Michael Carrol is Senior Consultant of Microbiology and Aseptic Manufacturing at Design Space InPharmatics. He is an accredited Microbiologist with over 35 years of product development, quality control and GMP manufacturing experience in the pharmaceutical, biotechnology and medical device industries. In this episode, Ed, Meranda, Brian and Mike discuss the Parenteral Drug Association, the role of regulatory approvals and other stories from Mike’s illustrious career. They talk about the...

Bettina Kaplan is the Head of Quality Assurance Services, Robbi Freisem and Susan Fasso are Senior Quality Assurance Consultants and Maria Arakil is a Quality Assurance at Design Space InPharmatics. Together, this talented panel of subject matter experts join Ed, Meranda and Brian to discuss all things Quality Management Systems. QMS are highly complex and many organizations struggle to implement them. They discuss a brief history of QMS, the timing required and guiding documents, such as the...

Jim Mencel is Senior Drug Substance Consultant at Design Space InPharmatics. With an extensive background in CMC management, Jim has a wealth of knowledge on the topic of process validation. Process validation is an integrated and mandatory process in the pharmaceutical industry to ensure all processes are in compliance with regulatory standards. In this episode, Jim provides his thoughts on the significance and science of process validation in the pharmaceutical industry as it pertains to...

Shelli Connelly is a Senior Drug Product Consultant at Design Space InPharmatics. With over 20 years of long- term success in the pharmaceutical manufacturing industry, Shelli has expertise in pharmaceutical process validation, business development activities, strategic planning, and more. In this episode, Shelli shares her thoughts on filter validation, including what to do if you pick the wrong filter, how filter vendors represent the best resources and the importance of having a partner...

Edward Narke is a Principal and Regulatory Managing Director and Meranda Parascandola is the Head of Business Development & Marketing at Design Space InPharmatics. Today, Ed and Meranda discuss topics they’ve covered on DSI’s ongoing blog series, The Regulatory Odd Couple. They dive deep into the process of regulatory drug development, including the importance of having regulatory starting materials, building the quality overall summary and the role that excipients play in that process....

Ed Narke is the co-founder, Principal and Managing Regulatory Director at Design Space InPharmatics. In this episode, Meranda and Brian are turning the tables on Ed and turning him from interviewer to interviewee. Ed touches on his hometown roots, his extensive background in CMC and drug development and lessons learned throughout his career. He expounds on his current role at DSI and the impact his team has had on the industry. Ed lists some of the many mentors-turned-friends he’s had the...

Paul Long is a Project Management Consultant at Design Space InPharmatics. Paul has supervised government regulatory pharmaceutical industries for over twenty years and has a wealth of business knowledge. He knows how to build and lead high-performing, cross-functional teams, how to prioritize and the importance of meeting budgets and targets. In this episode, Paul, Ed, Meranda and Brian discuss the benefits and challenges of virtual project management during the COVID-19 pandemic, integral...

In this very special episode of CMC Live, hosts Ed Narke, Brian Lihou and Meranda Parascandola provide an in-depth recap of Season One, complete with direct quotes from all of their illustrious guests. Ed, Brian and Meranda reflect on everything from Jim Mencel’s perspective on expedited drug development programs and Dave Adams’ belief in trusting the API process to Daniel Torok’s analysis of the White Coat Effect and Judy Magruder’s effective strategies for early stage drug development. They...

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...

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...

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...

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!

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...

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...

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...

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...

Daniel Torok is a Senior Drug Substance Consultant at Design Space InPharmatics. With a background as a process chemist and years of experience in process development and API Operations, Daniel brings a unique perspective on CMC and the pharmaceutical industry. Today, Daniel discusses the vital role that trust plays in the relationship between a sponsor company and a contract manufacturing organization (CMO) as a Person In-Plant. He provides real-world examples of Person in-plant visits he’s...

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 share their collective experiences in the field of CMC. They dissect the process of filing for an Investigational New Drug (IND) and a New Drug Application (NDA), the concept of ‘rest-of-world awareness,’ and the importance of storyboards and...

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.

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...

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...

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.

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.

Design Space 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.