Overcoming Bioanalytical Challenges for PK/PD Assessment in Phase I Biologics Studies

Ensuring collaboration between bioanalytical experts and clinical trial sites for Phase I biologics studies is critical for successful drug development. This webinar will outline key clinical and bioanalytical considerations to enable appropriate pharmacokinetics/pharmacodynamics (PK/PD) data for biologics.

This webinar will highlight practical considerations for the successful conduct of first-in-human Phase I studies for biologics where substantial and challenging bioanalysis is required. A Phase I trial is the first opportunity for drug developers to translate observations from preclinical testing into humans. Such trials for biologics have become more complex, with multiple objectives, such as safety, tolerability, PK/PD, and food effects. Additional considerations include participant age, gender, ethnicity, interactions with co-administered therapies, and therapeutic outcome in a small population suffering from illness. Incorporating appropriate bioanalysis for timely PK/PD interpretations, and the need to manage costs, are additional challenges that must be overcome for successful program completion.

The clinical site relies on the bioanalytical experts to generate critical data needed for the understanding of PK/PD parameters. Appropriate bioanalytical strategies and platforms are needed to measure the parent drug and relevant metabolites, and to evaluate potential immunogenicity and biomarkers. Because of the diverse nature of biologics, no single bioanalytical approach can fulfill all the requirements. Analytical techniques are often used in conjunction, including immunoassays — which are sensitive and have high throughput — and LCMS-based methods, which have exquisite specificity. In this webinar, the following three areas will be discussed to optimize the clinical site and bioanalytical teams’ partnerships:

1. Planning for bioanalytical endpoints in Phase I biologics studies, with special emphasis on design and sample preparation
2. Assay selection, requirements, and regulatory expectations
3. Novel workflows focused on minimizing cost and timelines

Register for this webinar to learn how challenges can be overcome by partnering with fully integrated bioanalytical laboratories that support clinical sites as well as preclinical toxicology, as this ensures expertise and familiarity of the principal investigators and bioanalytical scientists throughout all phases of drug development.

Speakers

Dr. Lynne Le Sauteur, PhD, Vice President, Laboratory Sciences, Altasciences

Dr. Le Sauteur joined Altasciences in September 2019 and leads a team of over 260 specialists involved in bioanalysis, immunogenicity, biomarkers, and immunotoxicity assessments for large and small molecules, oligonucleotides and gene therapy. She received her PhD in Pharmacology and Therapeutics from McGill University and has over 20 years’ experience in biologic drug development.

Prior to joining Altasciences she was Director of Downstream Processing and Analytics, as well as Program Leader, Biologics and Biomanufacturing for the Human Health Therapeutics Research Center at the National Research Council of Canada, where she led numerous teams and initiatives to discover, biomanufacture, and characterize novel biologics for unmet needs, in collaboration with different biopharmaceutical companies. Prior to the NRC, Lynne worked at Charles River Laboratories, where she established the Immunology Department, and led the scientific and strategic growth of that group from one to over 80 employees, effectively delivering expertise to sponsors in advancing numerous biologics through the drug development value chain.

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Dr. David Nguyen, MD, MBA, General Manager and Medical Director, Altasciences

Dr. David Nguyen is an anesthesiology trained principal investigator with experience in all major inpatient surgical specialties, including neurosurgery, cardiothoracic, and obstetrics, as well as outpatient procedures and GI services. He is intimately familiar with transfusion medicine, fluid management, infusion reactions, and emergency anaphylactic airway response. While treating chronic pain patients, Dr. Nguyen received a first-hand account of both the opioid crisis as well as the frustrations and poor quality of life for a patient suffering from chronic pain, which was the impetus that drove him to become a patient advocate for responsible medical cannabis use.

At Altasciences, his goal is to push forward high-quality pharmaceutical therapies for patients and to ensure subject safety on all trials. Prior to joining Altasciences in 2017, he expanded his clinical knowledge to include dermatology and regenerative medicine, prompting the launch of his medical aesthetic practice, Dr. Dave’s Dermal Institute, where he functioned as both medical director and primary practitioner. He brings the same customer-focused approach from this practice to participants in clinical trials, ensuring subject satisfaction at all levels.

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