Combination Drug Products: A Development Roadmap to Clinical Trials

As a combination drug product development project moves from the laboratory into production to generate supplies for clinical research, it is necessary to involve multiple functions including manufacturing, engineering and analytical support to make and release these materials. This is especially true for inhalation and nasally administered powders. The complexity of transferring a drug product is increased when the product involves a drug-device combination.

In this webinar, the speakers will examine what you need to know about your product to effectively support these transitions, including understanding the target product profile, critical quality attributes, product and device variability, analytical testing, regulatory requirements and the interaction of testing and manufacturing parameters. Similarly, the receipt, inspection, and assembly of the device components will be discussed within the context of their impact on device efficiency, and thereby their effect on product delivery and performance. Aspects of device evaluation will also be discussed in terms of performance and more routine testing such as assays.

Register for this webinar to learn about critical steps to transfer the development process, sponsor and service provider responsibilities, and an efficient framework to collaborate with partners will be presented to help minimize delays and accelerate timelines on your pathway to the clinic.

Speakers

Justin Lacombe, PhD, Chief Scientific Officer, Experic LLC

Justin Lacombe, Ph.D. 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 M.Sc. and Ph.D. 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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