HatchConf Conception

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“Conception”

HatchConf

September 25, 2012

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“Everything that can be invented has been

invented”.

attributed to Charles H. Duell,

Commissioner, U.S. patent office, 1899, in

letter to President McKinley.



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By 2030, depression is projected to be the #1 leading cause of overall

disease burden in high-income countries – and #3 worldwide

Half of all Americans live with a chronic medical condition; those commonly

associated with depression include arthritis, heart disease, diabetes,

asthma, lung disease, and cancer

Depression among people with chronic physical illness has been linked to

an increase in the use of health care services, disability, and work

absenteeism when compared to those without depression

Source : “Practice-Based Interventions Addressing Concomitant Depression and Chronic Medical Conditions in the

Primary Care Setting,” August 13, 2012, US Agency for Healthcare Research and Quality (ARHQ).



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Treatment Resistance in Psychiatry

Depressive symptoms (QIDS-SR score) after up to 12 wks antidepressant treatment


An

nu

al E

xp

en

dit

ure

s P

er

Pati

en

t, $

Outpatient, non-mental health

Pharmacy, non-mental health

Inpatient, non-mental health

Emergency department, non-mental health

Outpatient, mental health

Pharmacy, mental health

Inpatient, mental health

Emergency department, mental health

14,000

12,000

10,000

8000

6000

4000

2000

0

0 1 2 3 4 5 6 7 8+

MGH-AD Score

Direct Medical Costs Per Patient With Depression by MGH-AD Score (N = 78,477)

TRD increases the cost of care – and represents a significant opportunity for

Genomind to help payers manage their costs

Source - Cost Burden of Treatment Resistance in Patients With Depression, The American Journal of Managed Care, May-2010

MGH-AD indicates the Massachusetts General Hospital treatment-resistant depression staging method, antidepressant-only version.

(a) The pharmacy cost category represents outpatient pharmacy costs for medications delivered via retail and mail order distribution.

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Psychiatric diagnosis is often purely symptomatic

Psychiatric disorders are treated primarily based upon a trial-and-error

process

However, using genetic data to prescribe psychotropic medications has a

significant body of peer-reviewed studies/literature and is ready for use in the

clinic

Strong and growing interest from clinicians in using genetic information for

prescribing

Strong and growing interest from consumers and advocates in using genetic

data to reduce the stigma of mental illness



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“

”



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Founded in 2009 to improve diagnostics and therapeutics in neuropsychiatry

Co-founders: Dr. Ronald Dozoretz and Dr. Jay Lombard

Developed and commercialized the Genecept™ Assay

Introducing the Genecept Plus™ Assay in Fall 2012 to add biomarkers for

medical foods in psychiatry

Developing genetically based biomarker tests for MCI and dementia risk

Validating additional biomarkers for autism and schizophrenia

Investigating proteomics and other biomarkers for psychiatry

Opportunity to develop new medical foods and 505(b)(2) pharmaceuticals for

mental health

Genomind Overview



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Scientific Advisory Board, International Thought Leaders

Scott T. Aaronson, MD

Sheppard Pratt, University of Maryland

School of Medicine

Associate Medical Director at the Retreat at Sheppard Pratt, a premiere, self-funded psychiatric

setting, and specialist for treatment resistant disorders.

P. Murali Doraiswamy, MD

Duke University Medical Center

Globally recognized researcher focused on intervention and treatment for Alzheimer’s and other

memory disorders.

Maurizio Fava, MD

Massachusetts General Hospital, Harvard

Medical School

Regarded as one of the foremost psychopharmacologists in the world and a leading expert on the

role of medical foods in psychiatry.

Allan I. Levey, MD, PhD

Chairman of Department of Neurology,

Emory University

Member of the prestigious National Alzheimer's Coordinating Center. The Institute for Scientific

Information identified him as one of the most highly cited scientific researchers worldwide.

Anil Malhotra, MD

Zucker Hillside Hospital, Albert Einstein

College of Medicine

Regarded as one of the world’s leading authorities on the genetics of schizophrenia and

response to treatment. Primary area is genetics of the dopamine receptor.

Roy H. Perlis, MD, MSc

Massachusetts General Hospital, Harvard

Medical School

Heads international consortium to study genetics of antidepressant response, identified first

genetic association with treatment resistance in major depression.

Stephen M. Stahl, MD, PhD

University of CA, San Diego Founder of the Neuroscience Education Institute, the leader in neuroscience education.

Rudolph E. Tanzi, PhD

Mass General Institute for

Neurodegenerative Disease

Research investigating the genetic causes of Alzheimer's, including discovery of 3 genes causing

early-onset familial AD



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Genomind has demonstrated the ability to develop and deliver products and

services into mainstream neuropsychiatry:

Neuroscience Education Institute The Leader in Learning TM

Founded By SAB member Stephen M Stahl MD



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Payors

Policy

Makers

Advocates

Healthcare

Professionals

Hospital &

Health Systems

Patients

Science

Community



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Culture and mission focused on improving the lives of people with mental health conditions

Product development and bioinformatics expertise in diagnostics, medical foods, and CNS

therapeutic interventions

Extensive intellectual property - 12 patents pending

Deep relationships with healthcare leaders and institutions, including insurers/managed care,

health and hospital systems, and consumers/advocates

Strong track record in building and growing new companies and in leveraging innovation

Expertise with direct sales to clinicians, digital marketing and sales, and social media

Fulfillment and supply chain management expertise in a HIPAA- and GINA-compliant manner

Reimbursement and claims management experience

Regulatory and technology expertise

Execution on all fronts is a significant barrier to entry for potential competitors



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Patent-pending Genecept Assay, the first product from Genomind:

Gene-based assay informs treatment decisions for patients with mental

health conditions, such as depression, anxiety, bipolar disorder,

schizophrenia, ADHD, and chronic pain

Neurotransmitter based genes, including serotonin, dopamine, and

glutamate

Pharmacokinetic genes related to drug and nutritional metabolism

“Translational genomics” – genes relevant to psychotropic prescribing

Clinician consultation is a significant element of the product and

differentiates it from a stand alone lab test

Unique automated report implements proprietary algorithms for

integrating data



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4

Patients provide 1ml of saliva into a plastic

specimen kit manufactured by our partner

DNA Genotek

A shipping packet, barcode & instructions are

provided so the patient sample can be sent

securely & analyzed by our CLIA-certified lab

The lab performs our proprietary panel of

genetic tests focusing on neurotransmitter and

metabolism pathways

A patent pending algorithm results in an on-

line analytical report delivered to a clinician

within 3-5 days to inform treatment decisions

Genomind certified physicians and PharmDs

are available to discuss results with treating

clinicians via telephonic consult

1

2

3

5

The results of the test, combined with the expertise of a

psychopharmacologist, will help to achieve better responses to treatment



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Builds brand loyalty and trust

Offers hands-on “velvet glove” approach to

clinician engagement

Educates clinicians and increases

likelihood of continued, sustainable use of

the tests

Upholds regulatory guidance and address

concerns about knowledge of users

Provides proprietary information to extend

the value of CME education through third

parties

Can be leveraged for the clinician’s family

consultations and program discharge

planning

Step 5



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“Direct to Clinician” consultative sales strategy

Current customers - Retention and volume growth from current clinician/early

adopter base through account management, strengthening clinical relationships,

and education

New customers - Target potential new clinicians and rapid conversion to consistent

referring clinicians using consultative sales approach, referrals from current users,

and clinician engagement with scientific team

“Institutional” opportunities

Target innovative and progressive hospitals, health care organizations, and

behavioral health clinics that share Genomind’s commitment to advancing the

standard of care and improving patient outcomes

The Menninger Clinic, ranked #1 nationally for adult psychiatric care, using the

Genecept Assay in their Comprehensive Assessment/Stabilization Program

Channel Partners leverage reach into relevant market segments

Closing one national managed care company commercial pilot; others in process

Extensive use of marketing, digital media, and PR to support sales



Cost effectiveness and compliance study of Genomind

patients. Target N = 1,000 Fall 2012

(first 550 patients)

“Real world” study of clinicians and patients utilizing

the Genecept Assay, with online recruiting and

assessment tools. Target N = 1,000

December 2012

(first 100 patients)

Outpatient setting for national mental health and

wellness company. Spring 2013

Outpatient setting for national commercial insurer Summer 2013

Real world study of 50 patients with treatment resistant

depression Summer 2013

Outpatient setting comparing AGT and TAU

Includes Medicaid (TennCare) patients served by

Amerigroup and United

Nation’s largest community-based mental health

services provider

Summer 2013

Inpatient setting comparing assay-guided treatment

(AGT) using the Genecept Assay with treatment as

usual (TAU) Fall 2013

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Research Partner Description Completion Date



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Genomind AssureRx Genelex Genomas SureGene

Product

Genecept

GeneSiteRx

GeneMedRx

PIMS Phyzio Type

System

SULT4A1-1

Description Growth company

market player.

Extensive gene

assay providing

pharmacokinetic,

pharamdynamic and

brain nutrient

insights on drug and

non-drug therapies

Growth company

market player.

Limited gene assay

providing

pharmacokinetic

insights on SSRI

drug metabolism

Small market player.

Limited gene assay

linking SSRI

response affected by

the serotonin

transporter only


Limited gene panel

which provides

pharmacokinetic

includes on drug

metabolism


Limited gene panel

linking SSRI

response to

schizophrenia only

Business

Strategy

Multiple revenue

streams

Development of CNS

companion

diagnostics including

medical food

development and

robust bioinformatics

capabilities

Single revenue

stream

Continued

development of CNS

diagnostics only

Single revenue

stream

No clear business

strategy

Single revenue

stream

No clear business

strategy – Company

for sale

Single revenue

stream

Diagnostic

expansion into TRD

Operational

Strength

Strong

Strong

Weak

Weak

Weak



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Psychiatric conditions,

including: depression,

anxiety, bipolar, OCD,

ADHD,schizophrenia, chronic

pain

Autism Mild cognitive impairment

(MCI), pre-dementia,

Alzheimer’s

Biomarker informs treatment

decisions, avoids trial and

error

Biomarker offers solution for

early intervention

Biomarker offers opportunity

for early intervention

GeneceptTM Assay

Genecept PlusTM Assay

Drugs, L-methylfolate,

CERAVANCE™

GenvitaTM Assay

Drugs, Natural-613

Genecept Plus Assay

GenlightenTM Assay

Drugs, Medical Foods,

Natural-770

Enhanced Diagnostics for Enhanced Therapeutics

Diagnosis/

Condition

Value

Proposition

Diagnostics &

Medical

Foods/Drugs

$81 B CNS Therapeutic Market

Market

Size

(2015)

$20 B $7 B $8 B


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Identify the problem you want to solve

Conceptualize your business vision – and your first step product/service

Write it down !

Find core resources to start – experts and advisors, “who will do the work”,

$$$

How will you make $$ ? Customers ? Sales ? Margins ?

Name your company

Develop your 5-minute valprop – try it out on many

Look hard (glass half empty) for competition !

What is your “ESQ” (Entrepreneurial Stomach Quotient) to launch a

business ?

Get started – the “windshield survey” vs “data mining” approach

Do It – Don’t Just Think It

Date post:	17-Jan-2015
Category:	Health & Medicine
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HatchConf Conception

Health & Medicine