Blog | DSInpharmatics

September 24, 2020

Published by Meranda Parascandola at September 24, 2020

A Storybook Approach for A Successful End of Phase II (EOP2) CMC Meeting

Ideally, even before the research phase, you should study the relevant FDA regulations/guidances and forms for an IND submission, which can be found on the FDA’s web site (and below), and determine how your organization can best meet those requirements. Companies that devote disciplined, systematic attention from day one move far more efficiently toward opening trials than companies who chose to delay.

October 27, 2020

Published by Meranda Parascandola at October 27, 2020

What to Control; CQAs and CPPs and the Key Variables in the Regulatory Submission

The FDA’s regulatory requirements for process validation highlights the need for defining Critical Process Parameters (CPPs) based on Critical Quality Attributes (CQAs). As described by the FDA, a CQA is a characteristic within a range that ensures a specified level of product quality. These requirements highlight the focus of QbD, or Quality by Design. The ICH describes this view of quality assurance that focuses more on validating the process through control parameters and less on defining quality based on product testing.

November 10, 2020

Published by Meranda Parascandola at November 10, 2020

Does Your Program Need a CMC or CMC Regulatory Expert? Don’t Wait Too Long!

When a CMC emergency crops up, you grit your teeth, your blood pressure spikes and you pledge to bear down and make the right decision. And that’s exactly why you might make the wrong decision. In today’s biotech industry, (where MONEY and TIME, can make you or break you) it can be harder to bounce back.

December 3, 2020

Published by Meranda Parascandola at 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 15, 2020

Published by Meranda Parascandola at 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

Published by Meranda Parascandola at 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.

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