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Engineering Personalized Medicine AIMBE Feb 22 2011

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Engineering Personalized Medicine AIMBE Feb 22 2011

  1. 1. AIMBE Engineering Personalized Medicine Michael N. Helmus, Ph.D., Consultant Medical Devices, Biomaterials Drug Delivery, and Nanotechnology (508) 767 0585 mnhelmus@msn.com Feb. 22, 2011
  2. 2. Michael N. Helmus, Ph.D., Consultant mnhelmus@msn.com Personalized Medicine 'The molecular methods that make personalized medicine possible include testing for variations in genes, gene expression, proteins and metabolites, as well as new treatments that target molecular mechanisms. Test results are correlated with clinical factors - such as disease state, prediction of future disease states, drug response, and treatment prognosis - to help physicians individualize treatment for each patient' Personalized Medicine Coalition www.personalizedmedicinecoalition.org/sci encepolicy/personalmed-101_overview.php
  3. 3. Personalized Medicine to Drive New Technology Less Invasive Therapies Custom Implants Biosensors Implantable biosensors, eg CHF Telemetered devices and implants Molecular Diagnostics Genomic basis of Disease Local and Targeted Drug Delivery Pharmacogenomics Tissue Engineering Cell Therapy New Imaging, eg. Histologic Grade OCT Personalized Medicine: Local and Targeted Diagnostics and Therapeutics to allow “individualized treatment for each patient”
  4. 4. Michael N. Helmus, Ph.D., Consultant mnhelmus@msn.com Leverage Potential Disruptive Technologies Drug Delivery Therapeutic Polymers Biodegradables Tissue Engineering Stem Cells Smart Materials Imaging, e.g. Molecular Imaging Genomics Proteomics Glycomics Computation NanoStructures MEMS Telemetered/sensored implants
  5. 5. Michael N. Helmus, Ph.D., Consultant mnhelmus@msn.com Functionality-Biocompatibility Recellularization,andneogenesisoftissue Time Passive Biomaterials Bioactive, Biodegradables & Drug Delivery Tissue Engineering Disruptive Biocompatibility Based Technologies Genomics Identifying effective Therapies
  6. 6. Michael N. Helmus, Ph.D., Consultant mnhelmus@msn.com Interventional Placements of Implantable Devices and Treatments e.g. CABG, Heart Valves, Joints Tissue Engineered Constructs, Chordae Tendon Repair, Biodegradable Injectables for Heart Failure Functionality Time Surgical Interventional - Stents MIS Disruptive Technology: Surgical Procedures Niche Market: Elderly? History of Stent Grafts for AAA Genomics Identifying Effective Therapies
  7. 7. Michael N. Helmus, Ph.D., Consultant mnhelmus@msn.com Nanopores for drug delivery Nanoenabled Diagnostics and Therapies Nanoparticles to cross The blood brain barrier: Diagnostics, drug delivery Gold shell nanoparticles for Tumor ablation Nanofiber Scaffolds for Vascular prostheses & Tissue engineering Nanodiagnostics for point of care Diagnosis: infectious disease, biomarkers Quantum Dots for Molecular Imaging Nanoporous filters: Drug delivery, Hemodialysis, Plasmapheresis, Oxygenation – Celgard has been available for 30 + years
  8. 8. Michael N. Helmus, Ph.D., Consultant mnhelmus@msn.com Implantation of tissue engineered construct. Tissue Engineered Devices Biopsy/tissue sample for autologous cell &/or isolation of stem cells. Culturing of cells to expand if needed. Scaffolds: Decellularized tissue, Polymer, Biodegradables, Bioderived, eg collagen Seeded scaffolds for direct implantation or growth of tissue in bioreactor Healed device
  9. 9. Michael N. Helmus, Ph.D., Consultant mnhelmus@msn.com Small Molecules Proteins/Growth Factors Gene Transfection Remodeled Organ In Situ Healing Injectables to recruit bmc’s/tissue stem cells to Regenerate in situ.
  10. 10. Identification of Drivers for New Technology • Cost Containment • New Diagnostics and Point of Care • Infectious Disease • Epidemic/Pandemic Surveillance • Biomarkers for Disease • Enablement for interventions: e.g. vulnerable plaque Personalized Medicine
  11. 11. Cleveland Clinic announces its top 10 medical innovations of 2010 1. Molecular imaging biomarker for early detection of Alzheimer's Disease 2. Targeted T-cell antibody for metastatic melanoma 3. First cancer vaccine approved by the FDA 4. Jupiter Study: Statins for healthy individuals 6. Telehealth monitoring for individuals with heart failure 7. Endoscopic weight-loss procedure 8. Exhaled nitric oxide (NO) breath analysis for diagnosing asthma 9. Oral disease modifying treatment for multiple sclerosis 10. Capsule endoscopy for diagnosis of pediatric GI disorders http://www.cleveland.com/healthfit/index.ssf/2010/11/2010_innovations_summit_clevel.h
  12. 12. • New Therapeutics – Cancer – Infectious Disease – Immune Disease – Minimally/Less Invasive Procedures – Implants – Tissue Engineering Drivers for New Technology cont.
  13. 13. Michael N. Helmus, Ph.D., Consultant mnhelmus@msn.com Commercializing Technology Pulling Technology across the Valley of Death Product Commercialization Discovery & Research Development & Engineering Manufacturing & Marketing “Valley of Death” Value
  14. 14. •The bridge to commercialization • Proof of principle in a clinically relevant setting • Drivers for Development • Cost Containment, New Therapies, New Diagnostics and Point of Care Medicine •Intellectual Property Commercializing
  15. 15. Michael N. Helmus, Ph.D., Consultant mnhelmus@msn.com Recent Examples Personalized Medicine * Microfluidics chip can spot rare cancer cells in blood Mass General Hospital - microfluidics chip to detect groups of rare tumor cells in a patient's blood sample. The technique could help improve research into cancer metastasis and spare patients from undergoing invasive procedures used for collecting tumor samples. MIT Technology Review (10/5) *J&J Invests in New Noninvasive Cancer Test Johnson & Johnson (J&J) has announced that it is investing $30 million in a new test that could detect—and help doctors treat—a variety of cancers from a simple blood draw, according to reporting by Yahoo Canada News. While experts concede that such a test is still years away, some are predicting that it could revolutionize cancer detection and treatment. AdvaMed Smart Briefs
  16. 16. Michael N. Helmus, Ph.D., Consultant mnhelmus@msn.com Setting Expectations How to innovate while addressing concerns. Suggests need to establish well delineated practice guidelines as the technology translates into the clinic (CNN) – Cancer breakthrough -- or nightmare? January 11, 2011 “A simple blood test. It's able to detect minute quantities of cancer cells that might be circulating in your bloodstream. It's reported to be able to detect a single cell. It's intended to allow cancer patients to start treatment much earlier. It's supposed to save lives. It's a cancer breakthrough. But it's not that simple. The test could just as easily start a cancer epidemic.”
  17. 17. Personalized medicine. Personalized medicine includes the detection of disease predisposition, screening and early disease diagnosis, prognosis assessment, pharmacogenomic measurements of drug efficacy and risk of toxic effects, and the monitoring of the illness until the final disease outcome is known. JS Ross, GS Ginsburg, The Integration of Molecular Diagnostics With Therapeutics Jeffrey S. Ross, MD, Geoffrey S. Ginsburg, MD, PhD American Journal of Clinical Pathology. 2003;119(1) http://www.medscape.com/viewarticle/447846
  18. 18. When its personal, its not quick enough!!!
  19. 19. When it becomes personal!! Hi Fever, fainting, coughing ER visit, immediate admission to ICU Chest X-Ray consistent with bacterial infection Hi dose Antibiotics Rapid progression to BiPap and intubation and ventilator within 4 days with continuing deterioration
  20. 20. Discussion with family About 4 weeks prior: Exposure to Polyurethane sealant during renovation, poor ventilation, walls exposed 2 weeks prior: reexposure to Polyurethane sealant Immediately administered prednisone and antifungal (as precaution) Lavage indicated no fungal or bacterial involvment Stopped Antifungal 9 days on ventilator Diagnosis hypersensitivity pneumonia When it becomes personal!!
  21. 21. Disease Management Admission Circulating WBC Biomarkers Circulating Antibodies Biosensors Radiology Complete blood count Complete metabolic profile Blood gases or pulse oximetry Bronschoscopy, Bronchoalveolar lavage, transbronchial biopsy Thoracoscopic or open-lung biopsy Radiographically guided transthoracic aspirate Legionella, Chlamydia, Mycoplasma serology Fungal serology Evaluation for congestive heart failure, pulmonary embolus, neoplasm, connective tissue disease Deteriorating patient without definitive diagnosis of cause Earlier impetus for lavage and biopsy Earlier treatment with steroids Eliminate diagnosis of fungal infection Eliminate or reduce need for ventilation More rapid recovery, mitigating DVT Personalized Medicine Early Disease Diagnosis: Molecular Pathology Screening Subclinical Disease processes Predisposition
  22. 22. Bilateral below knee DVT Increased heparin, Vena cava filter Indication of allergic reaction to due to skin hives/rash Suspicion heparin allergy, change to LMW heparin Significant bodywide rash Warfarin therapy Post release, discovery of hi FVIII disease When it becomes personal!!
  23. 23. Disease Management cont. Hospital based complications DVT Increase heparin, Vena Cava Filter Heparin Allergy LMW Heparin More severe Heparin Allergy Warfarin Personalized Medicine Mitigating Complications: Molecular Pathology Screening Pharmacogenomics Subclinical Disease processes Biosensors High FVIII disease Identification of Heparin allergy Earlier Warfarin administration Pharmacogenetics Titrate Warfarin dose When can Warfarin dose be eliminated
  24. 24. Micromechanical Sensing & Detection Nanotechnology Approaches to Sensing and Detection Dr. James S. Murday Dr. Richard J. Colton, Naval Research Laboratory http://www.frtr.gov/pdf/meetings/dec04/murday_12-04.pdf C nanotube networks: Detection via field- induced polarization of adsorbates on SWNT surface BioFETs: thin for efficient sensing (~2 nm). source drain; specific attachment of DNA or protein Biosensors Will Drive Personalized Medicine
  25. 25. Michael N. Helmus, Ph.D., Consultant mnhelmus@msn.com INSTRUMENTATION/PACKAGING • Spectrometry • Light Scattering • Microfluidics • Nanosensors • Biochips • Thin film transistor arrays • Scattering techniques • Tissue culture techniques MODELING • Computational modeling: - biomolecules - crystallographic structures - biokinetics and dosimetry • Tissue-light interactions modeling APPLICATIONS • Disease Biomarkers • DNA/Gene expression • Chemical and Biotoxin Exposure • Pathogen sensing • Molecule detection • Single molecule detection Biosensor Development Modified from: http://www.ornl.gov/sci/biosensors/abstg_orgchart.pdf#search=%22Advanced%20Biomedical%20Scie nce%20and%20Technology%20Group%22
  26. 26. Personalized Medicine to Drive New Technology Local and Targeted Diagnostics and Therapeutics to allow “individualized treatment for each patient” Drug Delivery, Tissue Engineering & Cell Therapy Biomarker & Disease Detection Less Invasive Procedures Michael N. Helmus, Ph.D., Consultant Medical Devices, Biomaterials Drug Delivery, and Nanotechnology (508) 767 0585

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