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June 19-21, 2018
The Aloft Boston Seaport, Boston

Day One
Wednesday June 20, 2018

Day Two
Thursday June 21, 2018

Chair’s Opening Remarks

Evaluating Best-Practise Containment & Navigating the High Potent Regulatory Landscape from EHS to GMP

  • Reinhold Maeck Head of Corp EHS Regulatory Intelligence, Boehringer Ingelheim


  • Ensuring compliance: GMP and worker safety considerations
  • What has changed based on the new European EMA-Guideline?
  • How to best link OEL and PDE results discussed on an isolator

Requirements for Fully-Integrated Service-Offerings in a HPAPI and Cytotoxic Environment


Drug product development based on potent compounds can be quite challenging.  Complications with the interface between operations in drug substance and drug product handling can also result in increased program complexity and cost.  In this presentation, we will discuss best practices and infrastructure requirements that facilitate accelerated timelines to clinic and market:

  • CASE STUDY: the development, rapid scaling and commercial production of HPAPI drug substance
  • Integrated  containment requirements for particle engineering and drug products

Case Study:  Containment of a High Potency Sensitizer that Sublimes – Unique Challenges & Solutions


  • Understanding the handling challenges of an API on commercial scale
  • Designing with appropriate engineering controls to mitigate risks of exposure to powder and vapor
  • Supplementing engineering controls with facility controls, PPE, and administrative controls

Identifying & Mitigating Against Risks

Morning Refreshments & Networking

HPAPI Contained Transfer Devices in a Risk-Based Era: Performance Validation Perspectives


  • Managing risks in a risk based era
  • What are the risks?
  • Lab generated data vs. real world production
  • How can equipment providers help lower risk?
  • Available solutions for reducing risk

Continuous Processing: Unique Challenges Encountered in the Construction & Use of a Continuous Processing Suite

  • Michael West Director, Environment, Health & Safety, Pfizer


  • Understanding the benefits of continuous processing in manufacturing potent compounds
  • Detailing the challenges encountered in establishing continuous processing capabilities
  • Case studies detailing risk management processes in the context of innovative manufacturing practices

Case Study: Ipsen Approach to Potent and Toxic Compound Management


  • Types of compounds being managed
  • OEB approach
  • Engineering, administrative and occupational exposure protection approaches
  • Lessons learned
  • Future approaches

Mastermind Session: Developing Effective Communication Strategies to Break Down Organizational Siloes


  • How can different disciplines interact more effectively to increase productivity and reduce risk?
  • Discuss the most pressing communication challenges encountered at various points in the development and outsourcing process
  • Leave with clear actions on how to improve future communication strategies

This session facilitates in-depth discussions between participants in an informal environment. After splitting into small groups, discuss the communication challenges you are facing and collaborate on future strategies to improve communications.

Establishing Risk-Based Decision Making & Best Practice Operator Training

Networking Lunch

Applying a Risk Based Approach for Defining Exposure Controls in the Workplace


  • The OEL and Band are not the only criteria for selecting exposure controls
  • The value proposition for applying a risk based data driven decision making for exposure controls
  • The dose makes the poison



Best Practise Potent Compound Training: Understanding the Unique Training Requirements for Operators Handling HPAPIs


Detailing specific elements that make training in this field successful

  • Establishing expectations around handling potent compounds
  • Understanding how to share knowledge most effectively within organizations and with external collaborators

Implementing Successful Outsourcing Strategies

Afternoon Refreshments & Networking

Enhancing Communication During the Outsourcing Process & Beyond

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


  • Understanding the key factors involved in maintaining an effective relationship with a CMO
  • Establishing mutually-beneficial and sustainable partnerships throughout the full life cycle of potent compound development
  • Investigating the points at which drug developers should monitor and assess CMOs


Panel Discussion: How Do You Decide on the Right CMO to Work With?


  • Evaluating the key criteria used to assess contract development and manufacturing organizations in the highly potent space
  • Understanding the questions you should be asking both at the business and technical level
  • How can both small and large organizations work more effectively with contract companies? What are the differences in approach with differently sized companies?
  • Which stakeholders and departments should be involved in the CMO assessment and selection process to ensure that it’s as robust as possible?


Chair’s Closing Remarks

Close of Summit