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The Race to Market

The development of a new drug product therapy is a complex process that requires careful planning and meticulous execution. Even with these prerequisites, it can result in long lead times, high costs, and immense risks, with development timelines often exceeding 10 years from discovery to regulatory approval. For combination products, the process of bringing a product to market is complicated further. With growing competition in the market of injectable products, drug delivery systems have become increasingly important for the patient, caregiver, and healthcare professionals in terms of ease of use as well as product differentiation. These factors require pharmaceutical and biotechnology companies to identify a strategy for a drug delivery system early in the drug development phase to effectively and efficiently bring the combination product to market.

As the expert that understands the intricacies of the self-injection process and the complexities of the combination product development timelines, a device developer is often contracted to help companies maximise investments and minimise potential delays to commercial launch. Combining this knowledge and experience with a strong set of in-house capabilities, the development process can often be expedited, ultimately ensuring the successful commercialisation of the combination product in a timely manner.

Of Primary Importance

An auto-injector consists of a drugcontaining primary container and a device containing many moving parts and mechanical forces specifically designed to ensure that the drug product is fully injected within the specified delivery requirements. Both the drug product and device are highly regulated components, and the efforts to deliver the drug safely and effectively is an undertaking that requires close collaboration between the company and the device developer.

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Taras Seniuch is Director of Business Development at SHL Group: designer, developer, and manufacturer of advanced drug delivery devices such as auto-injectors and pen injectors. With over 17 years of experience within the pharma and medical device industry, Taras leads the business development efforts for the CMO, SHL Pharma, which provides assembly and secondary packaging solutions for SHL-designed devices for pharma and biotech products.
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