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Pharmaceutical Technology TRENDS IN MANUFACTURING 2022 eBOOK 53 transitions in the injectable product life cycle. For teams looking ahead to that launch, these five steps are worth considering at the outset. Plan for the impact of a market-by-market approach Standing out from the noise of a competitive market has always been a priority for drug developers—and that need is as salient as ever amid the growing de- mand for patient-centric delivery systems. When assessing target profile components in ser- vice of a differentiation strategy, several market fac- tors can influence the decision to choose one delivery format over another. Use case (whether products are handled at home or at the clinic) as well as user com- petencies and expectations typically top the list. But other considerations matter too, including patient characteristics, varying regulatory frameworks, and market-specific payer arrangements. Considering the wide range of region-to-region variability in demographics, socioeconomics, and other factors, a device that serves one market's ad- herence, regulatory, or handling needs may not do as well for those of a different region. The result: a single launch may realistically transform into a complex se- ries of customized, regionally specific sub-launches. Managing a single manufacturing strategy this way can be as technically, operationally, and logistically challenging as it sounds. It's a necessity that should be acknowledged upfront in timelines, budgets, and resource allocations to pre-empt unnecessary or un- expected delays in a market-by-market launch plan. Become fluent in the evolving regulatory language of drug-device combinations By virtue of their business, drug companies typi- cally see themselves as experts on their molecule or substance class—not necessarily in delivery de- vices. But that's exactly the expertise that regula- tors are increasingly demanding of the fast-grow- ing market for combination products. Agencies from both the United States and the Eu- ropean Union place injectable medications in a regu- latory framework that covers both the API and the delivery device, setting compliance rails that likewise straddle the drug and medical device universes. For example, US launch plans must contend with the FDA's Title 21 Code of Federal Regulations (CFR) Part 4, an issuance that established these therapies as combination products. The associ- ated rules tick boxes for both current good manu- facturing practices (CGMP) and medical device regulations—either wholly conforming to both or complying with just one and adding compliance measures as required from the other (2). In the EU, similar expectations apply under Article 1(8) of the Medical Devices Regulations, with some nuances. Notably, regulations f lex according to which product (drug or device) plays the dominant role—but in the case of autoinjec- tors or pens, frameworks span both drug and device regulations (3). As with market variables, regulatory conditions and their associated documentation requirements can mightily affect a company's intended pivot to As with market variables, regulatory conditions and their associated documentation requirements can mightily affect a company's intended pivot to parenteral delivery.