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dstout

Gaming for good health

Published by Danielle Stout on September 19, 2011.

So lately the buzz has been healthy video games (which in the first UP:ROOT shows how there is a big market for this too). Okay, okay, I’ll be honest. My particular obsession with Call of Duty: Black Ops is far from healthy, but there are many other options in both mainstream and healthcare gaming that provide unique ways to promote wellness. Here’s my take, as a part of the 26% of female gamers, on some of the coolest advances in gaming for health and wellness.

Motion gaming minimizes sedentary play

Even though motion gaming has been around for quite some time (remember stepping as hard and fast as you could on the old Power Pads for Nintendo’s track and field games?), motion gaming as we know it now with facial, spatial, body and, for some even voice, recognition still  has a lot of exploration and growth happening. This is prime time for medical marketers to find solutions on these platforms as the early adopters have helped identify holes in the games first made available. These types of systems and all of their intricacies that have yet to be fully utilized hold a huge potential, but  for now my recommend best use of this platform in healthy gaming is Your Shape Fitness Evolved for Kinect.  Besides utilizing full body scanning for customizing arm and leg span and making movements and positioning more accurate it also helps you rack up Gamer Points as you burn certain amounts of calories which is a huge motivator especially for those gamers who like those additional bragging rights on their Xbox Live account.

Virtual reality gaming can help patients escape from painful treatment

In Fallout 3—one of the usual, not-so-healthy games—your character finds a group of people escaping the harsh reality of a post-apocalyptic world through virtual reality. Well, that theory is not just for video games now, mostly. Firsthand Technology teamed with research psychologists to build a virtual reality game that reduces pain related activity in burn patients undergoing painful therapy or treatment.

Gaming can mimic physiological effects to deter unhealthy behavior

Forget about just trying to escape reality; instead try replacing a harmful habit in an entertaining (and much healthier) manner that provides the same effects. A team at Teachers College, Columbia University in New York are developing Lit, a smoking cessation game, which uses breathing techniques to simulate effects of smoking.  Rather than just asking them to attempt breathing exercises (which could get old fast), it gives them an interactive environment that rewards them and encourages continued use.

Click here to view, “Lit, a smoking cessation game.”

Gaming provides a fun format for learning

Had someone asked me to spend at minimum an hour every evening talking about military weapons I would have answered with a resounding “no.”  However in my habitual playing of Black Ops, I’ve pretty much done that. Thing is you don’t really realize how much you’ve learned until you are watching a commercial for TopShot and can name the equipment faster than the host can. Asking patients to read up on a disease or product may not produce results, but getting them to engage in a fun game with repetitiveness may have them retaining more information. So you don’t have to find such awesome ways to take advantage of the new modes of gaming, as I’ve shown. Even just a simple, yet fun, game that divulges information will do the trick. Now go play, and tell your loved ones it’s for medical research!

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dmarinacci

GSW loves SXSW. True or False?

Published by Dawn Marinacci on August 29, 2011.

It’s TRUE!  Many of us attended SXSW earlier this year and were blown away by the electric atmosphere, the inspiration, creativity and greatness over the course of the week (interactive festival). And already, voting for SXSW 2012 is underway. Several weeks ago we gathered up a group of like-minded creators and innovators here at GSW and before we knew it, we had 14 ideas to submit for a chance to be selected as a presenter for 2012.  We’d love to go back and have a presence on the big stage. Public voting counts so will you vote for GSW at SWSW?  Below is a quick look at each panel and a link to vote. Check them out, and give them a thumbs up (that counts as your vote)! You can also check them out by clicking this link. Happy voting!

Avoid communication pile-up on the digital highway

  • Organizer: Andy Brown
  • Communication defines us: what we see, how we think and react, and subconsciously how we make decisions, sometimes when we don’t even realize it. How do we use these channels to our advantage without overloading everyone’s capacity to process and have belief in all things in front of us?

Vote here!

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Buffy, Faith, and the Single-Slayer Syndrome in Tech

  • Organizer: Susan McGowan
  • Women in tech are often used to being the lone female on a team, and this conversation examines how this experience affects them, and how it can lead to (unintentionally) keeping other women out. Hear from women who have survived the Hellmouth and are ready to bring a new generation into the Slayer line.

Vote here!

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Die Post-Its, DIE!

  • Organizer: Sherrie Divierte
  • In this session, we will hear from Organization, Productivity and Technology Wizards who will analyze some of the best tech solutions to conquer the infinitely old “To-Do” lists.  In the end, not only will you save a few trees, you might also save yourself from drowning in sticky notes!

Vote here!

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Finding InterActive Wellness and Rockin’ the Balance

  • Organizer: Kathryn Bernish-Fisher
  • Ever wonder how to maintain a proper work-life-device balance? This panel will show you how to mash up the latest wellness research, real tools and wisdom of the crowds to create your own map to a life well lived across the personal and professional channels and circles and social networks.

Vote here!

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Got PMP? You should if you manage interactive

  • Organizer: Jo Musisca
  • The Project Management Professional certification is a highly valuable tool for use in your digital projects, and not just a way to add some extra letters to your email signature. Jo gives some insights on how to use a PMP certification to the greatest advantage at your agency.

Vote here!

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It’s a Tumor! How iHealth can improve your health.

  • Organizer: Jeff Stauffer
  • Jeff and his awesome panel explain how individuals can take control of their own health by utilizing all the amazing digital tools available today.

Vote here!

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mHealth: Destroy Boundaries. Create Connections

  • Organizer: Leigh Householder
  • In this panel, experts from the communications, technology, and the pharmaceutical world will discuss how the wireless computers in our pockets have dramatically transformed the way people and healthcare brands interact.

Vote here!

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My S#!t Don’t Stink: Interactive’s Overlooked QA

  • Organizer: Jennifer Town
  • In this panel, you’ll learn the pitfalls of doing your own QA, why QA should never-ever-ever be skipped (yes, even though you’re on a deadline), and some of the most common issues QA sees. We’ll also bring together developers, QA testers, and other stakeholders to discuss the nitty-gritty of occupying the same digital sandbox without getting sand in your WYSIWYG.

Vote here!

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Sit! Stay! Obedience training for unruly clients

  • Organizer: Patrick Myers
  • In this session, Patrick will discuss ways to properly train a client for a healthy working relationship—as well as provide insights on how to teach an old client new tricks. Learn simple strategies that can help you get to better creative and experience fewer soiled briefs.

Vote here!

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Swimming with sharks: Programming the scuba way

  • Organizer: Jude Divierte
  • This discussion will apply the teachings of Open Water certification to help you understand how to navigate the sometimes rough seas of the interactive workplace without getting eaten alive.

Vote here!

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Take 2 Apps and Call Me in the Morning

  • Organizer: Leah McDougald
  • Leah and her panel discuss how to bridge the gap between the increasing user demand for information and how to most efficiently produce it in a tight-budgeted and highly regulated industry like pharma.

Vote here!

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What is this thing you call “idea”?

  • Organizer: Dave Sonderman
  • How do you point to, compare and evaluate today’s viral, environmental, sharable, socialized ideas? This panel discussion will explore the ways agencies are successfully reviewing, debating, presenting, and evaluating their amorphous creations before they become approved and funded.

Vote here!

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Who’s In Charge? Too Many Cooks in the Project

  • Organizer: Stephanie Perkins
  • With too many cooks in the kitchen, unwanted stress, frustration and hostility can quickly turn even the simplest of tasks into the perfect storm. Find out how to best align client needs, talent pools, and peer input so that the project can be delivered smoothly from conception to completion.

Vote here!

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0-9 in 3.5 years: Building a Digital Powerhouse

  • Organizer: Damon Caiazza
  • Ever wonder how to organically grow an industry leading innovative team? Damon will explain the keys to building a healthy and diverse strategy, creative and development team that actually drives change within your organization.

Vote here!

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dstout

Think twice about friending physicians

Published by Danielle Stout on August 10, 2011.

A pair of doctors nonchalantly approaches a patient’s home and, by using a credit card, picks the lock of the door in order to search for anything imperative to solving their patient’s case. Such is a common occurrence on House.  But outside the Hollywood studio world of medical practice, doctors are being warned to not even accept a look into patient’s online social presence.

An article in The Wall Street Journal’s Health Blog indicates the British Medical Association explicitly states that “doctors and medical students who receive friend requests from current or former patients should politely refuse.”  The American Medical Association’s policy is a little more lax stating only that those who have an online interaction with their patients should “maintain appropriate boundaries of the patient-physician relationship in according with professional ethical guidelines.” Let’s say a certain patient that is very “friend request” happy adds their doctor and chooses not to apply any privacy settings to their status updates, photos, etc (unaware that the information they divulge in those could cause an ethical dilemma for their new “friend”). The blog article uses the example of a doctor seeing a photo where a pregnant patient is holding a cigarette and a beer. Should the doctor bring this up in their next appointment?

Dr. House would justify the actions of his team’s break-ins that the patient made a mistake of lying (or simply leaving out information), so they must combat that with another transgression. In House’s practice, two wrongs really do make a right. By the end of the episode a patient has usually forgiven the team for the break-in (no charges filed) and also APOLOGIZES for having lied in the beginning. In the real world would a patient be so forgiving? In the example of the pregnant patient, would they apologize to the doctor when questioned about the photo? Or would they take offense when it was their own disregard for privacy that revealed it? How is the doctor in the wrong if the patient ALLOWED the doctor to access that information? A patient’s inability to button up their online presence when they made the initial request to invite their physician into it should not be the doctor’s problem. Now, if a doctor happens upon a photo of a patient online in such a situation, then it gets a little sticky. But in that manner, how would a doctor handle the situation if they had personally seen the pregnant patient smoking in public?

Alas, the indefinite policies with patient information on social media press on; this just being another example of how attempting to remove physicians from the situation seems the best answer. But this is where we should be asking ourselves as medical marketers how we can make it easier for doctors and patients to interact digitally without crossing those ethical boundaries.  If we establish a “virtual office” space, then wouldn’t everything the patient reveals there be considered freely given in a medical setting? Is there a solution that helps doctors keep up on patient’s progress between appointments without opening it up to too much patient disclosure?

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pcomber

Well meaning regulations are not the solution

Published by Peter Comber on July 26, 2011.

The American Medical Association voted, at its annual meeting on June 21st, to support ad-industry policies discouraging altered, unrealistic body images in advertising.

The association says: “Advertisers commonly alter photographs to enhance the appearance of models’ bodies, and such alterations can contribute to unrealistic expectations of appropriate body image — especially among impressionable children and adolescents.” The statement continues saying there exists a link between the kind of images they would like to outlaw and eating disorders and other health problems in the young and impressionable.

It seems reasonable and the right thing to do. The latest in a long chain of right and reasonable rules and regulations attempting to make our society better and safer that, in my opinion, are having the opposite effect. I fear we are regulating ourselves towards mass ignorance.

The more rules and regulations we create for our world, the less each individual feels responsible and the less attentive they become in their choices. A healthy and safe society is a society with values, comprised of people who are attentive, able to analyze and criticize. People who think.

Just as the sharp rise in prevalence of allergies seems to be linked to the extremely hygienic conditions that many people live in, the over-sanitization of our society will produce generations of undiscerning individuals.

Because it started a conversation and raised awareness with the general public, the famous Dove “Evolution” campaign has had a more positive effect than the proposed regulations ever could (at the time of writing the film on YouTube had been viewed 13,308,630 times). Our goal should be to help children understand that perfection is merely an ideal, exalted in movies, TV, magazines and the advertising within them, an ideal that doesn’t exist in reality; every individual is beautiful, and flawed.

Celebrating real people and setting realistic expectations shouldn’t mean eliminating fantasy and fiction from our world. Because if you ban manipulated images in advertising you will have to extend the ban to editorial content and all published images.Then you will find that an un-manipulated photo of an anorexic model is equally damaging and you will have to establish a table of minimum required proportions between height, weight, and waist/hip measurements for all models used in published photography. At that point you will have created an official standard of what a healthy and beautiful body is and it will still be tragically unattainable for the majority.

I completely support the American Medical Associations ultimate goal which is to prevent eating disorders and health problems in children and adolescents. I just believe that their approach of censoring images will not be effective. Promoting the development of the personal skills required to navigate successfully through life is the real solution.

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brizzo

“Moving in” to the Medical Home Model–Is your practice considering the change?

Published by Brenda Rizzo on July 5, 2011.

Have you noticed a difference in the way you receive your healthcare? Does your doctor belong to a Medical Home Model (MHM)? How would you know?

In July 2011, Ohio will be converting 44 practices into Patient Centered Medical Home models. What does this mean? MHMs will move from the traditional fee-for-service model where healthcare providers (HCP) get paid based on the number of patients they see per day to a new model which requires quality, thoughtful, healthcare and promotes more time spent with the patient. Wouldn’t it be nice to know you don’t have to hurry up and get everything in that you wanted to talk to your HCP about in 15 minutes because that is all they have to spend with you?

In order to be considered at Medical Home Practice (MHP), certain criteria must be met. Providers must have same day appointments available to reduce costly ER visits, for example. Practices will have social workers call after a patient visit to make sure they have completed blood tests or X-rays. A patient advisory council must be formed to inform the practice and discuss delivery of care. MHPs will be measured on their accessibility to patients, whether or not the patient sees the same doctor with each visit and how they manage chronic conditions like asthma or diabetes.

Diabetes management will be evaluated for appropriate care on steps such as hemoglobin A1C testing, a measure of glucose control. MHMs will be expected to conduct or refer for eye exams, foot exams and assure flu shots are given for diabetic patients in their practice. They will be tracked on outcome measures such as the number of avoidable hospitalizations for long-term diabetes complications, short term diabetes complications, uncontrolled diabetes without complications or amputations related to diabetes.

Other chronic disease conditions have similar measures of quality healthcare, with similar requirements to be considered as a MHM. Disease states are not the only focus of these  models. There are models based on types of care, as in preventive, acute and chronic; based on settings of care such as home health, hospital care, nursing home care and ambulatory care. Other clinical areas can be cancer, heart disease, maternal and child, and respiratory diseases.

The Agency for Healthcare Research and Quality (AHRQ) is evaluating states performance on these measures as well. They are also looking for cost savings based on the benchmark of state employee usage of services. They do this by first determining the number of covered lives with diabetes by age, gender, and race/ethnicity.  Based on some benchmarking data they will be looking for excess costs associated with poor control of blood glucose.  Benchmarking data shows that if an HgbA1C is kept under 6%, less complication will occur. They know that carefully designed programs can expect reductions in HgbA1C by .48% and more intensive disease management programs can achieve a 1.09% reduction. So they will be looking for examples and implementations of these types of programs.

Finally AHRQ will be looking for disparities in treatment offered among non-Hispanic black, Hispanic, and non-Hispanic white groups. Currently the state of Ohio is rated at the low end of average in overall health care quality, with a very weak performance in diabetes management. Let’s hope the new models in July will help us to improve the quality healthcare for our citizens in this state.

How are these new models being paid for you ask? Insurers and employer groups are funding these new models of care and are paying doctors more for their extra work.  Their hope is that through these MHMs, health care costs will diminish and therefore they too will realize a benefit.  In Ohio, Anthem Blue Cross and Blue Shield, Humana, Medical Mutual of Ohio, Partners for Kids, OSU Health Plan, and UnitedHealthcare have all signed on to participate in this collaboration. Ask your insurer or employer group if they plan on participating in a MHM if you think it sounds like a great new model, and has potential for better healthcare.

But most importantly as we consider marketing and communication of new products for healthcare, do our strategies and tactics fit into this new model? Do we propose turnkey programs that help to educate, monitor care and provide follow-up? How can we be partners and advocates for better healthcare delivery and respond to the needs of the MHM?

For more information visit:

http://statesnapshots.ahrq.gov/snaps10/map.jsp?menuId=2&state

http://www.medicalhomeimprovement.org/projects/national.html

http://www.ncqa.org/tabid/631/default.aspx

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bnasal

Daydream Your Way to Creativity

Published by Bob Nasal on June 29, 2011.

Has your manager ever caught you daydreaming? No worries—just tell them you’re working on enhancing your creativity. How could they possibly object to that? Doesn’t every organization need creative ideas and the more the merrier?

Ah, “creativity”—one of those special words. It may inspire and motivate you. Or it may sound very foreign. “Creative? Sorry, not me. Not only haven’t I been there, done that—I don’t have any idea how to get there, do that.” In our business, it’s easy to mentally abdicate and leave creativity to “the creative.”You know, those exalted conjurors of new and wondrous ideas that seem to blossom effortlessly when the need arises.

But we can be shortchanging ourselves. We all have creative ability—capacity that we can tap to spark our professional and personal lives. There isn’t a task or job or project in our organization that wouldn’t benefit from a dose of creativity. So how do we get it, how do we grow it?

There are multitudinous books and articles on this topic. If you search and find an approach or two that works for you, congratulations. What I’m describing is an approach that builds on research into the role of daydreams in developing creativity. Data indicate that most of us spend about 30% of our awake time in daydreaming, or mind wandering. We can all relate to this—doing one task while our mind has totally detached and is freely roaming in its own virtual neighborhood. Research indicates that there’s a dedicated daydreaming network residing in our brains. Some have called it the default network, and it’s constantly humming below our consciousness.

There are familiar stories of people who worked hard and long to try to solve a particular problem or come up with a new approach or theory—but without success. It was only after they stopped trying so hard that they experienced the “Eureka!” moment and found what they were looking for. Unshackling the mind, letting it float where it will, and accessing unconscious ideas can lead to valuable creative insights.

A great example of such a moment occurred with the creation of a tool most of us use every day. As read in a post from Christine Duvivier, the Post-It was the culmination of a daydream. Although it is frowned upon–Arthur Fry was letting his mind wander during a sermon one Sunday in church. He was thinking about how his bookmarks never seemed to stay put in his hymnal. His solution? The clever, crafty, and always useful Post-It.

Sounds great, doesn’t it? Take a mental vacation and solve our problems? Well, yes and no—it’s not that easy. The key seems to lie in a paradox—we can’t just let go and fantasize about the beach on Maui (as attractive as that might feel). We shouldn’t try to tightly “manage” our daydreams, but, on the other hand, we do have to pay attention to them. A study has shown that the people who caught themselves and were aware that they were daydreaming were the most creative. Also, those people who were involved in a mildly challenging task while daydreaming (versus doing a hard task or nothing at all) did better at creative problem solving. So it’s essential to notice the daydream and then evaluate it—does it contain a new thought, idea, or theme that’s helpful? If so, we’ve added to our mental toolbox.

But I suspect that many of us, including me, are like turned-off smartphones. Lots of messages coming in—silent, invisible, waiting to be accessed—if only we’d hit our “ON” buttons and pay attention. So that’s our mission and who knows where it might lead?

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jjaeckel

Is Nothing Sacred?

Published by John Jaeckel on June 24, 2011.

Congressman Anthony Weiner’s well-documented recent scandal provides ample proof of the potential lack of privacy in social media (especially when mixed with unhealthy doses of impropriety and narcissism)

That unfortunate episode aside, one need look no further than Facebook to see how quickly and easily an innocent status update can morph into a breach of privacy of some sort.

Then, consider the implications for those in the highly regulated medical and pharma industries— and the potential costs and calamities are multiplied exponentially.

As one accumulates more and more friends and followers— sometimes on the basis of knowing someone by their first name from work or a social organization— a tagged photo containing any number of people or situations is presented to, let’s face it, hundreds of casual friends, coworkers, clients or near strangers.

And there’s the rub. Social media are a great way of expanding networks of friends and contacts quickly. Yet with that expansion comes increasing complexity and responsibility.

What percentage of Facebook and Twitter users co-mingle work and personal contacts, not to mention work and personal information? My guess is, it’s very high.

Let’s say you’re working on a new drug launch and grouse on your Facebook page about your hours or something someone said at work, revealing something proprietary—or you’re chatting with a friend or coworker and somehow, even accidentally, the text of said chat gets forwarded to one of their friends or contacts.

However slight, the potential for far-reaching disaster lurks.

Social media companies can safeguard passwords. But the services themselves, by their very nature, can be a minefield in terms of protecting a measure of privacy.

Social media encourage us to share, and as the media themselves expand the ways in which they can be used, we are presented with more ways to share (some we often use unwittingly):  status updates, likes, dislikes, fan pages, politics and religion, tagged photos, tweets. Re-tweets. Direct messages. Chats. Link/friend/follow requests. Introductions.

But where and how do we draw the line? Here are a few suggestions to consider for protecting privacy.

Don’t Forget Your Privacy Settings

Facebook and MySpace, for example, provide safeguards and limits that allow users to restrict access to some or all of their information, from some or all viewers. These are worth investigating and using.

Consider Separate Accounts

Another option is to create separate work and personal accounts. Sometimes work and personal don’t always mix.

In an insightful piece written recently for the Huffington Post, actor Alec Baldwin comments on how social media often allows people to develop and carry on relationships that a decade or more ago always took place in person. Social media have somewhat stripped away the obvious filter of:  that’s not something I should do or say in this situation or in mixed company.”

There don’t seem to be as many or as immediate consequences when something is done or said online. But as Weiner’s and so many other cases (most less sordid and less publicized) recently prove, there are consequences nonetheless.

Ask an Important Question

Another good rule for sharing information on social networks is: “would I share this openly— in person— among a group of friends or co-workers?”

“Would I want them sharing it, in turn, with my employer, my spouse (or my ex), or strangers—like someone who works at the FDA— or my competitors?”

Companies can create social media guidelines for their employees. Employees, for their part, should abide by these— as they should provide a measure of boundary and protection for their personal information as well.

But as with anything, enjoy, but tread softly and carefully.

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jtown

Wiki-media: are brands being smart or lazy?

Published by Jennifer Town on June 9, 2011.

I went to Ohio State for graduate school, and as part of my funding, I taught for a couple years. Freshman comp, mostly. During the course of my teaching years, I discouraged, as most English teachers do, the use of Wikipedia as a source. Skeptical of the collaborative nature of the medium (Anyone can edit it? Really?), I was following the edicts of my professors and peers. But you know what?

I love Wikipedia. And who doesn’t?

Wikipedia is about 10 years old. And, yes, I got that information on Wikipedia—although looking up “Wikipedia” on Wikipedia feels a little bit funny. Since 2001, the Wikipedia model has sprung up all over the place. Another way to put this is “Web 2.0,” which—old news by now—encompasses all the social networking, blogging, social bookmarking, podcasting, and wiki-ing your heart desires.  

But the beat goes on: just last month, for example, Google users gained the power to edit  the U.S. in Google Maps. We’ve been able to edit other portions of the world for almost three years now. Afraid you’ll end up driving your car off a cliff because So-and-So says there’s a Starbucks at the end of that road? Don’t worry—as in previous versions, changes are moderated first and then pushed to the live site.

In May 2011, Footlocker launched the wiki “Sneakerpedia.” Basically, it’s a community of people who love sneakers, a place where “sneakerheads” can share their favorite pair of “kicks.” This site merges the “pedia” part of Wikipedia (shoes are catalogued with date launched, type, brand, etc) with the social networking of Web 2.0 (users can share their personal sneaker stories).  

The Footlocker branding is limited to small text under the site heading, but Footlocker is counting on increased search results, as well as increased authority in the sneaker community. Footlocker, the site implies, not only understands the “sneakerhead” culture—it offers that community a place to share its personal stories and passion. And like Google maps and Wikipedia itself, the user becomes the expert, adding details about their sneakers, down the type of stitching and color.

Sneakerpedia Trailer from Sneakerpedia on Vimeo.

Footnote (no pun intended): If I was still teaching today, I would still put a red x through a bibliography if it contained a Wikipedia reference, for a number of reasons, but most of all, because it’s just plain lazy. But can’t remember whether the Badlands are in South Dakota or Wyoming, or who won the 1999 World Series? Go ahead, Wikipedia it up.

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mtscott

What impact will follow-on biologics have for pharmaceutical marketers?

Published by Michael Scott on June 6, 2011.

The answer, like most things, is “it depends.” An important question remains to be answered: Are Congress and the FDA really going to declare “interchangeability” between an innovator biologic medication and a follow-on biologic? With interchangeability, you’d have a situation much like that with most current generic drugs. Brands will have a short time to recoup costs and will be competing with generics that can be substituted by a pharmacist without the intervention of the doctor.

Just a few short years ago FDA said that it “has not determined how interchangeability can be established for complex proteins.” The Biotechnology Industry Organization (BIO) states that “the current state of science is not sufficient to establish interchangeability for complex follow-on biologics.”

Follow-on biologics have already been approved, but not as interchangeable products
An explosion of generic drugs has resulted from the generic pathway established in 1983 by the Hatch-Waxman Act: Section 505(b)2 of the Food, Drug, and Cosmetics Act (FDCA), which allows for an abbreviated new drug application (ANDA).

According to FDA Guidance for Industry: Applications Covered by Section 505(b)2, an ANDA is “an application…where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference.” In other words, the generic manufacturer can rely on published literature and the FDA’s finding that the original branded drug is safe and effective. The ANDA pathway generally does not require costly Phase III studies, but it was not written to apply to biologics.

In 2004, FDA stated that it could not reach a final decision concerning the approval of Omnitrope, a follow-on recombinant human growth hormone (rhGH) manufactured by Sandoz, through the 505(b)2 ANDA process (the application used Pfizer’s Genotropin as its reference). FDA felt that it was an issue that had to be settled by Congress because there was so much uncertainty in the scientific and legal issues surrounding biologics.

A response that continues to raise more questions, years later
Ordered by a federal district court to hold a hearing on the ANDA, FDA approved Omnitrope in 2006 but issued a 53-page “decision letter” addressing petitions from Pfizer, BIO, and Genentech requesting that FDA not allow this ANDA for a biologic (protein) product. At the very beginning of the letter, FDA spells out several items that its response does NOT address, including:

  • Interchangeability—Omnitrope was designated as a “BX” generic; these are “drug products for which the data are insufficient to determine therapeutic equivalence”                            
  • Scientific issues with protein products, especially those not well-characterized by currently available analytical techniques (rhGH was considered by FDA to be “extensively and adequately characterized”)

In addition, Sandoz had conducted three original Phase III trials in pediatric patients with growth failure. So this decision did not establish a precedent.

Fast-forward five years
The Biologics Price Competition and Innovation Act, signed into law in 2010, attempts to provide a pathway to interchangeability for biologic medications in general, despite the fact that—as far as I know—researchers have not solved the issues wisely avoided by FDA in 2006. The law as written states that the follow-on biologic must show data from “analytical studies that demonstrate that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive compounds.”

For FDA to declare a follow-on biologic “interchangeable,” the manufacturer must show that “the risk in terms of safety or diminished efficacy of alternating or switching between use of the [follow-on] biologic product and the reference product [innovator or brand] is not greater than the risk of using the reference product” alone.

Follow-on = Me-too?
Right now, it seems to me that the only way to demonstrate interchangeability (lack of additional risk) would be through large, costly Phase III studies. The price of entry into manufacturing biologics is high, so the steep discounts seen for generics will not materialize (follow-on biologics could easily be 80%-90% of the price of the original). And given the fact that it may be reckless, in the current state of knowledge, to declare a follow-on biologic “interchangeable” (allowing substitution without the knowledge of the physician), will patients and physicians choose a 10% discount for a “biosimilar”?

So the situation won’t be remotely comparable to generics, if science prevails. You’ll be looking at biologics that are based on an innovator product, priced at 90% of the original, with no automatic substitution. Unlike chemical “me-toos” (new brands in a class, such as statins), follow-on biologics will not be able to promote better efficacy or safety. I think for now, biotech innovators have little to worry about, and follow-on biologic manufacturers face an uphill battle.

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pdeschamps

Life lessons turned to business

Published by Phil Deschamps on May 25, 2011.

Now that my kids are at the age where they are making decisions about where they want to go to college and what they want to study, I am often caught using a phrase that my father taught me about Life. He said: ” Life disproportionally rewards passion” so make sure that you study and work in something that you are passionate about and life will take care of itself.

I find myself using that line often as I teach my kids not to get stressed out about what they should study. I simply tell them study what you are passionate about and you will become better than most who are doing it because they picked it without much thought.

After one such conversation I started thinking about how I could apply this philosophy to my work. As a business leader it is easy to fall back into the mechanics of business, effectiveness, efficiency, process optimization. Not always, but often, this gets in the way of people doing what they are passionate about. This is what still drives the marketing and advertising world. I sat in on a presentation last Friday where the CEO of a company who had just chosen us to help them redesign and redeploy their worldwide brand. The CEO wanted to see the pitch presentation that won us the business. The team delivered the presentation as if we were still fighting to win. They were passionate. The CEO responded with equal passion and it was a launching pad for new ideas that were bigger and better than either of us could have come up with independently. It immediately struck me at the end of the meeting how true my fathers’ advice was. Passion makes the world go around.

I will continue to keep his advice front and center in how I manage our business. And I thank my incredible team for allowing me to see the effect of passion in real life.

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