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Introduction to the TSRL, Inc. Accelerator Model

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An overview of our Technology Accelerator business model. We describe a hybrid model leveraging minimally-dilutive funding and experienced pharmaceutical management to “de-risk” and drive projects to IND. Our area of expertise is prodrugs and infectious diseases (www.tsrlinc.com).

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Introduction to the TSRL, Inc. Accelerator Model

  1. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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
  14. 14. NON-CONFIDENTIAL Questions? Thank You! 14

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