UCSF Diagnostics Cohort
Fall 2013
Todd Morrill

Resources, Activities, Costs
1
Remember how we will fit DX into the BMC?

2
IP Resources in Dx
• Original / core license
– Licensed or filed
– Nothing to talk about unless it is protected
– Analyte,...
Financial Resources in Dx
• Cost to develop / burn rate
• Time to market
• Pre-launch builds

• Incremental funding if nec...
MammOptics

Financial / Operations Timeline
2012
Cash Reserve

Q1 Q2

Q3 Q4

Q1

Q2

Q3 Q4

2016

2015
Q1

Q2

Q3

Q4 Q1

...
MammOptics

Financial / Operations Timeline
2012
Cash Reserve

Q1 Q2

Q3 Q4

2013
Q1 Q2

2014

Q3 Q4

Q1

Q2

Q3

Q4 Q1

Q...
MammOptics

Financial / Operations Timeline
2012
Cash Reserve

Q1 Q2

Q3 Q4

2013
Q1 Q2

2014

Q3 Q4

Q1

Q2

2016

2015

...
MammOptics

Financial / Operations Timeline
2012
Cash Reserve

Q1 Q2

Q3 Q4

2013
Q1 Q2

Q3 Q4

2014
Q1

Q2

2016

2015

Q...
MammOptics

Financial / Operations Timeline
2012
Cash Reserve

Q1 Q2

Q3 Q4

2013
Q1 Q2

Q3 Q4

2014
Q1

Q2

Q3 Q4

2016

...
MammOptics

Financial / Operations Timeline
2012
Cash Reserve

Q1 Q2

Q3 Q4

Q1

Q2

2016

2015

Q3 Q4

Q1

Q2

Q3

Q4 Q1
...
© 2012 Steve Blank
Activities
• Development plan
• It takes a long time to get financed!
– Limited CEO resource

• Product validation aka cli...
© 2012 Steve Blank
Remember how we will fit DX into the BMC?

15
Next week
• Slides as per the syllabus
•

Close-to-final slide on reimbursement
–
–
–

•

Close-to-final slide on regulati...
Upcoming schedule
•
•
•
•

Nov 19 – Your final regular presentation
Nov 26 – No class
Dec 3 – Training session for the fin...
Open Office Hours
• Wed Nov 13 – most of the day
• Thu Nov 14 – after 2pm
• Mon Nov 18 – most of the day

Please set up th...
UCSF Life Sciences Week 7 Diagnostics Resources, Activities, Costs
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UCSF Life Sciences Week 7 Diagnostics Resources, Activities, Costs

  1. 1. UCSF Diagnostics Cohort Fall 2013 Todd Morrill Resources, Activities, Costs 1
  2. 2. Remember how we will fit DX into the BMC? 2
  3. 3. IP Resources in Dx • Original / core license – Licensed or filed – Nothing to talk about unless it is protected – Analyte, test method, reagents, apparatus, etc. • Freedom to operate – Much harder to get. Make reasonable assumptions – US PTO and search engines can help • Protection from competition – Very hard
  4. 4. Financial Resources in Dx • Cost to develop / burn rate • Time to market • Pre-launch builds • Incremental funding if necessary
  5. 5. MammOptics Financial / Operations Timeline 2012 Cash Reserve Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2016 2015 Q1 Q2 Q3 Q4 Q1 Q2 Q3 2017 Q4 Q1 Q2 2018 Q3 Q4 Q1 Q2 $30M $20M $15M $5M Series A $3.5 MM System Initialize Proof of Concept Beta Prototype Laboratory Prototype Clinical Milestones Design Milestones Q1 Q2 2014 $40M $10M Regulatory/ IP Milestones Q3 Q4 2013 BetaVersion Testing Pilot Studies Provisional Patent Technology Licensing 6 12/4/2009 Q3
  6. 6. MammOptics Financial / Operations Timeline 2012 Cash Reserve Q1 Q2 Q3 Q4 2013 Q1 Q2 2014 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 $20M Series B $9 MM $15M Series A $3.5 MM System Design Milestones Q2 2018 $30M $5M Clinical Milestones Q1 2017 $40M $10M Regulatory/ IP Milestones Q3 Q4 2016 2015 Regulatory / Clinical Beta Prototype Laboratory Prototype Marketable Product BetaVersion Testing Pilot Studies IRB / IDE IC and Processin g Patents Application and System Patents 7 12/4/2009 Q3
  7. 7. MammOptics Financial / Operations Timeline 2012 Cash Reserve Q1 Q2 Q3 Q4 2013 Q1 Q2 2014 Q3 Q4 Q1 Q2 2016 2015 Q3 Q4 Q1 Q2 Q3 Q4 Q1 $40M Series C $30.5 MM $30M $20M Series B $9 MM $15M $10M $5M System Regulatory/ IP Milestones Clinical Milestones Design Milestones Regulatory / Clinical Second Release 1st Release Test Publication Pilot Studies IRB / IDE IC and Processin g Patents US Interim Trials US Pivotal Clinical Trials Cat III CPT Application and System Patents 8 Q2 Q3 2017 Q4 Q1 Q2 Q3 Q4 2018 Q1 Q2 Q3
  8. 8. MammOptics Financial / Operations Timeline 2012 Cash Reserve Q1 Q2 Q3 Q4 2013 Q1 Q2 Q3 Q4 2014 Q1 Q2 2016 2015 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 2017 Q4 $40M $30M $20M Q1 Q2 2018 Q3 Q4 Q1 Q2 Series D $35 MM Series C $30.5 MM $15M $10M $5M Launch Design Milestones Second Release Clinical Milestones Regulatory / Clinical Publication 2nd Release Test Publication US Pivotal Clinical Trials Clinical Results Non-Specific Codes Regulatory/ IP Milestones US Interim Trials FDA – Class II – 510 (k) with Clinical Trials Initial Product Launch 9 12/4/2009 Q3
  9. 9. MammOptics Financial / Operations Timeline 2012 Cash Reserve Q1 Q2 Q3 Q4 2013 Q1 Q2 Q3 Q4 2014 Q1 Q2 Q3 Q4 2016 2015 Q1 Q2 Q3 Q4 Q1 Q2 Q3 2017 Q4 $40M Q1 Q2 2018 Q3 Q4 Q1 Q2/ IPO M&A Q3 $50 MM Series D $35 MM $30M $20M $15M $10M $5M Launch Design Milestones Regulatory / Clinical Regulatory/ IP Milestones Clinical Milestones Publication Clinical Results Post-Market Clinical Studies Non-Specific Codes FDA – Class II – 510 (k) with Clinical Trials Specific Codes (Cat. I CPT / APC) Initial Product Launch 12/4/2009
  10. 10. MammOptics Financial / Operations Timeline 2012 Cash Reserve Q1 Q2 Q3 Q4 Q1 Q2 2016 2015 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 2017 Q4 $20M Series A $3.5 MM Proof of Concept Q2 Q3 Q4 Q1 Q2/ IPO M&A Q3 $50 MM Series B $9 MM $15M System Initialize Q1 2018 Series D $35 MM Series C $30.5 MM $30M $5M Laboratory Prototype Launch Regulatory / Clinical Beta Prototype Marketable Product BetaVersion Testing Second Release 1st Release Test 2nd Release Test Publication Publication Clinical Milestones Design Milestones Q1 Q2 2014 $40M $10M Regulatory/ IP Milestones Q3 Q4 2013 Pilot Studies US Interim Trials US Pivotal Clinical Trials Clinical Results Post-Market Clinical Studies Non-Specific Codes Provisional Patent Technology Licensing IRB / IDE IC and Processin g Patents FDA – Class II – 510 (k) with Clinical Trials Cat III CPT Application and System Patents Specific Codes (Cat. I CPT / APC) Initial Product Launch 11 12/4/2009
  11. 11. © 2012 Steve Blank
  12. 12. Activities • Development plan • It takes a long time to get financed! – Limited CEO resource • Product validation aka clinical trials – Sensitivity and selectivity specs – Validation study: patients, time, cost – Regulator who will oversee it
  13. 13. © 2012 Steve Blank
  14. 14. Remember how we will fit DX into the BMC? 15
  15. 15. Next week • Slides as per the syllabus • Close-to-final slide on reimbursement – – – • Close-to-final slide on regulation – – – • What agency, division, etc. will provide approval Estimated time-to-approval following data submission Any other regulatory issues Close-to-final slide of clinical trials – – • Codes you will use and associated $$ value Justification for those codes Estimated price, and JUSTIFY the difference! How many samples / patients Estimated cost in $$, time and other resources (e.g. your time) Close-to-final slide on ecosystem – With flows including dollars and estimated amounts
  16. 16. Upcoming schedule • • • • Nov 19 – Your final regular presentation Nov 26 – No class Dec 3 – Training session for the final Dec 10 – Final presentations etc. Please don’t let customer interviewing languish during Thanksgiving, or after…
  17. 17. Open Office Hours • Wed Nov 13 – most of the day • Thu Nov 14 – after 2pm • Mon Nov 18 – most of the day Please set up the call as soon as possible in advance. I may (not) be available short notice.
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