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Case Study: Druggability Technologies (DRGT)

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Case Studies , Translational Pharmaceutics , Clinical Trial Manufacturing , Commercial Manufacturing

Case Study: Druggability Technologies (DRGT)

Overview

Druggability Technologies (DRGT) needed a partner to rapidly develop a clinical formulation and commercial product

Druggability Technologies (DRGT) was a pharmaceutical company developing an array of drugs in diverse indications to achieve measurable and meaningful improvement in their clinical utility. The company used its proprietary platform to screen and select Super-API compositions and its portfolio contains over 30 preclinical and clinical-stage compounds including DRGT-46, as a novel therapy for pain.

DRGT wanted to rapidly develop a clinical formulation and, if successful, a commercial product. Gábor Heltovics, former CEO of DRGT contacted Quotient Sciences to enable the rapid development, clinical assessment, and commercial readiness of their DRGT-46 product using our integrated services and network of harmonized development and manufacturing sites in the UK and the US. DRGT benefited from using our unique Translational Pharmaceutics® platform, integrating formulation development, real-time clinical manufacturing, and clinical testing to accelerate progress to scale-up. Request a copy of the case study here.

 

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Case Study: Endevica Bio

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Case Studies , Translational Pharmaceutics , Peptide Drug Development

Case Study: Endevica Bio

Overview

A case study with Endevica Bio on how Translational Pharmaceutics successfully supported a novel synthetic peptide product with an integrated pharmacy compounding approach

Endevica Bio, based in Chicago, USA, is a pharmaceutical company that is developing TCMCB07, a novel synthetic peptide product for the potential treatment of cachexia. This has the potential to create a new standard of care for millions of patients who develop cachexia every year.

This molecule was an ideal candidate for Quotient Sciences’ integrated Translational Pharmaceutics® platform.  In our case study, Russell Potterfield, CEO of Endevica Bio, explains how Quotient Sciences has supported their business with an integrated formulation development and Phase I clinical study program, accelerating the development of TCMCB07, and saving costs in the process.

Request a copy of our case study today and contact us to find out how we can accelerate drug development timelines saving as much as 12 months in the process with our Translational Pharmaceutics® platform.

 

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Amit Patel - Senior Director, Technical Services, Formulation Development

Amit Patel - Quotient Sciences

Amit Patel

Senior Director, Technical Services, Formulation Development

Subject Expert
About

Amit Patel, Senior Director of Technical Services, has held various technical and operational leadership roles during his 15-year career in the pharmaceutical industry. 

Amit has led projects from conceptualization to commercialization for solid oral dosage forms of complex modified release and immediate release formulations. During his career, he has also gained extensive regulatory and quality systems experience, including support for regulatory audits, and expertise in process optimization through concepts of Quality by Design (QbD), process validation, cleaning validation, and product life cycle management.

Since joining Quotient Sciences, Amit has been overseeing process development, registration, process validation, and continued process verification of our late-stage and commercial drug product manufacturing programs. Prior to Quotient Sciences, Amit worked with Nesher Pharmaceuticals, where he led the formulation development and technical services departments. 

Amit holds a Master of Pharmaceutical Chemistry from Fairleigh Dickinson University and a Bachelor of Pharmacy from Sardar Patel University Gujarat.

Kevser Sevim - Senior Modelling and Simulation Research Fellow

Kevser Sevim - Quotient Sciences

Kevser Sevim

Senior Modelling and Simulation Research Fellow

Subject Expert
About

Dr. Kevser Sevim brings her expertise to the dynamic modelling and simulation (M&S) team at Quotient Sciences. Her primary focus revolves around advancing the understanding of ADME studies and biopharmaceutics in compound design and selection, utilizing a range of M&S data analysis packages including GastroPlus and Phoenix WinNonlin.

Over her five years of experience in this role, Kevser has played a key role in accelerating drug development and manufacturing through the application of in-silico PBPK modeling (physiologically-based pharmacokinetic modeling). Her contributions provide valuable scientific support across both discovery and development programs.

Kevser holds a PhD from the University of Leicester, UK, where she specialized in the modeling of drug release from biodegradable and bioerodible polymers. Before her doctoral studies, she earned a Bachelor of Science degree in Chemical Engineering from Gazi University, Turkey.

Stuart McDougall - Principal Research Fellow - Arcinova

Stuart McDougall - Quotient Sciences

Stuart McDougall

Principal Research Fellow - Arcinova

Subject Expert
About

Stuart McDougall has over 30 years of experience in the pharmaceutical industry within metabolism, pharmacokinetic, and bioanalysis roles. Previous positions include being the global leader of Sanofi-Aventis' bioanalytical strategy team and a member of Covance's global bioanalytical leadership team.

Stuart is a pharmacology graduate from the University of Dundee, a harmonization team leader for the Global Bioanalytical Consortium (GBC), a representative for Quotient Sciences on the European Bioanalytical Forum (EBF), and an author and co-author of numerous scientific papers.

Expertise & focus areas

Iain Shaw - Senior Director, 14C Enabled Drug Development

Iain Shaw - Quotient Sciences

Iain Shaw

Senior Director, 14C Enabled Drug Development

Subject Expert
About

Iain Shaw has over 30 years of experience in the pharmaceutical industry, including over 15 years focused on 14C-enabled drug development.

Iain joined Quotient Sciences in 2008 as Director of Customer Service. Today, he is responsible for the portfolio of 14C programs that Quotient Sciences offers to address questions around drug metabolism and pharmacokinetics using human ADME, microADME, intravenous microtracer techniques, and Quotient Sciences' Synthesis-to-Clinic integrated ADME programs.

Prior to joining Quotient Sciences, Iain held early development program management, clinical development, and analytical positions at pharmaceutical companies and contract research organizations (CROs), including at Covance (now part of Fortrea) and PPL Therapeutics.

Expertise & focus areas

Quotient Sciences, University of Nottingham, AstraZeneca and Added Scientific Ltd receive MRC grant to advance 3D printing of solid dosage forms

News & Announcements , Customer Milestone , Nottingham, UK

Quotient Sciences, University of Nottingham, AstraZeneca and Added Scientific Ltd receive MRC grant to advance 3D printing of solid dosage forms

Quotient Sciences

The Faculty of Engineering and School of Pharmacy, at the University of Nottingham, are delighted to announce the receipt of an MRC Confidence in Concepts grant. Working in collaboration with Quotient Sciences, Added Scientific and AstraZeneca, the grant will translate towards clinical applications some of the advances made at Nottingham in the 3D printing of pharmaceutical dosage forms. The 12-month project aims to demonstrate the ability to manufacture personalised dosage forms in a regulated industrial environment focused on medicines development and clinical trials. Professors Ricky Wildman and Clive Roberts, who the lead the project, commented: “This project is an exciting opportunity to work with leading industrial partners in clinical trials, additive manufacturing and pharmaceuticals, and is an important step for us in exploring the potential of 3D printing for the improvement of human health and wellbeing through more personalised medicines.”

''The scope for 3D printing in the pharmaceutical industry is significant, with potential applications including the rapid development of prototype dosage forms and the ability to personalise drug products to individual patient needs, for example in rare, orphan and paediatric diseases,” said Dr Peter Scholes, Chief Scientific Officer at Quotient Sciences. “We are excited to be part of this collaborative program which will look to translate the research performed at the University of Nottingham into an industrial manufacturing setting”.

Dr Johanna Laru, Associate Director, Pharmaceutical Sciences, R&D at AstraZeneca commented: “We know the best science doesn’t happen in isolation. This grant builds on our existing collaboration with the University of Nottingham, Quotient Sciences and Added Scientific, and we look forward to working together to further assess the potential of 3D printing in the medicines development.”

Added Scientific are very excited to be part of this work after our involvement in an earlier collaborative project looking at the feasibility of printing pills. The opportunity to observe, learn and benefit from the first human trials of this technology will be invaluable to the company and our engineers and scientists.

Quotient Sciences Appoints Claes Glassell as Non‐Executive Chairman of its Board

News & Announcements

Quotient Sciences Appoints Claes Glassell as Non‐Executive Chairman of its Board

Quotient Sciences logo

Quotient Sciences, the innovative drug development and manufacturing organization, today announces the appointment of Claes Glassell as non‐executive chairman of its board of directors. A highly accomplished leader in the pharmaceutical industry with over 35 years’ experience, Glassell has held numerous leadership positions, including at the board level, to help companies through high phases of growth.

“His track record of strong leadership and board experience in the pharmaceutical industry will be hugely valuable as we position ourselves as a world‐leading drug development and manufacturing organization,” said Mark Egerton, Ph.D., Quotient CEO. “Claes has extensive experience supporting high‐growth businesses such as Quotient across multiple geographies.”

Since 2016, Glassell has been a director of the board at Cambrex and currently serves as nonexecutive chairman of the board of LSNE Contract Manufacturing. From 2011 to 2015, he was CEO of CMC Biologics, a contract manufacturing organization focused on biologic pharmaceuticals.
Previously, he held senior positions and served on the boards of several public and private companies, including Vitrolife AB, Cellartis AB, Nobel Chemicals, and Cerus.

“I am excited to join Quotient at this important juncture following the recent investment by Permira,” said Glassell. “Quotient Sciences and its disruptive approach to drug development have created a unique business model that truly accelerates drug development. I welcome the
opportunity to work with an outstanding management team, supported by a strong board and investors, to help Quotient through its next stage of growth.”

“I am delighted that Claes has accepted this position,” said Mubasher Sheikh, partner and head of healthcare at Permira. “Claes brings a set of highly relevant skills and experience to the board, and I look forward to working with him and the executive team."

Quotient Sciences Acquires Pharmaterials, a UK-based Contract Development and Manufacturing Organization

Acquisitions & Growth , Reading, UK

Quotient Sciences Acquires Pharmaterials, a UK-based Contract Development and Manufacturing Organization

Quotient Clinical is now Quotient Sciences

Nottingham, U.K., 14 November 2017: Quotient Sciences, the drug development services organization, announces it has acquired Pharmaterials, a contract development and manufacturing organization (CDMO) based in Reading, U.K. The acquisition strengthens and expands Quotient Sciences' formulation and manufacturing services footprint in the U.K. and supports the growth of the Translational Pharmaceutics® platform, following the acquisitions of SeaView Research and QS Pharma in February 2017.

Pharmaterials has a significant track record in supporting the development of small molecule drug products for oral and inhaled delivery. The company’s portfolio of services spans the characterization and optimization of drug substance physical forms, the development of preclinical and clinical formulations through to clinical trial manufacturing, and subsequent global drug product supply. The business was founded in 2000 and is located in a 48,000-square feet facility that houses 13 GMP manufacturing suites, with space for future expansion.

Mark Egerton, CEO of Quotient Sciences, said: "The acquisition of Pharmaterials strengthens Quotient Sciences' service portfolio from preclinical formulation development through to commercial manufacturing. The addition expands Quotient Sciences' global CDMO services with added capacity and capabilities to better serve our clients’ needs."

With over 700 employees, six operating sites across the U.S. and U.K. and a 30-year track record for quality services, Quotient Sciences is focused on delivering an innovative portfolio of services that are proven to shorten development timelines, reduce associated costs and accelerate the delivery of new medicines to patients globally.

Quotient Clinical Rebrands as Quotient Sciences, Launches New Global Identity

News & Announcements , Acquisitions & Growth

Quotient Clinical Rebrands as Quotient Sciences, Launches New Global Identity

Quotient Clinical is now Quotient Sciences

Nottingham, U.K., 10 November 2017: Quotient Clinical, the drug development services organization, announces its renaming to Quotient Sciences (Quotient), following the acquisitions of Co-Formulate, QS Pharma and SeaView Research. This new identity signifies a global footprint and an extended range of services and symbolizes the commitment to ensuring a consistent and high-quality experience for customers.

With 700 employees and five operating sites across the United States and the United Kingdom, Quotient Sciences is focused on delivering a portfolio of innovative services encompassing formulation development, clinical trial and commercial manufacturing, and clinical pharmacology.

Quotient Science’s Translational Pharmaceutics® platform integrates formulation development, real-time adaptive GMP manufacturing and clinical research, transforming the traditional industry approach of outsourcing to independent contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs). Translational Pharmaceutics is proven to accelerate development timelines and reduce overall costs.

“We are excited about the future of Quotient Sciences,” said Mark Egerton, CEO, of Quotient Sciences. “By integrating services typically found in disparate CDMOs and CROs, we break down barriers and support our customers to improve R&D productivity and accelerate the delivery of new medicines to patients around the world. We have a 30-year track record of service to a global customer base, including large multinational pharmaceutical companies to smaller virtual biotech organizations.”

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