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10-03-2026
EU HTA Regulation: Early Signals, Open Questions, and Practical Choices for Biotechs
In this webinar we cover practical strategies for JCA readiness, from predicting your PICO scope and optimizing your pivotal trial, to understanding the implications for business development and out-licensing.
13-02-2026
Learning from Rejections: AI and the Insights Hidden in the FDA’s Complete Response Letters
This white paper examines the potential and limits of learning from published Complete Response Letters.
12-02-2026
Preparing for Machine-Assisted Review: What Regulators’ Use of Generative AI Means for Sponsors
Regulatory authorities are integrating generative AI into their internal review processes. This changes how submissions are examined, even though the underlying scientific and evidentiary expectations remain the same.
22-01-2026
When Patient Engagement Scales Faster Than PV Oversight
Olga Minkov, Senior Director Medical Operations at SSI Strategy, discusses how PV accountability remains constant as AI-enabled patient engagement expands across the organization.
17-12-2025
The Evidentiary Drift in Oncology: When Regulators Say Yes, and Payers Say Maybe
Regulatory approval and payer access in oncology are increasingly judged by different evidentiary standards. This paper explores how early approvals can create downstream challenges for reimbursement and access.
17-12-2025
Global Submissions Strategy: Aligning for Divergence in Oncology Drug Development
Global oncology submissions increasingly face divergent regulatory and HTA expectations. This paper examines how early evidence and dossier design choices shape the feasibility of aligned global submissions.
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Building Better Biotechs
