In collaboration with Probity Medical Research (PMR)
For the occasion of the 2023 EADV, Dr. Bissonnette from Innovaderm Research and Dr. Papp from Probity Medical Research (PMR) seized a rare moment to engage in a compelling conversation. These industry leaders share a common journey—the conception and evolution of their clinical research companies, which began as local endeavors in Canada and blossomed into influential international entities. The pair covered some of the main challenges of conducting vitiligo studies, the intricacies of early phase studies, and offered insights into alopecia areata (AA) studies. This exclusive interview will bring to light the pivotal role these entities play in shaping the future of clinical trials.
Innovaderm’s Beginnings
Dr. Kim Papp— I remember years ago, when you started out with your Contract Research Organization (CRO), I distinctly recall thinking it could potentially be a precarious adventure, given the intense competition and the challenges in initiating such a complex organizational framework. Over the past decade, however, your company has undergone a remarkable transformation, transitioning from a regional entity to a globally recognized force. I would be interested in learning about the overarching vision you now hold for the future of Innovaderm Research?
Dr. Robert Bissonnette— That is an interesting question, you are absolutely right; our journey began on a modest scale. Initially, I embarked on this path as an academic researcher, exploring clinical and translational research. I incorporated Innovaderm 23 years ago, initially as a clinical research site. Over time, it transitioned into CRO activities with aesthetic studies and progressing into early-phase studies involving topical drugs. We then pursued phase 1b, phase 2, to establish ourselves as the preeminent dermatology focused CRO. Presently, we manage phase 2 and phase 3 trials across North America and Europe. What sets us apart is our capacity to extend beyond, offering avenues for further exploration. In essence, our vision is to stand as the foremost CRO both in dermatology and rheumatology.
Dr. Kim Papp— And rheumatology? Interesting.
Broadening Innovaderm’s Scope to Rheumatology
Dr. Robert Bissonnette— We initiated our involvement in rheumatology studies, recognizing the significant overlap between dermatology and rheumatology targets. Many drugs used or explored in dermatology find applications in rheumatology as well. To establish a meaningful presence as a CRO in rheumatology, a requisite level of scale is imperative. Expanding into this therapeutic area is challenging when confined to a single country, particularly given the difficulty of recruiting participants for rheumatology studies. At our current scale, we believe we present an appealing prospect for companies developing rheumatology drugs, enabling us to extend our reach and impact. It is safe to say that collaboration with your rheumatology sites is on the horizon. Reflecting on the early stages of my involvement in clinical research, I observed your initial forays in the field, which have grown significantly in size and magnitude.
Probity’s Beginnings
Dr. Kim Papp— Honestly, it began as somewhat of a selfish endeavor because, around 30 years ago, the process was relatively straightforward. I was among the first to emphasize the necessity of having source worksheets to establish standardized methods for data capture, ensuring a consistent and precise data collection. Within a couple of years, the industry became notably more complex. Contracts grew more convoluted, budgeting processes became more challenging, and even collecting payments presented difficulties. The initial idea was to identify a platform that could serve as a cost-sharing solution, and from that emerged PMR. This model has proven highly effective, enabling me to participate in a multitude of studies that would have been challenging in the past. Moreover, it has provided opportunities for many others. We have expanded this approach beyond dermatology, supporting various indications. The model is versatile and operates not only in North America but also in South America and Australia. Our primary objective is to offer a structure of experienced and competent clinical trialists capable of not only effective recruitment but also maintaining high standards of technical and clinical quality. Thus far, the journey has been quite successful.
Key Clinical Trial Success Factors—Quality and Recruitment
Dr. Robert Bissonnette— In clinical research, for sponsors and CROs, two pivotal factors are quality and recruitment. When both are present, things typically run smoothly; however, if one is lacking, sponsors and CROs encounter significant challenges.
Dr. Kim Papp— Certainly, gaining access to this dynamic population is becoming more challenging as well. I believe a close, harmonious relationship between sites and CROs is crucial. Clear communication and a shared purpose are essential; without them, collaboration can turn into conflict. Ultimately, we are all pursuing the same goal. Robert, I have known you for quite some time, and I am aware that your aim, like mine, is to find better treatments for the patients.
Dr. Robert Bissonnette— Yes, absolutely.
Dr. Kim Papp— At your core, you are a clinician, a genuine enthusiast for the laboratory environment.
Innovaderm, Front Line Focused
Dr. Robert Bissonnette— What I aim to instill in the team at Innovaderm is that our CRO is focused on our 3 main frontlines:
- Clients: Our clients, including biotechs and pharmas, serve as the driving force behind our CRO.
- Investigators: Sites and investigators, if the investigators are satisfied, may choose to work with us again on future studies, potentially favoring us over competing CROs or sponsors with similar studies. They might even speak positively about our work to sponsors.
- Patients: The patients constitute our third frontline. As an organization, we must design studies, write protocols, and ensure that everything we do benefit the patients. This concept is not always straightforward; we often find ourselves in disagreements with sponsors requesting elements that may not be in the best interest of patients. Ultimately, if a study is not patient friendly, it may struggle with recruitment or experience a high dropout rate.
In conclusion, the insight into the evolution and future trajectories of both organizations serves as a testament to the leadership of Dr. Papp and Dr. Bissonnette in the clinical development industry. This candid discussion not only provided a valuable glimpse into the dynamic clinical research industry, but also showcased the importance of innovation, collaboration, and patient centricity. As we look towards the future of clinical trials, it is clear that these elements will continue to play a crucial role.
