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 Cost Type Specifics Rate e Percentage Total Indirect 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q PERSONNEL Indirect $ - $ - $ - $ - $ - $ - $ - $ - Indirect $ - $ - $ - $ - $ - $ - $ - $ - Indirect $ - $ - $ - $ - $ - $ - $ - $ - SUB-TOTAL - Indirect Indirect $ - $ - $ - $ - $ - $ - $ - $ - ANIMALS Direct $ - $ - $ - $ - $ - $ - $ - $ - Direct $ - $ - $ - $ - $ - $ - $ - $ - Direct $ - $ - $ - $ - $ - $ - $ - $ - SUB-TOTAL - Direct Direct $ - $ - $ - $ - $ - $ - $ - $ - HUMAN SUBJECTS Direct $ - $ - $ - $ - $ - $ - $ - $ - Direct $ - $ - $ - $ - $ - $ - $ - $ - Direct $ - $ - $ - $ - $ - $ - $ - $ - SUB-TOTAL - Direct Direct $ - $ - $ - $ - $ - $ - $ - $ - LABORATORIES Direct $ - $ - $ - $ - $ - $ - $ - $ - Direct $ - $ - $ - $ - $ - $ - $ - $ - Direct $ - $ - $ - $ - $ - $ - $ - $ - SUB-TOTAL - Direct Direct $ - $ - $ - $ - $ - $ - $ - $ - CROs Indirect $ - $ - $ - $ - $ - $ - $ - $ - Indirect $ - $ - $ - $ - $ - $ - $ - $ - Indirect $ - $ - $ - $ - $ - $ - $ - $ - SUB-TOTAL - Indirect Indirect $ - $ - $ - $ - $ - $ - $ - $ - OTHER VENDORS

40 360Tracker: Stakeholder Map

Including partners!

41 Additional Links

• NIH Grant-Writing Best Practices: Recording PDF • https://sbir.nih.gov/funding/individual-announcements • FedBizOpps.gov • https://grants.nih.gov/grants/funding/funding_program.htm#RSeries • Grants.gov • https://sbir.nih.gov/engage/listserv • SBIR | STTR Home • https://www.sbir.gov/tutorials/program-basics/tutorial-3 • How To Write a Good Commercialization Plan (MS Word document download) • https://grants.nih.gov/grants/guide/pa-files/PA-18-576.html • Phase I Commercialization Plans • https://sbir.nih.gov/sites/default/files/ic_nida/Commercialization-Plan_clean.docx • SF424 (R&R) SBIR/STTR Application Guide for NIH and Other PHS Agencies • https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general/g.440- • Annotated Form Set for NIH Small Business (SBIR/STTR) Grant Applications sbir-sttr-information-form.htm • STTR / SBIR Application Guide • https://sbir.nih.gov/faqs • Sample Applications • https://grants.nih.gov/policy/clinical-trials/specific-funding-opportunities.htm • NIH Table of Page Limits • https://oamp.od.nih.gov/Contract-Opportunity#ProposalInstructionsForOfferors • Format Attachments • America’s Small Business Development Center (SBDC) • NSF I-Corps Short Course • Business model canvas • SBIR Road Show (next one: September 17, 2019, Albany, NY) • McGovern Center (Cornell University) • Start-Up Tools: • America’s Small Business Development Center (SBDC) http://www.nyssbdc.org – free membership, library services • NSF I-Corps Short Course http://unyicorps.org/programs/attend-a-short-course/ • Business model canvas https://www.strategyzer.com/canvas/business-model-canvas • SBIR Road Show – September 17, 2019, Albany, NY; others - http://www.sbirroadtour.com/dates.php • McGovern Center (Cornell University) http://www.mcgoverncenter.cornell.edu • Other incubators and accelerators

42 Intellectual Property & Partnerships

If: Then: Technology owned by University prior to the research project The technology remains University’s Existing Technology Technology is owned by a company prior to the research project The technology remains the company’s

University researcher creates new technology without any contribution from University will own the new technology the company employees Company employees create new technology without any contribution from University will own the new technology University researcher New technology is created within University facilities University will own the new technology University researchers and company employees both contributed to a new The new technology will be owned jointly technology, or technology is developed using both company and University facilities Joint ownership means both University and the company will have full rights to make, use, sell, or offer New to sell the technology. Technology

New technology is developed and University owns any rights, company may The option would begin as soon as your company be granted an exclusive 180 day option to negotiate a license for University’s receives written notice that a new technology has been rights in that technology developed. Your company may also receive this option to negotiate a license for any of University’s rights in a joint technology.

4343 Page Limits for For R01, R03, R21, and other Applications

Section of Application Activity Codes Page Limits * Project Summary/Abstract For all Activity Codes 30 lines of text Project Narrative For all Activity Codes excluding C06,UC6 and G20. three sentences Introduction to Resubmission and For all Activity Codes (including each applicable component of a multi-component application) 1 Revision Applications Specific Aims For all Activity Codes that use an application form with the Specific Aims section (including each component 1 of a multi-component application)

Research Strategy For Activity Code DP1 5 1 1 For Activity Codes R03, R13, U13, R13, U13, R21,R35, R36, R41, R43, SC2, SC3, X01 , X02 , R50, UT1 6

For Activity Code DP2 10 For Activity 12 Codes DP3, DP5, G08, G11, G13, RC2, RC4, RF1, R01,R15, R18, R21/R33, R24, R28, R33, R34, R42, R44 , R61/R33, RL1, SB1, SC1, SI2, UB1, UC2, UH2,UH3, UG1, UC4, UF1, UG3/UH3, UH2/UH3, U01, U18, U2 1 1 4, U2C, U34, U42, U44,UT2, X01 , X02

For all other Activity Codes Follow FOA instructions Commercialization Plan For Activity Codes R42, R44, SB1, UT2, U44, UB1 (Attachment 7 on SBIR/STTR Information form) 12

Biographical Sketch For all Activity Codes (including DP1 and DP2 which previously had special page limits) 5

*FOA instructions always supersede these instructions. 1 X01 and X02 FOAs can be either 6 or 12 pages. Review the FOA for details. https://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/page-limits.htm 44 National Institutes of Health

1. National Cancer Institute (NCI) - includes NCI and NCCIH RFPs. 15. National Institute of Environmental Health Sciences (NIEHS) 2. National Eye Institute (NEI) - RFPs hosted by OLAO 16. National Institute General Medical Sciences (NIGMS) - RFPs hosted by OLAO 3. National Heart, Lung, and Blood Institute (NHLBI) - Includes NHLBI, CSR, 17. National Institute of Mental Health (NIMH) - RFPs hosted by NIDA NHGRI, NIAMS, NIBIB and NIDCR RFPs. 18. National Institute on Minority Health and Health Disparities (NIMHD) - RFPs 4. National Human Genome Research Institute (NHGRI) - RFPs Hosted by NHLBI hosted by OLAO 5. National Institute on Aging (NIA) - RFPs Hosted by NIDA 19. National Institute of Neurological Disorders and Strokes (NINDS) - RFPs hosted 6. National Institute on Alcohol Abuse and Alcoholism (NIAAA) - RFPs Hosted by NIDA by NICHD 20. National Institute of Nursing Research (NINR) - RFPs Hosted by OLAO 7. National Institute of Allergy and Infectious Diseases (NIAID) - Includes NIAID and 21. National Library of Medicine (NLM) - Includes NLM, CIT and OD RFPs. HHS Biodefense. 22. Center for Information Technology (CIT) - RFPs Hosted by NLM 8. National Institute of Arthritis and Musculoskeletal and Skin Disorders (NIAMS) - 23. Center for Scientific Research (CSR) - RFPs Hosted by NHLBI RFPs Hosted by NHLBI 24. Fogarty International Center (FIC) - RFPs Hosted by NICHD 9. National Institute of Biomedical Imaging and Bioengineering (NIBIB) - RFPs Hosted by NHLBI 25. National Center for Complementary and Integrative Health (NCCIH) - RFPs Hosted by NCI 10. National Institute of Child Health and Development (NICHD) - Includes NICHD, NIAAA, NIMHD, NIDDK and FIC RFPs. 26. National Center for Advancing Translational Sciences (NCATS) - RFPs Hosted by NHLBI 11. National Institute on Drug Abuse (NIDA) - Includes NIDA, NINDS, NIMH, NCATS and NIA RFPs. 27. NIH Clinical Center (CC) 12. National Institute on Deafness and Other Communication Disorders (NIDCD)- 28. Office of the Director (OD) - RFPs Hosted by NLM and OLAO RFPs hosted by OLAO 29. Office of Logistics and Acquisition Operations (OLAO) - Includes OLAO, NEI, 13. National Institute of Dental and Craniofacial Research (NIDCR) - RFPs Hosted NIDCD, NIGMS, NINR, OD and ORS RFPs. by NHLBI 30. Office of Research Services (ORS) - RFPs Hosted by OLAO 14. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) - RFPs Hosted by NLM

45 NIH SBIR/STTR Niche Assessment Program (NAP)

Provides active Phase I (or Fast-track Phase I) awardees with market research, and consumer and competition analysis. Topics include: • End-users’ Needs and concerns • Competing technologies and products • Competitive advantage of the SBIR/STTR-developed technology • Market size and potential market share • Barriers to market entry • Market drivers • Status of market and industry trends • Potential customers, licensees, investors, or other commercialization partners • Pricing

46 NIH SBIR/STTR Commercialization Accelerator Program (CAP)

Trains Phase II awardees on how to be market ready. Topics include: ⎯ Tailored market entry strategies ⎯ Strategic partnerships ⎯ FDA regulatory requirements ⎯ Financing strategies ⎯ Investor pitches ⎯ Intellectual property matters

47 Grant-Writing Essentials Series Part 2:

The Commercialization Plan

July 25, 2019 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