By integrating drug substance, drug product, and clinical testing activities, Translational Pharmaceutics® accelerates molecules through development. This saves time and money in reaching key milestones as quickly and efficiently as possible, ensuring better decision-making and more streamlined outsourcing.
Our expertise in understanding dependencies between drug substance properties, formulation design, and clinical outcomes enables us to enhance development efficiency.
By having both drug substance and drug product manufacturing activities under one organization, we can now deliver integrated chemistry, manufacturing, and controls (CMC) development activities for both pre-clinical and clinical studies in parallel, simplifying the supply chain and shortening the time from candidate selection to the clinic by a further 2–4 months.
Translational Pharmaceutics® has now been used by pharmaceutical and biotech companies on over 500 drug programs. The financial benefits and time savings were quantified in a publication by the Tufts Center for the Study of Drug Development.
The seamless coordination between drug substance and drug product manufacturing results in a more efficient and accelerated development plan. Integrating all activities under a single organization, and removing silos, encourages close relationships between multidisciplinary experts and creates a more agile approach to pharmaceutical development. Learn how a fully integrated program can speed up the transition from candidate selection to POC and shorten the pathway to clinical drug development.
It's common for most new drugs to require some sort of formulation change or optimization during their development, whether to respond to suboptimal exposure profiles, to transition from an early development formulation to one suitable for chronic administration, or as part of a life-cycle management strategy.
At Quotient Sciences, our unique approach to drug product optimization, using our integrated Translational Pharmaceutics platform, enables us to design, manufacture and obtain clinical data on new formulations in an accelerated timeframe all under a single organization. This approach saves significant time by reducing the CMC data package needed for your clinical assessments, maximizes flexibility in being able to fine-tune formulations, and conserves API.
“We are very excited with the results of our first human study using our novel lipid-based aprepitant formulation, which allows us to plan the advancement of our lead OXL001 product into Phase 2 studies for the treatment of cancer... We have been able to leverage Quotient Sciences’ Translational Pharmaceutics® platform to gain rapid access to the clinic, helping deliver these favourable results in a smooth and rapid fashion.”
Dr Simon Yaxley, Director of Oxilio Limited
“Quotient Sciences' has been a great partner to work with. Their project management was top-notch and costs remained within budget throughout our collaboration. Their scheduling and execution have been impeccable; the program has run like clockwork. As a client, you can’t really ask for more!”
Ofir Moreno, Vice President of Research & Development at MEI Pharma
“Our small biotech company worked with Quotient Sciences on developing a complex formulation and validating the different iterations of the formulation in PK clinical studies using the Translational Pharmaceutics® approach. The project was successful, and we were generally impressed by the skillsets, professionalism, and courtesy of Quotient Sciences' scientists and other subject experts. We have also chosen to work with Quotient Sciences on two subsequent projects.”
“Quotient Sciences’ real-time manufacturing capabilities were a key factor in determining the speed at which this study could be concluded, offering the rare combination or GMP manufacturing and clinical administration on the same site, even for complex formulations and dosage forms. This allowed us to progress much faster.”
Dr Phil Collis, Vice President of Development at BioCryst Pharmaceuticals
“My first response was this is too good to be true, they can’t do that. We’ve been looking for this type of solution for years – it can’t be done. However, we made a site visit and, within three days, accepted the proposal... We had clinical data within weeks... reducing the overall timeline by half, if not more.”
Deborah Gouveia, Vice President, Program & Alliance Management at Stealth BioTherapeutics
In this latest blog written by Quotient Sciences' Senior Drug Development Consultant, Dr Aruna Railkar, she reviews some of our solubility-enhancement, modified-release, and pediatric case studies that required specialized formulation expertise.