Drug Development

October 23, 2020

A Discussion on CMC Strategy and Submissions with Ed Narke, Brian Lihou & Meranda Parascandola

Edward Narke is a Principal and Regulatory Managing Director, Brian Lihou is the Head of Operations and Meranda Parascandola is the Head of Business Development & Marketing at Design Space InPharmatics. Today, Ed, Brian and Meranda join the show to discuss CMC marketing application strategies and submissions. Specifically, they speak to the important role regulatory reviewers play in deciphering data and ensuring all authors are following one cohesive story. They break down other CMC issues they’ve encountered with projects they’ve worked on and provide insights and protocols clients can follow to yield a successful program.
October 29, 2020

Why Now is the Most Important Time for Selecting a CMO

Rick Offerman is a Senior Project Management Consultant at Design Space InPharmatics. With over twenty years of experience as a process chemist, Rick brings a unique perspective to the drug manufacturing process. In this episode, Rick, Ed, Meranda and Brian discuss the challenges with scaling for process. There are several challenges involved as each scenario is different every time. They delve deep into the importance of carrying out evaluations and other necessary steps to manage these complexities as well as the value of taking an integrated approach.
November 6, 2020

Halloween Special – Ghosts, Spirits and CMC Regulatory, A Halloween Story

In this very special and spooky episode of CMC Live, Ed, Meranda and Brian host a happy hour and invite other members of the Design Space InPharmatics team to share the scariest stories from their careers. From walking through a morgue to gain access to medical records to a very noisy liquid oxygen tank, these stories will be sure to raise the hair on the back of your neck!
November 13, 2020

Outsourcing in China: How far can it go?

David Blasingame is a Director of CMC at Rigel Pharmaceuticals and former Senior Consultant at Design Space InPharmatics. David is an accomplished process chemist with over twenty years of experience in process research and development, API and drug product manufacturing and developing cross-functional and external CMO relationships. In this episode, David, Ed, Meranda and Brian discuss the advantages and disadvantages of outsourcing drug manufacturing to China, the value of person in-plant approach, and the importance of communication and trust in building good partnership relationships.
November 20, 2020

Brexit: What You Need to Know for Drug Development

Amber Sheriff is a Senior Regulatory Affairs Consultant at Design Space InPharmatics. With more than 32 years of experience, Amber is an expert in regulatory strategies for orphan drug designation, exclusivity, controlled correspondences, and briefing books, to name a few. In this episode, Amber, Ed, Meranda and Brian discuss regulatory pathways in the European Union (EU), the impact Brexit has had on CMC filings, and the advantages and disadvantages of the three defined procedures to obtain approval for products in Europe.
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.