Interview with Dr Julia Levy, former CEO & President of QLT Inc.
Interview with Dr Julia Levy, former CEO & President of QLT Inc.
by [Carolyn Cross, Treasurer IPA Board of Directors]
Introduction
The greatest commercial success story of photodynamic therapy (PDT) belongs, without a doubt, to Vancouver-based QLT Inc. Led by co-founder and former CEO & President, Dr. Julia Levy, QLT initially developed the only FDA approved PDT drug (Photofrin) for cancer applications. When QLT pivoted to the multi-billion dollar under-served age-related macular degeneration (AMD) market with Visudyne, the company put PDT on the global map. In light of QLT’s extraordinary success, I was delighted for the opportunity to ask Dr. Levy some questions for the IPA newsletter. I was even more pleased to learn that she has written a book chronicling her QLT memoirs, which will be featured in an upcoming issue of the IPA newsletter.
Carolyn Cross: “Can you describe one of your most rewarding moments at QLT?”
Dr. Julia Levy, former CEO & President of QLT Inc.
Julia Levy: “This is an easy one. I think I was most thrilled and excited by the first patient ever being treated with Visudyne (or BPD-MA as we called it) for AMD. We had spent so much time and money developing the drug after making the decision to pursue the AMD indication. The scale-up, formulation, toxicology and the testing of animal models (ocular pre-clinical models must be primates) had put the company (and investors) at risk. But the moment came to treat the first patient.
We knew the drug was safe to administer to humans because we had already tested it in humans with metastatic skin lesions in order to determine drug levels for selectivity and efficacy on usually metastatic lesions to the skin with either breast or GI cancers. We had seen terrific outcomes there in helping patients get rid of surface lesions without, probably, effecting their survival times. But that wasn’t an indication you could approach FDA with to get an approval.
With AMD, we were going to perform an ablative treatment on someone’s eye. If successful, we might be developing the first pharmaceutical treatment for a disease that was the commonest cause of legal blindness in older people in the western world. The preclinical work we had done had allowed us to predict with some accuracy dose levels that could cause closure of blood vessels at the back of the eye when the drug had been injected intravenously shortly before light treatment. But would it work in humans?
The first patient was a fairly young man with choroidal neovasculature. He had agreed to the experimental treatment. The treatment went well but the patient vomited shortly after that. We worried that the drug might cause vomiting in humans. This turned out to be untrue since no other treated patients experienced this. The patient had been nervous and had consumed a large lunch of hamburger and chips shortly before.
The real thrill came later when we saw the results of the angiograms taken before and after treatment. At 24 hours. We saw then that the choroidal neovasculature (CNV) had been obliterated and while some normal choroidal vessels had been closed, these re-opened shortly after treatment.
Even though we had started at a low level of drug-light-dosing, we had already reached a level of efficacy in what we were trying to do. This outcome was amazing to me. Our preclinical work, knowledge of the drug molecule itself, and the dynamic of the interaction of tissue with drug had proven so clearly that we were on the right track; this gave me enormous pleasure. I was so proud of our team of scientists who had worked through this.”
Carolyn Cross: “What was your greatest challenge at QLT?”
Julia Levy: “Commercializing Photofrin was incredibly difficult. I address this challenge in my book. Having had that experience with Photofrin, however, made the commercialization of Visudyne much easier.”
Ed Levy, Tayyaba Hasan, and Julia Levy in Vancouver, Canada in 2019. (Left to Right)
Carolyn Cross: “Any regrets? What do you wish had been done differently?”
Julia Levy: “Again, Photofrin was our education. While we always make a number of mistakes in this complicated business, I actually treasured the mistakes we made as wonderful learning experiences, as long as they were reparable. I feel mistakes are the best form of education, as long as we are able to acknowledge they are mistakes.”
Carolyn Cross: “What advice would you offer the IPA community?”
Julia Levy: “My own thinking on the future of PDT is that we have to change our mindset that oncology is the only field to pursue. I think the bar is so high for any cancer indication, other than palliation, that FDA approvals and marketing success would be extremely difficult. Also, it would be a marketing challenge for any large pharma partner. I’m not saying PDT isn’t a terrific tool for treating some kinds of cancer, I’m saying it would be challenging to make a particular indication profitable. There is also physician buy-in, another complex and difficult challenge. PDT practitioners have to be part physicist, part chemist, part qualified technician. Some docs would prefer to prescribe a cytotoxic drug.”
Carolyn Cross: “What role did your husband play in the QLT success story?”
Julia Levy: “Ed played a key role in developing PDT while we worked together at QLT. He was our VP of Corporate Development and before that, he took over our device development. With his physics background, he was comfortable with lasers and laser companies. Additionally, Ed played a role in advising the FDA on putting together drug-device regulations to cover PDT.”
Carolyn Cross: “What do you enjoy doing these days?”
Julia Levy: “I’m retired now. I have been out of PDT for a few years but find myself re-engaged at this time. I have spent most of my time recently in acting as mentor/adviser to start-up biotech companies.”
Carolyn Cross: “...and writing your memoirs. We look forward to learning more about your extraordinary experiences when this book becomes available. Thank you so much for sharing your time and your insights.”
About the Author: Carolyn Cross, Treasurer IPA Board of Directors, Chairman and Chief Executive Officer at Ondine Biomedical Inc.
Image courtesy of Carolyn Cross