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25 results for "Translational Pharmaceutics"

Translational Pharmaceutics

Accelerating formulation development to address poor drug solubility using Translational Pharmaceutics

This webinar examines how to accelerate formulation development in order to address poor drug solubility using Translational Pharmaceutics, showcasing examples of how Translational Pharmaceutics has been used across all phases of clinical development:

Tufts CSDD Study Assessing the Financial Benefits of Translational Pharmaceutics®: A Platform for Accelerating Product Development

This webinar summarizes the key findings of the recent Tufts CSDD research into Translational Pharmaceutics, the innovative approach to drug development. It demonstrates significant time savings of >12 months and financial gains of >$100 million per drug approved.

Application of Translational Pharmaceutics® to reduce time, cost and risk in the early development of inhaled drug products - RDD

The efficiency and effectiveness of new drug development has remained problematic over the last decade. Translational Pharmaceutics has emerged as a new paradigm to improve R&D productivity.

Assessing the Financial Impact of Translational Pharmaceutics®

Tufts Center for the Study of Drug Development (CSDD) white paper sharing study results that indicate Quotient Sciences’ Translational Pharmaceutics® platform reduces development times by more than 12 months and lowers R&D costs by more than $100 million per approved new drug, compared to traditional multi-vendor development paradigms.

Translational Pharmaceutics and the Benefits of Real-Time Adaptive Manufacturing

This webinar explains the benefits of Translational Pharmaceutics, a unique approach which integrates formulation development, real-time adaptive GMP manufacturing and clinical research. It will illustrate how, by breaking down the siloes and integrating horizontally, we can operate with more flexibility in the early phases of drug development, reducing costs and shortening timelines.

Application of Translational Pharmaceutics in Accelerating the Development of MR Dosage Forms

Poster presentation at NERDG 2021 Annual Meeting. In this poster we demonstrate an optimized approach to developing oral modified-release (MR) dosage forms using the Translational Pharmaceutics platform. This approach uses emerging human data to inform adjustment of formulation composition in an adaptive clinical study.

Translational Pharmaceutics

Quotient Sciences helps you achieve your goals by enabling precise formulation development, streamlined manufacturing, quick pivot to clinical data and a significantly faster transition through drug development.

Assessing the Financial Impact of Translational Pharmaceutics®

Assessing the Financial Impact of Translational Pharmaceutics®

BioCryst Pharmaceuticals

BioCryst Pharmaceuticals is taking advantage of Quotient Sciences’ Translational Pharmaceutics® platform and First-In-Human program for the development of BCX4161, a promising candidate for the treatment of hereditary angioedema.

A rapid formulation development and clinical testing program to evaluate the pharmacokinetics of a novel enabled formulation of abiraterone acetate - AAPS 2016

Following initial dosing, the Translational Pharmaceutics platform also allows GMP drug products to be made in real-time in response to interim analysis of clinical data, typically on a 7-14 day cycle.

Xspray

Protein kinase inhibitors (PKIs) are used in the treatment of cancer and inflammation, but food interactions are a common problem with this class of drugs. Swedish drug delivery company Xspray has used its Hybrid Nanoparticle (HyNap™) technology to improve the bioavailability of the PKI nilotinib, reducing the required dose and significantly lowering the food interaction of the drug compared with the marketed product.

How can you conserve cash and still accelerate to your key early development milestones?

This webinar will explore some of the challenges faced by industry today and discuss how early drug development timelines can be accelerated, whilst at the same time conserving cash flow.

Accelerating drug product development from early phase to scale up and commercialisation

This webinar covers a real-world case study with Druggability Technologies, a specialty pharmaceutical company, which utilized Quotient’s integrated approach to advance the development of DRGT-46, a novel, fast-acting formulation of celecoxib, using proprietary super-API compositions developed by DRGT.

AAPS 2019 Poster- A Phase I Study Allowing Clinical Screening of Multiple Solubility-Enhancement Formulation Technologies, and an Assessment of Food, PPI and Dose Linearity Assessment with the Selected Formulation of BOS172767, in Healthy Volunteers

Presented at AAPS 2019: Translational Pharmaceutics was used to evaluate three BOS172767 formulations in on a integrated clinical study, and successfully identified the micronized capsule as the new lead formulation. This formulation had superior exposure compared to the IR reference capsules, and approximate proportional increase in exposure up to 800 mg. The food effect observed at 100 mg was reduced compared to that previously seen at 200 mg (FIH capsule) and elevated gastric pH (subjects taking PPIs) had minimal effect on exposure. A Level C IVIVC was achieved with a biorelevant dissolution test, which provides valuable information for future formulation development and setting of product specifications.

How to Reduce the Time and Cost for Optimizing Drug Product Formulations

Join industry experts John McDermott, Executive Director of Drug Product Optimization, and Kieran Crowley, Senior Scientific Director, both from Quotient Scienbces, as they outline studies and metrics in drug delivery and drug product optimization.

Developing an Oral Modified Release (MR) Formulation - Challenges and Considerations for Achieving Success

Join us and learn how to overcome challenges in order to deliver a successful MR formulation. Using case studies, we will describe the specialized formulation technologies that are available in order to achieve an optimal target product profile, and the use of innovative, adaptive clinical programs where human PK data is used to optimize modified release formulation compositions in real-time.

AAPS Northeast Regional Discussion Group (AAPS- NERDG)- April 2021

Connect with Quotient at the upcoming virtual AAPS Northeast Regional Discussion Group (AAPS- NERDG) Event

Pediatrics

MEI Pharma

MEI Pharma has leveraged Quotient's Translational Pharmaceutics® platform to expedite development of its next-generation cancer therapy ME-401.

Enhanced formulation decision-making in early phase clinical trials for parenteral products

This presentation describes the principles and applications of Translational Pharmaceutics: an R&D platform integrating formulation development, real-time adaptive GMP manufacturing and clinical testing in order to accelerate drug development cycles.

First-in-Human to Proof-of-Concept

Our Translational Pharmaceutics approach enables First-in-Human studies by re-engineering the transition of your drug molecule into clinical development and shortening the timeline to Proof-of-Concept.

The Role of Biopharmaceutics in Early Drug Development

This webinar discusses effective strategies being used by biotech and pharmaceutical companies to overcome biopharmaceutic challenges for small molecules in today’s drug development pipeline; and explores alternative approaches for accelerating your early development plan.

The Integration of Drug Substance and Drug Product

This webinar highlights how a fully integrated program can speed up transition from candidate selection to proof of concept and shorten the pathway to clinical development.

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