Gillian Slattery, Producer, Palio

On a sunny spring day in 1977, Girl Scout Troop 275 banded together with other local troops in an effort to clean up trash at local playgrounds and parks. Woodsy Owl encouraged us to give a hoot and not pollute; our planet was ours for protecting.

Fast-forward 35 years and the Girl Scouts continue their focus on going green and increasing environmental awareness. The organization has themed this year’s World Thinking Day as “We Can Save Our Planet.” Held each year on February 22, the purpose of World Thinking Day is to celebrate international friendships and work together for greater good.

Making strides towards saving the planet is everybody’s job. More companies are demonstrating their commitment through sustainability initiatives and encouraging employees to go green. Pharma is no exception, even though the industry has not, generally, engaged in the sort of high-profile green initiatives that many other consumer sectors have.

In celebration of World Thinking Day, what can you do to help your organization reduce its environmental footprint?

Go digital when possible. From marketing communication strategies to automating internal processes, going digital does more than fuel efficiencies and open new communication channels – it’s gentle on the environment. For example, companies that incorporate video interview technologies into their recruiting processes reduce the need for flying candidates in for interviews or driving to an office location. Technologies like FaceTime enable the sales force to get in front of individual doctors without having to get in a car. Take that, carbon footprint!

Please consider the environment before printing. We’ve all seen this phrase at the bottom of an email, but have we stalled on thinking of new ways to reduce reliance on paper? Whether personal or professional, it’s time to make a commitment to going fully digital, whether that is requesting electronic invoices from vendors or replacing a paper calendar with a smartphone app. Digital processes offer a host of benefits from conserving energy to increased efficiencies. They’re just kinder to the planet. At work and at home, shouldn’t we all be thinking before consuming?

Prevent environment-related illness. A clean, safe work environment ensures workers have the best opportunity to reach their potential. Think of the basics – clean air, access to healthy food, a workplace free of environmental hazards – but also consider the culture. Work stress, workplace bullying and even the wrong temperature can jeopardize morale and cause the best talent to flee. Whether its town hall meetings, engagement surveys or encouraging more frequent conversations, keep a pulse on company culture and address issues before they become problems.

Understand your partners’ business practices. Gain a better understanding of the processes of your suppliers to ensure they align with your commitment to accountability and green initiatives. From green chemistry to technology techniques, recycled packaging, and barcoding initiatives, use good green guidance across the entire supply chain. By working with like-minded partners, companies can show customers that they’re committed to being a strong corporate citizen.

From its inter-office practices to its physician-facing and consumer-facing marketing efforts, pharma has literally millions of processes that could likely be adjusted to reduce their impacts on the environment. How do you plan to think differently?

Palio is an advertising agency revolutionizing pharmaceutical and healthcare marketing to create experiences that will Never Be Forgotten.

Peter Hopper, Sr Dir, Integrated Client Services, Palio

Couldn’t sleep last night, so I ended up reading an article on my iPad that asked the question: mobile Web site or mobile app? I know. I had options, but it popped up in my RSS feed.

The article (published in RAIN, the Radio and Internet Newsletter) was a brief review of a column written by Jakob Nielsen, a Web usability expert, for AlertBox. Nielsen is predicting a strategic shift, based on his research on how end-users use their mobile devices. He claims that, hands down, the mobile app currently beats the mobile Web site from a user-performance perspective. But, in time, that will change.

The driving factor is the user-experience environment. It’s not news that the desktop and laptop real estate, computing power and user-interactivity (keystroking, mouse and track pad precision and functionality, etc) currently overwhelm the smart phone and tablet. And that is the point: the mobile device requires the smarter optimization gained by creating an app, while Web site optimization for the mobile device is currently limited. This smarter optimization makes the mobile app a better user experience. “An app can target the specific limitations and abilities of each individual device much better than a Web site can while running inside a browser,” states Nielsen.

But we are approaching a crossroads. The app benefit may indeed be short-lived. One factor: the expense of developing mobile apps will likely increase. Currently, the primary mobile app platforms are Android, iOS and Windows Phone. But these platforms are sub-dividing, iOS for iPhone and iPad, Android for smartphones and the Kindle Fire, for example: separate apps required for unique user experiences per mobile environment. Development technology, again, will likely step up to help alleviate some of this cost burden. But there are other factors, as well, including e-commerce and richer content that favor the mobile Web site, down the road.

What’s at risk? Letting your audience down.

Turning the corner, new Web technologies like HTML5 will drive better mobile site capabilities and user experiences. Add the benefit of a richer integration with the Web via a mobile site than within a mobile app.

When will this predicted strategic shift take place? Great question. No clear answer on the immediate horizon according to Nielsen. We know HTML5 and other Web technologies are advancing rapidly. However, the take-away from this discussion is recognizing the balance and the compromise when building your digital recommendations for your clients in the mobile environment, helping them understand that there is indeed a shift on the horizon, the unique implications of what and why you consider development options, and helping them evaluate the best road to take.

I hope this didn’t put you to sleep, but I did rest better last night after becoming a little more enlightened.

Palio is an advertising agency revolutionizing pharmaceutical and healthcare marketing to create experiences that will Never Be Forgotten.

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 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.

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 biosimilars. 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.

Structure of a typical chemical drug molecule (left) and a biologic molecule (right).On February 9, 2012 the FDA released the first draft guidance 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 in vitro 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.

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.

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.

Palio is an advertising agency revolutionizing pharmaceutical and healthcare marketing to create experiences that will Never Be Forgotten.

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.

Another type of awareness is growing among women: Women have been less likely to use apps than men, but that gap is decreasing too.

As you’ve seen on PharmApps, 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.

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.)

1. Staying healthy - You can choose from among many apps on many platforms that can help you to track your food intake, weight, BMI and athletic performance. Keep your heart healthy before you need to worry!
2. 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 Healthy Heart, Healthy Heart Numbers or My BloodWorks. 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.
3. Saving a life - Keep a couple of apps on hand to help you through an emergency to get reminders how to perform CPR and first aid.
4. Not just mobile - Even Facebook-only apps are getting into the game: The OhioHealth network of hospitals has devised the Facebook app Heartbeats for Health, 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?

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 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.

The CDC’s leap into mobile health gives iPad users touchpad access to the organization’s real-time health updates, blogs and podcasts, these tabs include:

• Newsroom 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
• Public Health Matters Blog: 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.
• CDC podcasts: 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.

Over 50,000 pages of content can be accessed through tabs for general health-related information:

• Health Articles  written by subject matter experts and health communicators from all CDC centers and programs.
• Vital Signs 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.
• Preventing Chronic Disease (PCD) Journal is a peer-reviewed electronic journal established to address the interface between applied public health research, practice, and policy.

Mindful of users desire to network, the app provides a conduit to share:

• Stay Connected: Follow CDC by tapping on tabs for Facebook, Twitter and YouTube. By accessing CDC’s social media through the iPad, users can view important information on health topics and events throughout the year.

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 CDC Mobile iPad Application on CDC’s web site or on PharmApps.

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: CDC is looking for a few good flu apps.

Palio is an advertising agency revolutionizing pharmaceutical and healthcare marketing to create experiences that will Never Be Forgotten.

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, 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.

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^® (crizotinib [Pfizer]) and Zelboraf^® (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.

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^® (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^® (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.

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 (>80%) compared with recent years (typically ~50%). Analysts expect fewer approvals in 2012.

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:

• There’s opportunity with orphan drugs. 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
• Drug compounds with companion diagnostic tests could provide a unique business opportunity. We’ve all heard about the promise of “personalized medicine” for years. Personalization of therapeutics per se 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
• Don’t discount small biotechs. 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
• Small biotechs need help with product launches. SLE is typically treated with general immunosuppressive drugs and has been the standard of care for 50 years, so the poor 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^® (tocilzumab [Roche/Genentech]) and Prolia^® (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

Palio is an advertising agency revolutionizing pharmaceutical and healthcare marketing to create experiences that will Never Be Forgotten.

Source:

The source article for my quick summary above, and my own food for thought, was published  (February 2, 2012) in Nature Reviews Drug Discovery.

Mullard A. 2011 FDA drug approvals. Nat Rev Drug Disc. 2012;11(2):91-95.