Innovative Treatment Technologies and How They Are Changing Treatment Delivery. Jeremy Mann Senior Associate October 15, 2009

Transcription

1 Innovative Treatment Technologies and How They Are Changing Treatment Delivery Jeremy Mann Senior Associate October 15, 2009

2 Faculty Ed Pigott, Ph.D., Principal, NeuroAdvantage, LLC Jeremy Mann, Senior Associate, OPEN MINDS 2

3 Agenda I. Advancement and Evolution in Medicine & Mental Health II. CNS Medical Devices the Role of Neurostimulators in Treatment Deep Brain Stimulators Vagus Nerve Stimulation Transcranial Magnetic Transmission The Brain Radio III. Advanced Medications & Novel Drug Delivery Systems Emergence of Long-Acting Therapies Role of Pharmaceuticals vs. Biotechnology Genomic Analysis IV. Non-Medication Technologies V. Impediments to Adoption of New Technology 3

4 Advancement and Evolution in Medicine & Mental Health 4

5 Penicillin Advancement and Innovation in Medicine & Mental Health Insulin Polio Vaccine EEG Heart Transplant 1930 s 1940 s 1950 s 1960 s 1970 s 1980 s 1990 s 2000 s MRI First Robotic Surgery ECT Haloperidol First Generation Antipsychotics Fluoxetine Second Generation Antipsychotics First Atypical Antipsychotic Long Acting Therapy First Deep Brain Stimulation Developed 5

6 Innovations in health care are not limited to drugs and devices but may also include new surgical procedures, new applications of existing technology, information technology, or communications advances. - Carolyn M. Clancy, M.D., Director, AHRQ Before the Joint Economic Committee July 9,

7 What will innovative treatment technologies look like in the future? Medical device developments Advanced medications Novel drug delivery systems Non-surgical & medication technologies 7

8 CNS Medical Devices The Role of Neurostimulators in Treatment 8

9 What is a Medical Device? Product which is used for a medical purpose in patients Diagnosis Therapy Surgery Differs from pharmaceutical drugs Medical devices provide a physical effect Pharmaceutical drugs provide a biochemical effect 9

10 Medical Device Heritage in CNS Electroconvulsive therapy (ECT) Treatment to induce seizures for therapeutic effect Gained widespread use in the 1940s Years ahead of most medical devices Used in treatment resistant depression and other severe mental illness 10

11 What is a Neurostimulator? Battery-powered medical device designed to deliver electrical stimulation to the to the brain 11

12 What is a Neurostimulator? Prominent neurostimulators in CNS Deep brain stimulators Vagus nerve stimulators Transcranial magnetic solutions 12

13 Neurostimulator Market Poised for Growth Projections identify this as a growth segment in medical devices Quality and quantity of stimulators to grow with advancements in technology Products have demonstrated long-term cost effectiveness 13

14 Deep Brain Stimulators (DBS) Implantable devices that deliver electrical pulses to stimulate the brain (similar to a pacemaker for cardiac conditions) 14

15 Applications of Deep Brain Stimulation FDA approved indications Essential tremor Parkinson s Disease Dystonia 15

16 Latest Developments in Deep Brain Stimulation Medtronic s Activa RC & Activa PC Approved in US in May, 2009 Advanced programming options for enhanced therapeutic affect Storage device for patient history Hand-held programmer Activa RC is first rechargeable stimulator 16

17 What s on the Horizon for Deep Brain Stimulation? Experimental Use & Research Tourette s Syndrome Major depression Challenged to Improve: 1. Patient selection 2. Implantation techniques 3. Speed and accuracy of intra-operative procedures 4. Battery life and battery recharging 5. Lead design 6. Lead programming 7. Develop remote programming and cycling strategies to improve device performance 17

18 Vagus Nerve Stimulation (VNS) Implantable neuroregulation device to deliver low energy electrical signals 18

19 Applications of Vagus Nerve Stimulation FDA approved indications Partial-onset epilepsy Treatment-resistant depression 19

20 Latest Developments in Vagus Nerve Stimulation Cyberonics announces licensing deal Entered collaboration with NeuroVista Corporation on October 1, 2009 Obtained a variety of technology and patents Enables the market leader to accelerate development program for improved VNS technology 20

21 Cyberonics Vagus Nerve Stimulation Device 21

22 What s on the Horizon for Vagus Nerve Stimulation? Experimental use and research Anxiety disorders Alzheimer s disease Migraines Fibromyalgia VBLOC Therapy (Enteromedics) Novel application for obesity Delivers electric signals through implanted leads to block vagal nerve transmission Neuroregulates nerve and organ function 22

23 Transcranial Magnetic Stimulation (TMS) Use of short pulses of magnetic fields to control mood by stimulating appropriate nerve cells Non-invasive treatment 23

24 Applications of Transcranial Magnetic Transmission FDA approved indications Major depressive disorder 24

25 Latest Developments in Transcranial Magnetic Stimulation Neuronetics introduces NeuroStar TMS Indicated for treatment of depression for patients who have not benefitted from prior antidepressant treatment. 25

26 What s on the Horizon for Transcranial Magnetic Stimulation? Most TMS use is off-label Approved by hospital ethics boards Used under FDA investigational device exemption Utilization under strict research protocols Experimental use and research Parkinson s disease Auditory hallucinations Schizophrenia Tinnitus Migraines Eating Disorders Obsessive Compulsive Disorder Other Mood Disorders 26

27 A TMS Investigational Device for Migraine Relief. 27

28 The Next Big Thing in Neurostimulation? The Brain Radio Product in development by Medtronic Surgically implantable radio device capable of monitoring and influencing brain activity May be used to treat symptoms of diseases such as Parkinson s and depression We want to measure the average activity of thousands of brain cells, said Tim Denison, a senior principal engineer at Medtronic Neurological Technologies, who presented the ISSCC paper. Essentially we want to build a brain radio that we can tune to the particular frequencies of the patient, he added. 28

29 Advanced Medications & Novel Drug Delivery Systems 29

30 Recent innovations in biomedicine seem poised to revolutionize medical practice. - Dana P. Goldman, Baoping Shang, Jayanta Bhattacharya, Alan M. Garber, Michael Hurd, Geoffrey F. Joyce, Darius N. Lakdawalla, Constantijn Panis, Paul G. Shekelle - Consequences Of Health Trends And Medical Innovation For The Future Elderly 30

31 R&D Supports Innovation Rise in novel delivery systems Less than half the medications approved in 2009 (through 8/20/09) were traditional oral delivery systems (12 of 26) Number of medications in development with innovative delivery systems continues to grow 31

32 Emergence of Long-acting therapy for Severe Mental Illness Long-acting atypical antipsychotic medications RISPERDAL CONSTA Two-week injection schedule Treatment of schizophrenia Longer-term treatment of Bipolar l Disorder INVEGA SUSTENNA Four-week injection schedule Acute and maintenance treatment of schizophrenia 32

33 33

34 Emergence of Long-Acting Therapy for Addiction Treatment Long-acting naltrexone VIVITROL Monthly injection schedule Treatment of alcohol dependence in patients unable to abstain from alcohol in an outpatient setting prior to initiation of treatment with Vivitrol 34

35 35

36 Emergence of Patches for Medication Administration EMSAM (Selegiline) Drug Patch for Depression DAYTRANA (methylphenidate) Drug Patch for ADHD 36

37 37

38 The Biotech Boom is Here Biotech grows 51% in two years 633 biotech medications in drug development in 2008, up from 418 in

39 Fundamental Differences Between Biotech and Pharma Pharma Analyzes natural compounds for cause and effect relationships Identify promising reactions and test to validate Drug refinement to bring product to market after extensive testing Biotech Genetic engineering Often a research engine for pharma, licensing drug discoveries to bring them to market 39

40 Convergence of Biotech and Pharma Creates New Development Opportunities New product opportunities on the horizon 40

41 Future CNS Research Likely to Focus on Causation Innovation will shift from medications (pharma or biotech) that treat illness when symptoms have worsened to early intervention Early intervention will evolve into preventive care 41

42 Genomic Analysis Genomic analysis points to causation of and ultimately intervention in behavioral disorders Uncovers causation of behavioral health disorders Promotes early intervention in the short term Potential for preventive care in the longer term 42

43 A Large Role of Genetics in Schizophrenia? Studies Link Chromosome Mutations to Vulnerability to Schizophrenia Presence of specific chromosomal mutations may increase likelihood Some experts estimate 73%-90% cases are related to genes 43

44 New Schizophrenia Gene Discovered Variation of Neuregulin Gene Influences schizophrenia delusions Discovered in February, 2009 at John Hopkins Offers potential for future innovation 44

45 Non-Surgical and Medication Technologies

46 Light and Sound Therapy Increases blood flow Strengthens brainwave patters Non-invasive, natural treatments 46

47 Forced Exercise for Parkinson s Patients 47

48 NeuroVR Therapy Full Immersion VR Cave VR 48

49 49

50 Health Tracker for Blackberry 50

51 OPEN MINDS 2009 All rights 51 reserved.

52 OPEN MINDS 2009 All rights 52 reserved.

53 OPEN MINDS 2009 All rights 53 reserved.

54 BodyMedia Armband Sensor Set Galvanic skin response Skin temperature Heat flux Near-body ambient temperature Heart beats Glucose monitor Weight Blood pressure 54

55 55

56 ResCare RestAssured Staff Sharing Model Using Remote Technology & Staff Remote caregiver Telecams Sensors Two-way audio On-call first responder 56

57 PERS Plus System Basic System Butler System 57

58 58

59 Impediments to Adoption of New Technologies 59

60 Clinical & Reimbursement Approval Processes May Impede Adoption Becoming harder to get FDA approval Higher cost to demonstrate than in a pill world Trials difficult to construct due to business partnerships needed Becoming harder to get insurance approvals High level of scrutiny for adding expensive technologies to insurance coverage 60

61 Infrastructure May Impede Adoption Organizational capability to evolve treatment protocols and processes needed CMHCs and other service providers must advance practice operations to accommodate new technologies Importance of collaboration grows as professionals identify niche areas to grow their practices As treatments grow in complexity, continuity of care barriers emerge 61

62 Physician Capabilities May Impede Adoption Understanding of neurology more critical in treatment systems (the new role of psychiatrists) Blurs the lines between psychiatry and neurology Increase in surgical applications in psych MDs must be more tech savvy to guide patients in new era 62

63 Questions & Discussion 63

64 Upcoming Events The 2010 OPEN MINDS Best Management Practices Institute: Finance and Technology Tools to Maximize Performance February 11 12, 2010, Hilton Resort, Clearwater Beach, Florida The 2010 OPEN MINDS Marketing & Innovation Institute: Preparing Executives for the Next Generation of Behavioral Health & Social Services March 13 14, 2010, Walt Disney World Resort, Orlando, Florida The 2010 OPEN MINDS Strategic Planning Institute: Tools for Managing in Tough Times May 20 21, 2010, La Cantera Resort, San Antonio, Texas 64

65 Bringing the Management of Behavioral Health & Social Services Into Focus York Street, Gettysburg, PA