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Program

(all times are EDT)

 

Thursday, May 20, 2021
   

9 - 9:45am 

 

 

 

 

                        

Welcome and Opening Keynote

9am          Opening remarks

9:05am     Keynote introduction:
                  Kazuo Tsubota, MD, PhD, FARVO, MBA

9:10am     Keynote:
                  Bill Aulet, MIT Sloan School of Management
                 
Fostering an entrepreneurial spirit

9:45 - 10am

Break

10 - 11:15am

 

 

 

 

 

 

 

 

 

The basics

Session 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:
                   How to evaluate ideas for start-ups

10:10am     Eugene de Juan, MD; ForSight Labs, LLC:
                   The big picture

10:20am   David Huang, MD, PhD, FARVO; Casey Eye Institute:
                   Building the start-up team

10:30am   Mark S. Blumenkranz, MD; Stanford Byers Eye Institute:
                   Innovating from academia: Opportunities and challenges for
                   translational science in the public eye

10:40am    Scheffer Tseng, MD, PhD; TissueTech, Inc.:
                    Scientific research in product development

10:50am     Panel Discussion led by David Huang, MD, PhD, FARVO; Casey Eye Institute

11:15 - 11:30am
Break
   

11:30am - 12:30pm

 

 

 

 

 

 

 

Regulatory and international perspectives

Session chairs: Daniela Ferrara, MD, MS, PhD and Gary Novack, PhD

11:30am     Gary D. Novack, PhD; PharmaLogic, UC Davis:
                     What the entrepreneur needs to know about regulatory affairs, briefly

11:40am     Philip Risser; Daniela Ferrara, PhD; Genentech/Roche:
                     Clinical Trial Authorization in Europe

11:50am     Naohiko Aketa, MD, PhD; Pharmaceuticals and Medical Devices Agency:
                     1 - 3 items you give as advice to new product developers

Noon           Tieuvi Nguyen, PhD and Wiley Chambers, MD; FDA:
                     1 - 3 recommendations to new product developers

12:10pm     Q&A Discussion Panel:
                     Best practices in regulatory affairs for entrepreneurs

12:30 - 12:45pm
Break
   

12:45 - 2pm

 

 

 

 

 

Nuts and bolts: Meeting you where you are and Open Networking
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.

12:45pm     Introduction of session
12:50pm     Round 1
1:20pm       Attendees move to second table
1:25pm       Round 2

View the discussion options and table host list

 

Friday, May 21, 2021
 

9 - 9:45am

Welcome and Featured Speaker

9am          Opening remarks and featured speaker introduction: Cheryl Rowe-Rendleman, PhD               

9:05am     Featured speaker: Susan Washer; Applied Genetic Technologies
                  Top 10 lessons learned from mistakes made

9:45 - 10am

Break
   
10 - 11am
Financing and pitching for entrepreneurs

Session chairs: Mark Gordon, MS, RAC, FRAPS and Joan Miller, MD, FARVO

10am       Reza Dana, MSc, MPH, MD, FARVO; Harvard Medical School: 
                    Generating Business Strategy in Early Stage of Newco Development

10:10am   Stella M. Robertson, PhD; Arrochar Consulting, LLC; Bios Partners, LP: 
                   Funding a Start-up: Grants, angels and venture capital

10:20am   Eric Buckland, PhD; Translational Imaging Innovations, Inc.; 
                     Valuation: What is your business worth before you sell product? - pre vs post money

10:30am   Christy Shaffer, PhD; Hatteras Venture Partners
                    Selling and pitching your idea to a venture capitalist

10:40am    Panel discussion/Q&A

11 - 11:15am

Break
11:15am - 12:30pm
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 were selected in a competitive process to present 6-minute pitches. Expert feedback by specialists in the eye and vision space will be provided at the end of each presentation. The session ends in a Q&A with the expert panelists and FDA regulators. This is your opportunity to learn from the best.

Expert panelists:
Dimitri Azar, MD, MBA, FARVO; University of Illinois at Chicago
Cynthia Grosskreutz, MD, PhD; Novartis Institute for Biomedical Research
Patrick Johnson, PhD; Sydnexis
Jeff Weinhuff; Visionary Ventures

Pitches presentations:
Sean McCafferty:
CATS Tonometer - The New Shape of IOP
Daniela Claessens:
Dr. Wavelike or How I Learned to Stop Worrying and Love the App
Dong Hyun Kim:
A Novel Drug Candidate in Dry Eye Disease: RCI001
Frances Lasowski
:
Eye Drops Changing the Dosing Paradigm
Grith Lykke Sorensen:
Anti-MFAP4 - Next Generation Therapy for Treatment of Diabetic- and Age-related Eye Diseases

Closing panel:
Wiley Chambers, MD; CDER, FDA
Tieuvi Nguyen, PhD; CDRH, FDA

12:30 - 12:45pm
Break
   
12:45 - 1pm
Wrap-up: Best things we heard today, Q&A

Session chair: David N. Zacks, MD, PhD and Shelley Boyd, MD

1 - 2pm
Open networking reception,
browse additional Eye Pitch submissions

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 for devices
    Table host: Brad Cunningham, MSE, RAC; FDA/CDRH and John Hall, BS, MBA, CCRA
  • 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; SparingVision
  • 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 M. Robertson, PhD; Arrochar Consulting, LLC; Bios Partners, LP
  • 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.
  • 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 — Ex-US
    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 — US
    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  
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