Infrastructure for Developing Pharmacogenomics
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1 13 May 2010 Infrastructure for Developing Pharmacogenomics Genotype-Guided Psychotropic Management at the Institute of Living Gualberto Ruaño, M.D., Ph.D. Director of Genetics Research, Hartford Hospital Professor Adjunct, University of Puerto Rico Medical Sciences
2 Institute of Living at Hartford Hospital Clinical and research achievements Founded in 1822 on principles of Moral Treatment Merged with Hartford Hospital in 1994 Ranked among the nation s Top 20 psychiatric hospitals by U.S. News & World Report for 3 rd consecutive year
3 Institute of Living at Hartford Hospital Clinical and research achievements The Olin Neuropsychiatry Research Center The Burlingame Center for Psychiatric Research and Education The Braceland Center for Mental Health and Aging The Anxiety Disorders Center The Laboratory of Personalized Health and Genetics Research Center Genomas Inc.
4 DNA-Guided Psychotropic Therapy Presentations at American Psychiatric Assoc. CYP Genotyping in Patients Treated for Depression 2007 Combinatorial CYP450 Genotyping for Depressed Inpatients 2008 Genotype-Guided Psychotropic Therapy APA Symposium: Mayo, IOL, Genomas 2009 Longer Hospitalization Associated with Combinatorial CYP450 Drug Metabolism Deficiencies 2010
5 PhyzioType System Configuration and Bioclinical Algorithms 3 Genes 6 Chr. Loci 34 Alleles PROPRIETARY Patent Pending 2D6 2C9 2C19 20 alleles 6 alleles 8 alleles Indices Metabolic Reserve Metabolic Alteration Allele Alteration Gene Alteration NULL Low Metabolic Reserve 0 Reserve, 1 Alteration DEFICIENT Med Metabolic Reserve 0.5 Reserve, 0.5 or 1 Alteration FUNCTIONAL High Metabolic Reserve 1 Reserve, 0 Alteration SUPRA Ultra Metabolic Reserve 1.5 Reserve, 0.5 or 1 Alteration P E R S O N A L I Z E D H E A L T H PHP P O R T A L
6 PhyzioType: Gene Loci Combinatorial Independent Segregation 2D6 2C9 2C19
7 PhyzioType System Configuration and Bioclinical Algorithms Double and Triple Gene Alterations 45% 2C19 2D6 2C9 2C19 2D6 None 2C9 No Gene Alterations 9% 2C19 N=577 LPH Patient Referrals Nov C9 2D6 2C9 2C19 2D6 Single Gene Alterations 46%
8 Drug Metabolism Reserve Psychiatric Patient Referrals to LPH (N=577) 8
9 Drug Metabolism Alteration Psychiatric Patient Referrals to LPH (N=577) 9
10 Allele and Gene Alteration Psychiatric Patient Referrals to LPH (N=577)
11 PhyzioType Reimbursement: Value : Psych Referrals vs. Cardiology Ruaño, Goethe et al, Personalized Medicine
12 # Patients PhyzioType Reimbursement: Value : Hospitalization Length of Stay Mean 6.3 SD 3.4 N Hospitalization Days
13 PhyzioType Reimbursement: Value : Hospitalization Length of Stay 13
14 PhyzioType Reimbursement: Value : LDL and Cardiometabolic Risk
15 LPH Laboratory of Personalized Health Pharmacogenetics Lab, Clinical Launchpad Pioneering high complexity pharmacogenetics laboratory + clinical practice Anchor for commercialization of PhyzioType Systems throughout New England and nationally Referral Center for Institute of Living + Mood Disorders Program CT-wide distribution and reimbursement agreement with Clinical Lab Partners Used by 92 Clinicians in Patients referred in PhyzioType tests in 2009 Reimbursement rate >95% LABORATORY OF PERSONALIZED HEALTH LPH Licensed by CT Dept of Public Health (#CL-0644) CLIA certified and registered (Clinical Laboratory Improvement Amendments) ID #07D CMS (Centers for Medicare and Medicaid) 3 successful biannual inspections (most recent March 2009) 53 patient service centers in CT Subsidiary of Hartford Hospital 15
16 PhyzioType System Continued Successful Clinical Adoption Cumulative Test Volume by Quarter 2008 Actual 2009 Actual 2010 Projected* Q1 is Actual Qtr 1 Qtr 2 Qtr 3 Qtr 4 0 Qtr 1 Qtr 2 Qtr 3 Qtr 4 0 Qtr 1 Qtr 2 Qtr 3 Qtr 4 Ordering Tests Patients Tests/ Tests Docs Ordered Tested Patient Doc 2008 Actual Actual Qtrs to March ' Projection
17 PhyzioType Clinical Applications Drug GPS for DNA-Guided Medicine P H Y Z I O T Y P E S Y S T E M S Empirical Therapy Monitor Response Drug Intolerance or Resistance Drug Intolerance or Resistance Diagnosis Diagnose innate metabolic cause of drug intolerance or resistance Enable doctor to precisely benchmark patient Rule out confounders (mental status, active or sedentary lifestyle, diet)
18 PhyzioType Clinical Applications Drug GPS for DNA-Guided Medicine P H Y Z I O T Y P E S Y S T E M S Select Therapy for High Risk Patient Monitor Response Improved Compliance Optimized Therapy Prescription according to innate capacity of response or risk of side effects IF RESPONSE IS HIGH AND RISK IS LOW: Prescribe w. safeguard IF RESPONSE IS LOW AND RISK IS HIGH: Consider alternative drugs Pre-treat side effect
19 URL: Login:
20 PhyzioType System DNA-Guided Psychotropic Management
21 NEUROLEPTICS: Generic (Brand) & Drug Selection
22 PhyzioType System: LPH1 Case Report and Clinical Management Utility Patient LPH1 is a 54-year Caucasian female with a history of anxiety and delusions who manifested: Intolerance, resistance to 18 psychotropic drugs over a 5-year period (akathisia, insomnia) *3 *1 DRUG Combinatorial Genotype 2D6 2C9 2C19 CYPARRAY BIO-CLINICAL METABOLISM HIGH Ruaño, Blair, Goethe et al, Connecticut Medicine 2007
23 PhyzioType System: LPH1 Case Report and Clinical Management Utility Patient LPH1 is a 54-year Caucasian female with a history of anxiety and delusions who manifested: Intolerance, resistance to 18 psychotropic drugs over a 5-year period (akathisia, insomnia) *3 *1 DRUG Combinatorial Genotype 2D6 2C9 2C19 *6 *6 *1 *3 *1 *2 CYPARRAY BIO-CLINICAL METABOLISM HIGH Ruaño, Blair, Goethe et al, Connecticut Medicine 2007
24 PhyzioType System: LPH1 Multi-gene drug metabolism deficiency 2D6 2C9 2C19 LPH1 *6 *6 *1 *3 *1 *2 Brother *4 *6 *2 *3 *1 *1
25 Percentage of Patients Number of Patients PhyzioType System: LPH1 Case Report and Clinical Management Utility Patient LPH1 is a 54-year Caucasian female with a history of anxiety and delusions who manifested: Intolerance, resistance to 18 psychotropic drugs over a 5-year period (akathisia, insomnia) *3 *1 DRUG Drug Metabolism Alteration CYPARRAY BIO-CLINICAL METABOLISM Combinatorial Genotype Population Prevalence Drug Metabolism Reserve Drug Sensitivity Syndrome HIGH Ruaño, Goethe et al, Connecticut Medicine 2007
26 PHP Personalized Health Portal Psychotropic Management: Patient LPH1 26
27 PhyzioType System: LC5 Case Report and Clinical Management Utility Patient LC5 is a 58-year Caucasian man with a history of depression who manifested: Intolerance and resistance to Lexapro, requiring compounding drug, 1/50 th standard dose, ~0.2 mg *3 *1 DRUG Combinatorial Genotype 2D6 2C9 2C19 CYPARRAY BIO-CLINICAL METABOLISM HIGH
28 PhyzioType System: LC5 Case Report and Clinical Management Utility Patient LC5 is a 58-year Caucasian man with a history of depression who manifested: Intolerance and resistance to Lexapro, requiring compounding drug, 1/50 th standard dose, ~0.2 mg *3 *1 DRUG Combinatorial Genotype 2D6 2C9 2C19 *1 *2a *1 *1 *2 *2 CYPARRAY BIO-CLINICAL METABOLISM HIGH
29 Percentage of Patients Number of Patients PhyzioType System: LC5 Case Report and Clinical Management Utility Patient LC5 is a 58-year Caucasian man with a history of depression who manifested: Intolerance and resistance to Lexapro, requiring compounding drug, 1/50 th standard dose, ~0.2 mg *3 *1 DRUG Drug Metabolism Alteration CYPARRAY BIO-CLINICAL METABOLISM Combinatorial Genotype Population Prevalence Drug Metabolism Reserve HIGH
30 PHP Personalized Health Portal Psychotropic Management: Patient LC5
31 PhyzioType System: AH1 Case Report and Clinical Management Utility Patient AH1 is a 27-year old Caucasian woman on Prozac and Wellbutrin with a complaint of: All my meds fail after a few weeks (according to note from referring psychiatrist) Combinatorial Genotype 2D6 2C9 2C19 *3 *1 DRUG CYPARRAY BIO-CLINICAL METABOLISM HIGH
32 PhyzioType System: AH1 Case Report and Clinical Management Utility Patient AH1 is a 27-year old Caucasian woman on Prozac and Wellbutrin with a complaint of: All my meds fail after a few weeks (according to note from referring psychiatrist) Combinatorial Genotype 2D6 2C9 2C19 *1 *1 *1 *1 *1 *1 *3 *1 DRUG CYPARRAY BIO-CLINICAL METABOLISM HIGH
33 Percentage of Patients Number of Patients PhyzioType System: AH1 Case Report and Clinical Management Utility Patient AH1 is a 27-year old Caucasian woman on Prozac and Wellbutrin with a complaint of: All my meds fail after a few weeks (according to note from referring psychiatrist) *3 *1 DRUG Drug Metabolism Alteration CYPARRAY BIO-CLINICAL METABOLISM Combinatorial Genotype Population Prevalence Drug Metabolism Reserve HIGH
34 Psychotropic Metabolic Side Effects Second Generation Antipsychotics Start Rx 6 weeks TG Blood Glucose MetSyn Diabetes CVD Central Nervous System Metabolic Appetite Energy Use
35 Marker Frequency Marker Frequency Marker Frequency Marker Frequency PhysioGenomics of PIMS: Risperidone Discovery from Side Effect Spectrum: Weight LEPR rs LEPR Leptin Receptor p = r^2 = 11.3% NPY5R PON1 rs rs NPY5R rs NPY5R Neuropeptide Y receptor Y p = Ruaño, Goethe, de Leon, Molecular Psychiatry,
36 Score: -10*log 10 (p-value) PIMS Total Genome Discovery: Waist High Resolution Genomic Learning Gene 1 Ge Gene 4 Gene 2 Gene
37 WAIST (cm) mea mea mean waist mean waist mea mea mean waist mean waist mean waist WAIST (cm) ist 100 WAIST (cm) mean waist ist PhyzioType Reimbursement: Value PIMS: Patients in BEST vs. WORST DRUG all all best best worst worst olanzapine best best worst worst Risperdal Seroquel Zyprexa ON risperidone best best worst worst 26% 36% BEST WORST quetiapine ON all BEST best best best WORST worst worst worst olanzapine ON best worst 31% 37% 38% 23% BEST WORST 115 PhyzioType System Predictions and Observed Clinical Endpoints for 3 AAPs: 233 patients on Risperdal 110, 227 on Seroquel, and on Zyprexa
38 Acknowledgements Consortium Collaborators and Grant Support Harold Schwartz MD John Goethe MD Godfrey Pearlson MD Lisa Namerow MD Bonnie Szarek RN Steve Woolley PhD Charles Calley PhD Vincent Calhoun PhD Jose de Leon, MD Margaret Susce, RN LPH Andreas Windemuth PhD Krystyna Gorowski Richard Seip PhD David Villagra Bruce Bower MD Kali Bogaard Mohan Kocherla Teresa Giuliano Supported by Grants 5 R44 MH R44 MH
39 CR-1 C2 SB12789 SB1501 SB1825 C3 C1 SB1541 SB1727 SB1461 SB12781 SB3039 DNA-Guided Medicine: Drug Selection PhyzioType TM Systems for Drug Management P H Y Z I O T Y P E S Y S T E M S Patient is here Ranking Drug Response SNP Array Assay Bioclinical Algorithm Physician Portal 39
40 PhyzioType System: LPH2 Case Report and Clinical Management Utility Patient LPH2 is a 59-year Caucasian woman with a history of major mood disorder who manifested: Failure to respond to many antidepressants despite ability to tolerate high doses. Combinatorial Genotype 2D6 2C9 2C19 *3 *1 DRUG CYPARRAY BIO-CLINICAL METABOLISM HIGH
41 PhyzioType System: LPH2 Case Report and Clinical Management Utility Patient LPH2 is a 59-year Caucasian woman with a history of major mood disorder who manifested: Failure to respond to many antidepressants despite ability to tolerate high doses. Combinatorial Genotype 2D6 2C9 2C19 DUP *2a *3 *3 *1 *1 *3 *1 DRUG CYPARRAY BIO-CLINICAL METABOLISM HIGH
42 PHP Personalized Health Portal Psychotropic Management: Patient LPH2 NEED DRUG SELECTION TABLE 42
43 PhyzioType System: LN1 Adolescent Psych: New Rx, Hx Side Effects LN1, 14-year old Caucasian adolescent, currently not on psychotropics. Hx. of severe reaction to Celexa. Psychiatrist is considering Wellbutrin or atypical antipsychotic. *3 *1 DRUG 2D6 2C9 2C19 Combinatorial Genotype *4 *41 *1 *1 *1 *2 CYPARRAY BIO-CLINICAL METABOLISM HIGH
44 PhyzioType System: LC5 Case Report and Clinical Management Utility Patient LC5 is a 58-year Caucasian man with a history of depression who manifested: Intolerance and resistance to Lexapro, requiring compounding drug, 1/50 th standard dose, ~0.2 mg *3 *1 DRUG Combinatorial Genotype 2D6 2C9 2C19 *1 *2a *1 *1 *2 *2 CYPARRAY BIO-CLINICAL METABOLISM HIGH
45 PhyzioType System CT Market Growth + Clinical Adoption % Respondents Agree Strongly* Increased confidence in clinical management Confident in validity and utility of results Interpretation helpful in optimizing clinical outcomes Incorporate DNA guided systems into clinical practice Positive patient feedback in regards to results 75% 96% 67% 84% 67% Most useful in the clinically complex patient Survey of 24 Clinician Users 92% *Scores of 4 or 5 in 5 point scale
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SiGMA/ MMHSCT GUIDELINES FOR ANTIPSYCHOTIC DRUG TREATMENT OF SCHIZOPHRENIA [compatible with NICE guidance] Medicines Management Committee August 2002 For review August 2003 Rationale The SiGMA algorithm
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