Meeting the Needs of Early-Phase Drug Sponsors with Highly Potent Active Pharmaceutical Ingredients (HPAPIs) in the Pipeline

This webinar aims to address the specific needs of these sponsors by providing valuable insights and practical strategies. Experts will explore various aspects, including formulation considerations, safety protocols, regulatory compliance, and risk management associated with HPAPIs.

Register Free: https://www.pharmtech.com/pt_w/highly-potent

Event Overview:

The early development of highly potent active pharmaceutical ingredients (APIs) presents early-phase drug sponsors with unique and complex challenges. One of the primary hurdles in handling these APIs is their potential harm to humans and the environment, necessitating strict safety precautions throughout the development and manufacturing process. Furthermore, these APIs often exhibit poor solubility, instability, and poor bioavailability. To effectively address these issues, it is necessary to have facilities equipped with containment technologies to safeguard personnel and the environment. The formulation and manufacturing of highly potent APIs must also adhere to best practices that manage the risks associated with exposure during production while ensuring the API's efficacy and stability throughout formulation.

This webinar aims to address the specific needs of these sponsors by providing valuable insights and practical strategies. Experts will explore various aspects, including formulation considerations, safety protocols, regulatory compliance, and risk management associated with HPAPIs.

Key Learning Objectives

• Understand the unique challenges posed by HPAPI in early drug development.
• Learn about the importance of containment in protecting personnel and the environment during formulation development and manufacturing.

Gain insight into best practices for managing risks associated with handling and developing highly potent APIs.

Speaker:

Brad Gold
Head of Pharmaceutical Development
Catalent

As Head of Pharmaceutical Development at Catalent’s facility in Greenville, North Carolina, Dr. Gold is responsible for overseeing all personnel, facilities and services related to formulation development, potent and cytotoxic products, fast-track development and clinical program support through to commercialization. In addition, Dr. Gold is responsible for implementing new technology platforms that include advanced drug delivery methods. He holds a doctorate in pharmaceutics/medicinal chemistry from the University of Kentucky, from where he also earned his master’s and bachelor’s degrees in chemistry.

Register Free: https://www.pharmtech.com/pt_w/highly-potent