Choosing the right model can provide an early signal to certain product attributes and adverse effects before proceeding to human studies.
B4D will guide you through the challenges of taking your product from preclinical through to your first in human study. The preclinical development of a product often starts in academia with early proof-of concept. Nonclinical studies should be designed to build toward the starting dose and regimen for the first-in-human (FIH) clinical study. The FIH clinical study is designed to maximize information both on the safety and the action of the drug. For this reason, FIH studies are ideally conducted in a population that expresses the drug target.
PRECLINICAL & CLINICAL EXPERIENCE
The first in human clinical study can make or break a company.
B4D has extensive experience in several therapeutic areas such as cancer, immunology, endocrinology and women’s health, to name a few. We have worked with both small molecules and biologics including cell therapies and drug conjugates, as well as many different formulations such as oral, parenteral and topical.
B4D has years of experience writing preclinical and clinical study protocols, reports and associated publications. We have document templates and expertise in developing company-specific GCP-related SOPs and all the requisite documents necessary for the conduct of the clinical study including the investigator’s brochure.
B4D has an established network of experienced experts (scientists, toxicologists, statisticians, clinicians, etc.) with whom we have worked on many previous projects, to obtain input into all aspects of development from preclinical to clinical study conduct.
Service 2: Preclinical
The first step is to identify the target indication based on the assumed mechanism of action of your product and then select the appropriate preclinical disease models. B4D will ascertain which disease models are favoured by both clinical experts and regulatory authorities and work with academic experts or CROs to conduct these experiments in validated models. B4D will assist in the design of the protocols ensuring that each study is maximized to provide information on effects on biomarkers, clinical indicators, safety, pharmacokinetics and dosing. While there is not a requirement for conduct under GLP at this stage, B4D will assure GLP-like conduct of these studies and the issuance of IND quality final reports.
Based on the type of product and the selected indication, B4D will work with toxicology experts with the required experience to develop a nonclinical program of studies to support the FIH clinical trial. Where possible, study elements will be combined to maximize the information obtained from a single study. B4D will identify qualified CROs to conduct these studies under GLP and can organize audits of the selected facilities. B4D will also map out the nonclinical requirements at each stage of clinical development to ensure you are prepared for each step in your regulatory filing without incurring large financial commitments in the early stages of clinical development.
In designing the first study B4D will consider both the competitive and regulatory landscape and include not only evaluations of safety and dose-finding but endpoints which provide proof of concept for target engagement. This provides the necessary information for determining the design and sample size of subsequent studies as well as support fundraising efforts. B4D will assemble a Clinical Advisory Board (CAB) consisting of clinical experts in the indicated therapeutic area to develop this novel FIH protocol. B4D will refine the protocol by engaging regulatory authorities in Pre-IND/CTA meetings prior to filing the IND/CTA.
Following regulatory approval, B4D can assist in all or select aspects of clinical operations to ensure the conduct of the clinical study adheres to the principles of Good Clinical Practice (GCP). B4D can identify qualified vendors through an RFP process and ensure the CRO selected is the best qualified for the study. Having previously worked in the therapeutic area, B4D can identify clinical trial sites through our network and work with the CRO on management of the sites throughout the conduct of the study. B4D also has preferred data management groups for all aspects of statistical analysis and data collection and management of clinical trial information. We also work with pharmacovigilance groups for the management and reporting of SAEs that may arise during the study. Throughout the process, B4D will use online management tools to ensure development milestones are met so that costly delays are not incurred at this vital stage of the product development process.
In addition to protocol writing, at the completion of the clinical trial and following the analysis of the data, B4D can produce the Final Study Report and also assist in the writing and submission of publications to targeted journals based on the study results.