June 20-22 2017

Boston, MA

2 weeks to go!


Day One
Wednesday 21 June 2017

Day Two
Thursday 22 June 2017

Registration, Coffee & Networking

Chair’s Opening Remarks

Keynote Panel Discussion: Investigating Future Trends in the Highly Potent Space


Highly potent compounds form a larger proportion of industry pipelines than ever before. These compounds have been utilized mainly in oncology indications, but what are the possibilities for these compounds to add value in the future and how can the field grasp these opportunities? Topics to be covered include:

  • What new technologies will revolutionize the highly potent space in the coming years?
  • What kinds of containment will novel technologies require?
  • Looking beyond ADCs in oncology – how can we analyse and effectively contain novel compounds?
  • Investigating potent proteins, small molecules and nanoparticles

Developing Effective and Scalable Processes

A Holistic View on Highly Potent Compound Development

  • Gregory Sowell Principal Scientific Manager, Small Molecule Process Chemistry, Genentech


  • Working with HPAPI in a multi-product early stage facility
  • Understanding the end-to-end process evaluation, facility design and personnel training involved in matching production and containment needs with appropriate facilities and equipment
  • Considerations of process understanding and technical development when transferring a HPAPI process to a CMO

Speed Networking & Morning Refreshments

Handling Potent Compounds Effectively in the Early Discovery Stages

  • Brad Stanard Associate Director, Occupational Toxicology and Product Stewardship, MedImmune


  • How to handle a lack of toxicological information early on in discovery
  • Understanding the mechanism of action of a novel compound and translating this into effective exposure and containment controls
  • Conducting risk assessments and characterization of early stage potent compounds

Risk-Based Design Approach to HPAPI Suite Design in a Multi-Use Contract Manufacturing Facility

  • Adam Kujath Site Director, Germantown, WI – API , Alcami


  • User Requirement Specification Development
  • Containment Strategy Risk Assessment
  • Process Hazard Analysis
  • Flexible and Expandable Design
  • Validation Strategy
  • Product Changeover

Networking Lunch

Examining the Latest Containment Technologies

Investigating Industry Best Practices: Flexible Containment Solutions for Pre-Clinical Through the Scale-Up Process


  • Define the hazard and risk during pre-clinical molecule development
  • Describe the typical processes performed in drug development
  • Review current state approaches for operator safety and control of product contamination
  • Apply Flexible Containment technology to the processes
  • Discuss scale up requirements from development to large scale production

A Hands-On Investigation of Potent Compound Handling Techniques

  • John Roosa Senior Engineering Specialist - New Technology Development, & Industrial Hygiene Lead, Merck


  • 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

Interactive Panel Discussion: Cross-Disciplinary Perspectives on the Relative Benefits of Flexible vs Fixed Containment

  • Scott Patterson VP, Commercial Sales, ILC Dover
  • John Roosa Senior Engineering Specialist - New Technology Development, & Industrial Hygiene Lead, Merck


  • 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 strategies to enable more effective and efficient cleaning

Afternoon Break & Refreshments

Investigating the Interplay between Toxicology and Regulatory Affairs

Integration Of ADEs Into The Drug Development Process


  • Understand Challenges of ADE setting and implementation of an ADE program
  • Points to consider for successful implementation of an ADE program
  • Establishing effective communications with stakeholders, both internally and externally

Panel Discussion: Understanding How to Optimize Interactions With Regulators in the Highly Potent Space

  • Patricia Weideman President & Principal, Sakari Consultants
  • Silke Weber Toxicology Project Lead, Roche
  • Jessica Graham Senior Research Investigator, Product Quality & Occupational Toxicology, Bristol-Myers Squibb


  • Understand how the regulators view this field and what you need to demonstrate
  • Defining risk and the role of the regulators in ensuring hazards are analysed appropriately
  • Learning how the European and US regulatory systems differ in relation to potent compound handling

Chair’s Closing Remarks

End of Conference Day 1