Healthcare CoP April 2018: Hammers, VAS, and the Government - What you need to know about Opioids

About the Speaker: 

Julie Ross, PhD has 20 years of experience in preformulation, formulation, product development, manufacturing, clinical trial logistics and program management.  She is currently providing her consulting services through her company, Paw Pharma Services, LLC.  Prior to her current role, she was the Senior Director of Pharmaceutical Development and Manufacturing at Novan.   Julie was also the Senior Director of Pharmaceutical Development at BioDelivery Sciences where she was responsible for the CMC activities associated with NDA approvals for BUNAVAIL and Belbuca as well as the reformulation of Onsolis.  Prior to joining BDSI, Julie was employed by Pfizer following the acquisition of King Pharmaceuticals where she was Director, Formulations working on multiple abuse deterrent formulations for the company as well as NCE products for cardiovascular imaging and diabetic wound healing. 

Abstract 

Deadly drug overdoses have more than doubled in the United States since 1999.  This is no longer a problem with just the poor and uneducated, and it now effects all areas of our society.  It has been stated that we are in an “opioid epidemic.”  As a result, the government is seeking solutions to the problem and many companies are devoting R&D efforts to develop abuse deterrent formulations (ADFs). 

Formulation aspects that render a product with abuse deterrent characteristics are quite varied, and several different approaches have been approved by the FDA.  The agency continues to support sponsors in their development of the products and two FDA guidance documents, Abuse Deterrent Opioids – Evaluation and Labeling (April 2015) and the recently published General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products (November 2017), detail guidelines for the development of these products and explain the current regulatory thoughts on the requirements for new products upon submission.   

In vitro evaluations to evaluate the ability to manipulate the prescription medicines to rapidly release the opioid and the in vivo clinical likability studies will be discussed with an emphasis on how they are conducted and what you can expect as a result.     

Learning Objectives: 

Attendees will get a better understanding for the following: 

1.      Why the need for abuse deterrent formulations? 

2.      What are abuse deterrent formulations? 

3.      Current regulatory landscape for abuse deterrent formulations 

4.      Testing required for abuse deterrent formulations