Greene Street Pharmaceuticals
A company that specializes in the formulation and development of abuse deterrent opioid transdermal delivery systems, as well as generic opioid transdermal delivery systems.
Monday, June 12, 2017
Embassy Suites, Chesterbrook, Pennsylvania (directions)
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About
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greene street is a privately held pharmaceutical company that specializes in the formulation and development of abuse deterrent opioid transdermal delivery systems, as well as generic opioid transdermal delivery systems. They have the know-how and proven experience to direct the formulation and development of transdermal products through a contractual agreement with K&H Pharmaceuticals, LLC.
The abuse of opioids, such as FENTANYL has reached epidemic proportions in the United States. Through discussions with primary care professionals, emergency response personnel, and patients who wear FENTANYL transdermal patches the company has a clear understanding of the path to abuse of opioid transdermal delivery systems.
greene street is directing the development of an opioid delivering transdermal patch that is formulated to allow the administration of safe and FDA approved levels of FENTANYL unless the patch is degraded or otherwise diverted for illegal drug abuse. They have advanced development towards the filing of a 505(b)(2) filing for an abuse deterrent FENTANYL transdermal delivery system and an ANDA for a generic FENTANYL transdermal delivery system.
Their path forward is clear: confirm findings through PK and permeation studies, scale up and perfect the technology with the goal to license the products.
Frank Jones, Founder and CEO, has 30+ years in pharma serving in both domestic and international companies in various executive positions and Bill Dixon is a lawyer who for almost 30 years has focused on business support, entrepreneurial development and start-ups. In 2006 Frank and Bill founded ProSolus Pharmaceuticals, LP (www.prosoluspharma.com) a successful transdermal company that was acquired by Mission Pharmacal in 2015. Frank and Bill founded greene street Pharmaceuticals, LLC with the desire to leverage their experience in the pharmaceutical transdermal space, to have a meaningful impact on the health of average Americans and to help confront the scourge of opioid addiction.
3 Major Issues
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- Strategic/business: Currently self funded through development for all products (9 products to date with 4 licenses to date), does it make sense to seek funding to develop on own through FDA submission (ANDA or 505b2) or continue license model.
- Strategic: Should the company explore investment for advancing to pilot/pk stage.
- Regulatory: Filing strategy - currently ANDA/505b2 - could a medical device route exist for transdermals?
Program:
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6:30 - Cocktails & Dinner (Cash bar and special 2-entree buffet menu)
8:00 - Frank Jones, Founder and CEO, will deliver Greene Street's "Elevator" Pitch to the Group
8:20 - A Panel will address three major issues crucial to helping the Company reach the next level.
9:00 - Open discussion: members and guests
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