10:30 - 11:00 – The Pinnacle 21 Vision: Our Near- and Long-Term Roadmap
Erin Erginer, Senior Director of Product

A strategic look at the unified product roadmap across Pinnacle 21 and ryze. Erin will highlight recent and upcoming innovations, including a new Rules Editor for customizable validation, enhanced metadata management capabilities, support for mapping specifications to streamline dataset standardization, and a solution to standardize eCRF and study builds. The session will also cover improvements to data exchange, foundational platform enhancements, and the broader vision for an integrated ecosystem designed to accelerate submission readiness and data quality. See what we’ve accomplished since last year, what the next 12-18 months will bring, and where we want to go in the future.

11:00 - 11:30 - The Case for Standardizing Forms
Martin Johnston, Solutions Consultant

Traditional approaches to Electronic Data Capture in clinical trials are often inefficient, fragmented, and burdensome for both data management teams and downstream stakeholders in biostatistics and programming. Disconnected processes result in redundant work, inconsistent data structures, and bottlenecks in the clinical data pipeline. These inefficiencies introduce challenges for mapping and validating data, which can delay submission readiness and regulatory review.

Martin will examine the systemic pain points of existing data collection workflows, highlighting how ad hoc form design and lack of standardization amplify complexity across trial operations, and explore ways to leverage standardization to harmonize how trial data is captured, mapped, and transformed. By introducing greater uniformity and automation into the pipeline, organizations can reduce manual rework, improve data quality, and accelerate the path to regulatory acceptance.

11:30 - 12:00 - Higher Standards: Management and Oversight of Custom Standards, Change Requests, Versions, and Approvals
Gilbert Hunter, Senior Customer Success Manager

Managing study data standards is a critical responsibility for Data Standards professionals, yet many lack the tools to review, approve, and track changes to their organization-specific standards and terminologies. Without governance and traceability, inconsistencies can affect downstream compliance and submission readiness.

Gilbert will demonstrate how P21E empowers study teams to take ownership of their metadata through features such as branching, inheritance, and version control. Learn how to jumpstart your custom standards by inheriting from existing regulatory or other standards, adapt them to study-specific needs, and maintain transparent, traceable histories of all changes. Leverage the ability to create an organization-wide "library" of custom standards that can be shared and reused by other study teams—driving consistency, efficiency, and compliance across both current and future clinical trials.

10:30 - 11:00 Product Overview, Vision, and Roadmap
Fred Mahakian, Sr. Director Product, Phoenix Portfolio
This session offers a present- and forward-looking view of the Phoenix Platform, focusing on its long-term vision and strategic roadmap. Following an exploration of what's next in Phoenix 8.6, we’ll share how the product is being reimagined to meet emerging needs, modernize its foundation, and support future innovation—while staying true to its core strengths.

With decades of legacy behind it, Phoenix is entering a new phase of evolution. Join us to see where Phoenix is now, where it's headed, headed and how we’re preparing it for what’s next.

11:00 - 11:30 Phoenix Cloud Walkthrough
With growing study complexity, tight timelines, and a shortage of skilled personnel, research teams need tools that make workflows fast, flexible, and frictionless. Guided by your input, we’re answering the call. Phoenix Cloud integrates our AWS-hosted solutions for analysis and modeling with cloud-native modules for data management, publication-ready graphing, GenAI-powered reporting, and more.

Let our team give you the tour from data ingestion to report production!

11:30 - 12:00 Panel Discussion - Voices from the Field: Tackling Process Automation in PK/PD Analysis
Discover how your peers are combining technology and hard-won wisdom to bring speed and consistency to common analyses.

Ana Henry, Executive Director, Training & Certara University (moderator)
Dr. Fabian Gärtner, Team Lead PK/TK Evaluation and Data Management, Bioanalysis, Nuvisan GmbH
Maria Learoyd, Head of Clinical Pharmacokinetics, Clinical Pharmacology and Quantitative Pharmacology, AstraZeneca
Catarina Pintassilgo, Scientist, Biolanalytical Sciences - Translational Medicine, Immunocore

10:30 - 10:45 - Failure to Launch: The Hidden Cost of Poor Strategy

This session sets the stage by exploring why so many promising therapies never reach patients. With only ~40% of approved drugs recouping their development costs, the stakes are high, and the root cause is often strategic, not scientific. We’ll examine how early misalignment across scientific, regulatory, and commercial functions leads to costly inefficiencies and missed opportunities. Attendees will learn to identify these blind spots early and how integrating biosimulation, regulatory foresight, and a compelling business case improves both development outcomes and investor readiness. This session also highlights how data-driven development plans can build confidence with stakeholders and unlock critical funding at each stage of the journey.

Speaker: Fran Brown, PhD, Global Head Drug Development Science

10:45 - 12:00 - Getting the Right Clinical Candidate

Selecting the right clinical candidate is one of the most pivotal decisions in drug development. This session explores how model-informed translational strategies, especially Quantitative Systems Pharmacology (QSP), can be used to pressure-test the mechanism of action, predict downstream performance, and evaluate whether the candidate has the right attributes to succeed in the clinic. We’ll also discuss the probability of pharmacological success and how integrating scientific modeling with early development strategy helps avoid false starts, prioritize assets with the strongest potential, and set the foundation for an efficient and successful development trajectory.

Speakers:
Pablo Morentin Gutierrez, Director of Translational PK/PD, AstraZeneca
Piet van der Graaf, PharmD, PhD, Senior Vice President, Quantitative Systems Pharmacology
Arne van Schanke, PhD, Director, Early Development, Certara
Stefano Zamuner, Vice President and Head, Clinical Pharmacology Modelling & Simulation, GSK