Pharmaceutics / Medical Equipment

A French start-up is developing cutting-edge therapeutic molecules targeting cell death mechanisms triggered by oxygen deprivation in organs, particularly during acute myocardial infarction. Management of patients by the interventional cardiologist consists of reopening the coronary artery occluded during the heart attack. Unfortunately, instead of providing only benefits to save the patients, the sudden influx of oxygen can paradoxically activate cell death in vulnerable heart tissue. The company’s therapeutic innovation lies in inhibiting these harmful adverse effects, offering protection not only to the heart but also to other organs affected by ischemic injury, such as in stroke or organ transplantation. A proof-of-concept study has already demonstrated the efficacy of the lead molecule in treating myocardial infarction. The start-up is now seeking European partners to perform preclinical regulatory evaluation (toxicology, safety, large species), formulation of the therapeutic molecule, and clinical design. Only suppliers that are capable of contributing to the development of a blockbuster drug will be considered. High standards in quality control are also essential for subcontracting. Advantages and innovations Technical Specification or Expertise Sought Partner for the experiment on a large animal model: The partner, a service provider or a platform, should have strong expertise in ischemia-reperfusion injury in the pig model and must have experience in large animal surgery with a protocol and experimental setup similar to that of the clinic (angioplasty balloon, MRI). To do this, he must have participated in several preclinical studies for big pharma that have provided validation (publication, medicine development, patent, etc.). The protocol used for evaluating the lead molecule should mimic the procedure used in the catheter laboratory by an interventional cardiologist. Partner for regulatory pre-clinical studies: The partner, a service provider accepted by the FDA/EMA, must have expertise in the analysis of a peptide-based molecule for pharmacological and toxicity (genetic or general) studies. Partner for IND and clinical trial: The partner, a service provider accepted by the FDA/EMA, must have expertise in parallel interaction between the EMA and FDA to obtain the required authorization to perform clinical trials. Partner for drug formulation: The partner, a service provider, must have expertise in pre-formulation characterization studies, including accelerated stability (stress) studies, stability-indicating analytical method development, and other physicochemical characterizations designed to pinpoint potential product candidate stability problems and enable formulation optimization. Expected role of a partner The partner must be a service provider. It must have quality certification in its field, particularly regarding preclinical regulatory requirements: Experimentation on a large animal model: The partner should have strong expertise in ischemia-reperfusion injury in the pig model and must be experienced in large animal surgery with a protocol and experimental setup similar to that of the clinic. To do this, he must have participated in several preclinical studies for big pharma that have provided validation (publication, medicine development, patent, etc.). The protocol used for evaluating the lead molecule should mimic the procedure used in the catheterization laboratory by an interventional cardiologist. Regulatory pre-clinical studies: The partner, a service provider accepted by the FDA/EMA, must have the expertise in the analysis of a peptide-based molecule for pharmacological and toxicity (genetic or general) studies. IND (Investigational New Drug) and clinical trial: The partner, a service provider accepted by the FDA/EMA, must have expertise in parallel interaction between the EMA and FDA to obtain the required authorization to perform clinical trials. Drug formulation: The partner, acting as a service provider, must demonstrate expertise in pre-formulation characterization studies, including accelerated stability (stress) testing, the development of stability-indicating analytical methods, and various physicochemical characterizations aimed at identifying potential stability issues in the product candidate and supporting formulation optimization.