Discovering a Career in Clinical Research – Finding a Cure for Yourself!

Ask anyone within the pharmaceutical industry about drug development and you will find it to be arduous. Heck, calling drug development arduous might even be an understatement but the benefits of potential life saving drug research far outweigh the risks and costs. Within the many facets of the pharmaceutical industry is clinical research which functions to simply determine the safety and efficacy of a potential drug candidate through phases of human trials. If the trials go right and satisfy the FDA’s requirements, voilà the next blockbuster drug is born (well, maybe). Thorough clinical research is vital for any pharmaceutical company and without proper testing of the drug in people; there is no drug to manufacture, no drug to sell, and no cure.

In this career spot, Labjourneys talks with Dr. Dan Rossignol and his experience in trying to guide drug targets through the rigors of clinical research, as well as meeting his own life goals. When I first met Dr. Rossignol you could instantly tell he was highly passionate and engaged with his work. At this particular time, the staff including him was hopeful that a new drug candidate was well on its way to becoming approved. Insert a few years later when I had a chance to reconnect with Dan, I was stunned to find out that the drug candidate failed and he was abruptly let go from his job. Dan’s story is a great example of turning failure into fortune and how no one should ever give up in pursuing their interests. Dan is currently rediscovering and redefining himself (and enjoying himself) as a consultant and kindly offers sage career advice about performing clinical research within the pharmaceutical industry.

Currently what is your position? What other positions have you held?

I am currently consulting and managing a project (clinical study) for the Juvenile Bipolar Research Foundation. A task that I find enormously satisfying. Clinical research is the ultimate in delayed gratification, but I am now working on a study that treats a dire unmet medical need, is based on some hard science, and has clear achievable endpoints.

Over the years, I also studied insect neurobiology (pesticide research), immunology at a pharmaceutical company, and clinical research (drug development) doing human clinical studies in a wide variety of disease areas. Shifting from one disease area to another has proven difficult at times; however, I like to think that working in all these fields has allowed me to bring perspectives from different fields to bear when difficult decisions need to be made.

Where did you grow up? What early influences help cultivate your interest in science?

I grew up in the northeast, part of a family deeply involved in the trades.   But my mother wanted me to be a doctor. Even though I loved science, I wanted to build houses. In order to keep peace in the family, I applied to one college, got in, and realized that science really was the place to be. I kept the building and remodeling as a hobby.

When did you realize your scientific calling?

When I was in elementary school I used to check out books on chemistry from the library. I remember drafting a periodic chart of the elements on an old window shade (is that the definition of nerd or what), but it was so cool how the rows and columns just made sense. And there was nothing mechanical in the house that got thrown out until I first took it apart to figure out how it worked. I do not know how many fuses I blew tinkering in the basement. Maybe it is an anomaly that I am still here to discuss this. Some of the stuff I did back then would probably have me in counseling if I tried to do it these days.

What challenges did you encounter when you were let go? How did you go about finding new employment?

I worked for one company for 23 years, developing a drug from discovery through clinical development. I knew that the drug worked, I just needed to find the disease that it could treat. Surprisingly, after the first Phase 3 pivotal trial failed, the company decided to close up shop on my department. It was a huge disappointment. Not so much that I was out of work, but that the drug I spent 23 years developing was no longer being pursued.

Once I was out the doubt started as to what would happen next. Did I do the right thing by staying with one project for so long?

Interviewing was very educational, as were the people who worked in “outplacement”. One headhunter told me “while you think that you cannot find the right job, companies are saying- why can’t we find someone who can do this job?” Another advisor said “go at that interview like you are the guy to solve all of their problems”. Those things help. But what I really needed to do was understand my value and where I belonged, and move on.

What aspects of your job to you like the most? During your course of your career what aspects did you like the most?

The science. Whenever possible I used scientific reasoning to back decisions that enabled me to stay above the politics. I also had the support of a boss that was also a scientist and mentor- who always had my back. Political and emotional objections generally failed in the face of these two levels of support. It might seem trite to say this, but the importance of having a boss you respect cannot be understated.

Dr. Rossignol gets a free consultation with President Lincoln.

Dr. Rossignol gets a free consultation with President Lincoln.

As humans we have become really good at treating a variety of illnesses where did you see the future of pharmaceuticals? What are the next challenges or concerns?  

I see health care moving to a prophylaxis paradigm (finally). The health care reimbursement system will logically move to a system where we must prevent disease rather than only treat disease, and if we eventually move to a single payer system, there will be strong incentives put in place to stay healthy or become healthy. We cannot let diseases due to lifestyle become so great a drag on the system that we will not be able to treat unpreventable catastrophic diseases.

The challenges of recouping costs of drug development will become greater, maybe insurmountable. Companies have gone to orphan diseases because the low-hanging fruit of easy-to-treat major diseases has been “picked”. But recovering the cost for development of a treatment for orphan diseases means charging each individual a lot. While this has been acceptable for some orphan diseases up to now, as the number of diseases being treated with expensive individualized treatments, costs will continue to increase. And experts have already predicted that the burden on the health care system will increase to the breaking point. We already see this for treatments of hepatitis and certain cancers. When the “pushback” from the healthcare providers gains enough traction then costs will be contained and it will be even more difficult to recoup development costs.

Who is your role model, and why?

I have been fortunate to have a number of remarkable mentors, my graduate school advisor, Dr. Vary, taught me the rigors of scientific training and how things need to be controlled to be studied. My post-doctoral advisor, Dr. Lennarz was patient, and let me fly off on a number of tangents, some of which actually bore fruit. I still see new citations of papers I published while in his lab. In clinical research, Dr. Lynn was a true role model. He never failed to acknowledge an achievement on his team, and never spent time blaming people for mistakes that were made. He lived by the mantra of watch one, do one, teach one. If you were not ready for that you had to stand aside.

What was the best advice you ever received?

Can I quote two?

“You like doing carpentry, but you have only done it in the summer. You have never had to shovel the snow off of a roof to put the roofing on.” That statement helped me decide to go to college.

Clinical: “would you have your grandmother participate in this clinical trial?”. No explanation needed.

What message would you tell a young person today who is interested in the pharmaceutical industry?

Look carefully at the direction that things are going. Stay flexible in what you think you can do, and be ready to pivot as directions change. And, despite what they tell you, management may not have all the answers. As you study and move forward, you can be more of a thought leader than you think you might be, so don’t be afraid to speak up (respectfully). Your expertise and potentially novel approach make it possible that you are more than some small voice in the flood of ideas that management should consider. But you have to keep the evidence on your side. You might even be responsible for changing the direction of a company.

Anything else you would like to share? 

Maybe two things.

Look around you and see how many people are truly evidence-based thinkers. You might be surprised. A very bright person once said that logic will never change the mind of someone who did not make their conclusions logically. Scientists (likely most of the people reading this) have a difficult time using things other than logic to change someone’s mind. But a different approach to convincing this mindset needs to be used. Scientists need learn how to educate and persuade without lecturing. Frankly, I have a hard time with that myself- I love to quote sources which drives people nuts.

When I started my first job I had the fleeting thought- maybe I can slow down now, maybe I am done publishing, maybe this will be my last job (people in the company I started with routinely worked there 30 years and retired from this company). LOL. Don’t fool yourself, even if it turns out to be your one-and-only job and you retire from that company, stay competitive, or there is no way that job will ever be your last job.

 

All the best!

 

Dr. Blog

 Dr. Blog holds a PhD in chemistry and draws on his years of industrial and life experience to offer honest career advice for the advancement of young scientists.