Introduction to the TSRL, Inc. Accelerator Model
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The document describes TSRL Inc.'s Technology Accelerator program, which aims to help move therapeutic assets past the "Valley of Death" by providing infrastructure, scientific and business resources, and funding to drive projects from pre-clinical development to an Investigational New Drug application. The accelerator selects potential drug candidates based on criteria to maximize commercialization potential and provides services like project management, drug development expertise, and access to networks to help obtain funding and partners. The goal is to generate necessary data packages and commercialization plans to support projects reaching their next development milestones.
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