Inhalation

© Copyright Inhalation catalent.com 18 In addition to traditional development and manufacturing considerations, inhaled products also require device char- acterization and selection. In many cases, an entirely new device must be designed, or an existing platform must be modifi ed to work with a specifi c formulation. Optimization of product and process, process scale-up and generation of a submission-ready regulatory package can also require skills and knowledge not available at traditional oral or injectable product development organizations. With development of in- halation products for NCEs taking about 5-6 years and cost- ing millions of dollars, a pharmaceutical company's relation- ship with the CRO it works with is critical. By choosing the right outsourcing partner, companies can often gain access to valuable expertise and experience across a broad range of inhaled dosage forms, allowing parallel development or format optimization for the tar- get disease state and patient population. A drug delivery company looking to develop products around its technol- ogy in addition to out-licensing its intellectual property to large pharmaceutical companies may not be looking for a CRO to take the product or technology through full devel- opment to regulatory submission, but may simply seek a data package to demonstrate the technical and/or clinical proof of concept to illustrate the value of their asset. For companies looking to commercialize their own products, a CRO with the infrastructure and expertise to take a devel- opment forwards beyond very simple studies, with expe- rience in overcoming the high regulatory hurdles, having cGMP capability, and possibly having the infrastructure for commercial manufacturing is probably the best bet. A CRO with complete development and manufacturing ca- pability for metered dose inhalers, dry powder inhalers, nasal spays, and solutions and suspensions for inhalation has the ability to partner with a company at any point in the development process from feasibility to commercial- ization (Figure 2). Services will include formulation and device screening along with the development of chemi- cal and performance methods. Later in the process, the formulation and analytical teams will work closely with the manufacturing team to perform process scale-up and optimization, while the analytical team optimizes and val- idates methods and provides analytical process support. Once in production, raw materials, manufacturing, mate- rials handling and analytical teams will work together to deliver clinical batches. The analytical and stability teams are then ready to perform the supporting stability studies. Although outsourcing any or all stages of product devel- opment to one contract facility has many advantages, including having to manage only one CRO and effi cient sharing of information and technology throughout the process, customers may come to a CRO with projects at various stages of development and require the CRO to pick up their projects seamlessly and progress from there on out. As an example, customers may conduct early feasi- bility studies internally or with providers that ultimately do not offer the services necessary for continued develop- ment. In these cases, the CRO must be suffi ciently agile to respond rapidly to both individual customer and individu- al project needs. The fi rst step for the customer, therefore, is to evaluate the offerings of various CRO providers to understand how their capa-bilities align with the type of work being outsourced. During the selection process, teleconferences and site visits with the CRO are valuable in assessing capabilities. These activities are typically managed through the CRO's business development groups and involve establishing some form of a mutual confi dentiality agreement to allow both parties freedom to exchange the necessary infor- mation to build an effective relationship. Most often it is the business infrastructure within the CRO and working relationship between the customer and CRO that will de- termine the success or failure of a particular venture. That said, development is development, and even with the best laid plans the unexpected can happen. In such instances, aside from technical expertise and the experience of hav- ing seen such issues previously, the real value that the CRO can bring to such situations is the ability to effectively part-ner with the customer to work through any problems proactively, effi ciently, and with open and honest commu- nications to a successful conclusion. Defi ning the project scope, including information such as the dosage form, the number of product strengths to be developed, the phases of product development requir- ing support, the development strategy, and timelines will help the CRO to identify the appropriate technical experts needed for development of the contract or quotation for the desired work. In some instances, the CRO can provide technical experts right from the beginning of the process to assist the customer in defi ning this scope. Once both parties have agreed on a scope, the CRO will generally prepare a proposal for the work that details the key de- liverables and the costs associated with each deliverable. To avoid delay in starting work with a CRO, it is import- ant to get a start on completing the necessary documents early in the business development stage. With all work, Figure 2

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