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.

Held annually since 2004, the TOPRA Symposium is Europe’s premier conference for healthcare regulatory affairs.