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					Convergent Medical
Technologies
Local Impacts,
Global Opportunities




Presented June 1, 2005
at the YORKBiotech Inaugural Meeting          John Soloninka PEng MBA
York University, Toronto
  Soloninka & Associates               President, Soloninka & Associates
              Why Do We Care about
                 Convergence?
   • Its an Exciting Innovation Engine - offering new “low-
     hanging fruit”

   • Today…a rapidly growing, multi-billion$ sector

   • Tomorrow, “Nano-Bio-Info-Cogno” unification of science
     enables an exciting redefinition of human health and
     mental/physical performance.

   • Unlike more narrowly focused “biotech”, CMT is the base
     for broad economic development and Investment.

Soloninka & Associates
        Convergent Medical Technologies
     • What is CMT?
          – What is Convergence?
          – What is driving it?
          – Where can it take us?
     • Applications, Regulation and Time to Market
          – Current applications and new technologies
          – Regulation and Time -to-market
     • Opportunities
          – Where to Look for applications/partners




Soloninka & Associates
                         What is CMT?
    • Synergistic “intermingling” of 2 or more distinct
      technologies creating a new, hybrid device, process or
      product applied in health prevention, screening,
      diagnosis, therapy, monitoring or functional
      enhancement.

    • From simple “Combination Products”...

    • To entirely new science with “disruptive” performance.




Soloninka & Associates
                Convergence Not Yet
                Accepted Terminology
                                                  CITATIONS
              PubMed (Medline+) Keywords        2001      2005
                              Medical Devices    488688   663377
                              Pharmaceutical      96783   139363
                               Biotechnology      11364    20105
                          Medical Technology       7993     8952
                              Nanotechnology        122     3406
                                 Convergence       6622     9327
                                   Convergent      4121     6371
              Medical Technology Convergence          3         6
               Convergent Medical Technology          0         1
                   Biotechnology Convergence         12        24
                        Combination Products                7177
                "Combination Product" Device                   14
            "Combination Product" Drug Device                  12
Soloninka & Associates
               Converging Technologies

                   BIO TECH
                Pharmaceuticals           Genomics                  INFO TECH
                  Diagnostics           Bioinformatics               Hardware
                 Research/Info           Proteomics                  Software
                     Tools                                        Communications
                   Industrial
                                         Biosensors
                           Bioelectronics Biochips        Nanodevices
                           Microfluidics                  Nanosensors
                         Nanobiotechnology               Nanoelectronics
                           Drug Delivery

                                        NANO TECH
                                          Electrical
                                         Structural
                                         Biomedical
                                    Energy & Environment
                                                                           Adapted from:
                                                                           Biology, Bioconvergence, Information
                                                                           and Enterprise:Taking the Broad View
                                                                           May 20th 2004 Alan Barrell,
Soloninka & Associates
                         Why Now?

      “90% of all the scientists born in the
          human race are alive today”


                                Prof. John Story - INSEAD
                                    Quoted by Allan Barrell, Convergence 2004




Soloninka & Associates
             The
     “Ice Tray” Model of
   Convergence Dynamics


   •   Silos: knowledge, methods and
       discoveries made in isolated
       technology sectors

   •   Connection: One well connects to
       another. Knowledge can be
       applied quickly to adjacent areas

   •   Convergence: greater innovation
       in the connected region, than in
       the individual wells.



Soloninka & Associates
                         The R&D Payoff




Soloninka & Associates
                Precedents for Growth
       •    1985
            °    no sales
            °    Human recombinant Insulin is released
       •    1998
            °    Biotech Sales = $10B
            °    Merck Index
                 °       Merck Market Cap = $300B
               ° Total Biotech Market Cap = $150B
       •    2005
            ° Biotech Sales = $36B
            °    Merck Market Cap = $100B
            °    Total Biotech Market Cap = $600B
                                                    Dr. Mark Poznansky, Canada’s Future In the Biocentury, Jan 05
Soloninka & Associates
                    Diminishing Returns in
                    New Drug Development




                                       Source: Challenge and Opportunity on the
                                       Critical Path to New Medical Products
                                       FDA, March 2004

Soloninka & Associates
 Devices/ICT…revitalizing Drugs?
  • Costs/time for new drug development too high
  • Systemic effects and toxicities eliminate too many
    candidates
  • Stagnation rather than innovation is occuring
  • Localized delivery, targeting and individualized therapy …
       – Fewer regulatory drop-outs.
       – Increases efficacy while decreasing side effects of existing drugs
       – Can lead to extended patent life.




Soloninka & Associates
        Device Companies Creating
               Higher Value




Soloninka & Associates
         Keeping Drug Development
                 Affordable
                                               106

                         Drug Candidates [#]   105
                                                     early effective
                                               104   selection & optimization

                                               103                     reduction of
                                                                       attrition risk
                                               102

                                               101

                                               100




                                                                                        Adapetd from: Jörg Lippert, Bayer
                                                                                        Computational Solutions
                                                                                        Bioconvergence 2004 2004-05-20
Soloninka & Associates
              Different Technologies,
        Different Culture and Perspectives

Devices                                  Drugs
Engineering, materials                   Biology, chemistry
Local effects                            Systemic effects
Technology development                   Research
Systematic & rapid product development   Slow, trial & error product development
Engineers                                Scientists
Product lifetime usually short           Product lifetime usually long




                                                 [adapted by Beth White Research Consulting Services
                                                       from Sumner K. Attitude Adjustment. MX, May/June
Soloninka & Associates                                 2003. Available on [w.devicelink.com]
             Drug Eluting Stent Case Study:
                 From Device to Drug
   Stent           Coating                               MOA                           Class

 Stainless               -                              Support                        device

 Stainless           Drug                    Support+ 2-day Anti-restenosis             CP

 Stainless   Drug Eluting Polymer           Support + 30-day Anti-restenosis            CP

 New alloy   Drug Eluting Polymer          Support + >30-day Anti-restenosis            CP

 New alloy   Drug Eluting Polymer   Support + >30-day Anti-restenosis + Gene Therapy    CP

 Resorable   Drug Eluting Polymer                Localized drug delivery               Drug




Soloninka & Associates
              From Theory to Practice
     • 2003: Converging Technologies for Improving Human
       Performance; NSF Roco, Bainbridge (Eds)

     • 2003: Drug Coated Stents and Beyond: How Convergence
       of Medical Devices & Drugs Is Changing Health Care. The
       Venture Capital Analyst; Brian Gormley (Ed)

     • 2003: Combination Products: An Impact Analysis on the
       Convergence of Medical Devices and Therapeutics;
       Navigant Consulting Inc./Frontline Strategic Consultants, of San
       Mateo, California

     • 2004: Bioconvergence Conference, London UK

     • 2005: Convergence Drug Device Summit, Pittsburgh PA

Soloninka & Associates
      Combination Product Market Size
          Drug Eluting Stents
          2003                      2008 (est)
          $2.1 billion              $6.3 billion

          All Combination Products
          2004 (est).              2009 (est)
          $6 billion               $10 billion

          •   88% Cardiovascular applications
          •   12% Wound Care, Orthopedics and all other applications
          •   DES will account for 70% of total market
                                                 [Combination Products: An Impact Analysis on the Convergence of
                                                     Medical Devices and Therapeutics. Navigant Consulting/Front
                                                                             Line Strategic Market Reports, 2003]




Soloninka & Associates
    Where Will Convergence Lead?
     •   US NSF, led by Dr’s Rocco and Bainbridge, seriously view NBIC as
         having the potential to change, business, society and human kind.
     •   Design of technologies from molecules up, with targeted intervention at
         the genomic/proteomic level, interfaced directly with our cognitive,
         motor and senory functions.
     •   Addressing not only health, but wellness, human physical and mental
         performance, learning, and social/political interaction.




Soloninka & Associates
        Convergent Medical Technologies
     • What is CMT?
          – What is Convergence?
          – What is driving it?
          – Where can it take us?
     • Applications, Regulation and Time to Market
          – Current applications and new technologies
          – Regulation and Time -to-market
     • Opportunities
          – Where to Look for applications/partners




Soloninka & Associates
                         YRBCC-HTX-S&A
                           CMT Survey
     • Objectives:
          – Characterize the source of CMT innovation
          – Determine if cluster dynamics were at play
          – Examine scope of technologies involved
     • 111 CMTs identified from literature, websites,
       conferences, FDA etc.
     • 15 interviews (CEO, VP R&D, CSO, PR)
          –   Source of Innovation and ownership of IP
          –   Nature of CMT and relationship to core competancies
          –   Regulatory experience
          –   View on CMT in future



Soloninka & Associates
                                BioPharma
        InductOs™ (rhBMP-2/ACS) [recombinant human Bone Morphogenetic
         Protein-2/Absorbable Collagen Sponge] for the treatment of single level
         (L4-S1) anterior lumbar spine fusions. [Wyeth]


     • Implanted polymer wafer for sustained-release drug delivery to
       treat malignant glioma. [Gliadel, Guilford Pharmaceuticals Inc.]




     •   TransDermal, programmable dosing, “electrotransport” patch [Alza: E-
         Trans]




Soloninka & Associates
                                Devices
        Drug Eluting Resorbable Stent: [Reva/Boston Scientific]




     • “Artificial pancreas”: implantable insulin pump and blood glucose
       monitor for closed loop continuous control. [Medtronic]




      Integrated, self-regulating responsive therapeutic device [ChipRx]




Soloninka & Associates
  Information and Communications Technology
       Cardioverter connected to the internet [CareLink: Medtronic]




       Swallowable video imaging capsules for M2A (mouth to anus)
        surveys [GivenImaging]
       Robotic Surgery [Intuitive Surgical]




Soloninka & Associates
  Nanotech/Advanced Materials/Manufacturing
                          Marker-coated nano spheres that are guided
                           via biomarkers to a tumor and vibrated
                           magnetically to ablate the tumor [XOMA,
                           California];




                          Metallic DNA for manufacturing circuitry
                           used in highly sensitive biodetection and
                           later biodiagnostics [Integrated Nano
                           Technologies]




                         • Near infection-free “diamond coated”
                           catheters for [Applied Diamond Coatings]

Soloninka & Associates
                     Biomarkers and Targeting

                             • Mapping mRNA expression as
                               Predictor of Disease State
                               [Chondrogene, Toronto]



    Control         CAD
                             • In Vivo Biophotonic Imaging:
                               Photoactive "luciferase" gene that
                               emits light when active to allow
                               direct measurement of gene
                               expression. [Xenogen, Alameda
                               CA]


                             •   Marker-Coated Nanobubbles,
                                 Cavitation-Activated Sonolysis [ImaRx
                                 Therapeutics]

Soloninka & Associates
                    Cognitive/Sensory
      • Brain Gate electrodes attached to the motor cortex translating
        signals into computer commands [Cyberkinetics]




      • On-demand continence activation.




      • Artificial Retina [Optobiotics]




Soloninka & Associates
                  “In-Silico” Modeling
                                                             i.v.
                                                                     DOSE
                                                                     p.o.          STOMACH
                                                                                     WALL


                                                                              SMALL INTESTINE




                                                                                                                    ARTERIAL BLOOD POOL
                                             VENOUS BLOOD POOL
                                                                                     WALL


                                                                              LARGE INTESTINE

  In silico determination/simulation of                                               WALL

  bioavailability, side effects,                                                   PANCREAS

  hydrophobosity, hydrophilicity, etc.                                              SPLEEN
  dramatically reducing costs of candidate
                                                                    PORTAL VEIN               GALL BLADDER
  screening and drug design
                                                                                     LIVER


                                                                                     KIDNEY


                                                                                  TESTES
                                                                                    HEART
                                                                                     BRAIN
                                                                                       FAT
                                                                                         BONE
                                                                                           SKIN
                                                                                            MUSCLE

                                                                                      LUNG


                                                                                                     Adapetd from: Jörg Lippert, Bayer
                                                                                                     Computational Solutions
                                                                                                     Bioconvergence 2004 2004-05-20
Soloninka & Associates
                         Analytics

     • Tensor Biosciences
          – Brain on a Chip


     • Scimagix - SIMS [Bioimagene]




Soloninka & Associates
     CMT
    Survey
                                Number of Technologies in Each Class

               90
               80
               70
               60
      Number




               50
               40
               30
               20
               10
                0
                    Device   Biologic   Pharma    Nano or   ICT   Targeting Analytics   Other   Mfg   Cognitive
                                                 Adv Mats

                                                              Class




Soloninka & Associates
     CMT                                                                               50
                                                                                                                 CMT Class




                                                              Number of Technologies
    Survey                                                                             40

                                                                                       30

                                                                                       20

                                                                                       10

                                                                                       0
                                                                                            Drug/Dev   Nano/Drug     ICT/Dev   ICT/Analytics Drug/ICT/Dev
                                                                                                                      Class



                                                                                             Which Clusters?

                                     16
               Number of Companies




                                     14
                                     12
                                     10
                                      8
                                      6
                                      4
                                      2
                                      0
                                          GTA Van Mtl   Ott                   Lon Bay          NJ   Bos WA Min      LA   NY    Ph   SD   DC   Ch   MD
                                                                                                       Cluster


Soloninka & Associates
                               CMT Survey
            CMT Definition: Most interviewed did not have a good grasp of what CMTs
             were, even if they were developing them. The definition is not necessarily
             relevant to them.
            IP: Most developed IP in house (to maintain ownership), perhaps in-
             licensing 10% or so. By contrast, some deliberately sought existing
             technologies.
            Regulatory: Many are too early in the approval stage to comment on the
             impact of CMT on time to market.
            Clusters: Geography, personal relationships and other "Cluster Dynamics"
             appeared irrelevant; they looked or found technology anywhere in the
             world. However, once they moved from the idea to commercialization, then
             all of the cluster dynamics kick in.
            Funding: Among those companies still in early stages, $$$$ were still the
             most important. It appeared that the skills for them are in science and less
             so in ensuring reimbursement or receptivity in the market for their
             products.




Soloninka & Associates
                  Regulatory Framework

     • Combination Products at FDA and HC
          – Office of Combination Products
          – Not a review body
          – Determines where product is reviewed
            (e.g. CDRH, CDER, CBER) based on the
            Primary Mode of Action




Soloninka & Associates
          Regulatory Approaches Are
                   Diverse

            Biologics
            BLA/IND                               Drugs
            cGMP+                                NDA/IND
            AERS+       Primary Mode of Action   cGMP
                              Consultation        AERS

                              Regulations

                                 Devices
                              PMA/510(k)/IDE
                              QSR
                              MDR



                                                           DIA Webinar January 19, 2004
Soloninka & Associates                                     Mark Kramer, OCP, 2004
               PMOA Proposed Rule:
             May 7, 2004 Federal Register

 • “Primary Mode of Action”:

      • The single mode of action of a combination
        product that provides the most important
        therapeutic action of the combination product.
      • One of Drug, Device, Biologic



                                               DIA Webinar January 19, 2004
Soloninka & Associates                         Mark Kramer, OCP, 2004
    PMOA: Three Hypothetical Examples

  • Vision-correcting contact lens with drug to make lens
    more “comfortable”

  • Contact lens as drug delivery system

  • Vision-correcting contact lens with concurrent
    delivery of glaucoma drug




                                                     DIA Webinar January 19, 2004
Soloninka & Associates                               Mark Kramer, OCP, 2004
                Time-To-Market Impacts
    • Faster Approval
         – New ComboProduct from existing drug/device use
         – No change in the metabolic pathway of the drug (ie. Was
           oral, now infused via an implanted polymer)
    • Slower Approval
         – Tissue engineering product (device), adopts drug MOA.
         – NCE, new indications, combined with novel device
    • Consider staging product releases
         – For platform products, set MOA precendent with the first
           release, then expand indications.




Soloninka & Associates
                         Reimbursement
   • Reimbursement must be premptively considered
        – New MOA > no precendents > no reimbursement.
        – Codes are just as important as insurance coverage
             • e.g. Medicare only covers drugs in hospital
   • Early Reimbursement Discussions A Must
   • Strategic product release
        – Set precendent with the first release, then expand indications.




Soloninka & Associates
        Convergent Medical Technologies
     • What is CMT?
          – What is Convergence?
          – What is driving it?
          – Where can it take us?
     • Applications, Regulation and Time to Market
          – Current applications and new technologies
          – Regulation and Time -to-market
     • Opportunities
          – Where to Look for applications/partners




Soloninka & Associates
                             Hot Areas
             • Cardiovascular
             • Orthopedic
             • Drug delivery
                  – Transdermal
                  – Time-release
                  – Localized delivery
             • Niche products
             • Extending existing drug patent life
             • NCI Alliance for Nanotechnology in
               Cancer, a $144.3 million, five-year initiative


Soloninka & Associates
                         A One-Two Punch: Drug/Medical Device Combination Products are Taking
                         Healthcare in a New Direction. Is the Pharmaceutical Industry Prepared?
Soloninka & Associates   Cindy Dubin; Drug Delivery Today: www.drugdeliverytech.com/cgi-bin/articles.cgi?idArticle=235
                    Market Attractiveness
        Many or                                      The Ideal:
        General                                    increasingly
         Uses                                        attainable

Previous Domain of
                         2a              1           by design
                                                    rather than
 Many Big Pharma                                      chance.
     Products

 Market

                                               New CMT or CTT
                                               can make orphan
                         3                2b   applications more
                                                   profitable


        Orphan


Soloninka & Associates   Incremental Benefit
                         Alliances are Key:
        You Can’t Be Expert in Everything
     • Normally, core technology done in-house

     • Convergence requires broad expertise only
       available through alliances or mergers

     • Lessons from Biotech/Pharma experience are
       essential




Soloninka & Associates
                     Example Alliances

   • Boston Scientific
        – Angiotech, Corautus Genetics, Osiris Therapeutics

   • Guidant
        – Novartis, Biosenors Internation, SyneCor, MediVas

   • Johnson and Johnson
        – SurModics, Wyeth, BioPharm, Orquest, Theratechnologies,
          Transform Pharmaceuticals

   • Medtronic
        – Transvascular, Endobionics, Wyeth, Yamanouchi Pharma


Soloninka & Associates
              An Engine Needs Fuel:
        Comparing Biotech Investment in 2001

                     California   Massachusetts                Quebec                        Ontario

No. of                      1st             2nd                          3rd                          4th
Companies
Life                     6,000            4,900                     3,200                       3,200
Scientists
Federal                  $1.8B           $2.1B                   $.120B                      $.210B
R&D
VC                       $4.5B           $2.0B                       $.2B                       $.09B
Investments



                                                  Dr. Mark Poznansky, Canada’s Future In the Biocentury, Jan 05
Soloninka & Associates
                                             The Gazette, Montreal
                                             Sunday October 26, 2003

               City            GDP
               Boston          $73,470
               San Francisco   $64,836
               St. Louis       $35,318
               Toronto         $33,581
               Montreal        $26,629
                                     Dr. Mark Poznansky, Canada’s Future In the Biocentury, Jan 05
Soloninka & Associates
                  We’re just starting….




Soloninka & Associates
Convergent Medical
Technologies
Local Impacts,
Global Opportunities




Presented June 1, 2005
at the YORKBiotech Inaugural Meeting          John Soloninka PEng MBA
York University, Toronto
  Soloninka & Associates               President, Soloninka & Associates

				
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