Meranda Parascandola - DSI InPharmatics

July 27, 2020

Published by Meranda Parascandola at July 27, 2020

Introduction to CMC Live

Welcome to CMC Live. This is the show where the DSInPharmatics team discuss CMC regulations and guidances simplified through real life experiences and risk-based advice. Each episode we speak with Subject Matter Experts as well as other leading industry authorities. In this episode trailer, Ed Narke, Meranda Parascandola and Brian Lihou introduce the podcast and explain what listeners can expect in future episodes.

July 31, 2020

Published by Meranda Parascandola at July 31, 2020

DSI Introduces New, Hands-On Opportunity for Drug Sponsors to Learn from CMC and Regulatory Subject Matter Experts

Announced its latest innovative offering for emerging biotech drug sponsors. CMC.Live is an interactive podcast where DSI’s team of subject matter experts and program managers watch the CMC and regulatory industry trends and discuss current hot topic areas. CMC.Live subscribers can listen to their conversations and ask questions (Ask the Experts).

July 31, 2020

Published by Meranda Parascandola at July 31, 2020

Expedited Drug Development with James Mencel

DS InPharmatics' Senior Drug Substance Consultant, James Mencel, joins the show to share his background with CMC management. In this episode, Ed, Meranda and James discuss the impact that expedited drug development programs have had on the pharma industry. They break down regulations, breakthrough designations and best practices when it comes to these programs.

August 4, 2020

Published by Meranda Parascandola at August 4, 2020

The Odd Couple – Part 6: Authoring the Stability of Drug Substance and Product Modules

Stability testing is an important part of the drug development and approval process, determining the safety and integrity of the drug and also its shelf life and storage conditions.

August 7, 2020

Published by Meranda Parascandola at August 7, 2020

Establishing Regulatory Starting Materials & Understanding the ICH with James Mencel

DS InPharmatics' Senior Drug Substance Consultant, James Mencel continues his discussion on expedited drug development programs, specifically the importance of establishing regulatory starting materials. In this episode, Ed, Meranda, Brian and James discuss how the FDA and sponsors deal with the challenges of establishing starting materials, the role of the International Council for Harmonisation (ICH) and striking the balance between appropriate regulatory control and sustainable manufacturability.

August 13, 2020

Published by Meranda Parascandola at August 13, 2020

The Odd Couple – Part 7: Authoring the Composition and Pharmaceutical Development Modules

Pharmaceuticals (both Synthetically and Biotechnology-derived) are being developed by many sponsors whose management teams have varying degrees of familiarity or experience with the regulatory requirements for these challenging products.