1. âConceptionâ
HatchConf
September 25, 2012
This information is confidential and proprietary to Genomind, LLC and is
provided to recipient with the understanding the recipient will observe and 1
comply with all terms and conditions of our non-disclosure agreement.
2. âEverything that can be invented has been
inventedâ.
attributed to Charles H. Duell,
Commissioner, U.S. patent office, 1899, in
letter to President McKinley.
This information is confidential and proprietary to Genomind, LLC and is
provided to recipient with the understanding the recipient will observe and
comply with all terms and conditions of our non-disclosure agreement.
3. This information is confidential and proprietary to Genomind, LLC and is
provided to recipient with the understanding the recipient will observe and 3
comply with all terms and conditions of our non-disclosure agreement.
4. This information is confidential and proprietary to Genomind, LLC and is
provided to recipient with the understanding the recipient will observe and 4
comply with all terms and conditions of our non-disclosure agreement.
5.
6. By 2030, depression is projected to be the #1 leading cause of overall
disease burden in high-income countries â 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 : âPractice-Based Interventions Addressing Concomitant Depression and Chronic Medical Conditions in the
Primary Care Setting,â August 13, 2012, US Agency for Healthcare Research and Quality (ARHQ).
This information is confidential and proprietary to Genomind, LLC and is
provided to recipient with the understanding the recipient will observe and 6
comply with all terms and conditions of our non-disclosure agreement.
7. Treatment Resistance in Psychiatry
Depressive symptoms (QIDS-SR score) after up to 12 wks antidepressant treatment
This information is confidential and proprietary to Genomind, LLC and is
provided to recipient with the understanding the recipient will observe and 7
comply with all terms and conditions of our non-disclosure agreement.
8. TRD increases the cost of care â and represents a significant opportunity for
Genomind to help payers manage their costs
Direct Medical Costs Per Patient With Depression by MGH-AD Score (N = 78,477)
Outpatient, non-mental health Outpatient, mental health
Pharmacy, non-mental health Pharmacy, mental health
Inpatient, non-mental health Inpatient, mental health
Emergency department, non-mental health Emergency department, mental health
14,000
Annual Expenditures Per Patient, $
12,000
10,000
8000
6000
4000
2000
0
0 1 2 3 4 5 6 7 8+
MGH-AD Score
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.
This information is confidential and proprietary to Genomind, LLC and is
provided to recipient with the understanding the recipient will observe and 8
comply with all terms and conditions of our non-disclosure agreement.
9. 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
This information is confidential and proprietary to Genomind, LLC and is
provided to recipient with the understanding the recipient will observe and 9
comply with all terms and conditions of our non-disclosure agreement.
10. â
â
This information is confidential and proprietary to Genomind, LLC and is
provided to recipient with the understanding the recipient will observe and 10
comply with all terms and conditions of our non-disclosure agreement.
11. Genomind Overview
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
This information is confidential and proprietary to Genomind, LLC and is
provided to recipient with the understanding the recipient will observe and 11
comply with all terms and conditions of our non-disclosure agreement.
12. Scientific Advisory Board, International Thought Leaders
Scott T. Aaronson, MD Associate Medical Director at the Retreat at Sheppard Pratt, a premiere, self-funded psychiatric
Sheppard Pratt, University of Maryland
School of Medicine setting, and specialist for treatment resistant disorders.
P. Murali Doraiswamy, MD Globally recognized researcher focused on intervention and treatment for Alzheimerâs and other
Duke University Medical Center memory disorders.
Maurizio Fava, MD Regarded as one of the foremost psychopharmacologists in the world and a leading expert on the
Massachusetts General Hospital, Harvard
Medical School role of medical foods in psychiatry.
Allan I. Levey, MD, PhD Member of the prestigious National Alzheimer's Coordinating Center. The Institute for Scientific
Chairman of Department of Neurology,
Emory University Information identified him as one of the most highly cited scientific researchers worldwide.
Anil Malhotra, MD
Regarded as one of the worldâs leading authorities on the genetics of schizophrenia and
Zucker Hillside Hospital, Albert Einstein
College of Medicine response to treatment. Primary area is genetics of the dopamine receptor.
Roy H. Perlis, MD, MSc Heads international consortium to study genetics of antidepressant response, identified first
Massachusetts General Hospital, Harvard
Medical School genetic association with treatment resistance in major depression.
Stephen M. Stahl, MD, PhD Founder of the Neuroscience Education Institute, the leader in neuroscience education.
University of CA, San Diego
Rudolph E. Tanzi, PhD Research investigating the genetic causes of Alzheimer's, including discovery of 3 genes causing
Mass General Institute for
Neurodegenerative Disease early-onset familial AD
This information is confidential and proprietary to Genomind, LLC and is
provided to recipient with the understanding the recipient will observe and 12
comply with all terms and conditions of our non-disclosure agreement.
13. 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
This information is confidential and proprietary to Genomind, LLC and is
provided to recipient with the understanding the recipient will observe and 13
comply with all terms and conditions of our non-disclosure agreement.
14. Payors
Patients
Policy Hospital &
Makers Health Systems
Healthcare
Science Professionals
Community
Advocates
This information is confidential and proprietary to Genomind, LLC and is
provided to recipient with the understanding the recipient will observe and 14
comply with all terms and conditions of our non-disclosure agreement.
15. 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
This information is confidential and proprietary to Genomind, LLC and is
provided to recipient with the understanding the recipient will observe and 15
comply with all terms and conditions of our non-disclosure agreement.
16. 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
âTranslational genomicsâ â 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
This information is confidential and proprietary to Genomind, LLC and is
provided to recipient with the understanding the recipient will observe and 16
comply with all terms and conditions of our non-disclosure agreement.
17. 1 Patients provide 1ml of saliva into a plastic
specimen kit manufactured by our partner
DNA Genotek
2 A shipping packet, barcode & instructions are
provided so the patient sample can be sent
securely & analyzed by our CLIA-certified lab
3 The lab performs our proprietary panel of
genetic tests focusing on neurotransmitter and
metabolism pathways
4 A patent pending algorithm results in an on-
line analytical report delivered to a clinician
within 3-5 days to inform treatment decisions
5 Genomind certified physicians and PharmDs
are available to discuss results with treating
clinicians via telephonic consult
The results of the test, combined with the expertise of a
17
psychopharmacologist, will help to achieve better responses to treatment
This information is confidential and proprietary to Genomind, LLC and is
provided to recipient with the understanding the recipient will observe and 17
comply with all terms and conditions of our non-disclosure agreement.
18. This information is confidential and proprietary to Genomind, LLC and is
provided to recipient with the understanding the recipient will observe and 18
comply with all terms and conditions of our non-disclosure agreement.
19. Builds brand loyalty and trust
Offers hands-on âvelvet gloveâ 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 Step 5
Can be leveraged for the clinicianâs family
consultations and program discharge
planning
This information is confidential and proprietary to Genomind, LLC and is
provided to recipient with the understanding the recipient will observe and 19
comply with all terms and conditions of our non-disclosure agreement.
20. âDirect to Clinicianâ 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
âInstitutionalâ opportunities
Target innovative and progressive hospitals, health care organizations, and
behavioral health clinics that share Genomindâs 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
This information is confidential and proprietary to Genomind, LLC and is
provided to recipient with the understanding the recipient will observe and 20
comply with all terms and conditions of our non-disclosure agreement.
21. Research Partner Description Completion Date
Cost effectiveness and compliance study of Genomind Fall 2012
patients. Target N = 1,000
(first 550 patients)
âReal worldâ study of clinicians and patients utilizing December 2012
the Genecept Assay, with online recruiting and
assessment tools. Target N = 1,000 (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 Summer 2013
Nationâs largest community-based mental health
services provider
Inpatient setting comparing assay-guided treatment
(AGT) using the Genecept Assay with treatment as Fall 2013
usual (TAU)
This information is confidential and proprietary to Genomind, LLC and is
provided to recipient with the understanding the recipient will observe and 21
comply with all terms and conditions of our non-disclosure agreement.
22. Genomind AssureRx Genelex Genomas SureGene
Product
Genecept GeneSiteRx GeneMedRx PIMS Phyzio Type SULT4A1-1
System
Description Growth company Growth company Small market player. Small market player. Small market player.
market player. market player.
Extensive gene Limited gene assay Limited gene assay Limited gene panel Limited gene panel
assay providing providing linking SSRI which provides linking SSRI
pharmacokinetic, pharmacokinetic response affected by pharmacokinetic response to
pharamdynamic and insights on SSRI the serotonin includes on drug schizophrenia only
brain nutrient drug metabolism transporter only metabolism
insights on drug and
non-drug therapies
Business Multiple revenue Single revenue Single revenue Single revenue Single revenue
streams stream stream stream stream
Strategy
Development of CNS Continued No clear business No clear business Diagnostic
companion development of CNS strategy strategy â Company expansion into TRD
diagnostics including diagnostics only for sale
medical food
development and
robust bioinformatics
capabilities
Operational
Strong Strong Weak Weak Weak
Strength
This information is confidential and proprietary to Genomind, LLC and is
provided to recipient with the understanding the recipient will observe and 22
comply with all terms and conditions of our non-disclosure agreement.
23. Enhanced Diagnostics for Enhanced Therapeutics
Psychiatric conditions, Autism Mild cognitive impairment
including: depression, (MCI), pre-dementia,
Diagnosis/ anxiety, bipolar, OCD, Alzheimerâs
Condition ADHD,schizophrenia, chronic
pain
Biomarker informs treatment Biomarker offers solution for Biomarker offers opportunity
Value decisions, avoids trial and early intervention for early intervention
error
Proposition
GeneceptTM Assay Genecept Plus Assay
Diagnostics & Genecept PlusTM Assay GenvitaTM Assay GenlightenTM Assay
Medical
Foods/Drugs
Drugs, L-methylfolate, Drugs, Natural-613 Drugs, Medical Foods,
CERAVANCE⢠Natural-770
Market
Size $20 B $7 B
$8 B
(2015)
$81 B CNS Therapeutic Market thetorecipient will LLC and and
This information is confidential and proprietary Genomind,
provided to recipient with the understanding observe
is
23
comply with all terms and conditions of our non-disclosure agreement.
24. Identify the problem you want to solve
Conceptualize your business vision â and your first step product/service
Write it down !
Find core resources to start â experts and advisors, âwho will do the workâ,
$$$
How will you make $$ ? Customers ? Sales ? Margins ?
Name your company
Develop your 5-minute valprop â try it out on many
Look hard (glass half empty) for competition !
What is your âESQâ (Entrepreneurial Stomach Quotient) to launch a
business ?
Get started â the âwindshield surveyâ vs âdata miningâ approach
Do It â Donât Just Think It
This information is confidential and proprietary to Genomind, LLC and is
provided to recipient with the understanding the recipient will observe and 24
comply with all terms and conditions of our non-disclosure agreement.