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Pharma Payment Mechanics

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The Centers for Medicare and Medicaid Services, CMS, recently released the latest 2017 Open Payments data, providing now a total of over four years of pharma payment data for analysis. The total database now contains details of over 74 million payments to nearly one million physicians and over four thousand hospitals.

Research payments have shown a healthy average annual increase of 14.8%, with 2017 payments totaling $4.66 Billion. Not so the “General” payments, covering the gamut of the typical payments such as consulting, speakership, food & beverage, royalties etc. which has been rising at an average annual rate of 3.4%, only about 1% over inflation, to a total for 2017 of $2.82 Billion.


Open Payments mid bar

Chart - Research vs General Payments

Under the Hood

Digging deeper, we see some trends within the General payments. Staple general payments to physicians, like Food & Beverage ($237 Million in 2017) and Travel ($188 Million in 2017), are basically flat at under 2% per annum – just under the rate of inflation, while Gifts are the same in 2017 as they were in 2014, at $29 Million.

However, Entertainment payments although the smallest of the payment categories, trebled in size last year to $1.5 Million.

Chart - Entertainment

Formula One Drivers

In terms of physician-company collaborative relationships, we also see a shift from Speaker roles (down 2.6% per annum to $612 Million in 2017), to Consulting roles (up 5.4% to $429 Million).

Speakers vs Consultant

Where the Rubber hits the Road

The utility of Open Payments data goes well beyond an overview of who is doing what. Targeted analysis may be performed of this rich dataset which can help in critical decision making:

  • By drug: Identify the most highly paid physicians in certain activities for a target list of drugs, categorized into speaking, consulting, and research engagements.
  • By competitors: Analyze the competition – see how your competitors compare in their marketing budgets, and where and on whom they spend their money.
  • By KOLs: Analyze the work of your own and other KOLs, find who is funding them, and how you stack up against them.
  • By Partners: Find new partners for your business plan, and analyze current partners, by identifying companies making complementary products who are spending in your target areas.
  • Trend Analysis: Find trends in your area of interest – who are the rising stars, and which types of work is becoming more valuable, and for which drugs.

How do I do drive these payment analyses?

With our long experience in healthcare data analytics and proprietary name matching software, Snowfish can perform custom analyses for you in a short timeframe, and provide automatic refreshes to the analyses whenever new data is released.

We have a white paper available for you covering the Open Payments database and its possibilities in more detail, and also have a real example of an analysis in Excel. The example shows the 30 most highly paid psychiatrists and neurologists, where we calculate the total payments made to each physician in each of a number of categories, and show not just the companies making the payments but also the associated drugs for the payments.

If you are interested in learning more about Snowfish’s industry-leading approach to healthcare data discovery and mining, and how we can help with your custom Open Payments analyses, please feel free to reach out to us. This is the time to capitalize on this fascinating new opportunity!

Snowfish is a strategic consulting firm that has almost two decades working exclusively with the pharmaceutical, biotech, and medical device industries. Please contact us at sales@snowfish.net or +703-759-6100 to learn more about our services.

Posted by Dave Fishman  |  0 Comment  |  in Management Consulting

Cannabis – A Unique History

A few months ago, I planned an outing to the Trans-Allegheny Lunatic Asylum in West Virginia. I know it is an odd place to visit but I enjoy all types of history, including medically-related.  The facility opened in 1864 and reached its peak in the 1950’s, housing 2,400 patients. Changes in the treatment of mental illness and the facilities physical deterioration led to its closure in 1994. In this one facility I was able to experience first-hand, 130 years of approaches to the treatment of mental illness.

apothacaryOne of the most interesting rooms in this massive facility was the Apothecary. Here, medicines were formulated and dispensed. While the practice of psychopharmacology is considered a relatively modern phenomenon, it is clear that this is not the case. I witnessed compounds that appeared to date back to the early 1900s.

I was wondering what compounds were in use to treat patients. There was a compound manufactured by Parke Davis which contained iron, arsenic, and strychnine, chocolate coated too. For very valid reasons, that combination fell out of favor.

Then I saw another glass flask which was in fact more germane to the modern era. This one from 1906 had cannabis indica as its main ingredient. Clearly, marijuana had a role in treatment of patients over 100 years ago. Why has it taken so much time before an FDA-approved cannabis-based therapy was available? I began to wonder how cannabis and its function in medical practice, has evolved over time. Cannabis TLA

In the U.S., cannabis was widely utilized as an over the counter medicine during the 19th and early 20th centuries, described in the United States Pharmacopoeia for the first time in 1850. Then in 1937 with the passage of the Marihuana Tax Act, a federal restriction was placed on cannabis use and sale.  Subsequent to this event, cannabis was dropped from the United States Pharmacopoeia in 1942, with legal penalties for its possession increasing in 1951 and 1956 with the enactment of the Boggs and Narcotic Control Acts, respectively, and prohibition under federal law occurring with the Controlled Substances Act of 1970. These legislative actions posed significant constraints  on cannabis research by restricting procurement of the substance for academic purposes. In the present day, the Drug Enforcement Agency (DEA) website still labels cannabis a Schedule I drug which is defined as having “no currently accepted medical use and a high potential for abuse.”

That said, over 28 states, the District of Columbia, Guam and Puerto Rico have taken their own initiative and have passed their own laws allowing for varying levels of cannabis use. Themajority limit this to medicinal cannabis used to treat a range of symptoms. The most common conditions include symptoms of cancer, glaucoma, human immunodeficiency virus, and multiple sclerosis. Recreational use is also legalized in eight states, CO, WA, OR, CA, NV, AK, MA, ME and more to soon follow.

The majority of states are treating serious medical conditions with cannabis and a smaller number are permitted recreational use.  I was clearly interested what is happening at the Federal Level.

EpiolexOn June 25th, 2018 GW Pharmaceuticals plc, announced that the U.S. FDA approved Epidiolex®  (cannabidiol) oral solution for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older. The company noted that Epidiolex is the first prescription pharmaceutical formulation of highly-purified, plant-derived cannabidiol (CBD), a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs. On June 27th, Revive Therapeutics announced that they have been granted Orphan Drug Designation for cannabidiol in the treatment of autoimmune hepatitis (AIH), a rare disease that causes inflammation of the liver.

There is a clear lack of consistency at the state and federal level concerning cannabis, particularly as a medical therapy. Over a hundred years ago it was legal and nationally available. Then it was completely banned. The majority of states and territories currently allow it for treating severe medical conditions. Eight states allow for recreational cannabis use. The Federal government after rigorous scientific testing approved GW Pharmaceuticals’ product and granted orphan status to Revive Therapeutics’.  All the while the DEA maintains cannabis as a Schedule I with “no benefit”.  Maybe someday this will get resolved but you got to wonder.  Is it the high cannabis can provide preventing the science?

Dave Fishman is President of Snowfish a strategic consulting firm that has almost two decades working exclusively with the pharmaceutical, biotech, and medical device industries. Please go to snowfish.net or contact us at sales@snowfish.net or +703-759-6100 to learn more about our services.

Posted by Dave Fishman  |  0 Comment  |  in Brand Management, Management Consulting, Medical Affairs, Product Development

ASCO Recommends Geriatric Assessment

elvis-costelloSinger Elvis Costello was just forced to cancel his tour to recover from surgery that he underwent to treat cancer. We wish him the best for a full recovery. While termed as “very aggressive”, news reports have noted that it his tumor is small and should be “defeated” through this single procedure. At this time, it is not clear to us as to the exact type of tumor or its makeup and if he requires any follow-on therapy to keep the tumor at bay. At age 63, Mr. Costello a.k.a. Declan Patrick MacManus will likely to be managed like most adults with his tumor type, grade, and stage. But according to new recommendations from the American Society of Clinical Oncologists (ASCO) if he were at least two years older and chemotherapy an option, he should ideally receive a geriatric assessment to determine his treatment path.

ASCO has already stressed the need for better treatment of older adults with cancer and despite that 60 percent of cancers occur in those over 65, they are severely underrepresented in clinical trials. Furthermore, due to physiologic changes related to aging and comorbidities, this group tends to have issues with poor tolerability and toxicity to oncology therapies. “Older people living with cancer often have different experiences and outcomes in their treatment than younger cancer patients,” said former ASCO President Julie M. Vose, MD, MBA, FASCO. “As we age, for example, the risk of adverse reactions from treatment significantly increases. In 2015, ASCO released landmark recommendations urging for a broadening of clinical trials to include older adults.

What is promising is that progress is being made. The AbbVie/Calico partnership includes oncology as a target of its research efforts. The approval of Vyxeos ™ a treatment for acute myeloid leukemia (AML) was based on studies which included patients 60 to 75 years old, a population that has long been poor candidates for standard therapy due to concerns of toxicity and therapy resistance.

These are only initial steps and there remains a lack of data in older adults for the majority of cancer therapies particularly chemotherapy, making treating them kind of a crap shoot. This is where ASCO envisions geriatric assessment filling a key need. Used for years within other specialties and disciplines, geriatric assessment helps to determine a particular management pathway for an older adult through evaluating physical ability, psychological status, nutrition, cognition, social circumstances and other, coexisting medical conditions. It is underused in oncology practice – with less than 25% of eligible patients receiving a geriatric assessment. Consequently, oncologists have not had the tools to establish the risk to benefit ratio of oncology therapies in older adults and key signals have been missed. With geriatric assessment, oncologist will be able to determine potential for poor tolerance to chemotherapy through identifying signs of dementia, fall risk, frailty, and comorbidities to name a few.

While geriatric assessment will likely improve decision making in oncology one patient at time, there is potential for a more pronounced impact. Its use may enhance overall awareness of the impact of aging on oncology practice and pave the way for more studies in older adults with more innovative therapies.  Widespread use of these assessment tools can also generate data able to be used by ASCO and the oncology community to make a case for changes in the ways that studies are evaluated in order to encourage inclusion of older adults. This is key to success of cancer treatment because with the aging population expected to double in just less than 50 years, so will the number of individuals with cancer.

Melissa Hammond, MSN, GNP is Managing Director at Snowfish a strategic consulting firm that has almost two decades working exclusively with the pharmaceutical, biotech, and medical device industries. Melissa is an expert in aging and aging issues as it relates to therapy development and commercialization.

Please go to snowfish.net or contact us at sales@snowfish.net or +703-759-6100 to learn more about our services.

Posted by Dave Fishman  |  0 Comment  |  in Management Consulting

Stakeholder Deep Dive: Professional Societies/Advocacy Groups

In this segment we focus on another set of stakeholders who are in the “usual suspects” category, but are really more complicated than meets the eye. Professional societies and patient advocacy groups have long been considered critical partners at all stages of a therapy’s lifecycle, including the early product planning phase. Their value is underscored by their role as the face of the key constituents that companies rely on to help informs product development and direction and to get the word out to others in their networks.

Professional societies and patient advocacy groups also value these relationships which range from joining forces with companies to further objectives such as education, support, or advocacy to viewing industry as just a trough of money used to support their own individual efforts. That said, while many groups may rightly be considered stakeholders and thus essential to engage, it is OK to put them into buckets based on how much they will allow industry to be actively involved.

We appreciate the challenges that organizations face related to industry partnering.  Rightfully so, it is in their best interest to remain unbiased and focused on the interests of their constituencies. Thus historically, these groups have had a somewhat on-again/off-again relationship with industry. Over the past decade that in order to remain financially stable, societies and advocacy groups need some level of industry funding. A ProPublica survey noted that more than two-thirds of responding patient advocacy organizations reported that they had received some level of industry funding in their last fiscal year with 12 percent received more than half of their money from industry.

Our own conversations with representatives from dozens of organizations has revealed that membership dues and fees for educational programs do not cut it anymore. Also, certain organizations that were primarily membership based are branching out, with a desire to reach communities that go well beyond their paying members. To ensure to optimize industry collaborations, professional and advocacy organizations have brought on specialized industry relations professionals. Most come directly from industry.

Resources are not infinite how does one increase the likelihood that a professional/advocacy group engagement strategy will be a win-win for all? Zero in on four major components:

  1. Alignment with the company on key objectives related to the disease state
  2. Their level of willingness to collaborate with industry as partners on meaningful programs and outreach, and
  3. Are their resources to collaborate with industry.
  4. If the relationship provides for interfacing with the executive team.

There is a variety of indicators which can be incorporated into a detailed analysis which utilizes complex analytics and innovative profiling. This process will help to identify the society/advocacy group partners upfront that present the best opportunities from the perspective of setting direction and ongoing collaboration as well as the level of investment required.

Snowfish has pioneered this unique approach of building custom stakeholder landscapes including KOL identification and mapping, designed to meet the needs of the particular product.

Melissa Hammond, GNP is Managing Director at Snowfish a strategic consulting firm that has almost two decades working exclusively with the pharmaceutical, biotech, and medical device industries. Please go to snowfish.net or contact us at sales@snowfish.net or +703-759-6100 to learn more about our services.

Posted by Dave Fishman  |  0 Comment  |  in Management Consulting

Data: Are You Using it as Effectively as You Could Be?

There is a tremendous amount of data out there, are you using it to inform your product launches? Every life science professional is well aware of Rx data, ICD-10, CPT codes, and procedure volumes. They are also quite familiar with all the clinicians that focus on a disease state. The question is do you understand the landscape outside of these traditional metrics?

We have built a practice that involves using a multitude of non-traditional data inputs to inform and accelerate product launches. These can also be linked to the traditional metrics. In certain cases, we have used over a hundred different sources to inform decisions and increase product acceptance. Below is just a small sample of the diverse types of data that we have used from a multitude of sources.

U.S. Census Data Associations Hospital Rankings Community Resources
Clinical Trial Sites Public/Private Partnerships Sunshine Act Data Geriatric Emergency Departments
Nursing Home Minimum Data Set (MDS) Medicare 5 Star Advantage Metropolitan Statistical Area Data Veterans Per Area
Income Level Support Groups ­­­Investigators NIH Grants
KOL Data Centers of Excellence Medicare ACOs Competitive Product Data
Clinical Trial Sponsors Hospital Infection Rates Domestic Violence Groups Insurance Formulary Committee

This data can be used to provide insights that are unique and targeted for a particular product. These may include, but are not limited to:

  • What are the best areas to place clinical trial sites?
  • Which hospitals have high levels of infections rates that might be amenable to a new product?
  • What KOLs are working with various companies around which products?
  • Which is a leading center of excellence and which clinicians are associated with the institution?
  • What is the best professional society or patient advocacy group to work with around a given disease state?
  • What are the relevant support groups within 15 miles of a target area?

The questions that can be posed and the answers that may be gleaned will be vast if you are willing to simply move beyond the traditional tools.  So, I will close with are you leveraging all the tools in your bag?

Dave Fishman is President of Snowfish a strategic consulting firm that has almost two decades working exclusively with the pharmaceutical, biotech, and medical device industries. Please go to snowfish.net or contact us at sales@snowfish.net or +703-759-6100 to learn more about our services.

Posted by Dave Fishman  |  0 Comment  |  in Management Consulting

As Companies Tackle “Age-Related Diseases”, How Much Do We Know About Geriatricians?

It is encouraging to hear the news of further investment  – $1B to be exact – into extending research collaboration between AbbVie and Calico focused on developing innovative therapies for “age-related diseases”. This partnership is evidence of the growing industry movement to embrace the differences across the lifespan and focus on therapies which can be tailored to this unique and medically complex population.

Such development initiatives underscore a very important stakeholder group  – geriatricians. While they are in high demand by patients, who are realizing their value,  their numbers are relatively meager as geriatrics does tend to have the appeal of other specialty tracks. Thus there is a low likelihood that an industry professional will come in contact with a geriatrician and it is often not clear what they bring to the table and how they differ from other clinicians such as internists and primary care.

According to the American Geriatrics Society, a geriatrician is “a medical doctor who is specially trained to meet the unique healthcare needs of older adults. Illnesses, diseases and medications may affect older people differently than younger adults and older patients often have multiple health problems and take multiple medications.”  Truly, this definition does not do this specialty justice. In fact, geriatrics is probably one of the most complex areas in which to practice.

As we age, common conditions tend to present “atypically”, therefore practitioners must have incredibly astute assessment skills and instincts. For example, a patient with a urinary tract infection may not necessarily have burning, but might have a dehydration and confusion. Similarly, an MI might present mild discomfort in the upper abdomen rather than crushing chest pain. Therapy options are also limited to some extent; there are certain drugs that have a high risk to benefit ratio in the elderly. So too, they must play detective when a drug reaction or interaction is suspected.

Due to the nature of their patient population, geriatricians often veer well beyond the realms of what is considered “medicine”. They must take a holistic approach to disease management and prevention. It is not unusual that a potential crisis is averted by maintaining or improving function through the incorporation of nutrition, hydration, psychiatric modalities, physical therapy, and referrals to social work. We think of geriatricians playing a critical role in the identification and management of dementia. What is often neglected is that their training readies them to take on the challenge of treating other chronic conditions in the presence of dementia.

In reference to training, there is no shortage of fellowship programs with 139 in the U.S. alone. In the U.S., geriatrics is not even a specialty, but rather a subspecialty of internal medicine. A residency in internal medicine with a one to two year fellowship for geriatrics is required for certification. In the EU, the training path differs by country with the norm being two to three years of geriatric concentration. Unlike in the U.S, 19 countries within the EU recognize geriatrics as a specialty.

As said before, geriatrics does not have the draw enjoyed by other specialties. Reasons range from funding and reimbursement to its perceived lack of “sexiness” by medical students and trainees. That said gaps are slowly being filled by non-physician clinicians such as nurse practitioners and physician assistants. Another trend is the geriatric concentration with certain specialists. Witness the geriatric psychiatrist, geriatric cardiologist, geriatric nephrologist, geriatric oncologist and even the geriatric emergency physician. This is driven on the appreciation that many of the patients seen in these specialty practices are older or elderly and the appropriate knowledge base is critical to ensure optimal management. Other innovative solutions such as continuing education for non-geriatric clinicians are also well established.

Given the steady focus in the development of therapies for age-related diseases, it is more imperative than ever to partner with this very important stakeholder group. With a solid grasp on the role and qualifications of geriatricians, industry professionals can develop innovative ways to involve and provide value to them. Additionally, there are endless opportunities to assist non-certified clinicians to practice geriatric medicine through effective therapy development and education along with linking clinicians up with valuable resources.

Melissa Hammond, MSN, GNP is Managing Director at Snowfish and a well-recognized industry expert in geriatrics. She can be contacted at Melissa.hammond@snowfish.net

Snowfish has pioneered this unique approach of building custom stakeholder landscapes designed to meet the needs of the particular product. Individuals and policies are able to be assessed across multiple groups and companies are able to plan their pre-launch and launch activities on a very detailed level. To learn more, please feel free to contact us at sales@snowfish.net

Snowfish can be reached at (703) 759-6100 or via e-mail at info@snowfish.net.  We are also on the web at www.snowfish.net.

Posted by Melissa Hammond  |  0 Comment  |  in Management Consulting, Medical Affairs, Product Development, Stakeholder Mapping

5 Reasons Why You Don’t Use Prescription Data to Identify Your KOLs

Over the years we have heard a number of concerns regarding KOLs from company employees:

“I am worried that if he is asked how to use it, what will he say”?

“She is not loyal to us”.

“I don’t know why he is up there [speaking], he never prescribes our product”.

These are the concerns of anxious sales representatives, marketing professionals and even medical affairs directors when referring to certain speakers that I have worked with earlier in my career in medical communications. That put quite a damper on what were essentially excellent scientifically strong and intellectually stimulation educational presentations. In any case, the point is that when it came to KOLs, there appeared to be a greater interest in brand loyalty than in diverse experience, credibility and linkages to other individuals and groups. Such loyalty was measured in terms of prescriptions.

Since then for many in our industry, thankfully the definition of a KOL has gone beyond someone with allegiance to a particular product. Yet it is not uncommon to run into our colleagues who ask why we can’t just use prescribing data to identify KOLs, particularly beyond the national level. The rationale is that this will help to uncover the true clinicians – those who can speak from their vast patient-facing experience. While there is some validity to this, there are even more reasons why the process for KOL identification should not include prescription data, period. We have outlined the top five reasons for avoiding prescribing data in your KOL mapping efforts.

     1. Is not a measure of expertise

Prescription data is a measure of just that, prescriptions. That said, it only tells us the specific products that a clinician uses for their patient and the volume. It does not signify if the individual has expertise in a given area or even if they treat a lot of patients (see #4). To that point, we do hear that especially at the regional/local levels, it is critical that the KOL speaks from their experience.  There are more effective – and less expensive – means to do this.

     2. It has not been a great indicator of a KOL

In our 15+ years of experience in KOL mapping, we have found that prescription volume has not been an accurate marker of an ideal KOL. In fact, there is an inverse relationship between these two once you are at the national level.  Alternatively, KOLs at any level are found to have multi-faceted profiles with demonstrated abilities to take their expertise outside of their own practices and link with their communities.

     3. Can lead to malalignment with the organizations objectives

By labeling a KOL based off one set of data (prescription data) can lead to a host of problems.  Medical Affairs might be looking for KOLs to shed light on a disease state at an advisory board but soon realize their knowledge is limited. Marketing is looking for a KOL that can communicate issues to a wider audience but realize they have no public speaking or writing experience. This becomes even more apparent when a company use one set of KOLs for a variety of disparate tasks. We have always advocating using a unique profile we’ve develop to ensure the right match within an organization.

     4. May not represent who you think it does

It is well established that a good deal of the care delivered is no longer exclusively through physicians. With over 280,000 in the US alone, the role of nurse practitioners (NPs) has been expanding significantly and they have been functioning at a much higher capacity than ever before.  This includes varying levels of prescriptive privileges in all 50 states and the District of Columbia with NPs writing an average of 23 prescriptions a day per the American Academy of Nurse Practitioners.  What is not always realized is that a fair share of these treatments is not captured under the NP themselves, but rather a physician with whom they work with.

Consequently, while a particular physician may show up as having an incredibly large prescription volume for a particular product or class of therapy, the reality is that they have five NPs, all of whom are using the physician’s number for their own prescriptions. They are then captured under the physician and not the NP. On the flip side, when trying to use this to map NP KOLs, this data will likely misrepresent them as low-volume clinicians who do not see many patients.

The bottom line is that prescription data may not even be an accurate picture of an individual’s clinical experience. There are better sources.

     5. May open company up to media or government scrutiny.

For this very reason, prescription data should be considered a proverbial third rail in KOL identification. Due to activities years ago by some players that were less than savory, our industry is still shaking off a reputation that suggests that anyone tied to it is biased. Most recently, reports by CNN and other news outlets have tied money paid to clinicians for speaking and consulting, to their prescription patterns. While these reports tend to inspect the prescriptions following such payments, it is just as likely to trigger a red flag if it is found that a KOL who is also an established high prescriber is receiving significant honoraria for a number of activities.

Therefore, while the intent may not be to only collaborate with KOLs who are product loyalists, use of prescription data to identify them may nonetheless send the wrong message and impair the credibility. It can also open the company up to some unwanted attention.

Overall, the definition of a KOL has evolved, with the ideal being one who is a trustworthy and capable expert who can convey their knowledge to others in order to improve patient care. So too have the methods for identifying them. With the multi-faceted approach which combines multiple and varied sources, such as what Snowfish provides, credible KOLs can be effectively mapped and engaged for all types of innovative programs. Whereas prescription data has value for many functions such as sales and marketing, for the reasons stated, it should be omitted from KOL mapping efforts.

Snowfish has pioneered this unique approach of building custom stakeholder landscapes including KOL identification and mapping, designed to meet the needs of the particular product. To learn more, please feel free to contact us at sales@snowfish.net.

Melissa Hammond, GNP is Managing Director at Snowfish a strategic consulting firm that has almost two decades working exclusively with the pharmaceutical, biotech, and medical device industries. Please go to snowfish.net or call +703-759-6100 to learn more about our services.

Posted by Dave Fishman  |  0 Comment  |  in Management Consulting, Medical Affairs, Product Development, Stakeholder Mapping

Stakeholder Deep Dive: Is there more than a doctor in the house?

Doctor BookA recent Snowfish post discussed the virtues of stakeholder engagement and the advantages afforded to companies who invest in mapping their own stakeholder landscapes. While we touched upon the endless number of stakeholder categories, the nuances within them was way more than a single article could handle. We will be publishing a series of posts which will take a deeper dive inside these categories to understand the individual entities which make up the fabric of a strong network.

The first broad group is the providers. They generally include the places that people go to get care along with the individuals that work within these organizations. They deliver care for a particular condition and are often instrumental in providing or referring for a particular therapy. They may conduct research related to the disease or therapy. They may treat patients fitting a particular profile. In fact providers were THE original “key opinion leaders (KOLs)” and “centers of excellence (CoEs) and mainly limited to physicians, researchers, and research institutions. Everyone else was considered an “influencer” of the physician or only tangential to the elite institutions.

Non-physicians stakeholders are no longer “influencers” only

Indeed those “influencers” have been realized to be way more critical than originally thought and are important facets of the provider stakeholder category. This multifaceted group has grown to include nurse practitioners, nurses, disease state educators, disease navigators, pharmacists, and even administrators, medical directors, quality improvement/assurance, and ethics professionals. Taking it down to more granular level, the majority of these groups of professionals may be divided into general versus specialist.

Clinical settings are as diverse as the individuals that work in them.

Depending upon the therapy and target population, clinical settings may be quite diverse. Outpatient clinics, group practices, and pharmacies join conventional hospitals and research centers on the list of potential stakeholders. Also of consideration are nursing homes, assisted living facilities, rehabilitation centers, and mobile health teams. These may be general or specialty focused, urban or rural, private or public, standard or innovative care model.

Identifying the right provider stakeholders

In the vast universe of providers there is only a subset that would be considered true stakeholders for a given disease. Thorough research of the stakeholder category and specific target groups coupled with the objectives for the therapy lend itself to developing the profile of the individuals and organizations to include. This is followed by mapping of the providers using critical inputs which should include factors related to expertise, and focus in the particular disease state.

Objective measures such as disease state specific clinical articles, trials, treatment staff, guidelines, affiliations, membership, etc. should be incorporated. In addition, subjective measures such as hospital survey rankings, KOLs, Medicare rankings, press releases, should also be used. The net result is a very select list of providers for engagement.

Given how care has evolved, it is clear that provider stakeholders are no longer limited to physicians and hospitals. Many other professionals and organizations must be engaged. The complexities of the provider landscape can only be addressed through a systematic mapping and targeting of the most important stakeholders and entities within them.

Snowfish has pioneered this unique approach of building custom stakeholder landscapes designed to meet the needs of the particular product. Individuals and policies are able to be assessed across multiple groups and companies are able to plan their pre-launch and launch activities on a very detailed level. To learn more, please feel free to contact us at sales@snowfish.net.

David Fishman, MBA is President at Snowfish a strategic consulting firm that has almost two decades working exclusively with the pharmaceutical, biotech, and medical device industries. Please go to snowfish.net or call +703-759-6100 to learn more about our services.

Posted by Dave Fishman  |  0 Comment  |  in Management Consulting, Product Development, Stakeholder Mapping

Staking out Success in New Product Planning

Figures-around-the-tableNew therapies entering the market face a fiercely competitive landscape and companies continue to work committedly to establish and maintain their edge. One way has been to get the right individuals and groups on board for expert guidance and to build momentum. Stakeholder engagement has always played a role in the product planning phase but this has historically been limited to leading physicians and researchers.

The stakeholder universe is way more complicated than that. Unlike years past, we have finally come to the realization that physicians are not the be-all-end-all and that optimal disease prevention and management requires a collaborated effort of interventions and disciplines. It truly “takes a village”.

Further adding to the complexity is that that understanding these stakeholders and what they are about is not enough. We also need to know their inter-relationships. Appreciating the synergies of these stakeholders and how they work together within a particular disease landscape can help define a strategy of how a product can best fit once it is launched. To achieve this most effectively, an approach should leverage clinical insights, analytics, and business acumen.

The process starts with assessing the stakeholder landscape. All stakeholders that have direct or even tangential influence are reviewed and analyzed. We tend to start by looking several degrees of separation from the “usual suspects” and then proceed to exclude those that are irrelevant. As seen below, clinicians only comprise small segment of the overall stakeholder landscape.

Government Public/Private Partnerships Patients
Non-Pharmacologic Approaches Professional Societies Payers
Diagnostics Clinicians Think Tanks
Hospital/Provider Groups Caregivers Corporate Initiatives
Advocacy Groups Competitors Celebrities

Now, doing this type of analysis requires more than a few sources. Rather a tremendous amount (I’m talking about 100+ sources) of information should be gathered and from “disparate” sources. We have found that often combining dissimilar datasets provides the most valuable insight. Additionally, there is no need to recreate the wheel, a lot of data exists both in the public domain and on many company’s servers. The secret ingredient to understanding stakeholder significance and interaction is not the data itself, but the ability to determine the types of data to include how to analyze it. Algorithms should be developed that incorporate an understanding of the entire disease state “ecosystem” including clinical, institutional, financial, advocacy, supportive, advocacy, and others.
Once a wealth of information is captured in a relational database, there is virtually an endless number of stakeholder analyses that can be conducted.

Snowfish has pioneered this unique approach of building custom stakeholder landscapes designed to meet the needs of the particular product. Individuals and policies are able to be assessed across multiple groups and companies are able to plan their pre-launch and launch activities on a very detailed level. To learn more, please feel free to contact us at sales@snowfish.net.

David Fishman, MBA is President at Snowfish a strategic consulting firm that has almost two decades working exclusively with the pharmaceutical, biotech, and medical device industries. Please go to snowfish.net or call +703-759-6100 to learn more about our services.

Posted by Melissa Hammond  |  0 Comment  |  in Brand Management, Management Consulting, Medical Affairs, Product Development, Strategic Partnering

Alzheimer’s – Science Sets Sail to Meet the Tsunami

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Departure of the Winged Ship by Vladimir Kush

The Grim Facts

It’s been called a coming “tsunami” with good reason. One in eight elder Americans have Alzheimer’s Disease (AD) and one in three elder Americans die with AD or another dementia. As baby boomers enter their golden years, the AD population is expected to nearly treble from 5.3 million in 2015 to 13.8 million by 2050, at an estimated cost of 1.1 trillion dollars and one in three of every Medicare dollar. Other developed nations face similar crises.

Government Responds

AD-SummaryMany national and state governments have recognized the tsunami threat and have put forward plans to address it. In 2011 President Obama signed the National Alzheimer’s Project Act (NAPA) with its number one goal to “Prevent and Effectively Treat Alzheimer’s Disease by 2025.” But behind the bold proposals actual government funding has been lack-luster. However, last month Congress passed a spending bill increasing Alzheimer’s research funding, effectively doubling the current $586 million to $1 Billion per year.

Presidential hopeful Hilary Clinton has proposed doubling funding again, calling for “rapidly” ramping up NIH spending on Alzheimer’s disease to $2 billion per year. While other leading presidential candidates have offered no such specific plans, they have been supportive: Bernie Sanders says he “believes very strongly” in more AD funding. Donald Trump, said that AD was a “total top priority for me”. In subcommittee hearings, Ted Cruz has strongly advocated more money be spent on AD Research. Marco Rubio said that a “Manhattan Project-style focus” is required on AD research.

With these greater gusts behind its sails can science now reach the NAPA goal and head off the tsunami?

The Science

To date there exists no effective cure for AD, nor any effective prevention. Worse still, there is scant understanding of the disease, its causes are unknown, as is its method of action on the brain. But there are clues for medical scientists to follow: from autopsies, for instance, it’s known that the brains of AD patients have distinctive plaques of the protein amyloid beta (Aβ), and also tangles of the protein tau.

Competing hypotheses for the cause of AD include: Mutations in various genes; reduced synthesis of the neurotransmitter acetylcholine; extracellular amyloid beta (Aβ) deposits; tau protein abnormalities; poor functioning of the blood brain barrier.

Here’s a glimpse at two of the most recent promising discoveries by AD researchers:

An Environmental Toxin

Back in the 1950s many native peoples of the island of Guam, the Chamorros, were dying of a paralytic disease with dementia symptoms. In post-mortems, US Army doctors noticed abnormal collections of proteins in the brains of sufferers similar to those of AD patients.

Fast-forward to the late 1990s when researchers led by Dr Paul Cox picked up the trail, visited Guam and found high levels of Beta-N-methylamino-L-alanine  (BMAA) in water pools and the seeds of the local cycad palm trees. BMAA  is an environmental toxin made by certain bacteria. The Chamorros use these seeds to make flour for tortillas and also cook fruit bats which eat the Cycad seeds and also showed high levels of BMAA.

And now Dr Cox and colleagues at the University of Miami’s Institute of Ethnomedicine have reported the results of an experiment on BMAA. Monkeys fed fruit laced with BMAA developed similar abnormal proteins (tangles) in the brain, proving the causal effect of BMAA. Further studies show BMAA mimics an amino acid called L-serine and inserts itself into brain proteins, causing them to misfold and tangle.

Currently clinical trials are testing whether giving patients L-serine tablets might prevent the misfolding effect.

The work was published in the January 2016 issue of the journal Proceedings of the Royal Society B

Brain Inflammation

AD Researchers at the Centre for Biological Science at the University of Southampton in England have recently found that “inflammation in the brain can in fact drive the development of the disease.” And that blocking a receptor in the brain that regulates immune cells could “protect against the memory and behavior changes seen in the progression of Alzheimer’s disease.

The researchers, lead by Diego Gomez-Nicola, first compared brain tissue samples from AD patients with those from healthy people of the same age. The Alzheimer’s samples were found to contain more of immune cells called microglia than healthy ones.

The research team then conducted a study on mice bred to develop the characteristics of Alzheimer’s. The mice were given a drug which blocks CSF1R, a receptor that regulates microglia. The treated mice were able to demonstrate “fewer memory and behavioral problems.” than the untreated mice.

The work was published in the January 2016 issue of the journal Brain.

The Future

Whether either of these two particular recent discoveries eventually lead to a method to prevent or treat AD is unknown. But with more and more funded AD research under sail there is reasonable hope that the effects of Alzheimer’s Tsunami can be at least reduced and a cure found within our lifetimes.

Snowfish integrates, clinical, analytic, and business insights for life sciences companies. We have long experience of working on geriatric issues, and particularly on AD and other dementias. We have built comprehensive databases and reports for clients on every aspect of the AD landscape, based on our own research and a wide variety of resources. Snowfish attends the major AD meetings including NAPA Advisory and NIH Alzheimer’s Summit meetings.

Snowfish can be reached at (703) 759-6100 or via e-mail at info@snowfish.net.  We are also on the web at www.snowfish.net.

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