Innovation Funding for Life Science Projects Pitch Deck

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EXAMPLE “PITCH DECK” INNOVATION FUNDING
PROJECTS IN 
LIFE SCIENCE
PRODUCED BY THE TTO BUSINESS DEVELOPMENT TEAM – NOVEMBER 2020
EMAIL: TTO@AU.DK
 
WE HOPE THIS WILL HELP YOU
UNDERSTAND THE DIFFERENCE
BETWEEN A 
PITCH
 AND A 
RESEARCH
PRESENTATION
THIS DOCUMENT HAS BEEN DESIGNED BY THE BUSINESS
DEVELOPMENT TEAM FOR PHDS AND POSTDOCS THAT WANT
TO APPLY TO THE INNOEXPLORER GRANT. PLEASE DISCUSS
THIS TEMPLATE WITH YOUR TTO BUSINESS DEVELOPER.
THE NOTES WILL GUIDE YOU THROUGH THE
TEMPLATE. PLEASE CONTACT US IF YOU HAVE
ANY QUESTIONS AT 
TTO@AU.DK
IT IS AN EXAMPLE PITCH DECK FOR INSPIRATION – AND
TESTED WITH OUR STAKEHOLDERS. HOWEVER – THIS IS YOUR
PITCH PRESENTION SO DELETE ANY SLIDE YOU DON’T LIKE.
AND PLEASE CONTACT US IF WE CAN HELP!
VIEW PRESENTATION IN “SLIDE SHOW” TO ACTIVATE WEB LINKS
 
 
MISSION
Misson
: Our goal is to create new therapeutics for Lupus patients via maturing a technology, acquiring
financing and creating a new company. Our lab at Aarhus Univeristy has created 
a first in class STING-
TBK1 inhibitors 
for the treatment of autoimmune diseases. Here, we seek to develop this technology.
SOCIETAL OUTCOMES
New drug
for Danish
Lupus
patients
Develop work
package for
investors
Danish
example of
STING
innovation
Jobs
OVERVIEW
TEXT
TEXT
TEXT
TEXT
TEXT
TEXT
2
 
 
TEAM
Project Leader
“ I am a post-doctorial researcher within the laboratory of Prof. XYZ: I wish to join the
innovation culture and learn the tools of the university entrepreneur. I hold a Ph.D in XYZ
and have XX years experience in XYZ.
Subject Matter Expert
“ I am a professor within the field of XYZ and hold XXX years experience related to XXX.
This is my first university spin-out, but I am keen to understand how we can learn the
commercial and regulatory aspects of this case and work with experts in this field.
Consultant
“ My firm has a key expertise in XYZ and will be able to ensure that this project is
managed on a professional basis, within industry standards.
DESIGN A TEAM BASED ON 
EXPECTED INDUSTRY PROFESSIONAL STANDARDS
FOR EXAMPLE: CONSIDER USING CONTRACT RESEARCH ORGANISATIONS  – INSTEAD OF
YOUR OWN LAB. HOW WILL YOUR PROJECT MANAGE REGULATORY ACTIVITIES AND
WHO IS THE PROJECT LEADER?
3
 
 
THE SCIENTIFIC FIELD
Our Research field:
 
We work in the field of gene editing research. Zinc finger
nucleases and transcription activator-like effector nucleases, have
significantly improved precise genome modification, but have key limits.
Crispr-Cas9 reaches a new level of targeting, efficiency, and ease of use.
The CRISPR/Cas9 system allows for site-specific genomic targeting in
virtually any organism.
Research Stakeholders
Key Trends
SOME EXAMPLES…
THE INNOEXPLORER PANEL MAY NOT KNOW YOUR FIELD.
SO - INTRODUCE IT AND THE KEY TRENDS IN ONE SLIDE.
PRESENT IT AS AN EXCITING STORY WITH A GLOBAL
PERSPECTIVE! WHATS HAPPENING?!
What are the
opportunities?
What are the
threats?
4
 
 
THE SCIENCE & THE PROBLEM
The Disease
Our group has 20 years experience with studying the XYZ pathway. Recently,……
Donec cursus viverra sapien, id accumsan risus porta accumsan. Integer tempor
malesuada nisl, ut gravida justo convallis in. Nunc mollis nisl vel purus ullamcorper, eu
viverra est ullamcorper. Vivamus quis magna egestas, accumsan nunc eu, vehicula
augue. Donec dapibus eros eu est pharetra euismod. Nam aliquet mauris eu ultrices
molestie. Vivamus commodo a metus a scelerisque. Nulla ac fringilla enim. Vestibulum
ante ipsum primis in faucibus orci luctus et ultrices posuere cubilia Curae; In at posuere
turpis. In fringilla facilisis risus id auctor. Etiam varius neque nec felis rhoncus interdum.
Duis rutrum mattis facilisis. Etiam sit amet mi lobortis, mattis metus id, efficitur mi.
Clinical Collaborator (Key Opinion Leader/ Subject Matter Expert)
“ I am a clinical professor within the field of XYZ and have worked to treat patients in this
field for XX years. I will join the project and serve as a Clinical Advisor, ensuring the team
are aware of current therapeutics, clinical practice and also reimbursement.
IT IS 
VERY IMPORTANT 
TO INCLUDE YOUR 
SCIENTIFIC DATA
. ON THIS PAGE, INTRODUCE THE
TECHNICAL PROBLEM AND EXPLAIN YOUR HISTORIC EXPERTISE. A KEY CHALLENGE OF POC
GRANTS IS THE NEED TO INCLUDE BOTH 
THE SCIENCE 
AND 
THE BUSINESS
….
Image?
5
 
 
THE SCIENCE & THE SOLUTION
Key Findings
Our group at the Biomedicine Department has identified a way of xxx……
Inventors
:
Lorem ipsum dolor sit amet,
consectetur adipiscing elit.
Nullam sed vestibulum felis.
Mauris eros nisl, pretium sed
auctor a, tincidunt ac justo.
Praesent non egestas massa.
Duis a enim iaculis,
ullamcorper quam sed, rutrum
sapien. Integer mattis felis
consectetur metus facilisis, nec
rutrum orci aliquam.
Pellentesque dapibus
bibendum blandit. Donec
faucibus orci ac libero
sollicitudin venenatis. Aenean
non odio non sem suscipit
sodales varius vitae lacus.
Praesent accumsan leo id
dapibus bibendum. Sed
vehicula at libero nec
scelerisque.
Image?
Image?
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Nullam sed vestibulum felis. Mauris eros nisl,
pretium sed auctor a, tincidunt ac justo. Praesent non egestas massa. Duis a enim iaculis, ullamcorper
quam sed, rutrum sapien. Integer mattis felis consectetur metus facilisis, nec rutrum orci aliquam.
Pellentesque dapibus bibendum blandit.
ADD IMAGES TO EXPLAIN YOUR KEY FINDINGS.
IN YOUR PITCH, SPEND TIME TO 
EXPLAIN WHAT THE IMAGE MEANS 
I.E. POINT TO
THE IMAGE AND EXPLAIN WHAT EXPERIMENT WAS PERFORMED AND WHAT
RESULTS WERE OBTAINED.
HOW DID THE RESULTS MAKE YOU
 FEEL? SHOW EXCITEMENT FOR
BREAKTHROUGHS!
…… BUT ALSO EXPLAIN ANY EXPERIMENTS THAT MAY NEED TO
BE REPEATED.
ALSO CONTINUE USING THE STANFORD 
NABC
 MODEL HERE AS WELL!
BE SURE TO EXPLAIN WHAT YOUR
TECHNOLOGY CAN DO – 
HOW DOES IT
SOLVE THE PROBEM AND WHY IS IT THE
SUPERIOR SOLUTION? MISSING THIS
INFORMATION IS
 
THE MOST COMMON
MISTAKE 
FOR UNIVERSITY SCIENTISTS.
6
ON THIS PAGE, CONTINUE TO INTRODUCE HOW YOUR SCIENTIFIC RESEARCH HAS PRODUCED A SOLUTION
TO THE PROBLEM. ONCE AGAIN – 
COMMUNICATE THE DETAIL OF YOUR SCIENTIFIC RESEARCH!!!
 
 
MARKET & PIPELINE ANALYSIS
Disease:?
Patient Demographic:?
Formulation:?
Current Drugs Used:?
Pipeline Drug projects:?
Market Rivalry?:
THIS SLIDE EXPLAINS YOUR TEAMS UNDERSTANDING OF THE MARKET. YOU SHOULD WORK
WITH YOUR TTO BUSINESS DEVELOPER TO CREATE THIS SLIDE.
IMPORTANTLY, YOU WILL NEED TO ENGAGE WITH MARKET STAKEHOLDER TO GAIN INPUT FOR
THIS SLIDE. FOR EXAMPLE: WHAT DOES YOUR SPIN-OUT NEED TO ACHIEVE TO CREATE A
PARTNERSHIP WITH A LARGER COMMERCIAL PARTNER?
IMPORTANT
:
THE MOST IMPORTANT OUTCOME OF A MARKET ANALYSIS IS THE ABILITY TO COMMUNICATE
WHY YOUR TECHNOLOGY SOLUTION IS 
BETTER THAN
 OTHER SOLUTIONS.
COMPARE
 THE ATTRIBUTES OF YOUR DRUG DISCOVERY OR DEVICE INVENTION TO OTHER
COMPANIES IN THE PIPELINE. 
CONTRAST
 YOUR APPROACH TO THE PIPELINE AND HIGHLIGHT
WHY YOU THINK IT IS DIFFERENT – 
AND SUPERIOR!
OUR VALUE PROPOSITION
OUR MARKET
7
 
 
RESOURCES & CAPABILITIES
Our resource & knowledge “gaps”
Today’s resource & knowledge assets
What are our strengths?
 
What are our weaknesses?
WHAT EXPERTISE DOES CONSULTANTS OFFER?
WHAT IS THE STATUS OF YOUR PATENT APPLICATION?
8
WHAT EXPERTISE DOES YOUR TEAM HAVE?
 
 
REGULATORY ADVICE
“We met with a regulatory consultant and have designed a programme to enable a
INVESTIGATIONAL NEW DRUG APPLICATION 
at the FDA in the US.
In addition, we believe that our disease focus enables us to apply for a 
FDA Expedited Development
Program
.”
Donec cursus viverra sapien, id accumsan risus porta accumsan. Integer tempor malesuada nisl, ut
gravida justo convallis in. Nunc mollis nisl vel purus ullamcorper, eu viverra est ullamcorper. Vivamus
quis magna egestas, accumsan nunc eu, vehicula augue. Donec dapibus eros eu est pharetra
euismod. Nam aliquet mauris eu ultrices molestie. Vivamus commodo a metus a scelerisque. Nulla ac
fringilla enim. Vestibulum ante ipsum primis in faucibus orci luctus et ultrices posuere cubilia Curae; In
at posuere turpis. In fringilla facilisis risus id auctor. Etiam varius neque nec felis rhoncus interdum. Duis
rutrum mattis facilisis. Etiam sit amet mi lobortis, mattis metus id, efficitur mi.
IMPORTANT
REGULATORY AFFAIRS 
IS ONE OF THE KEY AREAS WHERE UNIVERSITY
FUNDING APPLICATIONS FAIL. YOUR TEAM NEEDS TO CONSIDER
WHAT REGULATORY AUTHORITIES MAY DO.
THE TTO BUSINESS DEVELOPMENT TEAM CAN HELP YOU TO IDENTIFY
REGULATORY CONSULTANTS THAT COULD BE FUNDED VIA THE
INNOEXPLORER GRANT.
9
 
 
IP STRATEGY / SPIN-OUT BUSINESS MODEL
Here are the following key events and activities in our IP strategy…
10
PCT
Search Report
National Phase
12
30
Event: PCT
Action: “ We will….”
Time
(months)
Event: National Phase
Action: “TTO will….”
The company could follow the following business model…
SOME EXAMPLE TEXT…
Partnership to Acquisition
As the IND is filed with regulatory
authorities, the company will
initiate a process to create
relationships with potential partners
within the pharmaceutical sector.
Such partners would enable
validation of the business model
and value proposition of our lead
candidate. The partnerships would
design the pathway toward
eventual acquisition of the spin-out
company.
(SOURCE: A.T. KEARNEY ANALYSIS)
 
 
OUR BUSINESS MODEL CANVAS
11
Text…
Text…
Text…
Text…
Text…
Text…
 
 
OUR PLAN: GANTT CHART
“Over 12 months we will execute the following tasks. xxxxxxx.”
Total Budget: 1.450.000
MANY APPLICATIONS FAIL DUE TO A 
LACK OF
PLANNING 
AND 
IMPLEMENTATION THINKING.
YOU NEED TO DEMONSTRATE THAT 
YOUR
TEAM WILL NOT SPEND THE GRANT FUNDING
ON ACADEMIC RESEARCH, BUT WILL MANAGE
THE PROJECT TO ACHIEVE 
MARKET-
STANDARD OUTCOMES.
BUDGET IS SHOWN ALONG A “HORIZONTAL” PLAN OF THE GANTT. THIS
ALLOWS PANEL TO DISCUSS IF ALL TASKS ARE REQUIRED.
EXPLAIN WHAT TASKS THE GRANT WILL FUND AND WHY THEY ARE NEEDED.
12
 
 
OUR PLAN: DETAILED INFORMATION
13
 
 
ROADMAP TO SPIN-OUT / FUNDING PLAN
“Following completion of this grant, we plan to continue the development via a BII Pre-Seed Grant. This phase would
allow us to work towards an IND and develop a full business case for a future biotech spin-out.
Apply to BII
Pre-Seed
Grant
VC Seed
EXPLAIN WHAT WILL HAPPEN
AFTER
 YOUR GRANT HAS
COMPLETED AND BEEN
SUCCESSFUL.
HAVE YOU APPLIED FOR
OTHER GRANTS? HAVE YOU
SPOKEN TO FINANCING OR
INDUSTRY PARTNERS TO
DISCUSS WHAT PARTNERSHIPS
SCENARIOS ARE POSSIBLE?
DISCUSS THIS WITH YOUR TTO
BUSINESS DEVELOPER.
Time
Next Year
In 2 years.
These tasks describe classical drug
discovery and would take many years.
You will need to consider what your
project can achieve.
InnoExplorer
12 months; 200,00 EUR
14
 
 
RISK MITIGATION
We understand that all investments need to manage “risk”. We use the “Suitability-Feasibility-
Acceptability” framework to assess our project.
THERE ARE MANY WAYS TO COMMUNICATE HOW YOU
HAVE ASSESSED THE RISK IN YOUR PROJECT. DISCUSS
THIS SLIDE WITH YOUR TTO BUSINESS DEVELOPER. YOU
CAN READ ABOUT SFA 
HERE
.
15
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This pitch deck presentation template is designed by the Business Development Team for Ph.D.s and postdocs interested in applying to the InnoExplorer grant. It includes guidance on activating web links in slide show mode and tips for creating a compelling pitch. The template covers key sections such as mission, team design, and introducing the scientific field to potential investors. Customize the content to tailor it to your project needs and audience.

  • Pitch deck
  • Funding
  • Life science
  • Innovation
  • Business development

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  1. VIEW PRESENTATION IN SLIDE SHOW TO ACTIVATE WEB LINKS THE NOTES WILL GUIDE YOU THROUGH THE TEMPLATE. PLEASE CONTACT US IF YOU HAVE ANY QUESTIONS AT TTO@AU.DK THIS DOCUMENT HAS BEEN DESIGNED BY THE BUSINESS DEVELOPMENT TEAM FOR PHDS AND POSTDOCS THAT WANT TO APPLY TO THE INNOEXPLORER GRANT. PLEASE DISCUSS THIS TEMPLATE WITH YOUR TTO BUSINESS DEVELOPER. EXAMPLE PITCH DECK INNOVATION FUNDING PROJECTS IN LIFE SCIENCE PRODUCED BY THE TTO BUSINESS DEVELOPMENT TEAM NOVEMBER 2020 EMAIL: TTO@AU.DK IT IS AN EXAMPLE PITCH DECK FOR INSPIRATION AND TESTED WITH OUR STAKEHOLDERS. HOWEVER THIS IS YOUR PITCH PRESENTION SO DELETE ANY SLIDE YOU DON T LIKE. AND PLEASE CONTACT US IF WE CAN HELP! WE HOPE THIS WILL HELP YOU UNDERSTAND THE DIFFERENCE BETWEEN A PITCH AND A RESEARCH PRESENTATION AARHUS UNIVERSITY BUSINESS DEVELOPMENT

  2. 2 MISSION Misson: Our goal is to create new therapeutics for Lupus patients via maturing a technology, acquiring financing and creating a new company. Our lab at Aarhus Univeristy has created a first in class STING- TBK1 inhibitors for the treatment of autoimmune diseases. Here, we seek to develop this technology. OVERVIEW SOCIETAL OUTCOMES TEXT TEXT New drug for Danish Lupus patients Develop work package for investors TEXT TEXT Danish example of STING innovation Jobs TEXT TEXT AARHUS UNIVERSITY BUSINESS DEVELOPMENT

  3. 3 TEAM DESIGN A TEAM BASED ON EXPECTED INDUSTRY PROFESSIONAL STANDARDS FOR EXAMPLE: CONSIDER USING CONTRACT RESEARCH ORGANISATIONS INSTEAD OF YOUR OWN LAB. HOW WILL YOUR PROJECT MANAGE REGULATORY ACTIVITIES AND WHO IS THE PROJECT LEADER? Project Leader I am a post-doctorial researcher within the laboratory of Prof. XYZ: I wish to join the innovation culture and learn the tools of the university entrepreneur. I hold a Ph.D in XYZ and have XX years experience in XYZ. Subject Matter Expert I am a professor within the field of XYZ and hold XXX years experience related to XXX. This is my first university spin-out, but I am keen to understand how we can learn the commercial and regulatory aspects of this case and work with experts in this field. Consultant My firm has a key expertise in XYZ and will be able to ensure that this project is managed on a professional basis, within industry standards. AARHUS UNIVERSITY BUSINESS DEVELOPMENT

  4. THE INNOEXPLORER PANEL MAY NOT KNOW YOUR FIELD. SO - INTRODUCE IT AND THE KEY TRENDS IN ONE SLIDE. PRESENT IT AS AN EXCITING STORY WITH A GLOBAL PERSPECTIVE! WHATS HAPPENING?! 4 THE SCIENTIFIC FIELD Our Research field: We work in the field of gene editing research. Zinc finger nucleases and transcription activator-like effector nucleases, have significantly improved precise genome modification, but have key limits. Crispr-Cas9 reaches a new level of targeting, efficiency, and ease of use. The CRISPR/Cas9 system allows for site-specific genomic targeting in virtually any organism. What are the opportunities? What are the threats? SOME EXAMPLES Research Stakeholders Key Trends Huge funding on a global basis Patent Landscape is crowded Strong growth of university spin-outs AARHUS UNIVERSITY BUSINESS DEVELOPMENT

  5. 5 THE SCIENCE & THE PROBLEM IT IS VERY IMPORTANT TO INCLUDE YOUR SCIENTIFIC DATA. ON THIS PAGE, INTRODUCE THE TECHNICAL PROBLEM AND EXPLAIN YOUR HISTORIC EXPERTISE. A KEY CHALLENGE OF POC GRANTS IS THE NEED TO INCLUDE BOTH THE SCIENCE AND THE BUSINESS . The Disease Our group has 20 years experience with studying the XYZ pathway. Recently, Donec cursus viverra sapien, id accumsan risus porta accumsan. Integer tempor malesuada nisl, ut gravida justo convallis in. Nunc mollis nisl vel purus ullamcorper, eu viverra est ullamcorper. Vivamus quis magna egestas, accumsan nunc eu, vehicula augue. Donec dapibus eros eu est pharetra euismod. Nam aliquet mauris eu ultrices molestie. Vivamus commodo a metus a scelerisque. Nulla ac fringilla enim. Vestibulum ante ipsum primis in faucibus orci luctus et ultrices posuere cubilia Curae; In at posuere turpis. In fringilla facilisis risus id auctor. Etiam varius neque nec felis rhoncus interdum. Duis rutrum mattis facilisis. Etiam sit amet mi lobortis, mattis metus id, efficitur mi. Image? Clinical Collaborator (Key Opinion Leader/ Subject Matter Expert) I am a clinical professor within the field of XYZ and have worked to treat patients in this field for XX years. I will join the project and serve as a Clinical Advisor, ensuring the team are aware of current therapeutics, clinical practice and also reimbursement. AARHUS UNIVERSITY BUSINESS DEVELOPMENT

  6. 6 THE SCIENCE & THE SOLUTION ON THIS PAGE, CONTINUE TO INTRODUCE HOW YOUR SCIENTIFIC RESEARCH HAS PRODUCED A SOLUTION TO THE PROBLEM. ONCE AGAIN COMMUNICATE THE DETAIL OF YOUR SCIENTIFIC RESEARCH!!! Key Findings Our group at the Biomedicine Department has identified a way of xxx Inventors: Lorem ipsum dolor sit amet, consectetur adipiscing Nullam sed vestibulum felis. Mauris eros nisl, pretium sed auctor a, tincidunt ac justo. Praesent non egestas massa. Duis a enim ullamcorper quam sed, rutrum sapien. Integer mattis felis consectetur metus facilisis, nec rutrum orci Pellentesque bibendum blandit. faucibus orci sollicitudin venenatis. Aenean non odio non sem suscipit sodales varius vitae lacus. Praesent accumsan leo id dapibus bibendum. vehicula at scelerisque. ADD IMAGES TO EXPLAIN YOUR KEY FINDINGS. elit. IN YOUR PITCH, SPEND TIME TO EXPLAIN WHAT THE IMAGE MEANS I.E. POINT TO THE IMAGE AND EXPLAIN WHAT EXPERIMENT WAS PERFORMED AND WHAT RESULTS WERE OBTAINED. iaculis, HOW DID THE RESULTS MAKE YOU FEEL? SHOW EXCITEMENT FOR BREAKTHROUGHS! BUT ALSO EXPLAIN ANY EXPERIMENTS THAT MAY NEED TO BE REPEATED. ALSO CONTINUE USING THE STANFORD NABC MODEL HERE AS WELL! aliquam. dapibus Donec ac Image? Image? libero Lorem ipsum dolor sit amet, consectetur adipiscing elit. Nullam sed vestibulum felis. Mauris eros nisl, pretium sed auctor a, tincidunt ac justo. Praesent non egestas massa. Duis a enim iaculis, ullamcorper quam sed, rutrum sapien. Integer mattis felis consectetur metus facilisis, nec rutrum orci aliquam. Pellentesque dapibus bibendum blandit. BE SURE TO EXPLAIN WHAT YOUR TECHNOLOGY CAN DO HOW DOES IT SOLVE THE PROBEM AND WHY IS IT THE SUPERIOR SOLUTION? MISSING THIS INFORMATION ISTHE MOST COMMON MISTAKE FOR UNIVERSITY SCIENTISTS. Sed nec libero AARHUS UNIVERSITY BUSINESS DEVELOPMENT

  7. 7 MARKET & PIPELINE ANALYSIS OUR MARKET Disease:? THIS SLIDE EXPLAINS YOUR TEAMS UNDERSTANDING OF THE MARKET. YOU SHOULD WORK WITH YOUR TTO BUSINESS DEVELOPER TO CREATE THIS SLIDE. Patient Demographic:? IMPORTANTLY, YOU WILL NEED TO ENGAGE WITH MARKET STAKEHOLDER TO GAIN INPUT FOR THIS SLIDE. FOR EXAMPLE: WHAT DOES YOUR SPIN-OUT NEED TO ACHIEVE TO CREATE A PARTNERSHIP WITH A LARGER COMMERCIAL PARTNER? Formulation:? Current Drugs Used:? OUR VALUE PROPOSITION Pipeline Drug projects:? IMPORTANT: THE MOST IMPORTANT OUTCOME OF A MARKET ANALYSIS IS THE ABILITY TO COMMUNICATE WHY YOUR TECHNOLOGY SOLUTION IS BETTER THAN OTHER SOLUTIONS. Market Rivalry?: COMPARE THE ATTRIBUTES OF YOUR DRUG DISCOVERY OR DEVICE INVENTION TO OTHER COMPANIES IN THE PIPELINE. CONTRAST YOUR APPROACH TO THE PIPELINE AND HIGHLIGHT WHY YOU THINK IT IS DIFFERENT AND SUPERIOR! AARHUS UNIVERSITY BUSINESS DEVELOPMENT

  8. 8 RESOURCES & CAPABILITIES Today s resource & knowledge assets What are our strengths? WHAT EXPERTISE DOES YOUR TEAM HAVE? What are our weaknesses? WHAT EXPERTISE DOES CONSULTANTS OFFER? Our resource & knowledge gaps WHAT IS THE STATUS OF YOUR PATENT APPLICATION? AARHUS UNIVERSITY BUSINESS DEVELOPMENT

  9. 9 REGULATORY ADVICE We met with a regulatory consultant and have designed a programme to enable a INVESTIGATIONAL NEW DRUG APPLICATION at the FDA in the US. In addition, we believe that our disease focus enables us to apply for a FDA Expedited Development Program. IMPORTANT REGULATORY AFFAIRS IS ONE OF THE KEY AREAS WHERE UNIVERSITY FUNDING APPLICATIONS FAIL. YOUR TEAM NEEDS TO CONSIDER WHAT REGULATORY AUTHORITIES MAY DO. Donec cursus viverra sapien, id accumsan risus porta accumsan. Integer tempor malesuada nisl, ut gravida justo convallis in. Nunc mollis nisl vel purus ullamcorper, eu viverra est ullamcorper. Vivamus quis magna egestas, accumsan nunc eu, vehicula augue. Donec dapibus eros eu est pharetra euismod. Nam aliquet mauris eu ultrices molestie. Vivamus commodo a metus a scelerisque. Nulla ac fringilla enim. Vestibulum ante ipsum primis in faucibus orci luctus et ultrices posuere cubilia Curae; In at posuere turpis. In fringilla facilisis risus id auctor. Etiam varius neque nec felis rhoncus interdum. Duis rutrum mattis facilisis. Etiam sit amet mi lobortis, mattis metus id, efficitur mi. THE TTO BUSINESS DEVELOPMENT TEAM CAN HELP YOU TO IDENTIFY REGULATORY CONSULTANTS THAT COULD BE FUNDED VIA THE INNOEXPLORER GRANT. AARHUS UNIVERSITY BUSINESS DEVELOPMENT

  10. 10 IP STRATEGY / SPIN-OUT BUSINESS MODEL SOME EXAMPLE TEXT Here are the following key events and activities in our IP strategy National Phase 30 Search Report PCT 12 Time (months) Event: PCT Action: We will . Event: National Phase Action: TTO will . The company could follow the following business model Partnership to Acquisition As the IND is filed with regulatory authorities, the initiate a process relationships with potential partners within the pharmaceutical sector. company to will create Such validation of the business model and value proposition of our lead candidate. The partnerships would design the pathway eventual acquisition of the spin-out company. partners would enable toward (SOURCE: A.T. KEARNEY ANALYSIS) AARHUS UNIVERSITY BUSINESS DEVELOPMENT

  11. 11 OUR BUSINESS MODEL CANVAS Text Text Text Text Text Text AARHUS UNIVERSITY BUSINESS DEVELOPMENT

  12. 12 OUR PLAN: GANTT CHART MANY APPLICATIONS FAIL DUE TO A LACK OF PLANNING AND IMPLEMENTATION THINKING. YOU NEED TO DEMONSTRATE THAT YOUR TEAM WILL NOT SPEND THE GRANT FUNDING ON ACADEMIC RESEARCH, BUT WILL MANAGE THE PROJECT TO ACHIEVE MARKET- STANDARD OUTCOMES. Over 12 months we will execute the following tasks. xxxxxxx. EXPLAIN WHAT TASKS THE GRANT WILL FUND AND WHY THEY ARE NEEDED. Q1 Q2 Q3 Q4 R&D University [Who?] Assay design Salary: 150.000 Experiment 1 Salary: 150.000 Experiment 1 Salary: 150.000 Experiment 2 Salary: 150.000 R&D CRO [Who?] Experiment 3 Fee: 50.000 Experiment 3 Fee: 100.000 Experiment 3 Fee: 400.000 Business Development [Who?] Business case & market analysis Fee: 150.000 Regulatory [Who?] Training & Pre-liminary RA plan Fee: 150.000 Total Budget: 1.450.000 BUDGET IS SHOWN ALONG A HORIZONTAL PLAN OF THE GANTT. THIS ALLOWS PANEL TO DISCUSS IF ALL TASKS ARE REQUIRED. AARHUS UNIVERSITY BUSINESS DEVELOPMENT

  13. 13 OUR PLAN: DETAILED INFORMATION Task Expected Outcome AARHUS UNIVERSITY BUSINESS DEVELOPMENT

  14. 14 ROADMAP TO SPIN-OUT / FUNDING PLAN Following completion of this grant, we plan to continue the development via a BII Pre-Seed Grant. This phase would allow us to work towards an IND and develop a full business case for a future biotech spin-out. EXPLAIN WHAT WILL HAPPEN AFTER YOUR GRANT HAS COMPLETED AND BEEN SUCCESSFUL. In 2 years. Next Year Apply to BII Pre-Seed Grant HAVE YOU APPLIED FOR OTHER GRANTS? HAVE YOU SPOKEN TO FINANCING OR INDUSTRY PARTNERS TO DISCUSS WHAT PARTNERSHIPS SCENARIOS ARE POSSIBLE? DISCUSS THIS WITH YOUR TTO BUSINESS DEVELOPER. InnoExplorer 12 months; 200,00 EUR VC Seed Time Deliverables from this grant Possible deliverables for next phase? Complete Experiments 1-3. Achieve efficacy and toxicology evidence (in-vivo) Develop full Product Development plan (TTP) Further PoC in the right models CMC development plan Pre-clinical testing plan Clinical development plan Regulatory strategy GMP manufacturing / Quality These tasks describe classical drug discovery and would take many years. You will need to consider what your project can achieve. Train researchers on regulatory process and draft preliminary regulatory planning. Full business case & market analysis BUSINESS DEVELOPMENT Outsourcing IP strategy and preliminary FTO AARHUS UNIVERSITY

  15. 15 THERE ARE MANY WAYS TO COMMUNICATE HOW YOU HAVE ASSESSED THE RISK IN YOUR PROJECT. DISCUSS THIS SLIDE WITH YOUR TTO BUSINESS DEVELOPER. YOU CAN READ ABOUT SFA HERE. RISK MITIGATION We understand that all investments need to manage risk . We use the Suitability-Feasibility- Acceptability framework to assess our project. Suitable? Feasible? Acceptable? Our experimental plan We believe that we propose a classic drug discovery plan we appreciate the panel s critique We have all the knowledge and consumables ready but we need salary for staff. Experiments were validated by CRO and regulatory consultant. We would be grateful to hear the panels view today. CRO activity This CRO comes highly recommended by XXX and we believe they approach is scientifically valid. IPR We propose that IP is a must have for the project. Our patent agent has filed the priority application and awaits our data We appreciate the panel s questions AARHUS UNIVERSITY BUSINESS DEVELOPMENT

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