hatchconf conception
DESCRIPTION
TRANSCRIPT
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.
“Conception”
HatchConf
September 25, 2012
1
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.
“Everything that can be invented has been
invented”.
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.
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 comply with all terms and conditions of our non-disclosure agreement.
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.
4
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.
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.
6
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).
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.
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.
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 comply with all terms and conditions of our non-disclosure agreement.
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.
8
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.
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.
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 comply with all terms and conditions of our non-disclosure agreement.
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.
10
“
”
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.
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.
11
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
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.
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.
12
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
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.
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.
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 comply with all terms and conditions of our non-disclosure agreement.
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.
14
Payors
Policy
Makers
Advocates
Healthcare
Professionals
Hospital &
Health Systems
Patients
Science
Community
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.
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.
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 comply with all terms and conditions of our non-disclosure agreement.
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.
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
“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
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.
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.
17
17
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
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.
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.
18
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.
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.
19
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
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.
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.
20
“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
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.
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.
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
21
Research Partner Description Completion Date
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.
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.
22
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
Small market player.
Limited gene panel
which provides
pharmacokinetic
includes on drug
metabolism
Small market player.
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
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.
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.
23
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
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.
24
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