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Expedited Approval Pathways, CMC Challenges, Robert Cornog

On-Demand: How to Fast-Track Innovation While Addressing CMC Challenges in Expedited Approval Pathways

23 December 2025 Read More

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Expedited Approval Pathways, CMC Challenges, Robert Cornog
On-Demand: How to Fast-Track Innovation While Addressing CMC Challenges in Expedited Approval Pathways
23 December 2025
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First-in-Human, Dr. Andreas Reichl, Dr. Kevin Schaab
On-Demand: From First-In-Human To Proof-Of-Concept — Quicker, Smarter, Streamlined
14 October 2025
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Oral Peptides, Dr. Andy Lewis
On-Demand: CMC and Clinical Strategies for the Successful Development of Injectable and Oral Peptide Drugs
6 February 2025
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Translational Pharmaceutics, Formulation Development
On-Demand: Leveraging Real-Time Clinical Data to Deliver Certainty in Solubility Enhancement and Modified Release Development
12 December 2024
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GLP1, Oral Peptides, Dr. Andy Lewis
On-Demand: A Deep Dive Into the CMC, Technology and Financial Aspects of Successful Development of an Orally Delivered GLP-1
31 October 2024
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GLP1, Oral Peptides, Dr. Andy Lewis, Dr. Stuart Mair
On-Demand: Development of Orally Delivered GLP-1 Therapeutics …From Diabetes to Obesity and Beyond
18 July 2024
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Regulatory Affairs, CMC, Orphan Rare Diseases, Pediatrics
CMC Strategies to Manage the Risks Associated with Accelerated Submission Pathways
30 May 2024
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Preclinical, Formulation Development
Rationalizing the Preclinical-Clinical Hurdle – How to Overcome the Toxicology Exposure Challenge
26 March 2024
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Translational Pharmaceutics
How to Accelerate Drug Product Optimization Using Translational Pharmaceutics®
5 October 2023
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Drug Substance
Reach the Clinic Faster: Integrated Biopharmaceutics & Drug Substance Strategies
27 July 2023
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Translational Pharmaceutics
Strategies for Achieving Regulatory Milestones Faster Using Quotient Sciences Translational Pharmaceutics®
19 April 2023
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Bioanalysis, Michael Blackburn
Bioanalytical Strategies for Insulin Analogues & Other Large Peptides Using LC-MS
21 February 2023
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Drug Substance, Drug Product Optimization, Formulation Development
Navigating the Small Molecule CMC Pathway
19 January 2023
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Modified Release, Commercial Manufacturing, Formulation Development
Non-Clinical vs Clinical: Risks & Considerations When Developing Modified Release Dosage Forms
1 September 2022
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Translational Pharmaceutics
Getting it Right Early: The Importance of Biopharmaceutics in Early Drug Development
1 June 2022
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Translational Pharmaceutics
On-Demand Webinar: Tufts CSDD Study Assessing the Financial Benefits of Translational Pharmaceutics®
22 January 2020
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