The Association for Research in Vision and Ophthalmology- Bench to Bedside Meeting

Program

Thursday, April 29, 2021


4 – 8pm	Registration open

Friday, April 30, 2021


6am	Registration open Breakfast available Eye Pitch posters available for viewing

6:50 – 7am	Opening remarks Meeting co-chairs: Justine Smith, FRANZCO, PhD, FARVO and Claude F. Burgoyne, MD, FARVO
7 – 8:30am	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 area: Regulatory issues, raising funds, intellectual property, emerging trends in business and virtual companies. 7 – 7:25am Introduction of session and speakers 7:25 – 7:55am Round 1 7:55am Attendees move to second table 7:55 – 8:30am Round 2 View the discussion options and table host list
8:30 – 10:30am	The basics Session chairs: David Huang, MD, PhD, FARVO and Kazuo Tsubota, MD, PHD, FARVO, MBA 8:30 – 8:45am *Kazuo Tsubota, MD, PhD, FARVO, MBA; Keio University School of Medicine: How to Evaluate Ideas for Start-ups 8:45 – 9am Eugene de Juan, MD; ForSight Labs, LLC: The Big Picture 9 – 9:15am David Huang, MD, PhD, FARVO; Casey Eye Institute: Forming the Start-up Team 9:15 - 9:30am Mark S. Blumenkranz, MD; Stanford Byers Eye Institute: Innovating from Academia: Opportunities and Challenges for Translational Science in the Public Eye 9:30 – 9:45am Scheffer Tseng, MD, PhD*; TissueTech, Inc.: Scientific Research in Product Development 9:45 – 10:30am Panel Discussion led by David Huang, MD, PhD, FARVO; Casey Eye Institute
10:30 – 11am	Keynote: TBA

11 – 11:30am	Networking break

11:30am – 1pm	Financing and pitching Session chairs: Mark Gordon, MD and Joan Miller, MD, FARVO 11:30 – 11:40am Session Opening 11:40am – 12pm Reza Dana, MSc, MPH, MD, FARVO; Harvard Medical School: Developing the Business Plan: Approaches on how to obtain money – Venture Capitalists or Angels? 12 – 12:20pm Stella Robertson, PhD; Arrochar Consulting, LLC: Funding: Including alternative sources, pros and cons of Venture Capitalists vs Angels 12:20 – 12:40pm Eric Buckland, PhD; Translational Imaging Innovations, Inc.; Valuation: Moving widgets to business; pre vs post money 12:40 – 1pm Christy Shaffer, PhD; Hatteras Venture Partners: Selling and pitching your idea to a Venture Capitalist
1 – 2pm	Lunch with invited talk Mark Humayun, MD, PhD; University of Southern California: Top 10 lessons learned from mistakes made
2 – 3pm	Regulatory and international perspectives Session chairs: Daniela Ferrara, MD, MS, PhD and Gary Novack, PhD 2 – 2:10pm Gary D. Novack, PhD; PharmaLogic, UC Davis: What the entrepreneur needs to know about regulatory affairs, briefly 2:10 – 2:20pm Philip Risser; Genentech/Roche: Worldwide perspective on regulatory affairs 2:20 – 2:30pm Naohiko Aketa, MD, PhD; Pharmaceuticals and Medical Devices Agency: Top 3 recommendations to new product developers 2:30 – 2:40pm Malvina Eydelman, MD and Wiley Chambers, MD; FDA: Top 3 recommendations to new product developers 2:40 – 3pm Q&A Discussion Panel: Best practices in regulatory affairs for entrepreneurs
3 – 3:50pm	Eye Pitch Session 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: Dimitri Azar, MD, MBA, FARVO; University of Illinois at Chicago Daniela Ferrara, MD, MS, PhD; Genentech/Roche Cynthia Grosskreutz, MD, PhD; Novartis Institute for Biomedical Research Patrick Johnson, PhD; Sydnexis Jeff Weinhuff; Visionary Ventures Additional Panelists during Q&A: Malvina Eydelman, MD; FDA Wiley Chambers, MD; FDA
3:50 – 4:10pm	Networking break
4:10 – 5:30pm	Eye Pitch (continued) Session chair: Scott Whitcup, MD, FARVO
5:30 – 6pm	Wrap-up: Best things we heard today, Q&A Session chair: David N. Zacks, MD, PhD and Shelley Boyd, MD
6 – 7pm	Networking reception Eye Pitch poster presentations

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
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