WEBINAR EVENT
THURSDAY AUGUST 13, 2026
8AM PDT / 11AM EDT
Meet Lodestar™: your north star for regulatory submissions
For the first time, the entire submission process is defined, connected, and run inside one environment.
Lodestar™ is intelligent submission software that takes you from raw EDC data to FDA + EMA-ready, under one AI-assisted, auditable workflow.
Discovery has accelerated. Submission has not.
That changes now.
From database lock to eCTD assembly, the traditional path is a fragmented maze of tools, handoffs, and manual stitching, where issues surface late in the process, QC cycles drag on, and biometrics teams spend 80% of their time on mechanical work that should take minutes, not months. Lodestar™, the first-of-its-kind intelligent submission software, offers a different operating model.
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​For the first time, the process of the submission path has been defined and unified into 10 steps, run inside one AI-assisted, audit-trailed environment changing the game for sponsors and CROs when it comes to submission. No more bouncing between systems, no more xyz. Lodestar™, is not a faster version of the old process. It’s one that didn’t exist before.
Three perspectives, one conversation.
This session brings together three vantage points: the team that built Lodestar™, a sponsor applying it to a live study, and an independent expert who sees these challenges play out across the industry.
Michael Mendoza
SVP, Biometrics and Data Science, Koneksa
Mike will walk through how Lodestarâ„¢ connects the full submission path, what "AI-assisted, human-approved by design" looks like in practice, and where AI takes over the mechanical work while scientific judgment, protocol logic, and regulatory strategy stay with your team.
Kim Guedes
VP Clinical Operations, Intensity Therapeutics
Kim chose to run an active study on Lodestarâ„¢. She will speak to why a sponsor would put a real program on a new operating model, what it changes for clinical and biometrics teams working under submission pressure, and what she expects it to mean for her timelines.
Shari Medendorp
Founder & Principal, SVM Life Sciences
As an independent advisor to biotech, investors, and CRO teams, Shari brings a third-party read on whether these problems are universal. She will validate the pain points, such as fragmentation, late-stage surprises, and manual stitching, that sponsors and CROs live with today, and what a connected workflow would actually solve.
What You Will Take Away:
Why a connected workflow, not a faster version of the old one, is the real shift.
An independent expert's read on the pain points sponsors and CROs have absorbed for years.
What "AI-assisted, human-approved by design" means in a regulated workflow, with validation running continuously instead of only at the end.
A sponsor's honest reasoning for adopting a new model under real submission pressure.
The real-word impact: 80% reduction in programming hours, 65% lower biometrics costs, and QC cycles that run 16X faster.
More About the Speakers
Michael Mendoza
Senior Vice President, Biometrics and Data Science, Koneksa
Michael Mendoza, Senior Vice President, Biometrics and Data Science, Koneksa
Mike leads Koneksa's biometrics and data-driven drug development strategy, advancing scalable, technology-enabled clinical research. With more than 28 years of experience across pharmaceutical, biotech, and CRO organizations, he brings hands-on expertise spanning EDC, CTMS, RTSM, eCOA, clinical data lakes, centralized monitoring, and AI-enabled analytics, the full clinical data lifecycle from study startup through regulatory submission. As Koneksa's SME and a contributor to Lodestar™, Michael has built and led global, high-performing teams known for delivering inspection-ready results and aligning emerging technology with the evolving needs of clinical research.
Kimberly A. Guedes
Vice President, Clinical Operations, Intensity Therapeutics
Kim brings 30 years across clinical development and operations, spanning pre-clinical, Phase I–IV, and translational research, at sponsors and CROs including Yale University School of Medicine, KeifeRx, Centrexion Therapeutics, Merck, Bristol Myers Squibb, and Mitsubishi. At Intensity Therapeutics she leads cross-functional clinical teams across oncology rare-disease trials, building oversight frameworks for a global Phase III program and working directly with executive leadership on study design and strategy. A recognized SME in complex global regulatory, clinical development, and operations, she has delivered sequential Phase III trials ahead of schedule, and is the sponsor partner running a live study on Lodestar™.
Shari Medendorp,
Founder & Principal, SVM Life Sciences
Shari is a biometrics leader with nearly four decades in life-science drug development. As Founder and Principal of SVM Life Sciences, she advises biotech companies, investors, and CROs on product, strategic, and organizational development, giving her a clear, cross-industry view of the challenges teams face from clinical development through regulatory submission. Previously she served as President and EVP of Premier Consulting leading a team of regulatory and development experts partnering with emerging companies. She has been an executive Biometrics leader across multiple international organizations, leading biostatistics, statistical programming, data management, medical writing, and interactive response technology designing and delivering numerous successful programs and NDAs. She began her career as a lead biostatistician at the Cleveland Clinic and has co-authored some 70+ peer-reviewed publications, including publications in JAMA and the Annals of Neurology.
