Daniel J. Kramer

Daniel J. Kramer

Internal Medicine
711 Veterans Memorial Parkway
Suite 300
St. Charles, MO 63303

Last Updated: 09/26/2026

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Found 26 publications

2025 White Paper on Recent Issues in Bioanalysis: Redosing Patients with AAV Gene Therapy; CRS Immunogenicity Risk; Shedding Assays; NHP Studies Immunogenicity; CMC vs Bioanalytical Assays; Artificial Intelligence-Powered Genomic Pipelines for NGS (PART 3A - Recommendations on Gene, Cell, and Vaccine Therapies Immunogenicity & Technologies; Biotherapeutics & Biosimilars Immunogenicity Assessment & Clinical Relevance PART 3B - Regulatory Agencies' Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies).

2025 White Paper on Recent Issues in Bioanalysis: Redosing Patients with AAV Gene Therapy; CRS Immunogenicity Risk; Shedding Assays; NHP Studies Immunogenicity; CMC vs Bioanalytical Assays; Artificial Intelligence-Powered Genomic Pipelines for NGS (PART 3A - Recommendations on Gene, Cell, and Vaccine Therapies Immunogenicity & Technologies; Biotherapeutics & Biosimilars Immunogenicity Assessment & Clinical Relevance PART 3B - Regulatory Agencies' Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies).

Journal: Bioanalysis
Published: January 06, 2026

Anti-drug Antibody Validation Testing and Reporting Harmonization Addendum.

Anti-drug Antibody Validation Testing and Reporting Harmonization Addendum.

Journal: The AAPS journal
Published: September 12, 2025

Proceedings of the 15th European immunogenicity platform open symposium on immunogenicity of biopharmaceuticals.

Proceedings of the 15th European immunogenicity platform open symposium on immunogenicity of biopharmaceuticals.

Journal: mAbs
Published: April 04, 2025

Immunogenicity risk assessment for tailored mitigation and monitoring of biotherapeutics during development: recommendations from the European Immunogenicity Platform.

Immunogenicity risk assessment for tailored mitigation and monitoring of biotherapeutics during development: recommendations from the European Immunogenicity Platform.

Journal: Frontiers in immunology
Published: February 21, 2025

2024 White Paper on Recent Issues in Bioanalysis: Evolution of Immunogenicity Assessment beyond ADA/NAb; Regulated Genomic/NGS Assays; Hypersensitivity Reactions; Minimum Noise Reduction; False Positive Range; Modernized Vaccine Approaches; NAb/TAb Correlation (PART 3A - Recommendations on Advanced Strategies for Molecular Assays and Immunogenicity of Gene Therapy, Cell Therapy, Vaccine; Biotherapeutics Immunogenicity Assessment & Clinical Relevance PART 3B - Regulatory Agencies' Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies).

2024 White Paper on Recent Issues in Bioanalysis: Evolution of Immunogenicity Assessment beyond ADA/NAb; Regulated Genomic/NGS Assays; Hypersensitivity Reactions; Minimum Noise Reduction; False Positive Range; Modernized Vaccine Approaches; NAb/TAb Correlation (PART 3A - Recommendations on Advanced Strategies for Molecular Assays and Immunogenicity of Gene Therapy, Cell Therapy, Vaccine; Biotherapeutics Immunogenicity Assessment & Clinical Relevance PART 3B - Regulatory Agencies' Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies).

Journal: Bioanalysis
Published: January 25, 2025

CheekAge, a next-generation epigenetic buccal clock, is predictive of mortality in human blood.

CheekAge, a next-generation epigenetic buccal clock, is predictive of mortality in human blood.

Journal: Frontiers in aging
Published: July 05, 2024

Proceedings of the 14th European immunogenicity platform open symposium on immunogenicity of biopharmaceuticals.

Proceedings of the 14th European immunogenicity platform open symposium on immunogenicity of biopharmaceuticals.

Journal: mAbs
Published: March 05, 2024

Safety and Efficacy of Switching SAR341402 Insulin Aspart and Originator Insulin Aspart vs Continuous Use of Originator Insulin Aspart in Adults With Type 1 Diabetes: The GEMELLI X Trial.

Safety and Efficacy of Switching SAR341402 Insulin Aspart and Originator Insulin Aspart vs Continuous Use of Originator Insulin Aspart in Adults With Type 1 Diabetes: The GEMELLI X Trial.

Journal: Journal of diabetes science and technology
Published: February 29, 2024

Apigenin: a natural molecule at the intersection of sleep and aging.

Apigenin: a natural molecule at the intersection of sleep and aging.

Journal: Frontiers in nutrition
Published: December 20, 2023

CheekAge: a next-generation buccal epigenetic aging clock associated with lifestyle and health.

CheekAge: a next-generation buccal epigenetic aging clock associated with lifestyle and health.

Journal: GeroScience
Published: September 27, 2023

Pharmacokinetic similarity of switching SAR341402 insulin aspart biosimilar and NovoLog insulin aspart versus continuous use of NovoLog in adults with type 1 diabetes: The GEMELLI X trial.

Pharmacokinetic similarity of switching SAR341402 insulin aspart biosimilar and NovoLog insulin aspart versus continuous use of NovoLog in adults with type 1 diabetes: The GEMELLI X trial.

Journal: Diabetes, obesity & metabolism
Published: August 11, 2023

Efficacy, Safety, and Immunogenicity of Biosimilar Insulin Aspart Premix SAR341402 Mix 70/30 Compared with Originator Insulin Aspart Mix 70/30 in Adults with Diabetes (GEMELLI M): A Subgroup Analysis by Prior Type of Premix Insulin.

Efficacy, Safety, and Immunogenicity of Biosimilar Insulin Aspart Premix SAR341402 Mix 70/30 Compared with Originator Insulin Aspart Mix 70/30 in Adults with Diabetes (GEMELLI M): A Subgroup Analysis by Prior Type of Premix Insulin.

Journal: Diabetes therapy : research, treatment and education of diabetes and related disorders
Published: March 28, 2022
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Last Updated: 09/26/2026