June 20-22 2017

Boston, MA

2 weeks to go!

 

Day One
Wednesday 21 June 2017

Day Two
Thursday 22 June 2017

08:00
Registration, Coffee & Networking

08:50
Chair’s Opening Remarks

09:00
Keynote Panel Discussion: Investigating Future Trends in the Highly Potent Space

Synopsis

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

09:45
A Holistic View on Highly Potent Compound Development

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

Synopsis

  • 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

10:15
Speed Networking & Morning Refreshments

11:45
Handling Potent Compounds Effectively in the Early Discovery Stages

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

Synopsis

  • 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

12:15
Risk-Based Design Approach to HPAPI Suite Design in a Multi-Use Contract Manufacturing Facility

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

Synopsis

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

12:30
Networking Lunch

Examining the Latest Containment Technologies

13:30
Investigating Industry Best Practices: Flexible Containment Solutions for Pre-Clinical Through the Scale-Up Process

Synopsis

  • 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

14:00
A Hands-On Investigation of Potent Compound Handling Techniques

  • John Roosa Senior Engineering Specialist - New Technology Development, & 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

14:30
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

Synopsis

  • 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

15:15
Afternoon Break & Refreshments

Investigating the Interplay between Toxicology and Regulatory Affairs

15:45
Integration Of ADEs Into The Drug Development Process

Synopsis

  • 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

16:15
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

Synopsis

  • 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

16:45
Chair’s Closing Remarks

17:00
End of Conference Day 1