Meranda Parascandola

December 3, 2020

What It Means to Be “Breakthrough”: The Story Behind The FDA Designation

This bill expanded many of the existing governing powers of the FDA but also added one intriguing new provision: the breakthrough therapy (BT) designation, intended to expedite the development and review of drugs for serious or life-threatening conditions.
December 4, 2020

4 Experts, 120+ Years of Drug Substance Experience: Major Trends You Should Know

The market for the manufactured and supplied APIs is changing continuously, and there are many factors influencing these changes. Being aware of these changing trends is important. Perhaps what’s even more important is how you leverage the opportunities they bring and how to react to them. In this episode, Ed, Meranda and Brian talk with a group of drug substance services experts about the major trends you should know and be aware of, and how you can use them to your advantage. This panel includes experts who have appeared on the podcast before: David Blasingame, Jim Mencel, Dave Adams and Daniel Torok.
December 10, 2020

DSI Announces Virtual Attendance of JP Morgan Biotech Showcase 2021, January 11-15

Each year, healthcare, pharmaceutical, and biotechnology executives attend the JP Morgan Healthcare Conference, some to tout recent developments, others just to bounce from session to session. We work hard at DSI to make life science companies better at what you do in the Chemistry, Manufacturing and Controls (CMC) areas. We’ve […]
December 15, 2020

Phase 1 Stability; Agency Expectations

Before you decide how much stability data you require, it is vital to understand the nature of your Dosage Form and Delivery System Requirements (the route of administration and delivery system). Even if there is a diversity of testing in place, these choices have a significant impact on the scientific and regulatory aspects of a stability protocol, which can still fail to meet the most stringent regulatory reviews.
January 5, 2021

Key Strategies for Early-Stage Drug Development

How do you manage product development? What are the decisions and risks associated with it? How can you reduce these risks and get investor support? Design Space InPharmatics Senior Program Management Program Coordinator Judy Magruder shares critical insights on these and other early-stage questions on drug development.
January 8, 2021

2020: A Year in Review with Ed Narke, Brian Lihou & Meranda Parascandola

In this very special episode of CMC Live, hosts Ed Narke, Brian Lihou and Meranda Parascandola provide an in-depth recap of Season One, complete with direct quotes from all of their illustrious guests. Ed, Brian and Meranda reflect on everything from Jim Mencel’s perspective on expedited drug development programs and Dave Adams’ belief in trusting the API process to Daniel Torok’s analysis of the White Coat Effect and Judy Magruder’s effective strategies for early stage drug development. They share insights from David Blasingame on the advantages and disadvantages of manufacturing in China as well as Hedley Rees’ views on the importance of creating a value chain. Finally, Ed, Brian and Meranda discuss topics they’d like to integrate into Season Two and thank the listeners for their support throughout the year.