Evidence planning to support Asset Strategy is a structured approach that aligns evidence generation with the strategic goals of a product across its lifecycle. It ensures that the right data is available for regulators, payers, clinicians, and patients at the right time. This planning typically involves multiple functions: Clinical Development and Regulatory Affairs, Health Economics and Outcomes Research (HEOR), Market Access, Medical Affairs, and Commercial teams (MAPS, 20251; Olson, 20182).
Industry frameworks such as BCG’s IEP 2.03 describe integrated evidence planning as a staged process that begins early and evolves continuously. The steps include:
Early alignment before proof of concept – See another blog post here!
Draft planning prior to pivotal trials
Final integrated plan before Phase III or registration studies
Lifecycle reviews after approval
Continuous updates as new data and competitive dynamics emerge (Grueger, Andre, & Vaidyanathan, 20234).
What are challenges related to the Evidence planning process for Pharma?
Challenge 1: Planning Siloes
Despite the intent to align Evidence planning, many organizations still operate in siloes. Clinical teams often focus on regulatory endpoints, while HEOR and market access teams prioritize evidence to support product value or value demonstration, which can include cost-effectiveness and evidence specific to payer needs. Medical affairs may concentrate on scientific exchange and guideline inclusion. When these plans are developed independently, three issues arise:
Objectives and timelines do not align, creating redundancies and gaps
Resources are used inefficiently, with overlapping studies and conflicting endpoints
Integration occurs late, limiting the ability to adapt to market changes or stakeholder needs
Challenge 2: KPI and Metric Siloes
Measurement practices often reinforce fragmentation. Success is tracked by outputs such as the number of studies completed or publications delivered, rather than by metrics that demonstrate impact. Common issues include:
Metrics differ by function, making it difficult to define shared success
Impact on real-world decisions, such as guideline inclusion or payer adoption, is rarely measured
Incentives remain misaligned, reducing collaboration across teams
In my experience for the past 10+ years in Pharma Evidence Planning and Asset Strategy, Evidence planning siloes and Metric/KPI siloes are systemic challenges spanning teams and companies. The challenges and best practices warrant industry-wide collaboration, to support:
Standardizing planning stages and roles across functions
Developing shared metrics/KPIs that measure evidence impact
Establishing governance models with appropriate technology that enable true integrated evidence planning
If you are interested in contributing to this effort, please stay tuned for follow-up blogs and get in touch through our LinkedIn page!
Our industry’s Integrated Evidence Planning process must evolve, where Arysana’s ATLAS is redefining how teams plan for key evidence needs to meet the ever-changing competitive landscape.
References:
Olson, M. S. (2018). Developing an integrated strategy for evidence generation. Journal of Comparative Effectiveness Research, 7(1), 5–9. doi:10.2217/cer-2017-0073
https://pubmed.ncbi.nlm.nih.gov/29053021/BCG's IEP 2.0
https://www.bcg.com/publications/2023/the-future-of-integrated-evidence-planning-in-biopharmaGrueger, J., Andre, N., & Vaidyanathan, S. (2023, April 27). The future of integrated evidence planning in biopharma. Boston Consulting Group.
https://www.bcg.com/publications/2023/future-of-integrated-evidence-planning-in-biopharmaCapkun, G., & Olson, M. S. (2025). Integrated evidence planning for enhancing patient care: Harnessing the power of real-world evidence. Clinical Pharmacology & Therapeutics, 117(5), 1179–1181. https://doi.org/10.1002/cpt.3632
Turok, A., Whittam, A., Holloway, N., & Lakhmani, R. (2025, April 15). Evidence to action: Best practices for executing an integrated evidence plan. ZS Associates.
https://www.zs.com/insights/best-practices-integrated-evidence-planning-and-generationMisra, Y., Garner, D., Bandy, S., & Pham, S. (2025, April). HEOR: From proving product value to proving its own worth. Pharmaceutical Executive, 45(3). AESARA Inc.
https://www.pharmexec.com/view/heor-proving-product-value-proving-own-worthSlejko, J. F., Basu, A., & Sullivan, S. D. (2018). Returns to scientific publications for pharmaceutical products in the United States. Health Economics, 27, 282–293.
https://doi.org/10.1002/hec.3546DiMasi, J. A., Olson, M. S., Smith, Z., Getz, K. A., & Capkun, G. (2025). Assessing the value of integrated evidence approaches in drug development. Therapeutic Innovation & Regulatory Science, 59, 808–816.
https://www.bcg.com/publications/2023/future-of-integrated-evidence-planning-in-biopharmaISPOR. (2025, September). Fit-for-Purpose RWD: An Integral Part of Evidence Planning [Webcast]. https://www.ispor.org
Medical Affairs Professional Society (MAPS). (2025). Strategic integrated evidence generation planning: Company and non-company sponsored research guidance document.
https://medicalaffairs.orgSundem, G. (Host), Howley, J., Chapman, A.-M., Venkatachalam, M., & Joe, W. (2025). Integrated evidence generation planning [Podcast episode]. In G. Sundem (Host), Elevate. Medical Affairs Professional Society. https://medicalaffairs.org
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Blog was further refined with AI after a first human draft
