Aging White Paper - Snowfish LLC

7/30/2019 Aging White Paper - Snowfish LLC

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Penetrating the Universal Emerging Market:

Answers to 10 Key Questions on Developing and Marketing Therapies for the

Aging Population

People try to put us down [Talkin' 'bout my generation]

Just because we get around [Talkin' 'bout my generation]

Things they do look awful c-c-cold [Talkin' 'bout my generation]

Hope I die before I get old[Talkin' 'bout my generation]

-Roger Daltrey, 1965

What the now 68 year old Roger Daltrey was likely

unaware of is that 55 years later, we would be

embarking upon the most pronounced growth of the

older population ever experienced. Similar to many in

his generation Mr. Daltrey would indeed be getting

old before he died(fortunately). In 1965, when this

iconic song was released, the global population of

those aged 60 and over was 200+ million

(approximately 6% of the worlds population); today it

is around 760 million (~11%). The United Nations

estimates that this number will grow to 1 billion in the

year 2020.1 By the year 2050, it is expected that

individuals 60 and older will comprise 21% of the

earths citizens numbering 2 billion. Likely considered

implausible in 1965, the fastest upsurge will be those

85 and older.

While this is all said, among the life sciences industry

geriatrics has often remained the proverbial elephant

in the room. For the most part, it is not considered anexciting population and clinical trials are more difficult

to design due to multiple comorbidities. Ironically,

the life sciences industry possesses the dual

responsibility for expanding the average lifespan as

well as ensuring the future health and optimal

function for those who reach older ages. A result of


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innovation such as drug and device-delivered

therapies to manage acute events and chronic

conditions such as accidents, coronary artery disease,

diabetes and even certain cancers and infectious

diseases are no longer a death sentence.

Nonetheless, the resulting longevity and

accompanying frailty predisposes individuals to a

whole host of other chronic ailments including

Alzheimers disease, heart failure, and other forms of

cancer and infections. Additionally, those with

chronic diseases such as diabetes and hypertension

are living longer with them. Taking therapy discovery

to the next level requires a 360 degree perspective on

what this population truly needs to ensure that older

individuals have access to therapies which have safety

and efficacy profiles specific to them and an

adequately informed health care delivery system.

It is well understood that addressing this demographic

shift comes with significant challenges. However, it

also affords an incredible opportunity for life science

companies who can take on this challenge by

specifically addressing this age group. Indeed there

exists a huge potential to differentiate a companys

products based on addressing this population with

specific drugs, devices, and therapies. This is attuneto the transformation of wheelchairs to scooters

and the growth of 55+ and assisted living

communities.

This white paper will address the critical questions for

the industry and suggest prospective approaches that

the industry can leverage as progressive companies

target the enormous global emerging market that is

older adults.

1. Why Are We Living Longer And What Are theConsequences?

The lengthened lifespan is the result of the coupling

of two critical factors, a decrease in mortality from

infectious diseases and breakthroughs in the

treatment of chronic diseases such as heart disease

which have lengthened the average lifespan.2 In the

early part of the 20th century, the introduction of

anti-infective agents including antibiotics and sulfa

drugs afforded life-saving therapy for individuals

afflicted with most infectious conditions. Vaccines

targeted to once epidemic diseases like smallpox,

measles, scarlet fever, diphtheria, and polio virtually

eliminated deaths from these conditions. In the case

of chronic conditions, using the example of heart

disease, improvements in risk factor management

such as cholesterol lowering and primary

percutaneous coronary intervention in the case of

acute myocardial infarction have allowed patients to

live significantly longer with heart disease than they

might have even 50 years ago.

Longevity opens up the risk for acquiring other

diseases not common in younger individuals such as

pneumonia, dementia and cancer.3 Aging also leads

to certain disabilities such frailty in a number of

individuals. In one Dutch study, approximately 10%

of community-dwelling adults 65 and older were

considered frail.4 Moreover the same chronic

conditions that were managed well enough to get

people to an old age still require careful control.

Physiologic changes in aging (discussed in thefollowing section) also may result in alteration in the

response to the drugs used to treat them.

2. How is the Aging Population Different?Physiological changes occur with aging in all organ

systems.5 For example, the cardiovascular system is

affected by decreases in cardiac output, increase in

blood pressure and arterial stiffening via

arteriosclerosis. Individuals experience a decrease in

lung vital capacity and slower expiratory flow rates

coupled with impaired gas exchange. Progressive

elevation of blood glucose occurs with age on a

multifactorial basis Furthermore, aging impacts the

pharmacokinetics and pharmacodynamics of many

drugs by reducing hepatic metabolism (as low as 30-

50%) and renal function while increasing the volume


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of distribution of lipid soluble drugs since lead body

mass declines due to loss and atrophy of muscle

cells. Consequently this extends a drugs elimination

half-life.

3. Can Drugs Be Designed Specifically for OlderPeople?

Ideally, drugs destined for the geriatric population

should be developed so that they ideally fit the

needs of the aging body. They would produce

effects at a pace which maintains physiological

balance. This would be slow enough to reduce shock

to the system yet as quickly as possible to relieve

symptoms at minimal doses.

While such products do not yet appear to be

available, there is evidence of developments which if

applied effectively could eventually accomplish this

goal. For example, personalized medicine such as

intelligent dosing uses computer models to address

this challenge. The model takes into consideration a

multitude of factors to determine the ideal

medication dose for a given patient. In the area of

drug delivery, innovations such as a multi-unit

particulate system may allow drugs to be dosed in a

highly precise and individualized manner by allowing

a combination of different pellets within a capsule or

tablet to take effect at different times and at varying

strengths. More appropriate drug formulation is also

being examined; possibly greater availability of liquid

formulations, rapidly dissolving tablets, and even

drug-impregnated film that may be placed on the

tongue. Additionally, there has been interest among

some researchers to address deficits in visual and

tactile ability which result in difficulty of patients to

differentiate one pill from the other.

4. What About Including the Very Old in Trials?While the number of older patients enrolled in

clinical trials has somewhat increased over the first

decade of the new millennium, clinical trial data in

the very old and oldest old, i.e. patients over 75

and older and 85, respectively, is nevertheless

somewhat lacking. There is still not adequate data

available so that providers can be confident that the

medications they use in their geriatric patients are

safe and effective in this population. For example,

in a 2007 study sponsored by the Robert Wood

Johnson Foundation which reviewed 109 clinical

trials, it was revealed that a fifth of them excluded

patients above a specified age, and that almost half

of the remaining studies used criteria likely to

exclude the elderly disproportionatelyfrailty or

impaired cognition.6

In 1993, the FDA released guidelines focused on

increasing the amount of geriatric informationavailable in the label for drugs which will be

predominantly used in this population. 7 By 1997, a

Geriatric Use section was added to the label in

order to report any pharmacokinetic or

pharmacodynamic differences between the

geriatric and overall populations.8 Recently there

has been a greater push by regulatory agencies

both in the US and Europe with the release of ICH

guidelines titled, Guidance for Industry: E7 Studies

in Support of Special Populations: Geriatrics drivingtoward the goal of ensuring that real world

geriatric patients including oldest old, those with

comorbidities, and receiving concomitant therapies

are well-represented in clinical trials of new

therapies or formulations.9 At current time, these

remain only guidelines. The EU seems to be taking

a more aggressive role as the EMA as part of the

Agencys Road Map to 2015, has devised a

Geriatric Medicines Strategy and has even put

together a Geriatric Expert Group that is charged

with providing scientific advice to CHMP and the

EMA on issues related to the elderly.10


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5. I Have Heard of a Pediatric Indication. Isthere a Geriatric Indication?

True, most companies are familiar with filing for

pediatric indications. Since 1997, the opportunity to

obtain pediatric exclusivity has allowed companies tofurther differentiate their products as well as gain an

additional 6 months of protection against generic

competition in the United States. Pediatric dosing

makes excellent sense as drug metabolism in children

differs from that of adults thus increasing the risk of

adverse reactions and lack of efficacy. Such

differences are even observed across the span of the

pediatric age range. Without specific dosing in the

label, clinicians are playing guessing games with their

young patients.

When you take a careful look at the pediatric

situation with respect to the value of specific dosing,

it is easy to see how this parallels the geriatric field.

While many in the pediatric community warn that

children should not be treated as little adults, it could

be also cautioned that the elderly should not be

considered as vigorous adults. Most clinicians feel

that it is absurd to treat an 8 year old in exactly the

same manner as someone who is 35; why should itnot be just as illogical for a 75 year old to be treated

the same as a 35 year old? By its nature, aging

impacts the pharmacokinetics and

pharmacodynamics of many drugs. Reduced hepatic

metabolism (as low as 30-50%) secondary to changes

in hepatic blood flow, liver mass and hepatic

endothelium, reduction in renal function and

increased volume of distribution of lipid soluble drugs

all increase the elimination half-life of a drug. Altered

sensitivity, common to several drug classes of drugs,results in accentuated effects in the elderly.11 Put

together, this gives rise to an increase in adverse

events in this population. Accordingly, the medical

community is making due by practicing by the adage

of start low, go slow and in general, cutting the

dose of many common medications in the elderly.

Still, as these doses were not clinically studied, it is

not clear if as adverse events are attenuated the

drugs efficacy is being jeopardized.

Why havent we heard more about geriatric

exclusivity? Relative to the overall medication use in

the U.S, the elderly are a sizable population. Although

the 65 and older age group comprises only 13% of the

population, they account for approximately 34% of

prescription medication use. 12,13 Additionally, a recent

survey conducted by the CDCs National Center for

Health Statistics reported that almost 90% of

individuals 60 and older had used at least one

medication in the past month and 76% reported two

or more.14

It would make logical sense that drugs used

disproportionately by the elderly would already have

geriatric-specific dosing in their labeling. This is not

the case. Indeed, in a study performed by Steinmetz,

et al, looking at the 50 oral drugs most commonly

used by patients 65 and older in an in-patient setting,

only 8 contained some form of altered dosing

guidance in the label specific to geriatric patients.15

None included age-specific dosing.

In researching circumstances in which geriatric

exclusivity was granted, our search yielded only one.

In 2005, the FDA approved geriatric dosing for Savient

Pharmaceuticals Oxandrin (an anabolic steroid

indicated for weight gain) and granted the product 3-

year marketing exclusivity.16 This is quite notable

given the exclusivity for adding pediatric dosing is

limited to 6 months.

So goes the question of why companies are notpursuing geriatric dosing as a way to attenuate

competitive threat, both branded and generic.

Unmistakably, this pursuit does not make for a

clean trial as the elderly are more likely than their

younger counterparts to have more comorbidities and

thus be on other multiple medications. This is most


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likely why so few patients of 75 and older are

included in clinical trials in general, even for drugs

that are very appropriate to them. The opportunity

for industry is substantial. In addition to the potential

for an extra 3 years of exclusivity, providing specific

dosing guidance for geriatric patients will likely result

in providers using that particular drug over

competitors or even generics. They may feel

confident that they can circumvent adverse events

while maintaining the optimal level of efficacy. We

look forward to further discussion of geriatric

exclusivity and why it is not being utilized by life

science companies.

6. What Are Geriatric-Specific Endpoints?Most trials conventionally measure only endpoints

which tend to signify the efficacy of the therapy as

well as standard measures of safety and tolerability.

As noted earlier, age-related physiologic changes

may in fact alter an individuals response to a given

therapy. Some of these may include those which

impact cognition and function. Therefore, drugs

being evaluated for a geriatric population would

ideally include these endpoints which expand

beyond efficacy and safety for example, if the drugresults in delirium or incontinence.

Review of the literature, commentary, etc. has

revealed that there is still a call to action for such

endpoints. To confirm this, using the website

clinicaltrials.gov we performed a search of all

interventional trials involving patients >66 years of

age in which cognition was included as an outcome

measure. Out of 209 trials, only five did not

evaluating therapies for diseases involving the brainsuch as Alzheimers and Parkinsons disease.

Although there is significant interest in including

such endpoints for drugs used in older individuals,

the level of importance has not been recognized by

industry.

Efforts are being made by regulators to encourage

the inclusion of such geriatric-specific endpoints. In

the U.S. and in Europe, regulatory bodies have stated

the goal of ensuring that drugs used primarily in the

older population have been in clinical trials which

adequately represent these patients. The E7

(referred to earlier) specifies that certain specific

adverse events and age-related efficacy endpoints

should be actively sought in the geriatric population,

e.g., effects on cognitive function, balance and falls,

urinary incontinence or retention, weight loss, and

sarcopenia.9

7. How Will Such Innovations Be Paid For?It is impossible to have a discussion about health

care for the aging population without mentioning

cost-containment policies. As we discuss the role of

innovation in ensuring that quality and fulfillment of

life are achieved while extending it, a key question

is how this will all be paid. Moreover, are cost-

containment policies with respect to newer more

expensive therapies counterintuitive as they may

result in higher costs down the road? In certain

situations failure to use a certain medication may

result in severe consequences for which thetreatment may outweigh the cost of the actual

medication. This involves a careful cost-benefit

analysis to show that not using a certain medication

will in fact raise the cost of treatment.

In 2006, enacted as part of the Medicare

Modernization Act of 2003, older individuals were

now eligible for formal Medicare prescription plans

(Medicare Part D) either through Medicare

Prescription Drug Plans (PDP) or Advantage plans.

At the same time these plans offer the geriatric

population greater access to medications overall,

they are still somewhat restrictive. Given the latest

news regarding the elevated stroke risk in older

women with atrial fibrillation (AF) regardless of

anticoagulation status, we looked at the availability


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within these plans, of newer agents approved for

stroke prevention in AF, specifically Pradaxa and

Xarelto. In clinical trials in which the median age

was 71, Pradaxa demonstrated an advantage over

warfarin while Xarelto was comparable. Both

agents obviate the frequent monitoring and dietary

restrictions required for warfarin therapy. We

evaluated formularies for Medicare prescription

drug benefits offered by two of the top health

insurers in the U.S (one was a PDP and the other an

Advantage plan) to determine coverage of these

agents. The Advantage program did not cover

either drug. Although the PDP offers both drugs,

they are Tier 3 with an associated co-pay of $35-$45

and necessitate prior authorization. In comparison,

warfarin is Tier 2 with the co-pay ranging from $8 to

$12 co-pay with no prior authorization required.

The issue of prior authorization for Medicare plans

has been increasing. Based on results of the

Avalere Health Analysis in 2011, the percent of

drugs requiring prior authorization has increased

from 12.4% in 2008 to 16.7% in 2011.17

8. Are There Other Means to DifferentiateCurrent and Future Therapies for theGeriatric Market?

Snowfish feels that highlighting the safety and

necessity in this particular patient population can

build meaningful differentiation. This involves a

review of the drugs being used in older patients and

how they are used. Based upon this assessment, if

a particular product is not demonstrating benefit in

this patient population or places them at an

increased risk for an adverse drug reaction, a

suitable alternative should be identified and

developed.

An example of this is the Beers Criteria. Dr. Mark

Beers in collaboration with other experts released

the Beers Criteria for Potentially Inappropriate

Medication Use in Older Adults, informally known

as Beer's Criteria. The criteria is a reference for

healthcare professionals as it outlines drugs for

which the risks outweigh the benefits in those 65

years and older. 18 With a handful of revisions since

its inception, the Beers Criteria remains the

foremost guide to drugs which either pose high risks

of adverse effects or seem to have limited

effectiveness in the geriatric population. Currently

it categorizes drugs in the following ways: (1)

potentially inappropriate for older people because

they either pose high risks of adverse effects or

appear to have limited effectiveness in older

patients (2) potentially inappropriate for older

people who have certain diseases or disorders

because these drugs may exacerbate the specified

health problems (3) used with caution in older

adults.

In the meantime, other tools have been developed

including the Screening Tool of Older Persons

(STOPP) criteria.19 Furthermore various

mechanisms to reduce the prescribing of potentially

inappropriate drugs (PIMs) in the elderly have been

put in place at the regional and local levels.

Regardless of available to tools and initiatives,

considerable use of PIMs persists. A study from agroup at Weill Cornell Medical College identified

38% of U.S-based older adult patients receiving

home care were prescribed at least one PIM.20 A

similar prevalence was found in Australia in which

40% of a sample of community-dwelling older

adults was found to use at least one PIM.21 Lack of

awareness among the general community of

healthcare professionals may be one major reason

for this relatively high rate of PIM use. A survey of

eighty-nine physicians revealed that despite the fact

that an estimated 25% of their practice consisted of

patients > 65, many exhibited a poor knowledge of

PIMs and were unaware of prescribing guidelines

such as the Beers criteria.


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9. Is There an Adequate Supply Geriatric Experts toDrive Innovation?

A 1990 Institute of Medicine report titled Drug

Development for the Geriatric Population

commented that in the late 1980s there werefew geriatric trained faculty in medical schools.22

They blamed those circumstances on the lack of

drive to develop a geriatric research

environment.

As of 2012, there were 137 Liaison Committee on

Medical Education (LCME)-accredited medical

schools in the US. The encouraging news is that

the vast majority of schools offer in some form,

geriatric education or training. Still, the majority

of the faculty who lead these programs do not

have formal geriatric training; as of 2005, only

44% of directors of geriatric academic programs

underwent either geriatric fellowship or earned a

Certificate of Added Qualifications in geriatric

medicine. Furthermore, of schools awarding a

degree of doctor of medicine (MD), only seven

reported having a full-fledged department.

Instead, they tend to be divisions or sections of

other departments such as internal medicine. Asexpressed in a 2009 article by Bernard, et al, a

department provides for a seat at the table with

respect to budgeting, strategic planning and

allocation of resources within an academic

institution.23 Such status may indeed enhance

research program development. It should also be

noted that as of this posting, unlike pediatrics,

geriatrics is still considered a subspecialty. In

contrast, in 16 countries within the EU, geriatrics

is indeed a specialty.

10.Who Are the Current Life Science Players inthe Aging Market?

A handful of pharmaceutical companies have been

beginning to take an interest in therapies for

diseases of aging and those for frailty itself. Inparticular, Sanofi has instituted the Aging

Therapeutic Strategic Unit. This department is

charged with rethinking how treatments to the

aging population should be developed and

delivered. According to an article discussing the

Unit, there is concentration in detecting,

preventing and reversal of age-related

dysfunctions, disorders, and diseases including

Alzheimers, chronic pain, osteoarthritis, hearing

disorders, sarcopenia/frailty.

Pfizer put out a report titled Preventive Care and

Healthy Aging which was commissioned through

the Economist Business Intelligence Unit.3 This

report highlighted the significance of healthy aging

and the value of preventative care with respect to

reducing the cost of care and profiled eight

countries: Brazil, China, India, Japan, Russia, South

Africa, the U.K. and the U.S. It not only

summarized the significant challenges that must beovercome to implement this approach, but also

underscored the benefits that governments (and

citizens) can reap by implementing certain

changes. In general, this report reinforced the

notion that globally, we tend to take a very

reactive approach to healthcare delivery which is

counterintuitive to the care of older individuals.


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Conclusion

Well beyond what Roger Daltrey envisioned in the

1960s, his generation is spearheading the shift in

the global population to where eventually, one-fifth

will be aged 60 or older. It is medical innovation thathas both allowed for this phenomenon and that will

be necessary to maintain the health and well-being

along with longevity.

The issues described in this paper emphasize the need

for creativity within the life science industry in order

to take advantage of the various opportunities related

to the aging population. For example, recognizing that

patients will require continuation of therapy for

chronic conditions for many years after the initial

diagnosis, the industry can ensure that these

treatments are as effective and safe for a patient at

70 as it was at 50 and leverage this as a competitive

advantage.

1. World Population Ageing 2009. Available at:http://www.un.org/esa/population/publications/WPA2009/WPA2009_W

orkingPaper.pdf. Accessed 1/3/12

2. Global Health and Population Aging.http://www.prb.org/pdf07/TodaysResearchAging4.pdf. Accessed 1/3/12.

3. Preventive Care and Health Aging A Global Perspective. EconomistBusiness Unit. Available at:

http://digitalresearch.eiu.com/healthyageing/report. Accessed 1/3/12.

4.

Collard RM, Boter H, Schoevers RA, Oude Voshaar RC. Prevalence offrailty in community-dwelling older persons: a systematic review. J Am

Geriatr Soc. 2012;60(8):1487-92.

5. Boss GR. Age-Related Physiological Changes and Their ClinicalSignificance. West J Med .1981;135(6).

6. Zulman DM, Sussman JB, Chen X, Cigolle CT, Blaum CS, Hayward RA.Examining the evidence: a systematic review of the inclusion and analysis

of older adults in randomized controlled trials. J Gen Intern Med. 2011

Jul;26(7):783-90.

7. US Food and Drug Administration Guideline for industry. Studies insupport of special populations: geriatrics. 1994. Available at:

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM

129519.pdf. Accessed 1/3/13.

8. Federal Register (62 Federal Register 45313-45326). August 27, 1997.9. Guidance for Industry E7 Studies in Support of Special Populations:

Geriatrics. Available at:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM189544.pdf. Accessed 1/3/13.

10. EMA Geriatric Medicines Strategy. Available at:http://www.ema.europa.eu/docs/en_GB/document_library/Other/2011/

02/WC500102291.pdf. Accessed 1/3/13.

11. Crooks J, Stevenson IH. Drug response in the elderlysensitivity andpharmacokinetic considerations Age Ageing.1981;10(2):73-80.

12. Ferrini A, Ferrini R. 2000. Health in the Later Years. 3rd edition. Boston,MA, McGraw Hill.

13. Centers for Disease Control and Prevention and The Merck CompanyFoundation. The State of Health and Aging in America 2004.

14. Gu Q, Dillon CF, Burt VL. Prescription Drug Use Continues to Increase: U.S.Prescription Drug Data for 2007-2008. Available at:

http://www.cdc.gov/nchs/data/databriefs/db42.htm. Accessed 1/4/13.

15. Steinmetz KL, Coley KC, Pollock BG. Assessment of geriatric information on thedrug label for commonly prescribed drugs in older people. J Am Geriatr Soc.

2005;53(5):891-4.

16.

Savient Pharmaceuticals Files Citizens' Petition with the FDA for Oxandrin.Available at: http://investor.savient.com/releasedetail.cfm?releaseid=189758.

Accessed 1/4/13.

17. Initial Trend Analysis of 2011 Medicare Prescription Drug Plan Formularies.Available at:

http://www.avalerehealth.net/news/archive/Avalere_Health_Analysis_of_2011_

Part_D_Formularies.pdf. Accessed 1/4/13.

18. American Geriatrics Society 2012 Beers Criteria Update Expert Panel.American Geriatrics Society updated Beers Criteria for potentially inappropriate

medication use in older adults. J Am Geriatr Soc. 2012;60(4):616-31

19. Gallagher P, OMahony D. STOPP (Screening Tool ofOlder Persons potentiallyinappropriate Prescriptions): application to acutely ill elderly patients and

comparison with Beers criteria. Age Ageing. 2008; 37(6): 673-679.

20. Bao Y, Shao H, Bishop TF, Schackman BR, Bruce ML. Inappropriate medication ina national sample of US elderly patients receiving home health care. J Gen Intern

Med. 2012 Mar;27(3):304-10.

21. Beer C, Hyde Z, Almeida OP, Norman P, Hankey GJ, Yeap BB, Flicker L.. Qualityuse of medicines and health outcomes among a cohort of community dwelling

older men: an observational study.Br J Clin Pharmacol. 2011 ;71(4):592-9.

22. Report of a workshop - Drug Development for the Geriatric Population. 1990.Available at:

http://books.google.com/books?id=HUErAAAAYAAJ&printsec=frontcover&sourc

e=gbs_ge_summary_r&cad=0#v=onepage&q&f=false. Accessed 1/5/13.

23. Bernard MA, Blanchette PL, Brummel-Smith K. Strength and influence ofgeriatrics departments in academic health centers. Acad Med. 2009;84:627-632.

Melissa Hammond is Managing Director at Snowfish and an industry leader regarding the implications and opportunities of the g row

geriatric population to the life sciences industry. Snowfish provides actionable insights for the life sciences industry and has worked w

leading companies for nearly a decade. To learn more about Snowfish, please go to www.snowfish.net or call +1 -703-759-6100.
http://www.un.org/esa/population/publications/WPA2009/WPA2009_WorkingPaper.pdfhttp://www.un.org/esa/population/publications/WPA2009/WPA2009_WorkingPaper.pdfhttp://www.un.org/esa/population/publications/WPA2009/WPA2009_WorkingPaper.pdfhttp://www.prb.org/pdf07/TodaysResearchAging4.pdfhttp://www.prb.org/pdf07/TodaysResearchAging4.pdfhttp://digitalresearch.eiu.com/healthyageing/reporthttp://digitalresearch.eiu.com/healthyageing/reporthttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM189544.pdfhttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM189544.pdfhttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM189544.pdfhttp://www.ema.europa.eu/docs/en_GB/document_library/Other/2011/02/WC500102291.pdfhttp://www.ema.europa.eu/docs/en_GB/document_library/Other/2011/02/WC500102291.pdfhttp://www.ema.europa.eu/docs/en_GB/document_library/Other/2011/02/WC500102291.pdfhttp://www.cdc.gov/nchs/data/databriefs/db42.htmhttp://www.cdc.gov/nchs/data/databriefs/db42.htmhttp://www.avalerehealth.net/news/archive/Avalere_Health_Analysis_of_2011_Part_D_Formularies.pdfhttp://www.avalerehealth.net/news/archive/Avalere_Health_Analysis_of_2011_Part_D_Formularies.pdfhttp://www.avalerehealth.net/news/archive/Avalere_Health_Analysis_of_2011_Part_D_Formularies.pdfhttp://books.google.com/books?id=HUErAAAAYAAJ&printsec=frontcover&source=gbs_ge_summary_r&cad=0#v=onepage&q&f=falsehttp://books.google.com/books?id=HUErAAAAYAAJ&printsec=frontcover&source=gbs_ge_summary_r&cad=0#v=onepage&q&f=falsehttp://books.google.com/books?id=HUErAAAAYAAJ&printsec=frontcover&source=gbs_ge_summary_r&cad=0#v=onepage&q&f=falsehttp://books.google.com/books?id=HUErAAAAYAAJ&printsec=frontcover&source=gbs_ge_summary_r&cad=0#v=onepage&q&f=falsehttp://books.google.com/books?id=HUErAAAAYAAJ&printsec=frontcover&source=gbs_ge_summary_r&cad=0#v=onepage&q&f=falsehttp://www.avalerehealth.net/news/archive/Avalere_Health_Analysis_of_2011_Part_D_Formularies.pdfhttp://www.avalerehealth.net/news/archive/Avalere_Health_Analysis_of_2011_Part_D_Formularies.pdfhttp://www.cdc.gov/nchs/data/databriefs/db42.htmhttp://www.ema.europa.eu/docs/en_GB/document_library/Other/2011/02/WC500102291.pdfhttp://www.ema.europa.eu/docs/en_GB/document_library/Other/2011/02/WC500102291.pdfhttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM189544.pdfhttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM189544.pdfhttp://digitalresearch.eiu.com/healthyageing/reporthttp://www.prb.org/pdf07/TodaysResearchAging4.pdfhttp://www.un.org/esa/population/publications/WPA2009/WPA2009_WorkingPaper.pdfhttp://www.un.org/esa/population/publications/WPA2009/WPA2009_WorkingPaper.pdf

Aging White Paper - Snowfish LLC

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