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Quotient Sciences Expands UK Facilities to Support the Delivery of Translational Pharmaceutics® Programs

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47 results for "Early Development"

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. Translational Pharmaceutics has emerged as a new paradigm to improve R&D productivity.

Getting it Right Early- The Importance of Biopharmaceutics in Early Drug Development - Boston

Join us for a complimentary lunch seminar to learn effective strategies that biotech and pharmaceutical companies are using to overcome biopharmaceutic challenges for small molecules in today’s drug development pipeline and explore alternative approaches for accelerating your early development plan.

Getting it Right Early- The Importance of Biopharmaceutics in Early Drug Development - Webinar

Join us for a webinar to learn effective strategies that biotech and pharmaceutical companies are using to overcome biopharmaceutic challenges for small molecules in today’s drug development pipeline and explore alternative approaches for accelerating your early development plan.

Getting it Right Early- The Importance of Biopharmaceutics in Early Drug Development - San Francisco

Join our complimentary happy hour seminar in San Francisco area, on April 5th to learn about effective strategies that biotech and pharmaceutical companies are using to overcome biopharmaceutic challenges for small molecules in today’s drug development pipeline; and explore alternative approaches for accelerating your early development plan.

Getting it Right Early- The Importance of Biopharmaceutics in Early Drug Development - San Diego

Join our complimentary happy hour seminar in San Diego, CA, on April 7th to learn about effective strategies that biotech and pharmaceutical companies are using to overcome biopharmaceutic challenges for small molecules in today’s drug development pipeline; and explore 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.

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.

Accelerating Development Through Integrated Drug Substance & Drug Product Strategies | Oxford, (UK) Seminar

Join our complimentary seminar in Oxford, UK at Milton Park Innovation Centre on September 28th, 2022, and learn how a fully integrated program can speed up transition from candidate selection to proof of concept and shorten the pathway to clinical development.

Developing spray dried dispersions for early phase clinical trials and beyond

Formulation strategies and the DevelopabilityClassification System (DCS). Benefits of spray-drying to address poor drug solubility. Fit-for-purpose systems in early clinical research and effectively transitioning to solid oral dosage forms. Adaptive clinical manufacturing “tailored” to the clinical study and patient recruitment.

CPHI Seminar & Happy hour

Join Quotient Sciences at our CPhI 2022 Seminar & Happy Hour on

First-in-Human to Proof-Of-Concept: Addressing Development Challenges and Accelerating Timelines

Increasing pressure on R&D budgets means the design, speed and precision of early phase clinical programs is critical for success.

ADME Q&A Roundtable Webinar- Feb. 10

Register today for our ADME focused webinar series taking place on February 10th entitled: "ADME Q&A Roundtable: Leveraging a Synthesis-to-Clinic approach to rapidly support regulatory approval"

ADME Q&A Roundtable Webinar- Feb. 15

Register today for our ADME focused webinar series taking place on February 15th entitled: "ADME Q&A Roundtable: Leveraging a Synthesis-to-Clinic approach to rapidly support regulatory approval"

ADME Q&A Roundtable Webinar- Feb. 8

Register today for our ADME webinar series on February 8th, "ADME Q&A Roundtable: Leveraging a Synthesis-to-Clinic approach to rapidly support regulatory approval."

ADME Q&A Roundtable Webinar Series

Register today for our ADME focused webinar series taking place on February 10th & 15th entitled: "ADME Q&A Roundtable: Leveraging a Synthesis-to-Clinic approach to rapidly support regulatory approval"

DCAT Week 2022

Schedule an in-person or digital meeting with our drug development experts during DCAT week in NYC

CPHI Worldwide 2022

Quotient Sciences will be attending CPHI Worldwide 2022 from November 1-3.

Leveraging Bioanalysis to Accelerate Drug Development Programs: Challenges and Considerations

Join Quotient’s Vice President of Bioanalysis, Dr Stuart McDougall, as he discusses how best to leverage bioanalysis within drug development programs to accelerate timelines & enhance the likelihood of clinical & commercial success.

Non-Clinical vs Clinical: Risks & Considerations When Developing Modified Release Dosage Forms

Join Dr. Vanessa Zann, Senior Drug Development Consultant, Drug Development Consulting at Quotient Sciences. In this webinar, the Dr. Zann will use case studies to describe the specialized formulation technologies that are available in the “toolbox” 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.

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.

Clinical Pharmacology

AAPS Lunch & Learn Seminar

Join experts from Charles River & Quotient Sciences for a complimentary ‘Lunch and Learn’ Seminar during AAPS

Accelerating Development Through Integrated Drug Substance & Drug Product Strategies | Basel, Switzerland

Registration is now closed for our complimentary seminar in Basel Switzerland at Radisson Blu Hotel on September 20, 2022. Have questions about how a fully integrated program can speed up transition from candidate selection to proof of concept and shorten the pathway to clinical development? Get in touch with our team today.

JPAG Stability Symposium

Quotient Sciences' will be attending the JPAG Stability Symposium on June 30, 2022.

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.

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.

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.

Live Webinar: Improving Solubility and Accelerating Drug Development through Integrated Programs

Join Quotient & Lonza on February 23rd at 8am PST / 11am EST for a live webinar entitled: Improving Solubility and Accelerating Drug Development through Integrated Programs

CPhI NA Lunch Seminar: Moving Drug Substance Off the Critical Path

Save your spot at our CPhI North America lunch seminar on May 18, entitled: Moving Drug Substance Off the Critical Path- Streamlined Strategies to Accelerate to First-in-Human & Beyond

Accelerating Development Through Integrated Drug Substance & Drug Product Strategies | RTP Seminar

Join our complimentary lunch seminar in Research Triangle Park, North Carolina, on October 20th and learn how a fully integrated program can speed up transition from candidate selection to proof of concept and shorten the pathway to clinical development.

Webinar: Overcoming formulation challenges for complex programs: Integrated strategies for Poor Solubility, Modified Release & Pediatrics

Drug development for any molecule type is challenging, given the numerous stages an active lead molecule or new chemical entity (NCE) must transition through to gain regulatory approval and reach patients to demonstrate its benefits. In this talk, Quotient Sciences' Executive Director of Drug Development Consulting, John McDermott, will outline how an integrated program design can simplify development processes for complex molecules and reduce overall costs.

Overcoming Complex Formulation Challenges: Integrated Strategies for Poor Solubility, Modified Release & Pediatrics

Watch our on-demand webinar featuring John McDermott, Executive Director of Drug Development Consulting at Quotient Sciences, who discusses how an integrated program design can simplify development processes for complex molecules and reduce overall costs.

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.

Pre-formulation screening

Pre-formulation screening

Pre-formulation 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.

BIO Happy Hour Seminar: Moving Drug Substance Off the Critical Path

Save your spot at our BIO Happy Hour seminar on June 15th, entitled: Moving Drug Substance Off the Critical Path- Streamlined Strategies to Accelerate to First-in-Human & Beyond

BIO International 2022 Happy Hour Seminar: Moving Drug Substance Off the Critical Path

Save your spot at our BIO happy hour seminar on June 15, "Moving Drug Substance Off the Critical Path- Streamlined Strategies to Accelerate to First-in-Human & Beyond."

Moving Drug Substance Off the Critical Path — Streamlined Strategies to Accelerate to First-in-Human & Beyond

Join Dr. Stephen McQuaker, Director of Drug Development Consulting, as he explores case studies to demonstrate how drug substance and drug product development plans can be accelerated through innovative science and expertise to get drug substance off the critical path.

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.

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