Felicity Thomas

Patient-centric drug development is becoming more important in the bio/pharma industry.

Stability testing is an integral part of bio/pharmaceutical production, and harmonizing best practices and regulatory requirements is key to finding the best approach.

Characterizing particles and understanding bulk powder behavior is critical to get the best pharma product.

Pharmaceutical Technology Europe spoke with Manuel Leal, business development director for Idifarma to learn more about spray drying and how it can support patient-centric drug development.

Easier access to information, targeting smaller patient populations, and increased regulatory focus on patient outcomes are driving patient‑centric drug development.

Uncertainty remains around the UK’s departure from the EU, potentially causing irreparable damage to the bio/pharma sector.

Flexibility and well considered manufacturing approaches could help tablet manufacturers face the increasing pressure resulting from the shifting bio/pharma development landscape.

A monoplant may offer greater supply security and flexibility for specialist medicines.

Bio/pharma companies facing new challenges in light of the increasing HPAPI market may benefit from outsourcing.

As biologics continue to push boundaries, the industry needs to take a holistic approach to formulation to ensure success.

As drug pricing comes under the microscope internationally, it appears that collaboration with all stakeholders is key to tackling the issue.

Harmonization of best practices and regulatory requirements will enable developers to find the best stability testing approach.

Drug solubility can benefit from approaching solubility issues early on in the drug lifecycle.

As we approach the next instalment of Pharmapack Europe, a potentially perilous situation in relation to drug packaging has emerged for pharmaceutical companies should Brexit result in a ‘no deal’ scenario.

Technical advances in process understanding and control must be accompanied by a change in mindset.

Political instability is causing uncertainty in Europe and wreaking havoc with US regulatory timeframes.

A new initiative has been launched to help stimulate industry discussion on innovative tech for use across the drug supply chain.

The EU FMD deadline is closing in, so now is the time to look beyond the short term.

The new year has started with a bang in terms of mergers and acquisitions.

Early adoption of the right approach to address solubility can deliver significant benefits.

New approaches seek to address formulation and delivery challenges for these complex molecules.

As Brexit rapidly approaches, the lack of clarity around the regulatory balance between the regions could lead to a reduction in standards.

A brief preview of what to expect at pharma’s dedicated packaging and drug delivery event.

Taking stock on the ‘big-ticket’ news items, both good and bad, from the past 12 months.

During CPhI Worldwide in Madrid, Lynne Byers, executive director of NSF International detailed the facts about how Brexit can impact the pharmaceutical industry.

… Brexit may be a bumpy ride. Here, the new European editor of the PharmTech Group, Felicity Thomas, discusses Brexit and its implications for the pharma industry.