Dr. Nicki Hughes, Vice President of Bioanalytical Operations
In today’s technology-driven pharmaceutical and biotechnology industry, the role of bioanalysis during the process of drug discovery and development has become significant. By improving the overall quality, accuracy, and speed with which drug analysis in biological fluids is handled, bioanalysis enables safe and more efficacious drug development. Typically, once a drug compound is developed, the C-suite heavily relies on the scientific expertise of its bioanalytical team to develop a custom assay for analysis of their drug in a clinical trial. But, amidst the plethora of service providers supporting the drug development programs of companies, the most successful ones are those who have a differentiating factor in them. BioPharma Services (BioPharma)—a full-service Contract Research Organization (CRO) that specializes in Phase I/IIa, and Bioequivalence clinical trials for international pharmaceutical companies worldwide, found its differentiator in Dr. Nicki Hughes and her team.
As an industry veteran with over 20 years of experience in Bioanalytical Research, Dr. Hughes founded Bioanalytical Laboratory Services (BLS)—a Division of LifeLabs—in 2013. She has been a key contributor/invited speaker at WRIB—a world-class bioanalytical conference, and also a contributing author for these publications for more than ten years. She joined the BioPharma team in 2016 as the Vice President of Bioanalytical Operations after facilitating an acquisition that merged her former team at BLS with BioPharma’s existing bioanalytical operations. Although BioPharma added its bioanalytical operation in 2011, the acquisition reinforced the company’s footprint in delivering best in class bioanalytical services, making it a global leader in full-service clinical research. With a leader who is well-respected by both clients and regulators, BioPharma has developed a robust scientific team that is highly capable and flexible to meet a client’s specific needs, regardless of how challenging it might be. “CIOs rely heavily on the expertise, capabilities, reliability, and proven quality of work conducted at BioPharma to tackle each unique problem successfully.
We overcome Bioanalytical challenges through an in-depth understanding of each molecule, its metabolism, and the requested/ anticipated calibration range. Our ultimate aim is “no surprises” during the application of any bioanalytical method,” asserts Dr. Hughes.
In addition to BioPharma’s clinical and bioanalytical capabilities, additional support services include Biostatistics and Safety Data Analysis (CDISC), scientific and regulatory affairs, medical writing, and data management. BioPharma is headquartered in Toronto, Canada with their 180-bed clinical and bioanalytical facilities operating under a single site. In 2014, BioPharma expanded its clinical capabilities, opening up a 120-bed clinical centre in Columbia, Missouri, USA. Today, the company has conducted over 2200 trials to support drug submissions to all the major markets and offers more than 180 validated assays covering a wide variety of therapeutic areas. Moreover, the laboratory houses 4 Sciex API 4000 and 5 QTRAP 5500 LC-MS/MS systems and offers clients “customized” bioanalytical solutions to support clinical and non-clinical (GLP) studies for new chemical entities (NCEs). The company provides continued adherence to new guidances (FDA, National Medical Products Administration [NMPA], ICH M10, ANVISA, EMA) with its method validation approach, competitive market pricing without compromising on quality, as well as NDA programs for new-chemical entities—supporting both non-clinical and clinical study arms. “We set high expectations for the quality of our work and take immense pride in what we do. We track laboratory metrics and are proud of a >98 percent passing batch rate and ISR results of >95 percent. In our laboratory, “Just good enough” is “not good enough!” states Dr. Hughes.
Our ultimate aim is “no surprises” during the application of any bioanalytical method
BioPharma’s bioanalytical laboratory received GLP accreditation from the Standards Council of Canada (SCC) in 2015. Since then, the lab has run a series of successful studies in animal matrices followed by First in Human Phase 1 studies to support New Drug Application (NDA) programs. Steering ahead, BioPharma is looking to expand this area of research for other sponsors with standalone NDA programs to develop and validate assays for both the non-clinical and clinical arms of the application. “We are an excellent partner for this type of work with our exceptional scientific team, high-quality infrastructure, and commitment to providing rapid results during dose escalation and key decision-making. We work hand-in-hand with our clients to mitigate their challenges and ensure we meet their requirements at any cost. This boutique approach is what drives our success and makes us a unique player in the market,” concludes Dr. Hughes.