Integrated Programs: Early Development

Simplify early development and accelerate to Proof-of Concept Proof-of-Concept (POC) is a key milestone in the development of a new drug candidate. At Quotient Sciences, we understand the increasing pressures on R&D budgets, therefore the need to transition molecules through early development to POC needs to be fast and cost-effective.

Early Development

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. Our Translational Pharmaceutics® platform improves R&D productivity.

Getting it Right Early: The Importance of Biopharmaceutics in Early Drug Development

Chris Roe, Quotient Sciences' Principal Research Fellow, discusses strategies for overcoming biopharmaceutic challenges for small molecules in today’s drug development.

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.

Adaptive manufacturing: a new paradigm to improve efficiency and effectiveness in early oncology development - AAPS 2014

There is an unmet need in the industry for a more efficient and flexible approach to provide drug product for early clinical studies. Presented here is an innovate approach to overcome these challenges by utilising a real-time, adaptive manufacturing and supply platform.

14C Microtracer approaches to inform formulation development strategies in early clinical drug development - AAPS 2016

This poster describes how combining an intravenous (IV) microtracer regimen with an oral tracer regimen, can generate key pharmacokinetic (PK) parameters.

CC-99677, A Novel, Oral, Selective Covalent MK2 Inhibitor, Sustainably Reduces Pro-inflammatory Cytokine Production

Dr. Stuart Mair, Global Vice President, Medical, Early Development, has contributed to a scientific article on Arthritis Research & Therapy. Mitogen-activated protein kinase (MAPK)-activated protein kinase-2 (MK2) is activated downstream of p38 MAPK and regulates stability of mRNAs encoding inflammatory cytokines.

Real-time drug product manufacturing to enable accelerated early clinical development of spray dried dispersion based formulations - AAPS 2017

This poster describes how adopting a real-time drug product manufacturing approach allowed initiation of the FIH study within 12 weeks of initiating SDD process transfer.

Navigating the Small Molecule CMC Pathway

Learn about drug substance and formulation considerations for improving downstream clinical outcomes. Access on demand.

Clinical Pharmacology

When you are looking for a partner who is dedicated to Phase I trials and early development, rely on Quotient Sciences. We accelerate your molecule from first-in-human to proof-of-concept, helping you make critical decisions earlier.

Case Studies: Druggability Technologies (DRGT)

Clinical Pharmacology

CPHI 2023 Seminar: How To Accelerate Drug Product Optimization: Integrated Program Delivery Using Translational Pharmaceutics®

During CPHI 2023, we will be hosting a seminar entitled, 'How to Accelerate Drug Product Optimization Using Translational Pharmaceutics®'. There are limited spaces available. Register today.

Webinar: How to Accelerate Drug Product Optimization Using Translational Pharmaceutics®

Learn about the Translational Pharmaceutics approach and hear insights from our team. Join our webinar in October 2023.

Streamlining the Delivery of 14C Human ADME Data: An ADME Q&A Roundtable

Experts from Quotient Sciences and The Netherlands Organization for Applied Scientific Research (TNO) discuss streamlining human ADME studies.

Belmont Solubility Lunch Seminar with Nano PharmaSolutions

Join our complimentary co-hosted lunch seminar with Nano PharmaSolutions in Belmont, CA at Divino on May 18 to learn about how novel technologies and rapid clinical assessments can be utilized to achieve clinical success for poorly soluble molecules.

AAPS 2023 Seminar: How to Accelerate Drug Product Optimization Using Translational Pharmaceutics®

During AAPS 2023, we will be hosting a seminar entitled, 'How to Accelerate Drug Product Optimization Using Translational Pharmaceutics®'. There are limited spaces available. Register today.

Development of a Modified Release Tablet Containing an API Prone to Form Changes and Gelling in Aqueous Media

Development of an MR formulation of Cmp-1 was planned using RapidFACT®: an integrated approach that allows formulation optimization based on human PK data with an adaptive clinical design. Selection of a discriminatory in vitro dissolution test was an important early development activity.

Lunch & Learn Seminar in London with Charles River and Quotient Sciences

Join experts from Charles River & Quotient Sciences for a complimentary lunch seminar in London on the 28th March. Please register early to avoid missing out!

Lunch Seminar in Boston with Charles River and Quotient Sciences

Join experts from Charles River & Quotient Sciences for a complimentary lunch seminar in Boston on the 6th June. Please register early to avoid missing out!

Lunch & Learn Seminar in Basel with Charles River and Quotient Sciences

Join experts from Charles River & Quotient Sciences for a complimentary lunch seminar in Basel, Switzerland on the 30th March. Please register early to avoid missing out!

Biopharmaceutics and Pharmacokinetics

Leveraging Rapid Clinical Assessments to Accelerate Pediatric Formulation Development | San Diego

Our pediatric seminar series is returning to California this fall. Register to join us in San Diego.

Leveraging Rapid Clinical Assessments to Accelerate Pediatric Formulation Development | Belmont

Our pediatric seminar series is returning to California this fall. Register to join us in Belmont.

Leveraging Rapid Clinical Assessments to Accelerate Pediatric Formulation Development | South San Francisco

Our pediatric seminar series is returning to California this fall. Register to join us in South San Francisco.

AAPS 2020 Poster - A Quality by Deisgn Approach to Optimize and Accelerate Formulation and Process Development Leading towards Registration Batches Manufacturing

To improve the existing formulation composition and manufacturing process of compound X which was designed for early phase development Process optimization activities focused on improving the flow characteristics of the granules, minimizing or eliminating segregation and increasing the manufacturing yield with the aim of achieving a robust process prior to the product registration campaign.

Leveraging Rapid Clinical Assessments to Accelerate Pediatric Formulation Development

Join us for our upcoming seminar in London on June 14, "Leveraging Rapid Clinical Assessments to Accelerate Pediatric Formulation Development"

Bioanalytical Services

Determining drug exposure is vital for the assessment of drug safety and efficacy. Quotient Sciences Bioanalytical team develop and refine methods so exposure can be assessed reliably and accurately in a variety of biological matrices.

Bioanalytical services to accelerate drug development

Delivering rapid bioanalytical data is critical to drug development. From drug discovery, through to preclinical and clinical studies, understanding drug exposure and behavior are imperative to dose selection, and accelerating drugs to clinic and commercialization. Through the use of robust bioanalytical techniques, biological samples can be processed and analyzed to identify and quantify compounds of interest, such as small molecules and their metabolites, as well as peptides, proteins, nucleic acids and other analytes.

Bioanalytical Strategies for Insulin Analogues & Other Large Peptides Using LC-MS

Learn how our physiochemical-based approach enables us to accelerate the development of bioanalytical assays for insulin analogues from Michael Blackburn, Head of Bioanalytical Method Development and Labs.

Phase 1 Studies to Evaluate the Food Effect and Relative Bioavailability of Tablet and Capsule Formulations of Belumosudil in Healthy Adult Subjects

Quotient Sciences and Kadmon co-authored scientific publications on their recent NDA approved drug Belumosudil.

AAPS PharmSci 360 2023 | Orlando, FL

Quotient Sciences will be attending and exhibiting at AAPS PharmSci 360 2023 in Orlando from October 22-25.

Clinical Trial Manufacturing

Understanding that early phase clinical testing is a pivotal milestone in the development of your drug product, Quotient Sciences offers clinical trial manufacturing, testing and certification services designed to meet your individual requirements.

Preformulation Screening

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.

AAPS 2019 Poster- Applications and Benefits of Healthy Volunteer Trials to Accelerate Oncology Drug Development

Presented at AAPS 2019: Phase I drug development for oncology compounds is traditionally conducted directly in patient populations. Oncology molecules have historically been cytotoxic, meaning their safety and risk:benefit profile makes them unviable for dosing in healthy subjects. While this ensures reduced nonclinical requirements, rapid access to patient data and an earlier assessment of efficacious potential, it can also present challenges. For example, patients recruited in Phase I trials typically are at end of life care and will be taking multiple co-medications and have multiple co-morbidities (e.g. liver and kidney function may vary greatly among the recruited subjects). Practically, recruiting patients into Phase I studies can also be problematic, requiring multiple clinical sites and protracted recruitment times for what would traditionally be single site, quickly recruited healthy volunteer studies.