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From Surviving To Thriving, BioPharma Addresses Complex Challenges Through Clinical Trials

Dr Esmat Dessouki and Dr Fathi El Hadi Abuzgaya

Surgeons work an average of 60 hours per week in high-pressure environments, after years of medical school and extensive training. This doesn’t consider continuing education, credentialing, on-call responsibilities and much more.

For Drs. Fathi Abuzgaya and Esmat Dessouki, that hectic lifestyle didn’t keep them from pursuing and achieving even more. After forming a company that focused on Phase II and III clinical trials, the two colleagues decided to establish a contract research organization (CRO) that could be completely full-service, enabling pharmaceutical companies to benefit from a comprehensive resource for multiple phases of drug discovery and development.

Drs. Abuzgaya and Dessouki started BioPharma Services as a CRO in Toronto in 2006. They moved toward Phase I/IIA and bioequivalence clinical studies, combining high-level medical and scientific expertise with good people, great culture and a strong, stimulating research atmosphere.

Creating a Culture of Inclusion and Teamwork

Although Drs. Abuzgaya and Dessouki were still active with their busy orthopedic practices when they founded BioPharma, they both took on multiple responsibilities to help grow the company. They started small, building the business by recruiting a team of skilled professionals and focusing on a culture of inclusion. The goal was to find people that believed success is better achieved and celebrated as a team than as individuals, while also exhibiting confidence in initiating new ideas.

“Everybody matters at BioPharma Services. It’s a family culture,” says Dr. Dessouki, who is still heavily involved as the company’s Chief Medical Officer and Principal Investigator. “We’ve been fortunate to be able to recruit a team of good, hard-working individuals who think out of the box. Our job is to empower these employees and enable them to grow with the company.

“Without them, we would not be where we are today. Dr. Abuzgaya and I started the company, but we can’t take the credit for its success.”

The BioPharma team comprises a veteran group of physicians, scientists and clinicians whose key areas of focus, in addition to Phase I studies, include pharmacokinetic-pharmacodynamic (PK-PD), Human Abuse Potential and Abuse Deterrent Assessments, Bioequivalence/Bioavailability, and Good Laboratory Practices (GLP) research and development and sample analysis. They serve clients in two clinical centers: one in Toronto and another in St. Louis, Missouri, for a total capacity of 300 beds.

The company now is a full-service CRO able to serve clients from study design inception to clinical trial execution, data reporting and tabulation to a final Clinical Study Report. They also possess an in-house bioanalytical laboratory to support liquid chromatography with tandem mass spectrometry (LC/MS/MS) analysis in different matrices.

Addressing Complex Challenges While Contributing to Society

Despite the company’s growth, its founders’ entrepreneurial spirit and desire to be known as the preeminent CRO in North America for complex clinical trials have expanded BioPharma’s reach, scale and capability — all while maintaining its small feel and close-knit, team-oriented culture. Abuzgaya and Dessouki know the advantages a smaller company can offer, such as quicker decision-making, more agile processes, flexibility to change course during a project and dexterity in being able to adapt, problem-solve and do whatever a client needs.

Along with keeping that dynamic culture and nimble organizational structure at the core of its operations, BioPharma Services has developed a niche in conducting challenging studies, many of which other CROs aren’t able to successfully complete and often don’t even consider. They’re well-suited to take on these projects due to their network of connections, unique approach and wealth of expertise.

“Most anybody can handle the easy, everyday clinical studies, but we do the ones very few companies have the knowledge and resources to fulfill,” says Dr. Dessouki. “The ones that are not only interesting and challenging but also produce a contribution to society. We want to figure out some of the most difficult questions about devastating diseases and viruses that humankind has faced, and will likely continue to face in the future, and develop resources to help understand, control and treat them.”

Under the direction of Drs. Dessouki and Abuzgaya, BioPharma recently began performing complex studies on potential targeted therapies for gene therapy, interventional radiology and other cutting-edge subjects. They’ve gone from surviving — simply trying to compete with bigger competitors — to thriving as an established and successful specialized CRO with more employees who are leading experts in a wide variety of fields.

“As a scientist and a surgeon, this work is a passion for me, not just a business,” says Dr. Abuzgaya. “We have a top-notch team of scientists, statisticians, digital and data management professionals and others who prefer to be challenged and help people by tackling difficult problems and finding new solutions to address them.

“Our clients know that they might be able to have their study done more cheaply somewhere else but choose us because they’re aware of the level of expertise we provide and our attention to detail.”

Promoting The Safety of Study Subjects

Since BioPharma was formed 15 years ago, the biggest priority in the studies the company engages is always the safety of subjects who participate in various clinical trials. They don’t accept studies they consider a high risk for those volunteers and follow strict protocols throughout each project.

By having a clinical trial site in Canada, BioPharma clients have the option to shift the FDA Investigational New Drug Application until after early phase data has been procured. They can also more easily obtain approval for their study without providing as much preclinical and manufacturing data as required by the United States. Along with less expense, this benefit allows for more focus on protocol safety and the study itself.

The Future of BioPharma Services

Drs. Abuzgaya and Dessouki point out that one of the most significant changes since BioPharma Services was established has been the rapid emergence and integration of technology. They know the world is changing fast and it’s paramount that the company is proactively implementing applicable technology solutions to be competitive and successful.

“The real change in the near future is going to be remote monitoring, prompting the absence of onsite visits of a lot of study subjects,” says Dr. Abuzgaya. “Though there are still some tasks we need to complete at one of our two locations, the application of this type of technology and the corresponding development of software seems to be the future for much of the CRO industry. The COVID-19 pandemic already has precipitated these changes, and the digital world appears ready to take over.”

What do Abuzgaya and Dessouki see in the near future for BioPharma Services? For one thing, a continued emphasis on people, culture and community. A talented team of individuals devoted to their role of helping develop clinically tested drugs and other solutions that benefit individuals in North America and around the world. For another, continuing to burnish the company’s reputation as an ambitious, top-notch CRO able to take on even the most challenging of studies.

“We started from Phase II or III, we went to Phase I and bioequivalence, we added the lab,” says Dr. Dessouki. “But, really, I’ve always liked challenging studies and I really want BioPharma to be the known CRO in North America that can do the difficult stuff, not the easy everyday studies that anybody can do. And in the last couple of years, we have been going in that direction and growing it.”

The biggest goal for the BioPharma Services founders and their team is to continue growing, contributing and thriving, both professionally and personally, and to keep making a difference through their work by conducting challenging, complex studies that can change the world.

Or, as Dr. Abuzgaya puts it: “My vision is to sit on the beach somewhere, where there’s some warm ocean water, have a drink and call in virtually.”

His co-founder would agree. “That sounds like a good idea.”

Led by an expert panel of experienced medical physicians and research scientists, BioPharma has built a full suite of clinical solutions from Phase I to BE/BA services to assist our clients’ clinical drug development programs. We invite you to come and experience the true BioPharma service: our people, our culture and our community. Contact us to learn more or sign up to receive our newsletter.

About BioPharma Services Inc.

BioPharma Services Inc. is a full-service Contract Research Organization (CRO) specializing in the conduct of Phase I/IIa and Bioequivalence clinical trials for international pharmaceutical companies worldwide. BioPharma has clinical facilities both in the USA and Canada with a total capacity of 300 beds with access to healthy volunteers and special populations. Headquartered in Toronto, Canada, BioPharma’s comprehensive services also include Bioanalysis at our GLP Certified Laboratory, Scientific and Regulatory Affairs, Biostatistics and Safety Data Analysis (CDISC), Data Management and Medical Writing.

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