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NON-CONFIDENTIAL
Driving Value from Lead to Clinic
TSRL, Inc. Technology Accelerator
Drew Hertig, MBA
Business Development
ahertig@tsrlinc.com
A New Model for Preclinical Drug Development
1bd@tsrlinc.com  734-663-3607  www.tsrlinc.com
NON-CONFIDENTIAL
The Challenge
Many therapeutic assets are struggling to find funding to move past the “Valley of Death”
Inception Pre-lead Lead IND NDA
3-5 years 1 year 2 years 5 years
ValueofOpportunity
Development Timeline“Valley of Death”
Value Infection
Drug
Discovery
10k-30k
Lead
Selection
30-60
Preclinical
Development
10-20
Phase I
5-10
Phase II
2-5
Phase III
2
Approval
1
©2015 TSRL, Inc.
2
NON-CONFIDENTIAL
The Opportunity
Academic life science drug products require…
• Collaboration: Strong interdisciplinary science & business acumen
• Visibility: Industry is increasingly looking for academia for new products
• Relationships: NIH is emerging as a strong player in translational medicine
Funding climate for early stage assets changing
• VC funds have moved to later stage assets
• Government and foundations are increasingly stepping in with funding
• Commercial potential is not sufficiently analyzed
• Comprehensive data package demonstrating drug product potential is lacking
3
NON-CONFIDENTIAL
TSRL, Inc. Accelerator Model:
A hybrid model leveraging minimally-dilutive funding and experienced
pharma management to “de-risk” and drive projects to IND
4
NON-CONFIDENTIAL
Our Accelerator Strategy…
• Builds on our proven track record of designing and developing oral and
targeted drugs, with an initial focus on infectious diseases
• Develops drug assets in-house or in-licensed from academic and industry
organizations
• Selects potential drug assets against a set of criteria established to maximize
the potential for commercialization success
• Provides infrastructure, laboratory, scientific and business resources, as well
as in-kind services to drive projects to IND
5
NON-CONFIDENTIAL
Incubator vs Accelerator: What’s the Difference?
Working Space: Business incubators typically provide office and/or wet-lab
space, with the opportunity for entrepreneurs to mingle with each other
• Commercialization strategy assistance
• Access to high-level networks
• Flexibility to expand as company grows
JLabs, Janssen Labs innovation center, an incubator
“Nesting” Company: Accelerators offer additional
services, i.e. human capital and seed funding:
• All of the above services, plus
• Equipment/comprehensive preclinical research
services
• Seed funding in exchange for an equity stake in a
future NewCo
http://www.oxbridgebiotech.com/review/business-development/incubator-vs-accelerator-whats-difference/ 6
NON-CONFIDENTIAL
TSRL TA Value-Add Model
• Develop plan/budget
• Generate data and drive
project to IND or POC
• Nourish partnerships and
collaborations
• GOAL: Obtain total data
package and refined comm
plan for next inflection point
1) The Idea
• Inventor/Entrepreneur
• Drug Therapy Concepts
• Intellectual Property
2) Screening
• Devise/evaluate concepts
for technical do-ability
• Analyze & uncover
commercial potential
• GOAL: Submit SBIR grant
with high likelihood of
success
4) Development
5) Decision
• No-go decision results in
feedback, development
plan, data package
• Go decision results in TSRL
Inc. partnership, NewCo,
external investment,
acquisition or out-license
• GOAL: Obtain ROI of 5-10x
per asset
Value of Project
ResourcesRequired
Pipeline Discovery
Preclinical Development
3) Go/No-Go
©2015 TSRL, Inc.
7
NON-CONFIDENTIAL
9 Grants/Yr.
Pipeline Discovery
Technology Disclosure
• Source from referrals, internal projects,
conferences, inbound and outbound websites,
through Accelerator RFPs
Technology Assessment & Rubric
• Prepare with Commercial Assessment (CA) and
Project Summary Document (PSD)
SBIR Grant Selection
• Select the best projects from a combination of
“fundability” and adherence to core portfolio
120 Disclosures/Yr.
15 Assessments/Yr.
8
NON-CONFIDENTIAL
Consultants
Infrastructure & Expertise
9
Wet Labs
Animal Labs
Grant Writing
Fundraising
Drug Development
Project Management
Oral Drug Delivery
Prodrug Science
Strategic Partners NIH / FDA
CROs
TSRL TA Team
& Collaborators
NON-CONFIDENTIAL
Technology Accelerator
Project
C
Project
B
Project
A
Funding
• Prior funding
• Stage/level of funding
Science
• Expertise-fit
• Development risk
• Feasibility
Intellectual Property
• Strength of IP
• Prior art
• Scope
Commercial Potential
• Market size
• Reimbursement
• Development costs
• Competitive landscape
Business Structure
• Licensing (inventor
equity)
• Risk-adjusted portfolio
• Business formation
Commercial Assessment
People
• Inventor credibility,
network, and business
acumen
• Management skill and
track record
Product
• Clinical path
• Time to market
• Manufacturing
10
NON-CONFIDENTIAL
We Are Looking to Collaborate With…
• Life science entrepreneurs seeking to commercialize their early stage
drug therapy concepts
• In need of support for:
• Drug development expertise – drug delivery and PK/PD core
• Minimally dilutive funding
• Commercialization assessment
• Infrastructure capabilities for generating crucial preliminary data
• Admin/business operations support
….and who are time-constrained and welcome a collaborative
partner to expedite their drug product development
11
NON-CONFIDENTIAL
Consideration in Return
• Collaborative Research and Development Agreement as your first
industry partner
• ≥50% of grant-specific aims performed at TSRL, Inc. laboratories or
within our network
• Equity consideration upon exit
• First right-of-refusal
• Non-royalty/sublicense consideration
Our TA team works as collaborators on your project—
as a result, we have a vested interest in your success
12
NON-CONFIDENTIAL
Summary
• TSRL Inc. Technology Accelerator provides life science entrepreneurs with:
• Infrastructure » office & bench space, AAALAC-accredited animal facilities, BSL-2,
radiation safety license, controlled substance license
• Laboratory services » equipment, SOPs, QC
• Scientific resources » in-kind services, development/research strategy support
• Business resources » administrative, commercialization plan support, business
development, marketing
• Experience » analytical chemistry, animal models, PK/ADME, drug delivery,
regulatory (FDA/Pre-IND), industry management experience
• Network » collaborators, partners, consultants, relationships (NIH)
Our mission is to provide investigators with means to bridge the “Valley of Death” and
to advance potentially life-saving drug products
13
NON-CONFIDENTIAL
Questions?
Thank You!
14

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Introduction to the TSRL, Inc. Accelerator Model

  • 1. NON-CONFIDENTIAL Driving Value from Lead to Clinic TSRL, Inc. Technology Accelerator Drew Hertig, MBA Business Development ahertig@tsrlinc.com A New Model for Preclinical Drug Development 1bd@tsrlinc.com  734-663-3607  www.tsrlinc.com
  • 2. NON-CONFIDENTIAL The Challenge Many therapeutic assets are struggling to find funding to move past the “Valley of Death” Inception Pre-lead Lead IND NDA 3-5 years 1 year 2 years 5 years ValueofOpportunity Development Timeline“Valley of Death” Value Infection Drug Discovery 10k-30k Lead Selection 30-60 Preclinical Development 10-20 Phase I 5-10 Phase II 2-5 Phase III 2 Approval 1 ©2015 TSRL, Inc. 2
  • 3. NON-CONFIDENTIAL The Opportunity Academic life science drug products require… • Collaboration: Strong interdisciplinary science & business acumen • Visibility: Industry is increasingly looking for academia for new products • Relationships: NIH is emerging as a strong player in translational medicine Funding climate for early stage assets changing • VC funds have moved to later stage assets • Government and foundations are increasingly stepping in with funding • Commercial potential is not sufficiently analyzed • Comprehensive data package demonstrating drug product potential is lacking 3
  • 4. NON-CONFIDENTIAL TSRL, Inc. Accelerator Model: A hybrid model leveraging minimally-dilutive funding and experienced pharma management to “de-risk” and drive projects to IND 4
  • 5. NON-CONFIDENTIAL Our Accelerator Strategy… • Builds on our proven track record of designing and developing oral and targeted drugs, with an initial focus on infectious diseases • Develops drug assets in-house or in-licensed from academic and industry organizations • Selects potential drug assets against a set of criteria established to maximize the potential for commercialization success • Provides infrastructure, laboratory, scientific and business resources, as well as in-kind services to drive projects to IND 5
  • 6. NON-CONFIDENTIAL Incubator vs Accelerator: What’s the Difference? Working Space: Business incubators typically provide office and/or wet-lab space, with the opportunity for entrepreneurs to mingle with each other • Commercialization strategy assistance • Access to high-level networks • Flexibility to expand as company grows JLabs, Janssen Labs innovation center, an incubator “Nesting” Company: Accelerators offer additional services, i.e. human capital and seed funding: • All of the above services, plus • Equipment/comprehensive preclinical research services • Seed funding in exchange for an equity stake in a future NewCo http://www.oxbridgebiotech.com/review/business-development/incubator-vs-accelerator-whats-difference/ 6
  • 7. NON-CONFIDENTIAL TSRL TA Value-Add Model • Develop plan/budget • Generate data and drive project to IND or POC • Nourish partnerships and collaborations • GOAL: Obtain total data package and refined comm plan for next inflection point 1) The Idea • Inventor/Entrepreneur • Drug Therapy Concepts • Intellectual Property 2) Screening • Devise/evaluate concepts for technical do-ability • Analyze & uncover commercial potential • GOAL: Submit SBIR grant with high likelihood of success 4) Development 5) Decision • No-go decision results in feedback, development plan, data package • Go decision results in TSRL Inc. partnership, NewCo, external investment, acquisition or out-license • GOAL: Obtain ROI of 5-10x per asset Value of Project ResourcesRequired Pipeline Discovery Preclinical Development 3) Go/No-Go ©2015 TSRL, Inc. 7
  • 8. NON-CONFIDENTIAL 9 Grants/Yr. Pipeline Discovery Technology Disclosure • Source from referrals, internal projects, conferences, inbound and outbound websites, through Accelerator RFPs Technology Assessment & Rubric • Prepare with Commercial Assessment (CA) and Project Summary Document (PSD) SBIR Grant Selection • Select the best projects from a combination of “fundability” and adherence to core portfolio 120 Disclosures/Yr. 15 Assessments/Yr. 8
  • 9. NON-CONFIDENTIAL Consultants Infrastructure & Expertise 9 Wet Labs Animal Labs Grant Writing Fundraising Drug Development Project Management Oral Drug Delivery Prodrug Science Strategic Partners NIH / FDA CROs TSRL TA Team & Collaborators
  • 10. NON-CONFIDENTIAL Technology Accelerator Project C Project B Project A Funding • Prior funding • Stage/level of funding Science • Expertise-fit • Development risk • Feasibility Intellectual Property • Strength of IP • Prior art • Scope Commercial Potential • Market size • Reimbursement • Development costs • Competitive landscape Business Structure • Licensing (inventor equity) • Risk-adjusted portfolio • Business formation Commercial Assessment People • Inventor credibility, network, and business acumen • Management skill and track record Product • Clinical path • Time to market • Manufacturing 10
  • 11. NON-CONFIDENTIAL We Are Looking to Collaborate With… • Life science entrepreneurs seeking to commercialize their early stage drug therapy concepts • In need of support for: • Drug development expertise – drug delivery and PK/PD core • Minimally dilutive funding • Commercialization assessment • Infrastructure capabilities for generating crucial preliminary data • Admin/business operations support ….and who are time-constrained and welcome a collaborative partner to expedite their drug product development 11
  • 12. NON-CONFIDENTIAL Consideration in Return • Collaborative Research and Development Agreement as your first industry partner • ≥50% of grant-specific aims performed at TSRL, Inc. laboratories or within our network • Equity consideration upon exit • First right-of-refusal • Non-royalty/sublicense consideration Our TA team works as collaborators on your project— as a result, we have a vested interest in your success 12
  • 13. NON-CONFIDENTIAL Summary • TSRL Inc. Technology Accelerator provides life science entrepreneurs with: • Infrastructure » office & bench space, AAALAC-accredited animal facilities, BSL-2, radiation safety license, controlled substance license • Laboratory services » equipment, SOPs, QC • Scientific resources » in-kind services, development/research strategy support • Business resources » administrative, commercialization plan support, business development, marketing • Experience » analytical chemistry, animal models, PK/ADME, drug delivery, regulatory (FDA/Pre-IND), industry management experience • Network » collaborators, partners, consultants, relationships (NIH) Our mission is to provide investigators with means to bridge the “Valley of Death” and to advance potentially life-saving drug products 13