Most central labs are built to process samples. Ours was built to understand them. Evolving from a world-class bioanalytical backbone, Frontage Central Lab brings scientific depth, quality rigor, and operational discipline to every protocol, amendment, and shipment. This talk unpacks how our BioA heritage uniquely equips us to manage complex sample logistics, adapt to protocol deviations, and align with today’s complex and evolving clinical trials!
Archives: Agenda
Lunch and networking
PANEL: Handling clinical trial finances: tips for managing funding, investment and budgets
• Ensuring your trial is cost-conscious and efficient without compromising on quality or on patient care
• Forecasting and budgeting in order to accurately predict costs and minimize unforeseen expenses
• Keeping your clinical budget on track
• Negotiating prices and contracts in order to ensure maximum benefit without going over budget
What does patient centricity mean in an outsourcing context?
- Ensuring patients are at the forefront of conversations with CROs and vendors
- Considering vendor selection processes with the patient in mind: what does this look like?
- Working closely with patient advocacy groups alongside CROs and vendors to deliver a patientcentric clinical trial
Afternoon refreshments, networking
Reserved for Harvest Integrated Research Organization (HiRO)
The ongoing road to clinical trials from a startup perspective: Bench to bedside with a novel pan-cancer target
- Human endogenous retrovirus (HERV) sequences comprise 8% of the total human genome DNA, and they entered the genome between 10 and 50 million years ago
- HERVs are unique tumor targets that are overexpressed in more than 80% of solid tumors, but not in normal tissues
- SunnyBay Biotech has developed therapeutics targeting the HERV-K supergroup of HERVs
- Our approach for moving novel HERV-K therapeutic antibody-drug conjugates (ADCs), which reduce tumor growth, inhibit metastasis, and prolong survival in murine models of breast and lung cancers, from the lab into the clinic will be discussed
END OF CONFERENCE
New alternate methods for clinical trials: Discussion of the use of human induced pluripotent stem cells for drug development
- Overview of recent regulatory shifts (FDA Modernization Act 2.0, April 2025 FDA policy) enabling non-animal methods for oncology IND submissions.
- Addressing tumor heterogeneity and efficacy challenges through isogenic iPSC-derived tumor models engineered with specific mutations (e.g., KRAS, TP53, EGFR) using CRISPR/Cas9, enabling precise assessment of variant effects.
- Utilizing human induced pluripotent stem cells (iPSCs) for predictive toxicology (e.g., CARTOX assays) and disease modeling to enhance safety assessments and clinical trial efficiency, particularly in small molecule and antibody-based therapies.
- Employing differentiated iPSC-derived healthy tissue models (e.g., cardiomyocytes, hepatocytes, neurons) to evaluate off-tumor/on-target toxicities in CAR-T therapies, mitigating risks of unintended tissue damage.
- Operational considerations, validation strategies, and practical lessons from developing scalable iPSC biobanks supporting New Approach Methodologies (NAMs) in oncology drug development.