8:20 am Chair’s Opening Remarks

8:30 am Keynote: The Value of Containment

Synopsis

  • Using the Return-on-HSE-Investment process to calculate ROI, NPV, DPP, IUC… will be presented
  • Details of the capital and ERC costs of containment equipment and installations vs the savings associated with eliminating open handling or LEV solutions will be examined
  • The resulting changes in relationships with executive leadership will be discussed

Implementing Robust, Data-Driven Containment Strategies

9:00 am A Hands-On Investigation of Potent Compound Handling Techniques

  • John Roosa Associate Director & Industrial Hygiene Lead, Merck

Synopsis

  • Understanding and mitigating against common failures of techniques
  • Examining the pitfalls of industrial handling techniques and investigating strategies to improve processes
  • Sharing best-practices to maintain safety and containment

9:30 am Safe Handling of HPAPI in Development and Scale-Up Manufacturing

Synopsis

  • Risk assessment for HPAPI handling in pre-clinical development
  • Value analysis of single use technology vs. rigid systems
  • Effectiveness of Open isolators vs. Closed isolators
  • Case study for dispensing HPAPI and OSD processes
  • Scale up Manufacturing for HPAPI dispensing

 

10:00 am INTERACTIVE PANEL DISCUSSION: Cross-Disciplinary Perspectives on Innovative Containment Strategies & Their Implementation

Synopsis

This interactive panel session will enable you to participate in a discussion around the value of a variety of containment approaches. Voice your opinion and interact with the experts on issues such as:

  • Investigating the situations in which flexible and disposable containment systems can add the most value
  • What levels of containment can be reached by flexible facilities?
  • Strategies to clean flexible containment systems – investigating innovative approaches to enable more effective and efficient cleaning

 

10:45 am Morning Refreshments & Networking

11:15 am Protecting Your People and Your Products: Aseptic Transfer of Potent Compounds

  • Chris Rombach Head of North American Sales, ChargePoint Technology

Synopsis

  • Current approaches; benefits and limitations
  • Reducing HVAC requirements through engineered transfer design
  • Retrofitting existing processes
  • VHP capabilities, implementation and management

Designing Facilities to Successfully Contain Potent Compounds

11:45 am From “One-Off” Projects to Control by Design: One Company’s HPAPI Evolution

  • Ben English EHS Program Specialist, Nektar Therapeutics

Synopsis

  • EH&S and IH assessment and control strategies for short-term/ limited scope high-potency API (HPAPI*) manufacturing in areas not specifically designed for HPAPI work
  • Designing an API pilot plant to control HPAPI materials
  • Planning for construction of a HPAPI pilot plant without disrupting other GMP manufacturing operations

*Nektar’s definition of HPAPI is to a lower limit of 30 ng/m3 for the purpose of this presentation

12:15 pm Minakem: A Fully Integrated HPAPI CDMO

Synopsis

  • 40+ years’ experience in development and manufacturing of High Potent ingredients
  • New state of the art R&D high containment lab for handling HPAPI with OEL below 0,1 mg/m3
  • GMP production from grams to hundreds kg per batch
  • Integrated supply chain for non-HP and non GMP intermediates and starting material

12:30 pm Lunch & Networking

1:30 pm Exposure Data-Driven Guidance for Laboratory Handling of Potent Compounds

  • Sarah Jones , Senior Manager, Occupational Hygiene Lead

Synopsis

  • Is current engineering guidance adequate when working with highly hazardous compounds in R&D labs?
  • Lessons learned relating to containment performance of lab equipment and employee work practices
  • Communicating good and bad news to a science based community

2:00 pm Speaker Debate: What’s the Best Approach to Potent Compound Containment?

Synopsis

This interactive session will provide an opportunity to witness a point-counterpoint debate between two experts in the field with differing opinions on the best ways to approach potent compound assessment and containment.

2:30 pm Afternoon Refreshments & Networking

Implementing Successful Outsourcing Strategies

3:00 pm Facilitating Robust and Safe Outsourcing Procedures

  • Abizer Harianawala Senior Director, Product Development and Technical Operations, TARIS Biomedical

Synopsis

  • Establishing mutually-beneficial and sustainable partnerships throughout the full life cycle of potent compound development
  • Understanding the aspects that need to be aligned both at the business and technical level
  • Evaluating the key criteria used to assess contract development and manufacturing organizations in the highly potent space

3:30 pm Presentation Details to be Confirmed

4:00 pm Chair’s Closing Remarks

4:15 pm Close of Summit