Ophthalmic medications have a particular set of challenges that can impact their speedy and successful path to market. From prototype formulation through preclinical testing, early-phase clinical and manufacturing and development, ophthalmic drug development presents with specific and unique complexities. It is best to entrust drug development to a partner with regulatory knowledge, technical expertise, and a thorough understanding of the market in this growing therapeutic area. From current reality to future trends, being at the forefront of ophthalmic drug development delivers tangible benefits to sponsors.

In Issue 27 of The Altascientist, we dive into all areas of ophthalmic drug development, including: 

• Prototype development, formulation, and manufacturing
• Preparing for first-in-human studies
• Species and strain selection parameters
• Routes of administration
• Specialized ocular assessments and equipment
• bioanalysis
• Phase I clinical research
• Phase II to commercialization

Three case studies are also included!

The Clinical Data Interchange Standards Consortium (CDISC) is a worldwide organization for data standardization, ensuring that drug research data delivers the maximum value for sponsors, regulatory agencies, and patients. Data that is accessible, compatible, comparable across regions, and reusable for meta-analysis or reanalysis, serves to improve our understanding of human therapeutics by providing meaningful, efficient research data for the entire global drug research community. Implementing standards to collect, structure, and analyze data makes it easier to aggregate information and take advantage of big data.

In Issue 26 of The Altascientist: 

• Introduction to standardization and its benefits
• Client considerations for nonclinical and clinical data standardization Case Study — Realized Efficiency
• Case Study — Realized Efficiency
• Case Studies — Legacy Data Conversion
• The future of CDISC and data strategy

The structure of an early-phase drug development pathway is not set in stone. In fact, certain studies that are generally considered Phase I do not have to be conducted before Phase II commences. Conversely, some studies that are typically done in Phase II can be advanced into a Phase I combined protocol to have access to key data earlier in the program. Early Phase I studies have become increasingly complex in order to gather comprehensive data related to safety and drug pharmacology. Having early access to trial results and data helps inform decisions later in the development journey, can support funding opportunities, and helps solidify the overall plan around sound data.

In Issue 25 of The Altascientist: 

• Timing of early clinical pharmacology studies
• Phase I combined protocols
• Special populations
• Resource allocation
• Examples of flexible Phase I study timing

Conducting ethnobridging studies locally, during Phase I clinical trials, in the target population, can reduce drug development timelines by the number of years typically needed to complete clinical development in the target region, as compared with North America or Europe. A Phase I ethnobridging strategy allows you to recruit patients in “global” safety and efficacy trials (Phases II and III) without repeating Phase I development in that region and population.

In Issue 24 of The Altascientist: 

• The importance of Asian ethnobridging in clinical research
• Bridging requirements per the ICH E5 Guidance
• Strategic program considerations per the ICH E7 Guidance
• Accelerating Asian drug development
• Language requirements for global clinical trials
• Altasciences’ expertise and experience with ethnobridging