Recent Scientific Data Challenges the Status Quo

Our most recent white paper presents detailed genomic, proteomic, and functional data on the Sinclair Nanopig™’s metabolism and immune systems. These findings validate this animal model as a valuable tool for regulatory pharmacology and drug safety, enhancing cross-species assessments and improving understanding of drug metabolism and potential toxicities.

The groundbreaking data also supports the use of the Sinclair Nanopig™ to reduce reliance on traditional non-rodent models in drug development.

Read it now!

Questions? Consult with one of our experts.

You may also be interested in the following resources:

• Webpage: Miniature Swine in Nonclinical Studies
• Scientific Article: A Changing Paradigm for Non-Rodent Species in Nonclinical Safety Studies
• Webinar: How to Select the Right Species for Your Toxicology Studies​​​​​

Four Preclinical Sites to Support Your Program

With four purpose-built preclinical facilities across the U.S., we conduct over 700 safety assessment studies annually in rodent and non-rodent species. Our small and large molecule solutions include pivotal toxicology, safety pharmacology, and PK/PD studies, with comprehensive bioanalytical services to ensure your IND submissions meet global regulatory requirements.

Our specialties include:

Therapeutic Indications

• ophthalmology
• dermatology
• CNS research

Therapeutic Products

• cell and gene therapy
• oligonucleotides
• monoclonal antibodies
• antibody-drug conjugates

Learn more about the specific capabilities provided at each of our preclinical facilities.

Questions on how we can support your drug development program? Consult with one of our experts.

Related resources that may interest you:

• Webpage: Comprehensive Preclinical Drug Development Solutions
• Scientific Article: Navigating the IND Submission Process
• Webinar: How to Select the Right Species for Your Nonclinical Program

In the complex and dynamic field of metabolic drug development, partnering with an accomplished contract research organization is essential.

Altasciences has over 25 years of experience in metabolic diseases and supports every stage of the development process, from the initial discovery phase and preclinical studies to clinical trials and beyond.

Here are a few highlights:

• The teams at our four preclinical sites are proficient in obesity and metabolic models, and both GLP and non-GLP studies in rodents, dogs, minipigs, and NHPs.
• Our clinical teams have completed over 50 early-stage trials involving anti-diabetic and hypoglycemic agents, such as insulin, GLP-1, SGLT-2, and DPP-4, with 75 type I and type II diabetic patients enrolled in a single-center trial over four weeks.
• Our clinical database includes over 400,000 participants to more quickly qualify for inclusion/exclusion criteria based on pre-existing conditions, demographics, medication use, and BMI.
• Our scientists have developed bioanalytical assays for exenatide, glucagon, insulin glargine (M1, M2), insulin aspart, and metformin.
• We can develop additional assays tailored to your program.
• We’ve conducted numerous pharmacodynamics and immunogenicity assessments, including high-glycemic load challenge/tolerance tests, glucose clamps, insulin-induced hypoglycemic events in type 1 diabetes, and anti-drug antibody evaluations.
• We support data management both at our clinics and at external sites.
• Our pharmacokinetic, pharmacodynamic, and statistical experts support the analysis of drug concentration, biomarker, subjective measure, and immunogenicity data.
• Our medical writers and scientists have designed thousands of studies and are accustomed to preparing clinical protocols and high-quality reports.

Ready to get started? Speak with one of our experts.

You may also be interested in the following resources:

• Webpage: Metabolism and Endocrinology
• The Altascientist: The Many Faces of Metabolic Disorders
• Case Study: Concomitant Administration of Multiple Doses of Cagrilintide With Semaglutide 2·4 mg for Weight Management

Timing is Everything

Early collaboration with an experienced CDMO is crucial in drug development to mitigate manufacturing risks and ensure the efficient formulation of your API for preclinical and clinical testing.

For over 25 years, we’ve been providing manufacturing and analytical testing services for solid and liquid dosage forms in most therapeutic areas.

You benefit from:

• optimized processes
• insights into scaling production to reduce costs
• assured regulatory compliance
• accelerated timelines

What's more, our manufacturing site is strategically located near our preclinical and clinical facilities, for seamless transitions from one phase to the next.

Contact us today to discuss the next stage of your drug development journey.

You may also be interested in:

• Infographic: Choosing the Optimal Dosage Form for Your Molecule
• Webinar: Overcoming the Challenges of Manufacturing for Clinical Trials
• eBook: Achieving Optimal Formulation for Preclinical Testing

In this webinar, we dive into the scientific rationale driving species selection and how it can impact your study designs. We also focus on how in vitro species comparison studies can help determine the right species for your in vivo programs.

START WATCHING!

Deciding which animal model to utilize for your preclinical program is not always obvious. Speak with one of our experts who can help identify the appropriate species to generate the most relevant safety data needed to progress your program to Phase I clinical trials.

​​Related resources that may interest you:

• eBook: Navigating the IND Submission Process
• Scientific Poster: Best Practices to Reduce the Number of Animals Used in Toxicology Studies
• Webpage: Comprehensive Preclinical Research Services