FDA's Project Optimus

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Processa Pharmaceuticals’ Dr. David Young to Present at World Orphan Drug Congress USA 2025
Globenewswire· 2025-04-15 12:00
Core Insights - Processa Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company focused on developing next-generation cancer therapies with enhanced efficacy and safety [1][5] - Dr. David Young, the Founder and President of Research & Development, will present at the World Orphan Drug Congress USA 2025 [1][2] - The presentation will discuss the application of FDA's Project Optimus principles to improve drug approval processes for rare oncology and non-oncology diseases [3] Company Overview - Processa's strategy involves modifying existing FDA-approved oncology therapies to enhance their metabolism and distribution while preserving their cancer-killing mechanisms [5] - The company aims to develop more effective therapy options with improved tolerability for cancer patients through a regulatory science approach [5] Event Details - Dr. Young's presentation is scheduled for April 24, 2025, at 2:00 p.m. Eastern Time at the Boston Convention & Exhibition Center [2] - The focus of the presentation will be on optimizing dose determination to balance efficacy and safety in drug development [3]
Processa Pharmaceuticals' Dr. David Young to Present at World Orphan Drug Congress USA 2025
Newsfilter· 2025-04-15 12:00
Core Insights - Processa Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company focused on developing next-generation cancer therapies with enhanced efficacy and safety [1][5] - Dr. David Young, the Founder and President of Research & Development, will present at the World Orphan Drug Congress USA 2025, discussing FDA's Project Optimus principles [2][3] Company Overview - Processa's strategy involves modifying existing FDA-approved oncology therapies to improve their metabolism and distribution while retaining their cancer-killing mechanisms [5] - The company aims to develop more effective therapy options with better tolerability for cancer patients through an efficient regulatory path [5] Presentation Details - Dr. Young's presentation is titled "Applying Principles of FDA's Project Optimus to Oncology and Non-Oncology Rare Diseases" and is scheduled for April 24, 2025 [2][3] - The presentation will focus on optimizing drug dosing to enhance the balance of efficacy and safety for rare oncology and non-oncology diseases [3]