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Agnes Klein

Senior Medical Advisor, Biologic and Radiopharmaceutical Drugs Directorate, Health Canada
DIA Volunteer

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When did you realize you wanted to work in clinical trials and drug development?

When I was hired to the Canadian government. I always wanted to do clinical research and discover new and better treatments.

In your opinion, what is the greatest challenge in your field?

Keeping up with advances in regulations and science. Also, the constant change in patient expectations and the need to ensure the safety, quality, efficacy, and effectiveness of medications can create a challenging push-pull situation. But those challenges are useful, as they keep me on my toes.

What in your opinion is the biggest gap between research and practice in your field?

The lack of public understanding of the difference between the role of the regulator, the drug developer, and the public need.

Where do you see your field going? What is your vision of the field in 2030?

Fast progress will continue to increase the push-pull situation and raise public expectations. On the one hand, the cost of new therapies and advances in medicine and clinical sciences may not keep up with public expectations. On the other hand, rapid advancements in AI will continue to raise expectations for unachievable miracles. This is a business where hard work is needed, and sometimes the public may not understand that.

What do you like most and least about your job?

I love my job and cannot think of anything that I like least.

What book are you currently reading and why?

I like to read detective novels and fantasy books. I am now reading the second of a trilogy that is called The Magician King. I am looking forward to purchasing the third book in the trilogy. I also read books in French; presently, I am reading a small volume called The Code of Esther.

What advice would you give your younger self about to enter the “real world?”

Find your niche and stay in it. Carve yourself a reputation for excellence in what you do. That is the advice I give to every recruit who enters the regulatory world in government.

What have you become better at saying “no” to?

I am not sure I have become that good at saying “no.” Although today I did say “no” to a colleague. I am not sure she was very pleased, but that is how it goes.

Imagine a day without work, the internet, and any other obligations. What would you do?

I have many other interests. My favorite is arts and crafts. It would be wonderful to just be able to do nothing else but knit or paint or embroider, or just draw aimlessly and doodle on a page…

How has DIA helped you?

DIA has provided excellent connections. DIA has also helped me realize that I am in the right profession for myself. I wanted to end up in academic medicine. While what I currently do was meant to be a stop gap, I now realize that it has all the advantages of academic medicine, minus its “political” disadvantages.

What would you like to see DIA do for you in the future?

More of the same: feed my love for what I do.

Agnes V. Klein MD, DPH, a graduate in Medicine and Public Health from the University of Toronto, is currently the Senior Medical Advisor in the Biologics and Genetic Therapies Directorate at Health Canada. Klein has interests in multiple aspects of drug development, clinical trial design, and medical bioethics. She has over 40 years of experience in various aspects of the development and regulation of therapeutics, including pharmaceuticals and biologics. Over the years, Klein has received wide recognition and awards for her regulatory work, both from outside Health Canada and within the Department, including the DIA Award for Outstanding Service, the Queen’s Jubilee Medal, the Deputy Minister’s Recognition Award and a CSPS Fellowship. Klein has also given many presentations on regulatory, clinical, and scientific matters and has written and contributed to several publications on drug development and clinical trials.

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