Letter of Support (LOS)

Critical Path Institute Alpha-synuclein seeding amplification assay For the application of binary assessment of α-syn SAA as an enrichment biomarker for patient selection in clinical trials investigating therapies that are intended to treat, prevent, or delay neurodegenerative disorders characterized by a common synuclein biology. 8/19/2024: Letter of Support (PDF - 425 KB) Diane Stephenson, PhD Nordic Bioscience PRO-C3 fragment of collagen III in plasma Prognostic biomarker for enrichment of clinical trials of solid tumors 6/6/2023: Letter of Support (PDF - 391 KB) Daniel Guldager Kring Rasmussen, MSc, PhD C-Path, PSTC Molecular Biomarkers: miR-217, miR-216a, miR-216b, and miR-375  Translational safety biomarkers to detect and monitor drug-induced pancreatic injury 5/5/2023 Letter of Support (PDF - 158 KB) Refer to Predictive Safety Testing Consortium Website

Joint Head and Neck Radiotherapy-MRI Development Cooperative / MD Anderson Cancer Center

Dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) quantitative parameters, K_trans and V_e, for monitoring of mandibular injury/osteoradionecrosis
  DCE-MRI K_trans and V_e as exploratory monitoring biomarkers of osteoradionecrosis (ORN) in at risk patients with head and neck cancer (HNC) treated with radiation therapy 11/23/21: Letter of Support (PDF - 137 KB) Dr. Stephen Lai

Nordic Bioscience A/S, Bristol Myers Squibb (BMS), University of Pennsylvania (UPENN)

PRO-C6
  Heart failure with preserved ejection fraction (HFpEF)
 
  8/25/21 Letter of Support (PDF - 202 KB) Daniel Guldager Kring Rasmussen, MSc, PhD

International Progressive Multiple Sclerosis Alliance Fluid Biomarkers Implementation Team

Plasma/serum neurofilament light (NfL) chains
  Assess response to treatment in clinical trials
 
  5/25/21 Letter of Support (PDF - 241 KB) Kathryn Smith sRNAlytics, Inc. Isomicro-RNAs’ levels in blood as measured by assay As a monitoring biomarker, indicating progression of Huntington’s Disease in patients bearing the HD mutation 1/17/19: Letter of Support (PDF) David W. Saltzman  NeuroRx, Inc. Glx (Glutamine and Glutamate) in the brain as measured by Magnetic resonance spectroscopy  As a pharmacodynamic biomarker, an objective imaging biomarker measure of depression to be used in conjunction with current measures of depression (rating scales) in clinical trials. 4/3/18: Letter of Support (PDF) Johnathan C. Javitt  FLUIDDA, Inc. Functional Respiratory Imaging (FRI) of Lung and Airway Structural and Functional Parameters Measured by Low-dose High-definition Volumetric Computerized Tomography (HDCT) Scans and Quantitative Imaging Technology  Exploratory pharmacodynamic/response (PD/R) biomarkers for use in bioequivalence (BE) studies of locally-acting orally-inhaled drug products (LAOIDP) in clinical trials of patients with conditions of the lung 1/10/18: Letter of Support (PDF) Jan De Backer  TBI Endpoints Development (TED) Initiative and Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) Glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase-L1 (UCH-L1) in blood  Exploratory prognostic enrichment biomarkers to identify patients who are likely to develop persistent disability during the course of mild traumatic brain injury (TBI) clinical trials   1/10/18:Letter of Support (PDF) Dr. Geoff Manley or view TED Initiative website and/or TRACK-TBI website Health and Environmental Sciences Institute (HESI) Genomics Committee Genomic biomarker panel TGx-DDI Exploratory safety biomarker panel to facilitate safety genotoxicity assessment in nonclinical studies 10/24/17; Letter of Support (PDF) Syril Petit or view the HESI committee website TBI Endpoints Development (TED) Initiative and Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) Cortical contusions and diffuse axonal injury, as measured by magnetic resonance imaging (MRI) Exploratory prognostic enrichment biomarkers to identify patients who are likely to develop persistent disability during the course of mild traumatic brain injury (TBI) clinical trials 3/31/17: Letter of Support (PDF) Dr. Geoff Manley or view TED Initiative website and/or TRACK-TBI website Safer and Faster Evidence-based Translation (SAFE-T) Consortium and Predictive Safety Testing Consortium (PSTC) urinary alpha-glutathione S-transferase (α-GST), urinary clusterin (CLU), urinary cystatin C (CysC), urinary Kidney Injury Molecule-1 (KIM-1), urinary neutrophil gelatinase-associated lipocalin (NGAL), urinary osteopontin (OPN), urinary albumin (ALB) and urinary total protein (TPRO) Exploratory safety biomarkers for monitoring drug-induced renal tubular injury in early clinical drug development 11/23/2016: Letter of Support (PDF) Gary Steven Friedman, Stefan Sultana, Jean-Charles Gautier, John-Michael Sauer or view either the Critical Path Institute Website or the IMI SAFE-T Consortium Website Safer and Faster Evidence-based Translation (SAFE-T) Consortium and Predictive Safety Testing Consortium (PSTC) Soluble biomarkers of endothelial cell injury and inflammation: E-Selectin, P-Selectin, sICAM-1, sICAM-3, sVCAM-1, thrombomodulin VEGF, CRP, GROa, IL-6, IL-8, IP-10, I-TAC, MCP-1, MIG, SAA and MIP-1a Exploratory safety biomarkers for monitoring drug-induced vascular injury (DIVI) in early clinical drug development 11/7/2016: Letter of Support (PDF)

Michael Lawton, Tanja Zabka, Brad Enerson, John-Michael Sauer  or view either the Critical Path Institute Website or the IMI SAFE-T Consortium Website

The Safer and Faster Evidence-based Translation Consortium (SAFE-T)

Cytokeratin 18 (CK‐18), Total and Hyperacetylated High Mobility Group Protein B1 (HMGB1), Osteopontin, and Macrophage Colony-Stimulating Factor 1 Receptor (CSF1R)

Exploratory Monitoring Biomarkers for Use in Drug Development as a Clinical Safety Assessment of the Risk of Drug-induced Liver Injury (DILI) Progression

7/25/2016: Letter of Support (PDF)

Drs. Gerd Kullak-Ublick, Sif Ormarsdottir, John-Michael Sauer or Douglas Keller or view either the Critical Path Institute Website or the IMI SAFE-T Consortium Website

Mosaiques-diagnostics
GmbH

CKD273
(Urinary Peptide Panel)

Prognostic Enrichment Biomarker Panel for use in Early Stage Diabetic Kidney Disease 

6/14/2016: Letter of Support (PDF) 

Harald Mischak

FLUIDDA

Functional Respiratory Imaging (FRI) of Lung and Airway Structural and Functional Parameters Measured by Low-dose High-definition Volumetric Computerized Tomography (HDCT) Scans and Quantitative Imaging Technology

Prognostic Biomarkers of Disease Progression and Pharmacodynamic Response for use in Idiopathic Pulmonary Fibrosis (IPF)  

6/6/2016: Letter of Support (PDF) 

Jan De Backer

Xhale, Inc.

2-Butanone in Human Breath

Monitoring Biomarker to Evaluate Drug-Dosing Compliance on a Dose-by-Dose Basis

11/19/2015:Letter of Support (PDF)

Donn Dennis

Memorial Sloan-Kettering Cancer Center, Medivation Inc., and Janssen Diagnostics, LLC

Circulating Tumor Cell (CTC) Enumeration

Disease Activity Biomarker for use in Metastatic Castration-resistant Prostate Cancer (mCRPC)

9/25/2015: Letter of Support (PDF)

Debra J. Rasmussen 

C-Path, Polycystic Kidney Disease (PKD) Outcomes Consortium

MRI, Computerized Tomography (CT), or Ultrasound (US) Biomarker: Total Kidney Volume (TKV)

Exploratory Prognostic Biomarker for Enrichment in Autosomal Dominant Polycystic Kidney

4/23/2015: Letter of Support (PDF)

Refer to Polycystic Kidney Disease Outcomes Consortium Web Site

C-Path, CAMD

Molecular Neuroimaging Biomarker: Dopamine Transporter (DAT)

Exploratory Prognostic Biomarkers for Enrichment in Early Stage Parkinson's Disease Clinical Trials

3/16/2015: Letter of Support (PDF)

Refer to Coalition Against Major Diseases Web Site

C-Path, CAMD

Magnetic Resonance Imaging Biomarker: Low Baseline Hippocampal Volume

Exploratory Prognostic Biomarkers for Enrichment in Early Stage Alzheimer's Disease Clinical Trials

3/10/2015: Letter of Support (PDF)

Refer to Coalition Against Major Diseases Web Site

C-Path, Coalition Against Major Diseases Consortium (CAMD)

Cerebral Spinal Fluid (CSF) Analyte Biomarkers: Aβ_1-42, Total tau, Phosphotau

Exploratory Prognostic Biomarkers for Enrichment in Early Stage Alzheimer’s Disease Clinical Trials

2/26/2015: Letter of Support (PDF)

Refer to Coalition Against Major Diseases Web Site

C-Path, PSTC, Skeletal Muscle Working Group (SMWG)

Serum and Plasma Biomarkers: Myosin Light Chain 3 (Myl3), Skeletal Muscle Troponin I (sTNI),  Fatty Acid Binding Protein 3 (FABP3), Creatine Kinase, Muscle Type (CK-M, the Homodimer CK-MM)

Early Clinical Drug Development

1/22/2015: Letter of Support (PDF)

Refer to Predictive Safety Testing Consortium Web Site

Critical Path Institute's (C-Path) Predictive Safety Testing Consortium (PSTC), Nephrotoxicity Working Group (NWG)

Urinary Biomarkers: Osteopontin and Neutrophil Gelatinase-associated Lipocalin (NGAL)

Early Clinical Drug Development

8/20/2014: Letter of Support (PDF)

Refer to Predictive Safety Testing Consortium Web Site