Combination Drug Products: What Lies Beneath – Risk Analysis for Product Development

A robust approach for combination drug product development requires an understanding of the drug product characteristics, the effects of processing and device design and how they impact product performance. Risk management connects the dots and interactions of these critical factors.

A key component of risk management is the utilization of Quality by Design (QbD) principals. A QbD approach can integrate the elements and requirements of ISO 13485:2016 for medical devices as well as ICH 8 – Pharmaceutical Development. ICH Q9 – Quality Risk Management, and ICH Q10 – Pharmaceutical Quality System.

In this webinar, the speakers will:

• Take a deep dive into the critical components of a QbD approach including the evaluation of the quality target product profile (QTPP), critical quality attributes (CQA) of the drug product, critical processing parameters (CPP), and critical material attributes (CMA) of raw materials.
• Draw parallels with device design controls which align with compliance requirements and product performance characteristics which align with user/device interactions (human factors).
• Discuss differences in experimentation from development studies to quality control.
• Review FDA requirements that include an implicit risk analysis.

Speakers

Justin Lacombe, PhD, Chief Scientific Officer, Experic LLC

Justin Lacombe, PhD is Chief Scientific Officer at Experic. Justin leads the pharmaceutical development and engineering teams to provide expertise, insights and practical solutions that address many of the technical challenges that pharmaceutical companies encounter during drug and combination product development.

Justin’s focus is on robust scale-up and process development using Quality-by-Design and design controls principles. He has specialized expertise in manufacturing, combining small-volume powder dosing technology for rheologically complex powders, primary packaging development, and formulation optimization. Based on his diverse experience, Justin has been a proponent of conducting powder filling studies earlier in the development process to avoid late-stage delays when scaling manufacturing processes to clinical and commercial quantities.

In previous roles, Justin was deeply involved in the development of inhaled pharmaceutical products, initially on metered dose inhalers at Catalent Pharma Solutions, and more recently and extensively on dry-powder inhalation products as senior manager, R&D, at Teva, from particle engineering to fill and finish. Justin earned his MS and PhD in chemical engineering from Rutgers University and has presented extensively on topics of manufacturing drug product interaction, process development optimization, and drug-device combination products.

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Julie D. Suman, RPh, PhD, President, Scientific Affairs, Next Breath

Dr. Julie D. Suman is co-founder and President of Next Breath, an Aptar Pharma Company, a contract research organization dedicated to the development and analytical testing of nasal, inhalation, and injectable delivery systems. She also supports Scientific Affairs for Aptar Pharma. Dr. Suman directs the research division that supports product development and regulatory submissions for North American and International Clients in the pharmaceutical, biotechnology and medical device markets.

Dr. Suman holds a B.S. in Pharmacy from Duquesne University (1996) and a Ph.D. in Pharmaceutical Sciences from the University of Maryland, Baltimore (2002). She is a co-editor for Respiratory Drug Delivery Proceedings, an international symposium, and an adjunct assistant professor at the University of Maryland, School of Pharmacy in Baltimore, Maryland. She is also an Affiliate Assistant Professor in the Department of Pharmaceutics, School of Pharmacy, Virginia Commonwealth University. Dr. Suman is the Past-Chair of the AAPS Inhalation Technology Focus Group.

Dr. Suman is also a member of the Parental Drug Association Visible Particulate Taskforce. She is a licensed Maryland pharmacist. Dr. Suman has published her research in peer-reviewed journals and has been presented during podium sessions at international meetings, the FDA Topics in Bioequivalence Seminar Series and has been an invited speaker at ANVISA in Brazil. Dr. Suman’s doctoral research, which focused on the relationship between in vitro tests for nasal sprays and in vivo deposition, has been recognized for excellence by a research award presented at the International Society for Aerosols in Medicine, 2001.

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