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Pharmaceutical Manufacturing and Packing Sourcer

Has COVID-19 Altered the Drug Delivery Sector Forever?

Recently, we’ve had a lot of discussions internally at our company about the overall regulatory strategy for one of our specific types of technologies. I think in having these discussions with a lot of the pharmaceutical and biotechnology companies – especially the smaller companies – there’s a lack of clarity regarding the regulatory path that some of these companies should take. For example, many of these companies think devices and drugs are each single products, but really, they should be considered as combination products. When considering the regulatory path, you have to consider that these two items are going to be used together. The regulatory processes you would take would very much depend on how you wanted to market the product. Also, one must consider if the drug and device are going to be packaged together or separately. There are a number of different options, and how one markets the product at the end of the day is very much dependent on that regulatory path.

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John Vasilakos, PhD, is Global Head of MTS Business Development and Senior Research Immunologist at Kindeva Drug Delivery. Previous industry roles include Senior Research Immunologist and Business Development of TLR Ligands at 3M Drug Delivery Solutions Division and Vice President of Immunology at Biothera. He has spent over 25 years in the biopharma industry focusing on vaccines and immunotherapy for cancer and chronic viral diseases. He holds a PhD from the University of Cincinnati School of Medicine, US.

Lisa Dick, PhD, is a Technology Platform Leader at Kindeva Drug Delivery with over 20 years of experience in the drug delivery field. She leads formulators, analysts, materials, scientists, and engineers to develop solid coated microneedle drug products, hollow microneedle-based drug products, and associated devices for these transdermal systems. She has previously contributed to development of inhalation drug products from early-phase feasibility through launch and marketed product support. She has extensive experience with drug product development, materials, including extractables and leachables, quality, and contributes to regulatory filings. She regularly presents podium talks at meetings and authors scientific articles.

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John Vasilakos
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Lisa Dick
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