We recently spoke with Patrick Nealon, Executive Vice President and General Manager of Oncology at Syneos Health in Boston. He talked about his company’s activities in oncology research around the world. We’re pleased to share the following excerpts from our conversation.
Keosys:
Syneos Health is a unique player in oncology, correct?
Patrick:
We are unique in that we are the only fully integrated biopharmaceutical solutions organization—we are both a clinical research organization (CRO) and a contract commercial organization (CCO). Our Oncology Business Unit is also therapeutically aligned so that all of our Project Managers and Clinical Operations Team focus solely on Oncology and do not work in other therapeutic areas at the same time. The therapeutic alignment begins with my leadership team and then includes those in Clinical, Project Management, and our Customer Relations Executives.
Keosys:
And you’re large.
Patrick:
We employ approximately 25,000 people and support customers in more than 110 countries.
Keosys:
What brought you to Syneos Health?
Patrick:
I accepted my role as the Head of the Oncology BU because I have worked for most of my career focused on cancer treatments and there is still no cure for cancer, although we have made incredible strides over the last 10 or 15 years in terms of keeping people alive longer and delivering treatments with fewer side effects. I also felt that after 30 years of working in small to large biotech and pharma companies I would be able to share with my employees at Syneos Health what our customers are expecting and hoping for us to deliver.
Keosys:
What sorts of research is Syneos Health involved in?
Patrick:
If you’re going to support customers in oncology clinical trials today, you really need to be up-to-speed on the latest innovations for treating cancer, i.e. immuno-oncology (checkpoint inhibitors); CAR T (cell therapy); and gene therapy, which has been around for at least 17 years now but continues to be an interesting and dynamic way of treating cancer. In fact, the world’s first gene therapy was approved in China for the treatment of head and neck cancer back in 2003. We are also involved in more novel targeted therapy approaches like ADCs (antibody drug conjugates).
Keosys:
How many different companies are you collaborating with currently?
Patrick:
We are working on different treatments with more than 200 companies globally.
Keosys:
Are any regions of the world more active than others?
Patrick:
Our business in the Asia-Pacific region has grown significantly, especially in China. The CFDA (China Food and Drug Administration) made a decision in 2017 to change the requirements on imported drug registration. They made these changes to encourage drug companies outside China to run clinical trials within China and outside China in parallel. This was intended to shorten the time between approval outside China and approval inside China and meet the need for new drugs for Chinese patients. With this change, we have definitely seen growth in this segment of our market.
Keosys:
Anything in particular you might share about doing clinical research in the far corners of the world?
Patrick:
When running trials in the far corners of the world, our customers understand the importance of the potential influence of ethnicity on drug pharmacokinetics. Pharmacokinetics is the branch of pharmacology having to do with how a drug moves through the body. This includes the time of its absorption, bioavailability, distribution, metabolism, and excretion. Multiple studies have demonstrated the ways a variety of drugs are metabolized differently in persons of Asian descent because of body mass index or the patient’s enzymes. As a result, clinical trials to show pharmacokinetics, pharmacodynamics, metabolism, dose range, and bioavailability must be run and thoroughly understood before a new drug can be approved in these countries.
Keosys:
Talk to us about advancements you’re seeing in the design or operation of clinical trials.
Patrick:
When you write your trial protocol, you include the statistical methodology that you will use in order to see signals on how your study drug performed. Many of these statistical tools go back 20 or 30 years, but recently, statistical approaches to running oncology clinical trials have changed. We now have master trials including “umbrella trials,” “basket trials,” and “platform trials” that are designed to allow for the testing of multiple therapies, doses, or tumor types in a single, complex study. You may know that Syneos Health has been the CRO responsible for running one of the most well-known basket studies for Acute Myeloid Leukemia, called the Beat AML® Master Trial and sponsored by the Leukemia Lymphoma Society.
This important study was designed to expedite development of innovative therapies for Acute Myeloid Leukemia (AML), and some preliminary and positive results were presented at ASH in December 2019. This was a remarkable study in which multiple biopharma companies joined together to test several different treatments. It was made possible because of the advanced statistical methods that we are using and the new ways that we are designing protocols.
Keosys:
That’s certainly a proud achievement.
Patrick:
I am proud of what we do at Syneos Health, and I know the people who work in my business unit are proud of what we do. It takes a lot of work. It takes a lot of energy. It takes commitment and passion. Every day we working to help patients maintain a better quality of life, continue to live, and to eventually find a cure for cancer.
Many, many of the things we work on fail, but despite that, you cannot get down. You just have to move to the next product and hope that it will have a better outcome.
