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CVG’s Venture Connection-Gualberto Ruano on the opportunity for innovation in the translation of...

Date post: 13-Jan-2015
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Great potential for innovation and impact on patient outcomes in personalized medicine lies in theranostics according to personal medicine pioneer Gualberto Ruano. Ruano spoke at CVG’s Venture Connection program at UConn’s Business School in Hartford earlier this month. He sees the prime opportunity for innovation in the translation of Biomedics into clinical practice. Greg Zaic, principal at NMT Capital spoke about the development of pharma into very individualized treatments He foresees our children receiving very specific, highly successful therapies. However, the cost of research and development for all those solutions to disease management when before there were only a few options will be very expensive.
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1 Gualberto Ruaño, M.D., Ph.D. President, Genomas Inc. Director of Genetics Research, Hartford Hospital Why are We Investing in Personalized Medicine? DNA-Guided Healthcare in All-Too-Real-time DNA-Guided Medicine 15 September 2011
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Page 1: CVG’s Venture Connection-Gualberto Ruano on the opportunity for innovation in the translation of Biomedics into clinical practice

1

Gualberto Ruaño, M.D., Ph.D.President, Genomas Inc.

Director of Genetics Research, Hartford Hospital

Why are We Investing in Personalized Medicine?

DNA-Guided Healthcare in All-Too-Real-time

DNA-Guided Medicine

15 September 2011

Page 2: CVG’s Venture Connection-Gualberto Ruano on the opportunity for innovation in the translation of Biomedics into clinical practice

2

Genomas OverviewBringing DNA-Guided Medicine to Healthcare Today

Genomas has developed and is marketing a unique biomedical platform that

utilizes proprietary biomarkers, treatment algorithms, and a web-based

physician portal delivery system to provide clinical decision support for

physicians and personalized drug treatment for patients

Products are DNA-guided to improve the therapeutic benefit of widely used

prescription drugs while also reducing the risk of significant side effects

Patented technology platform, proprietary algorithms and physician interface

portal can be extended to a wide range of drug categories

Powerful technology platform initially offered for mental health and already

extended to diabetes medications (lipid and glucose lowering)

Currently focusing primarily on Mental Health: Antidepressants (SSRIs,

SNRIs), Neuroleptics (first and second generation antipsychotics), Stimulants

Technology platform applicable to numerous disease states; current pipeline

in Cardiovascular and Diabetes: Statins, TZDs, Incretins

Founded in 2004, located at in Hartford Hospital, Hartford CT

Page 3: CVG’s Venture Connection-Gualberto Ruano on the opportunity for innovation in the translation of Biomedics into clinical practice

33

Hartford Hosp., IOL, CLP, THOCC, UPRGenomas Partners in DNA-Guided Medicine

Discovery Diagnostic TreatmentDevelopment

TechnologyDatabases

Healthcare Management

PersonalizedPrescription

BiologicalsDrugs

Biotechnology Pharmaceutical

DNA-Guided Medicine

Page 4: CVG’s Venture Connection-Gualberto Ruano on the opportunity for innovation in the translation of Biomedics into clinical practice

4

Genetic Prescription System: Drug GPSPhyzioType Systems + DNA-Guided Medicine

P H Y Z I O T Y P E S Y S T E M S

Bringing DNA-Guided Medicine to Healthcare Today

Prescribe RightLABORATORY OF

PERSONALIZED HEALTH

LPH

Page 5: CVG’s Venture Connection-Gualberto Ruano on the opportunity for innovation in the translation of Biomedics into clinical practice

5

PhyzioType SystemsMedical Device for DNA-Guided Medicine

P H Y Z I O T Y P E S Y S T E M S

SNP Ensemble

Assays

PHP

P E R S O N A L I Z E D H E A L T H

P O R T A L

Physician

Interface

233

202

126 2

192

227

145

29 26 215

225

238

21 72 40 169

55 81 58 149

110

74 50 121

104

54 200

218

168

241

105

214

148

191

80 132

216

16 34 70

CR

-1 C2

SB

1278

9

SB

1501

SB

1825 C3

C1

SB

1541

SB

1727

SB

1461

SB

1278

1

SB

3039

Biomathematical

Algorithms

Page 6: CVG’s Venture Connection-Gualberto Ruano on the opportunity for innovation in the translation of Biomedics into clinical practice

66

LPH Laboratory of Personalized HealthClinical Lab, Commercial 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

Reimbursement rate >95%

Used by 195 Clinicians in 2010

1141 Patients referred in 2010

3272 PhyzioType tests in 2010

Licensed by CT Dept of Public

Health (#CL-0644) + R.I.

CLIA certified and registered

(Clinical Laboratory Improvement

Amendments)

ID #07D1036625 CMS (Centers for

Medicare and Medicaid)

4 successful biannual inspections

(most recent June 2011)

53 patient service centers in CT

Subsidiary of Hartford Healthcare

LABORATORY OF PERSONALIZED HEALTH

LPH

Page 7: CVG’s Venture Connection-Gualberto Ruano on the opportunity for innovation in the translation of Biomedics into clinical practice

7

7

1 2 3

Physician requests HILOmet PhyzioType

System and sends patients for a blood draw to CLP patient

service centers.

Phlebotomist acquires sample and enters the

requisition into the CLP system, including activation of claims.

Messengers bring blood sample to

Genomas CLIA lab for DNA extraction and

genotyping.

Genomas prepares reports for uploading into the PHP, sends hard copy results to

requesting physician.

P A Y O R SCLP files 3 claims per HILOmet PhyzioType System with payors

based on generic molecular diagnostic codes. CLP remits payment to Genomas at a contractually agreed upon rate per

component test.

PhysicianClinician

Personalized Health Portal

LPH Laboratory of Personalized HealthClinical Lab, Commercial Launchpad

CLP Patient Service+ Billing

Laboratory of Personalized

Health

Page 8: CVG’s Venture Connection-Gualberto Ruano on the opportunity for innovation in the translation of Biomedics into clinical practice

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PHP Personalized Health PortalDecision Support for Clinical Practice

Patient

Referral

LABORATORY OF PERSONALIZED HEALTH

LPH

DNA Typing

PHP

P E R S O N A L I Z E D H E A L T H

P O R T A L

Decision Support

Clinical

Practice

DNA-Guided

Medicine

M.D.

M.D.

M.D.

M.D.M.D.M.D.

M.D.

M.D.

M.D.M.D.

M.D.

P H Y Z I O T Y P E S Y S T E M S

Page 9: CVG’s Venture Connection-Gualberto Ruano on the opportunity for innovation in the translation of Biomedics into clinical practice

9

DRUG SELECTION TABLE: 80 Brands

ANTIDEPRESSANTS: Generic (Brand) & Drug Selection

Page 10: CVG’s Venture Connection-Gualberto Ruano on the opportunity for innovation in the translation of Biomedics into clinical practice

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HILOmet PhyzioType SystemContinued Successful Growth Track

0

500

1000

1500

2000

2500

3000

3500

Qtr 1 Qtr 2 Qtr 3 Qtr 4

0

500

1000

1500

2000

2500

3000

3500

Qtr 1 Qtr 2 Qtr 3 Qtr 4

Cumulative Test Volume by Quarter

0

500

1000

1500

2000

2500

3000

3500

Qtr 1 Qtr 2 Qtr 3 Qtr 4

20092008 2010

Ordering Tests Patients Tests/

Docs Ordered Tested Doc

2008 Actual 44 339 124 7.7

2009 Actual 92 820 293 8.8

2010 Actual 195 3272 1141 16.7

Ordering

Clinicians

Page 11: CVG’s Venture Connection-Gualberto Ruano on the opportunity for innovation in the translation of Biomedics into clinical practice

11

The BioMed Model in HealthcareIT + Dx, Translational Medicine Critical to CT

Health PersonalizedDecision Support for Drug Precision Treatment

Mental Illness, Diabetes/Cardiovascular

PhyzioTypeTM

Systems

Page 12: CVG’s Venture Connection-Gualberto Ruano on the opportunity for innovation in the translation of Biomedics into clinical practice

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Business Models in Healthcare IndustryAttractive features of the BioMed business

Doctors and Hospitals

Personalized health

$10M investment

Utility clinical studies

2 years to revenue

CLIA or device approval

IP on diagnostics and IT

New industry

1,000’s service tech jobs

BioMed

Big Pharma

Blockbuster drug

$100M investment

Phase I-III Clinical trials

10 years to revenue

FDA drug approval

IP on biologicals

Acquisition by Pharma

100’s selective science jobs

BioTech

Page 13: CVG’s Venture Connection-Gualberto Ruano on the opportunity for innovation in the translation of Biomedics into clinical practice

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Drivers for Personalized Medicine Alignment of Quality Healthcare, Insurance

Doctors

Improved Patient Care

Diagnosis

Patients

Better Outcome

Treatment

Payers

Superior Value on Health Insurance

Reimbursement

PhyzioType Systems

Page 14: CVG’s Venture Connection-Gualberto Ruano on the opportunity for innovation in the translation of Biomedics into clinical practice

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Drivers for Personalized MedicineThe Consumer formerly known as Patient

• Genomics is expected to arrive at the clinic

• New medication diagnostics may be required for patient safety

• Personalized healthcare will be expected by patients

• Health spending accounts and personal choice on healthcare use

Page 15: CVG’s Venture Connection-Gualberto Ruano on the opportunity for innovation in the translation of Biomedics into clinical practice

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“The FDA and the drug industry both

foresee a time when physicians will

tailor drug treatments for individual

patients based on variations in their

DNA sequence.”

7 January 2004

Drivers for Personalized MedicineFDA and Regulatory Policy

Page 16: CVG’s Venture Connection-Gualberto Ruano on the opportunity for innovation in the translation of Biomedics into clinical practice

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Drivers for Personalized MedicineEntrepreneurs

Page 17: CVG’s Venture Connection-Gualberto Ruano on the opportunity for innovation in the translation of Biomedics into clinical practice

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DNA-Guided Medicine: Beyond AverageMedical GPS: Genetic Prescription System

Nu

mb

er

of

Peo

ple

Side Effect Risk

SD SD

AVERAGE

You are

Here

20th Century:

Public Health

Side Effect Risk

INDIVIDUALIZED

21st Century:

Personal Health

You are

Here

Page 18: CVG’s Venture Connection-Gualberto Ruano on the opportunity for innovation in the translation of Biomedics into clinical practice

18

[email protected]

860-545-3773

www.genomas.com

Thank You !

DNA-Guided Medicine


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