Eye-Opening Insights on Ophthalmic Drug Development
Our Commitment to Better Vision
and Eye Health
With a deep understanding of the unique challenges presented by ocular drug development, Altasciences combines cutting-edge research, advanced technological platforms, and comprehensive regulatory expertise to support your program from lead candidate selection to market.
Our end-to-end ophthalmic expertise includes:
• 50 years of experience with all ophthalmic therapeutic indications—no study ever rejected for reasons of design, conduct, or data integrity;
• all ophthalmic routes of administration and specialized techniques;
• many different types of formulations, including nanoparticles and ocular implants;
• ocular studies performed in multiple species (rodent and non-rodent);
• more than 40 ophthalmology clinical trials conducted;
• on-site Diplomate, American College of Veterinary Ophthalmologists (DACVO);
• significant investment in specialized equipment like optical coherence tomography (OCT) and RetCam; and
• state-of-the-art bioanalytical instrumentation and assay platforms.
Ready to dive deeper? Explore our full range of integrated CRO/CDMO ophthalmic drug development services and how they can accelerate your timeline by up to 40%.
Do you have an ocular drug compound in your development pipeline?
Speak with one of our experts about your study and let’s get you started!
Related resources that may interest you:
Webinar: Gene and Cell Therapy―Enhanced CNS and Ocular Delivery in NHPs
Fact Sheet: Our Comprehensive Ophthalmic Drug Development Services
Scientific Journal: The Complexities of Early Phase Ophthalmic Drug Development
Unveiling the Layers of Nonclinical Dermal Studies
In this issue of The Altascientist, we review the specific nonclinical requirements to move a dermal program forward to Phase I clinical trials and how to minimize inherent challenges―a case study using the minipig model is included.
Altasciences has decades of experience supporting dermal drug development programs, from initial efficacy to clinical proof of concept. We boast one of North America's largest herds of miniature swine, including the most popular breeds of minipigs for dermal studies.
Speak with one of our experts today and let's get your program underway.
Related resources that may interest you:
• Webpage: Preclinical Research Services
• eBook: Scratching the Surface of Nonclinical Dermal Testing
• Webinar: Downsized Miniature Swine―A New Spin on the Oldest Model
Planning a First-In-Human Clinical Trial?
Unique FIH Solutions
for Small and Large Molecules
Advancing your molecule to first-in-human (FIH) clinical trials is a major milestone. Our FIH solution provides a customized approach that is safe, and delivers quality data with speed and ease.
This eBook provides an overview of how our unique process can facilitate your early-phase clinical program:
• small molecule manufacturing experts quickly formulate your drug product and deliver it to the clinical site, ready for dosing;
• coordinated processes between our clinic and our bioanalytical labs;
• timed interim sample analysis for proactive dose escalation decisions and rapid turnaround of PK/PD analysis between cohorts;
• transparent communication between our teams and locations, and strict attention to early-phase timelines; and
• a database of over 400,000 normal healthy volunteers and strict safety protocols.
Access the eBook here to learn more.
Speak with one of our experts.
You may also be interested in the following:
Webpages:
• Phase I Clinical Trial Units
• First-in-Human Trial Capabilities
Scientific Journal:
• The Advantages of Conducting Early Phase Clinical Research in Canada
Five Promising Treatment Areas in Early-Phase Drug Development in 2024
Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues. In this blog article, we review some of these areas of investigation where Altasciences has robust expertise and solution offerings.
Inside The Altascientist: The Benefits of PCR for Your Gene Therapy Programs
The gene therapy landscape continues to accelerate in preclinical and clinical research, with programs constantly in development for targeted, personalized medicines. The goal is to safely incorporate genetic alterations to restore and repair the proteins of missing and/or faulty genes.
Collaborating for Success Tips for Improving Partnerships Between QA and Clinical Operations at Your Site
Risk-Based Auditing and its Application to GLP Computerized System Validation Procedures
Insights for Optimizing Your Preclinical Formulation and Drug Product Manufacture
Setting the Stage for Success
In this issue of The Altascientist, we explore critical considerations for formulation development and manufacturing for preclinical testing.
You'll discover strategies employed by our experts to support your projects, as well as a case study.
Topics covered include:
• e-formulation studies
• biopharmaceutical assessments
• steps in preclinical drug product manufacturing
• quality control procedures
• regulatory aspects
• risk management
Ready to discuss your pharmaceutical formulation and manufacturing needs? Send us a message.
Related resources that may interest you:
• Webpage: Comprehensive Drug Development, Manufacturing, and Analytical Testing Services
• Podcast: Key Considerations When Formulating APIs for Preclinical Testing
• eBook: Maximizing Formulations for First-in-Human Trials
Looking to Reshore Your Drug Development Program?
Addressing the Biosecurity Act—A Network of Sites That Works for You
As geopolitical uncertainties still linger following the report of the Biosecurity Act, numerous pharmaceutical and biotech firms are prioritizing stability by reshoring their R&D outsourcing. Altasciences, with our nine facilities spread across the United States and Canada, is ideally positioned to meet your requirements.
Our network includes:
• preclinical facilities in Seattle, Sacramento, Columbia (MO), and Scranton;
• clinical units in Los Angeles, Kansas City, and Montréal;
• bioanalytical laboratories in Seattle, Columbia (MO), and Laval; and
• manufacturing facility in Philadelphia.
Discover more about each of our strategically located sites and how they can support your drug development programs.
Related resources that may interest you:
• Webpage: Altasciences’ Early-Phase Drug Development Services
• eBook: Regulatory Comparisons for Starting FIH Clinical Trials
• eBook: Advantages of Conducting Clinical Trials in Canada