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	<title>Palio &#187; Medical Strategy</title>
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	<description>Never be forgotten</description>
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		<title>Compliance and Community</title>
		<link>http://www.palio.com/compliance-and-community/</link>
		<comments>http://www.palio.com/compliance-and-community/#comments</comments>
		<pubDate>Mon, 23 Apr 2012 13:25:53 +0000</pubDate>
		<dc:creator>lgoodale</dc:creator>
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		<description><![CDATA[by Maureen Wendell, VP, Account Services, Palio Put a physician, a pharmaceutical expert and a sociologist together in a room, get them talking about their work, and you’ll eventually come around to something everyone has an opinion on: compliance. The physician might bemoan how, for lack of patient compliance, millions of people suffer long-term health [...]]]></description>
			<content:encoded><![CDATA[<p><strong>by Maureen Wendell, VP, Account Services, Palio</strong></p>
<p>Put a physician, a pharmaceutical expert and a <a href="http://cybersteps.org/sociology-internet-consumer-part-2" target="_blank">sociologist</a> together in a room, get them talking about their work, and you’ll eventually come around to something everyone has an opinion on: compliance.</p>
<p>The physician might bemoan how, for lack of <a href="http://www.epill.com/statistics.html" target="_blank">patient compliance</a>, millions of people suffer long-term health degradation and shorter life expectancies. The pharmaceutical expert can probably bring data to the discussion, talking about how there are endless studies correlating certain types of information and patient education to better long-term compliance.</p>
<p>The sociologist? She just smiles and says: “People are going to act like people. You might want to leverage that.”</p>
<p>Compliance is the big win-win issue for pharma – crack the code, patients have better outcomes while marketers sell more product. But broadly boosting compliance – especially with social media and marketing tools – often becomes a game of gizmos. This product has an app, that product has a web portal, etc.</p>
<p>Good stuff, but it’s ultimately window dressing that doesn’t get to the heart of compliance. For that, we need the sociologist’s insight. “People are going to act like people,” means several things for compliance:</p>
<p><strong>Community builds compliance. </strong>Physicians – even trusted ones – are a lot like newspapers for many patients. They get <em>information</em> from a physician, but they form their <em>opinions</em> about what’s important through interactions with trusted peers.</p>
<p>These interactions have lots of opinions, lots of shades of gray and are very unlike the cut-and-dried information that comes from physicians or other medical providers. And while that’s certainly a cause for concern among medical professionals who want to make sure the right information is conveyed, one fact remains: People most strongly believe the stories they tell themselves.</p>
<p>So, the role of community in compliance is to give them a place where they can find those trusted peers, bounce their thoughts around, and know that they are not alone. It’s a strategy that’s worked for many compliance-intensive medical treatments and conditions, such as Alzheimer’s, diabetes and lap-band surgeries.</p>
<p><strong>A community is more than a Web forum. </strong>The sociologist would probably also tell her companions that communities – going as far back as civilization – have a few common rules. Successful communities have onboarding processes – ways that new members can learn the formal and informal rules without stubbing their toes along the way. Communities also recognize and celebrate the wisdom of “elders” – people known to provide value and wisdom over time – and generally make it known what behavior is celebrated, as well as what is not tolerated. Finally, communities recognize that there are both public and private conversations, and have provisions for both. None of those things are particularly hard to implement in a Web or social-media environment, but they’re often treated as afterthoughts – when in fact they are the heart of the community-building infrastructure.</p>
<p><strong>Your app? It’s not that big a deal. </strong>The flip side of how compliance and community fit together is that, if community is of great importance, then the tools are just that – tools. Make them user friendly and, yes, make them fully social. But the big strategy behind your app should be how it connects users to a community of compliance. Because the community will provide far more positive reinforcement and, ultimately, greater compliance, than a standalone tool on a tablet or smart phone.</p>
<p>Getting to the win-win of broad, self-reinforcing compliance for pharma marketers is a big job, with a seat at the table for everyone from marketing to PR to the social media director and the advertising team. But also save a seat – if only symbolically – for the sociologist. And for people acting like people.</p>
<p>Palio is an advertising agency revolutionizing pharmaceutical and healthcare marketing to create experiences that will Never Be Forgotten.</p>
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		<title>Mobile Apps – Just What the Doctor Ordered</title>
		<link>http://www.palio.com/mobile-apps-%e2%80%93-just-what-the-doctor-ordered/</link>
		<comments>http://www.palio.com/mobile-apps-%e2%80%93-just-what-the-doctor-ordered/#comments</comments>
		<pubDate>Thu, 22 Mar 2012 17:24:06 +0000</pubDate>
		<dc:creator>lgoodale</dc:creator>
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		<description><![CDATA[Saul Morse, VP, Multichannel Integration, Palio Personal questions. Needles. Uncomfortable smocks that don’t close in the back. Getting – or just waiting for – that phone call with your lab results. With your doctor’s office closed will you even hear before the weekend starts or will it loom overhead? Pokes and prods too numerous to count. [...]]]></description>
			<content:encoded><![CDATA[<p><strong>Saul Morse, </strong><span class="Apple-style-span"><strong>VP, Multichannel Integration, Palio</strong></span></p>
<p>Personal questions. Needles. Uncomfortable smocks that don’t close in the back. Getting – or just waiting for – that phone call with your lab results. With your doctor’s office closed will you even hear before the weekend starts or will it loom overhead? Pokes and prods too numerous to count.</p>
<p>The list of healthcare anxieties goes on and on. And while they are different for nearly everyone, there’s no denying that they exist. Could technology help soothe addled patients and make them feel both more in control of their health? Evidence suggests that may be the case.</p>
<p>The medical industry and patients have developed some comfort with first generation social media sites and often have significant experience with them. Whether it’s looking for cold relief or sharing real-world experiences working in an emergency room, Facebook, YouTube, Twitter and LinkedIn are increasingly populated with healthcare information. A second wave, including <a href="http://www.medcitynews.com/2012/02/how-the-medical-industry-is-using-and-could-use-pinterest/?edition=hospitals" target="_blank">Pinterest</a>, <a href="https://plus.google.com/u/0/up/start/?continue=https://plus.google.com/u/0/?tab%3DwX&amp;type=st&amp;gpcaz=fa20eecc" target="_blank">Google+</a> and <a href="http://www.stumbleupon.com/su/1KE5S4/www.health.com/health/" target="_blank">StumbleUpon</a> offers hospitals, medical device and pharmaceutical companies a new set of tools for building a social media strategy.</p>
<p>But public-facing sites are only half the picture; and their very strengths – a large and public base of users – can be a drawback, because patients are rightfully leery of handling private medical data in such public venues. Even pure-information sites in the healthcare space deal with overall perceptions about the Web: It’s big, it’s insecure, and you never know who’s looking at your visitation patterns, search history or other personal details.</p>
<p>But <a href="http://www.mediplacements.com/article-801302411-department_of_health.html" target="_blank">health apps </a>for mobile and tablet platforms may hit a sweet spot.</p>
<p>Apps can offer a more-personalized, more-intimate experience for users, while addressing many security and privacy concerns. While the Web can also deliver this, apps avoid some of the “Who’s going to see this?” perception challenges that a major website may face.</p>
<p>Apps also offer an opportunity for specialized drug-specific, condition-specific or <a href="http://rapidcityjournal.com/lifestyles/phone-apps-keep-knowledge-at-your-fingertips/article_2955efee-5f15-11e1-a9f6-001871e3ce6c.html" target="_blank">treatment-specific platforms</a>. Many conditions, such as diabetes, are best managed with a steady flow of information – from the patient to a data log, and then on to a physician or other caregiver. The ubiquity of mobile apps and the tendency of users to interact with them many times a day make them a natural for this sort of application.</p>
<p>Finally, mobile apps can reduce anxiety by allowing for always-with-you, always-on anytime access to a community. Whether it’s patients with the same condition, a support group or even real-time access to caregivers, mobile platforms mean that feeling alone with your condition – a major source of anxiety for many people – can be alleviated.</p>
<p>Mobile apps aren’t perfect – from platform compatibility to security issues, they face many challenges with other healthcare 2.0 technology. But for a nation of nervous and worried patients, they offer real opportunities for better education and better care. Also, use <a href="http://www.pharmapps.com" target="_blank">PharmApps.com</a> as a resource for healthcare apps.</p>
<p>Palio is an advertising agency revolutionizing pharmaceutical and healthcare marketing to create experiences that will Never Be Forgotten.</p>
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		<title>FDA Releases Draft Guidance for Biosimilar Product Development</title>
		<link>http://www.palio.com/fda-releases-draft-guidance-for-biosimilar-product-development/</link>
		<comments>http://www.palio.com/fda-releases-draft-guidance-for-biosimilar-product-development/#comments</comments>
		<pubDate>Mon, 20 Feb 2012 15:22:39 +0000</pubDate>
		<dc:creator>lgoodale</dc:creator>
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		<description><![CDATA[&#160; Figure: Structure of a typical chemical drug molecule (left) and a biologic molecule (right). By Jim Mittler, PhD, Medical Director, Palio The availability of generic drugs ensures free market competition and makes access to life-saving medications more affordable to millions of Americans. The Drug Price Competition and Patent Term Restoration Act (aka, the Hatch-Waxman [...]]]></description>
			<content:encoded><![CDATA[<p>&nbsp;</p>
<p><strong>Figure:</strong> Structure of a typical chemical drug molecule (left) and a biologic molecule (right).</p>
<p><strong><span class="Apple-style-span">By Jim Mittler, PhD, Medical Director, Palio</span></strong></p>
<p>The availability of generic drugs ensures free market competition and makes access to life-saving medications more affordable to millions of Americans. The Drug Price Competition and Patent Term Restoration Act (aka, the Hatch-Waxman Act) was signed into law in 1984 and set forth the process in which drug companies could seek FDA approval of Abbreviated New Drug Applications (ANDAs) for a generic counterpart of a reference product (ie, an already-approved branded drug). Under this statue, the approval of a generic drug is solely based on showing comparable bioavailability (blood levels) between the generic and reference product. As such, there is an assumption that establishing similar bioavailability means the efficacy and safety of the generic is the same as the reference product. The intent of the Hatch-Waxman Act is to decrease the amount of time to bring less-expensive generic drugs to market by not requiring the generic company to perform traditional clinical trials to prove efficacy and safety.</p>
<p>Scientific advances in the field of biotechnology have led to the development of biologic therapies that are very much different than traditional chemical drugs (see Figure above). Most biologics are protein molecules that are orders of magnitude larger and structurally more complex. As such, they are considerably more difficult to synthesize and scale-up for mass production. Similar to the Hatch-Waxman Act that paved the way for generic drugs, the Biologics Price Competition and Innovation Act of 2009 (BCPI Act) was enacted by President Obama as part of the Affordable Care Act in March 2010 and creates an abbreviated licensure pathway for “generic” biologic therapies, termed <em>biosimilars</em>. Because biologic products are synthesized in living systems (eg, microorganisms or plant or animal cells), there is greater potential for differences in the quality of the protein structure and the type and amount of inactive components of the formulation between a reference product and a biosimilar. These differences can affect the stability of the manufactured product, the tolerability and safety, and/or the clinical effectiveness of the biosimilar.</p>
<p>Structure of a typical chemical drug molecule (left) and a biologic molecule (right).On February 9, 2012 the FDA released the first<a href="http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm291232.htm" target="_blank"> draft guidance</a> to help the pharmaceutical industry navigate the statutory requirements added by the BPCI Act. Through the new approval pathway companies must demonstrate that their product is biosimilar to, or interchangeable with, a reference biologic product already approved by the FDA. There are 3 guidance documents that provide the FDA’s current thinking on important scientific and regulatory factors involved in biosimilar development. In order to set a higher standard for interchangeability compared to generic drugs that only require pharmacokinetic studies, the FDA advises that companies demonstrate biosimilarity based upon data derived from <em>in vitro</em> analytical studies, animal studies, and a clinical study or studies, unless FDA determines that certain studies are unnecessary. The FDA will use a “totality-of-the-evidence” approach to assess whether the biosimilar product can be expected to produce the same clinical result as the reference product in any given patient. This includes the risk in terms of safety or diminished efficacy of alternating or switching between the use of the biosimilar product and the reference product is not greater than the risk of using the reference product without such alternation or switch.</p>
<p>Cost is another story. Many biologic therapies are well over $10,000 a year and some are closer to $100,000 for a 3-month course (ie, Provenge [sipuleucil-T]). Given the higher burden of proof to show biosimilarity, the development costs will be much greater for companies that develop and manufacture biosimilar products compared to generic drugs. There are several therapeutic categories in which biologics are the standard of care and products are priced on the efficacy they bring. I think of Extavia (interferon beta-1b [Novartis]) that is used to treat relapse-remitting multiple sclerosis. Extavia is actually a branded bioequivalent (ie, same manufacturer) to Bayer’s Betaseron; however, it still commands near-premium pricing – it’s only discounted ~14% compared to Betaseron. It will be interesting to see how true biosimilars are priced when they come to market.</p>
<p>This new legislation will expedite biosimilar product development but there is a higher burden of proof required for the biosimilar companies to show interchangeability compared to generic drug companies, which is a good thing. As a former scientist, I know the complexities of recombinant DNA technology and protein engineering. The FDA guidance certainly makes me feel more comfortable should I ever need a biosimilar therapy.</p>
<p>Palio is an advertising agency revolutionizing pharmaceutical and healthcare marketing to create experiences that will Never Be Forgotten.</p>
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		<title>Cardiology, Women and Apps</title>
		<link>http://www.palio.com/cardiology-women-and-apps/</link>
		<comments>http://www.palio.com/cardiology-women-and-apps/#comments</comments>
		<pubDate>Tue, 14 Feb 2012 15:01:20 +0000</pubDate>
		<dc:creator>lgoodale</dc:creator>
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		<description><![CDATA[&#160; by Meleik Goodwill, PhD, Medical Director, Palio February is American Heart Month, but even 10 years after efforts to specifically increase awareness around women’s heart health began, many people still think of heart attacks as an old man’s condition. Heart disease, however, remains the No. 1 killer of women. Awareness is growing, but there is still much to be done. [...]]]></description>
			<content:encoded><![CDATA[<p>&nbsp;</p>
<p><strong>by Meleik Goodwill, PhD, Medical Director, Palio</strong></p>
<p>February is<a href="http://www.cdc.gov/features/heartmonth/" target="_blank"> American Heart Month</a>, but even <a href="http://www.nhlbi.nih.gov/educational/hearttruth/" target="_blank">10 years</a> after efforts to specifically increase awareness around women’s heart health began, many people still think of heart attacks as an old man’s condition. Heart disease, however, <a href="http://www.nlm.nih.gov/medlineplus/heartdiseaseinwomen.html" target="_blank">remains</a> the No. 1 killer of women. Awareness is <a href="http://www.goredforwomen.org/uploadedFiles/Statistics_and_Tracking/Mosca%20Study%20Circulation%20Article.pdf" target="_blank">growing</a>, but there is still much to be done.</p>
<p>Another type of awareness is growing among women: Women have been <a href="http://www.fastcompany.com/1794983/can-apps-empower-women" target="_blank">less likely</a> to use apps than men, but that gap<a href="http://pewinternet.org/~/media/Files/Reports/2011/PIP_Apps-Update-2011.pdf" target="_blank"> is decreasing</a> too.</p>
<p>As you’ve seen on <a href="http://www.pharmapps.com">PharmApps</a>, we here at Palio believe strongly in the power of apps to put great amounts of information, analysis and communication in the pocket of everyday people, and few topics can be more important than this.</p>
<p>So, in honor of all the hearts you’ll see today and this week of Valentine’s Day, we thought we’d point you in the direction of some apps that can help us all work together to improve women’s heart health. (And, in many cases, that of their male loved ones too.)</p>
<ol start="1">
<li>Staying healthy - You can choose from among many apps on many platforms that can help you to track your <a href="http://itunes.apple.com/us/app/calorie-tracker-livestrong.com/id295305241?mt=8" target="_blank">food intake</a>, <a href="http://itunes.apple.com/us/app/weight-watchers-mobile/id331308914?mt=8" target="_blank">weight</a>, <a href="http://itunes.apple.com/us/app/bmi/id285516353?mt=8" target="_blank">BMI</a> and athletic performance. Keep your heart healthy before you need to worry!</li>
<li>Preventing a repeat occurrence - If you or a loved one has already had a heart attack or other health scare, regularly and easily record heart rate, blood pressure, cholesterol level, and other vital signs and symptoms with an app like <a href="http://www.ringfulhealth.com/apps/heart/" target="_blank">Healthy Heart</a>, <a href="http://itunes.apple.com/us/app/healthy-heart-numbers/id420146337?mt=8#" target="_blank">Healthy Heart Numbers</a> or <a href="http://itunes.apple.com/us/app/mybloodworks/id463529273?mt=8" target="_blank">My BloodWorks</a>. Records like these can be invaluable to help a cardiologist predict risks, prescribe or adjust medication, or see whether a course of treatment or lifestyle changes are working.</li>
<li>Saving a life - Keep a couple of apps on hand to help you through an emergency to <a href="http://www.macworld.com/appguide/app.html?id=79948&amp;expand=false" target="_blank">get reminders </a>how to perform CPR and first aid.</li>
<li>Not just mobile - Even Facebook-only apps are getting into the game: The OhioHealth network of hospitals has devised the Facebook app <a href="https://www.facebook.com/OhioHealth?sk=app_232897400117772" target="_blank">Heartbeats for Health</a>, which gives you points every time you track heart-healthy decisions that you’ve made. You know you’re checking Facebook anyway. Why not make it good for you?</li>
</ol>
<div><em>Palio is an advertising agency revolutionizing pharmaceutical and healthcare marketing to create experiences that will Never Be Forgotten</em></div>
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		<title>CDC’s first iPad App already a winner</title>
		<link>http://www.palio.com/cdc%e2%80%99s-first-ipad-app-already-a-winner/</link>
		<comments>http://www.palio.com/cdc%e2%80%99s-first-ipad-app-already-a-winner/#comments</comments>
		<pubDate>Fri, 10 Feb 2012 17:31:56 +0000</pubDate>
		<dc:creator>lgoodale</dc:creator>
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		<description><![CDATA[&#160; Meleik Goodwill, PhD, Medical Director, Palio The Federal Centers for Disease Control released its first iPad App, rated by iSnoops.com as “Hot,” with 4.5-stars.  This app specifically enabled for iPads was created with the recognition that more and more people are using mobile technology to search for health information. Industry experts rate the app [...]]]></description>
			<content:encoded><![CDATA[<p>&nbsp;</p>
<p><strong> Meleik Goodwill, PhD, Medical Director, Palio</strong><em></em></p>
<p>The Federal Centers for Disease Control released its first iPad App, rated by iSnoops.com as “Hot,” with 4.5-stars.  This app specifically enabled for iPads was created with the recognition that more and more people are using mobile technology to search for health information. Industry experts rate the app so positively due to the breadth of information offered and the instaneous nature of the updates, a feature important during times of public health crisis, such as during a flu pandemic.</p>
<p>The CDC&#8217;s leap into mobile health gives iPad users touchpad access to the organization&#8217;s real-time health updates, blogs and podcasts, these tabs include:</p>
<ul>
<li><strong>Newsroom </strong>features the latest health news from the CDC Newsroom. From this tab you can access current and archived press releases, media advisories, and press briefing transcripts</li>
<li><strong>Public Health Matters Blog</strong>: Here CDC bloggers share their passion for public health, its evolution, and the continual strides that are being made to protect and save lives through education, awareness, research, and promoting healthy lifestyles.</li>
<li><strong>CDC podcasts</strong>: Listen to CDC podcasts on your iPad for reliable health and safety information when and where you want it. The tab links to CDC’s vast library of audio and video podcasts.</li>
</ul>
<p>Over 50,000 pages of content can be accessed through tabs for general health-related information:</p>
<ul>
<li><strong>Health Articles</strong>  written by subject matter experts and health communicators from all CDC centers and programs.</li>
<li><strong>Vital Signs</strong> offers recent data on important public health issues. Topics include: colorectal and breast cancer screening; obesity; alcohol and tobacco use; access to health care; HIV testing; seat belt use; cardiovascular disease and more.</li>
<li><strong>Preventing Chronic Disease (PCD) Journal</strong> is a peer-reviewed electronic journal established to address the interface between applied public health research, practice, and policy.</li>
</ul>
<p>Mindful of users desire to network, the app provides a conduit to share:</p>
<ul>
<li><strong>Stay Connected</strong>: Follow CDC by tapping on tabs for <strong>Facebook</strong>, <strong>Twitter</strong> and <strong>YouTube</strong>. By accessing CDC&#8217;s social media through the iPad, users can view important information on health topics and events throughout the year.</li>
</ul>
<p>The CDC App is free for anyone to download. If you have an iPad, tap directly on the icon for the iTunes App store. At the top right of the page, type CDC iPad App in the search box. You will be taken to a page where you can download the CDC App. (Look for the app with the CDC logo.) You can read more about it at <a title="Link to more information about CDCs iPad app on CDC.gov" href="http://www.cdc.gov/mobile/Applications/CDCGeneral/promos/ipad_promo.html" target="_blank">CDC Mobile iPad Application</a> on CDC’s web site or on <a href="http://www.pharmapps.com/cdc/" target="_blank">PharmApps</a>.</p>
<p>This is not the CDC’s first venture in mobile technology. In addition to it’s own site being mobile-optimized for more than two years, the agency continues to offer cash awards for developers to create technology-enabled ways to augment its public health efforts by developing apps for flu and other conditions. Read more: <a href="http://www.fiercemobilehealthcare.com/story/cdc-looking-few-good-flu-apps/2011-04-25#ixzz1lExP4kQk" target="_blank">CDC is looking for a few good flu apps</a>.</p>
<p>Palio is an advertising agency revolutionizing pharmaceutical and healthcare marketing to create experiences that will Never Be Forgotten.</p>
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		<title>2011 FDA Drug Approvals and Food for Thought</title>
		<link>http://www.palio.com/2011-fda-drug-approvals-and-food-for-thought/</link>
		<comments>http://www.palio.com/2011-fda-drug-approvals-and-food-for-thought/#comments</comments>
		<pubDate>Mon, 06 Feb 2012 16:07:44 +0000</pubDate>
		<dc:creator>lgoodale</dc:creator>
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		<description><![CDATA[by Jim Mittler, PhD, Medical Director, Palio It was a banner year for FDA drug approvals. The approval of 30 new therapeutics is the second highest number in the past decade (2004 saw 36 approvals). There were 24 new molecular entities and 6 new biologics that address major unmet medical needs, hit new molecular targets, [...]]]></description>
			<content:encoded><![CDATA[<p><strong>by Jim Mittler, PhD, Medical Director, Palio</strong></p>
<p>It was a banner year for FDA drug approvals. The approval of 30 new therapeutics is the second highest number in the past decade (2004 saw 36 approvals). There were 24 new molecular entities and 6 new biologics that address major unmet medical needs, hit new molecular targets, and/or leverage molecular profiling to add a degree of precision to the art of medicine. Analysts highlight the high degree of innovation in the 2011 approvals, which includes 11 first-in-class products and 11 orphan drugs.</p>
<p>Cancer had the highest number of new drug approvals with 8, and analysts note that the approval rate for cancer drugs is higher than in the past. Seven of the 8 newly approved cancer agents had received orphan drug status, which might have expedited the path to regulatory approval. Also notable is the approval of 2 cancer drugs – Xalkori<sup>®</sup> (crizotinib [Pfizer]) and Zelboraf<sup>®</sup> (vemurafenib ]Roche]) – that have companion gene diagnostic tests, which define patient populations who can respond to the drug and exclude those who will not. Therapeutic-diagnostic codevelopment programs led to shorter clinical trial development time and speedier FDA approvals in these 2 cases.</p>
<p>While most of the newly approved drugs/biologics were sponsored by large pharma, smaller biotech companies found success in getting products approved. Notable is the approval of Vertex’s Incivek<sup>®</sup> (telaprevir) for the treatment of hepatitis C virus (HCV) infection. Incivek has been pegged as a blockbuster and is expected to change the face of HCV treatment. Despite the successful approval of biotech products in 2011, launch success has been poor. Human Genome Sciences launched Benlysta<sup>®</sup> (belimumab), the first new treatment for systemic lupus erythematosus (SLE) in over 50 years but market uptake has been poor; perhaps due to high expectations on the part of investors and/or poor perception of the benefits on the part of physicians.</p>
<p>Overall, the FDA was efficient in their review of new drug applications (NDAs) and biologics license applications (BLAs), generally hitting their PDUFA timelines. Nineteen drugs were approved in the first round of review. There was an unusually high percentage of approvals in 2011 (&gt;80%) compared with recent years (typically ~50%). Analysts expect fewer approvals in 2012.</p>
<p>Annual reports like this get me thinking about new business opportunities. There’s opportunity to seek out therapeutic agents that have great potential and several things we can take away from the recent crop FDA drug approvals:</p>
<ul>
<li><strong>There’s opportunity with orphan drugs. </strong>One-third of the 2011 FDA approvals were orphan drugs. The high approval rate of orphan drugs has been a clear trend over the past half-decade, which will continue given the shift by drug developers towards potential “niche busters.” There’s a distinct business opportunity with orphan diseases in that there’s a small population of patients, but there’s significant market exclusivity for approved products<strong></strong></li>
<li><strong>Drug compounds with companion diagnostic tests could provide a unique business opportunity.</strong> We’ve all heard about the promise of “personalized medicine” for years. Personalization of therapeutics <em>per se</em> is a bit of an overpromise at this time for all but a few diseases; however, “precision medicine” is viable right now. Guiding the clinical use of a medication by using molecular profiling approaches is very beneficial from a marketing perspective. First, it can expedite the FDA approval pathway as we saw with 2 of the cancer drugs approved in 2011. Second, it inherently presents opportunity for unbranded prelaunch initiatives required to bring an understanding of the molecular pathway involved in the disease process and subsequently exploited as the mechanism of action of the drug. Third, once launched, a drug with a companion diagnostic test will reset the risk/benefit equation by identifying those patients who are most likely to respond to therapy or are at most risk for a particular side effect. There is a bit of a give and take. The product will be niched for a smaller patient population; however, the barrier to use of the drug would be substantially lowered when clinical outcomes can be predicted. This is particularly advantageous for new products where the long-term risk/benefit is unknown. Lastly, drugs with companion diagnostics will create the need for clinical decision support tools given the complexity of genetic information typically generated by advanced diagnostic testing</li>
<li><strong>Don’t discount small biotechs.</strong> Biotechs are coming of age. Consider Vertex with its newly approved HCV treatment, Incivek. The company was founded in 1989 and only now has a potential blockbuster. Human Genome Sciences’ Benylsta is a product that has emerged from the biotechnology boom of the mid-1990’s. Biotechnology is a powerful tool for drug discovery efforts that allows for better identification of lead compounds. The technology is constantly evolving, becoming more powerful. I anticipate more potential drug candidates come to fruition with small biotechs that have focused drug discovery efforts through the application of modern biotechnology</li>
<li><strong>Small biotechs need help with product launches. </strong>SLE is typically treated with general immunosuppressive drugs and has been the standard of care for 50 years, so the<strong> </strong>poor<strong> </strong>uptake of molecularly targeted Benlysta is surprising. But analysts have said that all biotech launches have been “very poor” last year, with the exception of Incivek. One reason could be that the phycisian audience doesn’t correctly perceive the benefit of the drug. Looking back, I cannot recall as much prelaunch conditioning for Benlysta as there has been for other big pharma–backed biotech products; specifically thinking about the prelaunch campaigns on the role of interleukin-6 in rheumatoid arthritis or RANK ligand in osteoporosis, which preceded the launch of Actemra<sup>®</sup> (tocilzumab [Roche/Genentech]) and Prolia<sup>®</sup> (denosumab [Amgen]), respectively. Perhaps the smaller biotechs do not have the prelaunch budgets that big pharma has, but clearly these initiatives are important and can be uniquely leveraged from a marketing perspective. Not that all this can be done on a shoe-string budget, but there’s a potential business opportunity to package a suite of prelaunch tactics aimed at the smaller biotechs <strong></strong></li>
</ul>
<p>&nbsp;</p>
<p>Palio is an advertising agency revolutionizing pharmaceutical and healthcare marketing to create experiences that will Never Be Forgotten.</p>
<p>&nbsp;</p>
<p>Source:</p>
<p>The source article for my quick summary above, and my own food for thought, was published  (February 2, 2012) in <em>Nature Reviews Drug Discovery</em>.</p>
<p>Mullard A. 2011 FDA drug approvals. <em>Nat Rev Drug Disc</em>. 2012;11(2):91-95.</p>
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		<title>The Question of Question Sites</title>
		<link>http://www.palio.com/question-question-sites/</link>
		<comments>http://www.palio.com/question-question-sites/#comments</comments>
		<pubDate>Fri, 16 Dec 2011 22:16:07 +0000</pubDate>
		<dc:creator>lgoodale</dc:creator>
				<category><![CDATA[Advertising]]></category>
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		<guid isPermaLink="false">http://www.palioblog.com/?p=5798</guid>
		<description><![CDATA[Meleik Goodwill, Medical Director, Palio One of the classic definitions of marketing is delivering value in order to capture value. So it would seem that when someone’s got a question about your product, service or organization, you answer it. Your answer delivers value, allowing you, hopefully, to capture anything from a new customer to incremental [...]]]></description>
			<content:encoded><![CDATA[<p><strong><a href="http://www.palioblog.com/wp-content/uploads/2011/11/question-mark.jpg"><img class="alignnone size-medium wp-image-5815" style="border-width: 2px; border-color: black; border-style: solid;" title="question-mark" src="http://www.palioblog.com/wp-content/uploads/2011/11/question-mark-240x300.jpg" alt="" width="240" height="300" /></a></strong></p>
<p><strong>Meleik Goodwill, Medical Director, Palio</strong></p>
<p>One of the classic definitions of marketing is delivering value in order to capture value. So it would seem that when someone’s got a question about your product, service or organization, you answer it. Your answer delivers value, allowing you, hopefully, to capture anything from a new customer to incremental brand awareness.</p>
<p>So when your organization is asked a question, the correct response – every time – is to answer it, right? The answer, it turns out, is a definite “maybe.”</p>
<p>One of the many things muddying up the answer is the proliferation of question sites – platforms like <a href="http://bits.blogs.nytimes.com/2011/04/04/quora-makes-changes-aimed-at-doctors-and-lawyers/" target="_blank">Quora</a>, Yahoo Answers and others where members can post questions, relying on the collective intelligence of other members for input.</p>
<p>In theory, these are a great example of how enabling technology can aggregate expertise and collectively boost the knowledge available to anyone with an internet connection. And, most of the time, that’s the end result.</p>
<p>But there’s a big difference between 50 (or 5,000) strangers chiming in with suggestions on how to best fry a chicken, versus that same enthusiastic, opinionated and sometimes ill-informed group suggesting the best cholesterol medication, or whether vaccines are, in fact, safe.</p>
<p>Getting back to that chestnut about delivering and capturing value, the marketer’s instinct on things like this is usually some variant of “dive in!” After all, there’s an aggregated audience of people seeking information about your product or service, right? But the answer isn’t that clear-cut.</p>
<p>There’s a lack of clarity from regulators on how pharma should handle <a href="http://www.zimbio.com/B2B/articles/XZEgk1qhhsb/Pharmaceutical+Social+Media+Right+Prescription" target="_blank">social-media messaging</a>, and the very nature of question sites is that their messages have a level of permanence, typically indexed in search engines for future reference in a way that last month’s Facebook update comment is not. Plus, like dinner parties the world over, there are some people who show up just to argue – and a public, search-engine indexed fight with someone who just wants to tear down your brand isn’t moving the marketing program forward.</p>
<p>Does that mean pharma marketers should ignore these sites entirely? Not at all. A solid regimen of monitoring and privately responding to questions (a feature that Quora offers but <a href="http://answers.yahoo.com/" target="_blank">Yahoo Answers</a> does not) allows marketers to keep an eye on things and offer authoritative information when warranted.</p>
<p>Answers to public questions are not off the table, but as with so much of the online world, context is king – answering with an official corporate response on the popular site <a href="http://www.reddit.com/r/askscience/" target="_blank">Reddit</a>, for example, risks derision no matter how accurate and complete the response is, simply because the community values individual rather than corporate presence.</p>
<p>Question sites are one of the hundreds of new channels marketers must navigate. But whether it’s answering a prospect’s question or making a sales presentation, the fundamental question marketers deal with never really changes: How, with this particular audience and this particular channel or platform, can I deliver value?</p>
<p><em>Palio is an advertising agency revolutionizing pharmaceutical and healthcare marketing to create experiences that will Never Be Forgotten</em></p>
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		<title>Social Media: Helping Patients Engage in their own Care</title>
		<link>http://www.palio.com/social-media-helping-patients-engage-care/</link>
		<comments>http://www.palio.com/social-media-helping-patients-engage-care/#comments</comments>
		<pubDate>Mon, 05 Dec 2011 16:35:41 +0000</pubDate>
		<dc:creator>lgoodale</dc:creator>
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		<guid isPermaLink="false">http://www.palioblog.com/?p=5511</guid>
		<description><![CDATA[Andy Smith, EVP, General Manager, Director of Global Operations, Palio Last year on Pixels &#38; Pills, I wrote about the mainstreaming of social media, highlighting a report from Nielsen Co. that found Americans are devoting almost a quarter of their Internet time on social networking sites and blogs, a 43 percent increase compared to one [...]]]></description>
			<content:encoded><![CDATA[<p><strong><a href="http://www.palioblog.com/wp-content/uploads/2011/11/People.jpg"><img class="alignnone size-medium wp-image-5821" style="border-width: 2px; border-color: black; border-style: solid;" title="People" src="http://www.palioblog.com/wp-content/uploads/2011/11/People-300x273.jpg" alt="" width="300" height="273" /></a></strong></p>
<p><strong>Andy Smith, EVP, General Manager, Director of Global Operations, Palio</strong></p>
<p>Last year on Pixels &amp; Pills, I wrote about the <a href="http://www.pixelsandpills.com/2010/08/24/social-media-connecting-patients//" target="_blank">mainstreaming of social media</a>, highlighting a report from <a href="http://blog.nielsen.com/nielsenwire/online_mobile/what-americans-do-online-social-media-and-games-dominate-activity" target="_blank">Nielsen Co</a>. that found Americans are devoting almost a quarter of their Internet time on social networking sites and blogs, a 43 percent increase compared to one year ago.</p>
<p>Now, a year later, social is still dominating, with the 2011 version of the Nielsen report finding:</p>
<p><span id="more-5511"></span></p>
<ul>
<li>Social networks and blogs continue to dominate Americans’ time online</li>
<li>Social media has grown rapidly – today nearly 4 in 5 active Internet users visit social networks and blogs</li>
<li>Americans spend more time on Facebook than they do on any other U.S. Website</li>
<li>Close to 40 percent of social media users access social media content from their mobile phone</li>
<li>Social networking apps are the third most-used among U.S. smartphone owners</li>
<li>Internet users over the age of 55 are driving the growth of social networking through the Mobile Internet</li>
<li>Although a larger number of women view online video on social networks and blogs, men are the heaviest online video users, overall streaming more videos and watching them longer</li>
<li>70 percent of active online adult social networkers shop online</li>
<li>53 percent of active adult social networkers follow a brand, while 32 percent follow a celebrity</li>
<li>Across a snapshot of 10 major global markets, social networks and blogs reach more than three-quarters of active Internet users</li>
<li><a href="http://mitchwagner.tumblr.com/post/6756253296/why-tumblr" target="_blank">Tumblr</a> is an emerging player in social media, nearly tripling its audience from a year ago</li>
</ul>
<p>Pharmaceutical companies shouldn’t overlook the value of social networks for connecting with patients and strengthening brand awareness. In fact, by limiting participation on social networks to blasts about new medicines or company news, pharma companies are missing out on an opportunity to better serve patients.</p>
<p>Social media’s interactive nature provides patients with the opportunity to become engaged in their own health care, whether that’s requesting a particular prescription during a physician visit or carrying product messages back to their own social network. Pharma companies that engage the end consumer – the patient – can extend their message through a cadre of brand ambassadors. Social media can also be useful to communicate drug/device safety alerts, deliver daily tips to support a better state of wellness, remind patients to refill prescriptions, recruit clinical trial participants or connect individuals with a support community.</p>
<p>While the Food and Drug Administration has yet to issue formal guidelines, some drug makers have been advised against using Facebook to promote prescriptions. However, the issue wasn’t the platform; its beef was that the promotion only articulated benefits, not the risks. The lesson is that transparency is essential. Beyond promoting a particular medicine, pharma should use Facebook to:</p>
<ul>
<li>Build relationships and spark discussions – not as a linear platform for conveying information</li>
<li>Provide valuable, informative information – not just promotional content</li>
<li>Spark one-to-one dialogue, and encourage patients to participate by sharing their own experiences</li>
<li>Avoid avoidance; monitor what people are saying and should things go awry, offer clear messages and alternative avenues for getting information</li>
<li>Work in tangent with other social networking platforms. Want a YouTube video to go viral? It’ll never happen without a coordinated Facebook campaign</li>
</ul>
<p>Pharma companies should embrace social media for what it is – a valuable medium for carrying key messages, building relationships and increasing product loyalty. But that’s what it is – a medium. What doesn’t change is the core work of examining the marketing strategy, crafting transparent and clear messages, and engaging social media to add value and build relationships.</p>
<p><em>Palio is an advertising agency revolutionizing pharmaceutical and healthcare marketing to create experiences that will Never Be Forgotten.</em></p>
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		<title>Forgoing Face Time? Get Tethered!</title>
		<link>http://www.palio.com/forgoing-face-time-tethered/</link>
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		<pubDate>Wed, 23 Nov 2011 10:00:22 +0000</pubDate>
		<dc:creator>admin</dc:creator>
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		<guid isPermaLink="false">http://www.palioblog.com/?p=5245</guid>
		<description><![CDATA[Todd LaRoche, EVP, Managing Director of Creative, Palio There is no slow season in health care. Whether seeing patients in between personal and professional appointments or a spike in patient visits during cold and flu season, doctors are always busy. For sales reps, this results in a greater challenge getting face time with doctors. Sales [...]]]></description>
			<content:encoded><![CDATA[<p><strong><a href="http://www.palioblog.com/wp-content/uploads/2011/11/rep-and-doc1.jpg"><img class="alignnone size-medium wp-image-5834" style="border-width: 2px; border-color: black; border-style: solid;" title="rep-and-doc1" src="http://www.palioblog.com/wp-content/uploads/2011/11/rep-and-doc1-231x300.jpg" alt="" width="231" height="300" /></a></strong></p>
<p><strong>Todd LaRoche, EVP, Managing Director of Creative, Palio</strong></p>
<p>There is no slow season in health care. Whether seeing patients in between personal and professional appointments or a spike in patient visits during cold and flu season, doctors are always busy. For sales reps, this results in a greater challenge getting face time with doctors.</p>
<p>Sales reps may not be used to communicating in a two-minute window, but doctors, nurses and office staff are conditioned to interact that way. Last year on <a href="http://www.pixelsandpills.com/2010/07/06/changing-communicate-doctors/" target="_blank">Pixels and Pills</a>, I wrote about being brief and getting to the point when communicating with doctors. That still holds true, but with more doctors tethered to their smartphones and iPads, we need to <a href="http://online.wsj.com/article/SB10001424052748703702004576268772294316518.html?mod=WSJ_Tech_LEFTTopNews" target="_blank">use technology</a> to change how we communicate with doctors.</p>
<p><span id="more-5245"></span></p>
<p><strong>Give them what they want.</strong> Sales reps need to get better at <a href="http://blogs.stayinfront.com/?p=316" target="_blank">tracking information</a> related to each sales call, including the doctor’s contact information and preferred mode of communication, patient population needs and prescription-writing activity. With a compressed amount of time to detail new medicines and deliver marketing messages, it’s important to address those most relevant to each practice. Having better information, sales reps can then implement more doctor-centric strategies and design more relevant campaigns.</p>
<p><strong>Get your high tech game on.</strong> It’s important to identify creative ways to convey information. For doctors who are digitally savvy and prefer electronic communication, <a href="http://www.palioblog.com/advertising/expanding-potential-edetailing/" target="_blank">an interactive iPad app</a> or digital brochure can deliver value and foster stronger relationships – all while providing an efficient and more cost-effective means of communicating beyond the traditional face-to-face call. And, physicians can review information at a time that is convenient to them – not when they have an office full of patients.</p>
<p><strong>Speak in sound bites. </strong>If you can convey information in a 140-character tweet, you can do it in the real world. But if you have mere minutes of a physician’s time – whether in the office or at a virtual event – a succinct presentation style can be a real differentiator.</p>
<p><strong>Recognize that it’s all in the details.</strong> While overall sales and market penetration matter immensely to the organization’s bottom line, at the individual sales rep’s level there are other metrics worth tracking in this limited-face-time environment. Average amount of time spent discussing products with a physician, requests for additional information, volume of sample product distributed or prescription-writing activity are just three of many ways to track messaging effectiveness by proxy measures. Understanding how physicians want to receive and interact information can help you determine the best technology solutions to facilitate information exchange and meet their needs.</p>
<p>Technology is creating new and exciting opportunities for communication that enable us to take evolving communication preferences into account when providing new product information, clinical alerts or product updates. By incorporating communication technology, electronic promotional activity, and virtual events into our communication arsenal and demonstrating depth and breadth of product knowledge, sales reps can provide valuable interactions with doctors and achieve their objectives.</p>
<p><em>Palio is an advertising agency revolutionizing pharmaceutical and healthcare marketing to create experiences that will Never Be Forgotten.</em></p>
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		<title>Who&#8217;s Responsible for This?</title>
		<link>http://www.palio.com/responsible/</link>
		<comments>http://www.palio.com/responsible/#comments</comments>
		<pubDate>Fri, 18 Nov 2011 16:06:50 +0000</pubDate>
		<dc:creator>admin</dc:creator>
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		<guid isPermaLink="false">http://www.palioblog.com/?p=5767</guid>
		<description><![CDATA[Gregory Alderisio, Senior Copywriter, Palio Let’s say you see an ad in a magazine or on the Web and you absolutely hate the headline. Who do you blame? Naturally, the wretched, abominable writer. Or what if the art direction is so banal or so hideous you recoil in horror. Whose fault is that? Of course, [...]]]></description>
			<content:encoded><![CDATA[<p><strong><a href="http://www.palio.com/wp-content/uploads/2011/11/WHO¹S-RESPONSIBLE-FOR-THIS-final1.tiff"><img class="alignnone size-full wp-image-5769" style="border-width: 2px; border-color: black; border-style: solid;" title="WHO¹S RESPONSIBLE FOR THIS final[1]" src="http://www.palio.com/wp-content/uploads/2011/11/WHO¹S-RESPONSIBLE-FOR-THIS-final1.tiff" alt="" width="228" height="152" /></a></strong></p>
<p><strong>Gregory Alderisio, Senior Copywriter, Palio</strong></p>
<p>Let’s say you see an ad in a magazine or on the Web and you absolutely hate the headline. Who do you blame? Naturally, the wretched, abominable writer. Or what if the art direction is so banal or so hideous you recoil in horror. Whose fault is that? Of course, the hapless, no-talent art director.</p>
<p>Pretty much everything wrong with an ad can be laid at the feet of two people: the AD and CW. It’s the same with the glory. A good headline: well, obviously that came from the unique mind of a gifted writer. An inspired visual? Kudos to the innovative genius of the art director. Why would it be any other way? A pair of people did the ad so let’s praise/stone them depending upon how it turned out. And of course at their year-end review, the creative team with too many boring, dull, moronically-simplistic ads gets labeled as lazy, timid or unimaginative. On the other hand, the team with award-winning work gets a raise, a bonus and a big fat ego.<span id="more-5767"></span></p>
<p>Because that’s the way many agencies are run, it’s got to be a good system, right? Well, maybe not.</p>
<p>What if instead of praising or blaming two people for the work, we praised/blamed everyone? Not just in words, but in more tangible ways. Planners, account people, medical directors, creative directors, producers – what if all their raises, bonuses, perks and promotions depended upon the creativity of the work their accounts produced? Overnight agency output would improve. Because it can’t be just the creative team who’s motivated to do good work, that’s not enough. Two people alone can’t push good work through a sea of indifference and nitpickers. Every department has to want the good stuff and have a vested interest in getting it sold and seeing it produced.</p>
<p>This may sound self-serving but ultimately it serves the client because clients get better work that attracts more attention. And brands that get noticed are brands that have a better chance to succeed and make clients happy.</p>
<p>If we’re comfortable calling out creative work that’s dull and lifeless, we should be just as comfortable doing the same with a dull key thought, a me-too insight, or a toothless medical claim. We can’t just sleepwalk our way through customer research, message development and strategy generation then sell ho-hum ideas to our clients and expect the work produced to be brilliant.</p>
<p>When work is great, chances are it came from an inspired insight or a focused strategy and that contribution needs to be acknowledged. Great work is also impeccably produced so we have to recognize producers and art buyers when a finished idea looks just as cool as everyone imagined it would when it was merely a line drawing.</p>
<p>In other words, we all sink or swim together. The sooner every department is held accountable for the creative output in a concrete way, the quicker the entire agency will be devoted to bringing truly memorable ideas to the market.</p>
<p>&nbsp;</p>
<p><em>Palio is an advertising agency revolutionizing pharmaceutical and healthcare marketing to create experiences that will Never Be Forgotten.</em></p>
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