Taking cognitive/ emotional assessments and therapies to scale


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Three digital health entrepreneurs–who have collectively raised over $75 million in venture capital in the last 18 months– and an investor discussed their respective visions and approaches to revolutionize brain and mental health in areas such as ADHD, substance abuse, and general brain fitness.
--Chair: Rita Carter, Science writer and BBC Contributor
--Edward Kliphuis, Investment Director at Merck Ventures
--Dr. Eddie Martucci, CEO of Akili Interactive Labs
--Dr. Corey McCann, CEO of Pear Therapeutics

Learn more at sharpbrains.com

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  • Taking cognitive/ emotional assessments and therapies to scale

    1. 1. Taking cognitive/ emotional assessments and therapies to scale
    2. 2. Taking cognitive/ emotional assessments and therapies to scale Chaired by: Rita Carter, Science writer and BBC Contributor Edward Kilphuis, Investment Director, Merck Ventures Dr. Eddie Martucci, Chief Executive Officer, Akili Interactive Labs Dr. Corey McCann, Chief Executive Officer, Pear Therapeutics
    3. 3. MERCK VENTURES Edward Kliphuis, Investment Director December 6, 2016 SharpBrains Virtual Summit 2016
    5. 5. MERCK VENTURES5 Introduction: who are we? Merck Ventures is the corporate VC arm of Merck KGaA Healthcare New Businesses Performance Materials MerckVentures €300mevergreenfund Life Sciences
    6. 6. MERCK VENTURES6 • Design ‘killer’ experiments • Emphasis on business development • Top tier investment syndicates How do we add value? Pharma-quality focus on products, but with biotech creativity and speed P A R E N T  Leverage R&D expertise for “wet due diligence”  Nurture assets: active R&D, BD, commercial involvement  Offer access to manufacturing, screening capabilities etc. in exchange for equity  Early front-row seat, early due diligence, preferred relationship  Catalyze exchange and creation of novel ideas  Foster corporate entrepreneurship within Merck P O R T F O L I O MERCK VENTURES Confidential – please do not distribute • Through network management, board & SAB • Hands-on board support • Interim C-level/executive support
    7. 7. MERCK VENTURES7 Global team;Merck Ventures Team Andreas Jurgeit Director LS AMSTERDAM Nadia Sobotzki Analyst LS AMSTERDAM Clemens Lakner Associate LS DARMSTADT Sven Harmsen Director PM BOSTON Christian Patze Analyst PM BOSTON Edward Kliphuis Director NB AMSTERDAM Anna Faddeeva- Vakhrushkeva Analyst NB AMSTERDAM Alexander Hoffmann Principal NB AMSTERDAM Roel Bulthuis Managing Director & SVP AMSTERDAM Marco Rau Legal Counsel DARMSTADT Laura Braeuninger- Weimer Head of Venture Ops DARMSTADT Sandie McCulloch Executive Assistant AMSTERDAM Jasper Bos Head of Healthcare & VP GENEVA Hakan Goker Senior Director HC AMSTERDAM Bram Vanparys Director HC AMSTERDAM Alicia Irurzun-Lafitte Principal HC BOSTON Jeroen Bakker Associate HC AMSTERDAM Cheryl Zimberlin Associate HC AMSTERDAM Vincent van der Mark Analyst HC AMSTERDAM Cheng-Fu ‘Tony’ Chang Analyst LS AMSTERDAM
    8. 8. MERCK VENTURES8 Vision: improve patient outcomes • Using the latest technology to improve the delivery of care • Improve the lives and well-being of patients, living with a specialty chronic condition • Delivering value and improved outcomes to Payors and Health Care Providers • Going beyond selling the drug and providing digital care
    10. 10. MERCK VENTURES10 Targeting the brain Fundamental to providing care beyond the pill Assessment Intervention I. Stand alone interventions a. ADHD b. Autism c. Aging associated cognitive decline d. Depression II. Combination treatment: addressing secondary indication in addition to disease-modifying agents a. Cognitive decline associated with chronic diseases b. Depression associated with chronic diseases c. Providing patients control over their own indication I. Screening tool for early disease detection a. Multiple sclerosis b. Alzheimer’s c. Further indications associated with cognitive decline II. Disease monitoring a. Screening brain functionality as a proxy for disease progression / treatment effect b. Monitoring adherence c. Empowering patients through ABC: • A = autonomy (control over own situation); • B = belonging (connection with other people); • C = competence (sense of satisfaction to master a task)
    11. 11. MERCK VENTURES11 Merck Ventures: Portfolio company overview by TA Oncology (ex. discovery tech) NeurologyFertility Discovery Technologie s Auto- immune Merck Serono Spin-off Legacy BD Deal ActiveExit
    12. 12. MERCK VENTURES12 Digitally enabled solutions open up a new frontier The key is to deliver patient-centric care 12 » Multiple Sclerosis » Rheumatoid Arthritis » Cancer » Psoriasis » Crohn’s disease » Severe Asthma » Psoriatic Arthritis » Ulcerative Colitis » Systemic Lupus » Osteoarthritis Merck Ventures’ initial target: Chronic Diseases It’s not about developing software, it’s about delivering a service to the patients, providers and payers enabled by digital tools
    13. 13. MERCK VENTURES13 Let’s continue the dialogue How can we improve patient outcomes together
    15. 15. MERCK VENTURES15 NB focus areas 15 New Business focus areas Investment strategy to enable future business opportunities  Digital Health / health tech: technology enabled healthcare  Big data & analytics  Biosensing and wearables  Software & apps: patient enabling and patient empowerment  Digital medical devices  Affective computing for monitoring, safety and/or commercial  Robotics & supply chain optimization  Advanced materials & 3D printing  Miniaturization & nanotechnology  Custom manufacturing / Point-of- sale printing  Printed electronics  Materials for cross-divisional applications  “Green” (bio)tech  Genome editing of plants / seeds  Food / vitamins & preventive solutions Existing businessesNew businesses
    16. 16. SharpBrains Virtual Summit December, 2016 SharpBrains Virtual Summit December 2016 Dr. Eddie Martucci, Chief Executive Officer, Akili Interactive Labs
    17. 17. Imagine what medicine can be 17
    18. 18. 18 • Source technologies targeting critical neural systems • File and in-license foundational IP • Re-construct tech into consumer-grade engine • Add algorithm IP • Identify patient populations & test feasibility • Conduct Pilot-/Pivotal- phase clinical trials • All development under medical device quality systems • Direct FDA interaction “Interactive Digital Medicine” Production Studio
    19. 19. Treatments • Daily-use digital interventions for treatment of conditions/symptoms • Adaptive algorithms automatically optimize experience to any user • Proprietary personalized reward cycles to keep users engaged & challenged • Portal for physicians and caregivers to track compliance & progress • At-home, accessible, safe treatment • < 7 min one-time or repeated use • Suits ultra-frequent, at home deployment • Multiple scheduling configurations (daily, weekly) • Fast diagnoses or tracking of treatment efficacy & side effects Screens & Monitors Two Product Lines Proprietary mechanism enables therapeutics and assessments
    20. 20. Alzheimer’s biomarker Undisclosed program Sensitivity to symptoms Sensitivity to drug ] Build neurotypical data Akili Ongoing Programs ADHD Autism Spectrum Disorders Sensory Processing Disorder Depression (geriatric) Alzheimer’s disease Depression (adult) ADHD/autism (college-age) Cerebrovascular Dementia Parkinson’s disease TBI Multiple Sclerosis ICU Delerium 20 FEASIBILITY PILOT EFFICACY TRIALS PIVOTAL TRIALS Monitor Programs Therapy Programs FEASIBILITY DATA VALIDATION COMMERCIALIZATION
    21. 21. 21 How do we scale technology in mainstream medicine?
    22. 22. 22 leverage existing models How do we scale technology in mainstream medicine?
    23. 23. 23 How do we scale technology in mainstream medicine? expand the model leverage existing models
    24. 24. 24 Product Profile Regulated digital medicine platform • FDA-cleared, Doctor- prescribed, Used at home • Monthly subscription model for therapeutic
    25. 25. 25 • FDA-cleared, Doctor- prescribed, Used at home • Monthly subscription model for therapeutic • Direct patient relationship via high-touch customer service • Centralized data-portal for all stakeholders (parents, doctors, etc.) Product Profile Regulated digital medicine platform
    26. 26. ssssss 26 Non-exclusive R&D collaboration on clinical trial for Akili’s product as a digital biomarker for amyloid in asymptomatic elderly populations. Direct investment in Akili, and collaboration on Akili’s first digital medicine pediatric ADHD efficacy trial Direct investment in Akili's Series B Direct investment in Akili’s Series B Akili’s Partnerships Philanthropic investment (through DELSIA venture arm) to fund efficacy study for autism digital medicine
    27. 27. Web, Mobile and Physical Media Treatment Support 27 Healthcare Solutions Applications Doctor Parent Patient
    28. 28. 28 Imagine what medicine can be
    29. 29. October 8th – 11th, 2015 ◦ Boca Raton, Florida Dr. Corey McCann, Chief Executive Officer, Pear Therapeutics
    30. 30. 30 Rate 1 2 3 2002 2004 2006 2008 2010 2012 Year
    31. 31. 31
    32. 32. 32 Identification and evaluation Concept development and prototyping GMP device development Clinical validation and pivotal studies Regulatory approval Commercialization and reimbursement
    33. 33. 33 Indication Content Partner Prototype Pilot study Opiate Dependence Pivotal study Regulatory submission Approval General Anxiety Disorder Insomnia Major Depressive Disorder Traumatic Brain Injury Acute & Chronic Pain Combat-PTSD ADHD Stage Schizophrenia Substance Use Disorder Product reSET-OTM reSETTM reVIVETM reCALLTM ThriveTM PEAR-007 PEAR-006 PEAR-010 PEAR-009 PEAR-008
    34. 34. 34 Mobile Dashboard CBT Modules Contingency Management Craving & Trigger Assessment Fluency Training
    35. 35. 35 Concept Proficiency Abstinence and Appointments Module Use Cravings and Triggers
    36. 36. 36 TAU reSETTM Week 4 6 7 8 9 10 1153210 12 10 20 30 40 50 0 %Abstinent Time Point reSET (n=255) TAU (n=252) P-value* Week 9-12 29.7% 16.0% 0.0076 Population All comers Week 9-12 10.1% 3.0% 0.0099Non-abstinent at start 1 Campbell et al. Am J Psychiatry. 2014.
    37. 37. Confidential- do not distribute 37 1 Campbell et al. Am J Psychiatry. 2014. Treatment Retention Module Completion Time (weeks) Average#modules completedperweek Module Retention Averagetimespenton modules(inminutes) Time (weeks) TAU reSETTM P = All- Comers 36.5% (n=252) 27.8% (n=255) 0.0316 Time (weeks) PercentageRemaininginTreatment Abstinent Non-Abstinent 0 1 2 3 4 5 6 7 8 9 10 11 12 20 40 60 Abstinent Non-Abstinent 1 2 3 4 5 6 7 8 9 10 11 12 Abstinent Non-Abstinent 0 1 2 3 4 5 0 2 4 6 8 10 12 60 70 80 90 100
    38. 38. Confidential- do not distribute 38
    39. 39. Confidential- do not distribute 39 reSET™: Digital therapeutic to enhance abstinence in Opiate Dependence Buprenorphine reSET-O™: branded drug/device combination therapy with best in class efficacy for Opiate Dependence =+
    40. 40. Confidential- do not distribute 40 1 Marsch et al. J Substance Abuse Treatment. 2014. 3 Christensen et al. 2014 2 Bickel et al. Exp Clin Psychopharmacol. 2008. In-office Therapy reSET-OTM p<0.01%WeeksOpioid Abstinence 20 40 60 80 00 2 4 6 8 0 200 400 600 800 Avg Therapist Contact Time (min) MeanweeksofContinuous OpioidAbstinence reSET-OTM In-office Therapy
    41. 41. 41 Enhanced abstinence when used in lieu of in-office therapy and as partial substitution Efficacy for patients addicted to opiates, cocaine, stimulants, marijuana, and alcohol Enhanced abstinence and program retention, reduced addiction severity, high-risk sexual behavior, and recidivism Efficacy demonstrated in studies ranging from 12 weeks to 1 year Use across in Intensive Outpatient Therapy (IOT), Methadone Maintenance Therapy (MMT), and in prison settings Efficacy as a monotherapy, and when used in combination with medication
    42. 42. 1. “DHS Addictions and Mental Health Division Medicaid Procedure Codes and Reimbursement Rates For Substance Use Disorder Treatment and Recovery Services”. 2013. http://www.yamhillcco.org/docs/default-source/provider-forms/oop- final_ycco_cd_fee_schedule_eff_jul13.pdf?sfvrsn=0 2. Campbell et. Al. Internet Delivered Treatment for Substance Abuse: A Multi-site Randomized Control Trial. American Journal of Psychiatry. June 2014. 3. Understanding the Cost of Rehab. Addictioncenter.com. https://www.addictioncenter.com/rehab-questions/cost-of-drug-and-alcohol-treatment/ 4. Drug Abuse Treatment Outcome Studies (DATOS): Treatment Retention and Follow-up Outcomes. http://www.datos.org/adults/adults-retention.html 5. Greenfield, Lawrence. Effectiveness of Long-Term Residential Substance Abuse Treatment for Women. The American Journal of Drug and Alcohol Abuse. 2004. Vol. 30, No. 3. 6. http://icer-review.org/wp-content/uploads/2014/04/CEPAC-Opioid-Dependence-Final-Report-For-Posting-July-211.pdf 7. Assumes drug price/month from first column plus an additional $3,2401 for standard intensive outpatient therapy. 8. Vivitrol: Evaluation of efficacy and safety in opioid dependence. https://www.vivitrol.com/HCP/Efficacy/OpioidDependence. Accessed July 2016. 9. “Braeburn Pharmaceuticals Announces Commercialization Plans for Probuphine Implant, Six Month Treatment for Opioid Dependence”. May 2016. https://braeburnpharmaceuticals.com/braeburn-pharmaceuticals-announces-commercialization-plans-for-probuphine-buprenorphine- implant-six-month-treatment-for-opioid-dependence/. 10. “Second Probuphine Pivotal Trial Shows Statistically Significant Decrease in Opioid Use for Patients Suffering from Opioid Addiction”. Titan Pharmaceuticals. 2011. http://www.titanpharm.com/news/press-releases/detail/76/titan-pharmaceuticals-announces-positive-top-line-results 11. Christensen et. al. Adding an Internet-Delivered Treatment to an Efficacious Treatment Package for Opioid Dependence. Journal of Consulting and Clinical Psychology, 2014. Vol. 82, No. 6. Outpatient Therapy Inpatient Therapy reSETTM Vivitrol (Naltrexone) Probuphine Suboxone / Zubsolv Buprenorphine Generic Tablet reSET-OTM Price / Month (incl. Behav. Tx) Retention (After 12 Wks of Tx) Abstinence (After 12 Wks of Tx) TBD $3,240 1 $30,000 3 $4,640 7 $4,065 7 $3,740 7 $3,740 7 TBD 63% 2 30% 4 72% 2 28% 6 64%10 52% 6 52% 6 80%11 15-25% 2 30% 5 30% 2 33% 8 31%10 34%11 34%11 34%11
    43. 43. Confidential- do not distribute 43 1 clinicatrials.gov 2 Ben-Zeev et al. 2013. Psychiatric Rehabilitation Journal. 36(4) 289- 296. 3 Ben-Zeev et al. 2014. Schizophrenia Bulletin. 1-10. 4 Ben-Zeev et al. 2016. JMIR Mental Health. 3(3) e34. 1 Clinicaltrials.gov 2 Defide et al. Neuropsychopharmacology. 2013. reCALLTMTHRIVETM
    44. 44. reSETTM Launch of FDA approved product in SUD as monotherapy Launch of additional products in insomnia, pain, GAD, and beyond Portfolio 44 Launch of FDA approved product in schizophrenia in combination with atypical antipsychotics THRIVETM reSET-OTM Launch of FDA approved product in combination with buprenorphine for Opiate Dependence 2017 2018 2019
    45. 45. Confidential- do not distribute 45
    46. 46. Q&A
    47. 47. Thank you to all Participants!
    48. 48. Sponsors Thank you to all Speakers & Sponsors!
    49. 49. To learn more, visit sharpbrains.com