Speakers: Paul Feldman, Ph.D. (Intarcia Therapeutics); Jessica Hawes, Ph.D. (CDER, FDA); Vladimir Bantseev, Ph.D. (Genentech); Christopher Rhodes, Ph.D. (Drug Delivery Experts); James Oberhauser, Ph.D. (Gilead); Louis-Georges Guy, Ph.D. (AccelLAB); Mark Bush, Ph.D. (Nuventra)
Organizers: Doris Zane, Ph.D. (Intarcia Therapeutics)
Date: 2020-02-11
Time: 8:45-17:00 Pacific Time
Location: SF Bay Area: Foster City Crowne Plaza
Registration: http://www.PBSS.org

About the Topic:

As defined by FDA, combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. The Agency expects to receive large numbers of combination products for review as technological advances continue to merge product types and blur the historical lines of separation between FDA’s medical product centers, which are made up of the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH).

As Drug/Device combination products typically involve components that would normally be regulated under different types of regulatory authorities, and frequently by different FDA Centers, they raise challenging regulatory challenges. Differences in regulatory pathways for each component can impact the regulatory processes for all aspects of product development, such as preclinical testing, marketing applications, manufacturing and quality control. This symposium will cover some of these challenges faced in the development of drug/device combination products presented by speakers from Industry, FDA and Contract Research Organizations.

Presentations:

• Application of The Intarcia Medici Drug Delivery SystemTM for Long Acting HIV Prevention for Global Health – Paul Feldman, Ph.D., Head of Discovery and Translational Medicine, Intarcia Therapeutics, Inc.
• Nonclinical Studies Supporting Investigational & New Drug Applications for Peptide Products – Jessica Hawes, Ph.D., Division of Metabolism and Endocrinology Products, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), FDA.
• Nonclinical toxicology strategies for Drug/device combination: PDS with ranibizumab for nvAMD as an example – Vladimir Bantseev, Ph.D., FAAO, Senior Scientist, Toxicology Therapeutic Area Lead – Ophthalmology, Safety Assessment, Genentech.
• Exenatide and Its Life Cycle – Christopher A. Rhodes, Ph.D., President & CEO, Drug Delivery Experts.
• Injectable Device Solutions for Complex Formulations – James Oberhauser, Ph.D., Senior Director of Device Development and Clinical Packaging Engineering, Gilead.
• Preclinical evaluation of drug device combination products: particularities and challenges – Louis-Georges Guy, Ph.D., Director, Science, AccelLAB.
• Drug/Device Combination Products: A Pharmacokinetic Perspective – Mark Bush, Ph.D., Vice President, Clinical Pharmacology and Pharmacokinetics, Nuventra, Inc.

Event Information

Event Topic:
Development of Drug/Device Combinations

Event Description:

Date/Time:
Date(s) - 02/11/20
8:30 am - 5:00 pm

Event Location:
Other: Foster City Crowne Plaza

Event Details

Event Type