Critical Path Innovation Meeting (CPIM) Topics Held to Date
Critical Path Innovation Meeting Topic | Critical Path Innovation Meeting Date |
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Use of MRI of Joints as Potential Clinical Trial Endpoints in Patients with Rheumatoid Arthritis
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June 2013
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Use of Hyperpolarized Noble Gas MRI to Measure Lung Function in Patients with Cystic Fibrosis
|
July 2013
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Use of Bone Scan Assessment as a Potential Clinical Trial Endpoint or for Qualification as a Biomarker
|
July 2013
|
Use of in vitro Testing to Predict Drug Sensitization Potential
|
October 2013
|
Potential Approaches in Drug Development for Adrenomyeloneuropathy
|
December 2013
|
Issues in the Laboratory Measurement of Dystrophin
|
July 2014
|
Bile Salt Export Pump Inhibition as a Biomarker
|
May 2015
|
Use of Disease Progression Modeling for Amyotrophic Lateral Sclerosis
|
June 2015
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Use of a Database of Clinical Trial Data
|
August 2015
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Use of a Database of Genomic and Clinical Data
|
September 2015
|
Patient Reported Outcome Assessment for Primary Sclerosing Cholangitis
|
October 2015
|
Drug Development for Mitochondrial Diseases
|
October 2015
|
Use of Circulating Tumor Biomarkers
|
October 2015
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Patient Reported Outcome Assessment for early stage breast cancer
|
October 2015
|
Using Genetic Data to Advance Drug Development
|
January 2016
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A Novel Analytic Method for Pharmacokinetic Data Interpretation
|
January 2016
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A Diagnostic Tool to Advance Cancer Drug Development
|
January 2016
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Approaches to Developing Therapies for Patients with Severely Debilitating and Life Threatening Conditions
|
February 2016
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Biomarkers for Traumatic Brain Injury Clinical Trials
|
March 2016
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Use of a Placebo Response Tool in Clinical Studies | April 2016 |
Digital Pathology Software System | April 2016 |
Mucolipidosis Type IV Translational Research | May 2016 |
Natural History Studies in Primary Sclerosing Cholangitis | June 2016 |
Development of Release Active Products | July 2016 |
Multi-System Assessment of Postnatal Development Following Extremely Preterm Birth | July 2016 |
Pediatric Cholestatic Liver Disease Endpoints | July 2016 |
Disease Interception Therapy in Rheumatoid Arthritis | July 2016 |
Symptom Measurement in Hepatocellular Carcinoma | July 2016 |
Targeting Shared Molecular Etiologies Underlying Multiple Rare Diseases (SaME) | July 2016 |
Natural History Studies in Angelman Syndrome | July 2016 |
Update on the Pediatric Trials Consortium | August 2016 |
Development of a Genomic Database | September 2016 |
Disease Interception Therapy in Type 1 Diabetes | October 2016 |
Atopic Dermatitis in Pediatric Patients | October 2016 |
Disease Interception Strategy in Cataracts and Presbyopia | October 2016 |
Registry for Pediatric Inflammatory Bowel Disease | November 2016 |
C1M Assessments in Rheumatoid Arthritis | November 2016 |
Tool to Evaluate Duplicates in Clinical Trials | December 2016 |
Raman Spectroscopy to Analyze Compounded Drugs | December 2016 |
Biomarkers to Identify Drug Induced Pancreatic Injury | January 2017 |
A Tool to Assess Clinical Trial Site Performance and Data Quality | January 2017 |
The Role of Inflammation and Immune Response in Duchenne | January 2017 |
Approaches to Advance Regulatory Science Training | February 2017 |
Novel Drug Development Tools and Biomarkers to Support Tuberculosis Drug Regimen | March 2017 |
Development of Innovative Novel Excipients | March 2017 |
Use of Biomarkers to Enrich for Cardiac Events in Cardiovascular Clinical Trials | March 2017 |
Use of Virtual Reality Platform in Clinical Trials | March 2017 |
Development of a Patient Reported Outcome Instrument for Alopecia Areata | April 2017 |
Pediatric Microdosing Research Using Accelerator Mass Spectrometry (AMS) | May 2017 |
Challenges Related to Drug Development for Cerebral Cavernous Malformations (CMM) Patient Community | May 2017 |
Health Related Quality of Life Assessment in Diabetes | June 2017 |
Physical Activity Accelermetry Assessment for Analgesic Clinical Trials (PAACT) | June 2017 |
Outcome Measures for Type 1 Diabetes | July 2017 |
3D Bioprinted Human Tissue Models | August 2017 |
Outcome Measures for Type 1 Diabetes | August 2017 |
Chronic Obstructive Pulmonary Disease (COPD) Assessment Test | August 2017 |
The Use of Wearable Devices to Collect Endpoint Data in Clinical Trials | September 2017 |
Outcome Assessments in Acute Pancreatitis | October 2017 |
Bring Your Own Device PRO Assessments | October 2017 |
Adrenomyeloneuropathy (AMN) | October 2017 |
Drug Development Tools for Charcot-Marie Tooth Disease | November 2017 |
Genetic Prion Disease | November 2017 |
Clinical Assessment Tools for Alopecia Areata | December 2017 |
Disease Severity Score for Influenza and other Acute Respiratory Viruses | January 2018 |
Translational Pharmaceutics based drug development in the US | February 2018 |
Development of Prophylactic Treatments for Asthma and Other Allergic Diseases | March 2018 |
Hutchinson-Gilford Progeria Syndrome Biomarker Development | April 2018 |
Biomarkers and Clinical Outcome Assessments for Fragile X Syndrome | April 2018 |
A Patient-Centric Approach to Long-term Follow-up Studies | May 2018 |
Clinical Outcome Assessment tools for Batten Disease | July 2018 |
Clinical Research Networking Technology Platform | October 2018 |
Electronic product information in clinical trials | October 2018 |
A Patient-Centric Approach to Long-term Follow-up Studies | October 2018 |
Clinical Outcome Assessments for Prader-Willi Syndrome | November 2018 |
Definitions for clinically meaningful levels of hypoglycemia | December 2018 |
Drug development tools to aid rare disease natural history development | December 2018 |
Development of COA through personalized digital health coaching in clinical trials and drug development | February 2019 |
Voice activated PRO tools for Charcot-Marie-Tooth (CMT) Disease | February 2019 |
Personalized oligonucleotide therapies for genetic neurodegenerative diseases | May 2019 |
Digital drug development tools for Parkinson’s Disease | May 2019 |
New approaches to analgesic drug development | September 2019 |
Statistical Approaches to Biosimilar Clinical Study Design | October 2019 |
Clinical Outcomes for Chronic Obstructive Pulmonary Disease | October 2019 |
Disease Interception in Non-Small Cell Lung Cancer (NSCLC) | November 2019 |
Self-Management Self-Test (SMST) in Psychiatric Disorders | December 2019 |
Master Protocol to Promote Expanded Access in Oncology | February 2020 |
The Use of the Sequential Parallel Comparison Design in the Development of treatments for Major Depressive Disorder | February 2020 |
Clinical Outcome Assessments of for Cutaneous Lupus Erythematosus | February 2020 |
Use of Artificial Intelligence (AI) to created Synthetic Controls in Clinical Trials | March 2020 |
Clinically Meaningful Endpoints for Wound Healing Clinical Trials | June 2020 |
Advancing Development of Therapies for Spinal Muscular Atrophy | August 2020 |
Goal Attainment Scaling (GAS) | August 2020 |
Mass-Action Law Pharmacodynamics (MAL-PD) | October 2020 |
Cyclin Dependent Kinase-like 5 (CDKL5) Deficiency Disorder (CDD) Observational Study | December 2020 |
The Use of Serum Neurofilament-light (sNfl) in Progressive Multiple Sclerosis (MS) Trials | December 2020 |
Embedding Qualitative Patient Interviews in Neurofibromatosis Clinical Trials to Facilitate Drug Development | February 2021 |
Down Syndrome Associated Alzheimer’s Disease (DS-AD) | March 2021 |
Fabry Disease Structural Endpoints for Assessment of Drug Efficacy in Fabry Nephropathy clinical Trials | April 2021 |
Optimizing pain measurements in neonates to expedite analgesic drug development | June 2021 |
Obtaining Reliability and Acceptance of Novel Endpoints using Digital Health Technologies | July 2021 |
Basket Trials to Study Sleep Wake Instability across Multiple Rare Disorders | November 2021 |
Innovative Conceptual Approaches to Clinical Trial Design and Analysis for an Integrated Research Platform in Non-Alcoholic Steatohepatitis (NASH) | January 2022 |
Rare Genetic Dilated Cardiomyopathy | February 2022 |
Extracellular RNA Splice Variant Biomarkers of Myotonic Dystrophy | April 2022 |
Use of Digital Pathology in Good Laboratory Practice (GLP) Environment for Nonclinical Studies | June 2022 |
Advancing Nocturnal Scratch as a Digital Endpoint for Atopic Dermatitis | July 2022 |
Transfer RNA-Readthrough Treatment for Rare Genetic Diseases | September 2022 |