Wednesday, March 10, 2010

Early Stage Drug and Device Development - It takes a team to win!

Implementation of early stage integration of sales and marketing goals with clinical and regulatory groups early in the development of the drug or device is essential. Implementation of early stage integration of marketing and clinical structures, clinical/regulatory submission teams, whether through new product development groups, joint project management teams, formal communication processes, co-governed portfolio management authorities or otherwise is critical.

In these arrangements, there are definite benefits from some form of pooling of ideas. While portfolio groups and multi-faceted oversight can be challenging, there is ROI. One group, must be in control of the process and although many pharma companies choose sales and marketing to carry the ball, the development must be a function of clinical, regulatory and project teams.

Each group's level of strategic influence will vary in the process, however, the important point is that all functions and strategic groups, are heard. Group input becomes a part of the overall development process which inevitably and favorably impacts costs, timelines, resources, capacity and improves quality, quality control and quality assurance.

Enable group communication, knowledge sharing, coordination and "gate-keeping" of information. It takes a team to win. Group communication unites people from different backgrounds in the development process. Groups with diverse experiences and expertise come together to achieve common goals and objectives on time and cost-effectively.

Sound "gate-keeper" activities and "hands-on" project direction and management early on allows teams and groups to navigate go/no go product profile decisions more effectively. The benefits are real and provides a clearer overall picture of clinical and commercial assets and outlooks, especially when clinical candidates are being developed in parallel.

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