Blog

February 11, 2021
Year of the Ox

Will the Year of the Ox Bring You Luck?

What daring goals did you set in 2020?  Did you reach them? 2021 is a New Year. Your year to get clear on where you're going and how to get there.
February 4, 2021
Super Bowl

What the Super Bowl Can Teach Us about CMC Strategy

It all starts with a game plan. Just like any Super Bowl contender starts with a game plan, anyone involved with drug development should too. A CMC game plan becomes your pathway to success.
January 21, 2021

Understanding Regulatory Submissions and the Role of Regulatory CMC Project Management

What is regulatory CMC? An individual in a regulatory affairs CMC role provides the strategy and knowledge needed to ensure that CMC practices are carried out in accordance with the requirements of regulatory bodies, such as the FDA (US Food and Drug Administration) and EMA (European Medicines Agency). CMC regulatory is pivotal in ensuring that drugs and treatments being manufactured are safe, effective, and of high quality for patients.
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.
December 15, 2020
PHASE 1 STABILITY

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.
December 3, 2020
FDA’s Breakthrough Therapy Program

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.