Meranda Parascandola - DSI InPharmatics

January 21, 2021

Published by Meranda Parascandola at 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 25, 2021

Published by Meranda Parascandola at January 25, 2021

Complexity of Project Management in Drug Development with Paul Long

Paul Long is a Project Management Consultant at Design Space InPharmatics. Paul has supervised government regulatory pharmaceutical industries for over twenty years and has a wealth of business knowledge. He knows how to build and lead high-performing, cross-functional teams, how to prioritize and the importance of meeting budgets and targets. In this episode, Paul, Ed, Meranda and Brian discuss the benefits and challenges of virtual project management during the COVID-19 pandemic, integral project management tools and how project management fits into drug development and the overall CMC space.

January 29, 2021

Published by Meranda Parascandola at January 29, 2021

Lessons Gleaned from Twenty Five Years of a Regulatory CMC Life with Ed Narke

Ed Narke is the co-founder, Principal and Managing Regulatory Director at Design Space InPharmatics. In this episode, Meranda and Brian are turning the tables on Ed and turning him from interviewer to interviewee. Ed touches on his hometown roots, his extensive background in CMC and drug development and lessons learned throughout his career. He expounds on his current role at DSI and the impact his team has had on the industry. Ed lists some of the many mentors-turned-friends he’s had the pleasure of meeting throughout this journey and thanks them for the life lessons they taught him. Finally, Ed talks about the importance of developing powerful, positive routines in order to navigate this virtual new normal in the remote world. Those who embrace change are more likely to experience accelerated growth and wind up ahead of the pack.

February 4, 2021

Published by Meranda Parascandola at February 4, 2021

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.

February 11, 2021

Published by Meranda Parascandola at February 11, 2021

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 12, 2021

Published by Meranda Parascandola at February 12, 2021

Regulatory Odd Couple with Ed Narke & Meranda Parascandola

Edward Narke is a Principal and Regulatory Managing Director and Meranda Parascandola is the Head of Business Development & Marketing at Design Space InPharmatics. Today, Ed and Meranda discuss topics they’ve covered on DSI’s ongoing blog series, The Regulatory Odd Couple. They dive deep into the process of regulatory drug development, including the importance of having regulatory starting materials, building the quality overall summary and the role that excipients play in that process. Ed and Meranda share their thoughts on the analytical framework of API and other stages of pharmaceutical development.