Breakfast with an expert: 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 early informational meetings with FDA’s CDER and CBER. Do you know the differences?
    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 
  • Finding new ophthalmic indications for generic drugs
    Table host: 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 Middleheim
  • Ten essential items of your pitch deck — the basics
    Table host: Gene 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
  • 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
  • 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: Michele Garufi, PhD; NixOx
  • 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; Glaucoma Research Foundation

Virtual company

  • Moving towards the IND: Advice for the virtual company — best practices of virtual companies
    Table host: Alon Harris, PhD; Indiana University School of Medicine