Foreign Trained Professionals; the Unsung Heroes of the CRO Industry Currently, annual immigration in Canada amounts to almost 500,000 new immigrants – one of the highest rates per population of any country in the world. As of 2023, there were more than eight million immigrants with permanent residence living in Canada – roughly 20 percent of the total Canadian population. In light of these statistics, it is no surprise that BioPharma Services Inc. (BPSI) would be comprised of a diverse team of staff who have come to Canada from all over the world. This Blog will focus on the personal emig ..read more

Debunking the Top 4 Most Common Myths About Clinical Trials At BioPharma Services, we are dedicated to advancing healthcare through rigorous clinical research, particularly in the early phases of drug development. Our clinical trials are crucial for assessing the safety and efficacy of new pharmaceutical drugs. However, widespread misconceptions about clinical trials often discourage potential volunteers, impacting not only the progression of new treatments but also the broader landscape of healthcare innovation. To bridge this gap, we aim to address and dispel these myths by providing cle ..read more

Eight Reasons to Choose Canada for Your Phase 1 Clinical Trial For many study sponsors, the end goal of their clinical drug development program is to enter the United States drug market. However, conducting your Phase 1 clinical trial in Canada is an alternative route that can fast-track the CTA process and get the approval for the initiation of your study. It also allows you to use your limited interactions with the United States Food and Drug Administration (FDA) efficiently to discuss matters that truly add value to your asset after you have collected the results of your clinical trials ..read more

Leveraging the 505(b)(2) Program to Prolong the Life of a New Chemical Entity (NCE) This is an continuation of When is 505b2 a good choice for your new drug application? In the world of pharmaceuticals and drug development, the journey from discovery to market can be a long and arduous one. Even after years of research, extensive clinical trials, and obtaining regulatory approval, a drug’s life on the market can be limited due to various factors such as the initial invention of the NCE (New Chemical Entity) is not optimized for therapeutic usage and/or safety profile as well as patient com ..read more

Importance of Study Restriction: The Avoidance of Drug-Drug Interactions Part 1 Drug interaction management is a significant concern in designing clinical trials, especially those focusing on pharmacokinetic (PK) endpoints. Such interactions, both expected or unexpected drug-drug interactions, may arise from the prescribed treatment regimen, emerging therapy for side effects, or participants’ lifestyle which can interfere with the study evaluation and threaten participants’ safety While these interaction’s are inevitable in clinical trials, proactive identification of potential interaction ..read more

NDA Enabled Phase 1 Clinical Trials: Unveiling the First Step The journey of a new drug from concept to market is a complex and highly regulated process. At its core lies the New Drug Application (NDA) submission – a critical milestone that paves the way for new medications to reach patients in need. But how do drugs reach this stage of approval? The answer often begins with Phase 1 clinical trials.  In this blog post, we will explore the significance of Phase 1 clinical trials and the various types of trials that are conducted within this phase, setting the stage for the successful s ..read more

Survey Insights: Top 4 Reasons Our Volunteers Join Our Clinical Trials At BioPharma Services, we’re as committed to understanding why people choose to participate in our clinical trials as we are to advancing medical science. That’s why we reached out to 370 of our volunteers with a complex survey, asking them, in one of the sections, to share their main reasons for joining a research study. This was part of our effort to connect more deeply with our volunteers, learning directly from them through questionnaires and conversations. The responses we received offer a clear picture of the wide ..read more

It Takes a Village: An Interview with Dr. Ola Kassim No stranger to adversity, Olayiwola (Ola) Kassim was born and raised in Lagos, Nigeria. From an early age he saw doctors as heroes, as personified by his uncle who studied nursing abroad in the UK and his sister who later did the same. He lost his mother at only 3 years of age and his father a decade later. That was when his extended family came to the rescue and he was raised in both rural and urban communities in Nigeria.  In 1975, Dr. Kassim graduated and joined the Nigerian Youth Service Corp. (NYSC) where he met his wife. The t ..read more

Crafting Workplace Symphony at a CRO Unveiling the Canvas: A Maestro’s Tale In the heart of BioPharma Services’ flourishing ecosystem stands the People and Culture Champion. Functioning as the architect of engagement, a mediator in reducing turnover, and a meticulous curator of our organizational culture, this role has evolved into a guiding force, steering our professional dynamics towards inclusivity and empowerment.  Each note struck resonates profoundly with the pulse of our dynamic workspace, creating an atmosphere where every individual’s contribution is significant. This role em ..read more

ANDA or 505(b)(2): Choosing the Right Approval Pathway for Your Drug 505(b)(2) pathway approvals have experienced double-digit growth recently. Many drug companies are electing to pursue 505(b)(2) applications to obtain a new drug approval (NDA). For developers seeking to obtain approval for previously approved drug products in the United States, FDA offers two abbreviated approval pathways – an abbreviated new drug application (ANDA) for generic drugs and a new drug application (NDA) described in section 505(b)(2) of the Act. Both ANDA and 505(b)(2) applications rely on the agency’s findi ..read more