Posted on by Mar 10 2013

Spotlight on rare diseases: Part 3

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Part 3: Creative Thinking in an Orphan-drug World

How do we best communicate about orphan drugs?

Thus far, we have explored the challenges facing rare diseases and the orphan drugs designed to treat them. Now, we come to the really big questions—who must our communications reach, what do we say, and how do we say it?

There is no textbook or primer to help us answer these questions. We have to employ a combination of common sense, logic, insight, and creativity, to name just a few of the essentials. As marketers, you may already have launched an orphan drug, or you may be in the process of bringing an orphan drug into the marketplace. No doubt, you have experiences from which we can all learn.

Rare Disease Day reminded us that there is always an opportunity to do more. It got us thinking, “What do you wish you could do in the rare disease space? What do you wish you could do differently—or could have done differently—in your personal orphan drug experience?”

At Kane & Finkel, we have worked on numerous orphan drugs in various marketing stages. Here is a bit of what we have learned over the years.

  • We start by recognizing that a careful balance of science, economics, and humanitarianism is needed:
    • We need a plausible science story for the KOLs and clinicians
    • We need to make a real emotional connection with patients and their caregivers
    • We need to address the economics of orphan drugs such that payers and national health services will support a price that is fair for both manufacturers and the concerned public
  • Assessing the true value of an orphan drug—and how that value is expressed to the market—goes beyond economics:
    • We look beyond a QALY or an ICER
    • We consider how patients are impacted
    • We evaluate other metrics of value such as prolongation of stable disease, longer time to additional treatment required, ability to partake in more activities of daily life, and the emotional satisfaction of knowing that patients are not being passed over by the healthcare system
    • Value also includes the quality of a response, and not just the number of responses in a given patient population
  • We exhaust a multitude of possibilities to uncover the right audience for the right targeted messages:
    • Patients, caregivers, and advocacy groups rise to the top of the pyramid in terms of who needs to know about a new treatment
    • Building personal relationships with physicians and other healthcare providers who treat patients with rare diseases is a real possibility because the disease prevalence is so low
  • Expanding beyond traditional communications vehicles is a must in the rare disease space—leveraging new media and new channels allows for more efficient and highly targeted messaging opportunities

Orphan drugs can make an enormous difference in the lives of the millions of people who suffer from rare diseases. Kane & Finkel aims to make an important difference to the success of orphan drugs.

What has your experience been with orphan drugs? What expertise do you feel is essential to the success of an orphan drug? Please share your thoughts or give us a call and let’s talk about it.

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Posted on by Feb 28 2013

Spotlight on rare diseases: Part 2

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Part 2: The Challenges of Bringing Orphan Drugs to Market

Orphan drug access  

Though proven to be effective, safe, and fulfilling a true unmet need, all too often orphan drugs fail to be approved or available where and when they are needed. Due to budgetary issues, this is proving to be an ongoing dilemma for companies aiming to bring an orphan drug to market in the EU. Several factors are in play:

  • Orphan drug designation, protocol assistance, and marketing authorisation are part of a centralised procedure in the EU and the US
  • In the EU, therapeutic value assessment, pricing, and reimbursement for these agents remain within the realm of member states’ responsibility—in essence, orphan drugs in the EU go through 2 approval processes and many drugs do not make it through due to pricing issues
  • In the US, orphan drug approval or rejection is under the sole purview of the FDA, and pricing negotiations are handled through CMS (Centers for Medicare & Medicare Services) and other insurers—for very expensive drugs, specific conditions may be set to prevent over-use

Key issues surrounding EU-member-state pricing negotiations

  1. Each state negotiates pricing separately
  2. Some member states do not have the expertise to perform the complicated therapeutic value assessments required
  3. Some companies may negotiate with member states that grant a higher price—which they then use as a reference price in further negotiations 
  4. With NICE in the UK taking over orphan drug pricing review in 2013, it remains to be seen how pricing and reimbursement will be handled, as many countries tend to model approval or denial on NICE action

  • NICE has a long-standing history of being very tough on approving (or rejecting) high-priced non-orphan drug products
  • They say they will develop “interim methods for the first few drug assessments and will take forward a consultation exercise in 2013/14 to ensure the process put in place is robust, transparent, and consistent.”
  • The agency does not expect to entirely re-invent the work of AGNSS (the prior review agency for most orphan drugs in the UK); NICE will need to build upon the “decision-making framework that AGNSS has developed to ensure that the needs of people with rare and very rare conditions are properly considered.”

Orphan drug post-approval expansion strategies

The “PROs” of orphan drugs include market exclusivity, fast-track approval status, and financial advantages. The “CONs” are that sales for an orphan drug with a single indication are limited unless there is a future strategy for expansion in place.

The graphic below, which is adapted from Datamonitor CMHC2548, illustrates some key expansion considerations.

Each of the 3 scenarios has an upside potential in terms of sales. Scenario 1 is very attractive, as it can provide quite rapid expansion into a new, larger market.

Gleevec/Glivec is a good example of success for the second scenario—obtaining multiple orphan drug indications. In the case of Gleevec/Glivec, this has resulted in a $4-billion-a-year blockbuster. (It would be best to keep in mind that a Gleevec/Glivec-like success is the exception, and certainly not the rule). With the current trend toward development of molecularly targeted agents, it may be necessary to invent additional expansion strategies. Very highly targeted agents, meant to address a specific single gene or even base-pair malfunction (for example Kalydeco from Vertex), may not be “expandable” into other disease sectors. However, the methodology developed to produce an agent like Kalydeco could be leveraged to address other genetic errors in an effort to develop other product targets.

When to develop the expansion strategy

In an ideal world, an expansion strategy would be considered before a decision is taken to develop or acquire an orphan drug. However, that said, there is no “bad” time to develop or evolve an expansion strategy.

Orphan drugs appear to have become much more common over the last decade, and with blockbuster drugs facing the patent cliff, orphan drugs will likely be the wave of the future.

Check back for the third blog in this series: “Creative Thinking in an Orphan-drug World.”

What do you feel are the top-priority challenges that must be addressed in orphan drug development, access, and promotion? Leave a comment and let’s talk about it.

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Posted on by Feb 22 2013

Spotlight on rare diseases: A three-part series

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Part 1: Understanding Rare Diseases, Orphan Drugs, and Government Incentives for Research and Development

Definition of a rare (or orphan) disease

According to EURORDIS, (Rare Disease Europe), in Europe, a disease or disorder is considered to be “rare” when it affects less than 1 in 2,000 people. Another “numerical” definition that is more commonly cited in the literature is 5 cases or less per 10,000. (Note that the terms “rare disease” and “orphan disease” are used interchangeably in the literature and the press.)

In the United States, for a disease to be designated as a rare disease by the FDA, it must affect fewer than 200,000 people, which works out to about 7.5 per 10,000.

The word “orphan” is defined as “lacking support, supervision or care.” The term is used for both rare diseases and drugs because the pharmaceutical industry historically has had little motivation for developing and marketing products for the small patient communities affected. In short, the cost of developing an orphan product for market would be greater than the expected sales using current marketing models.

To address the needs of this underserved patient population, governmental bodies and rare disease advocacy organisations in the US and in Europe including EURORDIS, have come together to advocate and lobby for economic incentives to make it worthwhile for pharmaceutical manufacturers to develop and bring to market orphan drugs.

The table below (adapted from Datamonitor CMHC2548) compares the key differences between the policies in place for orphan drugs in the United States and in the EU.

 

Incentivising orphan drug development

In 1983, the United States passed the Orphan Drug Act to incentivise pharmaceutical companies to develop and market orphan drugs. The orphan drug “revolution” reached Europe in 1999, with the passing of Regulation EC n° 141/2000, adopted by the European Parliament on 16 December 1999 and published in January 2000. Legislated incentives include:

  • Market exclusivity: Once an orphan drug is approved by the EMA (European Medicines Agency), competitive agents or “similar” products cannot be marketed for 10 years after marketing authorisation has been granted. For paediatric drugs, this extends to 12 years. In the US, marketing exclusivity is granted for 7 years.
  • EMA and FDA provide protocol assistance by offering scientific advice about the various tests and clinical trials necessary for marketing authorisation. This assistance either costs nothing or there is a fee reduction.
  • In the EU, fees are either waived or reduced for orphan designation, marketing authorisation, inspections, variations, and protocol assistance. In the US a 50% tax credit is given for clinical studies.
  • Companies developing orphan drugs may be eligible for grants or initiatives for research and development from EU Member State programmes and the FDA.
  • In the EU and US, orphan drugs may be granted an accelerated marketing procedure.

Designating a drug as an orphan drug

An “orphan drug” label is granted if the product fulfills the following criteria:

  • Intended for an indication with a prevalence not exceeding 5 in 10,000 persons in the EU or less than 200,000 affected individuals in the US
  • For the EU, the rare disease must be life-threatening, seriously debilitating, or a serious chronic condition
  • In the EU, no satisfactory method of diagnosis, prevention, or treatment of the condition is currently authorised. If any other method does exist, then the proposed orphan drug has to provide a significant benefit over the currently approved product for the same rare disease

Orphan designation can be granted at any time prior to market authorisation

The designation of a product as an orphan drug can be made at any stage of drug development, as long as it is medically plausible. The drug may be in the preclinical (not yet tested on human subjects) or in the clinical trial phase.

A full list of designated and authorised orphan drugs in Europe is available at: ec.europa.eu.  In addition, a searchable database for orphan drugs is available from the FDA.

Growing focus on orphan drugs in the pharmaceutical industry

The blockbuster model that has dominated pharmaceutical marketing has become increasingly vulnerable to genericisation. When the blockbusters fall off the “patent cliff” manufacturers may not have equally lucrative replacements. As such, orphan drugs have become attractive alternatives.

For example, the FDA reports that close to 200 orphan drugs enter development each year. Also, about one-third of drugs approved by the FDA are designated as orphan drugs. In fiscal year 2012, 33.3% of priority NMEs (new molecular entities) and 21.7% of standard NMEs approved by the FDA were orphan drugs. In the EU in 2012, 15.38% of all marketing authorisations were for orphan drugs.

Becoming increasingly prevalent is the acquisition of small development companies or their products in development by big pharma. The advantage for the acquirers is avoidance of the expensive early discovery work. The advantage for the aquirees is newfound resources and expertise to devote to successfully bringing the product to market.

A challenging space for marketers

It is important to understand some of the hurdles that face orphan drug development, approval, and marketing. They include, for example:

  • Obtaining an orphan drug designation (probably the easiest item on this list)
  • Designing clinical trials that meet regulatory needs and those of the medical community
  • Recruiting a sufficient number of study patients—a very real challenge for some orphan and ultra-rare diseases

But the most important hurdle to overcome concerns pricing and reimbursement. Member states may be reluctant to reimburse costly orphan drugs that may have to be given for the patients’ lifetimes. But other factors also exist:

  • Budgetary issues: is the rare disease recognized as a priority (or not) and has provision been made in the overall health budget?
  • HTA issues: are authorities able to monitor and manage use, in order to control budgets despite high prices?
  • For the UK in particular, orphan drug cost-effectiveness review will be taken over by NICE in 2013, which is likely to be a perturbing market factor, as many other European countries look to NICE for access guidance.

Our next post, “The Challenges of Bringing Orphan Drugs to Market” will dive deeper into the marketing challenges facing pharmaceutical companies in the orphan drug space.

Add Medimorphics to your RSS feed to be alerted when the next article in this series is posted.

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Posted on by Dec 06 2012

Freedom for pharma to speak off-label?

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US Court of Appeals in NYC reverses conviction of pharmaceutical sales representative who promoted off-label drug use (Monday, December 3, 2012). 

The Second Circuit Court voted 2 to 1 to overturn conviction, citing the Freedom of Speech Clause of the First Amendment.

FDA-approved promotion

The FDA approves drugs for indications specified in a product’s label. And while doctors can prescribe a drug for any therapeutic purpose they see fit, pharmaceutical companies are allowed to promote a drug only for its FDA-approved uses.

Important clinical findings not brought to the attention of treatment decision makers (and their patients)

Traditionally, pharmaceutical companies put in place robust clinical programs investigating the ongoing benefit of their products within the approved indication, as well as exploring other potential areas where products may prove useful. Demonstrated clinical benefit in indications outside a product’s approved labeling often results from such programs, with corresponding data presented in peer-reviewed publications. Despite the demonstrated benefit and availability of data in the public domain, findings that are off-label have historically been considered strictly off limits for promotional use.

United States v. Caronia

Pharmaceutical sales representative Alfred Caronia was convicted in 2008 for improper (i.e. off-label) promotion of Xyrem® (sodium oxybate) oral solution, indicated for the treatment of narcolepsy. He allegedly spoke about the use of Xyrem in unapproved areas, including fibromyalgia and insomnia.

Caronia’s conviction was overturned December 3, 2012 on First Amendment grounds of freedom of speech. The US Court of Appeals for the Second Circuit in Manhattan decreed that the government prosecuted Caronia for his words.  The Supreme Court has previously held (Sorrell v. IMS Health, Inc., 2011) that “Speech in aid of pharmaceutical marketing … is a form of expression protected by the Free Speech Claus of the First Amendment.”

Of note, the three Circuit Judges in Caronia’s appeal were divided 2 to 1. Lone dissenting judge, Judge Debra Ann Livingston, commented, “… the majority calls into question the very foundations of our century-old system of drug regulation.” She argued that if drug companies “were allowed to promote FDA-approved drugs for non-approved uses, they would have little incentive to seek FDA approval for those uses.”

FDA may need to broaden its view of proven product benefit

The US Supreme Court may be asked to rule on the constitutionality of FDA regulation of pharmaceutical promotion. However, the Caronia case suggests that pharmaceutical representatives may, in the near future, be allowed to speak about results from clinical studies in off-label indications—which could change everything we have known about what is and is not allowable in pharma. If this judgment holds, it will necessitate the FDA taking a broader view of clinical trial findings that differ from or amend data presented in approved product labeling. Whether they will or will not remains to be seen.

Download complete court ruling.

How do you think this ruling will impact the future of sales representative communications? Please share your comments.

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Posted on by Nov 27 2012

Live or die by market research? How to best use qualitative market research

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It’s safe to say that at one time or another, we’ve all sat on the dark side of the one-way mirror and thought, “Why don’t the doctors get it?”

Healthcare professionals are clinically trained to diagnose problems and make informed decisions based on facts and data. In market research (MR) of promotional communications, we as marketers challenge their traditional way of thinking with creativity that requires interpretation. The more creative elements of MR stimuli—where proprietary and compelling ideas are found—often receive vague or even negative feedback from respondents.

What can qualitative research achieve?

Qualitative MR is often conducted in an effort to gather early reactions to new concepts. The principal value that MR brings to a creative effort is the voice of the physician to either support or redirect specific elements. For example, a particular visual could have “hidden depth” of communication, or a copy message may be read in a totally unintended (and unwanted) way.

Limitations and pitfalls of qualitative MR

Practicalities of research

The size of a research audience, and where or how the research is conducted (in-person versus phone; focus groups versus individual interviews, etc.), can introduce a certain set of limitations that must be considered and managed when reviewing the results of MR. Because of the typically small number of doctors involved in qualitative research, one of the biggest traps is allowing single verbatim reactions undue influence.

The healthcare professionals themselves

As mentioned earlier, healthcare professionals are typically more literally minded—especially in a MR setting. In addition, a physician may be sensitive to the perception that he or she is someone who is influenced by advertising. These idiosyncrasies can heighten the respondent’s reactions, eliciting commentary that can at the worst of times be hostile or defensive, and must be filtered.

Creativity and conservatism

Bold promotional campaigns can powerfully differentiate a product within a market. But bold, creative approaches can provoke criticism from this often-conservative audience, which in turn can feed discomfort in even the most ambitious marketer. The risk we run is taking the commentary as a prescription for how to execute creative, rather than as guidance to influence our thinking.

If the MR prescription is followed, the resulting creative is often watered down to such a point that it is incapable of eliciting an emotional reaction of any kind (good or bad). In short, you end up with creative that is very “pharma.”

5 tips for best use of MR

  1. Involve your agency
    Your agency’s experience with the brand adds valuable insights that can help to make the research more robust and the outputs more meaningful and actionable. Involve the agency throughout the process in helping to develop the moderator’s guide, attending research, and reviewing audience reactions.
  2. Let research shape direction, not prescribe direction
    Creative can be sharpened through research insights, but don’t let a small group determine direction.
  3. Avoid placing undue significance upon individual verbatim remarks
    Assess each one-of-a-kind response in a measured way: if it rings an alarm bell, then probe further, but if it’s an outlier in the overall picture, don’t give it importance.
  4. Don’t let the inherent conservatism of the audience suppress the creative spark of communications
    It is often lamented that pharmaceutical advertising compares poorly with consumer campaigns. It could just be that our collective reaction to qualitative MR with healthcare professionals is perpetuating this distinction.
  5. Keep excellence of promotional communication front of mind
    The ultimate objective must be impactful, compelling communications.

It cannot be denied that MR plays a significant role in helping to shape communications that are compelling and meaningful to the audience. But MR results serve as one of many other communications guideposts—creative ingenuity, brand objectives, market dynamics—that must also be taken into account.

 

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Posted on by Oct 22 2012

Pinterest: Is the latest craze right for pharma?

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We’ve all heard the statistics, but here’s a refresher:

  • According to a Shareaholic study, Pinterest drives more referral traffic than Google+, LinkedIn, and YouTube combined
  • On October 18, 2012, Pinterest had nearly 5 million daily active users and nearly 20 million monthly active users (AppData)

 

Dive a bit deeper into RJMetrics analyses and you’ll see that not only is the number of users increasing, so too is their engagement.

Pinners become more engaged over time.

There’s no denying that Pinterest is one of the hottest social media platforms around, and it doesn’t appear to be going away any time soon. So, is it worth pharma’s attention?

Retailers such as WholeFoods (the clear winner) and Target have amassed tens of thousands of followers based on an understanding that the secret to Pinterest is not marketing to the audience, but rather, inspiring them.

And inspiration is something that pharma serves up daily—along with hope, passion, commitment, and innovation. So yes, Pinterest is tailor-made for pharma.

The Brave Early Adopters

Some pharma companies have taken the first brave step and begun to develop their Pinterest presence—of note, Genentech and AstraZeneca. Both companies are leveraging Pinterest as a corporate platform (AZ is focused on recruitment), highlighting company philosophy, culture, and personalities, as well as their focus on serving the healthcare needs of people around the world.

Using Pinterest as another means to broadcast your company vision expands not only your message reach, but also its engagement potential. And if done right, corporate messaging can tap into a specific interest category—perhaps a disease area—increasing the likelihood that your effort will shatter expected engagement levels and referral traffic to associated company (and product) web properties.

Here are some quick tips and best practices to keep in mind when setting up a Pinterest presence:

  1.  Find your following: Determine what you want to communicate and stick to it. Do you want to use the page for recruitment? Or to convey corporate vision? Or to promote a specific program or initiative? Once you have determined how you want to use the page, secure the vanity URL that makes the most sense and start creating boards that support your goal. For instance, if you choose the broader direction of communicating corporate vision, focus on causes the Pinterest audience can get behind. If yours is a company that specializes in multiple disease areas, consider creating dedicated boards focused on education and disease awareness for each disease category, then populate each board with appropriate promotions (imagery, videos, patient stories/artwork, etc.).
  2. Don’t forget to “repin” and follow: According to RJ Metrics, 80% of Pinterest activity is repinning. This involves searching and finding content related to your page that you pin from another user onto one of your boards. For instance, say you have a board titled The Fight Against Cancer, you might want to repin the quotes and imagery that abound on Pinterest regarding people’s personal journeys with cancer. Through repinning, other users become aware of your page and may choose to follow your activity. In addition, you should find other like-minded companies, associations/societies (e.g., The American Cancer Society), and people to follow as you build your audience.
  3. Be diligent: Understand what you are getting into. Take some time to learn about Pinterest and the legalities of pinning content (always link back to the original source and give credit where credit is due). In addition, as with any social media effort, someone needs to be in charge of keeping the content up-to-date and moderating comments. Unlike Facebook, on Pinterest, comments made by users to your pins can be deleted. To keep engagement up, it is better to respond to a comment than to delete it, but if you must delete, you can. See how Novo Nordisk handles comments to their Pinterest page.

The key to any multichannel strategy is to leverage channels that facilitate delivery of the right message, to the right audience, at the right time. Oftentimes, this means choosing a variety of media and allowing your customers to select the channel that they want to interact with (remember we’re in this to serve the needs of our audience). Clearly, Pinterest is a channel that more and more people are including on their daily online stops. Shouldn’t pharma be part of it?

What is your take on Pinterest? What do you see as its utility for healthcare marketing? Do you have any success stories to share?

If you haven’t already done so, check out our Pinterest page and the content we find “Pinteresting.”

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Posted on by Oct 08 2012

New drug approvals in the United States on a downslope? Let’s take a closer look.

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There have been numerous press releases, articles, and blogs online warning of trends pointing to decreasing new drug approvals, specifically new molecular entities (NMEs), in recent years. This follows on the heels of major blockbusters nearing patent expiry and the FDA ramping up to deliver speedier, more efficient approvals of generic drug products.

It’s all doom and gloom—everyone should leave pharma and head for greener pastures, right? Wrong. Let’s look at this with an eye to both the past and the future.

A recent news item from July 31, 2012, warned that for the first 6 months of 2012, only 14 NMEs had been approved. If that number were doubled to project the total for the year, it would likely mean that 28 drugs would be approved in calendar year 2012, “down” from 35 in 2011.1

Let’s take a closer look. The graph below covers the time period from 1977 to 2011.2-7

To start, look at the red line, which represents the number of NMEs approved by the FDA over time. There is no downward trend here─just a horizontal line averaging about 25 NMEs per year over the last 34 years.

This line represents innovation, not stagnation.

A similar lack of trend applies to the blue line, which represents the number of new drug applications (NDAs) approved by the FDA between 1977 and 2006. Here there is another horizontal line averaging a little fewer than 100 approvals per year.

In late 2011, the FDA reported on its performance in fiscal year 2011 (ended September 30, 2011). Here are some of the details8:

  • 35 new medicines approved in 1 year—over the last 5 years, this number was surpassed only by 37 new agents in 2009
  • Important patient advances included:
    • 2 new treatments for hepatitis C
    • A drug for late-stage prostate cancer
    • The first new drug for Hodgkin’s lymphoma in 30 years
    • The first new drug for lupus in 50 years
    • FDA approval times were faster in 2011 than approval times in the rest of the world
      • 24 of 35 approvals were faster in the United States vs any other country, including those covered by the European Medicines Agency
      • Almost half the agents (16) were approved under priority review, where the FDA has a 6-month goal to complete review
      • Two-thirds were completed in a single review cycle
      • 3 obtained accelerated approval, where FDA approves safe/effective drugs quickly and relies on postmarketing studies to confirm
      • 34 of 35 were approved on or before review time targets, including 3 cancer drugs in less than 6 months

Granted, the FDA is tooting its own horn here, but the statistics are not insignificant and are not out of line vis-à-vis earlier data.

Taking the long view, there is a fairly consistent approval picture over time, and 28 NME approvals in 2012 is definitely within the expected range.

So what is the takeaway? Over the past 3 decades or so, the pharma industry and the FDA have been producing and approving NMEs at a more-or-less consistent rate. With the current trends toward producing complex biologics and other highly targeted “specialist” agents, it is possible that a true downward trend might be seen in the future, due to the simple fact that producing such agents takes time.

The fact is, R&D innovation will continue to march ahead and drug approvals are likely to continue as expected. But, the world is changing. Blockbusters will continue to go off patent, generic pressures will increase, and line extensions and reformulations won’t be the holy grail they once were. In response, pharma needs to consider new ways of doing business. And that will require innovation that extends beyond the labs and into the boardrooms.

 

References: 1. Carroll J. What turnaround? Fitch dashes hopes on drug approval trend. FierceBiotech Web site. http://www.fiercebiotech.com/story/what-turnaround-fitch-raises-doubts-drug-approval-trend/2012-07-30. Published July 30, 2012. Accessed August 20, 2012. 2. US Food and Drug Administration. Summary of NDA Approvals & Receipts, 1938 to the present. FDA Web site. http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/SummaryofNDAApprovalsReceipts1938tothepresent/default.htm. Updated February 16, 2011. Accessed August 20, 2012. 3. US Food and Drug Administration. NME Drug and New Biologic Approvals in 2007. FDA Web site. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/ucm081690.htm. Updated February 10, 2009. Accessed September 27, 2012. 4. CDER New Molecular Entity (NME) Drug and New Biologic Approvals for Calendar Year 2008. FDA Web site. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/UCM081805.pdf. Updated December 31, 2008. Accessed September 27, 2012. 5. CDER New Molecular Entity (NME)/New BLA Calendar Year Approvals. FDA Web site. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/UCM091096.pdf. Updated December 31, 2009. Accessed September 27, 2012. 6. US Food and Drug Administration. CDER New Molecular Entity (NME) & New BLA Calendar Year Approvals. FDA Web site. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/UCM242677.pdf. Updated December 31, 2010. Accessed September 27, 2012. 7. US Food and Drug Administration. CDER New Molecular Entity (NME) & New BLA Calendar Year Approvals. FDA Web site. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/UCM276989.pdf. Updated December 31, 2011. Accessed September 27, 2012. 8. US Food and Drug Administration. FDA: 35 innovative new drugs approved in fiscal year 2011 [press release]. FDA Web site. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm278383.htm. Published November 3, 2011. Accessed August 20, 2012.

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Posted on by Sep 27 2012

Closed-loop marketing: pharma can learn much from the supermarket

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Individualizing communications by engaging customer insights

Closed-loop marketing—or CLM, for short—is a system of developing and revising communications based on direct and indirect consumer feedback. It’s also a set of technological tools (databases, smartphone and tablet apps, websites) that enable rapid collection and analysis of data, and rapid revision and dissemination of communications. In short, it’s on-demand communications customized for the customer.

Let’s start with a brief analogy: Think about the experience of shopping at the market, and how it’s changed.

  • Your grandparents bought their produce from a local greengrocer, who knew their names, what they liked, when major events in their lives might suggest certain needs or desires for purchases. But the greengrocer’s stock levels were low, inconsistent, and sourced mostly locally. Plus, he only had resources to service a small local neighborhood. (And he had a natural monopoly, so his prices and selection weren’t subject to competition.) “Promotion” was nonexistent, or done entirely through word of mouth and social channels.
  • Your parents shopped for food at a supermarket. They had access to an increasingly broad supply of products, at cheaper cost. But they had no personal connection to the product offerings. The supermarket’s value proposition was variety plus low cost. Other than keeping a keen eye on stock levels, store managers had little understanding of what your parents, specifically, thought or wanted. Promotion consisted of adverts and weekly inserts and coupons—with little to no direct feedback from consumers.
  • Today, you might shop at the same supermarket where your parents did—but your relationship with the supermarket will be different. Now, thanks to loyalty cards and smartphone apps (and website tools), the supermarket knows more about you than the greengrocer did about your grandparents—and the supermarket can tailor its truly global offerings and its promotions to your particular tastes. The supermarket doesn’t bother you with promotions that you don’t care about. Vons, Tesco or whatever your preferred market may be, knows that you’re a vegetarian with two cats (for example)—so they don’t bother you with offers for ground beef or kibble.

The supermarket uses CLM to achieve this—database-driven tools to customize offerings and communications to target demographics, with the ability to shift and realign messages in response to demonstrated customer behaviors and preferences. This same transformation is taking place in pharma.

How can pharma learn from the supermarket?

Adoption of CLM in pharma means that pharma reps and marketers can finally work in tandem with standard database marketing techniques that have been in place for years. It’s the convergence of the best of the old (from the example above, our greengrocer’s customer knowledge and personability) and the new (our supermarket’s global reach and efficiency).

Through several vendors (Veeva, Skura, Agnitio, among others)—database marketing is now available at the sales rep level. Usually armed with an iPad or other tablet, a sales rep can pull up a screen in advance of a discussion with a physician, select that physician’s profile, and automatically customize a presentation to that physician’s needs and interests.

The iPad will show the previous calls with that physician, areas of interest (based on selections from previous details), suggested conversation topics, and suggested interactive engagements.

CLM can also incorporate “self-driven” channels—for example, when a physician or pharmacist visits a product website, or logs in to a dedicated information-sharing portal. This information feeds into the professional’s profile and preferences, adding greater richness to the rep/physician dialogue.

To some degree, CLM isn’t really a new principle in pharma marketing so much as it is an acceleration and optimization of established best practices through technology. With CLM, the basic principles of effective marketing are alive and not just well, but thriving—now we not only identify and communicate a clear value proposition for a product based on the specific unmet needs in the market—we can do it based on the specific unmet needs of Dr. Jones.

Take a moment and share with us your CLM experiences—successes, failures and best practices.

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Posted on by Sep 14 2012

Why you should leverage analytics to continually optimize your online endeavors

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You spend brainpower coming up with the perfect online concept. You spend money buying media placement. And then you just set it and forget it? No way. The strength of online marketing lies in its accountability, immediacy, and insightful engagement—all of which are maximized by analytics.

At its most basic level, analytics equals accountability

Analytics are your best tool for calculating your online return on investment. The first crucial step is establishing your goals. Two marketing terms are often used interchangeably to describe campaign goals:

Key Performance Indicators (KPIs): KPIs are metrics used to quantify objectives that reflect the strategic performance of your online marketing campaigns. They provide business and marketing intelligence to assess a measurable objective and the direction in which that objective is headed.1

Conversion action: The desired action you want a visitor to take on your site. Includes purchase, subscription to the company newsletter, request for follow-up or more information (lead generation), download of a company’s free offer (research results, a video, or a tool), subscription to company updates and news.1

To confuse things further (or just to make them more interesting), a conversion can be a KPI. For example, you may decide that newsletter sign-ups are a campaign goal.

But that is only the beginning.

Immediate feedback for immediate action 

The magic of analytical tools lies in the patterns and trends they can reveal. Sharp increases or decreases in KPIs may indicate that your digital tactics need attention. Engagement metrics (such as the amount of time spent on a page, or new versus returning visitors) can help you determine if your content is interesting or needs some spicing up. A high bounce rate—when people land on a page and leave without taking action—may indicate that content on a particular page is just not engaging. It is also possible that you are talking to the wrong people. The good news is that as long as you have a constant eye on the data, you can vet these situations with relatively minor modifications, and turn a problem into an opportunity.

Behavioral insights clarify where your visitors are coming from and where are they going

Web analytics really shine when the tools help guide development of online content that is more informative, accessible, and persuasive. With the behavioral insight provided by analytics, you can learn not only where visitors are coming from, but also where they go after they leave your site. Perhaps a competitor is next on their list?

Through analytics, you can also understand what devices your audience is using. If a significant proportion of your visits come from smartphones and tablets, you have a solid case for optimizing your online media for mobile devices.

Digital communications are as good as the information that guides them

The most innovative communication is iterative: a cycle that’s constantly adapting and improving. In digital, if you keep an eye on what’s happening by leveraging the utility of analytics, you can pivot quickly. Once you have a baseline understanding of how your online endeavor has performed, you can start thinking about ways to optimize your results.

In short: Watch the data, trust the data, act on the data.

Reference: 1. American Marketing Association. MarketingPower Web site. http://www.marketingpower.com/_layouts/Dictionary.aspx? Accessed August 17, 2012.

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