Medhealth Outlook: Altasciences - Drug Development That is Faster by Design
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.
IND and CTA Submission Principles and Timelines
Pragmatic Approaches to Assessing Physical Withdrawal in Clinical Trials
In drug research and development, understanding how a therapy behaves not only during treatment, but also after discontinuation, is essential to building a complete safety and efficacy profile. For central nervous system (CNS)-active therapies in particular, physical dependence and withdrawal can significantly influence both clinical outcomes and real-world use.
ISSUE NO. 49 — Nonclinical Toxicology Studies
Transitioning from drug discovery to clinical trials depends on generating reliable, high-quality data, especially during IND-enabling toxicity studies. This step requires four key elements: a strong regulatory strategy aligned with GLP standards, careful selection of appropriate species and dosing levels, integrated analytical and bioanalytical methods to assess safety and pharmacokinetics, and robust CMC processes to ensure the drug is stable, pure, and ready for clinical use.
In Issue 49 of The Altascientist, we explore:
- Clarity on non-GLP vs. GLP studies and how to use each to de-risk your program and accelerate timelines
- A checklist to determine if your molecule is truly prepared for IND/CTA submission
- Key study design insights, from species and dose selection to bioanalytical and CMC alignment
- A real-world case study showing how an innovative study design overcame known pharmacological challenges and kept the program on track
Pre-Ind Toxicity Study Readiness
Before initiating toxicity study planning, a comprehensive review of existing data is essential to optimize study design and minimize regulatory hurdles. Leveraging cross-product benchmarking from established drug classes provides critical insights into previously observed safety signals, allowing for more targeted assessments.
Regulatory Pathways by Region―A Comparative Table
ISSUE NO. 48 — The Evolving Landscape of Metabolic Research: From GLP-1 to Multifunctional Agonist Therapy
Approaching the topic from the perspective of an integrated drug development organization (DDO: CRO/CDMO) with decades of relevant experience, this article reviews the current status of the GLP-1 market and explores where we anticipate the metabolic research field will expand in the coming years.
In Issue 48 of The Altascientist, we explore:
- The evolution of GLP-1 therapies to multi-agonist incretin treatments
- The status of the GLP-1 market and where we see the field expanding in the coming years
- A case study demonstrating how Altasciences accelerated a recent early-phase GLP-1 program by six months compared to industry standard timelines.
The Evolution of Glp-1 Therapies to Multi-Agonist Incretin Treatments
The development of incretin-based therapies stemmed from the discovery of the “incretin effect” in the 1960s. The incretin effect was the discovery that oral glucose ingestion triggers significantly higher insulin secretion than intravenous glucose. This process, mediated by intestinal hormones—GIP (isolated in the 1970s) and GLP-1 (characterized in the 1980s)—enhances insulin secretion in a glucose-dependent manner.
Hybridization LC-MS/MS: A Selective Solution for PMO and PPMO Bioanalysis
Shaping the Future of Microsampling at Altasciences by Jeff Plomley
In recent years, healthcare has been undergoing a subtle yet profound transformation.
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