Preclinical Research
Altasciences and Evidence Matters Advance AI-Driven Drug Development With Nonclinical Automation Breakthrough
Laval, Québec, July 7, 2026 — Altasciences, a fully integrated early-phase drug development organization, and Evidence Matters, a pioneer in clinical trial data science, are pleased to announce a successful proof-of-concept (POC) of RegulatoryFlow (“RegFlow”), following the announcement of the companies’ strategic collaboration in August 2025. The POC demonstrated the extension of AI-driven efficiencies from clinical reporting into nonclinical workflows, marking a significant step forward in accelerating drug development timelines.
Building on proven results in clinical reporting, where the collaboration has achieved up to first-draft clinical study reports (CSRs), the teams have now successfully applied similar AI capabilities to nonclinical data through high-quality parsing of raw and SEND datasets in a proof-of-concept. This advancement aligns with the Altasciences Acceleration Platform, designed to fast-track drug development across the early-phase development continuum.
“This milestone reflects the power of integrated thinking in drug development,” said Marie-Hélène Raigneau, CEO of Altasciences. “By extending AI-driven efficiencies from clinical into nonclinical workflows, we are helping sponsors move from first safety assessments to clinical proof-of-concept, faster, accelerating timelines while maintaining scientific integrity.”
The POC revealed strong initial results, including accurate parsing of datasets and the potential to expedite and streamline nonclinical reporting workflows. This represents a first-of-its-kind AI bridge between nonclinical and clinical phases, enabling more efficient development pathways and freeing internal resources to focus on higher-value scientific work.
“The current version of RegFlow is already capable of generating approximately one-third of a typical nonclinical report with high fidelity,” noted Dr. Ofer Avital, MD, Founder and Director of Evidence Matters. “We are ready to deliver the results sections as well as a focused laboratory sciences subsection as the next key milestones.”
Recent platform enhancements, including the latest software release, continue to improve performance in clinical reporting, with early feedback indicating enhanced data mapping and usability. The collaboration continues to evolve to expedite drug development through AI.
“Together with Altasciences, we are redefining what’s possible in integrated development,” said Dr. Avital. “What began as a transformation in clinical reporting is now evolving into a broader framework for accelerating the entire early-phase journey. We believe this approach has the potential to set a new industry standard.”
About Altasciences
Altasciences is an integrated drug development organization offering pharmaceutical and biotechnology companies a proven, flexible approach to nonclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 30 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include nonclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, research support, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements.
Julie-Ann Cabana
Altasciences
media@altasciences.com
Altasciences Supports Key Development Milestone for Steel Therapeutics’ Lead Therapeutic Candidate, Fizurex™
LAVAL, Québec – June 30, 2026, Altasciences, a leading drug development organization, today announced a significant milestone in the development of Steel Therapeutics, Inc.’s pivotal toxicology study for its lead product candidate, Fizurex™, for the treatment of anal fissures. The successful completion of the study plays a significant role in the advancement of Fizurex™ toward first-in-human trials.
The GLP-compliant study demonstrated a favorable safety profile, which has advanced Steel Therapeutics' plans to submit an Investigational New Drug (IND) application for Fizurex™ to the FDA in Q3 2026.
Fizurex™, a patent-pending, single-use topical wipe, was designed to provide a standardized, accessible treatment option for a painful and often undertreated medical condition. The product builds on years of use through compounding pharmacy prescriptions and is now advancing toward clinical development and regulatory review.
"We are proud to have supported Steel Therapeutics with the generation of the high-quality safety data needed to advance Fizurex™ toward IND submission and first-in-human evaluation," said Steve Mason, Co-Chief Operating Officer at Altasciences. "The successful completion of this pivotal toxicology study demonstrates the value of close collaboration between our scientific teams and highlights Steel Therapeutics' commitment to advancing innovative therapies that address unmet patient needs."
The study was conducted at Altasciences' GLP-compliant nonclinical research facility in Columbia, MO, and leveraged the company's expertise in toxicology, regulatory-supportive safety assessments, and integrated drug development services. The teams at Altasciences and Steel Therapeutics worked closely together to efficiently execute the program and maintain momentum toward key development milestones.
"This milestone brings us one step closer to bringing Fizurex™ to patients," said Matt Stahl, CEO and Founder of Steel Therapeutics. "We thank the Altasciences team for their dedication, expert execution, and scientific acumen in helping us reach this important achievement. This progress positions us well as we prepare for the next phase of development."
Following IND submission, Steel Therapeutics plans to initiate first-in-human clinical studies in 2027.
"Our goal is to help sponsors move promising therapies through development with confidence, efficiency, and speed," added Mason. "We congratulate the Steel Therapeutics team on reaching this important achievement and look forward to seeing the continued progress of the Fizurex™ program."
About Altasciences
Altasciences is a drug development solutions company helping pharmaceutical and biotechnology sponsors quickly move their programs from lead candidate selection to proof-of-concept. Through a flexible, customized approach, Altasciences partners with sponsors to accelerate development timelines, support informed decision-making, and achieve critical value inflection milestones faster. For more than 30 years, Altasciences has provided the expertise, resources, and strategic support needed to advance early-phase drug development efficiently and confidently. Altasciences’ solutions include nonclinical safety testing, clinical pharmacology and proof-of-concept, formulation, manufacturing, and analytical services, bioanalysis, program management, research support, medical writing, biostatistics, clinical monitoring, and data management, all tailored to specific sponsor requirements. To learn more, visit altasciences.com.
Julie-Ann Cabana
Altasciences
media@altasciences.com
Case Study: How We Helped a Sponsor Go From Safety Assessment to Proof-Of-Concept in 22 Months
For sponsors advancing novel therapeutics, development timelines directly influence strategic milestones, investor confidence, and how quickly programs can progress toward clinical validation. Acceleration impacts not only the pace of development, but also how early key decisions can be made, and how much flexibility remains as programs advance.
Regulatory Pathways by Region―A Comparative Table
Altasciences and Certara Announce Strategic Partnership to Accelerate Early Drug Development
LAVAL, Québec, and RADNOR, PA. — May 7, 2026 — Altasciences, a fully integrated drug development solution company, and Certara, a global leader in model-informed drug development (MIDD), today announced a strategic partnership to accelerate early-phase development programs.
Fewer than half of preclinical drug candidates successfully reach first-in-human trials. Failures are driven by toxicity, poor pharmacokinetics, lack of efficacy, and challenges translating results from animals to humans. Many of these risks can be mitigated through a fully integrated model-informed drug development approach.
Building on Altasciences’ Acceleration Platform, the integration of Certara’s strategic drug development services and biosimulation technology enables sponsors to establish proof of mechanism earlier, design more efficient studies, and make informed go/no-go decisions with greater confidence. By embedding modeling insights and digital workflows directly into development execution, study designs are optimized, dosing strategies are refined, and programs are more seamlessly integrated across nonclinical, clinical, bioanalytical, and manufacturing services.
“At Altasciences, we already help sponsors move from first safety assessment to proof of concept with speed and precision,” said Marie-Hélène Raigneau, CEO of Altasciences. “By embedding Certara’s modeling capabilities into our platform, we can further inform critical decisions earlier and with greater confidence. This collaboration is about reducing uncertainty at the moments that matter most.”
The partnership comes at an opportune time as the FDA continues to advance new guidance supporting more adaptive, data-driven, and real-time drug development approaches, capabilities that integrated MIDD execution models are well positioned to deliver.
“This partnership unlocks new opportunities to improve early development decisions for biotech sponsors and their investors,” said Jon Resnick, CEO of Certara. “By embedding modeling and simulation directly into execution, we enable faster, more informed decision-making that ultimately benefits patients.”
Together, Altasciences and Certara are advancing a model-first, fully integrated, and resource-efficient approach to early drug development that accelerates the path to proof of concept for biotech innovators, investors, and pharmaceutical companies across the globe.
About Altasciences
Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 30 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, research support, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.
Julie-Ann Cabana
Altasciences
media@altasciences.com
JAK1-siRNA Treatment for Inflammatory Skin Diseases: Real-World Nonclinical Insights
Findings shared here were originally presented in a poster session at ACT 2025
Navigating to the Clinic: Key Aspects of Translational Pharmacology, By Bruce Morimoto
Drug development is not for the faint of heart; a twist on the Hunger Games saying, “May the odds be (n)ever in your favor,” might adequately characterizes the challenge. As scientists, however, we manage these inherent risks by establishing best practices and learning from our collective successes and failures, as well as. In this field, experience truly matters.
First-in-Human-Enabling Toxicology Programs: Common Misconceptions by Grace M. Furman
Nomination of a clinical candidate and subsequent conduct of toxicology studies to support a first-in-human (FIH) clinical trial is an exciting milestone for sponsors! While many are highly experienced drug discovery professionals, some may have limited, or even no experience, in early clinical development, including the critical toxicology studies required to successfully support a FIH trial.