Sample Work in Health Care

1

SUICIDE DIAGNOSTIC

Discover to Market ProjectApril 28th, 2016

2

Agenda1. Invention Overview2. Marketing Strategic Planning3. Business Model and Valuation4. Overall Project

Recommendation5. Executive Summary

Talal Al Tubayyeb Wendy Chen Shari Calmann Rajat ParasharEric Wang

3

Recommendation

Market Segment

Business Model

Value Propositi

onValuatio

n

4 target market:• Nursing Home (1)• Prison Inmates (2)• Military Soldiers (3)• Veterans (3)

• Licensing Model• Startup Model• Price of product: $250

Competitive Advantage: • Novel – IP

advantage• High accuracy –

80%• Fulfill strong need

in market

• Market Size: 42,388,538 – 5 year

• Market Growth in 5 years: 17.4%

4

INVENTION OVERVIEW

5

Suicide Facts

■ Almost 42,000 people die of suicide each year in the United States

■ Almost 1 million people die of suicide each year worldwide

■ 10th leading cause of death■ Age: 15 – 24 years old■ More deaths by suicide than motor

vehicle accidents

http://www.save.org/index.cfm?fuseaction=home.viewPage&page_id=705D5DF4-055B-F1EC-3F66462866FCB4E6

6

Suicide Causes

Depression56%

30%

Alcohol Illicit Drugs

Anxiety10%

Suicide

Nock et al., Jama Psychiatry, 2013Zachary Kaminsky presentation

7

The Inventor

■ Zachary Kaminsky, Ph.D.– Assistant Professor of Psychiatry and Behavioral

Sciences– Johns Hopkins University School of Medicine

“Suicide is a major preventable public health problem, but we have been stymied in our prevention efforts because we have no consistent way to predict those who are at increased risk of killing themselves” –

Zachary Kaminsky, Ph.D

8

The Invention

■ Diagnostic biomarker ■ Predict suicide attempt and/or suicide ideation through blood test■ Using genome-wide DNA methylation profiling in post mortem brains■ SKA2 epigenetics and genetic variation may represents the level of

suicide risk in the presence of stress disorder■ SKA2 predicts suicidal behavior and post-traumatic stress disorder

(PTSD)■ The biomarker is capable of predicting suicidal ideation/attempt with

over 80% accuracy from blood■ Epigenetic alterations in SKA2 may represent a promising biomarker

for detecting suicidal behaviors

9

Stage of Development

■ Brain samples: – Mentally ill people vs. Healthy people ■ Results:– Level of SKA2 were reduced in samples from people who had died by

suicide

■ A study of three blood tests and genetics:– Genetics of recurrent early-onset depression (GenRED) cohort■ Results:– Preformed well at predicting suicide attempts

10

Value Proposition

■ Safe■ Non-invasive simple blood test■ Quick process■ Detects the presence of suicidal thoughts and attempts ■ Helps to prevent suicide

11

Factors of Suicide IssueIn U.S.A *

■ The annual suicide rate is 12.93 per 100,000 individuals. (19 in military**)■ Second leading cause of death in USA for 13-34 year olds■ Men die by suicide 3.5x more often than women■ In 2011, suicides made up 5.5 percent of deaths in state and federal prisons, which was

more than drug and alcohol intoxication, homicide and accidents combined.***

Worldwide■ An estimated 804,000 deaths by suicide occurred globally in 2012 (WHO 2014a). Of

these, 75.5 percent were in low- and middle-income countries (LMICs). ****

Resources:* American Foundation for Suicide Prevention. Suicide Statistics. Retrieved from http://afsp.org/about-suicide/suicide-statistics/**Kaminsky, Z., Discovery, Replication, and Functional Implications of the SKA2 Epigenetic Biomarker for Suicide [PowerPoint Slides] ***American Foundation for Suicide Prevention (http://www.nbcnews.com/news/other/suicides-kill-more-inmates-homicide-overdoses-accidents-combined-f8C11072563 ) **** Lakshmi Vijayakumar, Michael R. Phillips, Morton M. Silverman, David Gunnell, and Vladimir Carli. Mental, Neurological, and Substance Use Disorders. Ch9. Suicide

12

ENTRY TO MARKET

13

Entry To Market

■ 4 target market:• Nursing Home (1)• Prison Inmates (2)• Military Soldiers (3)• Veterans (3)




Resource: Williams, J., Skirton, H., & Masny, A. (2006). Ethics, policy, and educational issues in genetic testing. Journal Of Nursing Scholarship, 38(2), 119-125 7p. doi:10.1111/j.1547-5069.2006.00088.x

14

MARKETING STRATEGIC PLANNING

15

Potential Consumers

■ Nursing Homes■ Prison Inmates■ Veterans ■ Military Soldiers■ Hospitals/In patient■ Outpatient Clinics■ Mental Health Clinics■ Private Mental Health Care Professionals■ Schools

Concern- Ethical Issues:1. Stigmatization2. Discrimination (i.e. Life

Insurance)

“Genetic testing, like other healthcare procedures, might be desired for people who cannot give their own consent.” (Williams, 2006, p.122)

Resource: Williams, J., Skirton, H., & Masny, A. (2006). Ethics, policy, and educational issues in genetic testing. Journal Of Nursing Scholarship, 38(2), 119-125 7p. doi:10.1111/j.1547-5069.2006.00088.x

16

Market Segmentation

Human

Have Suicide History

Excessively Multiple Times

Few TimesReceiving Treatment

From Organization with Limited Resources

From Organization with Ample ResourcesNo Treatment

No Suicide History

Have Suicidal Ideation

No Suicidal Ideation, but Exposed to High Risk Factors*

Good Mental Health

*High Risk Factors include: Family History of Suicide, Substance Abuse, Intoxication, Access to Firearms, A Serious or Chronic Medical Illness, Traumatic Life Experience, A Recent Tragedy or Loss, Prolonged Stress, Agitation & Sleep Deprivation, Isolation

17

Best Target Consumers (Consumers with Least Ethical Issues)

1. Nursing Homes

2. Prison Inmates

3. Military Soldiers 4. Veterans

Best Target

Consumers

18

Suicide Risk Factors

Resource: Mezuk, B., Lohman, M., Leslie M., Powell V., (2015) Suicide Risk in Nursing Homes and Assisted Living Facilities: 2003–2011, HHS Public Access

■ 40% of adults older than 65 years old and older will need skilled residential nursing care at some point in their lifetime

■ Risk factors for suicide, such as social isolation, depression, and functional impairment, are common among long-term care (LTC) residents

■ Older adults have among the highest suicide risks in the United States–suicide rate among men aged 65 years and older: 30 per 100 000–by contrast, it is 7 per 100 000 for men younger than 25 years

■ Suicide among white males aged 85 and older (65.3 deaths per 100,000 persons) is nearly six times the suicide rate (10.8 per 100,000) in the U.S

Prison Inmates

Nursing Homes

Military Soldiers Veterans

19

Market Size

• 40% of adults older than 65 years old and older will need skilled residential nursing care at some point in their lifetime*

• 20% of people age 55 years or older experience some type of mental health concern**

*B Mezuk, M Lohman, M Leslie, V Powell, Suicide Risk in Nursing Homes and Assisted Living Facilities: 2003–2011, HHS Public Access, 2015 **National Association of Chronic Disease Directors, The State of Mental Health and Aging in America, 2008, Retried from: http://www.cdc.gov/aging/pdf/mental_health.pdf

Prison Inmates

Nursing Homes


US Population (319m)

Age 65+ (44.6m)

40% need nursing care

(17.84m)

20% Mental Health

Problem (3.6m

)

3.6 million people

•Increase rate 1.9% due to aging population

20

Global Market■ Aging population both globally and in the USA leads to the growing market of

long-term care

Population Change in the U.S. and the World from 1950 to 2050 (”PewResearch Center” 2014) Retrieved from: http://www.pewglobal.org/2014/01/30/chapter-4-population-change-in-the-u-s-and-the-world-from-1950-to-2050/The World Bank

http://data.worldbank.org/indicator/SP.POP.65UP.TO.ZS/countries/1W?display=map

Population older than 65 years old (% of total)

Japan 26%

USA 14%

Italy 22%Germany, Greece 21%Portugal, Sweden 20%Austria 19%Netherlands, Spain 18%

Canada16%

Prison Inmates

Nursing Homes


21

Suicide Risk Factors

US Department of Justicehttp://www.bjs.gov/content/pub/pdf/mljsp0011.pdf

• deaths in prisons accounted for 80% of all deaths in local jails and state prisons

• Suicide rate in prison: 41 deaths per 100,000

• Risk Factors*• Depression, Hopelessness, Anxiety,

Antisocial Personality, Substance Abuse

Prison Inmates

Nursing Homes


*Daniel, A.E. (2006). Preventing Suicide in Prison: A Collaborative Responsibility of Administrative, Custodial, and Clinical Staff. Journal of the American Academy and Psychiatry and the Law Online. (http://www.jaapl.org/content/34/2/165.full)

22

Market Size ■ Over 1 in 3 State prisoners, 1 in 4 Federal prisoners, and 1 in 6 jail inmates who had a mental health problem had received treatment since admission.

- Bureau of Justice Statistics (http://www.bjs.gov/)- Glaze, L.E., James, D.J. (2006) Mental Health Problems Of Prison And Jail Inmates, Bureau of Justice Statistics (http://www.bjs.gov/index.cfm?ty=pbdetail&iid=789

Prison Inmates

Nursing Homes


600,000

People

1/3 of State

Prisoner (423,600)

¼ of Federal Prisoner (53,750) 1/6 of

Local Jail (121,867)

(rounded from 599,217 people)

23

Suicide Risk Factors■ Almost 25% of nearly 5,500 active-duty,

non-deployed Army soldiers surveyed tested positive for a mental disorder of some kind, and 11% within that subgroup also tested positive for more than one illness. *

■ Most suicides occurred back home, not in Afghanistan or Iraq, and the rate has increased among troops who have never been deployed overseas

Prison Inmates

Nursing Homes


*Willingham, V. (2014, March 4). Study: Rates of many mental disorders much higher in soldiers than in civilians. CNN. Retrieved from http://www.cnn.com/2014/03/03/health/jama-military-mental-health/

http://www.cnn.com/2014/03/03/health/jama-military-mental-health/)



24

Market SizePrison

InmatesNursing Homes


Recruiting Training Job Assignment

Military Recruitment: 119,281 per year* High Suicidal Risk Population:

**Total active personnel 1,301,300 * 14% = 182,182• about 14% of soldiers had thought

about taking their lives, while 5.3% had planned a suicide and 2.4% had actually made one or more attempts. ***

*http://www.defense.gov/News/News-Releases/News-Release-View/Article/605268/dod-announces-recruiting-and-retention-numbers-for-fiscal-2014**https://en.wikipedia.org/wiki/United_States_Armed_Forces***http://www.defense.gov/News/News-Releases/News-Release-View/Article/605335

Total: 301,473 People per year

Recruitment in 2014• Army 57,101 people• Navy 33,765 people• Marine Coprs 26,018 people• Air Force 24,070 people

25

Suicide Risk Factor■ Although military members comprise less than 1 percent of

the U.S. population, veterans represent 20 percent of suicides nationally. Each day, about 22 veterans die from suicide.

US Department of Veteran Affairs. Retrieved from http://www.publichealth.va.gov/epidemiology/studies/suicide-risk-death-risk-recent-veterans.asp

Prison Inmates

Nursing Homes


26

Market Size■ According to the Centers for Disease

Control and Prevention, an estimated 30,000 to 32,000 lives are lost to suicide each year in the United States.

■ About 20 percent of those who successfully complete the act of suicide are Veterans.

■ Among the deaths from suicide, approximately half had a diagnosis of a mental health condition recorded in their medical records in the year prior to their deaths, and approximately three fourths, within the past five years.

Prison Inmates

Nursing Homes


General Suicide Population (31,000)

20% is Veteran (6,200)

75% Mental Health

Problem (4,650)

Market Size of Veteran:4,650 people per year

Mental Illness Facts and Numbers. National Alliance on Mental Illness Retrieved from http://www2.nami.org/factsheets/mentalillness_factsheet.pdf

27

Market Growth

Year 201621,368,156

Year 204314,539,505

Year 203017,421,211

• Veteran population is declining by 2.4% per year

Prison Inmates

Nursing Homes


28

Current Market Size

Prison Inmates

Nursing Homes


Market Size yearTargeted Market Market Size (in

people)Nursing Homes 36,000,000Prison Inmates 600,000Military Soldiers 300,000Veterans 4,650Total Market Size 36,904,650

Factor:• Nursing Homes

Grow with aging population at 1.4%

• Prison InmatesDecrease at 0.98%*

• VeteransDecrease at 2.4%

42,388,538 people in 2021

*Bureau of Justice Statistics, Prisoners under the jurisdiction of state or federal correctional authorities, December 31, 1978-2014, Retrieved from http://www.bjs.gov/index.cfm?ty=nps

http://www.bjs.gov/index.cfm?ty=nps

http://www.bjs.gov/index.cfm?ty=nps

29

OPPORTUNITIES & OBSTACLES

30

Ethical & Other Issues ■ When is it good not to know?■ When is it better to know?■ Moral/Ethical not just Scientific/Medical■ Consent & counseling needed for the test Providing tests to people in fragile mental

states can have legal issues How to consent a person suspect of

suicidal thoughts?■ Providing the test results – will it

guarantee the outcome – self fulfilling prophecy?

■ Close to 100% accuracy needed for widespread use

■ Can effect disability insurance■ Can effect payouts for life –

insurance■ Stigma placed on your life■ Society needs to decide/discover

which genetic testing are helpful vs. harmful for society

Genetic Testing needs to be closely regulated and monitored

Need buy in from medical community – need to first demonstrate effective use


Howard, P., Pasalodos-Sanchez, S., & Scotting, P. (2013). Implications and impact of genetic testing. Cancer Nursing Practice, 12(9), 25-30 6p.

Lázaro-Muñoz, G. (2014). The Fiduciary Relationship Model for Managing Clinical Genomic 'Incidental' Findings. Journal Of Law, Medicine & Ethics, 42(4), 576-589 14p. doi:10.1111/jlme.12177

Rothstein, M. A., Roberts, J., & Guidotti, T. L. (2015). LIMITING OCCUPATIONAL MEDICAL EVALUATIONS UNDER THE AMERICANS WITH DISABILITIES ACT AND THE GENETIC INFORMATION NONDISCRIMINATION ACT. American Journal Of Law & Medicine, 41(4), 523-567. doi:10.1177/0098858815622190

31

OPPORTUNITIES & OBSTACLESNURSING HOMES

PRISON INMATES

MILITARY VETERAN’S ASSOCIATION

OPPORTUNITIES

• Growing Population

• Many have granted decision making granted to others

• End of Life Care – no long term ethical issues

• Largest Market Size

• Many face Dementia or Alzheimer's

• 1 in 85 people may have Alzheimer’s by 2050

• Rights already striped – less ethical issues

• Help in rehabilitation of criminals & ultimately with reentering society

• Reduce financial drains on government

• 2nd Largest Market Size

• $$ to spend• Mandatory

testing already required

• Individual rights already signed over

• Need to ensure safety of all parties

• Large Market Size

• Limited Resources – need assistance in assessing most at risk patients

• Can assist in helping those at risk/in need, and thus reduce potential homelessness and job loss

• Having bad PR Williams, J., Skirton, H., & Masny, A. (2006). Ethics, policy, and educational issues in genetic testing. Journal Of Nursing Scholarship, 38(2), 119-125 7p. doi:10.1111/j.1547-5069.2006.00088.xPortacolone, E., Berridge, C., K. Johnson, J., & Schicktanz, S. (2014). Time to reinvent the science of dementia: the need for care and social integration. Aging & Mental Health, 18(3), 269-275 7p. doi:10.

1080/13607863.2013.837149Monette, M. (2012). Senior suicide: An overlooked problem. CMAJ, 184(17), E885-E886. Retrieved October 22, 2012, from http://www.cmaj.ca.proxy1.library.jhu.edu/content/184/17/E885.full.pdf htmlhttp://www.va.gov/homeless/for_at_risk_veterans.asphttp://abc7chicago.com/news/with-22-suicides-per-day-va-hit-with-scathing-evaluation-/777211/

http://www.va.gov/homeless/for_at_risk_veterans.asp

http://www.va.gov/homeless/for_at_risk_veterans.asp

32Williams, J., Skirton, H., & Masny, A. (2006). Ethics, policy, and educational issues in genetic testing. Journal Of Nursing Scholarship, 38(2), 119-125 7p. doi:10.1111/j.1547-5069.2006.00088.x

NURSING HOMES

PRISON INMATES

MILITARY VETERAN’S ASSOCIATION

OBSTACLES • Difficult to identify those who need to be tested - family not always with them, not as likely to voice mental state

• Medical diseases such as Alzheimer’s can cause erratic thoughts, and not consistent behaviors

• Knowing risk can cause detrimental effects on psyche of patient who may have not been suicidal

• Treated differently by other prisoners - stigma

• Environmental factors negate the benefit of the test

• Difficult to enter this market

• Red tape to get to right people to institute policy changes

• High competition

• Predisposed to PTSD stigmatization, now will have potential suicide risk stigma as well

• Population Declining

• Small Market Size comparably


33

PRICING STRATEGY

34

Pricing Strategy ■ The cost of genetic testing can range from under $100 to more than $2,000,

depending on the nature and complexity of the test.■ Benchmark■ Genetic Diagnostic Test■ 23andme $199 (wait for 12 weeks, analyze 60 disease)■ DNA paternity test $79 (wait for 3-5 days) • Blood Test Cost*** $432 *For a full specialized blood test, costs average■ Psychiatry Consultation• Psychologists $125• Therapists

Small Cities $75 - $150 Large Cities $200 - $300

Resource: Blood Test Cost. Cost Helper Health. Retrieved from http://health.costhelper.com/blood-test.html

35

Pricing Strategy

■ Cost: $15- $30■ Added value: High accuracy rate, less human labor, proceed multiple

test at one time (psychiatrist: 1 patient per hour- cost $200-300 / Genetic test: 20 tests in 1 hour)

■ Added monetary value: $4,750 ($250*19)■ Benchmark on general genetic test $200

■ Suggested Price: $250

36

Epigenetic Kit PricingProduct Discription Price

Acetylation and Decacetylation Assays

EPI001 Histone Acetyltransferase (HAT) Activity Assay Kit 100 assays in 96 well plates $397

CS1010 Histone Deacetylase Assay Kit, Fluorometric sufficient for 100 assays (96 well plates) $542

EPI004 Histone Deacetylase 3 (HDAC3) Activity Assay Kit 100 assays in 96 well plates $376

EPI005 Histone Deacetylase 3 (HDAC3) Inhibitor Screening Kit 100 assays in 96 well plates $478

EPI006 Histone Deacetylase 8 (HDAC8) Activity Assay Kit 100 assays in 96 well plates $376

EPI007 Histone Deacetylase 8 (HDAC8) Inhibitor Screening Kit 100 assays in 96 well plates $478

EPI003 In Situ Histone Deacetylase (HDAC) Activity Fluorometric Assay Kit 100 assays in 96 well plates $355

CS1040 SIRT1 Assay Kit sufficient for 100 assays $520

EPI010 Sirtuin 2 (SIRT2) Inhibitor Screening Assay Kit 100 assays in 96 well plates $478

37

Epigenetic Kit PricingProduct Discription Price

DNA Methylation AnalysisMOD50 Imprint® DNA Modification Kit For bisulfite DNA conversion & purification $214

MDQ1 Imprint® Methylated DNA Quantification Kit To measure global DNA methylation shifts from as low as 10 ng DNA $783

Select Immunoprecipation Kits for Epigenetics

CHP1 Imprint® Chromatin Immunoprecipitation Kit Complete ChIP reaction in 6 hours in flexible strip well format $791

RIPImprint® RNA Immunoprecipitation Kit High-capacity Protein A magnetic beads for successful RNA Immunoprecipitation, $483

CHP2Imprint® Ultra Chromatin Immunoprecipitation Kit Complete ChIP kit for sensitivity, compatibility with Next-Gen sequencing $458

CHP2NCImprint® Ultra Chromatin Immunoprecipitation Kit, Without Controls ChIP kit for maximum sensitivity, compatible with Next-Gen sequencing $631

CHROP Imprint® Ultra Chromatin Optimization Kit Kit designed to optimize sonication parameters for ChIP experiments $235

38

BUSINESS MODEL AND VALUATION

39

Company

Product

Project

Business Stages

Project Created with a specific purpose in mind, custom solution, not developed

Product Can develop it but sustaining the business is problematic due to infrastructure needs, build to sell

Company A sustainable business with IPO potential

40

Characteristics of product

Product[Suicide

biomarker]Opportunities

[Several market segmentations

but not no many]

Monetary[Medium]

Competitive Advantage

[Strong with no competitors]

Value Creation[Of interest but not so

significant]

41

Business Models Options

LicensingStartupJoint Venture

Licensing Rent or sell the IP to other companies;

Startup Establish a company by oneself;

Joint VentureTwo company integrate into one firm sharing capitals, technologies, networks

42

Business model----Licensing■ License the IP to other companies■ Combine the competitive advantages together ■ Technology + Channels ■ Potential Licensees: “The Licensing Agency”-----who gets legal permission and authority to

selling products made by licensors e.g. The Beanstalk Group (US Army)■ Terms of licensing: Payment---Guaranteed minimum payment & Royalties on sales(10%) Length of contract---10 years Renewal options------According to sales and market situation Termination conditions----Violation of contracts Control of patents, trademark------Licensor

43

Business Model---Startup■ Forming a startup company■ Which probably would be acquired by big players■ Revenue Model

■ Expense Model

Marketing [e.g. Advertising,

Education.]

Unit-based[unit

price=$250]

Revenue Streams(multiple stream)

[Market Sizing=42,388,538*250$10.6billion ]

44

Valuation – Licensing our product ■Valuation: value of equity interests Fully diluted: include all shares that could be issued,

but not all authorized

• Pre-money: value of equity before financing fully diluted shares x price per share

• Post-money: value of equity after financing The company’s value is expected to be $10,000M

■Post-money– Pre-money = amount raised

45

■Early stage investors are looking for rapid growth– We have a 10x growth pattern as our TAM (Target Addressable Market) is 30

million users for the first year.

■Valuation is responsive to milestone achievement– Prototype completion – Done– Product launch – 1st year– First 20M users – Year 1– Second 20M users –Year 2

■Budget past milestones for runway to raise next round■ We have a 5 year plan to enter the four markets identified with a total

user base of 40M users.

46

■ Where and when is the exit?

■ After 10 years of completion of license, we put our product for sale to a pharmaceutical company.

■ How much can this company sell for? Based on 5 years Plan

■ Based on the market size of 40M X $ 250 = $10,000 M

■ How much total money will it take to grow the company to the point that someone will buy it for?

■ $10,000 M

■ What percentage will the investor need to get the return (ROI) desired?

■ Cost to make the company

■ Desired IRR? (Internal Rate of Return) >25% (per annum)

47

Exit Strategy

■ Patent Expiration in 20 years – 2036 year■ We sell the company to a pharmaceutical giant after 10 years for $30

million (based on the revenue model)

48

EXECUTIVE SUMMARY

49

Recommendation

Market Segment

Business Model

Value Propositi

onValuatio

n

4 target market:• Nursing Home (1)• Prison Inmates (2)• Military Soldiers (3)• Veterans (3)


Competitive Advantage: • Novel – IP

advantage• High accuracy –

80%• Fulfill strong need

in market



50

THANK YOUDiscover to Market ProjectSuicide Diagnostic TechnologyWendy, Talal, Shari, Eric, Rajat

51

AppendixSpecial thanks to interviewees• Daniel Francis Ruthven, MD. (Clinical associate of

psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine)

• Hilary Wolkolff (Clinical Social Worker)• Gregory C. Reuss (Veteran of Marine Corps)• Jason Copeland (Recruiting Commander of Marine Corps)• Wayne Huang (Veteran of Army)• Stephen Lester (Army)• Charles Douglas Ferreira (Veteran of Marine Corps)• Chin-Lun Fang (Social Worker, Veteran of Army)• Jie Wang (Nursing home worker)• Kerry Wasser (Psychiatrist) • Amy Calmann (Psychotherapist)• Arnold Calmann (Lawyer) • Kasshif Alam (Insurance Industry)• Partner & Head of VA Hospital ER - wants to remain

anonymous

Documents

Sample Work in Health Care