Conducting Complex Clinical Studies Involving Speciality Services: an Interview with Louis Co
In 2003, when the global outbreak of Severe Acute Respiratory Syndrome (SARS) hit Canada, Louis Co was employed as a nurse in a hospital and a clinical research facility in Toronto. Together with his team of colleagues and physicians, they instituted new protocols to ensure staff and patients remained safe.
That experience is one of the reasons he and the rest of the BioPharma team were prepared when news of the spread of COVID-19 hit North America.
“When we first started hearing about COVID-19 in December 2019, I was monitoring it very closely,” says Co, the Vice President of Global Clinical Operations. “It was at that point we started instituting protocols, finding out what staff members’ travel plans were and taking a close look at the case counts around the world. We knew it was just a matter of time before it reached Canada.”
Because of Co’s SARS experience, along with some of his colleagues, including Dr. Fathi Abuzgaya, Principal Investigator and Co-Founder (who was Chief of Surgery at Centenary Hospital during the SARS outbreak in 2003), instituting procedures to handle the pandemic was fairly straightforward. They performed temperature checks, asked screening questions of employees and guests before they entered the facility, and ensured information was shared and communicated on a regular basis.
“The priority at BioPharma is always the safety of the staff and study volunteers, which is the reason why we haven’t had any major outbreaks at our Toronto and St. Louis facilities,” explains Co. “We’re proud that we’ve managed to keep our volunteers and staff safe, and that we’ve been able to operate throughout the pandemic.
“I think it was really due to our initial and early examination of COVID-19, our recognition of its contagiousness and spread, and then quickly instituting the cleaning and other safety procedures we implemented at both facilities.”
A Seasoned Team of Specialists
Since joining BioPharma in 2009, and now with two decades of clinical research study experience, Co has focused on optimizing operational effectiveness, executing effective change management and positioning BioPharma for growth and expansion.
Co credits BioPharma’s success to its seasoned team of professionals. The company started out as a small bioequivalence shop and expanded to specialize in Phase 1 clinical trials and Human Abuse Potential (HAP) and Human Abuse Liability Studies (HAL). In addition to being very agile, Co and his team focus on quality, speed and exceeding their clients’ expectations. The team is driven by their collective desire to succeed and contribute to the advancement of medicine.
Each member of BioPharma’s clinical trial management team is a leader in their respective field, each with more than 20 years in the medical and clinical research study fields. They’re a respected and diverse group of medical specialists — from Dr. John Oldenhof, the company’s Chief Scientific Officer, to Dr. Nicki Hughes, Vice President of Lab Operations, and everyone in between.
The experience, industry knowledge and networking capabilities of these professionals are key reasons BioPharma has been able to bring in a diversity of clinical studies, including those involving specialty services. They pride themselves on being able to operate with agility and nimbleness to conduct some of the more complex studies that many larger competitors can’t.
For example, the team recently conducted a clinical research study on Propofol, a commonly-used anesthetic. Unlike many of its contract research competitors, BioPharma has specialists on board who enable the company to work with this type of drug. The company can also conduct specialty procedures, such as lumbar punctures, bronchoscopy and biopsies.
“We’re proud of the research that we’ve done, especially the anesthetic clinical studies that traditionally would have been conducted in a hospital setting,” remarks Co. “In partnership with our clients, we are pleased to play a role in bringing affordable drugs to the marketplace.”
Advantages of In-house Equipment
Another reason for BioPharma’s success among contract research organizations (CROs) is its capability to conduct clinical trials in-house instead of in a traditional hospital setting. Those conducting trials in a hospital must receive the approval of a hospital ethics board, a group that might meet only once a month or every two months. Co and his team collaborate with an independent ethics board that convenes weekly meetings, significantly reducing the clinical trial startup time.
The company’s vast array of specialty equipment and the ways they are arranged and used varies by study. As Co describes, “Each first-in-man study we conduct is significantly different from the other depending on the compound we’re testing. Our Phase 1 clinical trial unit has 16 hospital beds located around a centralized nursing station, giving us a 360° view of all of our volunteers at any point in time.
“Our Phase 1 clinical study unit often has a 1:1 staff to volunteer ratio due to the complexity of clinical studies conducted. We are able to bring in various types of equipment as needed. Plus, we’re capable of a variety of different means of drug administration – besides the traditional, oral capsule, tablet, inhalation and IV administration, we’ve also conducted intraperitoneal injections via ultrasound – which is something not regularly done in CROs.”
Servicing U.S. and Canadian Clients
BioPharma Services boasts a strong team of pharmacy professionals in both its Toronto and St. Louis locations who oversee the day-to-day dispensing and preparation of medications. This allows the company to perform drug preparation tasks onsite that some other CROs would typically have to contract out.
The company conducts Phase 1 clinical trial studies at both locations. While regulations differ somewhat between Health Canada and the U.S. Food and Drug Administration (FDA), each has its own benefits, and BioPharma is intimately familiar with the approval process and has relationships with body regulatory bodies. Co reiterates that the company’s experience, depth of knowledge and professional networks, in addition to its people and organizational culture, are what separate it from other CROs.
“What I can say about the team here is that we are very agile. We focus on speed and quality and there’s just a desire to succeed,” Co says. “That really is our backbone. We’ve always envisioned BioPharma as being a leader in the industry and a place that people would want to come and work.”
About BioPharma Services
BioPharma Services, Inc., a Think Research Corporation company, is a full-service Contract Research Organization (CRO) based in Toronto, Canada, specializing in Phase I/IIa and Bioequivalence clinical trials for international pharmaceutical companies worldwide. BioPharma has clinical facilities both in the USA and Canada with access to healthy volunteers and special populations.