Advancing the CMC Development of Oncology Medicines
Oncology drugs dominate today’s industry pipeline with over >5500 molecules in development for 2019 alone. With this number of molecules, the stakes are high, increasing the pressure on pharmaceutical scientists to get medications to patients as quickly as possible. But does the focus on speed mean sacrifices are made elsewhere in the development plan? Drug developers need to be mindful of the challenges that come with oncology drug products in order to accelerate to proof-of-concept and onwards towards a successful commercial launch.
Advancing the Pharmaceutical Development of Orphan Drugs for Rare Diseases
With over 300 million people worldwide living with one or more identified rare diseases, the development of new treatments to address these unmet clinical needs is an area of significant focus in the pharmaceutical industry.
Strategies for Accelerating the Development of Modified Release Oral Forms
MR drug delivery can also have commercial benefits and is prevalent as part of product life-cycle management (LCM). Modest reformulation of an already approved drug from an IR to MR format allows both line and patent extension opportunities and continued market exclusivity.
Current practice in the conduct of the acceptability - Palatability - swallowability trials - A review of methodology associated with trials registered on the EU clinical trials portfolio
Guidance issued by the European Medicines Agency (EMA) states that patient acceptability must be an integral part of paediatric formulation development and described in the paediatric investigation plan (PIP). However, the methodology used to assess acceptability and the timing of this assessment is unclear. Previous reviews have used literature sources to review methods to assess acceptability with diverse methods reported
Accelerating the Developing of Orphan Drugs for Rare Diseases
Worldwide there are over 300 million people living with identified rare diseases. This white paper will discuss four principal CMC challenges for the developers of orphan drugs, and the potential solutions which are emerging.
Accelerating the Development of Oncology Medicines
Oncology drugs dominate today’s research focus with over >5500 molecules in development, representing over 35% of the total industry pipeline. 10 new oncology drugs were approved by FDA in 2019, of which half had an orphan indication and all had been granted priority review. Given the number of molecules in development, there is increasing pressure on development teams to identify successful drug candidates as quickly as possible, and accelerate patient access, particularly where no effective therapies are currently available.
Project Management at Quotient Sciences
Quotient is an innovative drug development and manufacturing partner supporting clients from candidate selection to commercial launch. With expertise in end-to-end Project Management and integrated project teams, we make drug development easier for our customers and dramatically reduce the time and cost of getting new medicines to patients.
Developing a Poorly Tasting Drug Substance into a Palatable Dosage Form
Many drug substances are extremely bitter or have other aversive attributes, which can make developing palatable drug products extremely challenging. This is a common problem seen in medicines spanning all therapeutic areas, from antibiotics and painkillers to antihistamines and decongestants. The careful design and development of formulated oral drug products is key to ensuring patient acceptability and compliance for achieving the desired clinical outcomes.
Accelerating Development of 505(B)(2) Product
Quotient has significant experience in 505(b)(2) product development and can support you in efficiently turning your innovative ideas into successful products. Over the past several years, the FDA’s 505(b)(2) regulatory pathway has enabled the approval of a variety of differentiated dosage forms for existing molecules. There has been an increasing number of product approvals in the US using this approach and similarly, in the EU, the Hybrid Medicine Authorization process can provide new product opportunities for previously approved compounds.
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.
Integrated Pharmacy Compounding and GMP Manufacturing Fact Sheet
Quotient Sciences provides integrated pharmacy compounding, formulation, GMP manufacturing and clinical testing solutions to help clients achieve their proof-of-concept (POC) milestone quickly, saving them precious development time and money. Begin your First-in-Human (FIH) Phase I testing with a fit-for-purpose, simple pharmacy preparation, and then seamlessly transition to a scalable, solid oral GMP drug product for Phase II trials, all within one organization.
A Clinical Assessment of Delayed-Release Coated Capsule Compositions for Regional Gastrointestinal Delivery using Gamma Scintigraphy
Applied Molecular Transport Inc. are evaluating targeted drug delivery capsules for administration of locally acting drugs directly to the site of action in the gastrointestinal (GI) tract. This study used gamma scintigraphy to evaluate GI transit and release from 3 capsule prototypes with different coating systems (1). In addition, data on pH, temperature and pressure during GI transit was obtained using SmartPill® and correlated with scintigraphy data (2).