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Aaron Eden
Created by Steve Blank
»   5/12 – What to Expect
»   5/19 – First Pitches
»   5/26 – Experiment Day
»   6/2 –Value Propositions
»   6/9 – Customers, Users, Payers
»   6/16 – Distribution Channels (Justin)
»   6/23 – Customer Relationships
»   6/30 – Revenue Models
»   7/7 – Partners
»   7/14 – Key Resources & Costs
»   7/21 – Lessons Learned Presentations
» Team Presentations
» Distribution Channels
» Mentoring
» What were your hypotheses about users and
  customers? Did you learn anything different?
» Did anything change about Value Proposition?
» What do customers say their problems are? How
  do they solve this problem(s) today? Does your
  value proposition solve it? How?
» What was it about your product that made
  customers interested? excited?
» If B-B, who’s: decision maker, size of budget, what
  are they spending it on today, how will this buying
  decision be made?
Channels




           10
Test Hypotheses: Channels




                            11
Two Critical Channel Questions




   How do you want to sell your product?

   Is subtle, but more important than the
   first: How does your customer want to buy
   your product?



                                               12
How Do You Want Your Product To Get
        To Your Customer?

    Yourself

    Someone else

    Retail

    Wholesale

    Bundled with other goods or services   13
How Does Your Customer Want to Buy
 Your Product From Your Channel?
   Same Day

    Delivered and installed


    Downloaded


    Bundled with other products


    As a service

                                     14
    …
Web Channels




               15
Physical Channels




                    16
Types of Channels


Direct            Indirect   Licensing



             • OEM
             • VAR
             • Reseller
             • Distributor




                                         17
The Channel as a Customer
» Some products are embedded in others
  (OEM)
» Some products are resold by others
  (VARs)
» Some products are distributed by others
» Who’s the customer?


                                            18
Distribution Complexity
                                                                                      Global Systems
                                                                             Systems Integrators
                                                                               WANs
                        Evangelists                                     Mainframes
                                                                    Direct Sales
Marketing Complexity




                                                                Minis
                                                             LANs
                                                         VARs
                                                PC Servers
                                           Desktop PCs

                                       Retail
                                   Printers
                               Keyboards
                                                                                             Service
                         Web, Telesales                                                    Technicians
                       Toner
                                                                                                         19

                                                   Solution Complexity
How Are Channels Compensated?
» Commission
» Percentage of sales price
» Discounted pre-purchase




                                  20
How Are Channels Motivated or Incented?

» Money! What makes them the most?
» Training
» Marketing to the channel
» SPIF




                                          21
Channel Economics: “Direct” Sales
                                                                   List
                                                          Revenue Price




                                                                                 End Consumer
                                                                     Discounts
 Cost of Goods




                                                                EU
                                    Profit + SG&A + R&D
 (Supply Chain)




                                                                                                22



Source: Mark Leslie, Stanford GSB
Channel Economics: Resellers
                                                                            List
                                                      Revenue              Price




                                                                                      End Consumer
                                                                          Discounts
    Cost of Goods




                                                                     EU
                                    Profit + SG&A + R&D   Reseller
    (Supply Chain)




                                                                                                     23



Source: Mark Leslie, Stanford GSB
Channel Economics: Distributors/Resellers
                                                                                      List
                                                 Revenue                             Price




                                                                                                End Consumer
                                                      Distributor




                                                                                    Discounts
    Cost of Goods                   Profit + SG&A +




                                                                               EU
                                                                    Reseller
    (Supply Chain)                        R&D




                                                                                                               24



Source: Mark Leslie, Stanford GSB
Channel Economics: OEM or IP Licensing

                                                                                                List
Your Revenue                                                                                   Price


           Cost of




                                        Distributor

                                                      Distributor




                                                                                          Discounts
                                          Master
            Goods     Profit + SG&A +




                                                                                             EU
                                                                    Reseller
           (Supply          R&D
            Chain)


 Cost of
 Goods      Profit + SG&A
                            Reseller
(Supply        + R&D
 Chain)

Your Product Becomes Your
 Customer’s Cost of Goods
                                                                                                      25



                                                                    Source: Mark Leslie, Stanford GSB
Example: Book Publishing

             National
Publisher                 Printer   Wholesaler   Retailer   Customer
            Distributor




                                                                       26
Book Publishing

                            National
              Publisher                 Distributor   Retailer   Customer
                           Wholesaler

•Percent of
     Retail     35%           15%          10%         40%

                $7.00        $3.00        $2.00        $8.00      $20.00



 • You get
    - 35% of retail
    - the distributor gets 10%
    - the wholesaler gets 15%
    - the retailer gets 40%
        - less any discount they offer the customer
                                                                            27
Book Publishing Economics

                 National
Publisher                               Wholesaler            Retailer            Customer
                Distributor

       Allowances

              Wholesale costs

                                Bills
                                                                         Markup
                                                   Credit
                                                 guarantees
                           Payment
                          guarantees
        Payment
       guarantees

                         Return rights

                              Credits
                                                                                             28
       Payments
Book Publishing Delivery

                National
 Publisher                     Printer     Wholesaler       Retailer
               Distributor


Prepare film                 Receive
 (content)                    Schedules
                              Print
                                           Determine     Merchandise
                               orders
                                           allocations      titles
                              Bundle
                               counts
                              Film

                                             Deliver        Sell
                                             orders       magazines

 Establish     Prepare       Print and
  identity      galleys         ship
 Create                      magazines
  demand

                                                         Acknowledge 29
                                                           returns
Nature of Products Impact Channel:
         Physical or Virtual?

» Access to customers changes
  dramatically
» Logistics related to product complexity
» People as products



                                            30
Bits vs. Atoms

                               Channel
                        Web              Physical




              Bits



Product


          Physical

                                                    31
Product and Channel Are Bits

                                          Channel
                              Web                   Physical
                    Rapid Agile and
                     Customer Development
                    Fastest to acquire early
              Bits   customers and scale


Product


          Physical

                                                               32
Web 2.0 – Product/Channel Are Bits

                                        Channel
                                Web               Physical
                      Google
                      Twitter
                      Facebook
              Bits
                      Zynga
                      Cloud Services

Product


          Physical

                                                             33
Product Is Bits, but Channel Is People

                                          Channel
                              Web                         Physical
                    Rapid Agile and             Rapid Agile and
                     Customer Development         Customer development
                    Fastest to acquire early    Traditional sales channel
              Bits   customers and scale         May require installation


Product


          Physical

                                                                              34
Traditional Enterprise Software

                                         Channel
                                 Web                  Physical
                       Google                Microsoft
                       Twitter               SAP
                       Facebook              Oracle
               Bits
                       Zynga
                       Cloud Services

Product


           Physical

                                                                 35
Physical Products Sold Over the Web

                                           Channel
                               Web                       Physical
                    Rapid Agile and             Rapid Agile and
                     Customer                     Customer
                     development                  development
              Bits  Fastest to acquire early    Traditional sales
                     customers and scale          channel
                                                 May require installation
Product
                    Rapid Customer
                     development
                    Logistics, shipping and
          Physical   manufacturing critical
                    Customer service
                                                                             36
Killing Traditional Storefronts

                                          Channel
                                Web                    Physical
                      Google                  Microsoft
                      Twitter                 SAP
                      Facebook                Oracle
             Bits
                      Zynga
                      Cloud Services

Product
                      Zappos
                      Amazon
                      Cafepress
          Physical
                      Netflix
                      Consumer electronics
                                                                  37
The Factories May Be in China

                                            Channel
                                Web                        Physical
                     Rapid Agile and             Rapid Agile and
                      Customer development         Customer development
                     Fastest to acquire early    Traditional sales channel
               Bits   customers and scale         May require installation


Product
                     Rapid Customer              Longer customer
                      development                  feedback cycle
                     Logistics, shipping and     May require large capital
           Physical   manufacturing critical       requirements for scale
                     Customer service
                                                                               38
We Still Make Things that Need Salespeople

                                          Channel
                                Web                     Physical
                      Google                  Microsoft
                      Twitter                 SAP
                      Facebook                Oracle
             Bits
                      Zynga
                      Cloud Services

Product
                      Zappos                    Cars
                      Amazon                    Solar panels
                      Cafepress                 Wind turbines
          Physical
                      Netflix                   Bookstores
                      Consumer electronics      Consumer electronics   39
Homework

»   Talk to 10-15 potential channel partners
    +   (Salesmen, OEM’s distributors, etc.)
»   What were your hypotheses about who/what your channel would
    be? Did you learn anything different?
»   Did anything change about Value Proposition?
»   Update your Google Group with Business Model Canvas
»   Draw your channel diagram

»    Summarized in a 5 Minute Presentation

»    Read
»    Startup Owner’s Manual pages :227-256, 332-342


                                                                  40
Appendix


           41
implantable drug infusion pumps
                       with remote physician control
                     for chronic pain patients at home

              “the right dose at the right time and place”




                                                                                     42


Christian Gutierrez (EL), Ellis Meng (PI), Carol Christopher (IM), Tuan Hoang (FE)
Chronic Pain v3                         FS Team



                                                                  Training                Patients
                                              Faster relief
KOLs               Trade shows
                   Formulary Acceptance
                                                                  Clinical data
                                           Efficient patient
Foundations                                management and                                 Clinicians
                   FDA                     Dosing flexibility     Support
Advocacy Groups
                                           Access to high-value
                                                                                          Institutions
OEMs                                       therapies and
                                           pharmacoeconomics      Hospitals
                   IP
                                                                                          Payors
Wireless           Proprietary
Developers                                 Reduce length of       Pain clinics
                   knowledge
                                           hospital stays and
                   Human Resources         pharmacoeconomics



                  Product Dev Costs                                          Unit sales

                  Manufacturing Costs                                        Support Services

Marketing Costs      FDA/Clinical Trials                                                                 43
Chronic Pain v4                         FS Team



                     Trade shows                                    Training
                                                Faster relief                               Patients
KOLs                 Formulary Acceptance
                                                                    Clinical data
                     FDA                     Efficient patient
Foundations                                  management and                                 Clinicians
                     CMS (Medicare)          Dosing flexibility     Support
Advocacy Groups
                                             Access to high-value
                                                                                            Institutions
OEMs                                         therapies and
                                             pharmacoeconomics      Hospitals
                     IP
Wireless                                                                                    Payors
Developers           Proprietary
                                             pharmacoeconomics      Pain clinics
                     knowledge
Electronic health    Human Resources
record providers


                    Product Dev Costs                                          Unit sales

                    Manufacturing Costs                                        Support Services

Marketing Costs        FDA/Clinical Trials                Bundled kits                Electronic records   44
Getting Out
Clinicians              » Dr. Stan Louie, Drug Formulation Expert (USC Pharmacy)
                        » Dr. Giovanni Cucchiaro, Anesthesiologist (CHLA)


Institutions/patients   » Dr. Diana Hull, Physician (Group Health in Washington
                          state, formerly at Kaiser California)
                        » Thomas Hsu, Insurance Specialist (Network Medical
                          Management; a California ICA)
                        » Two chronic pain patients
                            ˃ Pump user and creator of support forum
                            ˃ User of oral narcotics and patches

Regulatory              » Dr. Frances Richmond (Director Regulatory Science
                          Program, USC)


Entrepreneurs/          » Richard Hull (formerly at company selling Lapband)
                                                                                  45
Industry
Product Flow/Channel
Electronic                                                  Partners/
  Health                     Fluid Synchrony
                                                             OEMS
 Records

               Electronic   Support Pump +        Bundled
                Records     Services Controller     Kits




                                Hospitals
                            (Anesthesiologists
Patients                     Neurosurgeons)


                               Pain Clinic
                            (Anesthesiologists
                             Neurosurgeons)

                                                                        46
Channels (Direct)


Hospitals      • Direct to institutions
                  • Some formularies involved in purchase decisions
Pain Clinics
                  • Some doctors make purchase decision directly
               • Device company/Doctor relationship is key
               • Heavily influenced by :
                  • Clinical study results
                  • Regulatory approval
                  • Reimbursement




                                                                      47
Patient Care Flow (Now)
                                                                         Partners/
                                         Fluid Synchrony
                                                                          OEMS

                                        Support Pump +        Bundled
                                        Services Controller     Kits




                                            Hospitals
                    Surgery/Rx/         (Anesthesiologists
   Patient
 Discharged       reprogramming          Neurosurgeons)


                                          Pain Clinic
Trial period/      Scheduled           (Anesthesiologists
Home setting       follow-up            Neurosurgeons)
                                                                                     48
   Weeks/months
                        Key factors: Reimbursement , state regulations
Patient Care Flow (Proposed)
  Electronic                                                                       Partners/
    Health                                          Fluid Synchrony
                                                                                    OEMS
   Records

                                      Electronic   Support Pump +        Bundled
                                       Records     Services Controller     Kits
         Actionable feedback
         to doctors/institutions



           E-prescription / closing loop
                                                       Hospitals
                        Surgery/Rx/                (Anesthesiologists
   Patient
 Discharged           reprogramming                 Neurosurgeons)


                                                      Pain Clinic
Trial period/           Scheduled                  (Anesthesiologists
Home setting            follow-up                   Neurosurgeons)
                                                                                               49
   Weeks/months
        Days                Key factors: Reimbursement , state regulations
Regulatory Considerations

                        PMA                 510K
           Trial size   100’s of patients   20-100
           Costs           Up to $100,000 per patient
                        $10-50 MM           $1-10 MM
           Time         ~ 3-4 yrs + post   ~ 2-3 yrs
                        approval follow-on


• PMA approval with grouping of FDA approved drugs.
• Clinical trials results used to obtain CMS (Medicare) approval
• 510K restricts technology to predicate devices
   • Can be more difficult to market against incumbents
• European CE mark is easier to attain (safety and performance only)
                                                                       50
Take-Aways
• Channel is direct in this existing market
   • Channel for e-health is more complex and evolving
• State-to-state regulations can impact incentives
   • Can pose problems as electronic records systems vary
      across the country

                   Next Steps
• Understand costs associated with reaching
  doctors/institutions directly
• Understand structure of e-health channel
• Develop regulatory pathway (timelines and cost profile)   51
Advanced Chemistry for
Pharmaceutical Progress



 Team: Kiel Neumann (EL)
  Stephen DiMagno (PI)
  Allan Green (Mentor)
                           52
 PET is a non-invasive medical diagnostic
  technique for cardiac, brain, and tumor imaging
 GFP technology makes new (unknown) and
  known (but clinically inaccessible) [18F]-labeled
  radiotracers readily available
 Fast, multiplatform, high efficiency synthesis of
  these fleeting, precious agents.
 Initial target indications: pediatric neuroblastoma,
  Parkinson’s disease.
                                                         53
The Business Model Canvas


                         SOPs for precursors                                   Technical Assistance
 cGMP manufacturer       and drugs                                             (Image Atlas)
 Radiopharmacies                                  Accessibility (RCY)                                      Radiopharmacies
                         Recruit clinical sites                                FDA regulatory support
 Nuclear Medicine and                             Purity
                         In vivo animal studies
 Radiology departments                            Speed                                                    Equipment producers
                         Develop regulatory
                                                  PET/SPECT
                         plan for pre IND
                                                  Multiplatform                   Technical assistance     Prescribing physicians
                         meeting
                                                  Sensitivity (nca)
                         ID cGMP CRO
  Pharmaceutical                                  Specific compounds                                       Radiologist who perform
                         Fund-raising
  development                                                                                              studies
  companies


                                                                               Direct sales of precursor
                                                          General
                          IP                          methodology for
                          PoP data                   adding fluorine to                                        Drug developers
                                                                               R&D and clinical studies
                          IP                        lead compounds of
                                                                               presented in journals and
                          PoP data                        interest
                                                                               meetings
                          Regulatory plan                                      Sales of precursor             Radiologists
                          Understanding of the                                 through global finished
                          regulatory process                                   pharmaceutical
                                                                               distributor



                                                                        Sales of intermediates
 Contract cGMP precursor manufacture
 Salary, Rents                                                          Technology license                                          54
 Clinical trials
                                                                        Product license (royalty)
1) Radiologists and Nuclear Medicine Physicians
2) Radiopharmacy companies (Cardinal Health, Siemens, GE Healthcare, IBA,
   AAA)
3) Equipment manufacturers (GE, Philips, IBA, Advion)
4) cGMP manufacturers


1) Pharmaceutical companies
2) Radiologists and Nuclear Medicine Physicians



                                                                            55
- Face to face with attending Radiologist at Stanford
  University
- Face to face with radiopharmacist at UCSF
- Conference call with Nuclear Radiologist at
  Memorial Sloan Kettering
- Conference call with president of medium size
  drug company with PET product at the FDA
- Telephone conference with cGMP facility               56
-   Immediate need for our product
     -   Currently used SPECT product for neuroblastoma is limited by
         absence of correlative CT data
-   Our lead PET agent would provide more information on existing
    imaging equipment base
-   Two customers offered to participate in clinical trials
-   Potential for further development of other tracers identified in
    interviews
     -   Actual need for the general procedure
     -   Allow access to previously unknown tracers

                                                                        57
 Face to Face meeting with president of small radiopharmaceutical company
 Face to face with a clinician at Memorial Sloan-Kettering
 Face to face with Global Production Manager of Molecular imaging for one of
  world’s largest radiopharmaceutical companies
 OncoKinib collaboration between Geurbet, OncoDesign, and Ariana
  pharmaceuticals
 Face to face meeting with head of R & D and International Production
  Manager from Linz, Austria
 Eckert and Zeigler – German PET modular synthesis provider
 Face to face meeting with Executive Director and CEO of Scott Tech Center in
  Omaha, NE
 Introductory teleconference to CEO of Innovation Accelerator                 58
 Significant Interest in our technology
      Radiopharmacies want GMP product
         No interest in GMP reagent preparation
      Third-party manufacturers would use our developed synthetic pathways
      Internal competition with one world radiopharmaceutical leader
         Best to approach one of other two world leaders

 Scott Tech Center
      Willing to offer free advice on startup strategy
      Provided introduction to Innovation Accelerator
      Offered introduction to Director of Venture Technology of one of world’s leading
       radiopharmaceutical companies                                                    59
The Business Model Canvas



                                                                            Technical Assistance
cGMP manufacturer      SOPs for precursors
                                                                            (Image Atlas)               Radiopharmacies
Radiopharmacies        and drugs
                                                Accessibility (RCY)         FDA regulatory support
Nuclear Medicine and   Recruit clinical sites
                                                Purity                                                  Equipment producers
Radiology              In vivo animal studies
departments            Develop regulatory       Speed
                                                PET/SPECT                                               Prescribing physicians
                       plan for pre IND
                       meeting                  Multiplatform                 Technical assistance
                                                Sensitivity (nca)                                       Radiologist who perform
                       ID cGMP CRO
 Pharmaceutical                                 Specific compounds                                      studies
                       Fund-raising
 development
 companies
                                                        General
                                                    methodology for         Direct sales of precursor
                       IP                          adding fluorine to                                     Drug developers
                       PoP data                   lead compounds of         R&D and clinical studies
                                                        interest            presented in journals and
                       IP                                                   meetings                     Radiologists
                       PoP data
                       Regulatory plan                                      Sales of precursor
                       Understanding of the                                 through global finished
                       regulatory process                                   pharmaceutical
                                                                            distributor


                                                              Sales of intermediates
 Contract cGMP precursor manufacture
 Salary, Rents                                                                                                               60
                                                              Technology license
 Clinical trials
                                                              Product license (royalty)
• F-dopa iodonium intermediate
                  • F-dopamine iodonium intermediate   We provide accessibility
   Reagents




                  •ABX
                                                        Could license precursor
                  •Eckert & Ziegler                     synthesis for
                  •GE MX module for TracerLab
GMP Cassette or   •Siemens Explora                      incorporation in
 Components
                                                        modules

                  •TracerLab/ GE                        Require GMP precursor (or
                  •Eckert & Ziegler
                  •Siemens Explora                      cassette) to develop our
GMP Compliant
 Synthesizer
                  •Neoprobe
                  •Synthra
                                                        product with their
                                                        synthesizer

                  •Siemens PETNet
                  •GE Amersham                          Only want GMP
      PET
                  •Cardinal Health
                  •AAA
                                                        precursor in modules      61
Radiopharmacy
  distributor
                  •Iason                                without development
 Conference call with top 40 Fortune 500 chemical distribution company
      Open to cGMP production of our potentially proprietary precursors
      Interested in developing a general “plug-and-play” cassette
             Would allow implementation of our methodology and precursors for any
              radiochemistry module
             Important for FDA compliant production of any drug used in patient diagnostics
 Face to face meeting with Director of Business Development of a leading drug
  discovery outsourcing company
      Discussed preclinical studies and contract manufacturing of proprietary
       intermediates
-   Face to face with former Director of Chemistry of major pharmaceutical
    company
     -   Significant interest in general methodology application to proprietary
         compound syntheses
                                                                                               62
» Initially seeking to market method technology
  -too diffuse, but many opportunities (i.e. product-driven
  opportunities more than general technology-driven)
» Need to identify specific imaging product opportunities
» Validated hypothesis for immediate need of tracers
» Raised question on identity of lead compound pipeline
  for Parkinson’s disease
» Recruited two potential partners for clinical trials




                                                              63
Approximately 2.2 million procedures in the US.

Drug costs range from $700 (on-patent) to ~$150 (generic FDG)

US sales of radiopharmaceuticals for PET and SPECT $1.2 billion

US sales expected to grow to $6 billion by 2018

Global numbers approximately 2x



                                                                   64
            Source: Bio-Tech Systems Report #330; data for 2010.
2500 installed PET scanners
PET radiopharmacies cover the entire US market
Radiopharmacies have an interest in proprietary agents as a basis of competition
in their market.




                                                                                   65
Neuroblastoma                                 Parkinson’s Disease

Prevalence: about 6000 US cases               DatSCAN sales in Europe ~$100 M
about 1000 new cases per year
                                              The world's highest recorded
Subjects receive 3-6 images/year              prevalence of Parkinson's Disease of
to follow response to therapeutic protocols   any region is in Nebraska, with 329.3
                                              people per 100,000 population
World market at U.S. x 2 gives potential of
40,000-70,000 scans/year                      US – 600,000 patients 1 scan per year
                                              @ $500 = $300 M
Drug costs $500/per gives ~$20 - $35 M

                                                                                      66

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Lean Launchpad Tucson - Distribution Channels

  • 1. Aaron Eden Created by Steve Blank
  • 2. » 5/12 – What to Expect » 5/19 – First Pitches » 5/26 – Experiment Day » 6/2 –Value Propositions » 6/9 – Customers, Users, Payers » 6/16 – Distribution Channels (Justin) » 6/23 – Customer Relationships » 6/30 – Revenue Models » 7/7 – Partners » 7/14 – Key Resources & Costs » 7/21 – Lessons Learned Presentations
  • 3. » Team Presentations » Distribution Channels » Mentoring
  • 4. » What were your hypotheses about users and customers? Did you learn anything different? » Did anything change about Value Proposition? » What do customers say their problems are? How do they solve this problem(s) today? Does your value proposition solve it? How? » What was it about your product that made customers interested? excited? » If B-B, who’s: decision maker, size of budget, what are they spending it on today, how will this buying decision be made?
  • 5.
  • 6.
  • 7.
  • 8.
  • 9.
  • 10. Channels 10
  • 12. Two Critical Channel Questions How do you want to sell your product? Is subtle, but more important than the first: How does your customer want to buy your product? 12
  • 13. How Do You Want Your Product To Get To Your Customer? Yourself Someone else Retail Wholesale Bundled with other goods or services 13
  • 14. How Does Your Customer Want to Buy Your Product From Your Channel? Same Day Delivered and installed Downloaded Bundled with other products As a service 14 …
  • 17. Types of Channels Direct Indirect Licensing • OEM • VAR • Reseller • Distributor 17
  • 18. The Channel as a Customer » Some products are embedded in others (OEM) » Some products are resold by others (VARs) » Some products are distributed by others » Who’s the customer? 18
  • 19. Distribution Complexity Global Systems Systems Integrators WANs Evangelists Mainframes Direct Sales Marketing Complexity Minis LANs VARs PC Servers Desktop PCs Retail Printers Keyboards Service Web, Telesales Technicians Toner 19 Solution Complexity
  • 20. How Are Channels Compensated? » Commission » Percentage of sales price » Discounted pre-purchase 20
  • 21. How Are Channels Motivated or Incented? » Money! What makes them the most? » Training » Marketing to the channel » SPIF 21
  • 22. Channel Economics: “Direct” Sales List Revenue Price End Consumer Discounts Cost of Goods EU Profit + SG&A + R&D (Supply Chain) 22 Source: Mark Leslie, Stanford GSB
  • 23. Channel Economics: Resellers List Revenue Price End Consumer Discounts Cost of Goods EU Profit + SG&A + R&D Reseller (Supply Chain) 23 Source: Mark Leslie, Stanford GSB
  • 24. Channel Economics: Distributors/Resellers List Revenue Price End Consumer Distributor Discounts Cost of Goods Profit + SG&A + EU Reseller (Supply Chain) R&D 24 Source: Mark Leslie, Stanford GSB
  • 25. Channel Economics: OEM or IP Licensing List Your Revenue Price Cost of Distributor Distributor Discounts Master Goods Profit + SG&A + EU Reseller (Supply R&D Chain) Cost of Goods Profit + SG&A Reseller (Supply + R&D Chain) Your Product Becomes Your Customer’s Cost of Goods 25 Source: Mark Leslie, Stanford GSB
  • 26. Example: Book Publishing National Publisher Printer Wholesaler Retailer Customer Distributor 26
  • 27. Book Publishing National Publisher Distributor Retailer Customer Wholesaler •Percent of Retail 35% 15% 10% 40% $7.00 $3.00 $2.00 $8.00 $20.00 • You get - 35% of retail - the distributor gets 10% - the wholesaler gets 15% - the retailer gets 40% - less any discount they offer the customer 27
  • 28. Book Publishing Economics National Publisher Wholesaler Retailer Customer Distributor Allowances Wholesale costs Bills Markup Credit guarantees Payment guarantees Payment guarantees Return rights Credits 28 Payments
  • 29. Book Publishing Delivery National Publisher Printer Wholesaler Retailer Distributor Prepare film Receive (content)  Schedules  Print Determine Merchandise orders allocations titles  Bundle counts  Film Deliver Sell orders magazines  Establish Prepare Print and identity galleys ship  Create magazines demand Acknowledge 29 returns
  • 30. Nature of Products Impact Channel: Physical or Virtual? » Access to customers changes dramatically » Logistics related to product complexity » People as products 30
  • 31. Bits vs. Atoms Channel Web Physical Bits Product Physical 31
  • 32. Product and Channel Are Bits Channel Web Physical  Rapid Agile and Customer Development  Fastest to acquire early Bits customers and scale Product Physical 32
  • 33. Web 2.0 – Product/Channel Are Bits Channel Web Physical  Google  Twitter  Facebook Bits  Zynga  Cloud Services Product Physical 33
  • 34. Product Is Bits, but Channel Is People Channel Web Physical  Rapid Agile and  Rapid Agile and Customer Development Customer development  Fastest to acquire early  Traditional sales channel Bits customers and scale  May require installation Product Physical 34
  • 35. Traditional Enterprise Software Channel Web Physical  Google  Microsoft  Twitter  SAP  Facebook  Oracle Bits  Zynga  Cloud Services Product Physical 35
  • 36. Physical Products Sold Over the Web Channel Web Physical  Rapid Agile and  Rapid Agile and Customer Customer development development Bits  Fastest to acquire early  Traditional sales customers and scale channel  May require installation Product  Rapid Customer development  Logistics, shipping and Physical manufacturing critical  Customer service 36
  • 37. Killing Traditional Storefronts Channel Web Physical  Google  Microsoft  Twitter  SAP  Facebook  Oracle Bits  Zynga  Cloud Services Product  Zappos  Amazon  Cafepress Physical  Netflix  Consumer electronics 37
  • 38. The Factories May Be in China Channel Web Physical  Rapid Agile and  Rapid Agile and Customer development Customer development  Fastest to acquire early  Traditional sales channel Bits customers and scale  May require installation Product  Rapid Customer  Longer customer development feedback cycle  Logistics, shipping and  May require large capital Physical manufacturing critical requirements for scale  Customer service 38
  • 39. We Still Make Things that Need Salespeople Channel Web Physical  Google  Microsoft  Twitter  SAP  Facebook  Oracle Bits  Zynga  Cloud Services Product  Zappos  Cars  Amazon  Solar panels  Cafepress  Wind turbines Physical  Netflix  Bookstores  Consumer electronics  Consumer electronics 39
  • 40. Homework » Talk to 10-15 potential channel partners + (Salesmen, OEM’s distributors, etc.) » What were your hypotheses about who/what your channel would be? Did you learn anything different? » Did anything change about Value Proposition? » Update your Google Group with Business Model Canvas » Draw your channel diagram » Summarized in a 5 Minute Presentation » Read » Startup Owner’s Manual pages :227-256, 332-342 40
  • 41. Appendix 41
  • 42. implantable drug infusion pumps with remote physician control for chronic pain patients at home “the right dose at the right time and place” 42 Christian Gutierrez (EL), Ellis Meng (PI), Carol Christopher (IM), Tuan Hoang (FE)
  • 43. Chronic Pain v3 FS Team Training Patients Faster relief KOLs Trade shows Formulary Acceptance Clinical data Efficient patient Foundations management and Clinicians FDA Dosing flexibility Support Advocacy Groups Access to high-value Institutions OEMs therapies and pharmacoeconomics Hospitals IP Payors Wireless Proprietary Developers Reduce length of Pain clinics knowledge hospital stays and Human Resources pharmacoeconomics Product Dev Costs Unit sales Manufacturing Costs Support Services Marketing Costs FDA/Clinical Trials 43
  • 44. Chronic Pain v4 FS Team Trade shows Training Faster relief Patients KOLs Formulary Acceptance Clinical data FDA Efficient patient Foundations management and Clinicians CMS (Medicare) Dosing flexibility Support Advocacy Groups Access to high-value Institutions OEMs therapies and pharmacoeconomics Hospitals IP Wireless Payors Developers Proprietary pharmacoeconomics Pain clinics knowledge Electronic health Human Resources record providers Product Dev Costs Unit sales Manufacturing Costs Support Services Marketing Costs FDA/Clinical Trials Bundled kits Electronic records 44
  • 45. Getting Out Clinicians » Dr. Stan Louie, Drug Formulation Expert (USC Pharmacy) » Dr. Giovanni Cucchiaro, Anesthesiologist (CHLA) Institutions/patients » Dr. Diana Hull, Physician (Group Health in Washington state, formerly at Kaiser California) » Thomas Hsu, Insurance Specialist (Network Medical Management; a California ICA) » Two chronic pain patients ˃ Pump user and creator of support forum ˃ User of oral narcotics and patches Regulatory » Dr. Frances Richmond (Director Regulatory Science Program, USC) Entrepreneurs/ » Richard Hull (formerly at company selling Lapband) 45 Industry
  • 46. Product Flow/Channel Electronic Partners/ Health Fluid Synchrony OEMS Records Electronic Support Pump + Bundled Records Services Controller Kits Hospitals (Anesthesiologists Patients Neurosurgeons) Pain Clinic (Anesthesiologists Neurosurgeons) 46
  • 47. Channels (Direct) Hospitals • Direct to institutions • Some formularies involved in purchase decisions Pain Clinics • Some doctors make purchase decision directly • Device company/Doctor relationship is key • Heavily influenced by : • Clinical study results • Regulatory approval • Reimbursement 47
  • 48. Patient Care Flow (Now) Partners/ Fluid Synchrony OEMS Support Pump + Bundled Services Controller Kits Hospitals Surgery/Rx/ (Anesthesiologists Patient Discharged reprogramming Neurosurgeons) Pain Clinic Trial period/ Scheduled (Anesthesiologists Home setting follow-up Neurosurgeons) 48 Weeks/months Key factors: Reimbursement , state regulations
  • 49. Patient Care Flow (Proposed) Electronic Partners/ Health Fluid Synchrony OEMS Records Electronic Support Pump + Bundled Records Services Controller Kits Actionable feedback to doctors/institutions E-prescription / closing loop Hospitals Surgery/Rx/ (Anesthesiologists Patient Discharged reprogramming Neurosurgeons) Pain Clinic Trial period/ Scheduled (Anesthesiologists Home setting follow-up Neurosurgeons) 49 Weeks/months Days Key factors: Reimbursement , state regulations
  • 50. Regulatory Considerations PMA 510K Trial size 100’s of patients 20-100 Costs Up to $100,000 per patient $10-50 MM $1-10 MM Time ~ 3-4 yrs + post ~ 2-3 yrs approval follow-on • PMA approval with grouping of FDA approved drugs. • Clinical trials results used to obtain CMS (Medicare) approval • 510K restricts technology to predicate devices • Can be more difficult to market against incumbents • European CE mark is easier to attain (safety and performance only) 50
  • 51. Take-Aways • Channel is direct in this existing market • Channel for e-health is more complex and evolving • State-to-state regulations can impact incentives • Can pose problems as electronic records systems vary across the country Next Steps • Understand costs associated with reaching doctors/institutions directly • Understand structure of e-health channel • Develop regulatory pathway (timelines and cost profile) 51
  • 52. Advanced Chemistry for Pharmaceutical Progress Team: Kiel Neumann (EL) Stephen DiMagno (PI) Allan Green (Mentor) 52
  • 53.  PET is a non-invasive medical diagnostic technique for cardiac, brain, and tumor imaging  GFP technology makes new (unknown) and known (but clinically inaccessible) [18F]-labeled radiotracers readily available  Fast, multiplatform, high efficiency synthesis of these fleeting, precious agents.  Initial target indications: pediatric neuroblastoma, Parkinson’s disease. 53
  • 54. The Business Model Canvas SOPs for precursors Technical Assistance cGMP manufacturer and drugs (Image Atlas) Radiopharmacies Accessibility (RCY) Radiopharmacies Recruit clinical sites FDA regulatory support Nuclear Medicine and Purity In vivo animal studies Radiology departments Speed Equipment producers Develop regulatory PET/SPECT plan for pre IND Multiplatform Technical assistance Prescribing physicians meeting Sensitivity (nca) ID cGMP CRO Pharmaceutical Specific compounds Radiologist who perform Fund-raising development studies companies Direct sales of precursor General IP methodology for PoP data adding fluorine to Drug developers R&D and clinical studies IP lead compounds of presented in journals and PoP data interest meetings Regulatory plan Sales of precursor Radiologists Understanding of the through global finished regulatory process pharmaceutical distributor Sales of intermediates Contract cGMP precursor manufacture Salary, Rents Technology license 54 Clinical trials Product license (royalty)
  • 55. 1) Radiologists and Nuclear Medicine Physicians 2) Radiopharmacy companies (Cardinal Health, Siemens, GE Healthcare, IBA, AAA) 3) Equipment manufacturers (GE, Philips, IBA, Advion) 4) cGMP manufacturers 1) Pharmaceutical companies 2) Radiologists and Nuclear Medicine Physicians 55
  • 56. - Face to face with attending Radiologist at Stanford University - Face to face with radiopharmacist at UCSF - Conference call with Nuclear Radiologist at Memorial Sloan Kettering - Conference call with president of medium size drug company with PET product at the FDA - Telephone conference with cGMP facility 56
  • 57. - Immediate need for our product - Currently used SPECT product for neuroblastoma is limited by absence of correlative CT data - Our lead PET agent would provide more information on existing imaging equipment base - Two customers offered to participate in clinical trials - Potential for further development of other tracers identified in interviews - Actual need for the general procedure - Allow access to previously unknown tracers 57
  • 58.  Face to Face meeting with president of small radiopharmaceutical company  Face to face with a clinician at Memorial Sloan-Kettering  Face to face with Global Production Manager of Molecular imaging for one of world’s largest radiopharmaceutical companies  OncoKinib collaboration between Geurbet, OncoDesign, and Ariana pharmaceuticals  Face to face meeting with head of R & D and International Production Manager from Linz, Austria  Eckert and Zeigler – German PET modular synthesis provider  Face to face meeting with Executive Director and CEO of Scott Tech Center in Omaha, NE  Introductory teleconference to CEO of Innovation Accelerator 58
  • 59.  Significant Interest in our technology  Radiopharmacies want GMP product  No interest in GMP reagent preparation  Third-party manufacturers would use our developed synthetic pathways  Internal competition with one world radiopharmaceutical leader  Best to approach one of other two world leaders  Scott Tech Center  Willing to offer free advice on startup strategy  Provided introduction to Innovation Accelerator  Offered introduction to Director of Venture Technology of one of world’s leading radiopharmaceutical companies 59
  • 60. The Business Model Canvas Technical Assistance cGMP manufacturer SOPs for precursors (Image Atlas) Radiopharmacies Radiopharmacies and drugs Accessibility (RCY) FDA regulatory support Nuclear Medicine and Recruit clinical sites Purity Equipment producers Radiology In vivo animal studies departments Develop regulatory Speed PET/SPECT Prescribing physicians plan for pre IND meeting Multiplatform Technical assistance Sensitivity (nca) Radiologist who perform ID cGMP CRO Pharmaceutical Specific compounds studies Fund-raising development companies General methodology for Direct sales of precursor IP adding fluorine to Drug developers PoP data lead compounds of R&D and clinical studies interest presented in journals and IP meetings Radiologists PoP data Regulatory plan Sales of precursor Understanding of the through global finished regulatory process pharmaceutical distributor Sales of intermediates Contract cGMP precursor manufacture Salary, Rents 60 Technology license Clinical trials Product license (royalty)
  • 61. • F-dopa iodonium intermediate • F-dopamine iodonium intermediate We provide accessibility Reagents •ABX Could license precursor •Eckert & Ziegler synthesis for •GE MX module for TracerLab GMP Cassette or •Siemens Explora incorporation in Components modules •TracerLab/ GE Require GMP precursor (or •Eckert & Ziegler •Siemens Explora cassette) to develop our GMP Compliant Synthesizer •Neoprobe •Synthra product with their synthesizer •Siemens PETNet •GE Amersham Only want GMP PET •Cardinal Health •AAA precursor in modules 61 Radiopharmacy distributor •Iason without development
  • 62.  Conference call with top 40 Fortune 500 chemical distribution company  Open to cGMP production of our potentially proprietary precursors  Interested in developing a general “plug-and-play” cassette  Would allow implementation of our methodology and precursors for any radiochemistry module  Important for FDA compliant production of any drug used in patient diagnostics  Face to face meeting with Director of Business Development of a leading drug discovery outsourcing company  Discussed preclinical studies and contract manufacturing of proprietary intermediates - Face to face with former Director of Chemistry of major pharmaceutical company - Significant interest in general methodology application to proprietary compound syntheses 62
  • 63. » Initially seeking to market method technology -too diffuse, but many opportunities (i.e. product-driven opportunities more than general technology-driven) » Need to identify specific imaging product opportunities » Validated hypothesis for immediate need of tracers » Raised question on identity of lead compound pipeline for Parkinson’s disease » Recruited two potential partners for clinical trials 63
  • 64. Approximately 2.2 million procedures in the US. Drug costs range from $700 (on-patent) to ~$150 (generic FDG) US sales of radiopharmaceuticals for PET and SPECT $1.2 billion US sales expected to grow to $6 billion by 2018 Global numbers approximately 2x 64 Source: Bio-Tech Systems Report #330; data for 2010.
  • 65. 2500 installed PET scanners PET radiopharmacies cover the entire US market Radiopharmacies have an interest in proprietary agents as a basis of competition in their market. 65
  • 66. Neuroblastoma Parkinson’s Disease Prevalence: about 6000 US cases DatSCAN sales in Europe ~$100 M about 1000 new cases per year The world's highest recorded Subjects receive 3-6 images/year prevalence of Parkinson's Disease of to follow response to therapeutic protocols any region is in Nebraska, with 329.3 people per 100,000 population World market at U.S. x 2 gives potential of 40,000-70,000 scans/year US – 600,000 patients 1 scan per year @ $500 = $300 M Drug costs $500/per gives ~$20 - $35 M 66

Notes de l'éditeur

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