Issue link: https://www.e-digitaleditions.com/i/1467950
16 BioPharm International May 2022 eBook www.biopharminternational.com As always, organizations that proac- tively plan ahead will be best positioned to succeed with one of the most complex and challenging transitions in the inject- able 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 com- petitive market has always been a priority for drug developers—and that need is as salient as ever amid the growing demand for patient-centric delivery systems. When assessing target profile com- ponents in service of a differentiation strategy, several market factors can influ- ence 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 competencies and expectations typically top the list. But other considerations matter too, includ- ing patient characteristics, varying regu- latory frameworks, and market-specific payer arrangements. Consider ing t he w ide ra nge of region-to-region variability in demo- graphics, socioeconomics, and other factors, a device that serves one mar- ket's adherence, 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 series of customized, region- ally 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, bud- gets, and resource allocations to pre-empt unnecessary or unexpected 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 compa- nies typically see themselves as experts on their molecule or substance class—not necessarily in delivery devices. But that's exactly the expertise that regulators are increasingly demanding of the fast-grow- ing market for combination products. Agencies from both the United States and the European Union place injectable medications in a regulatory framework that covers both the API and the delivery device, setting com- pliance 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 manufacturing practices (CGMP) and medical device regulations—either wholly conforming to both or comply- ing 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 auto- injectors or pens, frameworks span both drug and device regulations (3). As with market variables, regula- tory conditions and their associated do c u ment at ion re qu i rement s c a n mightily affect a company's intended pivot to parenteral delivery. Timelines can be prolonged, budgets expanded, and outside know-how may be needed f rom t he me d ic a l d e v ic e w orld . Allotting the right resources upfront for these reg ulator y subtleties w ill drive more efficiency and value along the road to commercialization. ACCOUNT FOR OVERLAPPING COMPLEXITIES OF FORM AND FUNCTION Combining an injectable medication and a delivery device is a step with intricate, far-reaching technical implications for device selection, manufacturing pro- cesses, and the product supply chain. Upstream decisions about many aspects of a product's commercial profile can lead to unforeseen consequences and unexpected costs when it comes time to select and launch in a delivery device. Prima r y pack aging choices, for example, can ultimately dictate compo- nent selection and manufacturing pro- cesses—such as when an autoinjector that requires more advanced specs ends up limiting compatibility with assem- bly machiner y. Similarly, decisions around secondary packaging can influ- ence downstream steps in the workflow regarding label placement or measures to safeguard against pre-activation. Basic fill/finish parameters like vis- cosity and filling volume can also have domino effects. For instance, dose volume may dictate the length of the plunger rod in safety devices, while vis- cosity (and actuator strength) may limit appropriate autoinjector options. In all these cases and more, delivery devices demand a holistic, forward-thinking Partnerships for Outsourcing Development Basic fill/finish parameters like viscosity and filling volume can also have domino effects. Environmental initiatives can influence a company's launch of a new delivery device in several ways.