Companion Diagnostics – Partnering for Personalized Medicine

Industry Insights from Paul Meade, M. Sc, MPH

When the Human Genome Project was finally completed with the mapping of the genetic sequences of our DNA, there were many predictions about how the face of medicine would change forever. We would finally figure out how to cure diseases linked to genetic aberrations, find ways to enhance our interaction with the environment, and develop medicines that are tailored to fit our unique genome. But a decade later, we are all aware of just how painfully slow progress has been to date. However, one area that is advancing steadily is the use of companion diagnostics.

Everyone was quick to point to Herceptin and the prototype example of a diagnostic test that was required to be use prior to prescribing this chemotherapeutic agent for women with breast cancer that over-expressed the HER2/neu gene. But now there are more examples of such companion diagnostics, and the list continues to grow.

What does all this mean for the future of medicine, and the interaction among the diagnostic and biopharmaceutical companies? When we can go to a physician’s office, be correctly diagnosed, and then given a medicine to take knowing in advance that we will have a high probability of responding, without suffering from annoying side effects, then we will have personalized medicine.

Does that mean that people will have their own “designer” drugs specific to their unique genome? No, of course not. But it does mean that based on your similarity to a known genetic type, or genotype, your response to the medicine will be highly predictable, and therefore “personalized” to your specific needs. Thus, many drugs introduced in the future will have a unique companion diagnostic that will inform a specific response, and the cost benefit of taking such a drug will increase tremendously. As the old saying goes, “the most expensive drug in the world is the one that doesn’t work!”

Does that mean that companion diagnostics will be forever married to new therapeutic agents? Not really. As our knowledge of population genetics expands, and our characterizing of many different genotypes increases, we will likely get to the point whereby known genotypes will be mapped to known therapeutic agents, and the need for each new product to have its own companion diagnostic will diminish with time. But until then, expect to be given both a test and a prescription when you are treated at your nearby physician’s office. The road from general to personalized medicine is a long one that will take a great deal of research. But once we get there, the administration of medicines will gain a huge leap forward in effectiveness and efficiency.

The Thought Leaders Driving Thought Leader Select: A Blog Series–Daniel Bagi

Daniel Bagi joined Thought Leader Select to steer the company’s business development efforts in Latin America in the spring of 2010. With over two decades working for pharmaceutical and biotechnology companies, Dr. Bagi brings a high level of industry expertise to his consulting work with Thought Leader Select’s clients and prospects.

Daniel earned a Doctor of Medicine degree from the University of Monterrey (Mexico), and he has served the industry in a variety of capacities, including product development, regulatory affairs, licensing, and business development.  He directed global clinical development for a suite of anti-cancer drug therapies at Lorus Therapeutics of Markham, Ontario and IGT Pharma of Vancouver, British Columbia.

More recently, Dr. Bagi has served as a senior consultant to EM Diagnostics, a US-based breast cancer diagnostic company, and, since 2005, he has served as a medical consultant to Riso Pharma Tech, a Toronto company dedicated to developing pharmaceuticals for Latin America and the Middle East.

TLS Blog:  Good morning, Daniel.  Please tell us why you decided to join us at Thought Leader Select.

Daniel Bagi:  For me, one of the most important aspects of any professional endeavor is the work environment, which is defined by the attitudes and expertise of your colleagues.  Negativity can cause failure.  I was first approached by Neil Mellor (principal business development agent for North America), and Neil is just so upbeat—he exudes confidence and positivity in everything he does. Then, I met the president of the company, Paul Meade, and he had that same great level of positivity and vision—and it seems everyone in the company tries to emulate this particular value.

Just as important was the fact that Thought Leader Select’s work really fell into my universe of expertise as a corollary, a provider to the pharmaceutical industry.  This combination of positive people with good energy doing work in my area of expertise was irresistible.

TLS Blog:  How do your academic and/or professional backgrounds inform your work at Thought Leader Select?

Daniel Bagi:   After studying liberal arts, mainly history and literature, at the University of Toronto, I decided to go to medical school in Mexico.  What drew me to the medical field was the idea that I could really help people no matter how I applied the knowledge, the learning that I was embarking upon in my studies. I went to medical school with a great friend of mine who went on to become a cardiologist in the Dallas, Texas area.  I, on the other hand, knew I didn’t want to go into practice—I love the knowledge of medicine, but I would rather leave the practice to others —so I went to work doing clinical trials for pharmaceutical companies.  Now, here I am, 20 years later, working as a service provider to that same industry, having now served it in a variety of capacities—I ran a biotechnology company for several years, and I even provided investment banking analysis of the pharmaceutical industry, providing insights on management and burgeoning pipelines at the various companies I tracked.

After spending many years on the clinical research side of the business, I had the opportunity to get into business development and present and speak with clients and prospects.  I was able to work in Canada, the USA, Mexico and the rest of Latin America—you could say I took a “hemispheric” approach to business development!

TLS Blog:  What do you enjoy most about your work at Thought Leader Select?

Daniel Bagi:  I get a real adrenaline rush when I introduce and present something I believe in, like Thought Leader Select, to an audience—there’s nothing like it. I believe that a product or service, if it’s good enough, sells itself once people understand its purpose.

TLS Blog: Tell us what your life is like after you hang up your coat every day.

Daniel Bagi:  Well, I’ve always loved tennis and played as much as I can.  Up until a few years ago, the medical community’s consensus opinion was that endurance training such as long distance running was the best kind of cardiovascular exercise. Being a physician, I believe in the adage: physician heal thyself, ie: by staying fit, and I always believed that tennis was one of the best types of cardiovascular activity.  I’m happy to say that some of the more recent medical findings support this view, – that we are better suited for frequent short bursts of energy as a way of keeping our selves fit.   I’m also happy to say that I’ve passed along my love of the game to my oldest son, who is a top high school tennis player in Texas.

Family is very important to me.  I have five children, and I spend much of my time, when I’m not traveling for work, trying to have quality interactions with all of them.   With my career demands, I don’t know if I’ve always been considered to be the best husband, but I relish my role as a father.  Whatever it takes, I’m there for my kids—I don’t believe in forcing them to be anything other than themselves, and it’s important to me that they always know I will be there for them.

Personalized Medicine Shaping Pharma’s Future

Industry Insights from Paul Meade, M. Sc, MPH

I have spent the last 30 years directly or indirectly involved with the pharmaceutical industry. I worked for two international pharmaceutical companies and have advised many other pharmaceutical and biotechnology companies over the past few years. So I undoubtedly have a biased view in favor of this industry and its aims to promote health while making a reasonable profit for its research efforts.

While I can appreciate all the activities undertaken by pharmaceutical companies to develop medicines to improve the health of people throughout the world, I can also understand why many people have a jaded view of these companies. The perception that pharmaceutical companies take advantage of sick people and make them pay high prices for medicines to make them better is one that prevails among many societies. Yet, through the invention of antibiotics to control infectious diseases, and vaccines to prevent many childhood diseases, and many other products for a variety of diseases, the pharmaceutical industry has made significant improvements to healthcare. In addition to the high cost of medicines, few people realize that the total cost of pharmaceutical products as a portion of the total healthcare spending in the United States is less than 10%. Yet, many people believe that medicines are far too expensive.

Pharmaceutical companies, for the most part, are reasonably profitable; however, margins have been eroding steadily over the past few decades. This industry is one of high risks and great rewards, where only 1 in 1000 drugs ever make it to the market and the ones that do can take 7-8 years at a cost of over $800 million. So while the rewards can be great, the risks of discovery are also quite daunting.  Nonetheless, I believe the cost of medicines will continue to become lower over time, as companies exploit continuous technological improvements and constant refinements of their research processes.

One of the emerging sectors for new profitability and breakthrough improvements for healthcare companies is in the area of personalized medicine–drugs designed to work according to the genetic profile of the patient. Some drugs are effective for a large part of the population; whereas, others are specific to only a few that exhibit specific biomarkers. For instance, one drug, Herceptin, is specific for women with breast cancer that over-express a specific gene.

In the future, pharmaceutical companies will develop many more custom-designed drugs for specific genetic profiles. This way, patients will know if drugs will work for them, based on their respective genetic profiles. This new area of discovery and development will present many challenges to the pharmaceutical industry, but will yield many rewards, not only to the companies that produce these new drugs, but to society as well.

Paul Meade is the president and founder of Thought Leader Select.  In the spring of 2010, Paul earned a Master of Public Health degree from the Gillings School of Global Public Health at the University of North Carolina at Chapel Hill. Meade also earned a certificate in ethics from the school’s Public Health Leadership Program.