CMC

Aisa Pharma is a privately held, clinical-stage biopharmaceutical development company dedicated to bringing new disease-modifying treatments to patients with rare serious diseases. It focuses on repurposing and optimizing select calcium channel blockers, and its lead program is developing AISA-021, an oral therapy targeting N-type calcium channels for Raynaud's phenomenon associated with systemic sclerosis (scleroderma). The company is headquartered in Boston, Massachusetts, with additional presence in Sydney, Australia.

clinical developmentclinical operationsdrug developmentregulatory affairsrepurposing and optimizing calcium channel blockers

Alchemab Therapeutics has developed a platform that identifies novel drug targets and therapeutics by analyzing patient antibody repertoires. Using well-defined patient samples, deep B cell sequencing, and computational analysis, it identifies convergent protective antibody responses among individuals resilient to specific diseases. It is building a pipeline of protective therapeutics for hard-to-treat diseases, initially focused on neurodegenerative conditions and oncology.

antibody discoveryclinical developmentcomputational analysisdeep B cell sequencingDeep Learningpre-clinical developmenttoxicology

Atavistik Bio is a clinical stage biotechnology company developing novel allosteric therapeutics. Its approach enables selective modulation of disease-causing proteins. The company is advancing multiple programs, including its lead asset ATV-1601, an oral allosteric AKT1-selective inhibitor for Hereditary Hemorrhagic Telangiectasia (HHT), and a JAK2 V617F mutant-selective inhibitor program for myeloproliferative neoplasms. It has built a versatile discovery platform that identifies functional pockets across protein classes, with an internal focus on rare

allosteric drug discoverycheminformaticsclinical developmentDMPKmedicinal chemistryregulatory affairstranslational research

Biologics Consulting is an FDA regulatory affairs and product development consulting firm founded in 1993 by former FDA officers as a fully employee-owned (ESOP) company. It provides integrated multidisciplinary regulatory strategy and operations support for biologics, pharmaceuticals, medical devices, and combination products, with 30+ years of history, 4700+ projects, and clients in 58+ countries.

biostatistics consultationclinical developmentFDA meeting preparationFDA submissionsnonclinical pharmacology/toxicologyquality systems & trainingregulatory operationsregulatory strategystaff augmentation