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Sanofi Canada

2905 Place Louis-R.-Renaud 
Laval, Quebec, H7V 0A3

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Catherine Cunningham
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514-956-6120

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Content :

Bench to Bedside Conference for Youth

Speech delivered by Diane Lafontaine
Associate Director, Clinical Study Unit, Sanofi Canada

 

Good afternoon, and welcome to the second half of the Bench to Bedside Conference for Youth.

What an INSPIRING day we have had so far. I am so impressed with what we have heard from our speakers in the talks this morning.

While each speaker addressed different aspects of their career, there is one common theme that jumped out at me: Science opens doors.

Each of you will pursue different studies and different career paths, and if my own experience is any indication, there will be no limit to the wonderful opportunities that science will give you.

In my talk today, I will start by telling you a little bit about me, and the work I do as the Associate Director of the Clinical Studies Unit at Sanofi Canada, a pharmaceutical company based in Laval.

Earlier today, my colleague Franca Mancino told you a bit about our company and the work that we do to bring innovative treatments to patients around the world.

There are two things I hope to teach you in this presentation:

  • First - How your studies and careers can involve both research and patient care, and 

  • Second – How a medication goes from Bench to Bedside. I will talk about the various phases of clinical trials, which are the process through which new medications are tested and approved.

As I look at you here today, I remember myself when I was in school.

As a mother of three teenagers, one of whom is in CEGEP, I know exactly what you are experiencing at this stage of your life. You are wondering what’s next, and what the best decision will be for your academic studies and career.

I have no doubt that many of you are worried about making the RIGHT or WRONG decision.
I have good news for you: my experience has taught me that there IS no right or wrong decision. When you study science, you are opening yourself up to a world of opportunity.

When I was 16, I was a good student. Like ALL good students at the time, I was encouraged by my teachers to study science. My first step after high school was to pursue a Bachelor of Nursing degree at the Université de Montréal. I was attracted to nursing because of both the science curriculum and the focus on patient care.

After working in nursing for one year, I realized that I had a STRONG passion for clinical research. I therefore decided to pursue a Master’s degree in Pharmaceutical Science from the Université de Montréal. It was at this stage of my life that I learned the importance of seeking the opportunity to learn OUTSIDE of the classroom.

I had heard of a summer internship program through which third-year pharmacy students could work with a mentor at Nordic Pharma Group. When I learned about this internship, I was still a first-year pharmacy student. BUT, I had a passion to learn, and I recognized what an exciting opportunity this could be.

I spoke to the Dean of the pharmacy program, and told him why I would be the perfect candidate for the internship. I was motivated, hard-working, and passionate about clinical research.

I am happy to say that the Dean listened to what I had to say, and he found me a spot in the program, EVEN THOUGH I was younger than the rest of the participants. I’m glad he did, because that internship was an important part of my early career. It gave me valuable experience in clinical research that put me on the track to where I am today.

So what did I learn at this early stage of my career? That there is no right or wrong decision about what to study. My degree in nursing gave me a very relevant background for my advanced studies in pharmacy. As well, I learned not to be afraid to knock on doors, and to take advantage of opportunities to build relationships with mentors and learn OUTSIDE of the classroom.

My experience demonstrates that science TRULY opens doors, and will teach you a number of skills that you will use throughout your lives - both in AND out of the lab.

One of the themes of today’s event is the important link between the bench and bedside – how research on the bench translates into patient care at the bedside.

My job today involves overseeing Canadian clinical trials for Sanofi Canada, and I also work with Sanofi’s teams across North America as the Associate Director of Clinical Research Operations.
Clinical trials are an essential aspect of how a medicine is developed. Clinical trials provide information about the SAFETY and EFFECTIVENESS of new medicines and treatments to determine if they should become available to patients.

One of the most POWERFUL aspects of science is its potential to help AND heal people who suffer from debilitating diseases. Scientific research has, over the past centuries, led to advancements that have changed the lives of millions of people who once had no hope of being cured.

  • In 1914, the first public health vaccines and sera were produced in Canada.

  • In 1921, we saw the discovery of insulin for diabetes, based on the work of Dr. Frederick Banting, a young orthopedic surgeon in Ontario.

  • In 1959, we saw the discovery of vinblastine for use in chemotherapy, now a very common cancer treatment.

It is interesting to note that, even though these discoveries happened many years ago, the diseases that they target are still EXTREMELY important areas of scientific research, with patient needs that are still not met. Sanofi and other healthcare companies are continually working to find NEW and INNOVATIVE ways to treat and manage cancer, diabetes, cardiovascular diseases, infectious diseases, rare diseases and other conditions that affect millions of people around the world.

It is ALSO interesting to note that, in many cases, discoveries that led to medical breakthroughs were not part of a deliberate research plan. Many discoveries were made due to what were initially perceived as failed experiments, or mistakes. For example, the 19th century scientist Louis Pasteur – who is also the namesake of our Sanofi Pasteur vaccines division – identified the concept of immunization following a failed experiment on chicken cholera.

During Pasteur’s experiment, a culture of the responsible bacteria had spoiled and failed to induce cholera in some chickens he was infecting with the disease. Upon reusing these healthy chickens, Pasteur discovered he could not infect them, even with fresh bacteria, because the weakened bacteria had caused the chickens to become immune to the disease.

Nowadays, there is a very specific process through which treatments and medications are identified and tested before they are made available to doctors and patients. That process is called a clinical trial.

A clinical trial is the evaluation of a new medicine in human subjects, patients or healthy volunteers, to verify its safety and benefits, AND to identify its adverse reactions and side effects. Clinical trials are ESSENTIAL for the advancement of life-saving medical therapies.

The process of taking a medication from the pre-clinical to the clinical stage is significant.
In general, it takes between 10 to 15 years for a medication to go from discovery to treatment. The associated costs can be from 800 million to one billion dollars. 

It is also a process where many failures are required to achieve a single success. For every 5,000 to 10,000 compounds that enter research and development, only ONE might receive approval.
Before I explain the phases of a clinical trial, there are some important points to understand.
First, all clinical trials in Canada MUST have a pre-established protocol based on Good Clinical Practices, or GCPs, an international ethical quality standard for the trial’s design, conduct, performance, monitoring, and reporting. This protocol will ensure that the trial’s results are credible and accurate, and that the rights of participants are protected.

Before a protocol can be put in place, two levels of approval are required -  from Health Canada AND an independent ethics committee. These approvals confirm that a trial’s protocol is scientifically sound, and that it adheres to BOTH GCPs and the safety of participants.

The rights of patients who participate in clinical trials is a TOP priority. Participants are required to sign an informed consent in which they confirm that they are willing participate, that they understand the process, as well as any potential adverse events. The consent also allows for participants to withdraw from the trial at ANY given time. 

And now, I will take you through the phases of a clinical trial. Each phase has a very specific outcome.
First, the pre-clinical stage:
This stage is focused on discovery and driving innovation. Human subjects are not involved in this early stage of the process – instead, the focus is on molecules. Scientists and researchers work to identify the causes of a disease at the level of the genes, proteins and cells. Scientists then establish targets that potential new treatments may be able to affect. Researchers work to discover the right molecule to interact with the target.

In Phase 1 of a clinical trial:
At this point, the compound is tested mainly on a limited number of healthy human subjects, who are under strict medical supervision. The compound is tested over a short period of time. The PURPOSE is to evaluate the medication’s safety, how it evolves within the body, the tolerance threshold and adverse events.

In Phase 2:

  • Testing involves LARGER groups of patients.

  • The purpose is to test the treatment’s efficacy and determine the optimal dosage.
    These studies are usually comparative: one of two groups of patients is administered the treatment whereas the other group is given a placebo.

In Phase 3:
Testing involves a large number of patients, with the purpose of comparing the therapeutic efficacy of the compound to a reference treatment - if there is one - or to a placebo.

Such studies frequently involve many study centres. Generally, neither the patient, nor the medical professional who is leading the study centre ,are aware of what each patient is being treated with. This is what is known as a “double blind trial”. This approach allows the researchers and participants to avoid any bias or prejudiced opinion on either side regarding efficacy or adverse events.

Once these 3 phases have been successfully completed, the resulting data, together with the results of preclinical testing, are collected to compose a registration file that will be submitted to public health authorities for license to market. In Canada, that authority is Health Canada.

What many people do not realize is that clinical trials are not over once the medication has been approved. 

Trials called Phase IV, are carried out after approval in conditions close to those of usual medical care. Specific targets at this point are to detect possible rare undesirable side effects which had escaped attention in the previous phases and to define conditions of use for certain groups of at-risk patients.
As you can imagine, participating in a clinical trial can be a TREMENDOUS opportunity for a patient who suffers from a disease for which there is no known cure, AND for which there have not previously been any existing treatments.

Our goal ultimate goal is for patients to have access to these new and better treatments as they become available.

Part of my job as Associate Director of the Clinical Studies Unit at Sanofi Canada is to oversee our team of Clinical Research Associates. These individuals are responsible for preparing and overseeing many aspects of the clinical trials that Sanofi carries out.

When Sanofi Canada receives the mandate for a new clinical trial, our Clinical Research Associates establish the trial’s protocol to ensure that it reflects Good Clinical Practices; they research and recruit study centres; they train the teams who are responsible for the different study centres and they monitor the progress of the trial.

This can be a dynamic and rewarding career that involves working with research teams across the country and around the world and ensuring that a trial adheres to the highest industry standards.

___________________________________________________________
As I reach the end of my presentation, I would like to share my perspective on what the future may hold for science and research.

I believe that the future is SO promising. This is partly because Canada is recognized around the world as a great place to do clinical research. Canada is praised for the quality of its researchers, and their ability to target complex therapeutical areas within a diverse population base. Canada’s academic health R&D ranks among the Top 10 of countries worldwide in terms of biopharmaceutical research output and scientific impact.

You are the most technologically-savvy generation, and you will not be surprised to learn that technology will be a key factor in the way clinical trials are designed, conducted and reported. For example, patients participating in a clinical trial will be able to record and report their experience using an electronic diary, or via their smartphone, instead of using a pen and paper. 

Technology will also affect the design and implementation of clinical trials, and the way in which patients provide feedback.

If there is ONE message I can leave you with today, it is to be EXCITED about what your future in science will hold. This is an extremely exciting time for science and research.

The decisions that you make today will open doors in the future that you may never have expected, as they did for me.

Thank you, and enjoy the workshops this afternoon.
I am happy to talk to you if you have any questions.

Last update: January 17, 2015

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