Drug Development

Les Mintzmyer is a Sr. Biologics Manufacturing Consultant at Design Space InPharmatics. Today, Les joins the show to share his experience as a leader in the field of bio-pharmaceutical manufacturing. In this episode, Ed, Brian, Meranda and Les break down the Request for Proposal (RFP) process including three critical factors: verification, qualification and validation. Les speaks to best practices for identifying and selecting the appropriate Contract Manufacturing Organization (sometimes referred to as CMDOs) to partner with.

Dave Adams is a Senior Drug Substance Consultant at Design Space InPharmatics. Today, Dave joins the show to share his experience solving problems in active pharmaceutical ingredients (APIs). In this episode, Ed, Brian, Meranda and Dave discuss the importance of comprehensive development programs. Dave speaks to quality assurance, tech transfer procedures and real-world case studies that he has encountered throughout his career.

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.

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.