Overcoming poor drug solubility is a common and challenging task facing the formulation scientist today. Over 70% of new chemical entities are
reported to have this characteristic which can result in suboptimal oral bioavailability and an inability to demonstrate the therapeutic potential of the candidate drug.
This webinar will focus on the benefits of spray-drying in addressing the solubility challenge, detailing how simple, scaleable systems can be quickly developed to provide drug products for clinical evaluation. Approaches for transitioning spray-dried dispersions to formulated solid oral dosage forms for downstream development will also be described.
The benefits of integrating GMP manufacturing and clinical testing will also be shown in case studies using spray-drying technology. This will illustrate how arising clinical data are used to inform the real-time selection of formulation compositions to be made and dosed in subsequent study periods. Time and cost effective programs can be designed for poorly soluble molecules, to accelerate first-in-human, formulation optimisation and proof-of-concept studies.
Are you struggling with your drug product development timeline? Are ongoing drug formulation issues leading to escalating costs and missed deadlines?
RapidFACT significantly accelerates the process of optimising modified release drug products, both to improve oral bioavailability and/or achieve targeted GI delivery. Drug products can be optimised within a clinical study by the use of a continuous formulation design space, rather than undertaking cycles of formulation development and multiple clinical PK studies. A range of product performance attributes can also be investigated within a program, by varying the quantitative composition of one or more formulation components in response to emerging clinical data.
RapidFACT programs have been used extensively by Pharmaceutical Development teams from more than 50 pharmaceutical and biotechnology companies worldwide as a key tool in developing optimised drug products, for all routes of delivery, with over 100 programs now completed.
The webinar will include a presentation from Dr Peter Timmins, formerly of Bristol-Myers Squibb, describing the key variables that must be considered in the development of modified release formulations, and discuss strategies to understand the key relationships between formulation parameters and product performance using clinical data.
This webinar will showcase case studies and project metrics, illustrating the applications and benefits when developing modified release drug formulations.
Increasing pressure on R&D budgets means the design, speed and precision of early phase clinical programs is critical for success. The traditional staged approach to drug development has involved discrete clinical studies in Phase I and Phase II, separated by decision steps. However, increasingly protocols are being combined or interleaved to accelerate the pathway to POC.
In addition to optimizing the clinical plan, pharmaceutical project teams now also demand more data than ever before to answer key “developability” questions in Phase I. Can we assess the impact of formulation and formulation performance? How can we rapidly manufacture GMP product for Phase I? What drug product will we use for Phase II? Is there a valid biomarker to establish an early pharmacodynamics response? Are there any metabolism or bioavailability issues that need to be addressed?
During this webinar, the speakers will describe how Enabled-First-in-Human® programs integrate real-time GMP drug product manufacturing with healthy volunteer and patient clinical testing into a seamless early development plan. The effect is to significantly reduce time to proof-of-concept, minimize up-front investment and simplify supply chains.
This webinar will present a set of case studies on:
Dr Ofir Moreno, MEI Pharma, Inc will present the design and results of an early development program of a new molecule ME-401, which is in development for the treatment of lymphoid malignancies.
Dr Alyson Connor, Quotient Clinical, will present further cases studies illustrating the applications and benefits of Enabled-FIH.
Join industry experts John McDermott, Executive Director of Drug Product Optimization, and Kieran Crowley, Senior Scientific Director, both from Quotient Clinical, as they outline studies and metrics in drug delivery and drug product optimization, illustrating the applications and benefits for a range of drug formulations.
Real-time flexibility within the clinical study allows product compositions to be varied and performance attributes optimized in response to arising data. The presenters will provide an introduction to Translational Pharmaceutics and how RapidFACT® (Rapid Formulation development And Clinical Testing) accelerates the process for developing and optimizing drug product formulations.
The discussion will include an overview of the first 100 programs, scientific case studies, and several applications of RapidFACT including:
Proof-Of-Concept (POC) is a pivotal milestone in the drug development process. Analysis of attrition data from the pharma industry indicates that around 80% of drug candidates continue to fail at, or prior to, POC and do not progress into the later stages of development. Consequently, the early development processes must be re-engineered to improve R&D productivity and shorten project timelines, whilst at the same time allowing a more flexible and interrogative investigation of a drug candidates unique potential.
The Enabled-FIH approach was designed specifically to address these requirements. This webinar will present a set of case studies that will illustrate:
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RapidFACT has been proven to accelerate program timelines by at least 50 percent, and deliver significant cost savings. This has been achieved by the co-location of real-time GMP manufacturing and clinical testing, under Quotient’s Translational Pharmaceutics® platform, which enables formulation selection to be based on emerging clinical data. Applications have included assessments of solubility enhancement, modified release, and changes to drug delivery route.
This webinar will showcase studies and metrics from industry experts and users of RapidFACT, illustrating the applications and benefits when developing enabled drug formulations.