Pre-Conference Workshops

Pre-Conference Workshop Day: 22 June: 10.00 EST – 17.00 EST

Workshops are interactive sessions, making the most of our platforms capability for the audience to share their audio/video, participate in discussions, live polls and 1-2-1 breakout rooms. These sessions will be comprised of presentations, screens sharing, group discussions and problem-solving exercises.

WORKSHOP A

Integration of EHS in Product Development

9.00-11.00 EST  

New to EHS in Pharma, looking to refresh your skills and qualifications or learn how to lead a team?

This EHS bootcamp will explore how to successfully integrate environment, health and safety into your companies highly potent API process development and manufacturing.

In this workshop we will explore:

  • Challenges in how EHS should be integrated with product development for maximum business impact
  • Aligning hazard assessment classifications and understanding the toxicological criteria of a potent compound
  • Assigning banding classifications and ensuring containment equipment meets requirements and development demands
  • Combustible dust Assessments
  • Controls and administrative procedures in place to control potential exposure to hazardous APIs

Workshop Leaders:

Jay Brown

Jay Brown, Director EHS,
Mayne Pharma

WORKSHOP B

Mathematical Modelling for Estimating Exposure and Exposure Control

11.15-13.15 EST  

In this session we will introduce several models for estimating exposure and evaluating the impact of different types of exposure control options. Case studies demonstrating the application of the mathematical modeling tools for exposure modelling will be presented. As HPAPI pipelines increase in potency across pharma it is essential to be able estimate risks and health hazards early on, and often with limited data. Here we will explore an introduction into selecting appropriate exposure limits, applying predictive models and the data you need to do so. Attendees will be provided with copies of the tools.

Attendees will discuss:

• Estimating exposure and health hazards using predictive models and empirical data
• Getting quantitative answers to your exposure assessments and translating this into qualitative controls
• Sourcing and analyzing data

Workshop Leader:

Susan Arnold

Susan Arnold,
Assistant Professor Industrial Hygiene, UMN, Director,
Exposure Science and Sustainability Institute

WORKSHOP C

Outsourcing, Technology Transfer, and CMO-Client Relationships

13.30-15.30 EST  

As potent compounds continue to increase in prevalence, an ever-increasing number of drug developer companies are investing in outsourcing partners for the development and manufacture of potent compounds for clinical studies and commercial supply.

Attend this workshop to immerse yourself in interactive, hands-on sessions covering every aspect of the outsourcing journey.

Attendees will discuss:

  • The key factors involved in the CMO selection process
  • How to ensure that the key process and analytical aspects are communicated and transferred effectively to external manufacturer
  • Vendor-management approaches to create a sense of ‘co-ownership’ of programs

Workshop Leader:

Chris Sears

Chris Sears , Senior Director CMC,
Tarveda Therapeutics

 

WORKSHOP D

A Holistic View on Facility Design for HPAPI Manufacturing

15.45-17.45 EST  

Taking a more holistic view of containment and zooming out beyond individual elements, this workshop will investigate the role of facility design.

Topics to be discussed include:
• Beyond individual equipment items –how has the entire facility design integrated containment?
• Understanding the design of interfaces at which operators handle potent compounds
• Investigating how facilities will need to adapt to integrate new technologies and handle novel and increasingly potent compounds
• Contrasting the facility requirements at different stages and scales of development

Presentations include: Using System Risk Structures (SRS) Risk Management Methods to Define the Next Generation of Biopharmaceutical Manufacturing Facilities

• SRS – identifying, analyzing, and managing risks by structuring HPAPI, product quality, and operating risks
• Element of a manufacturing enterprise – process, facilities and infrastructure
• Using manufacturing the enterprise elements to controlling risks
• Agile, efficient facility design options for controlling risks

Workshop Leader:

Mark Witcher Consultant

Mark Witcher, Biopharmaceutical SME,
Exyte