Felicity Thomas

A comprehensive rewrite of Annex 1 has been proposed and aims to organize and structure requirements in 10 specific sections.

European pharma companies may have a vested interest in the outcome of the US elections.

Tight development timelines and accelerated approval pathways favor simple, cost-effective capsule formulations.

The general principle of lyophilization has hardly changed, but significant advances have occurred in process and product attribute understanding.

AstraZeneca has potentially taken poll position in the race to develop a novel coronavirus vaccine, but will AZD1222 be ready in 2020?

Supply chain traceability is essential in the manufacture of APIs to assure safety and quality.

End-user considerations are becoming increasingly important as they can provide a lot of value and help to ensure commercial success of a drug.

Particle engineering is a useful tool to manipulate API particles into a form that is manufacturable and deliverable to the patient.

Efforts are already underway to harmonize standards and regulatory approaches for testing of raw and ancillary materials, but continuous improvement is required.

COVID-19’s impact on the global economy is dealing a blow to merger and acquisition activity in the biopharma industry.

The right outsourcing partner should open up access to expertise and technical capabilities in a broad range of dosage forms to ensure commercial success.

Demand for custom drug delivery solutions is increasing and bringing forth an exciting period of valuable, innovative development opportunities.

There is much to learn from the COVID-19 pandemic, but future success may hinge upon the capacity for regulatory bodies to harmonize approaches.

Controlled-release formulations offer numerous advantages for developers and patients, and this market is expected to continue to experience growth in the near future.

COVID-19 vaccines are being developed rapidly, giving rise to a reinvigoration of the sector.

As Brexit talks intensify, bio/pharma companies from both the UK and EU need to consider and aim to prepare for all scenarios.

The importance of capability and capacity of a CDMO partner to deliver drug substance and product testing should never be underestimated, considering the increasing complexity of compounds in development.

Increasing prevalence of drug misuse and abuse is driving a heightened and more stringent approach to abuse-deterrent formulations.

Connected delivery solutions can provide value to industry and patients, through improved medication adherence and outcome optimization.

The global COVID-19 pandemic has highlighted the need for the pharmaceutical industry to strengthen its supply chain.

Pharma’s reputation is being boosted in light of the current COVID-19 pandemic efforts.

As a result of the rising use and development of biological drugs, the biopharma industry is witnessing an increase in the adoption of prefilled syringes.

Industry must never become complacent about the safety of drug products and should seek to continually perform surveillance even if the drug is well-established.

In light of the hype around chloroquine and hydroxychloroquine as potential COVID-19 treatments, it is important to remember that drug repurposing should never be rushed, irrespective of the urgency of the situation.

Reformulation strategies can provide drug developers with a head start to achieve promising options that benefit the patient.

Characterizing and controlling protein aggregation is vital to ensure safety and efficacy of a biopharmaceutical product. In this interview, important aspects of protein aggregation and the tools available to address this issue are discussed.

As COVID-19 rapidly spreads, the bio/pharma industry is committing significant efforts to fast track development of therapies.

Considering the potential interaction of a drug with the delivery device early on in in development is integral to achieving the best combination.

The new molecules entering the development pipeline are bringing forth exciting challenges in drug delivery.

Understanding formulation properties early in development can prevent some costly issues later on.