Collaborations to Date: How Far We’ve Come and Obstacles That Remain

Linda Johnson, MPASr. Director, Partnerships & Alliance Management

Diabetes Innovation Summit November 16, 2012

JDRF ‐ Leading The Global Fight Against T1D

Improving Lives.

Curing Type 1 Diabetes

Research

Accelerating Development of  New Therapies & Devices

Public Support from Individuals,Foundations & Corporations

DevelopmentAdvocacy

Advocating & Influencing onBehalf of People with T1D

CURE.  TREAT.  PREVENT.

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JDRF: Partners to Advance T1D Therapies

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JDRF works across the field to achieve its mission

Improving Lives. Curing T1D.

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....”

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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

Source: iData Research 2011

Market leader by Segment

Market Segment Activity in the US

BGM CGM Strips Lancets Insulin Syringes Pens PumpsTop 10 Market Leaders (2011)

Diabe

tes Diagnosis, Treatmen

t & Drug Delivery

Source: iData Research 2011

Market SegmentationMany areas for collaboration in a segmented market; multiple competitors in 

most major product categories

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Market Segment Activity in the US for Leading Device Companies

CGM Pumps

OTHERS

Diabe

tes Diagnosis, Treatmen

t & Drug Delivery

Source: iData Research 2011

Market SegmentationRoom for growth and new entrants in the CGM and Pump markets

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Use of DexComCGM in Accu‐Check system

20112008

integrate DexcomCGM technology into the wireless handheld 

OmniPod system

to integrate DexcomCGM technology 

into Animas pumps

develop CGM products for the hospital market 

Recent Industry Events: 2008‐2012Collaborations and acquisitions for new technology development

Use of Sulixen long‐acting insulin in Glide’s needle‐free injector

Lipoxen PLC

2009

Precisense A/S

Acquisition of Precisense

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development, supply and 

commercialization of BGM solutions

develop 1st generation automated system for the artificial pancreas

Acquisition of Medingoto expand position in the growing insulin delivery 

market 

Development of novel insulin 

delivery systems

Develop pramlintide‐insulin co‐formulation

Evaluate use of metreleptin in T1D

2010

Launches t‐Slim insulin pump

Acquisition of Calibra

Agreement to use DexCom sensor in t:slim system

2012

Development of novel sensor

Development of novel sensor

iBGStar®  launched

Source: iData Research; Thomson Pharma, Company Filings

Leveraging Resources Through Collaboration

ADANephropathy partnership

The Helmsley Charitable Trust

Projects & Initiatives

Canadian Clinical Trial Network

T1D trials in Southern Ontario

The Wellcome TrustDiabetes & Inflammation Laboraotry

Foundation for National Institutes of HealthBeta cell project

Innovative Medicines Initiative

Regulatory Science Research

Leverage JDRF resources and

influence actions

Sensor Initiative: ~20M BioImaging

Initiative Encapsulation

Initiative

Partnership with Canadian Gov’t

~$34M in clinical trial funding

Maximize output of research in T1D

Foster multidisciplinary collaborations

Create synergy and accelerate progress

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Obstacles and Challenges

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

How can we encourage broader collaboration in the Field?

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

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JDRF Artificial Pancreas Project (APP)

Control Software

Fully automated monitoring  glucose & delivery of insulin Improving devices, drugs & software

Leading advocate for clear regulatory pathways to speed development & approval 

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There will be multiple generations: each becoming more automated 

Development of an Artificial Pancreas

1Very Low Glucose Insulin Off PumpPump Shuts off when user not responding to low‐glucose alarm

2HypoglycemiaMinimizerPredictive hypoglycemia causes alarms followed by reduction or cessation of insulin delivery before someone gets low

3Hypoglycemia/Hyperglycemia MinimizerSame as Product #2 but added feature allowing insulin dosing above high threshold (e.g., 200mg/dl)

4Automated Basal/Hybrid Closed LoopClosed loop at all times with meal‐time manual assist bolusing

5Fully Automated Insulin Closed LoopManual meal‐time bolus eliminated

6Fully AutomatedMulti‐HormoneClosed Loop

JDRF‐AnimasPartnership

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1st Generation AP Systems

2nd

Generation AP

Systems

3rd

Generation AP

Systems

System evolution will be technology dependent.Needs assessment will vary by generation

Needs Assessment: 1st Generation AP Systems

Finalized algorithmic approach

Defined clinical and regulatory path

Pathway to commercial availability

Communications standards

6Fully AutomatedMulti‐HormoneClosed Loop

1Very Low Glucose Insulin Off PumpPump Shuts off when user not responding to low‐glucose alarm

2HypoglycemiaMinimizer

Predictive hypoglycemia causes alarms followed by reduction or cessation of insulin delivery before someone gets low

3Hypoglycemia/Hyperglycemia Minimizer

Same as Product #2 but added feature allowing insulin dosing above high threshold (e.g., 200mg/dl)

4Automated Basal/Hybrid Closed Loop

Closed loop at all times with meal‐time manual assist bolusing

5Fully Automated Insulin Closed LoopManual meal‐time bolus eliminated

1st Generation AP Systems2nd

Generation AP

Systems

3rd

Generation AP

Systems

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Needs Assessment: 2nd Generation AP Systems

Sensors

Improved accuracy & reliability

Differentiated redundancy (beyond Glucose Oxidase)

Calibration free, less invasive

Pumps

Performance feedback

Algorithms

Continuously optimizing

With and without meal bolus

Faster Insulin

Faster on and faster off

6Fully AutomatedMulti‐HormoneClosed Loop

1Very Low Glucose Insulin Off PumpPump Shuts off when user not responding to low‐glucose alarm

2HypoglycemiaMinimizer

Predictive hypoglycemia causes alarms followed by reduction or cessation of insulin delivery before someone gets low

3Hypoglycemia/Hyperglycemia Minimizer

Same as Product #2 but added feature allowing insulin dosing above high threshold (e.g., 200mg/dl)

4Automated Basal/Hybrid Closed Loop

Closed loop at all times with meal‐time manual assist bolusing

5Fully Automated Insulin Closed LoopManual meal‐time bolus eliminated

1st Generation AP Systems2nd

Generation AP

Systems

3rd

Generation AP

Systems

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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

6Fully AutomatedMulti‐HormoneClosed Loop

1Very Low Glucose Insulin Off PumpPump Shuts off when user not responding to low‐glucose alarm

2HypoglycemiaMinimizer

Predictive hypoglycemia causes alarms followed by reduction or cessation of insulin delivery before someone gets low

3Hypoglycemia/Hyperglycemia Minimizer

Same as Product #2 but added feature allowing insulin dosing above high threshold (e.g., 200mg/dl)

4Automated Basal/Hybrid Closed Loop

Closed loop at all times with meal‐time manual assist bolusing

5Fully Automated Insulin Closed LoopManual meal‐time bolus eliminated

1st Generation AP Systems2nd

Generation AP

Systems

3rd

Generation AP

Systems

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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

What Progress Have We Made?

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Partnerships with Industry to Speed Development

What Progress Have We Made?

Smart transmitter AP Consortium Support

Advanced CGMAP Consortium Support

Advanced CGMImproved Infusion

AP Consortium Support

Treat-to-Range APAP Consortium Support

Metreleptin and Pramlintide/Insulin AP Consortium Support

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What Progress Have We Made?Glucose‐modulating Drug Initiative: Strategy & Priorities

Improved insulins• New insulins that work faster

• New and improved delivery tools (i.e. intradermal, inhaled, intraperitoneal) 

– Dermal – microneedles

– Portal – DiaPort

– Thermal ‐ InsuPatch

Other hormones• Glucagon, Amylin, Leptin, others

New pathways• Glucose‐responsive insulins

• Repositioned drugs: Holistic approach needed to achieve overall metabolic health (i.e. Incretins, Metformin, SGLT2 inhibitors) 

Lack of insulins with improved PK-PD profiles is a recognized obstacle in the path to achieving euglycemia by closed loop artificial pancreas systems

JDRF-BDPartnership

JDRF-AmylinPartnerships

JDRF GRI Prize

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Comprehensive Strategy to Achieve Artificial Pancreas Patient Availability

Artificial PancreasCritical Areas of Alignment

Research

•Improved Insulin delivery systems•Development of multiple AP systems•Improved insulin•Other hormones

Clinical Trials

•In-clinic feasibility•Outpatient testing•Safety and effectiveness

Clinician Adoption

•Education/Outreach•Physician acceptance•Patient counseling

Reimbursement

•Major health plans•New codes•Health outcomes•Global assessmentcoverage

Regulatory

•Set expectations •Expedite approvaltime

•Influence guidance

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Collaboration Across Development Pipeline is Critical

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• 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

DiscoveryLab Research

($$)

Market –Broad 

Availability

Clinical Studies

($$$$$$$$)

Pre‐Clinical($$$$)

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?

THANK YOU!!