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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

07:30
Registration, Coffee & Networking

08:20
Chair’s Opening Remarks

08.30
Keynote Panel Discussion: Defining the Term – What Does ‘Highly Potent’ Actually Mean & Does it Matter?

  • Andrew Brewer Senior Principal Engineer, Global Biologics Manufacturing Science & Technology, Genentech
  • Bob Sussman Managing Director, SafeBridge
  • John Roosa Associate Director, New Technology Development & Industrial Hygiene Lead, Merck

Synopsis

There is clearly a lack of harmonization across industry in defining what constitutes a highly potent compound. This panel discussion will evaluate the factors that influence how conservatively these compounds are treated with the goal of establishing a more unified approach across industries:

• Understanding the threshold for potency – what should this be based on?
• Investigating the regulatory impact of the term ‘highly potent’
• How conservatively should these molecules be treated?
• What factors influence the approaches people take in handling these compounds?

Guaranteeing Safe & Efficient Development of Potent Compounds at Every Scale

09.15
High Potent Capabilities & Case Studies at AMRI

Synopsis

  • Identifying risk potential early in development
  • Integration of process safety studies into the highly potent space
  • Case studies involving tech transfer from highly potent development to highly potent manufacturing suites

09.45
Speed Networking

Synopsis

This session is the ideal opportunity to get face-to-face time with many of the brightest minds working with highly potent compounds. Benchmark against the industry leaders and establish meaningful business relationships to pursue for the rest of the conference and beyond.

10.45
Morning Refreshments

11.15
Highly Potent Containment & Controls in a Generics World

  • Shaun Larsen Director, Global EHS & Industrial Hygiene, Mylan

Synopsis

  • Controlling old processing equipment: Is this Possible?
  • The elephant in the room: How much containment is enough? A cost review
  • Case studies detailing successful cross-departmental collaboration to enhance potent compound development

11.45
Operation of a Fully Integrated & Versatile HPAPI Manufacturing Facility

  • Samuel Baron Associate Director, Manufacturing Science & Technology, SK biotech Ireland

Synopsis

  • Effective containment design strategy for handling HPAPIs form g to kg
  • IH monitoring philosophy
  • Purification strategy of HPAPIs

12.15
Networking Lunch

Discovering the True Potential of Innovative Containment Technologies

13.15
Flexible Containment Systems for Nanogram Level Containment

Synopsis

  • Presenting a case study for high containment of an OSD process with a Containment Performance Target of less than 30.0 nanogram/m3
  • Sharing the design concept for the process train containment, including the SMEPAC testing method and results
  • Discussing what the risks for containment to the nanogram level are and how these risks can be mitigated using best in class design and the benefit of a negative pressure system
  • Establishing the value proposition of flexible containment is including low capital cost and ongoing savings from elimination of cleaning

13.45
Investigating Task-Specific Flexible Containment Designs

Synopsis

  • Understanding that no two applications are the same
  • Pioneering a consultative design approach
  • Tailoring user training to ensure it is application-specific

14.00
A Hands-On Investigation of Potent Compound Handling Techniques

  • John Roosa Associate Director, 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

14.15
Interactive Panel Discussion: Cross-Disciplinary Perspectives on the Relative Benefits of Flexible vs Fixed Containment

  • Scott Patterson VP, Commercial Sales, ILC Dover
  • John Roosa Associate Director, 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

15.00
Afternoon Break & Refreshments

15.30
Containment, Convenience and Chemistry: Balancing HPAPI Control With the Chemistry and Efficiency Needs of a CDMO

  • Adam Kujath Global Senior Director, Manufacturing Science and Technology, Alcami

Synopsis

This presentation will discuss some practical challenges and resolutions for high containment manufacturing in the CDMO world with diverse chemistry needs and high throughput demands. In particular:

  • Specialized chemistry implementation
  • Integrated risk assessments
  • Management of change
  • Facility design

15.45
Presentation Details to be Confirmed

Biotech Showcase

Synopsis

As an increasing number innovative biotech companies become involved in the highly potent space, this section of the program is devoted to highlighting the work they are carrying out, as well as the challenges they have faced and overcome in pioneering these compounds.

Novel Compound Focus

16.00
Pentarin Miniature Drug Conjugates: Targeting Potent Payloads to Tumors

Synopsis

  • Pentarins are miniature drug conjugates synthesized by chemistry with high specificity for either cell surface or intracellular cancer targets
  • The miniature size of Pentarins drives rapid penetration deep into solid tumors where they accumulate with sustained release of potent payloads
  • Pentarins have achieved complete and durable regressions in tumor xenograft models with 2 Pentarins in clinical studies

 

Process Development Focus

16.15
Developing a Robust Occupational Toxicology Framework from Scratch in a Biotech Company Environment

Synopsis

Establishing the internal framework to band and handle compounds appropriately

  • Developing the right protocol and practises to support smooth relationships with CMOs and CROs
  • Improving communication between all stakeholders in the value chain

16.30
Panel Discussion: Lessons Learned from Innovative Organizations in the Highly Potent Space

Synopsis

  • Changing perspectives – moving from handling non-hazardous compounds to potent materials in the biotech environment
  • Handling a lack of local, internal expertise: How can a complex network of external consultants and contract companies be managed most effectively?
  • Establishing robust processes and systems for the internal communication of valuable information about a compound

 

17.00
Chair’s Closing Remarks

17.15
End of Conference Day 1