Workshop A Wednesday, June 19

8:00 am - 11:00 am
Strategies for Successfully Scaling-Up Highly Potent Compounds

Maintaining quality as well as safety at every scale is a major consideration when developing potent compounds. Whatever your experience in this field is, this workshop will provide you with actionable insights to improve the effectiveness of your scale-up strategy, first by analyzing the current best-practice potent compound scale-up, then diving deep into a case study detailing the scale-up of ADC payload production.

Attendees will discuss:
  • The scale-up landscape through a structured literature review
  • Approaches to balance speed, quality, cost and safety throughout scale-up
  • Case study – what to consider when scaling-up the synthesis of ADC payloads
Workshop Leader: William Goundry, Associate Principal Scientist, AstraZeneca

Workshop B Wednesday, June 19

11:30 am - 2:30 pm
Developing Effective Potent Compound Training Procedures

The most state of the art containment technologies and facilities need adequately and appropriately trained operators to ensure safety as well as effectiveness. This workshop will discuss the specific elements that make training in this field successful, as well as approaches to share and disseminate this information throughout organizations and beyond.

Attendees will discuss:

  • Ensuring operators are trained sufficiently to understand complex and new systems
  • Establishing expectations around the handling of potent compounds
  • Implementing approaches to measure the effectiveness of training to demonstrate effectiveness

Workshop Leader:  Jay BrownSenior EHSS Specialist, Alkermes

Workshop C Wednesday, June 19

3:00 pm - 6:00 pm
Outsourcing the Development and Manufacture of HPAPIs: Perspectives from the CMOs and Drug Innovators

This workshop will identify the importance of the relationship between the Drug Innovator and the Contract Manufacturing Organization (CMO). Drug innovators need the confidence that their CMOs understand the potential hazards of the drug substances they are handling in order to deliver the product on time and within spec. At the same time, CMOs need to insist that a robust assessment of the occupational and product safety concerns is documented so they can understand how these substances must be handled. This session will provide a general overview of the roles and responsibilities of the parties involved in this partnership and will identify many of the elements that a Drug Innovator should look for in a CMO (and vice versa).

Attendees will discuss:

  • Methods for evaluating the hazard of drug substances
  • How exposure potential is evaluated in the workplace
  • Communication between the Drug Innovator and CMO
  • Management’s role

Workshop Leader:  Bob Sussman, Managing Director, SafeBridge