News & Articles

In the European Union (EU) a network of approximately 50 regulatory authorities from the 30 European Economic Area (EEA) countries1, the European Commission (EC) and European Medicines Agency (EMA) form the basis of the European regulatory system and play a role in the authorisation and monitoring of medicines in this region.

Sponsors of investigational medicinal products (IMP) are encouraged to seek guidance from the FDA throughout the course of development in order to maximise the likelihood of regulatory approval. The FDA offers opportunities for Sponsors to request guidance on a development program free of charge and irrespective of the stage of development.

Oncolytic viruses (OVs) have gained significant attention and interest in the last two decades for their unique ability to selectively infect and replicate within cancer cells. The concept of oncolytic virotherapy involves using viruses to target and destroy cancer cells while sparing normal, healthy cells. OVs not only directly destroy tumor cells but also stimulate the host’s anti-tumor immune system response, which destroy neighbouring cancer cells.

The development of a new drug is a lengthy and expensive process. On average it takes 10-15 years, with an estimated cost of £1-2 billion for a potential drug to be approved for use. Analysis of clinical trial data from 2010 to 2017 show that 30% of compounds that reach Phase I clinical trials fail due to unmanageable toxicity, and many of those fail due to nephrotoxicity and acute kidney injuries.

The pathway for transitioning into a clinical-stage company is a crucial step in the development lifecycle of a product, as a favorable safety profile needs to be demonstrated and regulatory approval received before embarking on first in human clinical studies.

Patient safety is at the centre of drug development and monitoring the safety profile of a drug from the first patient dose through to market and beyond is a key activity for all drug developers.

The first regulation and guidance for copy biotech products (biosimilars), pioneered by the EMA, not only enabled the introduction of biosimilars in the EU, but also were a model for regulatory regions worldwide.

An overview of the key regulatory intelligence updates from FDA, EC, EMA & MHRA released in 2023.

The first regulation and guidance for similar biological medicinal products (‘biosimilars’) was introduced by the European Union, as it was considered impossible to make exact copies of biopharmaceuticals.

Ideally, all patients in the European Union should have equal access to safe, efficacious, and high-quality medicines. However, reality is more erratic, as many European citizens are all too familiar with the frustration of limited access to medicines.

Scendea is pleased to share our experience at the 11th annual MIBio conference, a gathering of experts in the fields of biologics formulations and drug delivery. The conference served as a platform for illuminating discussions on the stability of biopharmaceuticals.

This October, Scendea’s Principal Consultant, Ian Waterson, had the pleasure of attending the UK BioIndustry Association (BIA) conference on The Future of UK Regulation: Driving innovation in the Life Sciences.

A growing body of pre-clinical and clinical research has implicated the influence of bacteria on human health which over the last decade led to a flurry of venture capital and biopharma interest.

Micro, small and medium-sized enterprises (SMEs) are valuable sources of pharmaceutical innovation. In 2020, nearly 20% of all human medicines recommended for authorisation were developed by SMEs, with half of these targeting rare diseases.

Biocentury has helped biotech executives and investors make business critical decisions and build larger networks with peers across the innovation ecosystem. To kick of a European tour celebrating the 30th anniversary of the organisation, and in-depth interview with Emer Cooke, executive director of the European Medicines Agency was held in Amsterdam.

Vaccines have been in the spotlight in recent years and are a hot topic. Indeed, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been a focus, but other vaccine development has not halted. In the last 12 months alone a number of vaccines have been authorised in the EU and U.S and are presented below and discussed in this short summary.

Scendea were thrilled to attend the two-day Advanced Therapies 2023 Congress, held at ExCel London, on 14 and 15 March. The event is Europe’s largest cell and gene conference and exhibition, and brings together experts in the field of advanced therapy medicinal products (ATMPs) who are at the forefront of efforts aiming to improve patient access to quality, safe and effective cell and gene therapies.

Discover the latest developments in gene therapy, and how CRISPR-Cas Technologies are shaping the future of gene editing, in our new whitepaper, "Off-Target Challenges for Gene Editing". Authored by Scendea's Head of Non-Clinical & Principal Consultant, Dr Angeles Escarti-Nebot and Associate Consultant, David Kidd.

The COVID-19 pandemic has led to unprecedented public investments, at-risk investment in (clinical) development and manufacturing, and the streamlining of regulatory processes, resulting in rapid, focussed, and collaborative development of COVID-19 vaccines and acceptability of new vaccine platforms.

We are thrilled to announce the release of our new whitepaper, in collaboration with FGK, "Clinical Trial Regulation: A New Chapter for EU Clinical Trials", authored by Senior Consultant, Amy Cooke, Principal Consultant, Dr Maria Beatrice Panico, and Director of Regulatory Affairs at FGK, Dr Uwe Kramer.