The Commercialization Plan

The Commercialization Plan

Grant-Writing Essentials Series Part 2: The Commercialization Plan July 25, 2019 Marla Coppolino Director of Business Development and Outreach Institute of Biotechnology, Cornell University Douglas Greene, MD Founder and Chief Consultant DAGPHAMED Dalfoni Banerjee Principal Consultant & CEO 3Sixty Pharma Solutions Borderless initiatives mapping the future for regional and international collaboration Co-Founders: Michael Welling, Chair Partner, Meridian Risk Management Joanne Gere, Executive Director Westchester Biotech Project Roundtable for Researchers Translating Data Science Intellectual Property Commercialization Westchester Certificate Young Investigators Investors Forum Virtual Executive in Residence Westchester Biotech Blueprint 2030 Educators and Employers Government Relations Westchester Biotech Project Europe Expansion Space Contact: [email protected] Thank You to our Partners! “We always overestimate the change that will occur in the next two years and underestimate the change that will occur in the next ten.” Versions attributed to Bill Gates, Arthur C. Clarke, and others Grant-Writing Essentials Series Part 2 – The Commercialization Plan Roundtable for Researchers 25 July 2019 Grant-Writing Essentials Series • Part 1: NIH Grant-Writing Best Practices • Part 2: The Commercialization Plan Agenda Topic Presenter 1. Welcome & Introductions Dalfoni 2. In the Beginning… Intellectual Property Marla 3. Universe of the Commercialization Plan Doug 4. Pressure Testing Your Idea & Reaching Escape Velocity Doug 5. University & Company Partnerships Marla 6. Operationalization: Program & Project Management Tools Dalfoni 7. Questions & Discussion Joanne 9 Welcome & Introductions Dalfoni Banerjee Doug A. Greene Marla Coppolino Principal Consultant & CEO President & Founder Director, BD & Outreach, 3Sixty Pharma Solutions Dagphamed LLC Cornell University Center for Advanced Technology (CAT), Institute of Biotechnology Honored to be involved with the Westchester Biotech Project! 10 Intellectual Property In the beginning… 11 Intellectual Property The record begins with Bound laboratory notebooks … most important documentation! • Dates • Inventorship – who did what? • Method • Experimental design • Outcomes Invention. Provisional Patent disclosure filing granted 1212 Intellectual Property Intellectual Property (IP) – first and foremost, identify the unique, patentable aspects of your invention. You must take steps to protect it. What distinguishes your invention from the prior art? Clear understanding is critical! Research: Cautions! Do not share confidential info at - Conferences https://www.uspto.gov - Poster sessions - Online Invention. Provisional Patent disclosure filing granted 1313 Intellectual Property If you’re a researcher at a university… University Tech Transfer Offices – Benefits • No financial risk to you • Filings professionally managed • University pays for filing and attorney fees • Percentage of royalties back to you Invention. Provisional Patent disclosure filing granted 1414 Intellectual Property What you will need: • Date of invention • Title of invention Patents • Lead inventor, co-inventors • Methods, prototypes • Brief description of invention Copyrights • What problem does invention solve? • Software code • Existing technologies, products, solutions Plant patents that address same problem? • New or experimental lines, varieties • Relevant publications, patents, competing inventors • Unique features • Detailed description NOTE: First to file system (how to make and use, illustrations) (America Invents Act, March 2013) • Probable uses of invention Invention. Provisional Patent disclosure filing granted 1515 Intellectual Property Invention. Provisional Patent disclosure filing granted 1616 Universe of the Commercialization Plan... 17 Roadmap: SBIR/STTR Phase II or FastTrack Only 18 Level-Setting: NIH Grant Phases* ~$150,000~$150,000 ~$100,000,000 *Adapted from NIH presentation: Commercialization Support for Life Science Innovations. Similar process applicable to NSF, DoD, and other small business grants. 19 Partnering Launching Funding & Testing Idea Navigating 20 Commercialization Plan – A Brief Overview Applicable SBIR/STTR Grant Types Outline a. Value of the SBIR/STTR Project, Expected Outcomes, • Phase II and Impact • Direct Phase II b. Company • Phase IIB c. Market, Customer, and Competition • Phase I/Phase II Fast-Track d. Intellectual Property (IP) Protection • Commercialization Readiness Program e. Finance Plan (CRP) f. Production and Marketing Plan g. Revenue Stream Format 12 pages Content Follow any instructions provided in Funding Commitments the solicitation, plus the general Should seek commitment(s) of funds and/or resources from instructions investor(s) and/or partner organization(s) for commercialization of the product(s) or service(s) resulting from the SBIR/STTR grant. Intention to support conveyed via the Letters of Support attached to application. 21 Avoid The Commercialization Supernova Getting started can feel like you’re standing on the edge of the galaxy – where to begin? Consider this: You biggest – and most avoidable – struggle is a focus on acquiring industry partners… 22 Pressure Testing Your Idea & Reaching Escape Velocity 23 Internal & External Expertise and Perspectives • Market Research • Competitive Insights • Feasibility of Market Acceptance • Exit Strategy 24 Essential Considerations Scale-Up Animal Human In Vitro Non-GMP Testing (GMP) Prototyping 25 26 University & Company Partnerships 27 University & Company Partnerships University Research Company Support Benefit to Society 2828 University & Company Partnerships Go-to resources • Tech Transfer offices • Entrepreneurship offices • Business research librarians • Business mentors • Supportive programs – advisement and grants • On-campus incubators • NSF I-Corps Short Course – for customer discovery University http://unyicorps.org/programs/attend-a-short-course/ 2929 University & Company Partnerships Go-to resources • SBDC in New York State - http://www.nyssbdc.org/locations.html - http://www.nyssbdc.org/resources/researchnetwork.html • Local SBA offices https://www.sba.gov • Local high-tech incubators/ accelerators Company 3030 University & Company Partnerships Example Cornell + Allovate = Allergy therapy in a toothpaste • Academic scientists • Business leadership • Laboratories • Infrastructure • Innovation • Scale up • Validation • Branding • Core facilities • Target customers • Investors https://allovate.com University Company 3131 University & Company Partnerships ALL of the above (expertise, resources, etc.) – outlined in a comprehensive commercialization plan… A GALAXY of a plan! 32 Operationalization: Program & Project Management Tools 33 Operationalization: Program & Project Management Tools • Off the shelf • Create your own 34 Program & Project Management: 360Tracker Notes & RAID* Detailed Budget Grant Details & Stakeholder Map Company Info Timeline RACI† Grant Components Experiment Tracker Prioritization High-Level Milestones Lessons-Learned Gantt *RAID: Risks, Actions, Issues, Decisions †RACI: Responsible, Accountable, Consulted, Informed 35 360Tracker: Grant Details & Company Information 36 360Tracker: Grant Components Tracker ID# Task Status Target Date Owner Notes / Issues / Risks Format SMPL_FastTrack-1 Cover page information In progress 31 May 2016 (Tue) Emily S. SMPL_FastTrack-2 Cover letter In progress June 08, 2019 (Sat) Althea N. pdf SMPL_FastTrack-3 Project Funding In progress June 08, 2019 (Sat) Harry W. SMPL_FastTrack-4 Cover page supplement In progress April 22, 2016 (Fri) Jane D. SMPL_FastTrack-5 Other Project Information Planned June 20, 2019 (Thu) Bruce K. SMPL_FastTrack-6 Project summary/abstract In progress May 25, 2016 (Wed) Emily S. pdf SMPL_FastTrack-7 Project narrative Completed June 11, 2016 (Sat) Althea N. pdf SMPL_FastTrack-8 Bibliography In progress June 21, 2016 (Tue) Harry W. pdf SMPL_FastTrack-9 Performance Sites Completed July 16, 2016 (Sat) Karla P. pdf SMPL_FastTrack-10 Facilities and Resources*: Company Completed June 03, 2016 (Fri) Emily S. pdf SMPL_FastTrack-11 Facilities and Resources*: University Completed July 21, 2016 (Thu) Althea N. pdf SMPL_FastTrack-12 Facilities and Resources*: Research Partner In progress April 24, 2016 (Sun) Harry W. pdf 37 360Tracker: High-Level Milestones Gantt 38 360Tracker: RACI Cost Cost Tentative Study Description Next Steps Estimated (by DM) Actual Total Days Work Start Date Complete Date Responsible Accountable Consulted Informed INITIAL STUDIES Amy W, Ken H, 1 Study 1 Get proposals $ 10,000.00 30 01 September 2019 (Sun) 01 October 2019 (Tue) Jane D Arielle N Carol M Alvin B Amy W, Jane D, 2 study 2 Get proposals $ 10,000.00 30 01 September 2019 (Sun) 01 October 2019 (Tue) Ken H Arielle N Carol M Alvin B Amy W, Ken H, Jen 3 Study 3 Confirm design $ 10,000.00 21 15 September 2019 (Sun) 06 October 2019 (Sun) Alvin B Arielle N Carol M C Amy W, Ken H, 4 Study 4 Get proposals $ 25,000.00 60 15 September 2019 (Sun) 14 November 2019 (Thu) Jane D Arielle N Carol M Alvin B Amy W, Jane C, 5 Study 5 Confirm design $ 15,000.00 21 01 September 2019 (Sun) 22 September 2019 (Sun) Ken H Arielle N Carol M Alvin B SUBTOTAL: Initial Studies $ 70,000.00 OTHER STUDIES Amy W, Ken H, 2 PK Study Confirm design $ 15,000.00 Jen C Arielle N Carol M Alvin B 3 ADME 4 Other? SUBTOTAL: Other Studies $ 15,000.00 TOTAL: $ 85,000.00 39 360Tracker: Detailed Budget Including partner organizations and resources! Timefram Direct or Year 1 Spread Year 2 Spread

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