Accelerating Towards Timely & Harmonious Process Development Decision Making

7:45 am Registration & Morning Coffee

8:45 am Chair’s Opening Remarks

  • Robert Sussman Managing Director, SafeBridge Regulatory & Life Sciences Group

9:00 am Panel Discussion: Assessing the Current State of Play for Highly Potent Development and Manufacturing & Overcoming the “New Normal


  • Delving into the key challenges that arise in highly potent development and manufacturing from process design considerations to occupational health
  • Understanding where the gaps lie in effective assessment of hazard and how to combat this with effective controls 
  • Ensuring scale-up occurs in a timely manner

9:45 am Developing a Robust Commercial Manufacturing Process for a High Potency ADC Linker Payload


  • Discussing process development for the manufacture of a high potency ADC linker payload
  • Reducing high potency compound handling through minimizing isolation points
  • Applying statistical design of experimental methodology for the development of a highly robust process for the required 4-step, telescoped final stage of chemistry

10:15 am Containment for the Unknown


  • Solutions for pre-clinical process with no toxicology data
  • Effective containment development for new processes saving CapEx and accelerating success
  • Hard to contain process solved with flexible containment solutions

10:45 am
Morning Break & Speed Networking


Our speed networking is the ideal opportunity to get face-to-face time with many of the brightest minds working in gene therapy and introduce yourself to the attendees that you would like to have more in-depth conversations with. Benchmark against industry leaders and establish meaningful business relationships to pursue for the rest of the conference and beyond.

Establishing a High-Containment Robust Analytical & Purification Framework to Ensure Drug Product Quality for Patient Safety

11:45 am Developing Crystallization Processes for Highly Potent Compounds

  • Will Guy Research Associate III, Seagen


  • Revealing work-flow of solid forms screening with highly potent compounds
  • Discussing analytical sample handling of highly potent compounds
  • Showcasing the benefits and examples of crystallization as a method to purify highly potent compounds

12:15 pm Prep-HPLC Purification at Large Scale Under High Potency Conditions

  • Changxia Yuan Senior Director, API Early Phase Development, WuXi STA


  • Discussing the challenges of large scale prep-HPLC purification under highly potent conditions
  • Revealing the safety, quality and operation efficiency bottlenecks
  • Focusing on WuXi STA practices

12:45 pm Power of PAT in Data Rich Scale-up & Manufacturing of Highly Potent Drug Substances


  • The challenges of high potent drug substances manufacturing
  • Examples of PAT tools used in drug substance process development and manufacturing
  • PAT Data utilization and management

1:15 pm
Networking Lunch

Addressing Energy & Environmental Concerns with Facility Design & Cleaning

2:15 pm Quantifying the Measurement of Risk in the Cleaning of Pharmaceutical & Medical Devices to Increase Safety & CostEffectiven

  • Andrew Walsh President, Center for Pharmaceutical Cleaning Innovation


  • Unravelling ICH Q9 and the ASTM pharmaceutical and medical device cleaning standards
  • Clarifying the Cleaning Assurance Level (CAL)
  • Revealing how the Shirokizawa Matrix can guide cleaning validation

2:45 pm Revolutionizing Pharmaceutical Manufacturing: Harnessing the Power of Artificial Intelligence & In Silico Tools


  • Optimizing the drug discovery process using artificial intelligence to reduce the cost of the development of new therapeutics
  • Modelling the behavior of chemical reactions to predict the outcome of different manufacturing conditions to improve product quality and yield
  • Monitoring and controlling manufacturing and analytical processes using artificial intelligence and in silico tools to improve efficiency, product quality, and reduce batch rejection

3:00 pm ASTM E55: Clean by Design – The Specification, Design, & Test of Rapidly and Robustly CIP-Cleanable Equipment


  • Design for cleanability largely ignored, or with fuzzy specifications historically
  • Increased production efficiency and large savings in water and energy attract top management support
  • Improved safety for cleaning validation, verification, and maintenance staff in HPAPI facilities

3:30 pm Exploring Cleaning Verification/Validation Requirements While Introducing New Clinical or Commercial Products Into Multi-Product Pharmaceutical/Biopharmaceutical Manufacturing Facilities

  • Jayen Diyora Sr. Manager, Cleaning Validation, Bristol Myers Squibb


  • Uncovering the challenges of new product introduction into multiproduct facilities
  • Evaluating the new product introduction's impact on the existing cleaning validation/verification program
  • Discussing different approaches to identify and reduce risk of cross-contamination due to new product introduction with limited toxicological information

4:00 pm
Afternoon Networking Break

Examining Primary & Secondary Controls for Containment to Pre-Empt Failure & Ensure Process Safety

4:30 pm Panel Discussion: Validating Best Practices for Primary Containment Controls Depending on the Modality to Balance Quality, Practicality & Cost-Effectiveness


  • Exploring how different primary controls impact quality, practicality, and cost effectiveness
  • How can compromising these accelerate the route to market?
  • Uncovering how the modality can influence the importance of different primary controls

5:15 pm What Are Some Hidden Risks About Isolators?


  • Potential hazards linked to the handling of hazardous materials within glove boxes and isolators that pharmaceutical and fine chemical entities may overlook
  • What are the inherent risks associated with using isolators for hazardous materials, and how do they affect operator safety and product quality?
  • How to implement safety protocols that prioritize operator safety and minimize the likelihood of incidents or suboptimal product development when using glove boxes and isolators for hazardous materials?

5:45 pm Uncovering Strategic, Applied Industrial Hygiene Methods to Determine If Isolation Is Required and To What Extent

  • Akhil Buch Corporate Industrial Hygienist, Hikma Pharmaceuticals


  • Designing an industrial hygiene sampling strategy for small amounts of dense HPAPIs
  • Identifying proper statistical analyses to put resources where they are needed
  • Protecting people and product at considerable cost savings 

6:15 pm Chair’s Closing Remarks

  • Robert Sussman Managing Director, SafeBridge Regulatory & Life Sciences Group

6:30 pm Drinks Reception Hosted by Schedio & Buchiglas