Meranda Parascandola

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.
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.
July 27, 2020
CMC Live

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.
April 1, 2020

COVID-19 DSI Operation Update

While this has opened up many new avenues in sharing information, We want to reassure you of DSI’s service resilience during this time. In fact, as you may be aware, we have been supporting CMC for our clients' programs VIRTUALLY FOR OVER 14 YEARS.
December 19, 2019

2020 J.P. Morgan Health Care Investor Conference

A scientific review of the pertinent development data provides the necessary information to assure that informed decisions are made regarding the potential in-licensing of a development compound. By highlighting perceived risks and resource implications, the examination provides assurance that a given compound meets the requisite technical and quality elements. In advance of Biotech Showcase and the JP Morgan Healthcare Conferences next month, we are providing our complementary Drug Product Due Diligence Checklist. Send us a message if you would like a copy.
September 20, 2019

DSI Expert James Mencel to present at AMRI Symposium reACTION 2019

Drug Substance Development Expert, Dr. James Mencel, will be presenting “Expedited Filings and their CMC Implications: Considerations toward Better Planning”, sponsored by AMRI, a global contract research and manufacturing organization. Conference sessions will occur at AMRI’s Corporate Headquarters.