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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CVG’s Venture Connection-Gualberto Ruano on the opportunity for innovation in the translation of Biomedics into clinical practice
1. DNA-Guided Medicine
15 September 2011
Why are We Investing in Personalized Medicine?
DNA-Guided Healthcare in All-Too-Real-time
Gualberto Ruaño, M.D., Ph.D.
President, Genomas Inc.
Director of Genetics Research, Hartford Hospital
1
2. Genomas Overview
Bringing 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
2
3. Hartford Hosp., IOL, CLP, THOCC, UPR
Genomas Partners in DNA-Guided Medicine
Biotechnology DNA-Guided
Pharmaceutical Medicine
Discovery Development Diagnostic Treatment
Technology Biologicals Personalized Healthcare
Databases Drugs Prescription Management
3
4. Genetic Prescription System: Drug GPS
PhyzioType Systems + DNA-Guided Medicine
PHYZIOTYPE S Y S T E M S
LABORATORY OF
PERSONALIZED HEALTH Prescribe Right
LPH
Bringing DNA-Guided Medicine to Healthcare Today
4
5. PhyzioType Systems
Medical Device for DNA-Guided Medicine
PHYZIOTYPE S Y S T E M S
PERSONALIZED HEALTH
PHP
P O R T A L
SB12789
SB12781
SB1501
SB1825
SB1541
SB1727
SB1461
SB3039
CR-1
233
202
126
192
227
145
215
225
238
169
149
110
121
104
200
218
168
241
105
214
148
191
132
216
29
26
21
72
40
55
81
58
74
50
54
80
16
34
70
C2
C3
C1
2
SNP Ensemble Biomathematical Physician
Assays Algorithms Interface
5
6. LPH Laboratory of Personalized Health
Clinical Lab, Commercial Launchpad
Pioneering high complexity LABORATORY OF
PERSONALIZED HEALTH
pharmacogenetics laboratory +
clinical practice
Anchor for commercialization of
PhyzioType Systems throughout
New England and nationally LPH
Licensed by CT Dept of Public
Referral Center for Institute of Health (#CL-0644) + R.I.
CLIA certified and registered
Living + Mood Disorders Program (Clinical Laboratory Improvement
Amendments)
ID #07D1036625 CMS (Centers for
CT-wide distribution and Medicare and Medicaid)
4 successful biannual inspections
reimbursement agreement with (most recent June 2011)
Clinical Lab Partners
Reimbursement rate >95%
Used by 195 Clinicians in 2010
1141 Patients referred in 2010 53 patient service centers in CT
Subsidiary of Hartford Healthcare 6
3272 PhyzioType tests in 2010
7. LPH Laboratory of Personalized Health
Clinical Lab, Commercial Launchpad
CLP Patient Laboratory of Personalized
Physician 1 2 3
Service Personalized Health
Clinician
+ Billing Health Portal
Physician requests Phlebotomist acquires Genomas prepares
HILOmet PhyzioType sample and enters the Messengers bring reports for uploading
System and sends requisition into the blood sample to into the PHP, sends
patients for a blood CLP system, including Genomas CLIA lab for hard copy results to
draw to CLP patient activation of claims. DNA extraction and requesting physician.
service centers. genotyping.
PAYORS
CLP 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
7
component test.
7
8. PHP Personalized Health Portal
Decision Support for Clinical Practice
M.D.
M.D. M.D.
Patient M.D. Clinical
Referral M.D. M.D.
M.D.
M.D. Practice
LABORATORY OF M.D. M.D.
PERSONALIZED HEALTH PERSONALIZED HEALTH
DNA-Guided
Medicine PHP
LPH P O R T A L
PHYZIOTYPE S Y S T E M S
DNA Typing Decision Support
8
11. The BioMed Model in Healthcare
IT + Dx, Translational Medicine Critical to CT
PhyzioTypeTM
Systems
Health Personalized
Decision Support for Drug Precision Treatment
Mental Illness, Diabetes/Cardiovascular
11
12. Business Models in Healthcare Industry
Attractive features of the BioMed business
BioMed BioTech
Doctors and Hospitals Big Pharma
Personalized health Blockbuster drug
$10M investment $100M investment
Utility clinical studies Phase I-III Clinical trials
2 years to revenue 10 years to revenue
CLIA or device approval FDA drug approval
IP on diagnostics and IT IP on biologicals
New industry Acquisition by Pharma
1,000’s service tech jobs 100’s selective science jobs
12
13. Drivers for Personalized Medicine
Alignment of Quality Healthcare, Insurance
PhyzioType Systems
Diagnosis Treatment
Doctors Patients
Improved Better
Patient Care Outcome
Reimbursement
Payers
Superior Value on
Health Insurance 13
14. Drivers for Personalized Medicine
The 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
14
15. Drivers for Personalized Medicine
FDA and Regulatory Policy
“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.”
15
7 January 2004
17. DNA-Guided Medicine: Beyond Average
Medical GPS: Genetic Prescription System
20th Century: 21st Century:
Public Health Personal Health
AVERAGE INDIVIDUALIZED
Number of People
You are
Here
You are
Here
SD SD
Side Effect Risk Side Effect Risk 17