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Jdrf diabetes mine summit final 11 16-2012
 

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    Jdrf diabetes mine summit final 11 16-2012 Jdrf diabetes mine summit final 11 16-2012 Presentation Transcript

    • Collaborations to Date: How Far We’ve Come and  Obstacles That Remain Linda Johnson, MPASr. Director, Partnerships & Alliance ManagementDiabetes Innovation Summit November 16, 2012
    • JDRF ‐ Leading The Global Fight Against T1D CURE.  TREAT.  PREVENT. Improving Lives. Advocacy Curing Development Type 1 Diabetes ResearchAdvocating & Influencing on Public Support from Individuals, Behalf of People with T1D Foundations & Corporations Accelerating Development  of  New Therapies & Devices 2
    • JDRF: Partners to Advance T1D Therapies JDRF works across the field to achieve its missionImproving Lives.  Curing T1D. 3
    • 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
    • U.S. Market Overview for Diabetes TreatmentThe 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
    • 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
    • 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
    • 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 pumpto 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
    • 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
    • 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
    • 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
    • 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
    • Development of an Artificial PancreasThere 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 6Very Low Glucose  Hypoglycemia Hypoglycemia/ Automated  2nd Fully Automated  Fully Automated 3rdInsulin Off Pump Minimizer Hyperglycemia  Basal/Hybrid  Insulin Closed  Multi‐HormonePump Shuts off  st Predictive  Minimizer Generation Closed Loop Loop Generation Closed Loop 1 Generation AP Systemswhen user not  hypoglycemia  Same as Product  Closed loop at  Manual meal‐time  APresponding to  causes alarms  #2 but added  all times with  APbolus eliminated Systemslow‐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
    • 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 SystemsVery Low Glucose  Hypoglycemia Minimizer Hypoglycemia/ Hyperglycemia Minimizer Automated Basal/Hybrid  Fully Automated Insulin  Fully AutomatedInsulin Off Pump Predictive hypoglycemia causes  Same as Product  Closed Loop Closed loop at  AP Closed  AP Multi‐HormonePump Shuts off when  alarms followed by reduction or  #2 but added feature allowing  Loop Closed Loopuser 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  Systemslow‐glucose alarm bolusing eliminated 14
    • 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 SystemsVery Low Glucose  Hypoglycemia Minimizer Hypoglycemia/ Hyperglycemia Minimizer Automated Basal/Hybrid  Fully Automated Insulin  Fully AutomatedInsulin Off Pump Predictive hypoglycemia causes  Same as Product  Closed Loop Closed loop at  AP Closed  AP Multi‐HormonePump Shuts off when  alarms followed by reduction or  #2 but added feature allowing  Loop Closed Loopuser 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  Systemslow‐glucose alarm bolusing eliminated 15
    • 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 SystemsVery Low Glucose  Hypoglycemia Minimizer Hypoglycemia/ Hyperglycemia Minimizer Automated Basal/Hybrid  Fully Automated Insulin  Fully AutomatedInsulin Off Pump Predictive hypoglycemia causes  Same as Product  Closed Loop Closed loop at  AP Closed  AP Multi‐HormonePump Shuts off when  alarms followed by reduction or  #2 but added feature allowing  Loop Closed Loopuser 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  Systemslow‐glucose alarm bolusing eliminated 16
    • 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
    • What Progress Have We Made? Partnerships with Industry to Speed Development Smart transmitter Advanced CGM AP Consortium Support Improved Infusion AP Consortium Support Advanced CGMAP Consortium Support Treat-to-Range AP AP Consortium Support Metreleptin and Pramlintide/Insulin AP Consortium Support 18
    • 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
    • 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 feasibilitydelivery systems •Expedite approval •Physician acceptance •New codes •Outpatient testing•Development of time •Patient counseling •Health outcomes •Safety andmultiple AP systems •Influence guidance •Global assessment effectiveness•Improved insulin coverage•Other hormones 20
    • 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
    • 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!!