadly Sins of Product Launches (III): Sin #3 Electric numbers

CPhI Madrid 2015: Procaps & Juán Valdez café...Co-Marketing? Joint Venture?

PROCAPS, es una empresa comercializadora y productora de especialidades farmacéuticas cuyo domicilio social se encuentra en Barranquilla-Colombia, importante distrito portuario desde donde se desarrollan innumerables negocios de exportación e importación de productos en el país.

Juán Valdez 

En 1927 los cafeteros colombianos se unieron con el fin de crear una organización que los representara nacional e internacionalmente, y que velara por su bienestar y el mejoramiento de su calidad de vida. Así nació la Federación Nacional de Cafeteros de Colombia (FNC), considerada hoy como una de las ONG rurales más grandes del mundo. 

Nuestra Federación es una entidad sin ánimo de lucro, y no está afiliada a ningún partido político. Desde 1927 ha sido el principal gremio de Colombia, con presencia en todas las zonas rurales donde se produce café en el país. Su eje central es el productor de café y su familia, de forma que su negocio sea sostenible, que las comunidades cafeteras fortalezcan su tejido social y que el café colombiano siga siendo considerado como el mejor del mundo.

Amb@s son colombian@s.
Vinieron junt@s...
L@s dos ligadit@s...

The Seven Deadly Sins of Product Launches (III): Sin #3 Electric numbers

By Stan Bernard

Electric numbers 


Using outdated marketing tools and tactics. Many pharmaceutical companies and their partner agencies deploy obsolete launch techniques and promotional tactics. For example, numerous launch teams continue to rely on lengthy product positioning statements, product messages, and sales aids. However, in today’s text-heavy, six-second video world, these protracted approaches are tuned out. Doctors, patients, and other constituents today simply cannot keep up with the overwhelming number and amount of different products, trials, data, and details. Consequently, these stakeholders form an overall perception of the different products and select the product with which they feel most comfortable. 

Brand teams need to use simpler, more concise communications to convey the optimal perception of a product instead of the details. For example, Janssen used three short “i-Bites” instead of messages to promote Xarelto on its website and elsewhere: 

• “proven efficacy across multiple patient types;” 
• “demonstrated safety profile;” and 
• “convenient oral dosing.” 

Launch teams that create a clear, concise campaign communication platform for their drug candidate usually perform dramatically better than those focusing on countless product details and messages.

Ver anterior:
 The Seven Deadly Sins of Product Launches (II): Sin #2 Trying to win by differentiating your product.

The Seven Deadly Sins of Product Launches (II): Sin #2 Trying to win by differentiating your product.

By Stan Bernard

Trying to win by differentiating your product. 


In the majority of US Presidential elections, very few voters know the numerous details or specifics of a candidate’s policies; they typically vote based on how they generally feel about the candidate and the campaign agenda. Consequently, the most successful campaign parties use a two-step campaign approach. First, they seek to convince the electorate and constituents to focus on their carefully-selected campaign platform issues, particularly the perception of how their candidate would handle these issues. Then they campaign to create the optimal perception of how their party candidate would be best at handling these issues while serving in this leadership role. Essentially, by taking the lead on the campaign agenda, they force rivals to play their game. 

Launch teams that create a clear, concise campaign communication platform for their drug candidate usually perform dramatically better than those focusing on countless product details and messages the current environment, pharmaceutical launch teams that force competitors to play their game—according to their own issues, rules, criteria, and timetable— usually win the game. Unfortunately, the vast majority of brand launch teams are still fixated on product differentiation. 

For example, over the last few years rival novel oral anticoagulant brand teams have focused first on differentiating their agents based on traditional efficacy and safety parameters. In stark contrast, Janssen Pharmaceuticals has forced rivals to play an “indication game.” Their launch team campaigned first on the critical importance of demonstrating multiple indications of oral anticoagulants across diverse healthcare settings. Janssen then successfully positioned its new drug candidate Xarelto (which it licensed in the US from Bayer) as “the first and only novel oral anticoagulant with six indications approved by the FDA .” As a result of this two-step election-style campaign, Xarelto became the No. 1 prescribed novel oral anticoagulant in the US.

Ver anterior:
 The Seven Deadly Sins of Product Launches (I): Sin #1 Seeking to win the launch year.

Argentina: Erecciones de "marca" (I): Ahora...VIRILÓN

Ver anterior:

Argentina: Erecciones de "marca". Roemmers lanzó Invictus vs Viagras

Investigación Clínica: Competitive trial management (CTM) / Stan Bernard*

Originally, pharmaceutical clinical trials had two fundamental, interdependent roles: regulatory and clinical. In the US, the 1962 Kefauver-Harris Amendment, or “Drug Efficacy Amendment” to the 1938 Federal Food, Drug, and Cosmetic Act, required that drugs demonstrate efficacy and safety to be approved for patient use. In 1966, the Fair Packaging and Labeling Act required that all drugs have specific labeling to assist doctors and patients in the clinical use of these products. Four years later, the FDA required the first patient package insert (for oral contraceptives), which contained information for patients about specific risks and benefits. 

Soon thereafter, pharma companies began to leverage clinical trials for promotional purposes by seeking to highlight product details or differentiation from other products, which the FDA and other agencies over time progressively regulated. Over the past few decades, companies have been compelled or inclined to use clinical trials for reimbursement or payer purposes, as product cost-effectiveness and value have become increasingly important worldwide. Complete with their own unique and memorable brand names, clinical trials have progressed to embody battles in the larger brand wars and are now increasingly being used for competitive purposes in what can be termed “competitive trial management,” or CTM. 

Competitive trial management examples (CTM)

Pharma companies have leveraged CTM in a variety of ways to gain competitive advantages and steal market share: 

• Better: The most direct form of CTM is competitors’ head-to-head clinical trials against market leaders, almost unheard of 15 years ago. For example, over the last three years, Janssen has conducted several head-to-head studies with its SGLT-2 agent Invokana, demonstrating advantages in glucose-lowering, weight loss, and cost-effectiveness versus the market-leading ral T2D agent Januvia. Similarly, Amgen recently announced interim results demonstrating that Kyprolis helped patients with orelapsed multiple myeloma live twice as long before their blood cancer worsened compared to a regimen containing rival drug Velcade.  


• Counter: In a 2007 head-to-head study published in The New England Journal of Medicine, the experimental anticlotting drug Effient from Daiichi Sankyo and Lilly reduced heart attacks in patients with heart disease by 24% compared with market leader Plavix from Sanofi and Bristol-Myers Squibb. However, BMS planned ahead and leveraged CTM techniques to counter a head-to-head trial. Months prior to the announcement of the trial results, BMS conducted a systematic campaign among key US market stakeholders to highlight the significantly higher bleeding risks associated with Effient, ultimately undermining the study’s and the product’s benefits.  


• Faster: For its new PD-1 cancer agent, Keytruda, Merck & Co. streamlined its clinical trial package and transformed a first-in-human study into a registrational study in order to beat BMS’s rival Opdivo to the US melanoma market. According to Merck’s VP of early oncology clinical research, Eric Rubin, Keytruda’s rapid development required “less than four years from the first patient that we enrolled to approval.”  


• Broader and higher: Not to be outdone, BMS worked collaboratively with the FDA to obtain expedited approval for Opdivo and beat Keytruda to the larger US lung cancer market months ahead of schedule. Moreover, despite its initial submission for the third-line setting in squamous-type non-small cell lung cancer, BMS leveraged two studies to obtain labeling in both second- and third-line use, a much broader competitive opportunity, and an overall survival benefit.  


• Bolder: At the 2014 American Society of Hematology Conference, Janssen took out a full-page advertisement showing several different studies the company was planning to conduct with its investigational multiple myeloma agent daratumumab—not the ones that the company had completed. Janssen took this step to try to create the impression that its CD38-targeting monoclonal antibody could potentially be used across different patient segments and lines of therapy.  


• Newer: For its investigational submental fat treatment Kybella, Kythera Biopharmaceuticals worked extensively with the FDA to create a new patient-reported outcomes assessment tool called the “Patient-Reported Submental Fat Impact Scale.” As a result of the patient survey results, the company achieved novel product labeling that includes improvements in overall patient-reported satisfaction and self-perceived visual attributes. (Más)

(*) Stan Bernard MD, MBA is President of Bernard Associates, LLC, a leading global pharmaceutical industry competition consulting firm. He is also a member of Pharm Exec’s EAB Board. He can be reached at SBernardMD @BernardAssociatesLL C.com