Importance of Pre-Planning for Successful Clinical Trials

Clinical trials, whether they are the more straightforward first-in-human or the complex and multifaceted Phase III, are fraught with both foreseen and unforeseen difficulties. Moreover, the NIH and others have recognized a trend of increasing complexity in even the most straightforward of these trials.

Most Phase II and III studies have multiple endpoints, cohorts, and/or treatment regimens, potentially generating millions of data points and samples from a single study. The complexity of these trials is driven by the need to ensure rigorous trial design, to address specific and expanding regulatory requirements, and to address the demand for exploration of novel scientific objectives.

This webinar is part of a series addressing key challenges facing sponsors of clinical trials. In this webinar, you will learn insider tips on how best to support clinical trials with LabConnect’s pre-planning model:

1. Vendor selection and laboratory management
2. Assay development and validation
3. Sample tracking, shipment, and processing
4. Data reporting and filing support

Register for this webinar today to gain insights into the importance of pre-planning for successful clinical trials.

Speakers

Amanda Heller, Director, FSP Solutions, Scientific Operations, LabConnect

Amanda Heller has BS degrees in Biochemistry and Biology from Temple University. She has over 20 years of academic and industry experience in scientific project management and in the development, qualification, validation and automation of assays used in discovery research, preclinical and clinical trial programs. She is experienced in diverse immunological, biochemical, cell-based and biological methodology platforms across small and large molecule modalities. Amanda is experienced in robotics implementation and instrumentation evaluation, functional area and team leadership, client management, cross-team interdepartmental and sponsor collaborations, as well as building and maintaining strong partnerships with external contract laboratories.

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Ryan Ragland, Senior Scientific Project Manager, FSP Solutions, Scientific Operations, LabConnect

Ryan Ragland holds a PhD from the University of Michigan in Human Genetics. He worked at the University of Pennsylvania as a postdoctoral fellow in cancer biology and focused on DNA damage repair for seven years. With over 15 years of industry experience as a senior scientist and a scientific project manager, he has experience with managing the development and validation of a wide array of translational research assays, including but not limited to EIA, ELISA, PK, ADA, PK and flow cytometry. He has over four years of experience with managing clients, vendors, cross-team collaborations and overseeing external contract laboratories.

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Sarah Henson, Program Manager, FSP Solutions, Scientific Operations, LabConnect

Sarah Henson has a BS degree in Molecular Biology from the University of California, San Diego and a PhD degree in Microbiology, Immunology & Molecular Genetics from the University of California, Los Angeles. She has over 25 years of academic and industry experience in scientific project management and in the development, validation, troubleshooting and execution of assays used in support of clinical trial programs. She is experienced in methodology platforms used in support of large molecule drug products, including assays for PK, ADA and Nab. She is experienced in working with small and large pharmaceutical clients, establishing and maintaining strong relationships with client-contracted CROs and providing functional and technical team oversight.

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Catarina Horro Pita, PhD, Director, Regulated Bioanalysis and Biomarkers, A4P A LabConnect Company

Catarina Horro Pita has a PhD in Synthetic Organic Chemistry and a BSc in Chemistry and Environmental Chemistry. She has over 20 years of academic and industrial experience and, during her professional career, she has held a variety of managerial and scientific positions. As a result, she has gained excellent technical and regulatory (GLP/GCP) knowledge, focusing on the development, validation and sample analysis of small molecules in support of preclinical and clinical programs. Catarina’s current role involves the management and mentoring of a team of bioanalytical experts, overseeing the outsourced bioanalytical activities for a range of customers, from large pharma to small biotechs.

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