June 20-22 2017

Boston, MA

2 weeks to go!


Day One
Wednesday 21 June 2017

Day Two
Thursday 22 June 2017

Chair’s Opening Remarks

Keynote: Generating Toxicological Limits & Integrating them Effectively Within Organizations


  • How limits such as OELs, PDEs and ADEs can be integrated into the business effectively
  • The engagement of diverse functions within your company
  • Effective internal and external communications

Identifying and Mitigating Against Risks

Integrating Toxicological Information Effectively Throughout Organizations


  • Investigating how limits such as PDEs and ADEs can be integrated into different aspects of the organization effectively
  • How can you communicate and engage other functions other to use this data effectively?
  • How are effective communication plans made and adhered to?

Morning Refreshments & Networking

Control Banding – The Power of Hypnosis


  • The importance of a risk-based decision making approach versus a hazard based approach
  • Enhancing API risk-management programs by applying insights based on data
  • Analysing case studies detailing effective risk-management plans

Speaker Debate: Evaluating the Use of Control Banding


This interactive panel session will enable you to participate in a discussion around the value and applicability of the current control banding methods in use in this field. Voice your opinion and interact with the experts on issues such as:

  • How relevant and useful are control bands?
  • Is it possible to standardize banding across the industry more effectively in the future?
  • Can we validate the current banding systems to ensure they are more data-driven , scientific and validated?
  • Is there an alternative to the currently implemented model?

Interactive Mastermind Session: How Can We Fix the Communication Breakdown? Developing Effective Strategies to Overcome Organizational Siloes


Clearly, significant organizational siloes exist within the HPAPI development value chain, leading to breakdowns in communication, inefficiencies and hampering the progress of the field. In this interactive session, participants will discuss the communication challenges they are facing and collaborate on future strategies to improve communication. Topics to be discussed include:

  • What is the best way to establish effective communication strategies from the beginning of the highly potent development process?
  • How can different departments and disciplines interact more effectively?
  • What is the most effective way to get the entire project team to improve communications?

Networking Lunch

Implementing Successful HPAPI Outsourcing and CMO Management Strategies

Overcoming Tech Transfer Challenges and Optimizing CMO Management


  • Assessing key factors involved in the timing of outsourcing in the highly potent space
  • Managing CMOs effectively and ensuring safety standards are maintained to levels comparable to internal processes
  • Ensuring timelines and budget restraints are met by communicating effectively with CMOs throughout the outsourcing process

Global Chemical Registrations: Testing Strategies and CMO Communication

  • Jessica Graham Senior Research Investigator, Product Quality & Occupational Toxicology, Bristol-Myers Squibb


  • Overview of International Chemical Registrations – EU REACh, Korea “REACh” and China MEP
  • Registrational testing needs and testing strategies for international registrations – Studies required, timing, CRO selection
  • Enhancing communications between CMOs and Sponsors around appropriate regulations – what we’ve learned and how to optimize future communications

Panel Discussion: How Large Pharma and Innovative Small Biotech Companies Can Effectively Manage the Outsourcing Process


  • Analysing the differing requirements of big pharma and smaller innovator companies in ensuring success throughout the outsourcing process
  • Which members of the team need to be involved in site visits during the CMO selection process?
  • Evaluating the role of analytics in assessing CMO facilities
  • Investigating best-practices for successful CMO selection
  • Examining the role of CMOs in educating drug developers regarding steps in the process that require high containment
  • Validating CMOs by examining past experience with highly potent compounds

Chair’s Closing Remarks

Close of Summit