The Challenges of Risk Management in Biopharmaceuticals

Unlike traditional small molecule drugs, every part of the clinical development, manufacturing, and prescription process for biopharmaceuticals has an important impact on the safety and risk profile of a drug.  Identifying, collating and understanding all of the various drivers and their effect on drug safety presents challenges that are exaggerated or unique compared to traditional drugs.

For manufacturers, simply capturing relevant data to determine safety is difficult.  It is even harder to apply this information to the risk management of current drugs than it is to traditional drugs.  Extending this to future drug development with the aim to reduce risks and costs consequently becomes a challenge, which many companies have so far avoided. 

However, lessons from other industries in risk management and traditional pharmacovigilance practices can be combined to produce more holistic processes. 

To read the article in full, please click on the pdf link below:

Safety First the challenges of risk management in biopharmaceuticals.pdf