1. Collaborations to Date:
How Far We’ve Come and
Obstacles That Remain
Linda Johnson, MPA
Sr. Director, Partnerships & Alliance Management
Diabetes Innovation Summit November 16, 2012

2. JDRF ‐ Leading The Global Fight Against T1D
CURE. TREAT. PREVENT.
Improving
Lives.
Advocacy Curing Development
Type 1 Diabetes
Research
Advocating & Influencing on Public Support from Individuals,
Behalf of People with T1D Foundations & Corporations
Accelerating Development
of New Therapies & Devices
2

3. JDRF: Partners to Advance T1D Therapies
JDRF works across the field to achieve its mission
Improving Lives.
Curing T1D.
3

4. JDRF Global Leadership in T1D Research
 Largest T1D non‐profit: $1.6B in research
funded over past 40 years
 In FY11 JDRF funded:
- $116 million direct support
- In 18 countries
- Including over 50 clinical trials
 More than 80% of JDRF expenditures directly
support research and research‐related education
 Forbes magazine called JDRF “...a tightly run
organization that puts almost every dollar spent to
work curing disease....”
4

5. U.S. Market Overview for Diabetes Treatment
The U.S. market for diabetes diagnosis, treatment & drug delivery is
expected to exceed $17 billion by 2018
US Diabetes Market
Note: Total revenue includes insulin, test strips, pens and syringes, pumps, CGMs, BGMs
and lancets & lancing devices
5
Source: iData Research 2011

6. Market Segmentation
Many areas for collaboration in a segmented market; multiple competitors in
most major product categories
Market Segment Activity in the US
Top 10 Market Leaders (2011) BGM CGM Strips Lancets Insulin Syringes Pens Pumps
Diabetes Diagnosis, Treatment & Drug Delivery
 
  


 Market leader by Segment
6
Source: iData Research 2011

7. Market Segmentation
Room for growth and new entrants in the CGM and Pump markets
Market Segment Activity in the US for Leading Device Companies
Diabetes Diagnosis, Treatment & Drug Delivery CGM Pumps
OTHERS
7
Source: iData Research 2011

8. Recent Industry Events: 2008‐2012
Collaborations and acquisitions for new technology development
develop CGM
products for Agreement to use
development, Evaluate use of
the hospital DexCom sensor in
supply and metreleptin in T1D
market t:slim system
commercialization
of BGM solutions Launches t‐Slim
insulin pump
to integrate Dexcom
CGM technology Lipoxen PLC Use of DexCom Development of
into Animas pumps Acquisition of Medingo CGM in Accu‐
Use of Sulixen long‐ novel sensor
to expand position in the Check system
acting insulin in Glide’s
growing insulin delivery
needle‐free injector
market
2008 2009 2010 2011 2012
Precisense A/S
iBGStar®
Acquisition Development of
Acquisition launched
of Precisense novel insulin
of Calibra
delivery systems
integrate Dexcom
CGM technology into develop 1st generation
the wireless handheld automated system for Develop pramlintide‐
OmniPod system the artificial pancreas insulin co‐formulation Development of
novel sensor
8
Source: iData Research; Thomson Pharma, Company Filings

9. Leveraging Resources Through Collaboration
ADA  Sensor
Nephropathy partnership Initiative: ~20M
 BioImaging
Initiative
Leverage JDRF
Innovative Medicines  Encapsulation
Initiative resources and The Helmsley
Charitable Trust
Regulatory Science influence actions Projects & Initiatives
Initiative
Research
Maximize output of
research in T1D
Create synergy and
accelerate progress
Foundation for National
Canadian Clinical Trial  Partnership with
Institutes of Health Foster multidisciplinary Network
T1D trials in Southern Canadian Gov’t
Beta cell project collaborations Ontario
 ~$34M in clinical trial
funding
The Wellcome Trust
Diabetes &
Inflammation
Laboraotry 9

10. Obstacles and Challenges
How can we encourage broader collaboration in the Field?
 Few collaborations – what motivates companies to collaborate or not?
• Intellectual property (IP)
• Differences/synergies in strategic goals
• Need for technology / Need for partner
 Need for novel technologies
• Crowd‐sourcing for new ideas – potential IP concerns
• Looking ‘outside the box’ – Communications companies, other industries (i.e.
Apple, Google, GE Healthcare, etc.)
 Time to market
• Regulatory approval process / time
• Reimbursement and access
 Limited funding
• Funding for new technologies/companies has been limited
• Multi‐therapy companies need to prioritize T1D
• T1D funders need to leverage their funding and avoid overlap

11. Today’s treatments for glucose control are
less than optimal
 Insulin monotherapy only option for most patients
• basal/bolus, recombinant human insulin, rapid/intermediate/long‐acting, etc
 Glycemic volatility remains a challenge
• >50% time spent outside euglycemic range
 HbA1C remains elevated in most of the population
 Systemic hyperinsulinization has undesirable consequences
• hypoglycemia still a major source of morbidity
 Comorbidities exacerbate dysglycemia
• insulin resistance, hyperlipidemia, obesity, …
 Rates and severity of complications remain elevated
11

12. JDRF Artificial Pancreas Project (APP)
 Fully automated monitoring
glucose & delivery of insulin
Control
Software
 Improving devices, drugs &
software
 Leading advocate for clear
regulatory pathways to
speed development &
approval
12

13. Development of an Artificial Pancreas
There will be multiple generations: each becoming more automated
System evolution will be technology dependent.
Needs assessment will vary by generation
1 2 3 4 5 6
Very Low Glucose Hypoglycemia Hypoglycemia/ Automated 2nd
Fully Automated Fully Automated
3rd
Insulin Off Pump Minimizer Hyperglycemia Basal/Hybrid Insulin Closed Multi‐Hormone
Pump Shuts off
st Predictive Minimizer Generation
Closed Loop Loop Generation
Closed Loop
1 Generation AP Systems
when user not hypoglycemia Same as Product Closed loop at Manual meal‐time AP
responding to causes alarms #2 but added all times with APbolus eliminated
Systems
low‐glucose alarm followed by feature allowing meal‐time manual
reduction or
cessation of
insulin dosing
above high
Systems
assist bolusing
insulin delivery threshold
before someone (e.g., 200mg/dl)
gets low JDRF‐Animas
Partnership
13

14. Needs Assessment: 1st Generation AP Systems
 Finalized algorithmic approach
 Defined clinical and regulatory path
 Pathway to commercial availability
 Communications standards
1 2 3 4 Generation 5
2 nd
6 3rd
Generation
st
1 Generation AP Systems
Very Low Glucose Hypoglycemia
Minimizer
Hypoglycemia/
Hyperglycemia Minimizer
Automated Basal/Hybrid Fully Automated Insulin Fully Automated
Insulin Off Pump
Predictive hypoglycemia causes Same as Product
Closed Loop
Closed loop at
AP Closed AP
Multi‐Hormone
Pump Shuts off when alarms followed by reduction or #2 but added feature allowing Loop Closed Loop
user not responding to
cessation of insulin delivery before
someone gets low
insulin dosing above high threshold
(e.g., 200mg/dl)
all times with
meal‐time manual assist Systems
Manual meal‐time bolus
Systems
low‐glucose alarm bolusing eliminated
14

15. Needs Assessment: 2nd Generation AP Systems
 Sensors  Algorithms
 Improved accuracy & reliability  Continuously optimizing
 Differentiated redundancy  With and without meal
(beyond Glucose Oxidase) bolus
 Calibration free, less invasive
 Pumps  Faster Insulin
 Performance feedback  Faster on and faster off
1 2 3 4 Generation 5
2 nd
6 3rd
Generation
st
1 Generation AP Systems
Very Low Glucose Hypoglycemia
Minimizer
Hypoglycemia/
Hyperglycemia Minimizer
Automated Basal/Hybrid Fully Automated Insulin Fully Automated
Insulin Off Pump
Predictive hypoglycemia causes Same as Product
Closed Loop
Closed loop at
AP Closed AP
Multi‐Hormone
Pump Shuts off when alarms followed by reduction or #2 but added feature allowing Loop Closed Loop
user not responding to
cessation of insulin delivery before
someone gets low
insulin dosing above high threshold
(e.g., 200mg/dl)
all times with
meal‐time manual assist Systems
Manual meal‐time bolus
Systems
low‐glucose alarm bolusing eliminated
15

16. Needs Assessment: 3rd Generation AP Systems
 Multi‐hormone therapies
 Approved soluble and pumpable complementary hormones/drugs
(i.e. glucagon, Symlin)
 Dual chamber pump
 Sensors
 Single port sensing and infusion
 Implantable long life sensors
1 2 3 4 Generation 5
2 nd
6 3rd
Generation
st
1 Generation AP Systems
Very Low Glucose Hypoglycemia
Minimizer
Hypoglycemia/
Hyperglycemia Minimizer
Automated Basal/Hybrid Fully Automated Insulin Fully Automated
Insulin Off Pump
Predictive hypoglycemia causes Same as Product
Closed Loop
Closed loop at
AP Closed AP
Multi‐Hormone
Pump Shuts off when alarms followed by reduction or #2 but added feature allowing Loop Closed Loop
user not responding to
cessation of insulin delivery before
someone gets low
insulin dosing above high threshold
(e.g., 200mg/dl)
all times with
meal‐time manual assist Systems
Manual meal‐time bolus
Systems
low‐glucose alarm bolusing eliminated
16

17. What Progress Have We Made?
Glucose Sensor Initiative
 Purpose
‐ To accelerate the development & delivery of advanced continuous
glucose sensors
 Objective / Scope:
‐ Improved Sensor Performance – redundancy, error detection, accuracy,
reliability, etc…
‐ Improved ease of use – a major barrier to use of today’s CGM devices
17

18. What Progress Have We Made?
Partnerships with Industry to Speed Development
Smart transmitter
Advanced CGM
AP Consortium Support
Improved Infusion
AP Consortium Support
Advanced CGM
AP Consortium Support
Treat-to-Range AP
AP Consortium Support
Metreleptin and
Pramlintide/Insulin AP Consortium Support
18

19. What Progress Have We Made?
Glucose‐modulating Drug Initiative: Strategy & Priorities
Lack of insulins with improved PK-PD profiles is a recognized obstacle in the path to achieving
euglycemia by closed loop artificial pancreas systems
 Improved insulins
• New insulins that work faster
• New and improved delivery tools (i.e. intradermal, inhaled, intraperitoneal)
– Dermal – microneedles JDRF-BD
Partnership
– Portal – DiaPort
– Thermal ‐ InsuPatch
 Other hormones JDRF-Amylin
Partnerships
• Glucagon, Amylin, Leptin, others
 New pathways
• Glucose‐responsive insulins JDRF GRI Prize
• Repositioned drugs: Holistic approach needed to achieve overall metabolic health
(i.e. Incretins, Metformin, SGLT2 inhibitors)
19

20. Comprehensive Strategy to Achieve Artificial Pancreas
Patient Availability
Artificial Pancreas
Critical Areas of Alignment
Research Regulatory Clinician Adoption Reimbursement
Clinical Trials
•Improved Insulin •Set expectations •Education/Outreach •Major health plans
•In-clinic feasibility
delivery systems •Expedite approval •Physician acceptance •New codes
•Outpatient testing
•Development of time •Patient counseling •Health outcomes
•Safety and
multiple AP systems •Influence guidance •Global assessment
effectiveness
•Improved insulin coverage
•Other hormones
20

21. Collaboration Across Development Pipeline is Critical
Discovery Pre‐ Clinical Market –
Lab Research Clinical Studies Broad
($$) ($$$$) ($$$$$$$$) Availability
• Develop new therapies
• Understand patient needs
• Engage critical development
capabilities
• Validate scientific discoveries &
conduct clinical trials
• Leverage resources
• Bring new products to market
and ensure patient access
IMPROVING PATIENTS’ LIVES
21

22. Food for thought….
 How can we further encourage innovation and crowd sourcing of ideas?
 How can we encourage industry and others to collaborate more and in a
broader way, to improve patients lives today and get to a closed loop
faster?
 What other industries should we be looking at for sourcing new
technologies?
 How can we leverage the efforts of everyone funding research in type 1
diabetes?
 How can we improve the regulatory approval process to decrease the time
to market for new technologies and ensure reimbursement?

23. THANK YOU!!