challenge - Idea to Product Competition

Problem Analysis
Sexually transmitted infections (STIs) are a problem
60% of STIs are curable
People are not getting tested
Rate of US Commercial Health Plan Chlamydia Screening
STIgma Free
Inconvenience
100%
Innovating Point of Care Diagnostics for Personal Healthcare
Sexually Active Screened
Women, Ages 16‐25
80%
Time to Results
60%
37.50%
40%
Sasha Cai Lesher-Perez
Bethany Tong
20%
Stigma
0%
ʹ99 ʹ00 ʹ01 ʹ02 ʹ03 ʹ04 ʹ05 ʹ06
Idea to Product Global Competition Presentation
November 4, 2010
People prefer to test themselves at home
Source: WHO, CDC, Journal of Sexually Transmitted Diseases,
July 2006, Healthcare Effectiveness Data and Information Set
(HEDIS)
Solution Idea Development
2
Problem
Idea
Product
Market
Selection of STIs and Sampling Method
2008 US STI Incidence
Microfluidics
Small‐Scale
Autonomously Run
Herpes
3%
Minimum Reagent Cost
Portable
Fast End Results
Hepatitis
HIV
Syphilis < 1%
Trichomoniasis
Chlamydia
Urine
Blood
• Chlamydia
• Gonorrhea
• Trichomoniasis
• HIV
• Syphilis
• Hepatitis B
Gonorrhea
Multiplex Testing
HPV
Herpes
Hepatitis
HPV 39%
Trichomoniasis
47%
Vaginal Swab
Physical Examination
• Herpes
• Pubic Lice
• HPV
HIV
Syphilis
Lab‐On‐A‐Chip Technology
3
Problem
Idea
Gonorrhea 2%
Product
Market
4
Source: CDC
Product Design
Product Design
STIgma Free STI Diagnostic Device
• Chlamydia
• Gonorrhea
• Trichomoniasis
• Requires small urine sample
• 20 minute binary readout • 98% specificity; 90% sensitivity
• Easily disposable
• $30 price point
5
Problem
Idea
Product
Market
Chlamydia 8%
Problem
Idea
Product
Market
Intellectual Property Status
Initial Target Market: Sexually Active Youth, 15-19
2008 United States Chlamydia Incidence
Process fabrication and integration of a microfluidic platform utilizing biologic coupled electro‐mechanical detection of surface antigens
Men
65+
Women
55‐64
T
G
C
Local clinics were extremely receptive to STIgma Free
Colleges / Universities
Planned Parenthood
45‐54
Michigan
30
29
40‐44
Midwest
221
220
Northeast
261
208
West
119
241
South
253
161
Total
854
830
35‐39
Principal investigator permission
Well documented time sheets
30‐34
University resources as external resource
25‐29
71% of reported cases
20‐24
15‐19
University of Michigan has no claim on the IP
STIgma Free independently owns the IP
Idea
Problem
7
Source: Meetings with Tech Transfer, September 2010
Product
10‐14
Market
Market Strategy: Small Clinics to Home Users
STIgma Free Projected Sales (MM)
STIgma Free STI Diagnostic $225
Small Clinics (B2B)
$175
• Testing platform
• Feedback
• Validate efficacy
• Willingness and ability
• Volume sales
• Build credibility
$150
2000
3000
STIs
C
G
$134
$76
$66
Gen‐Probe
Roche
BD
C
$44
$50
Home Users
(B2C)
$0
9
Problem
Y2
Idea
Y3
Product
Y4
Y5
Market
Source: Industry analysis, Interviews UHS, PP
Product Development Timeline
Engineering Prototype
Biologics Prototype
$1,500
$10,000
$50,000
Winter 2010 Spring 2011 Fall 2011
Sample
Location
20 minutes
Urine
6‐8 hours
Urine
20 minutes
Vaginal Swab
10
Problem
Idea
Product
Market
Form LLC
(MEMS)
Product
Josh White, PhD
Engineering
Product Development
(Microfluidics)
Sasha Cai Lesher‐Perez, PhD (Microfluidics/Molecular)
Biologics
STIgma Free
Rameshwar Rao, PhD (Clinical Diagnostic Assays)
Jeremy Holzwarth, PhD (Biologics)
File Full Patent
Idea
Patrick Ingram, PhD Winter 2011
Hire counsel to establish freedom to operate
Problem
Timing
STIgma Free Org Chart
Conceptual Prototype
11
Market
T
Genzyme
$5
Y1
Product
$98
$68
$21
Idea
Problem
G
$75
File Provisional Patent
8
T
$174
$100
Research existing IPs 4000
Competitive Advantage
STIgma Free
$125
$25
Fall 2010
1000
Company
Small Clinical
Home Market
$200
Source: CollegeBoard, Industry analysis, Kalorama
Information, Interviews Planned Parenthood Ann Arbor (PP)
University of Michigan Health Services (UHS)
0
Source: CDC, Kalorama Research, STIgma Free Analysis
Market
Business Development
Bethany Tong, MBA
12
Problem
Idea
Product
Market
Summary
STIgma Free • Talented team
• Home STI Diagnostic Device
• Clear IP
• Large and growing market
• Solutions to significant health and social needs
13
Source: Industry analysis, Interviews
Idea
Problem
Product
Market
Appendix: Larger Clinical Market
Current Landscape: Large Clinical Market
$500
Gen‐Probe
Roche
$404
$400
$300
$373
17%
$100
Larger Clinical Market Penetration
BD
Other
$430
Gen‐Probe
BD
Roche
Other
Curable STI Incidence Rate, 1999
STIgma Free Diagnostic Device can be used a POC device in developing countries
Unpenetrated
17%
18%
32%
$200
Appendix: Global Health
43%
33%
New STI infections (millions)
North America
156
14
Europe
408
39
Middle
East
28%
31%
Adult population (millions)
Asia
46%
49%
50%
18%
1%
$0
2007
2008
Approximately 700 million curable STIs
worldwide (2010)
10%
Latin America
2009
Source: CollegeBoard, Industry analysis, Kalorama
Information, Interviews Planned Parenthood Ann Arbor (PP)
University of Michigan Health Services (UHS)
15
Problem
Idea
Product
165
10
1,770
169
260
38
Australia
11
1
Africa
269
69
Total
3039
340
Market
Source: World Health Organization
Appendix: Chlamydia
Appendix: Chlamydia trachomatis
• Statistics
• 1,210,523 infections reported to CDC in 2008 (underestimate)
• 401.3 cases per 100,000 population, increase from 367.5 in 2007 and 102.5 in 1989
• Young women 15‐19 are most susceptible
• Symptoms
• Appear 1‐3 weeks after exposure
• Women
• Abnormal vaginal discharge, Burning sensation when urinating, Lower abdominal pain, Low back pain, Nausea, Fever, Pain during intercourse, Bleeding between menstrual periods
• Men
• Discharge from the penis, Burning sensation when urinating, Burning and itching around penis opening
• Untreated
• Women: PID, chronic pelvic pain, infertility, ectopic pregnancy
• Antibiotics
• Single dose of azithromycin
• Week of twice daily doxycycline








•
•
•
Problem
Idea
Product
Market
Azithromycin
Doxycycline
Tetracycline
Erythromycin
Linked to prostatitis and epididymitis in men and cervicitis, pelvic inflammatory disease (PID), ectopic pregnancy, and acute or chronic pelvic pain in women
Neisseria gonorrhoeae
•
•
17
Obligate human pathogen
Estimated by CDC that about 1 million individuals in the United States are infected with chlamydia
C. trachomatis infection can be effectively cured with antibiotics once it is detected
CDC estimates that more than 700,000 persons in the U.S. get new gonorrheal infections each year. Only about half of these infections are reported to CDC.
In 2006, the rate of reported gonorrheal infections was 120.9 per 100,000 persons
In women, gonorrhea can cause of PID and in men, gonorrhea can cause epididymitis. Additionally, gonorrhea can spread to the blood or joints. This condition can be life threatening. Can spread to children of pregnant women causing gonococcal
ophthalmia neonatorum .
Similar antibiotics to Chlamydia can be used However, drug‐
resistant strains of gonorrhea are increasing.
Appendix: Gonorrhea
Appendix: Trichomoniasis
• Statistics
• 336,742 infections reported to CDC in 2008 (underestimate)
• 111.6 cases per 100,000 population, numbers are somewhat stable
• Symptoms
• Appear 2‐30 days after exposure
• Women
• Asymptomatic, Abnormal vaginal discharge, Burning sensation when urinating, Bleeding between menstrual periods
• Men
• Asymptomatic, Discharge from the penis, Burning sensation when urinating
• Untreated
• Women: PID, internal abscesses, chronic pelvic pain, infertility, ectopic pregnancy
• Men: epididymitis
• Antibiotics
• Single dose of azithromycin
• Week of twice daily doxycycline
• Drug resistant strains are increasing
19
Idea
Problem
Product
• Statistics
• Estimated 7.4 million new infections annually
• Most common curable disease in young women
• 85% of women have no symptoms
• Symptoms
• Appear 2‐30 days after exposure
• Women
• Abnormal vaginal discharge, Burning sensation when urinating, Irritation and itching of the genital area
• Men
• Asymptomatic, Irritation inside the penis, Discharge from the penis, Burning sensation after urination or ejaculation
• Left untreated
• Women: increase susceptibility to HIV infection
• Treatment
• Single dose of metronidazole or tinidazole
Market
20
DANGERS!
 Associated with increased risk of transmission of HIV.
 May cause a woman to deliver a low‐birth‐
weight or premature infant.
 Associated with increased chances of cervical cancer
 Evidence implies that infection in males potentially raises the risks of prostate cancer development and spread due to inflammation
•
•
•
•
•
•




FDA Device definition
FDA Costs
Specific Regulatory Codes
510 (k) Comparison Products Product
Market
Idea
Product
Market
Total 3568 (no data for Georgia, Hawaii, New Hampshire)
Midwest 1056
West 747
South 1289
Northeast 476
Michigan 119
[1] Midlej, V.; Benchimol, M. Trichomonas vaginalis kills and eats‐ evidence for phagocytic activity as a cytopathic effect. Parasitology 2010, 137, 65‐76
[2] American Social Health Association
Appendix: FDA Process
Idea
Appendix: STI Clinics in the U.S.
Appendix: Trichomonas vaginalis
GENERAL
• Caused by protozoan
• Puts mechanical stress on host cells and then ingesting cell fragments after cell death [1]
• Affects 7.4 million previously unaffected Americans each year [2]
• The most frequently presenting new infection of the common sexually transmitted diseases [2]
Problem
22
Problem
Appendix: FDA Device Definition
Federal Food Drug and Cosmetic Act 201 (h)

Medical Device: “An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:



Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them
Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
Intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of itʹs primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.ʺ
Appendix: FDA Regulations and Preliminary
Regulatory Strategy
Appendix: FDA Cost

510 (k) for FY 2011



$4348 for Standard businesses
$2,174 for small businesses (<$100 million in revenue)
We want to avoid Pre‐Market Approval AT ALL COSTS



$2,179
Must be on file for manufacturing site of device –
this probably wouldn’t apply but I figured I’d put on there in case you wanted it


But demonstrated clinical equivalence
LKI, GPW, LKH, GPT, LJP, LJC – Chlamydia serological reagents (Class I)
LGA – Oxidase test for gonorrhea (Class III)
MKZ – “Multiplex Chlamydia/Gonorrhea test” (Class I)

21CFR866.3120 – Chlamydia serological reagents
21CFR866.2660 – Microorganism differentiation and identification device. Mostly applied to Trichomonas
21CFR866.2420 – Oxidase screening test for gonorrhea
Appendix: Clinical Cost Estimates Gen-Probe
Clinical costs per Dr. Newton’s estimates
STD/Clinic related
 JWZ – Trichomonas Screening Kit (Class I)


$59,075 for FY 2011 + Trials
Appendix: 501(k) Comparison Products

Regulatory Laws
Establishment Registration Fee for FY 2011



There are 260 work days per year
There are 2080 work hours per week




At‐home related
LCX – OTC Pregnancy Test Kit (Class II)
NBW – OTC Blood Glucose (Class II)
NFT, NFV, NFW, NFY – OTC Drug Tests (Class II)
Large clinical machine (96 samples/run) ‐ $120,000
• Does extraction and PCR all‐in‐one
• Only use for 3 years
$120,000/3 = $40,000 per year
$40,000/260 work days = $153.85 per day for use of the system
Assume can run 80 samples per day
$153.85/80 samples = $2 per test for machine use Appendix: Clinical Cost Estimates Gen-Probe
Clinical Cost Estimates: Gen-Probe Device
Clinical costs per Dr. Newton’s estimates
Clinical costs per Dr. Newton’s estimates
Reagents cost $25 per test
Research technician ‐ $25/hour  $200/day
Machine cost
Reagent cost
Technician cost
$2
$25
$5
$200 day/80 tests = $2.50 per test
Total cost per test
$32
Takes 2 technicians  one to collect and one to analyze
Standard PCR based test for G/C
Research technicians cost $5 per test
FDA Costs (assuming 510k)
Costs to Manufacturing
510k filing fee Clinical trials
Prototypes
Legal fees for IP
Fees for Attorneys/Consultants
FDA Process
$61,500
$30,000
$60,000
$20,000
Costs to manufacturing
$171,500
$2,174
$31,000
•Assuming we test 500 total samples (500 Stigma Free ($30) and 500 tests ($32))
Registration fee for business
Clinical & Administration Fees FDA costs to market $2,179
$35,000
$70,353
Home vaginal pH detection test
Home UTI Test
“The pHEM‐ALERT@ test measures vaginal pH and is intended for use by women who have any of the following vaginal symptoms:
“The ACON UTI Urinary Tract Infection Test Strips are for the qualitative detection of Nitrite and Leukocytes in urine as an aid in the screening of urinary tract infection (UTI). It is intended for over‐the‐counter home use only.” [From 510k] Showed substantial equivalence to Bayer Multistix 10 SG Reagent Strips for Urinalysis Itching ‐ Burning ‐ Unpleasant odor ‐ Unusual discharge
This test may help decide if these symptoms are caused by an infection that may require
follow‐up by your healthcare provider. This test is only intended for women who have
normal menstrual periods (periodic vaginal bleeding) or who may currently be pregnant. If you are pregnant, always discuss your symptoms and the result of this test with your healthcare provider and NEVER treat yourself.” [From 510k]
Demonstrated substantial equivalence to current methods (2003)
Class 2 medical device
Over the counter product
Male Infertility Tests
First home male Infertility test (FertilMARQ) was designed and approved for the home‐use by the FDA in 2002Showed substatial equivalence to current fertility tests
Conducted clinical trials by comparing results from trained professional and a home user
Class 1 medical device
“The predicate and the proposed device have the following similarities: assay format, test methodology, and assay matrix. The assays differ in their intended use setting (professional use in point‐of care setting versus over‐the‐counter) and their intended use (the predicate device also detects additional analytes that may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid‐base balance in addition to information about urinary tract infections).”
“Conclusion:
The submitted information in this premarket notification is complete and supports a
substantial equivalence decision.”
Pregnancy Tests
1976 ‐ FDA approval sought for Warner‐Chilcott e.p.t. “Early Pregnancy Test,” later dubbed “error Proof Test” Substantially equivalent to three other tests
Predictor
ACU‐TEST
Answer
Pregnancy tests are considered class 2 medical Devices
The first home pregnancy tests were approved by the FDA by showing substantial equivalence to 3 clinic tests ‐ Predictor, ACU‐TEST, and Answer
External Advisor Board
Duane Newton, PhD
Market Analysis
Aileen Huang Saad,PhD
Doug Neal
Director, Clinical Microbiology & Virology Laboratories
Center for Entrepreneurship
Center for Entrepreneurship
Charlotte A. Gaydos, DrPH, MPH
Lindsay Klee
Paul Kirsch
Professor,
Johns Hopkins University
Associate Director Zell Lurie Institute
Assistant Director, Commercialization
Small Clinical Market
Colleges / ‐ 4 Yr College / Universities > 2,000 students
Universities
‐ Planned Parenthood Small Clinics
 Y1 enter MI @ 40% penetration
Michigan
30
 Y2 enter Midwest @ 20% penetration
 Y3 enter Northeast @ 20% penetration
Midwest
221
 Y4 enter West @ 20% penetration
 Y5 enter South @ 20% penetration
Northeast
261
 20% YOY growth  University Health Services @ 40 tests per West
119
day, 5 days per week, for 36 weeks (9 mo)
 Planned Parenthood @ 25 tests per day, 5 South
253
days per week, 50 weeks per year (12 mo)
 All @ $30 price point
Total
854
 UHS @ 1.8 mm units by Y5, $53 mm rev
 PP @ 1.5 mm units by Y5, $45 mm rev Home Market, Enter Y4
 Population US, 15‐24 = 43 million * 51% sexually active subset
 = 21.9 mm potential market of sexually active 15‐24 year olds
 10% penetration, 15% YOY growth 2.5mm units by Y5
 @ $30 price point  $75mm USD top line sales Y5
Planned Parenthood
29
220
208
241
161
830
Problem Identification


Sexually transmitted infections (STIs) are a problem
Enter clinic with “Monoplex” Assays
Validate efficacy of test
Expand to multiplex assay

See notes
1 in 10
people worldwide has an STI
1 in 5
people ages 15‐24 contracts an STI each year in the U.S.
$16.4 bn
Preliminary Regulatory Strategy
is the estimated direct medical costs associated with STIs in the U.S.
Over 60% of the 15 million reported new cases of STIs in the U.S. are curable
Source: World Health Organization (WHO), Center for Disease
Control (CDC)
Company
STIgma Free
Gen‐Probe
BD
Roche
STIs
C
C
C
C
G
Timing
Sample
20 minutes
Urine
6‐8 hours
Urine
Location
T
G
Urine
6‐8 hours
Urine
20 minutes
Vaginal Swab
G
Genzyme
Source: Industry analysis, Interviews UHS, PP
Electrical Components
• TSMC
Plastic Blow Molding
• PTI Engineered Plastics
Biologics
G
6‐8 hours
Idea
Product
Market
Market Considerations
Method
Fabrication
Summary of Competitive Landscape
Problem
4
0
Distribution 
STIgma Free
• Online platform FedEx
Mass Distribution (CVS / Walgreens / Clinical)
• Fischer Scientific
• VWR
• Long‐Term In‐
House
T
41
Problem
Idea
Product
Market
Source: Industry analysis, Interviews
42
Problem
Idea
Product
Market