Helping You Navigate the Complexities of Ophthalmic Drug Development

Ophthalmic drug development comes with a unique set of challenges and complexities. To maximize your chance of success, it is best to rely on a drug development partner with regulatory knowledge, scientific and technical expertise, and a thorough understanding of the market in this growing therapeutic area.

Altasciences’ clients benefit from working with a single CRO/CDMO partner, from prototype formulation through preclinical testing, to early phase clinical trials, and manufacturing. This could mean up to 40% in both time and cost savings.

Learn about the key considerations and critical steps in each phase of ophthalmic drug development, including case studies, in this issue of The Altascientist. 

Have questions? Speak with one of our experts.

You might also be interested in:

• Webpage: Full-Service Drug Development Solutions
• Scientific Article: Terminal Sterilization of Pharmaceutical Products

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.

Phase I and II Combined Protocols Can Give You Earlier Access to Important Data—Here’s How

Have you considered combining Phase I and II protocols to advance certain analyses? Think DDI, QT assessment, food, age, or gender affect, or cognitive or dependence evaluation. With earlier access to this highly relevant data, you have the power to make more informed decisions as you progress your drug through development, and possibly obtain a waiver for certain later-phase studies.

Our experts in protocol development are ready to design your ideal program, giving you the earliest, most complete understanding of your developmental product.

Read The Altascientist for a more complete discussion on combined protocols, including two scenarios.

DOWNLOAD your copy, or listen to the AUDIOBOOK.

Have five more minutes? Browse these webpages for more important information:

• First-in-Human Clinical Trials
• Early Phase Drug Development Solutions
• Clinical Development Solutions

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO service

Watch the Ethnobridging Webinar On‑Demand

Altasciences recently released a webinar on ethnobridging studies in which Dr. Affrime demonstrates how ethnobridging can help minimize time lags in development of drugs destined for Asian markets. Included are detailed case studies on how to include ethnobridging in your early clinical development plans to safely speed up worldwide regulatory approval.

Watch the Webinar On-Demand

To learn how Altasciences can assist you with your clinical research program,  contact us today!​​​​​​

You may also be interested in the following webpages:

• Ethnobridging Clinical Trials
• Early Clinical Development Services — Phase I/II

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services.

Planning Your First In Human Trial

Check out this issue of The Altascientist for your roadmap to successfully conducting FIH studies, including: 

• Determining the necessary regulatory interactions 
• Selecting the starting dose 
• Designing the trial 
• Planning for participant safety 
• Identifying and mitigating potential risks 
• Recruiting, educating, and retaining study participants
• Planning resources and conducting the trial
   

Download issue

You may also be interested in the following:

Webpages:  

• First-In-Human Clinical Trials
• Comprehensive Early Clinical Development Solutions 

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services.

A Chat with Dr. Morelli

Altasciences has decades of experience designing, conducting, and reporting on early phase clinical trials. We have the scientific expertise and seamless operational processes to deliver quality data with speed and ease. 

Watch as Dr. Morelli, Chief Medical Officer, shares his first-hand experience and insight into Altasciences’ planning and conduct of your first-in-human, complex, and innovator clinical trials.

Want to know more? Speak with an expert about your FIH and other clinical research needs.

You may also be interested in the following:

Webpages: 

• First-In-Human Clinical Trials
• Comprehensive Early Clinical Development Solutions
• Altasciences’ State-of-the-art Clinical Trial Facilities

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services.

Robust Sample Management

Read our latest issue of The Altascientist to better understand how we deliver reliable study results through robust sample management for your preclinical and Phase I to IV clinical studies, including:

• Customized processes
• Controlled environments  
• Standardized workflows for risk management
• Capability to handle a wide variety of matrices
• Stability testing

Download your copy, or listen to the audiobook today.

You may also be interested in the following:

Webinars:

• Sample Collection Kits and Lab Manual
• Bioanalytical Project Management
• Critical Sample Handling Processes for Clinical and Preclinical Studies

Podcast:

• Transitioning Novel Scientific Workflows to Routine Bioanalysis 

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services.

Altasciences Tackles the Issues and Challenges Associated with Schedule I Therapeutic Development

Schedule I, or Class I (CI) drugs are currently restricted to research in the U.S., meaning that they are not approved for medical use, and are deemed at highest risk for abuse. Recent research on psychedelics and entactogens, of which are schedule I, is beginning to demonstrate potential therapeutic effects of these drugs for various medical indications. Approvals of such drugs for medical or therapeutic use will inevitably result in the rescheduling of these drugs from their current CI status. 

In this issue of The Altascientist, we uncover the following:

• Regulatory environment and challenges — DEA 
• Required preclinical and clinical studies specific to Schedule I or Class I (CI) drugs 
• Manufacturing considerations

Download your issue

For novel CNS-active Schedule I drugs, partner with Altasciences and benefit from our Schedule I licenses across every stage of early phase drug development. Our knowledge and operational expertise across preclinical, clinical, and manufacturing stages ensures complete continuity, data transfer, information sharing, and efficient timeline management... in real-time. 

Speak with an expert today for more information or to review your specific program requirements. 

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.​​​​