clinical development

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapeutics to redefine the treatment landscape for rare diseases. Its lead product candidate, Deramiocel, is an allogeneic cardiac-derived cell therapy in late-stage clinical development for Duchenne muscular dystrophy (DMD). Capricor also leverages its proprietary StealthX™ exosome platform focused on vaccinology and targeted delivery of oligonucleotides, proteins, and small-molecule therapeutics.

allogeneic cardiosphere-derived cells (CDCs)cell and exosome-based biologyexosome engineeringmanufacturingprocess and analytical development

Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) is a late-stage life sciences company focused on advancing the development of anti-inflammatory and anti-fibrotic therapies for heart disease. Its lead small-molecule drug candidate, CardiolRx™, modulates inflammasome pathway activation and is being evaluated in clinical trials for pericarditis, myocarditis, and heart failure. The company is also developing CRD-38, a novel subcutaneously administered drug formulation intended for the treatment of inflammatory heart disease.

clinical trialsdrug developmentresearch and development

CaroGen Corporation is a Yale School of Medicine spin-out based in Farmington, Connecticut, developing a functional cure for chronic hepatitis B. Its lead candidate CARG-201 is a replicating RNA immunotherapy built on the AVIDIO™ virus-like vesicle (VLV) platform, currently advancing through Phase 1/1b under IND 31717. The company holds U.S. Patent No. 12,577,585 and has received ~$11.0M in NIH and DoD grants.

drug discovery and IND-enabling studiesGMP manufacturing oversightRNA immunotherapy development

CartilaGen is developing CG-001, an investigational intra-articular injection therapy designed to address oxidative stress following ankle fractures and other traumatic skeletal injuries, with the goal of reducing the risk of Post-Traumatic Osteoarthritis (PTOA). CG-001 is administered during standard ORIF surgery and is designed to block excess reactive oxidant species (ROS) that drive cartilage degeneration. A Phase 1 trial has been completed with no adverse safety findings, and Department of Defense funding has been secured to support planning of a Ph

drug developmentintra-articular injectionPTOA prevention research

CelaCare is a young biopharmaceutical company established from Harding University's College of Pharmacy. The company is engaged in the development of a portfolio of novel antimicrobial and immunotherapeutic products for mucosal and topical therapy based on its patent-protected technology.

antimicrobial and immunotherapeutic product developmentbiopharmaceutical development

Cellphire Therapeutics is a biotechnology company developing platelet-based therapeutics to treat controllable hemorrhage. Its products include CLPH-511, a frozen activated platelet for IV use, the freeze-dried platelet-derived hemostat FPH (Thrombosomes), and Cryopreserved Platelets (CPP), with two differentiated products in Phase 2 clinical studies. Through its veterinary subsidiary BodeVet, it launched StablePlate RX Canine, a canine freeze-dried platelet product.

biologic drug developmentcell manufacturingplatelet stabilization

Cerus Corporation is dedicated solely to safeguarding the world's blood supply and aims to become the preeminent global blood products company. Headquartered in Concord, California, it develops and supplies vital technologies and pathogen-protected blood components to blood centers, hospitals, and patients. The INTERCEPT Blood System for platelets and plasma is available globally and is the only pathogen reduction system with both CE mark and FDA approval for these two blood components.

pathogen-protected blood componentspathogen reduction

CervoMed is a clinical stage biotechnology company focused on developing treatments for age-related neurologic disorders. Its lead product candidate, neflamapimod, is an investigational, orally administered, small molecule brain penetrant that inhibits the protein kinase p38 alpha, and is in clinical development for neurodegenerative diseases such as dementia with Lewy bodies, frontotemporal dementia and recovery after stroke. Until August 2023, CervoMed was known as EIP Pharma Inc., now a wholly-owned subsidiary.

commercialization of drug treatmentsdrug development

Clarametyx Biosciences is a clinical stage biopharmaceutical company committed to developing novel immune-enabling therapies for serious or difficult-to-treat respiratory diseases. Its approach targets bacterial biofilms, the driver of many progressive lung diseases, aiming to modify the course of chronic respiratory disease rather than just manage symptoms. Its investigational agent is CMTX-101, evaluated in a Phase 2a study in cystic fibrosis.

clinical trialstherapeutic development

Cogent Biosciences is a biotechnology company developing precision therapies for genetically driven diseases. It focuses on rational precision therapies leveraging validated biology to address underlying drivers of disease, with a discovery organization in Boulder, Colorado pioneering small molecule therapeutics. Its lead therapy is bezuclastinib, being developed for systemic mastocytosis and GIST.

Drug commercializationsmall molecule drug discovery

Cognito Therapeutics is developing novel therapeutics for neurodegenerative diseases, including a non-invasive neuroprotective therapy called Spectris for Alzheimer's disease. Spectris delivers audiovisual stimulation designed to evoke gamma wave activity, and received FDA Breakthrough Device Designation for treatment of cognitive and functional symptoms associated with Alzheimer's disease. The company was founded by MIT neuroscientists Ed Boyden and Li-Huei Tsai.

non-invasive audiovisual sensory stimulationtherapeutic research

Corvidane is a privately held life sciences company developing novel therapeutic approaches for cardiometabolic disease, including atherosclerosis and metabolic dysfunction associated steatohepatitis (MASH). Its lead programme, CVMB-216, is a patented orally administered, multi-pathway therapeutic that activates a spectrum of clinically validated targets spanning lipid metabolism, inflammation and fibrosis. The company advances programmes through structured preclinical development toward regulated clinical pathways and pursues two indications for FDA app

drug developmentpreclinical developmentprocess scale-uptherapeutic developmenttranslational research

Deciphera Pharmaceuticals, LLC is a commercial-stage biopharmaceutical company focused on discovering, developing and delivering breakthrough medicines to patients. Headquartered in Waltham, MA with research facilities in Lawrence, KS and an international site in Zug, Switzerland, Deciphera is a member of Ono Pharma and leads Ono's expansion in the U.S. and Europe. The company develops medicines across oncology, immunology & inflammation, and neurology.

AI-enabled drug discoverycommercial-stage manufacturing and distributionData Analyticsdrug discoverykinase-inhibitor science

DemeRx is a clinical-stage biopharmaceutical company dedicated to transforming the treatment of addiction. It is developing DMX-1001 (oral noribogaine), an investigational therapy for alcohol use disorder, which affects over 29 million people in the U.S. The company was founded on the research of Dr. Deborah Mash on the neuroplastogen noribogaine, the active metabolite of ibogaine, aiming to restore and reset the brain's addiction circuitry.

drug developmentneuroscience research

DIMERx, Inc. is a clinical-stage biopharmaceutical company developing first-in-class, covalently linked dimer-based therapeutics to address major public-health challenges in pain management and the opioid crisis. Its pipeline includes DMX-101 (buprenorphine dimer, Phase 2), DMX-201 (arginine-agmatine dimer, IND-enabling) and DMX-105 (acetaminophen dimer, IND-enabling). Development is supported by competitive NIH awards, including an $18M mandate.

covalent dimerization technology platformdrug discovery and developmentmedicinal chemistrypreclinical developmentregulatory strategy

Emmaus Life Sciences, Inc. is a biopharmaceutical company engaged in the discovery, development and commercialization of innovative treatments and therapies primarily for rare and orphan diseases such as sickle cell disease, and is extending efforts to conditions affecting larger populations such as diverticulosis.

discovery, development and commercialization of treatments and therapiespreclinical development

Epigenetix Inc. designs epigenetic drugs; its first drug, EP31670 (NEO2734), is a first-in-class oral once daily dual BRD4 and p300/CBP inhibitor in clinical trials (late stage 1) focused on myelofibrosis and other cancers. Clinical trials are ongoing at the University of Miami (Sylvester), MD Anderson Cancer Center, Mayo Clinic, Dana-Farber Cancer Institute, and the University of Washington/Fred Hutchinson Cancer Research Center.

drug discoveryepigenetic drug design

Eradivir is a clinical-stage biotechnology company founded in March 2020 by Dr. Philip S. Low and Martin Low, based in West Lafayette, Indiana. It develops small molecules using its Bispecific Antigenic immuno-Therapy (BAiT) technology that target diseased cells and viruses, flagging them for clearance by the immune system. The company is developing therapies for influenza, RSV, and other serious diseases, including EV25 for influenza.

medicinal chemistrypreclinical developmentsmall molecule drug discoveryvirology research

Eureka Therapeutics, Inc. is a clinical-stage biopharmaceutical company located in the Bay Area developing transformative technology platforms that can access cancer-specific targets and harness the evolutionary power of T cells for the treatment of solid tumors and other malignancies. Its mission is to harness the evolutionary power of the human immune system to transform the lives of patients fighting cancer.

antibody developmentCMC/manufacturinghigh throughput screeningT-cell therapy development

Feldan Therapeutics is a clinical-stage biotech company specializing in the development of treatments based on the intracellular delivery of therapeutics. It has developed the Feldan Shuttle®, a proprietary peptide-based technology enabling safe, rapid, and efficient delivery of antisense oligonucleotides (ASO) to cells, giving access to intracellular targets otherwise beyond reach. The company is conducting a Phase 1 clinical trial of FLD-103 for basal cell carcinoma and advancing FLD-201, an inhaled therapy for mucus-driven respiratory diseases, in pre

intracellular delivery of antisense oligonucleotides (ASO)peptide-based delivery technologypreclinical development

Freedom Biosciences is a biotechnology platform developing next-generation neuropsychiatric therapeutics, including ketamine-based and 5ht2a-based treatments for mental health and substance use disorders. Co-founded by Dr. John Krystal and Dina Burkitbayeva, it develops combination therapies and has a pipeline of clinical and preclinical programs including FREE-001 for treatment-resistant depression and FREE-002 for comorbid major depressive disorder and substance use disorder.

drug discovery platformregulatory strategytranslational research

Gamma Biotherapeutics is a private, clinical-stage biotechnology company discovering and developing therapeutics that help the immune system fight cancer. Its lead program M3T01, a FasL-neutralizing monoclonal antibody, is advancing through a Phase 1 first-in-human clinical trial in patients with advanced solid tumors at Providence Cancer Institute in Portland, Oregon.

clinical trialsdrug discoverymonoclonal antibody development

G&L Scientific is an Integrated Product Development and Market Access platform serving the pharmaceutical, biopharmaceutical, and biotechnology industries. Established in 1998, it provides specialist Regulatory Affairs and Quality Assurance services across 100+ global markets, spanning drug and clinical development, regulatory submissions, product approval, market access, quality and compliance, and business transformation. It offers a flexible Functional Service Provider (FSP) model and won the Queen's Award for Enterprise 2022 and King's Award for Ente

Advisory, Transformation and DesignCMC servicescommercializationFull Service OutsourcingFunctional Service Provider modelMarket Accessquality assuranceRegulatory AffairsStaff augmentation

Guosa Life Sciences is an integrated clinical development enterprise and the Network Coordinating Center of the Clinical Development Network. It helps sponsors, biotechnology companies, governments, academic institutions and global health organizations accelerate development of innovative medicines through four integrated platforms: GLS Institute, GLS Academy, the Clinical Development Network and Solutions. It operates across the US, Sub-Saharan Africa, Asia, Europe and MENA, with 35+ countries of reach and 60+ research-ready sites.

biomarker analysisbiospecimen managementCapacity developmentcold chain logisticsGCP audits and inspection readinessIMP distributionPharmacovigilanceregulatory strategy and submissionsstatistical analysis