Program
(all times are EDT)
Thursday, May 20, 2021
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9 - 9:45am
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Welcome and Opening Keynote
9am Opening remarks 9:05am Keynote introduction: 9:10am Keynote: |
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9:45 - 10am |
Break |
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10 - 11:15am
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The basicsSession chairs: David Huang, MD, PhD, FARVO and Kazuo Tsubota, MD, PHD, FARVO, MBA 10am Kazuo Tsubota, MD, PhD, FARVO, MBA; Keio University School of Medicine: 10:10am Eugene de Juan, MD; ForSight Labs, LLC: 10:20am David Huang, MD, PhD, FARVO; Casey Eye Institute: 10:30am Mark S. Blumenkranz, MD; Stanford Byers Eye Institute: 10:40am Scheffer Tseng, MD, PhD; TissueTech, Inc.: 10:50am Panel Discussion led by David Huang, MD, PhD, FARVO; Casey Eye Institute |
| 11:15 - 11:30am |
Break |
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11:30am - 12:30pm
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Regulatory and international perspectivesSession chairs: Daniela Ferrara, MD, MS, PhD and Gary Novack, PhD 11:30am Gary D. Novack, PhD; PharmaLogic, UC Davis: 11:40am Philip Risser; Genentech/Roche: 11:50am Naohiko Aketa, MD, PhD; Pharmaceuticals and Medical Devices Agency: Noon Malvina Eydelman, MD and Wiley Chambers, MD; FDA: 12:10pm Q&A Discussion Panel: |
| 12:30 - 12:45pm |
Break |
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12:45 - 2pm
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Nuts and bolts: Meeting you where you are and Open Networking Two 30-minute discussions at table/topics of your choice. Each table will be led by an expert in the following topic area: Regulatory issues, raising funds, intellectual property, emerging trends in business and virtual companies. 12:45pm Introduction of session |
Friday, May 21, 2021
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9 - 9:45am |
Welcome and Featured Speaker
9am Opening remarks 9:05am Featured speaker introduction 9:10am Featured speaker: Susan Washer; Applied Genetic Technologies |
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9:45 - 10am |
Break |
| 10 - 11am |
Financing and pitching
Session chairs: Mark Gordon, MD and Joan Miller, MD, FARVO 10am Reza Dana, MSc, MPH, MD, FARVO; Harvard Medical School: 10:10am Stella Robertson, PhD; Arrochar Consulting, LLC: 10:20am Eric Buckland, PhD; Translational Imaging Innovations, Inc.; 10:30am Christy Shaffer, PhD; Hatteras Venture Partners: 10:40am Panel discussion/Q&A |
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11 - 11:15am |
Break |
| 11:15am - 12:30pm |
Eye PitchSession chair: Scott Whitcup, MD, FARVO If you have an entrepreneurial mindset and little to no experience moving an idea forward through the pipeline, this session is for you. Learn how to successfully navigate through unknown territory. Presenters will be selected through submissions for a 5- to 7-minute pitch. Feedback will be provided at the end of each pitch with the session ending in a Q&A with the audience. The experts specialize in the eye and vision space and this is your opportunity to learn from the best. Expert Panelists: FDA Panelists for closing panel: |
| 12:30 - 12:45pm |
Break |
| 12:45 - 1:15pm |
Wrap-up: Best things we heard today, Q&ASession chair: David N. Zacks, MD, PhD and Shelley Boyd, MD |
| 1:15 - 2pm |
Open networking reception,
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Nuts and bolts: Meeting you where you are
Session chair: Cheryl Rowe-Rendleman, PhD
Two 30-minute discussions at table/topics of your choice. Each table will be led by an expert in the following topic areas. Attendees will have an opportunity for brief dialog to address what is top of mind.
Table Topics:
Regulatory
- Regulatory primer for the bench scientist — the merits of regulatory planning for clinical trials and early informational meetings with the FDA's CDER and CBER. Do you know the difference?
Table host: Brad Cunningham, MSE, RAC; FDA/CDRH - Phase 0-3 clinical research — the use of staging for clinical trials from very early phase 0 thru phase 3 registration trials. Questions asked and assumptions made at each phase
Table host: Daniel Chung, DO, MA; Spark Therapeutics - Envisioning improved drug access: Generic drug development for ophthalmologics
Table host: Darby Kozak PhD; FDA and Markham Luke, MD, PhD; FDA
Raising funds
- Non-diluted funding for the scientist: SBIR, STTR for early start-up research ventures — the process and value for scientists seeking a start-up using NIH funding
Table host: Stella Robertson, PhD; Arrochar Consulting, LLC - The family, angel and venture capitalist — methods and vehicles for raising money for early business; identifying sources and expectations at each level
Table host: David Eveleth, PhD; Trefoil Therapeutics - From NIH Audacious Goals to business — discussing the cutting-edge ideas supported under NIH Audacious goals (translating ideas to business)
Table host: Marc de Smet, MD, CM, PhD, FRCSC; ZNA Middelheim - Ten essential items of your pitch deck — the basics
Table host: Eugene de Juan, MD; ForSight Labs, LLC
Intellectual property
- Should I publish? Discussion with business development professionals on strategic publication of scientific discoveries and negotiating publication rights for the scientist or physician
Table host: Cynthia Grosskreutz, MD, PhD; Novartis Institute for Biomedical Research - Patents and intellectual property: U.S., EU, RoW — the early process of protecting intellectual property: laboratory notebooks, disclosures, provisional patents, patents and the differences between U.S., EU and the rest of the world
Table host: Ashwath Jayagopal, PhD; Kodiak Sciences Inc. - CDA, NDA, mutual, one-way, no way! Understanding the basics of a confidentiality agreement
Table host: Andy Roberts, JD; Yale University - You, me, and tech transfer — Perspectives from researchers on working within their universities to translate their bench research to start-up
Table host: Randolph Glickman, PhD; University of Texas Health Science Center
Emerging trends in business
- Start-ups/Biotech run and led by women — perspectives from women researchers who are running a start-up to mid-size biotech or device company
Table host: Elizabeth Robinson, PhD and Michele Garufi, PharmD; founders of Nicox SA and Indaco Venture Partners SGR SpA - Start-ups/Biotech run and led by women — perspectives from women researchers who are running a start-up to mid-size biotech or device company
Table host: Susan Washer; Applied Genetic Technologies - Women in the board room — the value, points of view and regulations on the representation of gender in the board room (scientific boards, supervisor board, and nonprofit boards)
Table host: Adrienne Graves, PhD; former CEO, Santen Inc; current board member on public/private companies and nonprofits
Virtual company
- Moving towards the IND: Advice for the virtual company — best practices of virtual companies
Table host: Alon Harris, PhD; Icahn School of Medicine at Mount Sinai
