3M Drug Delivery Systems technology, product development, global regulatory expertise and commercial manufacturing can provide pharmaceutical and biotech companies with differentiated products, speed to market and increased probability of technical and commercial success.
The process starts with a cross-functional team drawn from both companies, pairing specialists from each, matching engineer to engineer, quality expert to quality expert, packaging designer to packaging designer. The relationship flows from product definition and pre-feasibility assessment all the way through to the product launch.
Pre-Feasibility Assessment
OBJECTIVE: A Pre-Feasibility Assessment report is usually completed under a confidential disclosure agreement and assesses the technical compatibility of 3M's transdermal or inhalation technology with the compound and the proposed product concept. It is based on chemical and physical characteristics of a compound compared with 3M historical data.
OUTCOME: 3M provides an opinion on likely technical success of the compound within that drug delivery system and 3M recommends whether or not further development should be considered.
Feasiblity
OBJECTIVE: Feasibility is a set of experiments conducted in a limited period of time for a limited cost. Feasibility is performed under confidential disclosure and determines, through laboratory formulation and analysis, the compatibility of the compound with 3M drug delivery technology. It also aims to identify key technical risk areas that would need to be addressed if the program goes forward into development and helps establish a realistic timeline and cost estimate for development.
OUTCOME: During feasibility, many aspects of the product concept and definition are taken into account. This work is based on defining formulations or systems to assess technical compatibility for the drug delivery system to meet the performance and marketing requirements defined by our partner. Feasibility provides a Go/No Go milestone decision for full product development. Key parameters and risks are identified for consideration in any future development efforts. Our partner is provided with a written report that identifies key findings and results. Typically a product prototype is available. At the end of feasibility, 3M makes a recommendation on proceeding with the project under a Development Agreement.
Development
OBJECTIVE: The objective of this phase is to develop a technically and commercially viable product for marketing and sales by our partner with 3M manufacturing and supplying the product. Our partner defines the product and the indication, conducts the necessary clinical studies and sets the marketing and sales strategy with consultation from 3M if desired.
OUTCOME: 3M and our partner jointly define the work plan which evolves over the course of development from pre-clinical to New Drug Application (NDA) or equivalent submission. Our partner defines the product, the indication, the clinical studies necessary, and the marketing and sales strategy. 3M will formulate and develop the product as defined by our partner. 3M will manufacture clinical supplies according to a product definition, complete the Chemistry, Manufacturing and Controls (CMC) section for global regulatory approval, scale-up manufacturing for phase III supplies and be prepared to launch product within the marketing timelines of our partner. This includes product formulation and stability testing, analytical method development, process development and scale-up to production, and toxicological support of components. In addition, 3M can assist with early clinical studies. All work is in compliance with cGMPs and global regulatory guidelines.
Commercialization
OBJECTIVE: This is the stage where it all comes together. A successful launch incorporates a well-defined strategy and implementation of tactics, ranging from the marketing platform to the logistics of shipping product on time. It can continue with additional launches around the world and line extensions to extend the product life cycle.
OUTCOME: The cross-functional team approach continues throughout this stage. After working with a 3M Development Team throughout the development phase, there is a gradual transition to a Launch Team. Following scale-up and validation, a 3M Account Manager works closely with your marketing and logistics departments to meet your launch objectives. A 3M Customer Support Representative is assigned to your account to ensure timely shipment of product throughout its life cycle, and the entire 3M Account Team assists with global registrations and line extensions to maximize product life cycle.
What is the best way to contact 3M Drug Delivery Systems for quick answers to my questions?
Selecting the Contact Us link found in various locations throughout the site. We will respond to your inquiry within two business days.
