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.
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.
Alternative Strategies for Development of Modified Release Dosage Forms
Modified-release (MR) formulations are in high demand. For formulators, they enable drugs to be released in the optimal gastrointestinal (GI) locations to achieve and maintain desirable plasma concentrations for extended periods, avoiding undesirable excursions outside the therapeutic range.
Assessing the Financial Impact of Translational Pharmaceutics®
Tufts Center for the Study of Drug Development (CSDD) white paper sharing study results that indicate Quotient Sciences’ Translational Pharmaceutics® platform reduces development times by more than 12 months and lowers R&D costs by more than $100 million per approved new drug, compared to traditional multi-vendor development paradigms.
Application of a Novel ‘Make and Test in Parallel’ Strategy to Investigate the Effect of Formulation on the Pharmacokinetics of GDC-0810 in Healthy Subjects
GDC-0810, administered orally, was used in Phase I and II clinical studies to treat estrogen receptor positive breast cancers.
Accelerating development of enabled formulations for poorly soluble drugs
Efficacy issues due to inadequate gastrointestinal (GI) absorption caused by insufficient aqueous solubility are encountered in up to 70% of new drugs in development.1 Typically, in vitro analysis and preclinical studies are used to predict the behaviour of the drug in vivo