Virtual Innovation Day: Smart Innovation through Hybrid and 505(b)(2) Regulatory Pathways

Event: Virtual Innovation Day: Smart Innovation through Hybrid and 505(b)(2) Regulatory Pathways

Original Air Date: Thursday, June 10, 2021

Join our panel of industry experts at our next Virtual Innovation Day for a deep dive into case studies and actionable insights for navigating pharmaceutical regulation with innovation.

Attend this virtual event for:

• Key considerations in the US 505(b)(2) and EU Hybrid (or alternative) application pathways 
• Encapsulation solutions for improved formulation and fixed dose combination
• Manufacturing equipment to address the challenges linked to multiple product dosing

Karl G. Wagner, Professor of Pharmaceutical Technology and Biopharmacy 

University of Bonn 

Karl G. Wagner is a professor in pharmaceutical technology at the University of Bonn, Germany. His research focus is on solid oral dosage forms with emphasis on enabling and modified release dosage forms, excipients and in vivo predictive biopharmaceutical tools. Prior to his position at the University of Bonn, Karl was heading an early formulation laboratory for new technologies at Boehringer Ingelheim (Germany) for 6 years. He has more than 26 years experience in designing multiparticulate modified release dosage forms, enabling formulations, compression analysis and development of biopharmaceutical tools. Karl is author of several peer reviewed articles and a frequently invited speaker at seminars and international meetings. 

Eric Kendig, VP of Regulatory and Strategy

Camargo

Eric is a VP of Regulatory and Strategy at Camargo, where he leads the development and implementation of regulatory strategy in close collaboration with clients, Camargo multidisciplinary experts, and the FDA. Eric joined Camargo in 2012 and has been involved in the strategic development of a wide range of pharmaceutical products including both new chemical entities and reformulation products. He has worked on 75+ development programs and represented Camargo clients in 30+ FDA meetings. Eric holds a Ph.D. from the Department of Environmental Health at the University of Cincinnati’s College of Medicine, where he also completed his postdoctoral training in the department of Pharmacology and Cell Biophysics. 

Angelo Airoldi, Product Manager

IMA Active

Angela has been a Product Manager at IMA capsule filling since 2014. He graduated in Automation Engineering at the University of Bologna (Italy), and has been working in the field of solid dose processing and manufacturing for more than 20 years. He is an expert in equipment for capsule filling, especially for different types of solid and liquid dosages in capsules. 

Julia Grapinet, MSc, Co-founder & Project Director

J2F Pharma

Julia has more than 8 years of experience in the pharmaceutical industry, working for Les Laboratoires Servier and Biogran as project manager, coordinating development strategies and CMC regulatory projects for worldwide registrations (EU, Africa, Brazil, GCC, Asia, Turkey, WHO).

Frédérique Bordes-Picard, Business Development Manager, Innovative Products

Lonza, Capsules & Health Ingredients

Frédérique joined Capsugel (now Lonza) in 2010 as Pharmaceutical Business Development Manager providing technical and regulatory support for new capsule-based product developments. Frédérique has developed specific expertise around capsule-based DPI product development & filing, supporting multiple companies in EMEA and US working on innovative or generic DPI projects.