What is your job position and how would you define it?

My name is Valentina Zhukova-Harill and I am a Chief Medical Officer. I provide management and leadership to the medical services team, which consists of two groups: medical services and pharmacovigilance. I am responsible for strategic direction and leadership to the medical officers and safety officers. At the company level, I also serve as a medical leader offering support and training for other departments.

What is your expertise area? 

I have more than 46 years of experience: 20 years as a clinical physician and 26 years in clinical research. My oncology experience covers various therapeutic areas specifically solid variety of solid tumours and oncology indication and haematological malignancies. I was involved in two Food and Drug Administration approvals in 2010 and 2015.

Why is your job position relevant at Aixial Group? 

The CMO oversees important aspects of clinical research such as medical review of safety data for trends, ongoing review of safety data, and evaluation of the risk-benefit of the investigational products. The CMO serves as a connection between the clients and our healthcare sides.

When does your expertise come into the product’s life cycle?

My involvement in product development typically started in the early phase, oncology first-in-human trial, up to approval by regulatory authorities and post-marketing surveillance. My team and I assist our sponsors with each of these steps.

What are some current and future challenges or trends impacting your area of expertise?

One of the major challenges is the high cost of standard-of-care options which will increase the pressure on the pharmaceutical industry to reduce the development time and also cost required to bring the most efficient treatment options to the market.