Entrepreneurship Lessons: From Discovery to Company

Round Table Discussion 7

Saturday 29th August 2020
14:00 - 15:00
Brasilia 6
Capacity: 500
Speakers

Part I - My Journey and the Pitch Deck:

The faculty will speak of what their company is about, their journey to becoming an entrepreneur and what they look forward to in the future. Together the experts on this panel will share stages of technology development from a preclinical phase product preparing FDA IND (Investigational New Drug) submission, to products in Phase II and Phase III trials, and to a product recently receiving 510(k) clearances for commercialization. Assets to be discussed will include device, drug, biologic and combinational products.

  1. Michael Chancellor will speak on the two paths physician entrepreneur can take in product development: Licensing their invention to an established company or start a biotech company:
    Phase III FDA combinational drug+biologic product. Cook MyoSite: AMDC treatment of female SUI
    Phase II FDA Orphan drug designation 505b2 drug. Lipella Pharmaceuticals, Inc: LP-10 treatment of hemorrhagic cystitis

  2. Samantha Pulliam will speak about steps required for Renovia Inc to receiving FDA 510(k) clearance for the next-generation leva® Pelvic Digital Therapeutic for the strengthening of pelvic floor muscles and the treatment of stress, mixed and mild to moderate urgency urinary incontinence (UI) in women.

  3. Mary Gardner will present her experience in founding DelNova, Inc, a preclinical stage biotechnology company focused on treatment of urinary retention associated with intradetrusor botulinum toxin injection.

Part II - Panel Discussion and Audience Q+A:
Michael Chancellor will facilitate conversation among the panel and full audience participation. An open dialogue among all participants in this 2020 ICS Round Table will share experience and lessons learned for future physician entrepreneurs.