Meranda Parascandola

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.