Regulatory Affairs

Edward Narke is a Principal and Regulatory Managing Director and Brian Lihou is the Head of Operations at Design Space InPharmatics. Today, Ed and Brian join the show to share their collective experiences in filing for an Investigational New Drug and a New Drug Application. They break down the concept of ‘rest-of-world awareness,’ the importance of storyboards and timelines for document submission.

Kyriakos Michailaros is Head of Drug Products Services at Design Space InPharmatics. With over twenty years of experience in exploratory, clinical phase and commercial projects within the pharmaceutical industry, Kyriakos brings a wealth of knowledge to today’s show. In this episode, Kyriakos, Ed, Meranda and Brian discuss product development reports, the important role that timing plays in these reports and trends in drug product manufacturing. Kyriakos shares specific examples from his career that showcase how influential these development reports have become with reviewers in the industry.

Hedley Rees is a Managing Consultant at PharmaFlow Limited, a UK based consultancy specializing in operations and supply chain management within the life science sector. Throughout his career, Hedley realized that there was and continues to be something seriously wrong with how medicine has come to market. As such, he has been a passionate advocate of modernization in the pharma and biotech industries. Hedley is also the author of Taming the Big Pharma Monster By Speaking Truth to Power and Supply Chain Management in the Drug Industry. In this episode, Hedley, Ed, Meranda and Brian discuss value chain, quality by design (QBD) and ongoing issues in the pharmaceutical industry.

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.

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.

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.

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.

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.