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National Science Foundation
I-Corps Program
May 23, 2012
www.bostonmountainbiotech.com
Team Members
Ellen Brune, Entrepreneurial Lead
• PhD Candidate in Chemical Engineering
• Doctoral Academy Fellow
• Graduate Certificate in Entrepreneurship
Robert Beitle P.E., Principle Investigator
• Faculty in the Department of Chemical Engineering
• Bioprocess Design and Development
Beverly Graham, Industrial Mentor
• Pel-Freez Biologicals
• 20+ years experience in Sales and Marketing in the biotech industry
The Biopharmaceutical Industry
• Typically spends $8B every year on protein-based
drug purification per drug
• Interested in a solution
to minimize their COGS
and improve their
margin
$50 Billion Dollar
Protein Therapeutic
Market
$24 Billion Dollar
Cell Line Sales
$1.4 Billion
Dollar E. coli
Target
Our Technology – Cells Make Less Trash
DNA
DNA
Lotus
Lotus Database
Provisional Patent Filed
March13, 2012
Application #: 61/610298
Key Partners Key Activities
Key Resources
Value Product Customer
Relationship
Customer
Channels
Customer
Segments
Cost Segments Revenue Segments
Our First Business Canvas
UA incubator
UAMS (GMP)
Bioproximity
Innovate AR
Parkside
Financial
Complete
MVPs based
on customer
feedback
Laboratory
GMP (?)
Scientists
Startup ($)
IP (exclusive)
R&D for the MVPs
People
Provide E. coli
cell line(s) for
simplified
downstream
processing
(purification)
Web Sales
Trade Shows
Direct Sales
Tech Support
Consultative
Segmented
and
niche market
Direct Sales
Royalties
Commercial Licensing
Customer Contacts
• Refine possible customer segments
• Food
• Industrial Enzymes
• Biopharmaceuticals
• Diagnostics
• Reagents
• Test hypothesis statements
• Composition of Minimum Viable Product
• Value Proposition
• Revenue model structure
• Establish relationships with potential
partners and customers
Customer Contact
101 total
Lotus
$8.2M/year
savings per
drug
$0
$5
$10
$15
$20
$25
$30
Millions
Total COGS Comparison
$24M
$16M
Application of Technology
• Discussion focused on three drug pipelines
• Our IMAC prototype is moderately useful
• Ion exchange friendly cell line would be disruptive technology
• Confirmed certain aspects of revenue model
• Viability of custom cell line construction as a RS
• Royalty payment of 5% is reasonable assumption
Competitor Comparison
Industry Standard
Invitrogen (LifeTech)
OneShot ™
Boston Mountain
Biotech
Estimated Required
Purification Steps
6+ 3
Purification Cost Savings
NONE 20 - 70% *
Average Commercial Cost
Savings per Year per Drug
$0 $8.2M
Customized Versions
-- Yes
Annual License Cost
per Drug
$75,000 +
3-5% of revenue
Negotiable Pricing
(average $240,000)
Lotus
Revenue and distribution channels
Academics / Not-for Profits
Contract Manufacturer
Biopharma Start-up
Large Pharma
Payments
Material Transfer
Actions
Contract
Sale
License
Agreement
Customer Segments
• Commercial Institutions:
• Primary Market
• $1.4B (Globally)
• License and Revenue sharing
agreements
• Academic Labs:
• Secondary Market
• Increase Visibility of Tech
• $140 M (North America)
• Product Sales
Key Partners Key Activities
Key Resources
Value Product Customer
Relationship
Customer
Channels
Customer
Segments
Cost Segments Revenue Segments
Our Final Business Canvas
• Large Pharma
• Protein CMOs
• Academic
Labs
• Drug
Discovery
Groups
• Enzyme
Manufacturers
• Diagnostics
Manufacturers
• Technical
Support
• Consultation
• Direct Sales
• Website
Sales
• Cell Lines
• Direct Sales
• Royalties and Licensing Fees
• Database Access Fee
• Simplify
Protein
Purification
• Increase Yield
and
Throughput
• Decrease
COGS and
Process
Waste
• UA Facilities
• Scientists and
Engineers
• Exclusive IP
• Startup Cash
• Cost to complete two MVPs
• Salaries for Scientists and Engineers
• Exclusive IP License Fee
• UA
• Business
Incubator
• GMP Facility
at UAMS
• Walton
College
• State
• Innovate AR
• Fund for AR
Future
• Parkside
Financial
• Production of
Cell Lines
• R&D for Cell
Lines and
Database
+
$50,000
Corporate Growth Roadmap
• Signed an exclusive license with the Univ. of Arkansas
• Finalize commercial prototype
• Sign CDAs with Merck and CSL Behring
• Begin commercial prototype pilot testing
• Start writing SBIR grants
• Finalize acquiring state-supported funding
National Science Foundation
I-Corps Program
May 23, 2012
www.bostonmountainbiotech.com
Canvas evolution slides start here
Our first canvas (original idea, with mistakes)
4 - University of Arkansas - Separatome based E. coli purification platform
UA incubator
UAMS (GMP)
Bioproximity
Innovate AR
Parkside
Financial
Complete
MVPs based
on customer
feedback
Laboratory
GMP (?)
Scientists
Startup ($)
IP (exclusive)
R&D for the MVPs
People
Provide E. coli cell
line(s) for
simplified
downstream
processing
(purification)
Web Sales
Trade Shows
Direct Sales
Tech Support
Consultative
Segmented and
niche market
Direct Sales
Royalties
Commercial Licensing
University of Arkansas: Separatome based E. coli purification platform
Provide E.
coli cell
line(s) for
simplified
downstream
processing
(purification)
Segmented
and
niche market
Biopharma
Biotechnolog
y
Food
Tech Support
Consultative
Web Sales
Trade Shows
Sales Force
Complete
MVPs based
on customer
feedback
Laboratory
(GMP ?)
Scientists
Startup ($)
UA incubator
UAMS (GMP)
Bioproximity
Value driven
R&D for the MVPs
People
Licensing
(implicit – academic)
(written – industry)
University of Arkansas: Separatome based E. coli purification platform
Provide E. coli cell
line(s) for
simplified
downstream
processing
(purification)
Simplify Protein
Purification
Increase Yield
Increase
Throughput
Decrease Cost
Segmented and
niche market
Biopharma
Biotechnology
Food
Tech Support
Consultative
Web Sales
Trade Shows
Direct Sales
Complete MVPs
based on
customer
feedback
Laboratory
GMP (?)
Scientists
Startup ($)
IP (exclusive
license)
UA incubator
UAMS (GMP)
ASTA
Bioproximity
Innovate AR
Parkside
Financial
R&D for the MVPs
People
Direct Sales
Royalties
Commercial Licensing
Database License
Protein CMOs
Drug Discovery
Research Groups
Industrial Enzyme
Manufacturers
Academic Protein
Research Labs
University of Arkansas: Separatome based E. coli purification platform
Simplify Protein
Purification
Increase Yield
Increase
Throughput
Decrease COGS
Decrease Waste
Tech Support
Consultative
Web Sales
Direct Sales
Provide MVP to
Customer
R&D
Production
Support
Laboratory
GMP
Scientists
Startup $
IP (exclusive license)
UA incubator
UAMS (GMP)
ASTA
Fund for Arkansas
Future
Bioproximity
Innovate AR
Parkside Financial
U of A
Business Plan
Competitions ($$$)
R&D for the MVPs
People
IP License
Direct Sales
Royalties
Commercial Licensing
Database License
Protein CMOs
Drug Discovery
Research Groups
Diagnostic
Research Groups
Industrial Enzyme
Manufacturers
Academic Protein
Research Labs
University of Arkansas: Separatome based E. coli purification platform
Simplify Protein
Purification
Increase Yield
Increase
Throughput
Decrease COGS
Decrease Waste
Tech Support
Consultative
Web Sales
Direct Sales
R&D
Production
Support
Laboratory
GMP
Scientists
Startup $
IP (exclusive license)
UA incubator
UAMS (GMP)
ASTA
Fund for Arkansas
Future
Bioproximity
Innovate AR
Parkside Financial
U of A
Business Plan
Competitions ($$$)
R&D for the MVPs
People
IP License
Direct Sales
Royalties
Commercial Licensing
Database License
Protein CMOs
Drug Discovery
Research Groups
Diagnostic
Research Groups
Industrial Enzyme
Manufacturers
Academic Protein
Research Labs
Large Pharma
Present canvas (after five iterations)
• Large Pharma
• Protein CMOs
• Academic Labs
• Drug Discovery
Groups
• Enzyme
Manufacturers
• Diagnostics
Manufacturers
• Technical
Support
• Consultation
• Direct Sales
• Website Sales
• Cell Lines
• Direct Sales
• Royalties and
Licensing Fees
• Database Access Fee
• Simplify Protein
Purification
• Increase Yield
and Throughput
• Decrease
COGS and
Process Waste
• UA Facilities
• Scientists and
Engineers
• Exclusive IP
• Startup Cash
• Cost to complete two MVPs
• Salaries for Scientists and
Engineers
• Exclusive IP License Fee
• UA
• Business
Incubator
• GMP Facility
at UAMS
• Walton
College
• State
• Innovate AR
• Fund for AR
Future
• Parkside
Financial
• Production of
Cell Lines
• R&D for Cell
Lines and
Database
4 - University of Arkansas - Separatome based E. coli purification platform
Backup material
Market
What kind of business are we building?
• IP based
• Data on E. coli sepratome
• E. coli cell lines that improve chromatography
• License of an E. coli expression platform
• Technical Services/Support
Disruptive Innovation
• Generate a new markets
• Reduction in entry cost barrier
• Simplified purification process
• Access existing markets
• Large Manufacturers
• Existing FDA approved drugs
• Pre-FDA drugs in the pipeline
• Sticky Technology
• Cell line tied to FDA approval
Hypothesis Statements
• On-going
• A cell line “tool kit” would be beneficial
• Protein manufacturers have control over cell line selection
• Added by teaching team
• Local council with biotech IP experience is available
• BMB revenue model is valid (royalties, fees)
• Speaking with biotech entrepreneurs will provide valued advice
4 - University of Arkansas - Separatome based E. coli purification platform
Our first canvas (original idea, with mistakes)
Unclear value proposition
Definition, not who
Unrealistic channel
Random list of hopefuls + current
4 - University of Arkansas - Separatome based E. coli purification platform
Contact Method
• Almost all of our contacts were done via conference
• Video
• Audio
• Multimedia
• Cold call strategy adapted slightly
• Set stage for conversation
• Two or three of us on each call
• Also used survey tools
• LinkedIn / Surveymonkey
• Respondents not included in contact count
IM sent email to contact (or PI)
Appointment set, short summary sent electronically
Conversation
Follow-up
4 - University of Arkansas - Separatome based E. coli purification platform
Lotus
IMAC
0-10mM 10-50mM 50-100mM 100-200mM 200-500mM
• Less background proteins are present by choosing appropriate strain
• Five cell lines, each line has different set of background proteins “removed”
• Cell line used to express target protein (e.g. insulin)

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Boston Mountain Biotech NSF Final Presentation

  • 1. National Science Foundation I-Corps Program May 23, 2012 www.bostonmountainbiotech.com
  • 2. Team Members Ellen Brune, Entrepreneurial Lead • PhD Candidate in Chemical Engineering • Doctoral Academy Fellow • Graduate Certificate in Entrepreneurship Robert Beitle P.E., Principle Investigator • Faculty in the Department of Chemical Engineering • Bioprocess Design and Development Beverly Graham, Industrial Mentor • Pel-Freez Biologicals • 20+ years experience in Sales and Marketing in the biotech industry
  • 3. The Biopharmaceutical Industry • Typically spends $8B every year on protein-based drug purification per drug • Interested in a solution to minimize their COGS and improve their margin
  • 4. $50 Billion Dollar Protein Therapeutic Market $24 Billion Dollar Cell Line Sales $1.4 Billion Dollar E. coli Target
  • 5. Our Technology – Cells Make Less Trash DNA DNA Lotus Lotus Database Provisional Patent Filed March13, 2012 Application #: 61/610298
  • 6. Key Partners Key Activities Key Resources Value Product Customer Relationship Customer Channels Customer Segments Cost Segments Revenue Segments Our First Business Canvas UA incubator UAMS (GMP) Bioproximity Innovate AR Parkside Financial Complete MVPs based on customer feedback Laboratory GMP (?) Scientists Startup ($) IP (exclusive) R&D for the MVPs People Provide E. coli cell line(s) for simplified downstream processing (purification) Web Sales Trade Shows Direct Sales Tech Support Consultative Segmented and niche market Direct Sales Royalties Commercial Licensing
  • 7. Customer Contacts • Refine possible customer segments • Food • Industrial Enzymes • Biopharmaceuticals • Diagnostics • Reagents • Test hypothesis statements • Composition of Minimum Viable Product • Value Proposition • Revenue model structure • Establish relationships with potential partners and customers Customer Contact 101 total
  • 9. • Discussion focused on three drug pipelines • Our IMAC prototype is moderately useful • Ion exchange friendly cell line would be disruptive technology • Confirmed certain aspects of revenue model • Viability of custom cell line construction as a RS • Royalty payment of 5% is reasonable assumption
  • 10. Competitor Comparison Industry Standard Invitrogen (LifeTech) OneShot ™ Boston Mountain Biotech Estimated Required Purification Steps 6+ 3 Purification Cost Savings NONE 20 - 70% * Average Commercial Cost Savings per Year per Drug $0 $8.2M Customized Versions -- Yes Annual License Cost per Drug $75,000 + 3-5% of revenue Negotiable Pricing (average $240,000) Lotus
  • 11. Revenue and distribution channels Academics / Not-for Profits Contract Manufacturer Biopharma Start-up Large Pharma Payments Material Transfer Actions Contract Sale License Agreement
  • 12. Customer Segments • Commercial Institutions: • Primary Market • $1.4B (Globally) • License and Revenue sharing agreements • Academic Labs: • Secondary Market • Increase Visibility of Tech • $140 M (North America) • Product Sales
  • 13. Key Partners Key Activities Key Resources Value Product Customer Relationship Customer Channels Customer Segments Cost Segments Revenue Segments Our Final Business Canvas • Large Pharma • Protein CMOs • Academic Labs • Drug Discovery Groups • Enzyme Manufacturers • Diagnostics Manufacturers • Technical Support • Consultation • Direct Sales • Website Sales • Cell Lines • Direct Sales • Royalties and Licensing Fees • Database Access Fee • Simplify Protein Purification • Increase Yield and Throughput • Decrease COGS and Process Waste • UA Facilities • Scientists and Engineers • Exclusive IP • Startup Cash • Cost to complete two MVPs • Salaries for Scientists and Engineers • Exclusive IP License Fee • UA • Business Incubator • GMP Facility at UAMS • Walton College • State • Innovate AR • Fund for AR Future • Parkside Financial • Production of Cell Lines • R&D for Cell Lines and Database
  • 15. Corporate Growth Roadmap • Signed an exclusive license with the Univ. of Arkansas • Finalize commercial prototype • Sign CDAs with Merck and CSL Behring • Begin commercial prototype pilot testing • Start writing SBIR grants • Finalize acquiring state-supported funding
  • 16. National Science Foundation I-Corps Program May 23, 2012 www.bostonmountainbiotech.com
  • 18. Our first canvas (original idea, with mistakes) 4 - University of Arkansas - Separatome based E. coli purification platform UA incubator UAMS (GMP) Bioproximity Innovate AR Parkside Financial Complete MVPs based on customer feedback Laboratory GMP (?) Scientists Startup ($) IP (exclusive) R&D for the MVPs People Provide E. coli cell line(s) for simplified downstream processing (purification) Web Sales Trade Shows Direct Sales Tech Support Consultative Segmented and niche market Direct Sales Royalties Commercial Licensing
  • 19. University of Arkansas: Separatome based E. coli purification platform Provide E. coli cell line(s) for simplified downstream processing (purification) Segmented and niche market Biopharma Biotechnolog y Food Tech Support Consultative Web Sales Trade Shows Sales Force Complete MVPs based on customer feedback Laboratory (GMP ?) Scientists Startup ($) UA incubator UAMS (GMP) Bioproximity Value driven R&D for the MVPs People Licensing (implicit – academic) (written – industry)
  • 20. University of Arkansas: Separatome based E. coli purification platform Provide E. coli cell line(s) for simplified downstream processing (purification) Simplify Protein Purification Increase Yield Increase Throughput Decrease Cost Segmented and niche market Biopharma Biotechnology Food Tech Support Consultative Web Sales Trade Shows Direct Sales Complete MVPs based on customer feedback Laboratory GMP (?) Scientists Startup ($) IP (exclusive license) UA incubator UAMS (GMP) ASTA Bioproximity Innovate AR Parkside Financial R&D for the MVPs People Direct Sales Royalties Commercial Licensing Database License Protein CMOs Drug Discovery Research Groups Industrial Enzyme Manufacturers Academic Protein Research Labs
  • 21. University of Arkansas: Separatome based E. coli purification platform Simplify Protein Purification Increase Yield Increase Throughput Decrease COGS Decrease Waste Tech Support Consultative Web Sales Direct Sales Provide MVP to Customer R&D Production Support Laboratory GMP Scientists Startup $ IP (exclusive license) UA incubator UAMS (GMP) ASTA Fund for Arkansas Future Bioproximity Innovate AR Parkside Financial U of A Business Plan Competitions ($$$) R&D for the MVPs People IP License Direct Sales Royalties Commercial Licensing Database License Protein CMOs Drug Discovery Research Groups Diagnostic Research Groups Industrial Enzyme Manufacturers Academic Protein Research Labs
  • 22. University of Arkansas: Separatome based E. coli purification platform Simplify Protein Purification Increase Yield Increase Throughput Decrease COGS Decrease Waste Tech Support Consultative Web Sales Direct Sales R&D Production Support Laboratory GMP Scientists Startup $ IP (exclusive license) UA incubator UAMS (GMP) ASTA Fund for Arkansas Future Bioproximity Innovate AR Parkside Financial U of A Business Plan Competitions ($$$) R&D for the MVPs People IP License Direct Sales Royalties Commercial Licensing Database License Protein CMOs Drug Discovery Research Groups Diagnostic Research Groups Industrial Enzyme Manufacturers Academic Protein Research Labs Large Pharma
  • 23. Present canvas (after five iterations) • Large Pharma • Protein CMOs • Academic Labs • Drug Discovery Groups • Enzyme Manufacturers • Diagnostics Manufacturers • Technical Support • Consultation • Direct Sales • Website Sales • Cell Lines • Direct Sales • Royalties and Licensing Fees • Database Access Fee • Simplify Protein Purification • Increase Yield and Throughput • Decrease COGS and Process Waste • UA Facilities • Scientists and Engineers • Exclusive IP • Startup Cash • Cost to complete two MVPs • Salaries for Scientists and Engineers • Exclusive IP License Fee • UA • Business Incubator • GMP Facility at UAMS • Walton College • State • Innovate AR • Fund for AR Future • Parkside Financial • Production of Cell Lines • R&D for Cell Lines and Database 4 - University of Arkansas - Separatome based E. coli purification platform
  • 25.
  • 27. What kind of business are we building? • IP based • Data on E. coli sepratome • E. coli cell lines that improve chromatography • License of an E. coli expression platform • Technical Services/Support
  • 28. Disruptive Innovation • Generate a new markets • Reduction in entry cost barrier • Simplified purification process • Access existing markets • Large Manufacturers • Existing FDA approved drugs • Pre-FDA drugs in the pipeline • Sticky Technology • Cell line tied to FDA approval
  • 29. Hypothesis Statements • On-going • A cell line “tool kit” would be beneficial • Protein manufacturers have control over cell line selection • Added by teaching team • Local council with biotech IP experience is available • BMB revenue model is valid (royalties, fees) • Speaking with biotech entrepreneurs will provide valued advice 4 - University of Arkansas - Separatome based E. coli purification platform
  • 30. Our first canvas (original idea, with mistakes) Unclear value proposition Definition, not who Unrealistic channel Random list of hopefuls + current 4 - University of Arkansas - Separatome based E. coli purification platform
  • 31. Contact Method • Almost all of our contacts were done via conference • Video • Audio • Multimedia • Cold call strategy adapted slightly • Set stage for conversation • Two or three of us on each call • Also used survey tools • LinkedIn / Surveymonkey • Respondents not included in contact count IM sent email to contact (or PI) Appointment set, short summary sent electronically Conversation Follow-up 4 - University of Arkansas - Separatome based E. coli purification platform
  • 32. Lotus IMAC 0-10mM 10-50mM 50-100mM 100-200mM 200-500mM • Less background proteins are present by choosing appropriate strain • Five cell lines, each line has different set of background proteins “removed” • Cell line used to express target protein (e.g. insulin)

Editor's Notes

  1. DNA NOT GENES!!
  2. BioMarin is currently NOT a profitable company because of their COGS
  3. Neulasta 4th quarter sales of $918M $3,672M yearly sales 3-5% is $110-180M based on sales not on revenue
  4. While we have looked at one company in the market, lets take a broader look at the entire market. The US protein expression kit market was estimated at 200 M in 2008 and had experienced 20% growth The global market for cells and cells lines was over 1.4B in 2011 and experiencing 10% growth