HatchConf Conception
1 like524 views
The document discusses Genomind, a company founded in 2009 to improve diagnostics and therapeutics in neuropsychiatry. It developed the Genecept Assay to use genetic data to prescribe psychotropic medications based on peer-reviewed research showing this approach can help reduce trial-and-error prescribing. Genomind is introducing an enhanced Genecept Plus Assay and investigating additional biomarkers for conditions like dementia and autism. It also has an international scientific advisory board of leading researchers in fields like genetics of treatment response and Alzheimer's disease.
HatchConf Conception
- 1. “Conception” 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. “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.
- 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.
- 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 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 – 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. “ ” 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 Alzheimer’s 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 world’s 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 “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 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 “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 Step 5 Can be leveraged for the clinician’s 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. “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 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) “Real world” 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 Nation’s 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 – 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, Alzheimer’s 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 – 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 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.