Enhancing precision medicine R&D processes

The life sciences industry is increasingly focused on precision medicine-based (PM) drugs and devices to ensure optimal outcomes for patients. Precision medicine therapeutics are those that are biomarker driven and will therefore require some kind of diagnostic test to identify appropriate patients for therapy. However, precision medicines add an additional layer of complexity to the classic drug development process. To effectively navigate these complexities, life sciences companies must adopt innovative approaches to enhance their R&D processes.

Today, leading organizations are focusing on key areas to enhance their R&D processes for precision medicine:

• Standardized assessment criteria: Developing a set of key questions and inputs required across R&D functions to inform decision-making for potential precision medicine programs. This includes a set of criteria to determine the likelihood a program will require a diagnostic based on scientific, clinical, technical, regulatory, commercial and financial inputs.
• Data-driven approaches: Integrating Data Science and Informatics across asset development to enable and strengthen biomarker / diagnostic strategies. Enhancing R&D functions’ knowledge of Data Science (DS) and Informatics skillsets and capabilities is a critical first step to best leverage and embed DS platforms and tools into development processes.
• Forums and stage-gates: Facilitating new cross-functional R&D forums in early development to assess biomarker hypothesis and testing plans, and results of diagnostic assessment criteria to ensure functions (e.g., Translational Medicine, Clinical, Diagnostics) are working with the same information, toward aligned upon objectives.
• Collaborative ways of working: Elevating levels of collaboration across R&D functions is integral to the success of precision medicine programs. Implementation of formal and informal ways of working across R&D functions aims to optimize opportunities for cross-functional input in an efficient manner.

Download our latest paper, Enhancing R&D processes in the age of precision medicine, to learn more about how these innovative approaches can help life sciences companies enhance their R&D processes for precision medicine.

We would like to thank our contributors on this whitepaper: 

• Aditya Kandath, Director, Performance Transformation, KPMG, US
• Julia Krauss, Director, Performance Transformation, KPMG, US
• Thomas Angiulo, Manager, Performance Transformation, KPMG, US