8:00 am Check-In & Light Breakfast
8:55 am Chair’s Opening Remarks
Bridging Drug Substance & Product Development to Optimize Steps in Pharmaceutical Formulation
9:00 am The Final Touch: Balancing Stability, Efficiency & Innovation for Fast-Tracked ADC Drug Product Delivery
Synopsis
- Determining the best format for ADC delivery to ensure stability and minimize wastage in earlier stages
- Focusing on the composition and concentration of ADCs to achieve the best formulation for bringing the drug product to the clinic
- Collaborating with the drug substance team to address challenges surrounding conjugation platforms upfront for the optimal drug product
9:30 am Handling Highly Potent Drug Powders with Precision & Safety for the Optimal Drug Formulation
Synopsis
- Unveiling the specifics of highly potent drug manufacturing for both generics and novel clinical materials
- Addressing the importance of controlling occupational exposure limits during handling of potent drug powders
- Exploring the formulation step to achieve final dosage forms such as tablets and capsules while ensuring safety
10:00 am Morning Refreshments & Networking
Standardizing Our Risk Assessment to Create Safer Environments for Better Occupational Health
10:45 am Addressing Complex Challenges of Ensuring Occupational Health & Safety for Multi-Stakeholders
Synopsis
- Overcoming hurdles with facilitating occupational health and safety standards when working with high potency compounds
- Communicating occupational band criteria with CMOs/CDMOs to seek alignment with BMS’ protocols
- Exploring solutions for handling high potency compounds during early research phase to translate knowledge into later development stages
11:15 am Roundtable Discussion: Putting Safety Above All: Developing Risk Assessment Protocols to Ensure Worker Safety & Health in Their Day-to-Day Handling of High Potency Drugs
Synopsis
Our 45-minute roundtable discussion will focus on developing consistent frameworks for risk assessment in occupational exposure when handling high potency compounds, with a strong emphasis on protecting workers and maintaining health in contained environments:
- Discussing best practices for consistently assessing and classifying occupational exposure bands for high potency compounds to ensure that all teams adhere to established safety standards
- Sharing strategies for creating and maintaining controlled environments including containment systems and engineering controls to prevent exposure
- Examining ways to integrate robust health monitoring programs and compliance measures to promote long-term well-being of workers while adhering to occupational safety regulations
12:15 pm Lunch & Networking
1:15 pm Transferrable Insights & Best Practices: Safe Handling of Potent Compounds From R&D to Pilot
Synopsis
- Understanding key safety considerations when handling potent compounds during R&D scale-up
- Sharing real practices of implementing safety measures for advancing from small-scale lab work (10mg) to pilot scale (50kg)
- Engineering novel solutions to maintain a safe work environment when handling potent compounds
Integrating Green Chemistry to Transform Our Environmental Impact for Sustainable Practices
1:45 pm Tackling Uncertainty: Targeted Risk Assessment & Management for High-Quality HPAPI
Synopsis
- Building a step-by-step guide on how to create quality standards for impurity manufacturing
- Spotlighting US Pharmacopeia’s approach to handling various impurities in-house
- Leveraging our symbiotic relationship with the FDA to minimize risk based on the evolving regulatory landscape