Clinical Trial Review and Consulting

The translation of an Investigational New  Drug (IND) from preclinical to clinical stage is the most crucial part in Drug Development. More than 2/3 of IND do not move from Phase 2 to Phase 3, because  predefined endpoints are not met.  This may happen even to highly effective INDs, when inclusion criteria or endpoints are not optimised for target engagement.

The lessons from oncology, where basket trials  have complemented traditional clinical trials defining disease on molecular alterations rather than tumor site have not yet broadly reached Drug Development in Neurology and Psychiatry.

Imaging Biomarker Studies using PET, MRI or combined modalities deliver quantitative measures of target presence and target engagement prior to inclusion of patients to clinical trials. If this technology is used to enrich the patient group, clinical endpoints are much more likely to be met.

Also, quantitative imaging biomarkers may serve as secondary or even primary endpoints in clinical trial design.

The clinical scientists at TraceCure have more than 25 years of experience in imaging biomarker design, application and evaluation for clinical studies, and often can offer tailor-made PET-tracers, meeting the specific principles of action of a drug candidate. Quantitative imaging endpoints often precede clinically measurable results, which may lead to significantly shortened trial protocols.

TraceCure offers comprehensive and confidential review and consulting on clinical trial design and imaging biomarker inclusion by an independent faculty of the worlds most renowned academic researchers in the field. This is the chance for industry to enrich internal decision-making with independent, high-impact, academic  peer-review.

TraceCure offers to act as single point of contact for clinical trial review and consulting, making sure that every project is reviewed by the most relevant, international academic faculty. While our own focus is on Oncology and Neurology / Psychiatry, our world-wide network of academic experts covers any clinical specialty. We have decades of experience in design, application and execution of clinical trials with established or novel PET radioligands specific to diverse biological modes of action and can advise on feasibility, costs and timelines for PET-enriched clinical trials. We also perform clinical trials and quantitative PET pharmacokinetic studies at the comprehensive clinical trial unit of the Cross Cancer Institute, University of Alberta, where 2 cyclotrons, 2 GMP-grade radiopharmacies, PET/MR and PET/CT are available within a framework of research contract agreements.

If TraceCure is involved early enough in the drug discovery and development process, preferably at the preclinical stage, we can deliver a comprehensive imaging biomarker strategy and serve as clinical trial site, offering a unique one-stop-shop value to further reduce administrative effort and financial expense for the client.

Furthermore, TraceCure is also developing, producing and delivering therapeutic radiometals and radioligands in collaboration with our academic labs and other commercial pharmaceutical companies, bringing expertise, infrastructure and scalable production capabilities to the table.