Preclinical Research
A Professional Perspective on the FDA Roadmap Announcement on “Phasing Out” Animal Testing Requirements
The FDA’s Roadmap to Reducing Animal Testing in Preclinical Safety Studies announcement in April 2025 for “phasing out” animal testing requirements has been in process for several years.
Altasciences Chosen by Steel Therapeutics to Support the Launch of Pivotal Toxicology Study for Fizurex™
Laval, Québec, August 21, 2025— Altasciences is pleased to have been chosen by Steel Therapeutics, Inc. (“Steel”), to initiate a pivotal toxicology study for Fizurex™, a novel topical therapy for the treatment of anal fissures.
The GLP-compliant study is currently being conducted at Altasciences’ preclinical facility. It marks a key milestone in Steel’s regulatory development, as the company prepares for an Investigational New Drug (IND) application in early 2026.
“We’re proud to be supporting Steel Therapeutics at this key stage of their development journey,” said Steve Mason, Co-COO at Altasciences. “Our teams are aligned in their commitment to accelerate the delivery of patient-centered therapies. The initiation of this study is another example of how early collaboration and scientific rigor can bring important treatments closer to market.”
Fizurex™, a patent-pending compounded wipe, has seen widespread use in clinical practice and is now progressing through the formal regulatory pathway to reach broader patient populations under FDA oversight. Steel engaged Altasciences due to their deep expertise in preclinical safety evaluation and proven ability to execute with speed and precision.
“Working with Altasciences allows us to maintain the highest standards of quality as we move Fizurex™ into its next phase of development,” said Matt Stahl, CEO and Founder of Steel Therapeutics. “This study represents a major step forward for our company and for the patients who stand to benefit from more consistent, scalable access to this treatment.”
Altasciences’ integrated, collaborative approach to drug development enables companies like Steel to move efficiently from discovery through to clinical trials, all under one organizational umbrella.
“We look forward to continuing our partnership with Steel Therapeutics as they advance their portfolio of innovative, patient-focused therapies,” added Mason.
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. To learn more about Altasciences, visit altasciences.com.
Julie-Ann Cabana
Altasciences
media@altasciences.com
Altasciences and VoxCell BioInnovation Announce Strategic Collaboration to Advance Preclinical Drug Development
Laval, QC, Canada, July 31, 2025 — Altasciences, a fully integrated drug development solution company, and VoxCell BioInnovation (“VoxCell”), a leader in 3D bioprinting and human-like tissue modeling, are pleased to announce a strategic collaboration aimed at enhancing preclinical research and accelerating the path from discovery to clinical trials.
This partnership combines Altasciences’ comprehensive early-phase drug development capabilities with VoxCell’s cutting-edge 3D tissue technology to offer a more predictive and human-relevant preclinical testing environment. By integrating VoxCell’s high-resolution 3D bioprinted tissue platforms into Altasciences’ discovery and preclinical services, both companies aim to reduce R&D timelines and increase the success rate of investigational therapies.
“We’re proud to partner with VoxCell BioInnovation to bring next-generation tissue modeling into the early stages of drug development,” said Steve Mason, Co-Chief Operating Officer at Altasciences. “This collaboration aligns with our commitment to the 3Rs as well as to innovative, efficient solutions that improve data quality and accelerate decisions for our clients.”
VoxCell’s proprietary bioprinted tissues are engineered to closely mimic the complexity of human tumors and other biological structures, offering drug developers an advanced platform for evaluating efficacy, safety, and toxicity—before moving into animal or human studies.
“Our mission has always been to make drug screening more human-relevant and predictive,” said Karolina Valente, CEO of VoxCell BioInnovation. “Altasciences shares this forward-thinking approach, and we’re excited to work together to support pharmaceutical and biotech companies in making faster, more informed decisions.”
The collaboration will focus initially on drug screening for ocular indications, with plans to expand into additional therapeutic areas and applications.
This partnership represents a shared vision: to transform early stage research through innovation, integration, and smarter science—delivering better outcomes for patients worldwide.
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. To learn more about Altasciences, visit altasciences.com.
Julie-Ann Cabana
Altasciences
jcabana@altasciences.com
ISSUE NO. 45 — Discovery Studies: An Agile Approach to Early Data for Quicker Decisions
The early identification of toxicity, and flexibility to explore parameters and characteristics of drug candidates in vivo via early discovery non-GLP studies, allow for improved drug development strategy and faster go/no-go decisions. This data from animal models, and particularly nonhuman primates (NHPs) where their genetic, immunologic, and physiologic similarities to humans make them the model of choice, is an important part of informing decisions about candidate molecules.
Access to early discovery studies’ data accelerates the process of refining candidate molecules and identifying promising therapeutic targets, novel delivery methods, and pharmacodynamic markers.
In Issue 45 of The Altascientist, we explore:
- the characteristics and advantages of non-GLP discovery studies
- emerging trends in drug delivery methods two early-stage biodistribution case studies
Altasciences at ASGCT 2025: An Open Forum for All Things Gene and Cell Therapy | By Kaylyn Koenig
I recently returned from attending the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting. This was my first conference since joining Altasciences, and I was excited to attend with some of my esteemed colleagues, Nobert Makori (Vice President of Toxicology), Steve Mason (Co-COO), and members of the Business Development team, Derek Storey, Gretchen Green, Todd Hartz, and Mike Zamora.
Altasciences at ARVO 2025: An Eye on the Future of Ophthalmic Drug Development by Gretchen Green
Altasciences recently attended and exhibited at the 2025 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, held at the Salt Palace Convention Center against the stunning backdrop of downtown Salt Lake City, Utah—arguably one of the most scenic U.S. conference locations.
Case Study: Two Examples of Successful Automation Integration at Altasciences for Pharmacokinetic Studies
By Martin Rougée, Optimization Scientist, Bioanalytical Operations
Automation offers several advantages to any industry. For a contract research organization (CRO), it can play an integral role in increasing the quality and speed of drug development while reducing costs, repetitive manual tasks, and human error. For biotechnology and pharmaceutical companies, automation can decrease their drug-to-market development time and remain financially competitive in an evolving market.
Highlights From the 17th Minipig Research Forum, by Shanté Jackson
I recently had the chance to attend the 17th Minipig Research Forum (MRF) in Amsterdam—and what an experience! This was my first time attending the forum, and visiting the Netherlands!
Consultant’s Corner—Reflections from a Study Monitor and Director: A Career in Toxicology, by Bill Brock
Some might say a reflective piece like this could come across as sounding “preachy”. Maybe it is. But it is reflective of a long and rewarding career built on the belief that we as scientists need to give back to the field of toxicology, supporting the growth of future leaders.
Highlights From the 2025 Society of Toxicology 64th Annual Meeting With Dr. Marianna Bacellar-Galdino, DVM, MSc, PhD
I had a fantastic time connecting with colleagues, clients, and peers at the Society of Toxicology (SOT) 64th Annual Meeting in Orlando, Florida. As my first SOT experience, I truly enjoyed the vibrant, enthusiastic atmosphere.