Product Development Consultancy
Building on a wealth of experience and specialized expertise, Aptiv Solutions enables sponsors to implement development programs that are intelligently designed, cost effective and timely – while also taking into account the practical considerations of translating a plan into action. The Aptiv Solutions Product Development Consultancy (PDC) group has wide-ranging experience across all key elements required to build a robust drug development strategy. Our experience gained through hands-on drug development applied through our project team approach enables us to provide clients with expert leadership and management in the development of therapeutic products.
From our offices in Europe and the US, our PDC Project Leaders guide cross-functional networked teams in the conception, refinement and conduct of product development with a global perspective. Our understanding of the full lifecycle of drug development and knowledge of the current landscape ensures the PDC Team is well placed to explore and execute traditional and alternative development strategies. The PDC approach encourages efficient use of valuable resources and progression of projects in a wide spectrum of therapeutic areas.
We believe that “smart” development is only possible by defining a clear product strategy, designing a focused intelligent development plan, and careful planning and management of implementation. The PDC Leader brings together the expertise and experience of the full product team – all members chosen for their therapeutic area and drug development knowledge – to achieve this goal.
We have experience across a range of therapeutic areas with an emphasis on Oncology, CNS, Cardiovascular, Respiratory Disease, Inflammation, Endocrinology and Infectious and Rare Diseases. We also maintain close links with key opinion leaders and regulators.
Clinical Product Development Expertise
- Assemble team of internal and external experts appropriate to the project and to meet client’s needs
- Full development strategy designed in partnership with the client
- Engage Key Opinion Leaders early and often
- Develop rational development plan
- Define clear decision points and contingency plans
- Ensure cross-functional collaboration
- Develop Risk Management and Mitigation strategy
- Develop cross-functional project plans, budgets and timelines
- Provide routine status reports
- Monitor activities against project plans
- Maintain accountability within the project team
- Develop Communication plan within the project
- Development of a Target Product Profile to help meet scientific & funding mile-stones
- Selection and management of scientific & clinical advisory boards, including pro-tocol design groups
- Due Diligence
