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  4. New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products
  5. Critical Path Innovation Meeting (CPIM) Topics Held to Date
  1. New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products

Critical Path Innovation Meeting (CPIM) Topics Held to Date

Critical Path Innovation Meeting Topic Critical Path Innovation Meeting Date
Use of MRI of Joints as Potential Clinical Trial Endpoints in Patients with Rheumatoid Arthritis
June 2013
Use of Hyperpolarized Noble Gas MRI to Measure Lung Function in Patients with Cystic Fibrosis
July 2013
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
Use of a Database of Clinical Trial Data
August 2015
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
Patient Reported Outcome Assessment for early stage breast cancer
October 2015
Using Genetic Data to Advance Drug Development
January 2016
A Novel Analytic Method for Pharmacokinetic Data Interpretation
January 2016
A Diagnostic Tool to Advance Cancer Drug Development
January 2016
Approaches to Developing Therapies for Patients with Severely Debilitating and Life Threatening Conditions
February 2016
Biomarkers for Traumatic Brain Injury Clinical Trials
March 2016
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
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