The complexities of innovation in Canada

VP Medical and Regulatory Affairs of Roche Canada shares her insight on what it takes to bring innovative medicines to Canadians

With her work at Roche Canada, Dr. Loredana Regep has gained deep insight into what it takes to develop innovative medicines for use in Canada. Get her take on the challenges, processes and potential rewards.

“The discovery and development of any new medicine or vaccine is a costly, complex and lengthy process. On average, it takes 10 to 15 years between drug discovery to approval, with no guarantees for success.

Before a drug is approved for use by patients, it has gone through three phases of research involving thousands of researchers, scientists, doctors and volunteers. The goal for each medicine is to ensure the right balance between efficacy and safety is being achieved.

Clinical trials are the best way to understand the safety and efficacy of a potential new treatment.

We believe investing in clinical trials and offering Canadians the ability to participate in medical research in their own backyard is, by far, the best thing we can do for the health of Canadians today and tomorrow.

And there are other challenges involved. The complexity of many diseases, such as conditions of the nervous system or cancer, have historically been the most challenging to understand and treat. The regulatory and legal landscape around the world make the implementation of international clinical trials time-consuming and expensive. Fragmented data infrastructure in some countries prevent us from collecting meaningful insights that would maximize the benefits and minimize the risks for any individual patient. Further, the increasing unpredictability of the public and private reimbursement landscape. These are all major challenges for any drug developer.

Before new medicines and vaccines are authorized for use in Canada, Health Canada reviews them to assess their safety, efficacy and quality. A pharmaceutical company must present scientific evidence so that Health Canada can make an informed decision about whether the benefits for a treatment outweigh the potential side-effects.

But the process doesn’t stop when a product is approved. Ensuring we’re monitoring the safety and efficacy of our medicines is a continuous effort.

Before and after a drug approval, we implement global and country-specific procedures to continuously monitor and collect data about the safety of our medicines. This ensures we are learning about them once they are being used by patients in a real-world setting.”

Dr. Loredana Regep 
VP Medical and Regulatory Affairs
Hoffmann-La Roche Limited (Roche Canada)