Felicity Thomas

Common approaches to analyze elemental impurities for compliance with regulatory requirements are robust but still have some limitations.

Rapid growth in biologics and increasing complexity of new compounds are some of the factors driving development of innovative delivery solutions.

Common approaches to analyze elemental impurities for compliance with regulatory requirements are robust but still have some limitations.

COVID-19 vaccine supplies are breaking news headlines, in both ‘good’ and ‘not so good’ ways.

Outsourcing partners can provide a multitude of advantages in the development of drug delivery solutions, including those designed for targeted patient populations.

Although a necessity, companies must strike a critical balance between protecting innovations with IP and providing affordable access to medicines.

Despite the COVID-19 pandemic disruptions, with continued support and industry resilience, the European bio/pharma outlook for 2021 is positive.

The right partner can help companies overcome key formulation challenges for biologic drugs.

Positive regulatory developments are aiding the growth of the cannabis pharmaceuticals market, but more clinical data are needed to break the stigma and bring science to the fore.

EMA’s SPOR implementation guide version two is expected to be published soon, starting the countdown for companies to ensure their data-based submissions are compliant.

The outlook for the European pharma industry is appearing to be favourable overall.

Transparency and open-dialogue are vital to sway the vaccine-hesitant community.

Amorphous solid dispersions are a useful tool in overcoming solubility issues, but they have not yet reached full potential in commercial success.

Bio/pharma continues preparations for a no-deal scenario as time for the UK and EU to agree upon a new deal runs out.

Industry wants clarification on compliance following the end of the Brexit transition period.

More complex and challenging compounds require a more tailored approach to formulation strategies.

Taste-masking can be of significant importance in ensuring success of a drug product, particularly those targeted to pediatric or geriatric populations.

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.