Regulatory Affairs

DS InPharmatics' Senior Drug Substance Consultant, James Mencel, joins the show to share his background with CMC management. In this episode, Ed, Meranda and James discuss the impact that expedited drug development programs have had on the pharma industry. They break down regulations, breakthrough designations and best practices when it comes to these programs.

DS InPharmatics' Senior Drug Substance Consultant, James Mencel continues his discussion on expedited drug development programs, specifically the importance of establishing regulatory starting materials. In this episode, Ed, Meranda, Brian and James discuss how the FDA and sponsors deal with the challenges of establishing starting materials, the role of the International Council for Harmonisation (ICH) and striking the balance between appropriate regulatory control and sustainable manufacturability.

InPharmatics’ Senior Program Management Consultant, Judy Magruder joins the show to share her vast experience consulting with biopharmaceutical product development organizations. In this episode, Ed, Brian, Meranda and Judy discuss how to approach early stage drug development, how to be flexible in the wake of regulatory challenges, instances where companies should pivot and the vital need for effective communication.

Design Space InPharmatics Senior Quality Assurance Consultant, Bettina Kaplan joins the show to share her experience with quality assurance and auditing in the pharmaceutical industry. In this episode, Ed, Brian, Meranda and Bettina discuss the impact that Covid-19 has had on auditing and how it has shifted the industry to focus on virtual audits. Bettina speaks to trends in quality auditing and the risks associated with not having audits done regularly.

DS InPharmatics Senior Regulatory Affairs Consultant, Dr. Catherine Bernard joins the show to share her experience in regulatory affairs in the pharmaceutical industry and preparing dossiers associated with CMC. In this episode, Ed, Brian, Meranda and Catherine discuss breakthrough designations, the role of agencies such as the FDA, and future trends in pharmaceutical regulation.

DS InPharmatics Head of Analytical Services, Colman Byrne joins the show to share his experience in analytical method development and validation. Colman is the most senior analytical services expert at DS InPharmatics and is very technically proficient in all aspects of analytics. In this episode, Ed, Brian, Meranda and Colman expound on the process of analytical method development, including challenges, physiochemical properties that can impact the process and regulatory parameters and agencies that exist.

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.