Formulation to Clinic―Navigating the Complexities of Ophthalmic Drug Development

 

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

The Altascientist issue 27 - Ophthalmic

Have questions? Speak with one of our experts.

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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.

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A well-planned clinical program designed to meet the regulatory requirements for the jurisdictions where you plan to request market authorization can be conduct

Data Excellence—the Core of Drug Development

 

Trust Altasciences to Deliver the Quality, Compliant Data You Need

How do we collect data? With much planning!

Your study plan documents complement your protocol, and provide additional details for data management and analysis.

Data Management

Our data managers plan for quality, clear data in support of your regulatory submission. Single- or multi-site, in a wide range of therapeutic areas, our decades of experience will deliver the data you need.

Let’s talk data—contact our experts today!

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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.

Access Earlier Clinical Data to Accelerate Your Program

 

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.

The Altascientist issue 25 - FLEXIBILITY IN PHASE I STUDY TIMING

DOWNLOAD your copy, or listen to the AUDIOBOOK.

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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

Managing Challenging Bioanalysis for PK/PD Assessments for Phase I Biologics Studies

 

How to Maximize Drug Development Success of Biologics

Combining Phase I trial conduct of biologics and bioanalysis is critical for successful drug development. Clinical development relies heavily on bioanalytical experts to generate critical data to understand pharmacokinetics and pharmacodynamics. 

Here are just some of the benefits of working with Altasciences:

  • Timed interim sample analysis for dose escalation decisions
  • Rapid turnaround of PK/PD analysis between cohorts 
  • Biomarker development and validation for exploratory or primary endpoints
  • On-site flow cytometry 
  • Centralized scheduling between clinic and lab
  • Ability to easily switch or combine platforms which are sensitive, have high throughput, and demonstrate exquisite specificity

Watch this complimentary webinar to see how you can overcome challenges throughout all phases of drug development.

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Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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.

Clinical Research… Beyond the Trial

Comprehensive Clinical Research Support

A successful clinical trial is more than just conduct. A complete suite of integrated, research support services and expert scientific input are key to reaching your study goals.

Stages of Drug Development

Enhance your drug development program with Altasciences’ research support services, whether as stand-alone offerings or as part of a complete program. Your chosen partners become ours, and we act as integral contributors, applying decades of knowledge and expertise, and moving in unison to deliver the highest quality results.

Let us know how we can support you!

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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.
 

How We Formulate Complex APIs Others Can’t

 

How We Succeed When Others Can’t

Andrew Buis, Senior Formulation Scientist at Altasciences, explains how we succeed in developing the most complex formulations when others fail, and even customize them based on specific client needs.

Points of discussion include:

  • Our facility design, equipment, and experience 
  • What our recent 35,000-sq.-ft. expansion means for clients
  • How we develop customized formulations
  • How we formulated APIs for clients when others failed

Watch the video now!

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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.

Insights Care: Chris Perkin — A Forward Thinker in the Research Space!

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PCR testing has been in the spotlight as the most reliable way of screening for COVID-19 in patients since the beginning of the pandemic. But what is PCR? And what are its other uses?

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